Evelyn Pringle June 16, 2006
Merck's top management team reportedly remains unphased by Vioxx litigation woes. In fact, Prudential Equity Group analyst, Timothy Anderson, says Merck's Chief Executive, Richard Clark, specifically told him that "Vioxx does not keep him up at night."
According to Mr Anderson, "the company believes that lower court cases will be overturned on appeal, and it is even considering trying to reintroduce Vioxx."
"A reintroduction might help Merck's legal case," Mr Anderson states, "as long as the FDA or its advisers do not decide that Merck's risks really do outweigh its benefits," he said in a June 21, 2006, article in Forbes.com."
Critics say that's not even a remote possibility because the FDA is still under fire for its own part in the Vioxx disaster and it wouldn't dare pull a stunt like that.
When it comes to saving Merck in the Vioxx litigation, the FDA is at odds with some of the most powerful leaders in Congress. Senator Charles Grassley (R-Iowa), chairman of the Senate Finance Committee, is on record as saying the Vioxx debacle has shown that the FDA has gotten too cozy with drug companies to conduct proper oversight.
"The Vioxx example showed that the FDA and Merck were too close for comfort," he said in a speech. "Testimony and documents at our Finance Committee hearing showed that the FDA allowed itself to be manipulated by Merck."
Documents indeed reveal that the FDA knew about the problems with Vioxx very early on. A memo written by Shari Targum, MD, Project Manager for the Division of Anti-inflammatory Drug Products, clearly shows that as of November 18, 1999, the Data and Safety Monitoring Board of the VIGOR study, a committee independent from Merck, was concerned over the deaths from cardiovascular events in the Vioxx group, compared to the group taking another painkiller.
This memo documents a clear date of recognition by the FDA of when cardiovascular events were brought to the attention of Merck.
Admittedly, if it was up to the Bush administration, the FDA would allow Vioxx back on the market today. Bush does everything in his power to protect the profits of Big Pharma, the industry most responsible for his 8-year rent free lease of the White House.
Under Bush, the FDA has in fact become Big Pharma's chief enabler when it comes to getting away with murder. A newly released report on June 26, 2006, titled, "Prescription for Harm: The Decline in FDA Enforcement Activity," says that FDA enforcement actions have declined by 50% since Bush took office.
"The number of warning letters issued by the agency for violations of federal requirements," the report said, "has fallen by over 50%, from 1,154 in 2000 to 535 in 2005, a 15-year low."
"During the same period," it noted, "the number of seizures of mislabeled, defective, and dangerous products has declined by 44%."
Bush has never hesitated to utilize the FDA in the Big Pharma protection racket. For instance, on January 18, 2006, the FDA issued new regulations for labeling prescription drugs, supposedly aimed at providing doctors and patients with clearer information about their risks. But in the preamble to the regulations, the FDA inserted a claim that lawsuits alleging a failure to warn of known or reasonably knowable risks are preempted by federal law.
Also, amicus briefs filed by FDA attorneys appointed by Bush, on behalf of the drug companies, have tried to claim that because private lawsuits threaten to disrupt the nation's system of drug regulation, federal standards preempt requirements established by state judges and lawmakers, and that if a state court finds that a drug is unsafe, it is in direct conflict with the conclusion reached by the FDA.
With Bush using the FDA to do the dirty work, Republicans lawmakers up for reelection this fall, don't have to make a spectacle of themselves fighting for such blatant industry-friendly legislation during an election year.
A partner in the LA based Baum Hedlund law firm, attorney Karen Barth Menzies, has been litigating claims against drug companies for more than a decade and says "the Vioxx public health debacle has served to highlight deep-seeded problems within the FDA."
"Drug companies are profit-driven," she explains, "and are loath to issue warnings about risks associated with their drugs, even those that become quite clear."
"Medicine is no longer about health," Ms Menzies notes, "its about market share and profits."
Since Bush took office, the FDA has sent out its legal squad to assert the preemption argument on behalf of drug companies in attempt to defeat private citizens in lawsuits numerous times. However, Ms Menzies' team of Baum Hedlund attorneys has knocked the FDA briefs out of the ball park in a several cases, including Witczak v Pfizer and Motus v Pfizer.
But "the FDA's legal arm has continued to intervene in private civil lawsuits on the side of drug companies," she says, "arguing that FDA's decisions should not be second-guessed by anyone, the federal preemption argument."
In the past 15 plus years, Ms Menzies notes, the FDA has been worse than "comatose" as the New York Times recently described the agency. "It has sided with industry and become an adversary against consumers," she points out.
"And it is precisely for this reason," she says, "that the public is in such desperate need for an agency that advocates for them, rather than the drug industry."
In light of recent disasters like Vioxx that have resulted in large part due to a lack of regulatory oversight, Ms Menzies contends that the "FDA's decisions must be second-guessed for the safety of the public."
Medical experts agree that the FDA must be second-guessed. "With an FDA that regularly displays incompetence and negligence in its deliberations about the efficacy and safety of medications," says Dr Grace Jackson, author of, Rethinking Psychiatric Drugs: A Guide to Informed Consent, "it cannot possibly be the case that this federal agency possesses the institutional expertise to which courts or litigants should now defer."
"Indeed," she notes, "if the FDA is preempting anything, it is the sound practice of medicine, and the integrity of American health care."
It will truly be a fatal day for the concept of separation of powers when a federal agency like the FDA can wield the power to enact federal law by filing legal briefs in private lawsuits, funded by tax dollars, to defeat American citizens who are already up against one of the most profitable industries on earth.
Moreover, if FDA attorneys are going waste tax dollars, the least they can to is come up with a few valid arguments. The argument that drug companies are not allowed to warn the public by adding a new warning to a label when dangers become known because it would violate FDA regulations, is ridiculous. There is not now, and there has never been, a law that prevents a drug maker from strengthening a warning or labeling consistent with the company's specific regulatory ability to do so under 21 CFR 314.70(c)(6)(iii)(A).
The guy responsible for this silly argument is the FDA's Chief Counsel, Daniel Troy, recruited straight off of Pfizer's legal team, was Big Pharma's inside man until he quit the FDA in the fall of 2004.
Instead of going after the drug companies for killing off citizens with lethal drugs in the name of profits, he devoted much of his time filing Joe Tax Payer funded briefs, on behalf of his former industry clients, and even invited drug company attorneys to submit their cases to him for amicus brief consideration.
On March 1, 2004, Jessica Rae Dart, an attorney involved in civil litigation against Pfizer, filed an affidavit in support of a plaintiff's motion and described a lecture she attended by Mr Troy that clearly shows him offering the FDA's services to trial lawyers representing drug companies.
On December 15, 2003, Ms Dart said, Daniel Troy, Chief Counsel of the FDA, headed a discussion for pharmaceutical firms and defense attorneys titled, "The Case for Preemption" at the 8th Annual Conference for the In house Counsel and Trial Attorneys, Drug and Medical Device Litigation" in New York City.
During Troy's "Case for Preemption" talk, she said, Troy stated that he was the initiator behind all the FDA Amicus Briefs and/or Statement of Interest filed on behalf of manufacturers "since the new administration" took over. Specifically, he stated, "I am not the only one who decides," but "I am the initial proposer."
According to the affidavit, Troy made it clear that he wanted to file more amicus briefs on behalf of the drug companies and actually invited members of the defense attorney's audience to approach him with requests for briefs, stating "we can't afford to get involved in every case," we have to "pick out shots," so "make it sound like a Hollywood pitch."
However, in an obvious effort to try and level the playing field for the little guy, in 2004, Representative, Maurice Hinchey (D-NY), chastised the administration for taking the FDA in a radical new direction, "seeking to protect drug companies instead of the public," and persuaded the House to cut $500,000 from the budget of the chief counsel's office as a penalty for the FDA's aggressive opposition to citizen's lawsuits.
Although the FDA's current Chief Counsel, Sheldon Bradshaw, might not have the direct and visible financial links to Big Pharma of his predecessor, critics say, he certainly does not represent a changing-of-the-guard in political leadership at the FDA.
"In fact," Attorney Menzies says, "following in his predecessor's footsteps, Bradshaw submitted a legal brief in support of Pfizer's federal preemption arguments."
Judges across the nation have flat-out rejected the FDA's argument. A Minnesota court said it declined "to treat statements from a single FDA legal brief as declarations afforded the preemptive force of law."
A California court ordered the brief stricken from the record calling it "hearsay and irrelevant," and an Illinois judge said it "contains nothing more than legal argument by [FDA] counsel."
Most recently, in a June 6, 2005, Vioxx court hearing, the FDA's position on preemption hit a major road block with New Jersey State Court Judge, Carol Higbee, who is handling the Vioxx cases, when she labeled the FDA's Final Rule's preamble "a political statement by the FDA." She scoffed at the agency's preemption claim and said:
"It is contrary to the U.S. Supreme Court's decisions. It is contrary to all the law on preemption. ... In addition to being contrary to the law of the land, it is also contrary to the Constitution of the United States."
Judge Higbee ended her comments by throwing cold water on any planned attempt by Merck's legal team to give the preemption argument a whirl, by telling them right-out in open court: "I am not going to allow you to use it."
Speaking to the Consumer Federation of America in March 2005, Senator Grassley, basically said the FDA can't be trusted to protect citizens against dangerous drugs like Vioxx because the agency is to "cozy" with companies like Merck.
Based on a clinical trial that took place in 2000, he told the audience, both the FDA and Merck were aware that heart attacks were 5 times more likely in patients taking Vioxx than among those taking a similar drug, but the FDA did nothing to change the labeling on the drug for nearly two years, while Merck aggressively marketed Vioxx on nightly TV.
Describing whistleblowers as "patriots" who risk their careers in the interest of public safety, Senator Grassley recounted the controversy over Vioxx that was fueled in large part by the efforts of FDA scientist, Dr David Graham, to shed light on the drug's potential risks.
Senator Grassley described how the FDA "disregarded and stonewalled" concerns raised by its own scientist. "Dr. Graham completed a study that found an increased risk of heart attacks and strokes in patients taking Vioxx," he told the Federation. "His immediate supervisor, however, dismissed this study as 'scientific rumor.'"
"The very same month that Dr. Graham warned the FDA of the cardiovascular risks of Vioxx," Senator Grassley continued, "the FDA approved the use of Vioxx for children."
He told the audience how the director of FDA's office of new drugs suggested that Dr. Graham water down his Vioxx conclusions and how Dr Graham replied that in good conscience he could not. "When Dr. Graham was asked to present his findings at my committee's Vioxx hearing," the Senator said, "he was also undermined."
News reports that day show that acting FDA Commissioner Lester Crawford called Dr Graham a "maverick who did not follow agency protocols."
"This statement," Senator Grassley told the Federation, "made on the eve of the hearing, could logically serve no purpose other than to intimidate Dr. Graham."
The Vioxx matter became the focus of the Senate Finance Committee, basically because of the drug's cost to public health care programs, and the Committee is responsible for oversight of the Medicaid and Medicare programs.
During a November 18, 2004, hearing, the ranking Democrat on the finance committee, Senator Max Baucus, discussed the tax dollars wasted on Vioxx: "In the 5 years that Vioxx was on the market, Medicaid spent more than $1 billion on the drug," he said.
In addition, he complained about the fact that government programs are now paying the medical bills for patients harmed by Vioxx. "Medicaid bears the cost of any additional medical care necessary when drugs cause injury," Senator Baucus said.
Merck's last CEO, Raymond Gilmartin, resigned on May 5, 2005, the same day that another Congressional Committee, the House Committee on Government Reform, released more than 20,000 pages of documents showing how Merck continued to promote Vioxx long after it was aware of the safety problems.
Documents released that day at a Reform Committee hearing on Merck's marketing practices, described in detail how Merck directed its 3,000-strong sales force to avoid discussions about the cardiovascular risks identified in the 2000 VIGOR study. During visits with doctors, sales reps were instructed to rely on a "Cardiovascular Card" that claimed Vioxx was actually protecting the heart rather than damaging it. The sales reps were specifically trained on how to speak, smile, and position themselves most effectively when talking to doctors.
If doctors asked about Vioxx increasing the risk, the sales reps were instructed to give them a pamphlet written by Merck's marketing department that claimed Vioxx was eight times safer for heart patients than similar pain medications, and omitted Merck's findings that Vioxx produced a 5-fold increase in the risk of heart attack and stroke compared with naproxen, the other painkiller used in the study.
The company's training efforts were obviously successful because Vioxx was approved by the FDA in May 1999, and the drug reached $2 billion in sales in two years, faster than any drug in Merck's history.
In 2000, the same year the VIGOR study was completed, Vioxx was the most heavily advertised drug in the US with $160.8 million spent on mass media promotion. And the blitz paid off well. In one year, retail sales of Vioxx rose from $329.5 million in 1999, to $1.5 billion in 2000, up 360%, according to a November 2001, report by the National Institute for Health Care Management.
For the same year, Pepsi only spent $125 million advertising its products. Vioxx also beat out Budweiser's spending of $146 million, and matched Dell Computer's ad expenditures of $160 million. And by far, the drug beat out Nike's advertising budget of $78.2 million for shoes, and Campbell soup's $58 million.
The increase in Vioxx sales from 1999 to 2000 accounted for 5.7% of the one-year increase in total prescription drug spending, more than any other single drug, the report said, and Vioxx was the 13th best selling drug in 2000.
In 2003, Merck upped the anti even more and spent 499.8 million on Vioxx promotion including the cost of sales reps detailing office and hospital-based physicians, advertising in medical journals and the retail value of samples passed out to doctors, according to IMS Health, Integrated Promotional Services in April, 2004. In return Vioxx saw growth of 24% and became the 6th best selling drug.
What's that old saying about the bigger they are the harder they fall?
Nowadays, instead of spending hundreds of millions of dollars promoting Vioxx, shareholders are paying hundreds of millions a year for attorney fees. As of December 31, 2004, in its 2005 annual report, Merck said it had a reserve of $675 million solely for its future legal defense costs related to Vioxx. And in the fourth quarter of 2005, Merck said it recorded another charge of $295 million to increase the reserve.
"This reserve is based on certain assumptions," the annual report said, "and is the best estimate of the amount that the Company believes, at this time, it can reasonably estimate will be spent through 2007."
There is no money listed anywhere in Merck's financial filings set aside to pay damages to any injured party, at least through 2007. The whole wad goes for Vioxx "legal defense costs."
And to think, Republicans have the nerve to say that personal injury attorneys who go up against attorneys with a war chest of close to $700 million a year are financial gluttons.
However, thanks to a helpful group of plaintiff's attorneys, going up against Merck in jury trials is getting bit easier. The group put together what they call a pre-made Vioxx trial package, complete with a guide to pursuing a claim against the corporate giant.
The package reportedly organizes and edits all of the information that shows Merck knew about the dangers of Vioxx but failed to inform consumers and includes the most damaging documents and evidence available against the drug maker. The package is offered on a small contingency fee basis and costs nothing until the lawsuit is won.
This month, Merck's legal eagles were hit up once again when the New England Journal of Medicine issued a correction to a paper it published last year on Vioxx that mistakenly said that heart risks only became apparent after 18 months. The Journal editors deleted the 18 month statements saying a statistical error by Merck undermined the evidence for them.
All through litigation thus far, Merck's main argument has been that the risk to patients from Vioxx did not begin until after 18 months of use, and with one sweep of the pen, the NEJM blew a hole in that defense.
But then juries are not buying into the 18 month defense in any event. In the first jury trial, in August 2005, the jury held Merck liable for the death of Vioxx victim, Robert Ernst, age 59, who died after only taking Vioxx for eight months.
Internal company documents introduced at the trial showed that Merck was aware of the problems with Vioxx as early as 1997. Attorney, Mark Lanier, showed jurors documents and e-mails to prove that Merck scientists knew about the cardiovascular risks (CVs), two years before the drug was approved.
For instance, one 1997 email written by Merck scientist Dr Alise Reicin, said: "The possibility of increased C.V. events is of great concern."
"I just can't wait to be the one to present those results to senior management," he wrote.
As evidence to prove that physicians were deliberately misled, the jury was shown a 2001 Dear Doctor letter, in which Merck specifically stated that in the largest study ever of more than 4000 patients taking Vioxx, only 0.5%, or about 20 patients, had incurred CVs, when in fact, 14.6% of the patients, or 590, had cardiovascular problems, according to a Merck report submitted to the FDA.
It was also proven at trial that in April 2001, the doctor who prescribed Vioxx to Mr Ernst, had received the letter with the fraudulent statistics.
Mr Lanier played a video for the jury that showed sales reps were told that Vioxx did not increase heart attacks and were trained to view doctors concerns about CVs as "obstacles" to be avoided or dismissed. Another training document told sales reps to play "Dodgeball" if doctors raised questions about CVs.
In a more recent on-going trial, on July 5, 2006, more damaging testimony against Merck was given by Dr Lemuel Moye, a professor of biostatistics at the University of Texas, in a California case filed by a 71-year-old, Stewart Grossberg, who told the jury that Merck's clinical trials conducted as far back as 1996, showed patients taking Vioxx were at risk for heart attacks and strokes, long before the drug went on the market, and that after reviewing the trials, he concluded that Vioxx carried more risks to patients than benefits.
But legal experts say that back in April 2006, Merck received the worst news possible when it lost an appeal to deny certification of a Vioxx-related class action lawsuit. They says the court's decision to certify third-party payers, like health insurance companies, HMOs, and unions, has to be the most disturbing development for the company to date.
By ruling against Merck, the court gave the OK to apply New Jersey's consumer fraud statutes to all members of the class, even to plaintiffs from states that have different laws. Experts predict that the consequences of this ruling will be profound and far-reaching, and the costs to Merck potentially staggering.
In light of the verdict in the April 2006, trial of Cona v Merck and McDarby v Merck, in which the jury said Merck violated New Jersey's consumer fraud statute because it misled physicians about the cardiovascular risks of Vioxx and concealed information about those risks from doctors, experts say, the appeals court's ruling might just turn out to be the nail in the coffin for Merck.
Christopher Seeger, the lead lawyer in the class action filed by HMOs, insurers, and unions, says that Judge Higbee, who is overseeing about 5,000 Vioxx cases, should apply the findings of this jury to the class action, which he said could be worth $10 billion.
Mr Seeger told Bloomberg News on April 5, 2006, that this was devastating for Merck: "This jury just said 'Yes' to consumer fraud, so I think we go right to damages."
Mr Seeger is referring to collateral estoppel a situation in which the judgment in one case prevents, or estops, a party from litigating the same issue in future cases. Because of the consumer fraud verdict, Mr Seeger contends that Merck may now be permanently bound by the jury's ruling.
Indeed, Bloomberg says, a judge could decide that the ruling that Merck failed to warn of Vioxx's risks could be applied to thousands of future trials in New Jersey, leaving the jury to decide only whether Vioxx caused specific heart attacks.
Barry Turner is an academic lawyer in the UK who has taught medical ethics and for a number of years has been involved in litigation activities related to the pharmaceutical industry.
He has been advocating the use of federal and state false claims statutes against Big Pharma for years. "I take the view that because of the harsh penalties imposed when these actions are successful," he explains, "that this is the legal strategy that will work against these people."
"PI suits," he says, "may very well be morally righteous but they will never make this industry change its ways."
"What is at issue," he continues, "is that companies factor litigation costs into 'research and development' and other costs of sales, so it does not hurt them to pay out in damages, what they already budgeted for."
"The Federal and State False Claims Act actions are different," he notes, "a drug company hit by a big one of these will have to pay out colossal amounts in fines and damages, hundreds of millions in most cases," he says, "and these come out of profits."
"Then the stock will go down," he explains, "and they can be hit again under the Sarbanes Oxley Act."
"And if anyone thinks that Sarbanes Oxley is feeble legislation," he says, "they can always ask the Enron executives."
"As well as defrauding the taxpayer," Mr Turners notes, "the consequences of these deliberate and deceitful acts hurts shareholders when the litigation causes serious downturns in stock value."
"This is a violation of Sarbanes Oxley," he says, "and sooner of later there will be a major action here."
In each of the cases Merck has lost, the juries have ordered the drug giant to pay large punitive damage awards, creating additional problems for the company. Punitive damages are awarded to punish a defendant and deter future misconduct. They are not covered by insurance because the conduct is an intentional act on the part of the insured; and the intent of punitive damages would be lost if a defendant could avoid payment simply by buying more insurance.
In the state of New Jersey, punitive damages are allowed to be as much as 5 times the amount of compensatory damages. The Texas $229 million punitive damage award against Merck, even when reduced, will still be about $26 million. Legal analysts say no company could avoid financial ruin if ordered to pay tens of thousands of $26 million punitive damage awards.
Punitive damages provide a basis for a derivative lawsuit seeking damages for conduct that compromised the value of the investments of shareholders. These types of lawsuits are being filed for much less than what Merck pulled with Vioxx.
For instance, in March 2005, a class action lawsuit was filed in the US District Court for the District of Massachusetts, on behalf of shareholders in Elan Corp PLC, after the company's withdrawal of the multiple sclerosis drug Tysabri, with many of the same allegations that can be made against Merck.
The complaint alleges that Elan failed to disclose and misrepresented material adverse facts in connection with Tysabri including serious immune-system side effects and that the information was concealed in order to fast track Tysabri for FDA approval.
In any event, notwithstanding that Merck continues to contend that it will try every single case, legal analysts say, state courts will never be able to handle the trials for the lawsuits already filed, much less the additional cases still being filed on a regular basis.
"At some point courts are going to be clogged with these cases and judges will start to put pressure on Merck and the plaintiffs to settle these cases," according to John Leubsdorf, professor of law at Rutgers Law School, on CNN Moneyline on April 26, 2006.
"The only scenario in which they won't settle," he says, "is if they win so much that all the plaintiffs go away."
But experts say that is definitely not going to happen.
Showing posts with label Troy. Show all posts
Showing posts with label Troy. Show all posts
Thursday, August 5, 2010
Monday, August 2, 2010
Daniel Troy - Bush Administration's Preemption Gang - Part I
Evelyn Pringle February 2008
In the fall of 2004, Daniel Troy left the FDA armed with the preemption policy he put in place. Now a partner at Sidley Austin Brown & Wood, Mr Troy works for a firm that he told Lily Henning of the Legal Times on September 20, 2005, "represents pretty much almost every company" in the brand-name drug industry.
In fact, Sidley Austin is one of the firm's representing Eli Lilly in settlement discussions with federal prosecutors and state attorneys general involving civil and criminal investigations into Lilly's off-label sales of the schizophrenia drug Zyprexa to patients in pubic health care programs for everything from dementia to ADHD, which could result in Lilly paying more than $1 billion in the biggest health care fraud settlement in history.
The Medicaid programs are seeking to recover the cost of Zyprexa and also the cost of the life-long medical care for all the citizens who were injured by the drug, due to Lilly's concealment of its link to drastic weight gain, high blood sugar levels, diabetes and a host of other serious side effects.
It's not too difficult to imagine what kind of expertise the firm might have to offer Lilly with attorneys on board who would have worked in government offices with direct access to all government attorneys involved in all federal investigations of the industry.
In fact, the picture of what is going on here is absolutely disgusting.
When the preemption preamble was announced in January 2006, less than 2 years after he cut funding to stop the FDA from ganging up on private citizens in litigation, New York Congressman Maurice Hinchey blasted Mr Troy and the Bush administration.
"This behavior is a four-year old political maneuver that blatantly contradicts the FDA's historic position on this issue as well as the purpose for which the agency was created: to protect the American people," he said in a press release on January 18, 2006.
"If the drug industry is shielded from being held accountable," he warned, "then they lose much of the incentive to be forthcoming with potentially harmful or lethal side effects."
On March 21, 2006, Mr Troy published the paper, "State-Level Protection for Good-Faith Pharmaceutical Manufacturers," in The Journal of The Federalist Society Practice Groups and presented an earlier version at Ave Maria Law School on March 21, 2006.
In the paper, Mr Troy writes that, "in the preamble to its long-awaited Physician Labeling Rule, FDA explicitly set forth its view that FDA approval of prescription drug labeling preempts most state law tort claims based on alleged deficiencies in FDA-approved labeling."
"Nonetheless," he notes, "it is unclear whether courts hearing state tort cases will give this language an appropriate degree of deference."
"At least until an authoritative ruling requires all courts in the United States to recognize the validity of FDA's exercise of preemptive authority over drug labeling, state-by state legal reform will remain an important aspect of efforts to ensure a pharmaceutical-liability regime that serves the long-term health interests of all Americans," he states.
On October 9, 2006, Mr Troy wrote an article in Legal Times, apparently to remind defense attorneys not to forget about the weapon he put in place. "The preamble to that rule makes an official statement of FDA's views on preemption easily available to courts hearing state-law tort cases," he writes.
"There is no question that the current product-liability environment represses innovation,
limits access, increases prices, and interferes with rational prescribing decisions," he states.
Yet during a December 15, 2003, presentation of "The Case for Preemption," at the Annual Conference for In house Counsel and Trial Attorneys, Drug and Medical Device Litigation, Mr Troy said that the FDA had "no good evidence" demonstrating that product liability concerns "keep good products off the market" and said that he had "combed the literature" to find such evidence, but had come up empty.
He then told the audience that he hoped the attendees would attempt to find such evidence for him, stating: "you guys really shoot yourself in the foot by not funding research to this effect.... I'll even take anecdotal evidence and stories if you have them."
Mr Troy recently teamed up with Carter Phillips, a former Bush Administration Assistant to the Solicitor General, in filing an amicus brief in support of preemption for the giant device maker Medtronic, against a lone citizen, in the US Supreme Court on behalf of the Advanced Medical Technology Association, Defense Research Institute, Medmarc Insurance Group and Medical Device Manufacturers Association.
Mr Troy and Mr Phillips are also two of the attorneys representing Warner-Lambert, now owned by Pfizer, in Warner-Lambert Co v Kent, again pushing for preemption against a private citizen, which is set for argument in the Supreme Court on February 25, 2008.
A brief has also been filed by the Bush Administration in support of preemption for Warner-Lambert, with a list of authors that reads like a government firing squad including the Solicitor General, Acting Assistant Attorney General, Deputy Solicitor General, Assistant Solicitor General, two attorneys from the Justice Department, the Department of Health and Human Services General Counsel, Associate General Counsel, Deputy Associate General Counsel and an attorney from the HHS.
The question in Warner-Lambert v Kent involves a Michigan statute that gives drug companies immunity unless a drug maker has defrauded the FDA. Kimberly Kent and 26 other Michigan residents sued the company for injuries caused by Rezulin (Troglitazone), a diabetes drug that was withdrawn in 2000.
Pfizer moved for dismissal, arguing that under Michigan's drug shield law, the plaintiffs' claims are preempted because the FDA had not found that the company committed fraud in gaining approval of Rezulin.
In its brief, the Bush Administration claims that, "Michigan law is preempted to the extent it requires courts to determine whether a manufacturer defrauded FDA and whether FDA would have denied or withdrawn approval of a drug but for the fraud."
"Permitting lay juries to second-guess the adequacy of a manufacturer's submission to FDA, and to impose damages (including punitive damages) based on their appraisal of any fraud, would interfere with FDA's exercise of its expert judgment," it says.
Mr Troy's previous employer, Wiley, Rein, & Fielding, has also piled on with a brief in support of Pfizer on behalf of the Pharmaceutical Research and Manufacturers of America (PhRMA), urging the court to apply its Buckman ruling and claiming that to not do so, would lead to a "proliferation" of state law fraud claims that would interfere with congressional authority and "burden" the health care and judicial systems.
In a March 31, 2006, paper entitled, "State-Level Protection for Good-Faith Pharmaceutical Manufacturers," Mr Troy was encouraging state lawmakers to pass shield laws based on the Michigan model, to "help to reduce the negative consequences of the current pharmaceutical-liability regime," he said.
"In so doing," he wrote, "they would help to encourage the development of new drugs, preserve the availability of existing drugs, reduce upward pressure on drug prices, and assure rational prescribing."
In regard to the ability of private citizens to file lawsuit against drug companies under the statute, Mr Troy wrote: "Importantly, the Michigan FDA Shield Law protects only those pharmaceutical manufacturers who act in good faith."
"A drug manufacturer who misleads FDA by withholding material information remains potentially liable for marketing a defective or unreasonably dangerous product," he advised.
"In other words," he wrote, "the statute provides protection only to drug manufacturers who act in good faith in their dealings with FDA, providing all information material to the agency's decision-making process."
"Manufacturers that FDA determines did not act in good faith in their dealings with the agency receive no protection from the Michigan FDA Shield Law," he stated.
However, Mr Troy's last sentence contains the set-up that provides the ultimate protection for the industry because, in order to avoid preemption, a litigant must obtain a statement from the FDA saying that the company did not act in good faith and did not provide all information material to the agency's decision-making process, and the Bush Administration is refusing to supply any such statements.
In fact, the FDA has refused to issue the statements to help private citizens avoid preemption, even in cases like Vioxx and Rezulin, where there is extensive testimony on record in Congressional hearings by FDA scientists who reported that the companies did withhold information.
In October 1996, Dr John Gueriguian, the official charged with reviewing the application for Rezulin, recommended in a report that the drug not be approved and noted that Warner's clinical trial data showed that Rezulin users developed liver problems at 4 times the rate of patients who received a placebo, and also expressed concern about potential cardiovascular damage from the drug.
Shortly before an FDA Advisory Committee was scheduled to meet on December 11, 1996, to consider its approval, Dr Gueriguian was removed from the process because Warner was upset about his report. In addition to the heart and liver risks, the report pointed out that Rezulin was no more effective than many drugs already on the market.
Dr Thomas Fleming took over for Dr Gueriguian, and his review also noted that Warner's clinical trials had "identified significant safety issues" and "suggested unpredictable damage associated with Rezulin," but the advisory panel was not informed of his findings either.
The panel voted to recommend approval of Rezulin on December 11, 1996, and the FDA granted approval on January 29, 1997.
In the case of Vioxx, a Texas judge threw out the lawsuit of 62-year-old women who sued Merck for failure to warn about the cardiovascular risk with Vioxx after she suffered a heart attack.
The case was dismissed a few months before trial under a Texas shield law, with an exception that allows plaintiffs to show that a company had misrepresented or withheld material information from the FDA during the approval process.
However, even though the plaintiff made the requisite showing that Merck had withheld vital information from the FDA about Vioxx, the judge dismissed the case based on the Supreme Court's decision in Buckman which bars plaintiffs from asserting claims based on fraud on the FDA.
The Congressional record is full of damning testimony about the damage caused by Merck's concealment of the risks of Vioxx. During a November 18, 2004, hearing before the Finance Committee, FDA career scientist Dr David Graham discussed the studies which demonstrated that Merck and the FDA were aware of the Vioxx risks before the drug was approved.
He testified about a Merck study named 090, which found a nearly 7-fold increase in heart attack risk with low doses of Vioxx conducted before the drug was approved, and yet the labeling at the time of FDA approval said nothing about the risks.
In November 2000, he said, the VIGOR study found a 5-fold increase in heart attack risk with high-doses of Vioxx, and yet the company said Vioxx was safe.
Dr Graham presented a chart to illustrate the significance of 100,000 people being adversely affected by Vioxx. "If we look at selected cities," he told Senator Grassley, who resides in Des Moines, "67% of the citizens of Des Moines would be affected, and what's worse, the entire population of every other city in the State of Iowa."
Mr Troy's former employer, Wiley Rein & Fielding, is also representing drug giant Wyeth in an attempt to get the Supreme Court to overturn a favorable jury verdict, along with a decision by the Vermont Supreme Court affirming the verdict, for a lone women in Vermont who had to have her arm amputated after a drug was administered the wrong way when she sought treatment for a migraine headache.
The usual gang of Bush Administration attorneys has also submitted a brief telling the high court to throw this case out as well.
A person would be hard pressed to find a firm more well connected than Wiley Rein & Fielding. On July 12, 2006, the firm announced that William Consovoy, an associate in the firm, had been chosen to serve as a law clerk to Supreme Court Justice Clarence Thomas.
His hiring should be helpful in the Levine case because, according to the press release, "Mr. Consovoy will begin his clerkship with the start of either the 2007 or 2008 Supreme Court term."
David Vladeck, a professor of law at the Georgetown University Law Center, gave testimony at the "Regulatory Preemption: Are Federal Agencies Usurping Congressional and State Authority" hearing on September 12, 2007, before Senate Judiciary Committee and stated in regard to the Levine case:
"Diana Levine was a successful musician in Vermont. She and her husband performed and recorded children's music. A few years ago, she sought medical treatment at a local clinic for nausea and was injected with an antihistamine. A subsequent infection resulted in gangrene and, tragically, Diana had to have her arm amputated."
"A jury awarded her $2.4 million in economic damages and $5 million in non-economic damages for her life-altering injuries. The drug company defendant appealed. The Vermont Supreme Court upheld the verdict and judgment upon review."
"In this case, the drug company has not accepted the jury findings and decisions of the Vermont courts. Instead, it is seeking review from the United States Supreme Court because it argues that federal regulation of the drug's label should prevent even the filing of the suit for these injuries."
"This tragic case demonstrates how our civil justice system can work," the Professor told the committee. "It also reveals a practice by this Administration to usurp laws through federal regulations at the expense of consumers."
An interesting turn of events took place in Michigan on February 23, 2007, that may alter the game plan for Mr Troy and the gang. The Michigan House of Representatives passed a bill that will end the absolute immunity enjoyed by the big drug companies in Michigan and allow consumers to hold companies accountable when drugs harm or kill.
The House Democrats had been trying for nearly two years to get a vote on the bill and now its headed to the Senate.
In the fall of 2004, Daniel Troy left the FDA armed with the preemption policy he put in place. Now a partner at Sidley Austin Brown & Wood, Mr Troy works for a firm that he told Lily Henning of the Legal Times on September 20, 2005, "represents pretty much almost every company" in the brand-name drug industry.
In fact, Sidley Austin is one of the firm's representing Eli Lilly in settlement discussions with federal prosecutors and state attorneys general involving civil and criminal investigations into Lilly's off-label sales of the schizophrenia drug Zyprexa to patients in pubic health care programs for everything from dementia to ADHD, which could result in Lilly paying more than $1 billion in the biggest health care fraud settlement in history.
The Medicaid programs are seeking to recover the cost of Zyprexa and also the cost of the life-long medical care for all the citizens who were injured by the drug, due to Lilly's concealment of its link to drastic weight gain, high blood sugar levels, diabetes and a host of other serious side effects.
It's not too difficult to imagine what kind of expertise the firm might have to offer Lilly with attorneys on board who would have worked in government offices with direct access to all government attorneys involved in all federal investigations of the industry.
In fact, the picture of what is going on here is absolutely disgusting.
When the preemption preamble was announced in January 2006, less than 2 years after he cut funding to stop the FDA from ganging up on private citizens in litigation, New York Congressman Maurice Hinchey blasted Mr Troy and the Bush administration.
"This behavior is a four-year old political maneuver that blatantly contradicts the FDA's historic position on this issue as well as the purpose for which the agency was created: to protect the American people," he said in a press release on January 18, 2006.
"If the drug industry is shielded from being held accountable," he warned, "then they lose much of the incentive to be forthcoming with potentially harmful or lethal side effects."
On March 21, 2006, Mr Troy published the paper, "State-Level Protection for Good-Faith Pharmaceutical Manufacturers," in The Journal of The Federalist Society Practice Groups and presented an earlier version at Ave Maria Law School on March 21, 2006.
In the paper, Mr Troy writes that, "in the preamble to its long-awaited Physician Labeling Rule, FDA explicitly set forth its view that FDA approval of prescription drug labeling preempts most state law tort claims based on alleged deficiencies in FDA-approved labeling."
"Nonetheless," he notes, "it is unclear whether courts hearing state tort cases will give this language an appropriate degree of deference."
"At least until an authoritative ruling requires all courts in the United States to recognize the validity of FDA's exercise of preemptive authority over drug labeling, state-by state legal reform will remain an important aspect of efforts to ensure a pharmaceutical-liability regime that serves the long-term health interests of all Americans," he states.
On October 9, 2006, Mr Troy wrote an article in Legal Times, apparently to remind defense attorneys not to forget about the weapon he put in place. "The preamble to that rule makes an official statement of FDA's views on preemption easily available to courts hearing state-law tort cases," he writes.
"There is no question that the current product-liability environment represses innovation,
limits access, increases prices, and interferes with rational prescribing decisions," he states.
Yet during a December 15, 2003, presentation of "The Case for Preemption," at the Annual Conference for In house Counsel and Trial Attorneys, Drug and Medical Device Litigation, Mr Troy said that the FDA had "no good evidence" demonstrating that product liability concerns "keep good products off the market" and said that he had "combed the literature" to find such evidence, but had come up empty.
He then told the audience that he hoped the attendees would attempt to find such evidence for him, stating: "you guys really shoot yourself in the foot by not funding research to this effect.... I'll even take anecdotal evidence and stories if you have them."
Mr Troy recently teamed up with Carter Phillips, a former Bush Administration Assistant to the Solicitor General, in filing an amicus brief in support of preemption for the giant device maker Medtronic, against a lone citizen, in the US Supreme Court on behalf of the Advanced Medical Technology Association, Defense Research Institute, Medmarc Insurance Group and Medical Device Manufacturers Association.
Mr Troy and Mr Phillips are also two of the attorneys representing Warner-Lambert, now owned by Pfizer, in Warner-Lambert Co v Kent, again pushing for preemption against a private citizen, which is set for argument in the Supreme Court on February 25, 2008.
A brief has also been filed by the Bush Administration in support of preemption for Warner-Lambert, with a list of authors that reads like a government firing squad including the Solicitor General, Acting Assistant Attorney General, Deputy Solicitor General, Assistant Solicitor General, two attorneys from the Justice Department, the Department of Health and Human Services General Counsel, Associate General Counsel, Deputy Associate General Counsel and an attorney from the HHS.
The question in Warner-Lambert v Kent involves a Michigan statute that gives drug companies immunity unless a drug maker has defrauded the FDA. Kimberly Kent and 26 other Michigan residents sued the company for injuries caused by Rezulin (Troglitazone), a diabetes drug that was withdrawn in 2000.
Pfizer moved for dismissal, arguing that under Michigan's drug shield law, the plaintiffs' claims are preempted because the FDA had not found that the company committed fraud in gaining approval of Rezulin.
In its brief, the Bush Administration claims that, "Michigan law is preempted to the extent it requires courts to determine whether a manufacturer defrauded FDA and whether FDA would have denied or withdrawn approval of a drug but for the fraud."
"Permitting lay juries to second-guess the adequacy of a manufacturer's submission to FDA, and to impose damages (including punitive damages) based on their appraisal of any fraud, would interfere with FDA's exercise of its expert judgment," it says.
Mr Troy's previous employer, Wiley, Rein, & Fielding, has also piled on with a brief in support of Pfizer on behalf of the Pharmaceutical Research and Manufacturers of America (PhRMA), urging the court to apply its Buckman ruling and claiming that to not do so, would lead to a "proliferation" of state law fraud claims that would interfere with congressional authority and "burden" the health care and judicial systems.
In a March 31, 2006, paper entitled, "State-Level Protection for Good-Faith Pharmaceutical Manufacturers," Mr Troy was encouraging state lawmakers to pass shield laws based on the Michigan model, to "help to reduce the negative consequences of the current pharmaceutical-liability regime," he said.
"In so doing," he wrote, "they would help to encourage the development of new drugs, preserve the availability of existing drugs, reduce upward pressure on drug prices, and assure rational prescribing."
In regard to the ability of private citizens to file lawsuit against drug companies under the statute, Mr Troy wrote: "Importantly, the Michigan FDA Shield Law protects only those pharmaceutical manufacturers who act in good faith."
"A drug manufacturer who misleads FDA by withholding material information remains potentially liable for marketing a defective or unreasonably dangerous product," he advised.
"In other words," he wrote, "the statute provides protection only to drug manufacturers who act in good faith in their dealings with FDA, providing all information material to the agency's decision-making process."
"Manufacturers that FDA determines did not act in good faith in their dealings with the agency receive no protection from the Michigan FDA Shield Law," he stated.
However, Mr Troy's last sentence contains the set-up that provides the ultimate protection for the industry because, in order to avoid preemption, a litigant must obtain a statement from the FDA saying that the company did not act in good faith and did not provide all information material to the agency's decision-making process, and the Bush Administration is refusing to supply any such statements.
In fact, the FDA has refused to issue the statements to help private citizens avoid preemption, even in cases like Vioxx and Rezulin, where there is extensive testimony on record in Congressional hearings by FDA scientists who reported that the companies did withhold information.
In October 1996, Dr John Gueriguian, the official charged with reviewing the application for Rezulin, recommended in a report that the drug not be approved and noted that Warner's clinical trial data showed that Rezulin users developed liver problems at 4 times the rate of patients who received a placebo, and also expressed concern about potential cardiovascular damage from the drug.
Shortly before an FDA Advisory Committee was scheduled to meet on December 11, 1996, to consider its approval, Dr Gueriguian was removed from the process because Warner was upset about his report. In addition to the heart and liver risks, the report pointed out that Rezulin was no more effective than many drugs already on the market.
Dr Thomas Fleming took over for Dr Gueriguian, and his review also noted that Warner's clinical trials had "identified significant safety issues" and "suggested unpredictable damage associated with Rezulin," but the advisory panel was not informed of his findings either.
The panel voted to recommend approval of Rezulin on December 11, 1996, and the FDA granted approval on January 29, 1997.
In the case of Vioxx, a Texas judge threw out the lawsuit of 62-year-old women who sued Merck for failure to warn about the cardiovascular risk with Vioxx after she suffered a heart attack.
The case was dismissed a few months before trial under a Texas shield law, with an exception that allows plaintiffs to show that a company had misrepresented or withheld material information from the FDA during the approval process.
However, even though the plaintiff made the requisite showing that Merck had withheld vital information from the FDA about Vioxx, the judge dismissed the case based on the Supreme Court's decision in Buckman which bars plaintiffs from asserting claims based on fraud on the FDA.
The Congressional record is full of damning testimony about the damage caused by Merck's concealment of the risks of Vioxx. During a November 18, 2004, hearing before the Finance Committee, FDA career scientist Dr David Graham discussed the studies which demonstrated that Merck and the FDA were aware of the Vioxx risks before the drug was approved.
He testified about a Merck study named 090, which found a nearly 7-fold increase in heart attack risk with low doses of Vioxx conducted before the drug was approved, and yet the labeling at the time of FDA approval said nothing about the risks.
In November 2000, he said, the VIGOR study found a 5-fold increase in heart attack risk with high-doses of Vioxx, and yet the company said Vioxx was safe.
Dr Graham presented a chart to illustrate the significance of 100,000 people being adversely affected by Vioxx. "If we look at selected cities," he told Senator Grassley, who resides in Des Moines, "67% of the citizens of Des Moines would be affected, and what's worse, the entire population of every other city in the State of Iowa."
Mr Troy's former employer, Wiley Rein & Fielding, is also representing drug giant Wyeth in an attempt to get the Supreme Court to overturn a favorable jury verdict, along with a decision by the Vermont Supreme Court affirming the verdict, for a lone women in Vermont who had to have her arm amputated after a drug was administered the wrong way when she sought treatment for a migraine headache.
The usual gang of Bush Administration attorneys has also submitted a brief telling the high court to throw this case out as well.
A person would be hard pressed to find a firm more well connected than Wiley Rein & Fielding. On July 12, 2006, the firm announced that William Consovoy, an associate in the firm, had been chosen to serve as a law clerk to Supreme Court Justice Clarence Thomas.
His hiring should be helpful in the Levine case because, according to the press release, "Mr. Consovoy will begin his clerkship with the start of either the 2007 or 2008 Supreme Court term."
David Vladeck, a professor of law at the Georgetown University Law Center, gave testimony at the "Regulatory Preemption: Are Federal Agencies Usurping Congressional and State Authority" hearing on September 12, 2007, before Senate Judiciary Committee and stated in regard to the Levine case:
"Diana Levine was a successful musician in Vermont. She and her husband performed and recorded children's music. A few years ago, she sought medical treatment at a local clinic for nausea and was injected with an antihistamine. A subsequent infection resulted in gangrene and, tragically, Diana had to have her arm amputated."
"A jury awarded her $2.4 million in economic damages and $5 million in non-economic damages for her life-altering injuries. The drug company defendant appealed. The Vermont Supreme Court upheld the verdict and judgment upon review."
"In this case, the drug company has not accepted the jury findings and decisions of the Vermont courts. Instead, it is seeking review from the United States Supreme Court because it argues that federal regulation of the drug's label should prevent even the filing of the suit for these injuries."
"This tragic case demonstrates how our civil justice system can work," the Professor told the committee. "It also reveals a practice by this Administration to usurp laws through federal regulations at the expense of consumers."
An interesting turn of events took place in Michigan on February 23, 2007, that may alter the game plan for Mr Troy and the gang. The Michigan House of Representatives passed a bill that will end the absolute immunity enjoyed by the big drug companies in Michigan and allow consumers to hold companies accountable when drugs harm or kill.
The House Democrats had been trying for nearly two years to get a vote on the bill and now its headed to the Senate.
Daniel Troy - Bush Administration's Preemption Gang - Part II
Evelyn Pringle February 2008
In the fall of 2004, Daniel Troy left the FDA armed with the preemption policy he put in place. Now a partner at Sidley Austin Brown & Wood, Mr Troy works for a firm that he told Lily Henning of the Legal Times on September 20, 2005, "represents pretty much almost every company" in the brand-name drug industry.
In fact, Sidley Austin is one of the firm's representing Eli Lilly in settlement discussions with federal prosecutors and state attorneys general involving civil and criminal investigations into Lilly's off-label sales of the schizophrenia drug Zyprexa to patients in pubic health care programs for everything from dementia to ADHD, which could result in Lilly paying more than $1 billion in the biggest health care fraud settlement in history.
The Medicaid programs are seeking to recover the cost of Zyprexa and also the cost of the life-long medical care for all the citizens who were injured by the drug, due to Lilly's concealment of its link to drastic weight gain, high blood sugar levels, diabetes and a host of other serious side effects.
It's not too difficult to imagine what kind of expertise the firm might have to offer Lilly with attorneys on board who would have worked in government offices with direct access to all government attorneys involved in all federal investigations of the industry.
In fact, the picture of what is going on here is absolutely disgusting.
When the preemption preamble was announced in January 2006, less than 2 years after he cut funding to stop the FDA from ganging up on private citizens in litigation, New York Congressman Maurice Hinchey blasted Mr Troy and the Bush administration.
"This behavior is a four-year old political maneuver that blatantly contradicts the FDA's historic position on this issue as well as the purpose for which the agency was created: to protect the American people," he said in a press release on January 18, 2006.
"If the drug industry is shielded from being held accountable," he warned, "then they lose much of the incentive to be forthcoming with potentially harmful or lethal side effects."
On March 21, 2006, Mr Troy published the paper, "State-Level Protection for Good-Faith Pharmaceutical Manufacturers," in The Journal of The Federalist Society Practice Groups and presented an earlier version at Ave Maria Law School on March 21, 2006.
In the paper, Mr Troy writes that, "in the preamble to its long-awaited Physician Labeling Rule, FDA explicitly set forth its view that FDA approval of prescription drug labeling preempts most state law tort claims based on alleged deficiencies in FDA-approved labeling."
"Nonetheless," he notes, "it is unclear whether courts hearing state tort cases will give this language an appropriate degree of deference."
"At least until an authoritative ruling requires all courts in the United States to recognize the validity of FDA's exercise of preemptive authority over drug labeling, state-by state legal reform will remain an important aspect of efforts to ensure a pharmaceutical-liability regime that serves the long-term health interests of all Americans," he states.
On October 9, 2006, Mr Troy wrote an article in Legal Times, apparently to remind defense attorneys not to forget about the weapon he put in place. "The preamble to that rule makes an official statement of FDA's views on preemption easily available to courts hearing state-law tort cases," he writes.
"There is no question that the current product-liability environment represses innovation,
limits access, increases prices, and interferes with rational prescribing decisions," he states.
Yet during a December 15, 2003, presentation of "The Case for Preemption," at the Annual Conference for In house Counsel and Trial Attorneys, Drug and Medical Device Litigation, Mr Troy said that the FDA had "no good evidence" demonstrating that product liability concerns "keep good products off the market" and said that he had "combed the literature" to find such evidence, but had come up empty.
He then told the audience that he hoped the attendees would attempt to find such evidence for him, stating: "you guys really shoot yourself in the foot by not funding research to this effect.... I'll even take anecdotal evidence and stories if you have them."
Mr Troy recently teamed up with Carter Phillips, a former Bush Administration Assistant to the Solicitor General, in filing an amicus brief in support of preemption for the giant device maker Medtronic, against a lone citizen, in the US Supreme Court on behalf of the Advanced Medical Technology Association, Defense Research Institute, Medmarc Insurance Group and Medical Device Manufacturers Association.
Mr Troy and Mr Phillips are also two of the attorneys representing Warner-Lambert, now owned by Pfizer, in Warner-Lambert Co v Kent, again pushing for preemption against a private citizen, which is set for argument in the Supreme Court on February 25, 2008.
A brief has also been filed by the Bush Administration in support of preemption for Warner-Lambert, with a list of authors that reads like a government firing squad including the Solicitor General, Acting Assistant Attorney General, Deputy Solicitor General, Assistant Solicitor General, two attorneys from the Justice Department, the Department of Health and Human Services General Counsel, Associate General Counsel, Deputy Associate General Counsel and an attorney from the HHS.
The question in Warner-Lambert v Kent involves a Michigan statute that gives drug companies immunity unless a drug maker has defrauded the FDA. Kimberly Kent and 26 other Michigan residents sued the company for injuries caused by Rezulin (Troglitazone), a diabetes drug that was withdrawn in 2000.
Pfizer moved for dismissal, arguing that under Michigan's drug shield law, the plaintiffs' claims are preempted because the FDA had not found that the company committed fraud in gaining approval of Rezulin.
In its brief, the Bush Administration claims that, "Michigan law is preempted to the extent it requires courts to determine whether a manufacturer defrauded FDA and whether FDA would have denied or withdrawn approval of a drug but for the fraud."
"Permitting lay juries to second-guess the adequacy of a manufacturer's submission to FDA, and to impose damages (including punitive damages) based on their appraisal of any fraud, would interfere with FDA's exercise of its expert judgment," it says.
Mr Troy's previous employer, Wiley, Rein, & Fielding, has also piled on with a brief in support of Pfizer on behalf of the Pharmaceutical Research and Manufacturers of America (PhRMA), urging the court to apply its Buckman ruling and claiming that to not do so, would lead to a "proliferation" of state law fraud claims that would interfere with congressional authority and "burden" the health care and judicial systems.
In a March 31, 2006, paper entitled, "State-Level Protection for Good-Faith Pharmaceutical Manufacturers," Mr Troy was encouraging state lawmakers to pass shield laws based on the Michigan model, to "help to reduce the negative consequences of the current pharmaceutical-liability regime," he said.
"In so doing," he wrote, "they would help to encourage the development of new drugs, preserve the availability of existing drugs, reduce upward pressure on drug prices, and assure rational prescribing."
In regard to the ability of private citizens to file lawsuit against drug companies under the statute, Mr Troy wrote: "Importantly, the Michigan FDA Shield Law protects only those pharmaceutical manufacturers who act in good faith."
"A drug manufacturer who misleads FDA by withholding material information remains potentially liable for marketing a defective or unreasonably dangerous product," he advised.
"In other words," he wrote, "the statute provides protection only to drug manufacturers who act in good faith in their dealings with FDA, providing all information material to the agency's decision-making process."
"Manufacturers that FDA determines did not act in good faith in their dealings with the agency receive no protection from the Michigan FDA Shield Law," he stated.
However, Mr Troy's last sentence contains the set-up that provides the ultimate protection for the industry because, in order to avoid preemption, a litigant must obtain a statement from the FDA saying that the company did not act in good faith and did not provide all information material to the agency's decision-making process, and the Bush Administration is refusing to supply any such statements.
In fact, the FDA has refused to issue the statements to help private citizens avoid preemption, even in cases like Vioxx and Rezulin, where there is extensive testimony on record in Congressional hearings by FDA scientists who reported that the companies did withhold information.
In October 1996, Dr John Gueriguian, the official charged with reviewing the application for Rezulin, recommended in a report that the drug not be approved and noted that Warner's clinical trial data showed that Rezulin users developed liver problems at 4 times the rate of patients who received a placebo, and also expressed concern about potential cardiovascular damage from the drug.
Shortly before an FDA Advisory Committee was scheduled to meet on December 11, 1996, to consider its approval, Dr Gueriguian was removed from the process because Warner was upset about his report. In addition to the heart and liver risks, the report pointed out that Rezulin was no more effective than many drugs already on the market.
Dr Thomas Fleming took over for Dr Gueriguian, and his review also noted that Warner's clinical trials had "identified significant safety issues" and "suggested unpredictable damage associated with Rezulin," but the advisory panel was not informed of his findings either.
The panel voted to recommend approval of Rezulin on December 11, 1996, and the FDA granted approval on January 29, 1997.
In the case of Vioxx, a Texas judge threw out the lawsuit of 62-year-old women who sued Merck for failure to warn about the cardiovascular risk with Vioxx after she suffered a heart attack.
The case was dismissed a few months before trial under a Texas shield law, with an exception that allows plaintiffs to show that a company had misrepresented or withheld material information from the FDA during the approval process.
However, even though the plaintiff made the requisite showing that Merck had withheld vital information from the FDA about Vioxx, the judge dismissed the case based on the Supreme Court's decision in Buckman which bars plaintiffs from asserting claims based on fraud on the FDA.
The Congressional record is full of damning testimony about the damage caused by Merck's concealment of the risks of Vioxx. During a November 18, 2004, hearing before the Finance Committee, FDA career scientist Dr David Graham discussed the studies which demonstrated that Merck and the FDA were aware of the Vioxx risks before the drug was approved.
He testified about a Merck study named 090, which found a nearly 7-fold increase in heart attack risk with low doses of Vioxx conducted before the drug was approved, and yet the labeling at the time of FDA approval said nothing about the risks.
In November 2000, he said, the VIGOR study found a 5-fold increase in heart attack risk with high-doses of Vioxx, and yet the company said Vioxx was safe.
Dr Graham presented a chart to illustrate the significance of 100,000 people being adversely affected by Vioxx. "If we look at selected cities," he told Senator Grassley, who resides in Des Moines, "67% of the citizens of Des Moines would be affected, and what's worse, the entire population of every other city in the State of Iowa."
Mr Troy's former employer, Wiley Rein & Fielding, is also representing drug giant Wyeth in an attempt to get the Supreme Court to overturn a favorable jury verdict, along with a decision by the Vermont Supreme Court affirming the verdict, for a lone women in Vermont who had to have her arm amputated after a drug was administered the wrong way when she sought treatment for a migraine headache.
The usual gang of Bush Administration attorneys has also submitted a brief telling the high court to throw this case out as well.
A person would be hard pressed to find a firm more well connected than Wiley Rein & Fielding. On July 12, 2006, the firm announced that William Consovoy, an associate in the firm, had been chosen to serve as a law clerk to Supreme Court Justice Clarence Thomas.
His hiring should be helpful in the Levine case because, according to the press release, "Mr. Consovoy will begin his clerkship with the start of either the 2007 or 2008 Supreme Court term."
David Vladeck, a professor of law at the Georgetown University Law Center, gave testimony at the "Regulatory Preemption: Are Federal Agencies Usurping Congressional and State Authority" hearing on September 12, 2007, before Senate Judiciary Committee and stated in regard to the Levine case:
"Diana Levine was a successful musician in Vermont. She and her husband performed and recorded children's music. A few years ago, she sought medical treatment at a local clinic for nausea and was injected with an antihistamine. A subsequent infection resulted in gangrene and, tragically, Diana had to have her arm amputated."
"A jury awarded her $2.4 million in economic damages and $5 million in non-economic damages for her life-altering injuries. The drug company defendant appealed. The Vermont Supreme Court upheld the verdict and judgment upon review."
"In this case, the drug company has not accepted the jury findings and decisions of the Vermont courts. Instead, it is seeking review from the United States Supreme Court because it argues that federal regulation of the drug's label should prevent even the filing of the suit for these injuries."
"This tragic case demonstrates how our civil justice system can work," the Professor told the committee. "It also reveals a practice by this Administration to usurp laws through federal regulations at the expense of consumers."
An interesting turn of events took place in Michigan on February 23, 2007, that may alter the game plan for Mr Troy and the gang. The Michigan House of Representatives passed a bill that will end the absolute immunity enjoyed by the big drug companies in Michigan and allow consumers to hold companies accountable when drugs harm or kill.
The House Democrats had been trying for nearly two years to get a vote on the bill and now its headed to the Senate.
In the fall of 2004, Daniel Troy left the FDA armed with the preemption policy he put in place. Now a partner at Sidley Austin Brown & Wood, Mr Troy works for a firm that he told Lily Henning of the Legal Times on September 20, 2005, "represents pretty much almost every company" in the brand-name drug industry.
In fact, Sidley Austin is one of the firm's representing Eli Lilly in settlement discussions with federal prosecutors and state attorneys general involving civil and criminal investigations into Lilly's off-label sales of the schizophrenia drug Zyprexa to patients in pubic health care programs for everything from dementia to ADHD, which could result in Lilly paying more than $1 billion in the biggest health care fraud settlement in history.
The Medicaid programs are seeking to recover the cost of Zyprexa and also the cost of the life-long medical care for all the citizens who were injured by the drug, due to Lilly's concealment of its link to drastic weight gain, high blood sugar levels, diabetes and a host of other serious side effects.
It's not too difficult to imagine what kind of expertise the firm might have to offer Lilly with attorneys on board who would have worked in government offices with direct access to all government attorneys involved in all federal investigations of the industry.
In fact, the picture of what is going on here is absolutely disgusting.
When the preemption preamble was announced in January 2006, less than 2 years after he cut funding to stop the FDA from ganging up on private citizens in litigation, New York Congressman Maurice Hinchey blasted Mr Troy and the Bush administration.
"This behavior is a four-year old political maneuver that blatantly contradicts the FDA's historic position on this issue as well as the purpose for which the agency was created: to protect the American people," he said in a press release on January 18, 2006.
"If the drug industry is shielded from being held accountable," he warned, "then they lose much of the incentive to be forthcoming with potentially harmful or lethal side effects."
On March 21, 2006, Mr Troy published the paper, "State-Level Protection for Good-Faith Pharmaceutical Manufacturers," in The Journal of The Federalist Society Practice Groups and presented an earlier version at Ave Maria Law School on March 21, 2006.
In the paper, Mr Troy writes that, "in the preamble to its long-awaited Physician Labeling Rule, FDA explicitly set forth its view that FDA approval of prescription drug labeling preempts most state law tort claims based on alleged deficiencies in FDA-approved labeling."
"Nonetheless," he notes, "it is unclear whether courts hearing state tort cases will give this language an appropriate degree of deference."
"At least until an authoritative ruling requires all courts in the United States to recognize the validity of FDA's exercise of preemptive authority over drug labeling, state-by state legal reform will remain an important aspect of efforts to ensure a pharmaceutical-liability regime that serves the long-term health interests of all Americans," he states.
On October 9, 2006, Mr Troy wrote an article in Legal Times, apparently to remind defense attorneys not to forget about the weapon he put in place. "The preamble to that rule makes an official statement of FDA's views on preemption easily available to courts hearing state-law tort cases," he writes.
"There is no question that the current product-liability environment represses innovation,
limits access, increases prices, and interferes with rational prescribing decisions," he states.
Yet during a December 15, 2003, presentation of "The Case for Preemption," at the Annual Conference for In house Counsel and Trial Attorneys, Drug and Medical Device Litigation, Mr Troy said that the FDA had "no good evidence" demonstrating that product liability concerns "keep good products off the market" and said that he had "combed the literature" to find such evidence, but had come up empty.
He then told the audience that he hoped the attendees would attempt to find such evidence for him, stating: "you guys really shoot yourself in the foot by not funding research to this effect.... I'll even take anecdotal evidence and stories if you have them."
Mr Troy recently teamed up with Carter Phillips, a former Bush Administration Assistant to the Solicitor General, in filing an amicus brief in support of preemption for the giant device maker Medtronic, against a lone citizen, in the US Supreme Court on behalf of the Advanced Medical Technology Association, Defense Research Institute, Medmarc Insurance Group and Medical Device Manufacturers Association.
Mr Troy and Mr Phillips are also two of the attorneys representing Warner-Lambert, now owned by Pfizer, in Warner-Lambert Co v Kent, again pushing for preemption against a private citizen, which is set for argument in the Supreme Court on February 25, 2008.
A brief has also been filed by the Bush Administration in support of preemption for Warner-Lambert, with a list of authors that reads like a government firing squad including the Solicitor General, Acting Assistant Attorney General, Deputy Solicitor General, Assistant Solicitor General, two attorneys from the Justice Department, the Department of Health and Human Services General Counsel, Associate General Counsel, Deputy Associate General Counsel and an attorney from the HHS.
The question in Warner-Lambert v Kent involves a Michigan statute that gives drug companies immunity unless a drug maker has defrauded the FDA. Kimberly Kent and 26 other Michigan residents sued the company for injuries caused by Rezulin (Troglitazone), a diabetes drug that was withdrawn in 2000.
Pfizer moved for dismissal, arguing that under Michigan's drug shield law, the plaintiffs' claims are preempted because the FDA had not found that the company committed fraud in gaining approval of Rezulin.
In its brief, the Bush Administration claims that, "Michigan law is preempted to the extent it requires courts to determine whether a manufacturer defrauded FDA and whether FDA would have denied or withdrawn approval of a drug but for the fraud."
"Permitting lay juries to second-guess the adequacy of a manufacturer's submission to FDA, and to impose damages (including punitive damages) based on their appraisal of any fraud, would interfere with FDA's exercise of its expert judgment," it says.
Mr Troy's previous employer, Wiley, Rein, & Fielding, has also piled on with a brief in support of Pfizer on behalf of the Pharmaceutical Research and Manufacturers of America (PhRMA), urging the court to apply its Buckman ruling and claiming that to not do so, would lead to a "proliferation" of state law fraud claims that would interfere with congressional authority and "burden" the health care and judicial systems.
In a March 31, 2006, paper entitled, "State-Level Protection for Good-Faith Pharmaceutical Manufacturers," Mr Troy was encouraging state lawmakers to pass shield laws based on the Michigan model, to "help to reduce the negative consequences of the current pharmaceutical-liability regime," he said.
"In so doing," he wrote, "they would help to encourage the development of new drugs, preserve the availability of existing drugs, reduce upward pressure on drug prices, and assure rational prescribing."
In regard to the ability of private citizens to file lawsuit against drug companies under the statute, Mr Troy wrote: "Importantly, the Michigan FDA Shield Law protects only those pharmaceutical manufacturers who act in good faith."
"A drug manufacturer who misleads FDA by withholding material information remains potentially liable for marketing a defective or unreasonably dangerous product," he advised.
"In other words," he wrote, "the statute provides protection only to drug manufacturers who act in good faith in their dealings with FDA, providing all information material to the agency's decision-making process."
"Manufacturers that FDA determines did not act in good faith in their dealings with the agency receive no protection from the Michigan FDA Shield Law," he stated.
However, Mr Troy's last sentence contains the set-up that provides the ultimate protection for the industry because, in order to avoid preemption, a litigant must obtain a statement from the FDA saying that the company did not act in good faith and did not provide all information material to the agency's decision-making process, and the Bush Administration is refusing to supply any such statements.
In fact, the FDA has refused to issue the statements to help private citizens avoid preemption, even in cases like Vioxx and Rezulin, where there is extensive testimony on record in Congressional hearings by FDA scientists who reported that the companies did withhold information.
In October 1996, Dr John Gueriguian, the official charged with reviewing the application for Rezulin, recommended in a report that the drug not be approved and noted that Warner's clinical trial data showed that Rezulin users developed liver problems at 4 times the rate of patients who received a placebo, and also expressed concern about potential cardiovascular damage from the drug.
Shortly before an FDA Advisory Committee was scheduled to meet on December 11, 1996, to consider its approval, Dr Gueriguian was removed from the process because Warner was upset about his report. In addition to the heart and liver risks, the report pointed out that Rezulin was no more effective than many drugs already on the market.
Dr Thomas Fleming took over for Dr Gueriguian, and his review also noted that Warner's clinical trials had "identified significant safety issues" and "suggested unpredictable damage associated with Rezulin," but the advisory panel was not informed of his findings either.
The panel voted to recommend approval of Rezulin on December 11, 1996, and the FDA granted approval on January 29, 1997.
In the case of Vioxx, a Texas judge threw out the lawsuit of 62-year-old women who sued Merck for failure to warn about the cardiovascular risk with Vioxx after she suffered a heart attack.
The case was dismissed a few months before trial under a Texas shield law, with an exception that allows plaintiffs to show that a company had misrepresented or withheld material information from the FDA during the approval process.
However, even though the plaintiff made the requisite showing that Merck had withheld vital information from the FDA about Vioxx, the judge dismissed the case based on the Supreme Court's decision in Buckman which bars plaintiffs from asserting claims based on fraud on the FDA.
The Congressional record is full of damning testimony about the damage caused by Merck's concealment of the risks of Vioxx. During a November 18, 2004, hearing before the Finance Committee, FDA career scientist Dr David Graham discussed the studies which demonstrated that Merck and the FDA were aware of the Vioxx risks before the drug was approved.
He testified about a Merck study named 090, which found a nearly 7-fold increase in heart attack risk with low doses of Vioxx conducted before the drug was approved, and yet the labeling at the time of FDA approval said nothing about the risks.
In November 2000, he said, the VIGOR study found a 5-fold increase in heart attack risk with high-doses of Vioxx, and yet the company said Vioxx was safe.
Dr Graham presented a chart to illustrate the significance of 100,000 people being adversely affected by Vioxx. "If we look at selected cities," he told Senator Grassley, who resides in Des Moines, "67% of the citizens of Des Moines would be affected, and what's worse, the entire population of every other city in the State of Iowa."
Mr Troy's former employer, Wiley Rein & Fielding, is also representing drug giant Wyeth in an attempt to get the Supreme Court to overturn a favorable jury verdict, along with a decision by the Vermont Supreme Court affirming the verdict, for a lone women in Vermont who had to have her arm amputated after a drug was administered the wrong way when she sought treatment for a migraine headache.
The usual gang of Bush Administration attorneys has also submitted a brief telling the high court to throw this case out as well.
A person would be hard pressed to find a firm more well connected than Wiley Rein & Fielding. On July 12, 2006, the firm announced that William Consovoy, an associate in the firm, had been chosen to serve as a law clerk to Supreme Court Justice Clarence Thomas.
His hiring should be helpful in the Levine case because, according to the press release, "Mr. Consovoy will begin his clerkship with the start of either the 2007 or 2008 Supreme Court term."
David Vladeck, a professor of law at the Georgetown University Law Center, gave testimony at the "Regulatory Preemption: Are Federal Agencies Usurping Congressional and State Authority" hearing on September 12, 2007, before Senate Judiciary Committee and stated in regard to the Levine case:
"Diana Levine was a successful musician in Vermont. She and her husband performed and recorded children's music. A few years ago, she sought medical treatment at a local clinic for nausea and was injected with an antihistamine. A subsequent infection resulted in gangrene and, tragically, Diana had to have her arm amputated."
"A jury awarded her $2.4 million in economic damages and $5 million in non-economic damages for her life-altering injuries. The drug company defendant appealed. The Vermont Supreme Court upheld the verdict and judgment upon review."
"In this case, the drug company has not accepted the jury findings and decisions of the Vermont courts. Instead, it is seeking review from the United States Supreme Court because it argues that federal regulation of the drug's label should prevent even the filing of the suit for these injuries."
"This tragic case demonstrates how our civil justice system can work," the Professor told the committee. "It also reveals a practice by this Administration to usurp laws through federal regulations at the expense of consumers."
An interesting turn of events took place in Michigan on February 23, 2007, that may alter the game plan for Mr Troy and the gang. The Michigan House of Representatives passed a bill that will end the absolute immunity enjoyed by the big drug companies in Michigan and allow consumers to hold companies accountable when drugs harm or kill.
The House Democrats had been trying for nearly two years to get a vote on the bill and now its headed to the Senate.
Sheldon Bradshaw - Bush Administration Preemption Gang
Evelyn Pringle February 2008
Sheldon Bradshaw stepped in to replace the pharmaceutical industry's inside guy, Daniel Troy, in the Office of Chief Counsel at the FDA in April 2005, and the Bush Administration's steadfast protection of the industry did not miss a beat.
On September 20, 2005, an article by Lily Henning entitled, "Is FDA's New Chief Counsel a Change in Name Only?" appeared in the Legal Times and reported that despite Mr Troy's return to the private sector, "his controversial legal policies remain in force at the agency."
"Like Troy," she wrote, "Bradshaw offers one-on-one meetings with the companies regulated by the agency, has kept low the number of warnings issued to companies violating regulations, and, perhaps most notably, has continued to intervene on behalf of drug companies in private civil lawsuits."
Ms Henning reported that Mr Bradshaw also continued the "open-door policy" that Mr Troy initiated, in meeting with drug and medical-device companies in "courtesy visits."
"Over the summer," she stated, "Bradshaw's visitors included Pfizer General Counsel Jeffrey Kindler, lawyers from Covington & Burling, Alston & Bird and other firms."
Mr Bradshaw left his post as a principal deputy assistant attorney general at the Department of Justice to become Chief Counsel and both he and Mr Troy were part of the Bush Administration's advance legal teams in 2001, according to Ms Henning.
Taking up the torch for his predecessor's preemption invention, in September 2005, Mr Bradshaw, and 9 other Bush Administration attorneys filed a brief in support of Pfizer, in the case of Kallas v Pfizer, telling the court to throw out a lawsuit filed by the parents of a teen age girl who committed suicide while taking the SSRI antidepressant, Zoloft.
Shyra Kallas was only 15-years-old when she went to a doctor for treatment of warts and came home with an off-label prescription for Zoloft, which was not FDA approved to treat children or adolescents with warts or any other ailment in October 2002.
In the brief, Mr Bradshaw claimed that the FDA would not have allowed Pfizer to add a warning about the risk of suicide with Zoloft and would have considered any such warning to be "false and misleading," an argument inserted in the FDA's first preemption brief by Mr Troy, at the request of Pfizer attorney, Malcolm Wheeler, in September 2002.
Houston attorney, Andy Vickery, handled the Kallas lawsuit, and the case was settled before any decision was reached on the preemption motion, but Mr Vickery points out that none of antidepressant makers ever asked the FDA if they could add a warning and therefore, the argument that the FDA would have rejected a request is pure speculation.
Prior to the Bush Administration, state consumer protection laws have always provided a legal remedy for citizens injured by pharmaceutical products when a company failed to warn about a risk. "Preemption completely divests the states of the rights and the role that they have had for years, and puts the foxes firmly in charge of the henhouse," according to Mr Vickery.
The King & Spalding law firm also represents pharmaceutical companies in preemption cases and judging by it's web site, the firm is another nesting place for the alumni of Mr Troy and Mr Bradshaw, with members that include 5 attorneys who served in the Chief Counsel's Office and one from the FDA's Center for Drug Evaluation and Research.
"The members of King & Spalding’s Government Advocacy & Public Policy Team utilize our experience and long-standing relationships with key members of the House, Senate, and the Bush Administration, to help clients effectively manage their interactions with the federal government," the site reports.
King openly states that the firm's "Special Matters and Government Investigations Group includes more than a dozen former federal prosecutors, congressional investigators and other enforcement officials".
"Many of our attorneys served in key positions within the U.S. Department of Justice (DOJ), other regulatory enforcement agencies, and Congressional investigative committees," the firm states. The site reports hiring Dan Donovan in January 2007, who is described as "managing congressional investigations and oversight hearings in the U.S. Senate for the past eight years."
King attorney, Mark Brown, who served as an Associate Chief Counsel at the FDA during the first Bush Administration, argued preemption on behalf of GlaxoSmithKline in O'Neal v SmithKline Beecham d/b/a GlaxoSmithKline, a case involving the Paxil-induced suicide of a 13-year-old boy, before federal Judge Frank Damrell, in the Eastern District of California, on January 21, 2008.
It's worth mentioning that in his last few years at the FDA, immediately before hooking up King, Mr Brown was the agency’s chief litigator in medical device enforcement actions, and represented the government against device makers.
The California-based law firm of Baum, Hedlund, Aristei & Goldman represents the plaintiffs in O'Neal, and senior trial attorney Ronald Goldman argued the case on behalf of the child's surviving family members.
Mr Bradshaw and his army of 9 attorneys' also filed a brief supporting Glaxo in this case, with the same old "false and misleading" argument.
Since 1999, Baum Hedlund has handled a number of lawsuits against Pfizer including the high profile case of comedian Phil Hartman and his wife, who was on Zoloft, when she shot her husband first and then herself while their children slept in another room, and a case featured in Fortune Magazine, filed on behalf of Kim Witczak, whose 39-year-old husband committed suicide while taking Zoloft.
During Zoloft litigation, Baum Hedlund soundly defeated the FDA's bogus "false and misleading" arguments with four federal courts and one state court in 2005, holding that preemption did not apply where the plaintiffs claimed that Pfizer should have provided a stronger warning suicidality. In the July 20, 2005 Witczak ruling, federal judge James Rosenbaum stated:
"It is obvious that state failure-to-warn laws do not pressure manufacturers to include false or invalid warnings. Instead, they give drug manufacturers every incentive to warn of real, known risks as soon as they are discovered -- even before any FDA action."
In response to Pfizer's argument that it should not be exposed to 51 separate tort-law regimes, the court stated: "If Congress intends to create a class of protected businesses, it has the means and ability to do so. The Court finds no proof that it has done so here."
In Baum Hedlund's latest Paxil case, on January 30, 2008, Judge Damrell dismissed the lawsuit but the family is expected to request a reconsideration of the ruling.
The only Paxil case ever make it to jury, involved a man who in 1998, shot his daughter, granddaughter, wife, and then himself, 2 days after ingesting Paxil. Andy Vickery tried the case and after weighing the testimony of the world famous psychiatrist and pharmacologist, Dr David Healy, against Glaxo's expert quack, John Mann, who received more than $30 million in research funding from drug makers in the 10 years prior to the trial, in 2001 the jury found that Paxil was the cause of the tragedy and hit Glaxo with a verdict of more than $6 million.
And yet, on November 24, 2004, when the first black box was added to antidepressants warning parents about an increased risk of suicide with children, Dr John Mann told the New York Times, "It would be ludicrous to think that antidepressants could actually contribute to suicide in the United States in any kind of significant way."
In May 2006, a federal judge in Pennsylvania was the first to use the Bush Administration's preemption policy to throw out a Paxil suicide case in Colacicco v Apotex. Joseph Colacicco sued Glaxo, and the maker of generic Paxil, when his wife committed suicide 21 days after she was prescribed the drug for mild depression.
Mr Bradshaw signed off on the government's brief in this case as well, along with 9 other government attorneys, to once again try and defeat a lone citizen already battling 2 drug giants. The plaintiff's attorneys include Derek Braslow, Harris Pogust, Robert Wilkey, and T Matthew Leckman from the Pennsylvania firm of Pogust Braslow & Millrood.
The Colacicco case is currently awaiting a decision in the 3rd Circuit Court of appeals.
The Bush Administration's backing of Glaxo in private litigation is directly at odds with efforts by state and federal officials to put a stop to Glaxo's peddling of the useless Paxil to kids while concealing the drug's risk of suicide.
In August 2004, Glaxo paid $2.5 million to settle fraud charges brought by New York State Attorney General Eliot Spitzer alleging the company hid Paxil studies that "not only failed to show any benefit for the drug in children but demonstrated that children taking Paxil were more likely to become suicidal than those taking a placebo."
According to Mr Spitzer's complaint, because it's studies failed to demonstrate efficacy and indicated a possible increased risk of suicidal thinking and acts for these youth:
"GSK sought to limit physicians' access to only the most favorable aspects of the data from these studies. To accomplish this, GSK embarked on a campaign both to suppress and, conceal negative information concerning the drug and to misrepresent the data it did reveal concerning the drug's efficacy and safety."
It should be pointed out in every article written on this subject, that for nearly all the studies that claim SSRIs work with kids and do not cause suicide, the same academic quacks appear as investigators and authors. The list of names includes but is not limited to, Dr John Mann, Dr Graham Emslie, Dr Martin Keller, Dr Karen Wagner, Dr Frederick Goodwin, Dr Neal Ryan, Dr Charles Nemeroff, Dr David Dunner, Dr Andrew Leon, Dr John March, Dr David Shaffer, Dr John Rush, Dr Mark Olfson, and Dr Robert Gibbons.
A report showing that Glaxo knew about Paxil's 8-fold increased suicide risk from clinical trials conducted as far back as 1989, was submitted to the court in the Baum Hedlund O'Neal case, by the plaintiff's expert, Dr Joseph Glenmullen, a psychiatrist and instructor at Harvard, but was sealed under a court order when it was filed in June 2007.
The report was unsealed in January 2008, and on February 6, 2008, Senator Charles Grassley (R-Iowa), on behalf of the Senate Finance Committee, sent a letter to Glaxo asking for an explanation of why the public was never properly informed of suicide risk associated with Paxil until May 2006 in a "Dear Doctor" letter which reported a "higher frequency of suicidal behavior" in patients on Paxil when compared to those on a placebo.
Preemption is not the only shield within the protection racket set up by Mr Troy and carried on by Mr Bradshaw at the FDA. A couple years ago, federal lawmakers investigated the drop in enforcement actions at the Chief Counsel's office, since Mr Troy began running the show and found an utter failure to police the pharmaceutical industry.
According to the July 2006, report, “Prescription for Harm: The Decline in FDA Enforcement Activity,” by the House Committee on Government Reform, under the Bush Administration, enforcement actions drastically declined during the same period in which the FDA most aggressively promoted the preemption policy.
The investigation found that the number of warning letters issued for violations of federal requirements had fallen by over 50%, to a 15-year low of 535 in 2005, down from 1,154 in 2000. Internal FDA documents also showed that in at least 138 cases in which agency field inspectors found violations, the FDA failed to take any action against the company.
The experts who were consulted for the investigation included Dr Jerry Avorn, Professor of Medicine at Harvard Medical School; Dr Michael Wilkes, Vice Dean of Medical Education at the University of California Davis School of Medicine; and Sammie Young, a former Director of Compliance in the FDA’s Bureau of Biologics, who worked at the agency for close to 30 years.
After reviewing the records, in a May 25, 2006 letter, Dr Avorn told the Committee, "In all of FDA's once-proud recent history, I cannot recall a time of greater concern about its work on the part of doctors, patients, and policy researchers."
"It is unlikely," he pointed out, "that the behavior of the regulated industries improved so much during these years to account for a reduction of 300 warning letters per year."
On June 10, 2006, Dr Wilkes stated in a letter to Rep Henry Waxman: The FDA "seems unable and unwilling to step in to protect the American public."
The FDA provided no records from the Chief Counsel, even though an investigation by the Special Investigations Division had credited a sudden decline in enforcement actions to a change in FDA policy issued by Mr Troy in September 2001, which required his approval of all warning letters and untitled letters before they were sent out.
Under the revised procedures, the Chief Counsel is required to “state in writing the reason for nonconcurrence” whenever it objects to an enforcement action, the report noted.
However, when the FDA was asked to explain why there were no records from Mr Troy's office, the agency said his office did not keep copies of the decisions or recommendations, or even a record of which files were reviewed.
On September 20, 2005, Lily Henning reported on actions taken by Mr Bradshaw in the Legal Times and wrote, "So far in 2005, 23 warning letters to advertisers and seven compliance letters regarding manufacturing or compliance problems have gone out."
"By contrast," she noted, "during the Clinton administration in 1999, 110 letters warning about illegal advertising claims were sent."
In any event, just like Mr Troy, Mr Bradshaw is now long gone, and according to Pharmalot's Ed Silverman on September 7, 2007: "There was no official announcement from the agency, at least not as far as we can tell, but Sheldon Bradshaw is joining Hunton & Williams, which has a significant pharmaceutical-industry practice and reps such companies as Pfizer."
However, the Hunton web site was more than happy to announce the arrival of it's employee with a bio that states: "As Chief Counsel, Mr. Bradshaw was responsible for providing legal advice to the Secretary and Deputy Secretary of the U.S. Department of Health and Human Services and to the FDA’s senior leadership – including the Commissioner, the Deputy Commissioners and the Directors of the various FDA Centers".
"In addition," it reads, "he oversaw FDA-related litigation and reviewed and approved every regulation and guidance promulgated by the FDA and every warning letter issued by the FDA."
The sites brags that Hunton served as statewide counsel for Merck in Vioxx cases and represented Lilly in Prozac cases all around the country and even brags about winning a lawsuit that alleged a client's product caused "complete deafness in a young child".
Probably most pertinent to Mr Bradshaw's area of expertise, Hunton claims to have "substantial experience in dealing with issues such as FDA preemption," and "off-label promotion".
The firm also says it handles consumer protection claims and investigations into business practices by attorneys general but does not mention cases by name. However, most of the cases filed on behalf of the states at the moment involve allegations that drug makers ripped off public health care programs by promoting drugs for off-label uses and injured consumers by concealing their side effects.
Mr Bradshaw's wealth of insider information gathered during his days as chief counsel, along with his direct line to all the Bush Administration attorneys he worked side by side with, will surely come in handy in this practice area of the firm.
Sheldon Bradshaw stepped in to replace the pharmaceutical industry's inside guy, Daniel Troy, in the Office of Chief Counsel at the FDA in April 2005, and the Bush Administration's steadfast protection of the industry did not miss a beat.
On September 20, 2005, an article by Lily Henning entitled, "Is FDA's New Chief Counsel a Change in Name Only?" appeared in the Legal Times and reported that despite Mr Troy's return to the private sector, "his controversial legal policies remain in force at the agency."
"Like Troy," she wrote, "Bradshaw offers one-on-one meetings with the companies regulated by the agency, has kept low the number of warnings issued to companies violating regulations, and, perhaps most notably, has continued to intervene on behalf of drug companies in private civil lawsuits."
Ms Henning reported that Mr Bradshaw also continued the "open-door policy" that Mr Troy initiated, in meeting with drug and medical-device companies in "courtesy visits."
"Over the summer," she stated, "Bradshaw's visitors included Pfizer General Counsel Jeffrey Kindler, lawyers from Covington & Burling, Alston & Bird and other firms."
Mr Bradshaw left his post as a principal deputy assistant attorney general at the Department of Justice to become Chief Counsel and both he and Mr Troy were part of the Bush Administration's advance legal teams in 2001, according to Ms Henning.
Taking up the torch for his predecessor's preemption invention, in September 2005, Mr Bradshaw, and 9 other Bush Administration attorneys filed a brief in support of Pfizer, in the case of Kallas v Pfizer, telling the court to throw out a lawsuit filed by the parents of a teen age girl who committed suicide while taking the SSRI antidepressant, Zoloft.
Shyra Kallas was only 15-years-old when she went to a doctor for treatment of warts and came home with an off-label prescription for Zoloft, which was not FDA approved to treat children or adolescents with warts or any other ailment in October 2002.
In the brief, Mr Bradshaw claimed that the FDA would not have allowed Pfizer to add a warning about the risk of suicide with Zoloft and would have considered any such warning to be "false and misleading," an argument inserted in the FDA's first preemption brief by Mr Troy, at the request of Pfizer attorney, Malcolm Wheeler, in September 2002.
Houston attorney, Andy Vickery, handled the Kallas lawsuit, and the case was settled before any decision was reached on the preemption motion, but Mr Vickery points out that none of antidepressant makers ever asked the FDA if they could add a warning and therefore, the argument that the FDA would have rejected a request is pure speculation.
Prior to the Bush Administration, state consumer protection laws have always provided a legal remedy for citizens injured by pharmaceutical products when a company failed to warn about a risk. "Preemption completely divests the states of the rights and the role that they have had for years, and puts the foxes firmly in charge of the henhouse," according to Mr Vickery.
The King & Spalding law firm also represents pharmaceutical companies in preemption cases and judging by it's web site, the firm is another nesting place for the alumni of Mr Troy and Mr Bradshaw, with members that include 5 attorneys who served in the Chief Counsel's Office and one from the FDA's Center for Drug Evaluation and Research.
"The members of King & Spalding’s Government Advocacy & Public Policy Team utilize our experience and long-standing relationships with key members of the House, Senate, and the Bush Administration, to help clients effectively manage their interactions with the federal government," the site reports.
King openly states that the firm's "Special Matters and Government Investigations Group includes more than a dozen former federal prosecutors, congressional investigators and other enforcement officials".
"Many of our attorneys served in key positions within the U.S. Department of Justice (DOJ), other regulatory enforcement agencies, and Congressional investigative committees," the firm states. The site reports hiring Dan Donovan in January 2007, who is described as "managing congressional investigations and oversight hearings in the U.S. Senate for the past eight years."
King attorney, Mark Brown, who served as an Associate Chief Counsel at the FDA during the first Bush Administration, argued preemption on behalf of GlaxoSmithKline in O'Neal v SmithKline Beecham d/b/a GlaxoSmithKline, a case involving the Paxil-induced suicide of a 13-year-old boy, before federal Judge Frank Damrell, in the Eastern District of California, on January 21, 2008.
It's worth mentioning that in his last few years at the FDA, immediately before hooking up King, Mr Brown was the agency’s chief litigator in medical device enforcement actions, and represented the government against device makers.
The California-based law firm of Baum, Hedlund, Aristei & Goldman represents the plaintiffs in O'Neal, and senior trial attorney Ronald Goldman argued the case on behalf of the child's surviving family members.
Mr Bradshaw and his army of 9 attorneys' also filed a brief supporting Glaxo in this case, with the same old "false and misleading" argument.
Since 1999, Baum Hedlund has handled a number of lawsuits against Pfizer including the high profile case of comedian Phil Hartman and his wife, who was on Zoloft, when she shot her husband first and then herself while their children slept in another room, and a case featured in Fortune Magazine, filed on behalf of Kim Witczak, whose 39-year-old husband committed suicide while taking Zoloft.
During Zoloft litigation, Baum Hedlund soundly defeated the FDA's bogus "false and misleading" arguments with four federal courts and one state court in 2005, holding that preemption did not apply where the plaintiffs claimed that Pfizer should have provided a stronger warning suicidality. In the July 20, 2005 Witczak ruling, federal judge James Rosenbaum stated:
"It is obvious that state failure-to-warn laws do not pressure manufacturers to include false or invalid warnings. Instead, they give drug manufacturers every incentive to warn of real, known risks as soon as they are discovered -- even before any FDA action."
In response to Pfizer's argument that it should not be exposed to 51 separate tort-law regimes, the court stated: "If Congress intends to create a class of protected businesses, it has the means and ability to do so. The Court finds no proof that it has done so here."
In Baum Hedlund's latest Paxil case, on January 30, 2008, Judge Damrell dismissed the lawsuit but the family is expected to request a reconsideration of the ruling.
The only Paxil case ever make it to jury, involved a man who in 1998, shot his daughter, granddaughter, wife, and then himself, 2 days after ingesting Paxil. Andy Vickery tried the case and after weighing the testimony of the world famous psychiatrist and pharmacologist, Dr David Healy, against Glaxo's expert quack, John Mann, who received more than $30 million in research funding from drug makers in the 10 years prior to the trial, in 2001 the jury found that Paxil was the cause of the tragedy and hit Glaxo with a verdict of more than $6 million.
And yet, on November 24, 2004, when the first black box was added to antidepressants warning parents about an increased risk of suicide with children, Dr John Mann told the New York Times, "It would be ludicrous to think that antidepressants could actually contribute to suicide in the United States in any kind of significant way."
In May 2006, a federal judge in Pennsylvania was the first to use the Bush Administration's preemption policy to throw out a Paxil suicide case in Colacicco v Apotex. Joseph Colacicco sued Glaxo, and the maker of generic Paxil, when his wife committed suicide 21 days after she was prescribed the drug for mild depression.
Mr Bradshaw signed off on the government's brief in this case as well, along with 9 other government attorneys, to once again try and defeat a lone citizen already battling 2 drug giants. The plaintiff's attorneys include Derek Braslow, Harris Pogust, Robert Wilkey, and T Matthew Leckman from the Pennsylvania firm of Pogust Braslow & Millrood.
The Colacicco case is currently awaiting a decision in the 3rd Circuit Court of appeals.
The Bush Administration's backing of Glaxo in private litigation is directly at odds with efforts by state and federal officials to put a stop to Glaxo's peddling of the useless Paxil to kids while concealing the drug's risk of suicide.
In August 2004, Glaxo paid $2.5 million to settle fraud charges brought by New York State Attorney General Eliot Spitzer alleging the company hid Paxil studies that "not only failed to show any benefit for the drug in children but demonstrated that children taking Paxil were more likely to become suicidal than those taking a placebo."
According to Mr Spitzer's complaint, because it's studies failed to demonstrate efficacy and indicated a possible increased risk of suicidal thinking and acts for these youth:
"GSK sought to limit physicians' access to only the most favorable aspects of the data from these studies. To accomplish this, GSK embarked on a campaign both to suppress and, conceal negative information concerning the drug and to misrepresent the data it did reveal concerning the drug's efficacy and safety."
It should be pointed out in every article written on this subject, that for nearly all the studies that claim SSRIs work with kids and do not cause suicide, the same academic quacks appear as investigators and authors. The list of names includes but is not limited to, Dr John Mann, Dr Graham Emslie, Dr Martin Keller, Dr Karen Wagner, Dr Frederick Goodwin, Dr Neal Ryan, Dr Charles Nemeroff, Dr David Dunner, Dr Andrew Leon, Dr John March, Dr David Shaffer, Dr John Rush, Dr Mark Olfson, and Dr Robert Gibbons.
A report showing that Glaxo knew about Paxil's 8-fold increased suicide risk from clinical trials conducted as far back as 1989, was submitted to the court in the Baum Hedlund O'Neal case, by the plaintiff's expert, Dr Joseph Glenmullen, a psychiatrist and instructor at Harvard, but was sealed under a court order when it was filed in June 2007.
The report was unsealed in January 2008, and on February 6, 2008, Senator Charles Grassley (R-Iowa), on behalf of the Senate Finance Committee, sent a letter to Glaxo asking for an explanation of why the public was never properly informed of suicide risk associated with Paxil until May 2006 in a "Dear Doctor" letter which reported a "higher frequency of suicidal behavior" in patients on Paxil when compared to those on a placebo.
Preemption is not the only shield within the protection racket set up by Mr Troy and carried on by Mr Bradshaw at the FDA. A couple years ago, federal lawmakers investigated the drop in enforcement actions at the Chief Counsel's office, since Mr Troy began running the show and found an utter failure to police the pharmaceutical industry.
According to the July 2006, report, “Prescription for Harm: The Decline in FDA Enforcement Activity,” by the House Committee on Government Reform, under the Bush Administration, enforcement actions drastically declined during the same period in which the FDA most aggressively promoted the preemption policy.
The investigation found that the number of warning letters issued for violations of federal requirements had fallen by over 50%, to a 15-year low of 535 in 2005, down from 1,154 in 2000. Internal FDA documents also showed that in at least 138 cases in which agency field inspectors found violations, the FDA failed to take any action against the company.
The experts who were consulted for the investigation included Dr Jerry Avorn, Professor of Medicine at Harvard Medical School; Dr Michael Wilkes, Vice Dean of Medical Education at the University of California Davis School of Medicine; and Sammie Young, a former Director of Compliance in the FDA’s Bureau of Biologics, who worked at the agency for close to 30 years.
After reviewing the records, in a May 25, 2006 letter, Dr Avorn told the Committee, "In all of FDA's once-proud recent history, I cannot recall a time of greater concern about its work on the part of doctors, patients, and policy researchers."
"It is unlikely," he pointed out, "that the behavior of the regulated industries improved so much during these years to account for a reduction of 300 warning letters per year."
On June 10, 2006, Dr Wilkes stated in a letter to Rep Henry Waxman: The FDA "seems unable and unwilling to step in to protect the American public."
The FDA provided no records from the Chief Counsel, even though an investigation by the Special Investigations Division had credited a sudden decline in enforcement actions to a change in FDA policy issued by Mr Troy in September 2001, which required his approval of all warning letters and untitled letters before they were sent out.
Under the revised procedures, the Chief Counsel is required to “state in writing the reason for nonconcurrence” whenever it objects to an enforcement action, the report noted.
However, when the FDA was asked to explain why there were no records from Mr Troy's office, the agency said his office did not keep copies of the decisions or recommendations, or even a record of which files were reviewed.
On September 20, 2005, Lily Henning reported on actions taken by Mr Bradshaw in the Legal Times and wrote, "So far in 2005, 23 warning letters to advertisers and seven compliance letters regarding manufacturing or compliance problems have gone out."
"By contrast," she noted, "during the Clinton administration in 1999, 110 letters warning about illegal advertising claims were sent."
In any event, just like Mr Troy, Mr Bradshaw is now long gone, and according to Pharmalot's Ed Silverman on September 7, 2007: "There was no official announcement from the agency, at least not as far as we can tell, but Sheldon Bradshaw is joining Hunton & Williams, which has a significant pharmaceutical-industry practice and reps such companies as Pfizer."
However, the Hunton web site was more than happy to announce the arrival of it's employee with a bio that states: "As Chief Counsel, Mr. Bradshaw was responsible for providing legal advice to the Secretary and Deputy Secretary of the U.S. Department of Health and Human Services and to the FDA’s senior leadership – including the Commissioner, the Deputy Commissioners and the Directors of the various FDA Centers".
"In addition," it reads, "he oversaw FDA-related litigation and reviewed and approved every regulation and guidance promulgated by the FDA and every warning letter issued by the FDA."
The sites brags that Hunton served as statewide counsel for Merck in Vioxx cases and represented Lilly in Prozac cases all around the country and even brags about winning a lawsuit that alleged a client's product caused "complete deafness in a young child".
Probably most pertinent to Mr Bradshaw's area of expertise, Hunton claims to have "substantial experience in dealing with issues such as FDA preemption," and "off-label promotion".
The firm also says it handles consumer protection claims and investigations into business practices by attorneys general but does not mention cases by name. However, most of the cases filed on behalf of the states at the moment involve allegations that drug makers ripped off public health care programs by promoting drugs for off-label uses and injured consumers by concealing their side effects.
Mr Bradshaw's wealth of insider information gathered during his days as chief counsel, along with his direct line to all the Bush Administration attorneys he worked side by side with, will surely come in handy in this practice area of the firm.
Sunday, August 1, 2010
FDA and Big Pharma Gang Up On Joe Citizen
Evelyn Pringle November 6, 2006
The botched safety processes at the FDA have had an extremely negative impact on the nation's public health and tens of thousands of people have died as a result of its negligent handling of the Vioxx debacle alone.
Americans today can no more trust what's in their medicine cabinets than could the pioneers in the 1800s who filled their medicine chests when the snake oil salesmen came to town.
The FDA is now apparently claiming infallibility by telling consumers that if it says a drug is safe and the warnings on a drug's label are sufficient, no consumer can bring a lawsuit against a drug's maker in a state court for injuries caused by a drug, even if it is shown that the drug company actively concealed information about known injuries associated with the drug not only from consumers, but from the FDA as well.
Throughout the FDA's 100 year history, state consumer protection laws have played an important role in protecting Americans from unsafe pharmaceutical products, and consumer protection advocates are rightfully questioning whether the FDA can or will provide the same protection.
Its no secret that the Bush-sanctioned FDA is bent on protecting drug company profits and doesn't care enough about protecting consumers from unsafe drugs. A March 2006 report to Congress issued by the Government Accountability Office, after an investigation of the FDA ability to monitor drug safety, said the FDA's performance was undermined by infighting between drug evaluation administrators whose allegiance is with industry and the Office of Drug Safety.
According to Attorney, Jim Gottstein, who recently scored a major victory in the Alaska Supreme Court protecting patients in state institutions from forced drugging with psychiatric medications, "the fact that current leaders of the FDA have taken the extraordinary step of interjecting the FDA into cases to argue pre-emption, leaves no doubt that it has abdicated its duty to protect the public from unsafe drugs in favor of protecting pharmaceutical profits."
State lawmakers are also crying foul over the FDA's arrogant undermining of state consumer protection laws because under Executive Order 13132, the FDA is required to consult with state authorities about the effects of regulations it issues on states. In the original proposed rule, the FDA specifically said that the regulation would not preempt state laws so state officials had no chance to object to the preemption rule.
According to the National Conference of State Legislatures, the preemption language in the preamble to the Final Rule is a thinly veiled attempt on the part of the FDA to confer upon itself authority it does not have by statute and does not have by way of judicial ruling. The NCSL called the FDA's action an abuse of agency process and a complete disregard for our dual system of government.
According to Baum Hedlund attorney, Karen Barth Menzies, "the FDA's statement is nothing more than the policy position of appointed officials with an agenda unrelated to public safety."
"As such," she says, "it should have zero preemptive effect."
When Congress enacted the Federal Food, Drug, and Cosmetic Act in 1938, it specifically rejected a proposal to include a private right of action for damages caused by products regulated by the FDA, on the grounds that a right of action already existed under state common law.
The new FDA preemption rule provides no exceptions even in cases like Vioxx where the FDA asked the company to change the warning label based on reports of serious adverse effects, and a drug maker like Merck refuses to change the label for more than 18 months while many more patients are killed and injured.
In addition, the FDA contends that the agency's approval of the drug label preempts not only claims related to label warnings but also claims related to false advertising.
Given the on-going heated debate over the FDA's ability to police the pharmaceutical industry as a whole, critics say it is a particularly inappropriate time to eliminate the role that private citizen lawsuits in state courts play.
But then again, what can we expect when the agency's top attorney, Daniel Troy, is recruited directly from Pfizer's stable of lawyers. Troy began the administration's preemption war against Joe Citizen to protect Big Pharma profits as soon as he set up shop at the FDA, by filing amicus briefs on behalf of drug companies, including Pfizer.
Even though Pfizer had been one of his clients and Troy's firm was paid over $350,000 for work he performed in the year before he was appointed chief counsel, Troy agreed to file a brief in support of Pfizer on behalf of the FDA, arguing, unsuccessfully, that state tort claims should be preempted.
He later justified writing the brief by claiming that he did not become involved in the case until after the 1-year period in which government employees may not participate in cases involving former clients. In hindsight, the 1-year grace period reportedly expired less than a month before Troy agreed to go to bat for his former client.
In stark contrast to Troy's pro drug company stance, in a 1996 speech, the Clinton appointed FDA chief counsel, Margaret Jane Porter, said the FDA had a "longstanding presumption against preemption" and that "FDA's view is that FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct, layer of consumer protection."
When simply filing amicus briefs did not work because no judge accepted the FDA's at best feeble and at worst ridiculous arguments, in January 2006, the FDA added the preamble to the new drug labeling rules stating that the Food, Drug and Cosmetic Act "pre-empts conflicting or contrary state law."
Judges are having mixed reactions to the FDA's preemption position. In a stinging rebuke, New Jersey judge, Carol Higbee, during a June 6, 2006 hearing involving Vioxx lawsuits, called the Final Rule's preamble "a political statement by the FDA."
As for the claim that state lawsuits should be preempted, she said, "It is contrary to the U.S. Supreme Court's decisions. It is contrary to all the law on preemption."
"In addition to being contrary to the law of the land," she stated, "it is also contrary to the Constitution of the United States."
She ended her comments by telling Merck's Vioxx attorneys, "And I am not going to allow you to use it."
On June 2, 2006, the Associated Press reported that a federal judge had refused to dismiss a lawsuit filed against Pfizer and Wyeth, on behalf of the parents of an 11-year-old boy who committed suicide after taking the antidepressants Zoloft and Effexor.
The judge rejected the preemption argument stating: "Federal labeling laws are minimum standards; they do not necessarily shield manufacturers from state law liability."
"Defendant's pre-emption argument ultimately fails because Congress has not expressed a specific intent to pre-empt state consumer-protection laws in the area of prescription-drug labeling," the court said.
"In the absence of Congress's express statement," the judge stated, "defendant must overcome the presumption against implying congressional pre-emptive intent. It has not done so."
In what can only be viewed as a rare ruling, In Bextra and Celebrex, on August 16, 2006, the US District Court for the Northern District of California dismissed the state law failure-to-warn claims saying they conflict with the FDA's determination of the proper warning and pose an obstacle to the full accomplishment of the objectives of the Food, Drug and Cosmetic Act.
The court attempted to justify the FDA's "180-degree reversal of its prior position" on preemption, by noting that an agency's view may change over time and especially with a change in administration.
But in New Jersey on September 29, 2006, a federal district court in McNellis v Pfizer Inc, refused to allow the preemption defense and based on the fact that the text of FDA regulations had remained unchanged for years, ruled that the regulations did not conflict with New Jersey's failure-to-warn laws.
The court also said that FDA regulations allow increased warnings when new risks emerge and that the Food, Drug and Cosmetic Act does not contain a preemption clause.
Following the McNellis decision, on October 16, 2006, a federal court in Pennsylvania refused to grant the drug maker's preemption motion in Perry v Novartis Pharma Corp, noting concerns about the effectiveness of the FDA's monitoring of recently approved drugs, making the availability of state tort suits an "important backstop to the federal regulatory scheme."
On October 5, 2006, the 2nd Circuit Court of Appeals was also critical of the FDA's preemptive reach stating, "[W]hatever deference would be owed to an agency's view ... an agency cannot supply, on Congress's behalf, the clear legislative statement of intent required to overcome the presumption against preemption," in Desiano v Warner-Lambert et al.
Three weeks later, on October 28, 2006, the Associated Press reported another state court victory against preemption in a case where Wyeth was ordered to pay nearly $6.8 million to a Vermont women after the Vermont Supreme Court upheld a lower court's ruling.
The court's decision said federal labeling requirements "create a floor, not a ceiling" for state regulation, noting that the FDA regulations allow drug companies to go beyond required warnings.
"When further warnings become necessary, the manufacturer is at least partially responsible for taking additional action, and if it fails to do so, it cannot rely on the FDA's continued approval of its labels as a shield against state tort liability," the court wrote.
Peter Lurie, deputy director of the health research group at Public Citizen, told the Associated Press that the case appeared to mark a push-back against efforts by the industry, the administration and the FDA to preempt state regulation of prescription drugs.
"If you have a wide enough berth that you can strengthen the label," he said, "you can't use the FDA-approved label as an automatic protection against lawsuits."
Since May 2006, all eyes in the legal field have been on the appeal in the case of Colacicco v Apotex, Inc, - F Supp 2d -, 2006 WL 1443357 (ED Pa), in the 3rd Circuit Court of Appeals, where the lower court ruled against a man whose wife committed suicide after taking Paxil.
Joseph Colacicco filed a lawsuit against both drug makers alleging that his wife committed suicide in October 2003, just 21 days after she began taking Paxil for mild depression with claims of wrongful death, negligence and a failure to warn her doctor of a link between Paxil and an increased risk of suicide.
In moving for dismissal, Paxil maker, GlaxoSmithKline, and Paxil generic maker, Apotex, relied on the FDA's position that state failure-to-warn claims are preempted.
The judge ruled that the defendants were entitled to a dismissal of all claims because the FDA controls the content of warnings and requires generic drug makers to use the same labeling as approved for the drug's original maker.
In this case, the judge on his own initiative, asked the FDA to submit an amicus brief. And in response, on the tax payer's dime, the FDA wrote a brief asking the court to rule against the American citizen and dismiss the lawsuit against the drug companies.
In fact the FDA was the strongest supporter of preemption in this case because according to the attorneys handling the case, Glaxo itself barely addressed the preemption issue during oral arguments on the motion.
In a decision that experts predict may end up before the US Supreme Court, the judge ended up dismissing the claims without ever considering whether the FDA regulations pose a conflict to the plaintiff's state tort claims.
Attorneys Derek Braslow, Harris Pogust and Matthew Leckman from the Conshohocken, Pennsylvania firm of Pogust & Braslow are representing the plaintiff in the case.
Attorney, Harris Pogust, says the judge's ruling "could potentially do away with all failure-to-warn pharmaceutical cases"
The FDA action he notes, "does not seem to be a public health concern as much as a political concern."
According to Mr Braslow, "the Judge readily admits that he did not analyze whether there is or was a conflict between state law and federal law and surmises that he probably would not find a conflict if he actually did the analysis."
"But, the Judge explained," he said, "that it doesn't matter - if the FDA says there is preemption, then there must be preemption. Far be it for a Judge to interpret the law."
"The Bush-era FDA," Mr Braslow notes, "in a complete reversal of the position it took in its 2000 rule proposal, has now officially cemented its role as a pawn for the pharmaceutical industry."
"It was not that long ago," Mr Braslow points out, "that the FDA came forward with amicus briefs on behalf of the consumer in prescription drug litigation."
"Now," Mr Braslow says, "an argument first put forward in a couple Zoloft suicide cases, has become the primary argument in every prescription drug case, and could," he warns, "potentially, mean the end for anyone seeking recourse from injuries resulting from prescription drugs, no matter how fraudulent the drug company's conduct."
"Make no mistake," he states, "the position taken by the Bush-era FDA is an attempt by the current administration to achieve tort reform for the benefit of big pharma and at the expense of the injured consumer, without the consent of Congress."
"The Bush-era FDA takes this position," he warns, "unconcerned by the reality that preemption would allow drug companies to peddle their drugs with impunity and avoid being justifiably called into court for deceiving the public about the safety and effectiveness of those drugs."
"Notwithstanding the FDA's position on preemption," Mr Braslow says, "courts examining this issue, if they take any time to actually look at the FDA regulations in question, would realize that there is no conflict between federal drug regulations and state tort claims."
"Federal drug regulations specifically mandate drug companies to strengthen their drug's label," he explains, "as soon as there is reasonable evidence of an association of a serious hazard with their drug."
"A state tort claim," Mr Braslow points out, "does not force a drug company to take any action that is not already permitted by federal regulations."
"Because federal regulations for prescription drugs are minimum standards," he notes, "federal regulations can never conflict with a state common law claim."
"The District Court erred," he states, "in abdicating to FDA legal opinion, as opposed to interpreting the law."
"What the Colacicco court did," he says, "was improperly abdicate to the FDA's legal opinion."
Critics say it's time for the FDA to get back to protecting consumers from dangerous products, rather than protecting the profits of the pharmaceutical industry.
According to career scientist, Dr David Graham, in a 2005 interview with Jeanne Lenzer in the journal Public Library of Science, "The pharma-FDA complex has to be dismantled and the American people have to insist on that, otherwise we're going to have disasters like Vioxx that happen in the future."
The botched safety processes at the FDA have had an extremely negative impact on the nation's public health and tens of thousands of people have died as a result of its negligent handling of the Vioxx debacle alone.
Americans today can no more trust what's in their medicine cabinets than could the pioneers in the 1800s who filled their medicine chests when the snake oil salesmen came to town.
The FDA is now apparently claiming infallibility by telling consumers that if it says a drug is safe and the warnings on a drug's label are sufficient, no consumer can bring a lawsuit against a drug's maker in a state court for injuries caused by a drug, even if it is shown that the drug company actively concealed information about known injuries associated with the drug not only from consumers, but from the FDA as well.
Throughout the FDA's 100 year history, state consumer protection laws have played an important role in protecting Americans from unsafe pharmaceutical products, and consumer protection advocates are rightfully questioning whether the FDA can or will provide the same protection.
Its no secret that the Bush-sanctioned FDA is bent on protecting drug company profits and doesn't care enough about protecting consumers from unsafe drugs. A March 2006 report to Congress issued by the Government Accountability Office, after an investigation of the FDA ability to monitor drug safety, said the FDA's performance was undermined by infighting between drug evaluation administrators whose allegiance is with industry and the Office of Drug Safety.
According to Attorney, Jim Gottstein, who recently scored a major victory in the Alaska Supreme Court protecting patients in state institutions from forced drugging with psychiatric medications, "the fact that current leaders of the FDA have taken the extraordinary step of interjecting the FDA into cases to argue pre-emption, leaves no doubt that it has abdicated its duty to protect the public from unsafe drugs in favor of protecting pharmaceutical profits."
State lawmakers are also crying foul over the FDA's arrogant undermining of state consumer protection laws because under Executive Order 13132, the FDA is required to consult with state authorities about the effects of regulations it issues on states. In the original proposed rule, the FDA specifically said that the regulation would not preempt state laws so state officials had no chance to object to the preemption rule.
According to the National Conference of State Legislatures, the preemption language in the preamble to the Final Rule is a thinly veiled attempt on the part of the FDA to confer upon itself authority it does not have by statute and does not have by way of judicial ruling. The NCSL called the FDA's action an abuse of agency process and a complete disregard for our dual system of government.
According to Baum Hedlund attorney, Karen Barth Menzies, "the FDA's statement is nothing more than the policy position of appointed officials with an agenda unrelated to public safety."
"As such," she says, "it should have zero preemptive effect."
When Congress enacted the Federal Food, Drug, and Cosmetic Act in 1938, it specifically rejected a proposal to include a private right of action for damages caused by products regulated by the FDA, on the grounds that a right of action already existed under state common law.
The new FDA preemption rule provides no exceptions even in cases like Vioxx where the FDA asked the company to change the warning label based on reports of serious adverse effects, and a drug maker like Merck refuses to change the label for more than 18 months while many more patients are killed and injured.
In addition, the FDA contends that the agency's approval of the drug label preempts not only claims related to label warnings but also claims related to false advertising.
Given the on-going heated debate over the FDA's ability to police the pharmaceutical industry as a whole, critics say it is a particularly inappropriate time to eliminate the role that private citizen lawsuits in state courts play.
But then again, what can we expect when the agency's top attorney, Daniel Troy, is recruited directly from Pfizer's stable of lawyers. Troy began the administration's preemption war against Joe Citizen to protect Big Pharma profits as soon as he set up shop at the FDA, by filing amicus briefs on behalf of drug companies, including Pfizer.
Even though Pfizer had been one of his clients and Troy's firm was paid over $350,000 for work he performed in the year before he was appointed chief counsel, Troy agreed to file a brief in support of Pfizer on behalf of the FDA, arguing, unsuccessfully, that state tort claims should be preempted.
He later justified writing the brief by claiming that he did not become involved in the case until after the 1-year period in which government employees may not participate in cases involving former clients. In hindsight, the 1-year grace period reportedly expired less than a month before Troy agreed to go to bat for his former client.
In stark contrast to Troy's pro drug company stance, in a 1996 speech, the Clinton appointed FDA chief counsel, Margaret Jane Porter, said the FDA had a "longstanding presumption against preemption" and that "FDA's view is that FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct, layer of consumer protection."
When simply filing amicus briefs did not work because no judge accepted the FDA's at best feeble and at worst ridiculous arguments, in January 2006, the FDA added the preamble to the new drug labeling rules stating that the Food, Drug and Cosmetic Act "pre-empts conflicting or contrary state law."
Judges are having mixed reactions to the FDA's preemption position. In a stinging rebuke, New Jersey judge, Carol Higbee, during a June 6, 2006 hearing involving Vioxx lawsuits, called the Final Rule's preamble "a political statement by the FDA."
As for the claim that state lawsuits should be preempted, she said, "It is contrary to the U.S. Supreme Court's decisions. It is contrary to all the law on preemption."
"In addition to being contrary to the law of the land," she stated, "it is also contrary to the Constitution of the United States."
She ended her comments by telling Merck's Vioxx attorneys, "And I am not going to allow you to use it."
On June 2, 2006, the Associated Press reported that a federal judge had refused to dismiss a lawsuit filed against Pfizer and Wyeth, on behalf of the parents of an 11-year-old boy who committed suicide after taking the antidepressants Zoloft and Effexor.
The judge rejected the preemption argument stating: "Federal labeling laws are minimum standards; they do not necessarily shield manufacturers from state law liability."
"Defendant's pre-emption argument ultimately fails because Congress has not expressed a specific intent to pre-empt state consumer-protection laws in the area of prescription-drug labeling," the court said.
"In the absence of Congress's express statement," the judge stated, "defendant must overcome the presumption against implying congressional pre-emptive intent. It has not done so."
In what can only be viewed as a rare ruling, In Bextra and Celebrex, on August 16, 2006, the US District Court for the Northern District of California dismissed the state law failure-to-warn claims saying they conflict with the FDA's determination of the proper warning and pose an obstacle to the full accomplishment of the objectives of the Food, Drug and Cosmetic Act.
The court attempted to justify the FDA's "180-degree reversal of its prior position" on preemption, by noting that an agency's view may change over time and especially with a change in administration.
But in New Jersey on September 29, 2006, a federal district court in McNellis v Pfizer Inc, refused to allow the preemption defense and based on the fact that the text of FDA regulations had remained unchanged for years, ruled that the regulations did not conflict with New Jersey's failure-to-warn laws.
The court also said that FDA regulations allow increased warnings when new risks emerge and that the Food, Drug and Cosmetic Act does not contain a preemption clause.
Following the McNellis decision, on October 16, 2006, a federal court in Pennsylvania refused to grant the drug maker's preemption motion in Perry v Novartis Pharma Corp, noting concerns about the effectiveness of the FDA's monitoring of recently approved drugs, making the availability of state tort suits an "important backstop to the federal regulatory scheme."
On October 5, 2006, the 2nd Circuit Court of Appeals was also critical of the FDA's preemptive reach stating, "[W]hatever deference would be owed to an agency's view ... an agency cannot supply, on Congress's behalf, the clear legislative statement of intent required to overcome the presumption against preemption," in Desiano v Warner-Lambert et al.
Three weeks later, on October 28, 2006, the Associated Press reported another state court victory against preemption in a case where Wyeth was ordered to pay nearly $6.8 million to a Vermont women after the Vermont Supreme Court upheld a lower court's ruling.
The court's decision said federal labeling requirements "create a floor, not a ceiling" for state regulation, noting that the FDA regulations allow drug companies to go beyond required warnings.
"When further warnings become necessary, the manufacturer is at least partially responsible for taking additional action, and if it fails to do so, it cannot rely on the FDA's continued approval of its labels as a shield against state tort liability," the court wrote.
Peter Lurie, deputy director of the health research group at Public Citizen, told the Associated Press that the case appeared to mark a push-back against efforts by the industry, the administration and the FDA to preempt state regulation of prescription drugs.
"If you have a wide enough berth that you can strengthen the label," he said, "you can't use the FDA-approved label as an automatic protection against lawsuits."
Since May 2006, all eyes in the legal field have been on the appeal in the case of Colacicco v Apotex, Inc, - F Supp 2d -, 2006 WL 1443357 (ED Pa), in the 3rd Circuit Court of Appeals, where the lower court ruled against a man whose wife committed suicide after taking Paxil.
Joseph Colacicco filed a lawsuit against both drug makers alleging that his wife committed suicide in October 2003, just 21 days after she began taking Paxil for mild depression with claims of wrongful death, negligence and a failure to warn her doctor of a link between Paxil and an increased risk of suicide.
In moving for dismissal, Paxil maker, GlaxoSmithKline, and Paxil generic maker, Apotex, relied on the FDA's position that state failure-to-warn claims are preempted.
The judge ruled that the defendants were entitled to a dismissal of all claims because the FDA controls the content of warnings and requires generic drug makers to use the same labeling as approved for the drug's original maker.
In this case, the judge on his own initiative, asked the FDA to submit an amicus brief. And in response, on the tax payer's dime, the FDA wrote a brief asking the court to rule against the American citizen and dismiss the lawsuit against the drug companies.
In fact the FDA was the strongest supporter of preemption in this case because according to the attorneys handling the case, Glaxo itself barely addressed the preemption issue during oral arguments on the motion.
In a decision that experts predict may end up before the US Supreme Court, the judge ended up dismissing the claims without ever considering whether the FDA regulations pose a conflict to the plaintiff's state tort claims.
Attorneys Derek Braslow, Harris Pogust and Matthew Leckman from the Conshohocken, Pennsylvania firm of Pogust & Braslow are representing the plaintiff in the case.
Attorney, Harris Pogust, says the judge's ruling "could potentially do away with all failure-to-warn pharmaceutical cases"
The FDA action he notes, "does not seem to be a public health concern as much as a political concern."
According to Mr Braslow, "the Judge readily admits that he did not analyze whether there is or was a conflict between state law and federal law and surmises that he probably would not find a conflict if he actually did the analysis."
"But, the Judge explained," he said, "that it doesn't matter - if the FDA says there is preemption, then there must be preemption. Far be it for a Judge to interpret the law."
"The Bush-era FDA," Mr Braslow notes, "in a complete reversal of the position it took in its 2000 rule proposal, has now officially cemented its role as a pawn for the pharmaceutical industry."
"It was not that long ago," Mr Braslow points out, "that the FDA came forward with amicus briefs on behalf of the consumer in prescription drug litigation."
"Now," Mr Braslow says, "an argument first put forward in a couple Zoloft suicide cases, has become the primary argument in every prescription drug case, and could," he warns, "potentially, mean the end for anyone seeking recourse from injuries resulting from prescription drugs, no matter how fraudulent the drug company's conduct."
"Make no mistake," he states, "the position taken by the Bush-era FDA is an attempt by the current administration to achieve tort reform for the benefit of big pharma and at the expense of the injured consumer, without the consent of Congress."
"The Bush-era FDA takes this position," he warns, "unconcerned by the reality that preemption would allow drug companies to peddle their drugs with impunity and avoid being justifiably called into court for deceiving the public about the safety and effectiveness of those drugs."
"Notwithstanding the FDA's position on preemption," Mr Braslow says, "courts examining this issue, if they take any time to actually look at the FDA regulations in question, would realize that there is no conflict between federal drug regulations and state tort claims."
"Federal drug regulations specifically mandate drug companies to strengthen their drug's label," he explains, "as soon as there is reasonable evidence of an association of a serious hazard with their drug."
"A state tort claim," Mr Braslow points out, "does not force a drug company to take any action that is not already permitted by federal regulations."
"Because federal regulations for prescription drugs are minimum standards," he notes, "federal regulations can never conflict with a state common law claim."
"The District Court erred," he states, "in abdicating to FDA legal opinion, as opposed to interpreting the law."
"What the Colacicco court did," he says, "was improperly abdicate to the FDA's legal opinion."
Critics say it's time for the FDA to get back to protecting consumers from dangerous products, rather than protecting the profits of the pharmaceutical industry.
According to career scientist, Dr David Graham, in a 2005 interview with Jeanne Lenzer in the journal Public Library of Science, "The pharma-FDA complex has to be dismantled and the American people have to insist on that, otherwise we're going to have disasters like Vioxx that happen in the future."
Big Pharma Braces For Democrat Hurricane
Evelyn Pringle November 2006
The morning after the mid-term elections, shares of drug company stock fell as Americans handed control of Congress back to the Democrats. Shares of Eli Lilly were down 1% in early trading, shares of Pfizer as much as 3%, and Schering-Plough dropped 3.7%.
Over all, since the election, major drug stocks have dropped more than 5%, according to Forbes.com on November 16, 2006. In fact, knowledge of the sure to come pressure from a Democratic Congress, caused stocks to fall across the board not only for drug companies, but for health insurers and pharmacy benefit managers as well.
Health insurers were hit the hardest. For instance, with Humana Inc, shares dropped nearly 6%, and shares of UnitedHealth Group were down 3.2%. Democrats say these firms have reaped great profits from the new Medicare prescription drug program that should have been passed on to seniors in the form of cheaper drug prices.
But the pharmaceutical industry itself remains at the top of the Democratic hit list. Democrats are pushing for stricter safety regulations at the FDA and plan to investigate drug pricing, direct-to-consumer advertising, and the marketing of drugs for off-label uses not approved by the FDA.
Democrats now have the power to hold hearings on the profits that drug makers, health insurers and pharmacy benefit managers have made since the prescription drug bill went into effect earlier this year.
And last but not least, Democrats reportedly will work to eliminate some of the liability protections the Republicans granted vaccine makers.
First up on the agenda is the promise to pass legislation to allow consumers to import cheaper drugs from Canada and have the government to negotiate for lower prices with drug companies on behalf of Medicare beneficiaries.
According to the November 24, 2006 New York Times, Big Pharma executives have been busy planning their battle strategy. “It’s all hands on deck,” Ken Johnson, a senior vice president at Pharmaceutical Research and Manufacturers of America, the industry's trade group, told the Times.
“It’s like a hurricane warning flag," he told the Times. "You don’t know where it will hit. You don’t know who will be affected. But everybody has to be prepared,” he said.
However, skeptics who question the ability of Democrats to make radical changes are quick to point out that Bush will still have the authority to veto any new legislation and his political appointees who run the FDA and Centers for Medicare & Medicaid, can drag their heels when it comes time to implementing provisions that will have a negative effect Big Pharma.
Moreover, as long as the Bush administration is in power, the FDA will no doubt continue to be the industry's strongest ally and there remains that nagging little matter involving the FDA's recently enacted "preemption rule" that seeks to ban private citizen lawsuits against drug makers in state courts once a drug and its label have been approved by the FDA.
The FDA apparently elected itself to be the sole authority for decisions regarding scientific and public health issues related to prescription drugs, including whether a drug's label contains an adequate description of indications, risks and benefits. In presenting this multi-billion dollar prize to Big Pharma, the FDA told drug makers:
"We think that if your company complies with the FDA processes, if you bring forward the benefits and risks of your drug, and let your information be judged through a process with highly trained scientists, you should not be second-guessed by state courts that don't have the same scientific knowledge."
The statement was made by FDA deputy commissioner, Scott Gottlieb, who recently managed a coup of his own by successfully gaining FDA approval to bring silicone gel breast implants back on the market, much to the joy of one of his former employers. Presumably, women who are injured by the implants will be barred from suing Mr Gottlieb's former employer as well in state courts.
Legal experts say the preemption rule was used to bring tort reform through the back door of the White House when the administration could not get it through the front. According to attorney, Ted Parr, of the Washington law firm of Ury & Moskow, "The FDA's position was a direct result of this administration's tort reform effort - after the administration failed to obtain tort reform in Congress, they decided to seek reform through administrative fiat."
Why would the administration engage in such a blatantly unlawful power grab? According to FDA career scientist, Dr David Grahma, "Because Big Pharma co-conspirators have realized that lawsuits threaten to bankrupt the drug companies."
"The products of these companies," he said during a June 29, 2006 interview for News Target, "are so universally harmful, and their ability to hide this truth is slipping away so rapidly, that the financial burden of settling lawsuits (or defending them in court) threatens to crush the entire pharmaceutical empire."
Dr Graham says the arrogance and greed in the industry will ultimately be its downfall. "They have pushed too hard, too far," he states, "and they have landed themselves in a realm of such obvious scientific fraud and criminal negligence that the backlash is inevitable."
The preemption claim comes at a time when experts are saying today's FDA is both unwilling and incapable of protecting consumers against Big Pharma. And the strongest criticism comes from within. On October 9, 2006, Dr Curt Furberg, of Wake Forest University Baptist Medical Center, was one of five current and former members of the FDA's Drug Safety and Risk Management Advisory Committer, who called for Congress to change how the FDA polices Big Pharma in the Archives of Internal Medicine journal.
Because of the FDA's poor performance in regulating the industry, Dr Furberg said, "new drugs are introduced on the market with inadequate safety documentation."
"Serious adverse drug reactions are later reported from the marketplace, and a large number of patients are unnecessarily injured before the drugs are withdrawn or better managed," he said.
The FDA's new preemption position breaks a long-standing presumption by the agency against preempting state tort claims and critics say the guy most deserving of the credit for the fiasco, is the FDA’s former Chief Counsel, Daniel Troy, appointed to his position at the FDA straight from Pfizer’s greenest pasture.
For a couple years, Mr Troy served as Big Pharma’s right-hand man until he quit the FDA in the fall of 2004, to return to the much more lucrative field of working directly for drug companies, but not before he stirred up plenty of grief for private citizens.
In the midst of the Vioxx and SSRI disasters, instead of prosecuting the drug makers for knowingly injuring consumers with dangerous product, Mr Troy devoted the majority of his time on the clock to filing 5 briefs on behalf of drug companies and against the private citizens who were paying his salary.
He even went so far as to give lectures on preemption during which he would invite Big Pharma attorneys involved in litigation against private citizens to submit their cases for his consideration and approval for future filing of amicus briefs by the FDA.
On March 1, 2004, an attorney in a case against Pfizer by the name of Jessica Rae Dart, filed an affidavit in support of a motion to describe a lecture given by Mr Troy in New York City that she attended. Ms Dart explained in great detail how he offered the FDA’s services to attorneys who were representing the giant drug companies.
On December 15, 2003, Ms Dart said in the affidavit, Daniel Troy headed a discussion for pharmaceutical firms and defense attorneys titled, “The Case for Preemption,” at the 8th Annual Conference for the In House Counsel and Trial Attorneys, Drug and Medical Device Litigation.
During Mr Troy’s portion of, “The Case for Preemption” discussion, she said, he stated that he was the initiator behind all the FDA Amicus Briefs and/or Statement of Interest filed on behalf of manufacturers “since the new administration” took over.
More specifically, he told the group, “I am not the only one who decides,” but “I am the initial proposer.”
Mr Troy made it clear, Ms Dart noted in the affidavit, that he wanted to file more briefs on behalf of Big Pharma and told attorneys in the audience how to submit successful requests for briefs, stating “we can’t afford to get involved in every case,” we have to “pick our shots,” so “make it sound like a Hollywood pitch.”
In 2004, Congressman, Maurice Hinchey (D-NY), sharply criticized the Bush administration for “seeking to protect drug companies instead of the public,” and persuaded Congress to eliminate $500,000 from the budget of the Chief Counsel’s office as a penalty for the FDA's aggressive opposition to lawsuits filed by private citizens.
In his amicus briefs, Mr Troy focused his main attention on protecting the profits of the makers of SSRIs starting off with Pfizer. These drugs are second only to Vioxx when it comes to a drug company's concealment of studies and information that if revealed, could have prevented tens of thousands of deaths and injuries over the years.
Although there have not been many successes when drug makers try to convince a court to dismiss a lawsuit based on the preemption rule, In re Bextra and Celebrex Marketing Sales Practices and Product Liability Litigation, No M: 05-1699 CRB, 2006 WL 2374742 (ND CA, August 16, 2006), another case against Pfizer, the court threw out the state failure-to-warn claims, saying the FDA specifically considered the safety risks alleged in the lawsuit and determined the risks should not be included on the label.
The court said the failure-to-warn claims “conflict with the FDA’s determination of the proper warning and pose an obstacle to the full accomplishment of the objectives of the FDCA.”
However, the court did not preempt the false advertising claims. The plaintiffs argued that Celebrex ads were false and misleading because they exceeded the labeled and approved gastrointestinal benefits and minimized the established risks.
Pfizer argued that because it submitted its ads for FDA approval, and the FDA did not object to them, the FDA had determined that the ads were both accurate and struck a fair balance between the risks and the benefits of the drug.
The court refused to preempt the false advertising claims without a record showing that the FDA had reviewed each ad and approved it. The court also noted the FDA’s silence about whether its regulations preempt false advertising claims, in contrast to its stated position on failure-to-warn claims.
However, according to Attorney Parr, state court judges overseeing other Bextra and Celebrex cases are likely to reach conclusions regarding preemption that are inconsistent, both with the federal court and with each other to some extent. "We really do not know yet how extensive the preemption problem will be nationwide," he says.
In May 2006, a federal court in Pennsylvania also applied the FDA’s preemption rule to the failure-to-warn claims against Paxil maker GlaxoSmithKline, and generic Paxil maker Apotex, in Colacicco v Apotex, Inc, Civ No 05-cv-5500, 2006 WL 1443357 (ED Pa May 26, 2006).
In this case, the FDA went to bat for the drug makers and filed a brief with the court stating in part, that in October 2003, when Paxil was prescribed to the suicide victim, "there was no reasonable evidence available at the time of an association between adult use of the drug and suicide."
On the other hand, the plaintiff has now drawn amicus support from a dozen scientists and doctors who evaluate pharmaceutical products and contend that preemption "would threaten the public health and eliminate an important counterpart to the public health objectives of the FDA."
The cases are currently making their way through the appellate process and experts predict that applications for review will proceed all the way up the US Supreme Court.
However, while the appeals process drags on for years, legal analysts say to look for more lawsuits with claims of consumer fraud, false advertising, and injuries from defective products which are not specifically implicated by the new preemption rule.
The morning after the mid-term elections, shares of drug company stock fell as Americans handed control of Congress back to the Democrats. Shares of Eli Lilly were down 1% in early trading, shares of Pfizer as much as 3%, and Schering-Plough dropped 3.7%.
Over all, since the election, major drug stocks have dropped more than 5%, according to Forbes.com on November 16, 2006. In fact, knowledge of the sure to come pressure from a Democratic Congress, caused stocks to fall across the board not only for drug companies, but for health insurers and pharmacy benefit managers as well.
Health insurers were hit the hardest. For instance, with Humana Inc, shares dropped nearly 6%, and shares of UnitedHealth Group were down 3.2%. Democrats say these firms have reaped great profits from the new Medicare prescription drug program that should have been passed on to seniors in the form of cheaper drug prices.
But the pharmaceutical industry itself remains at the top of the Democratic hit list. Democrats are pushing for stricter safety regulations at the FDA and plan to investigate drug pricing, direct-to-consumer advertising, and the marketing of drugs for off-label uses not approved by the FDA.
Democrats now have the power to hold hearings on the profits that drug makers, health insurers and pharmacy benefit managers have made since the prescription drug bill went into effect earlier this year.
And last but not least, Democrats reportedly will work to eliminate some of the liability protections the Republicans granted vaccine makers.
First up on the agenda is the promise to pass legislation to allow consumers to import cheaper drugs from Canada and have the government to negotiate for lower prices with drug companies on behalf of Medicare beneficiaries.
According to the November 24, 2006 New York Times, Big Pharma executives have been busy planning their battle strategy. “It’s all hands on deck,” Ken Johnson, a senior vice president at Pharmaceutical Research and Manufacturers of America, the industry's trade group, told the Times.
“It’s like a hurricane warning flag," he told the Times. "You don’t know where it will hit. You don’t know who will be affected. But everybody has to be prepared,” he said.
However, skeptics who question the ability of Democrats to make radical changes are quick to point out that Bush will still have the authority to veto any new legislation and his political appointees who run the FDA and Centers for Medicare & Medicaid, can drag their heels when it comes time to implementing provisions that will have a negative effect Big Pharma.
Moreover, as long as the Bush administration is in power, the FDA will no doubt continue to be the industry's strongest ally and there remains that nagging little matter involving the FDA's recently enacted "preemption rule" that seeks to ban private citizen lawsuits against drug makers in state courts once a drug and its label have been approved by the FDA.
The FDA apparently elected itself to be the sole authority for decisions regarding scientific and public health issues related to prescription drugs, including whether a drug's label contains an adequate description of indications, risks and benefits. In presenting this multi-billion dollar prize to Big Pharma, the FDA told drug makers:
"We think that if your company complies with the FDA processes, if you bring forward the benefits and risks of your drug, and let your information be judged through a process with highly trained scientists, you should not be second-guessed by state courts that don't have the same scientific knowledge."
The statement was made by FDA deputy commissioner, Scott Gottlieb, who recently managed a coup of his own by successfully gaining FDA approval to bring silicone gel breast implants back on the market, much to the joy of one of his former employers. Presumably, women who are injured by the implants will be barred from suing Mr Gottlieb's former employer as well in state courts.
Legal experts say the preemption rule was used to bring tort reform through the back door of the White House when the administration could not get it through the front. According to attorney, Ted Parr, of the Washington law firm of Ury & Moskow, "The FDA's position was a direct result of this administration's tort reform effort - after the administration failed to obtain tort reform in Congress, they decided to seek reform through administrative fiat."
Why would the administration engage in such a blatantly unlawful power grab? According to FDA career scientist, Dr David Grahma, "Because Big Pharma co-conspirators have realized that lawsuits threaten to bankrupt the drug companies."
"The products of these companies," he said during a June 29, 2006 interview for News Target, "are so universally harmful, and their ability to hide this truth is slipping away so rapidly, that the financial burden of settling lawsuits (or defending them in court) threatens to crush the entire pharmaceutical empire."
Dr Graham says the arrogance and greed in the industry will ultimately be its downfall. "They have pushed too hard, too far," he states, "and they have landed themselves in a realm of such obvious scientific fraud and criminal negligence that the backlash is inevitable."
The preemption claim comes at a time when experts are saying today's FDA is both unwilling and incapable of protecting consumers against Big Pharma. And the strongest criticism comes from within. On October 9, 2006, Dr Curt Furberg, of Wake Forest University Baptist Medical Center, was one of five current and former members of the FDA's Drug Safety and Risk Management Advisory Committer, who called for Congress to change how the FDA polices Big Pharma in the Archives of Internal Medicine journal.
Because of the FDA's poor performance in regulating the industry, Dr Furberg said, "new drugs are introduced on the market with inadequate safety documentation."
"Serious adverse drug reactions are later reported from the marketplace, and a large number of patients are unnecessarily injured before the drugs are withdrawn or better managed," he said.
The FDA's new preemption position breaks a long-standing presumption by the agency against preempting state tort claims and critics say the guy most deserving of the credit for the fiasco, is the FDA’s former Chief Counsel, Daniel Troy, appointed to his position at the FDA straight from Pfizer’s greenest pasture.
For a couple years, Mr Troy served as Big Pharma’s right-hand man until he quit the FDA in the fall of 2004, to return to the much more lucrative field of working directly for drug companies, but not before he stirred up plenty of grief for private citizens.
In the midst of the Vioxx and SSRI disasters, instead of prosecuting the drug makers for knowingly injuring consumers with dangerous product, Mr Troy devoted the majority of his time on the clock to filing 5 briefs on behalf of drug companies and against the private citizens who were paying his salary.
He even went so far as to give lectures on preemption during which he would invite Big Pharma attorneys involved in litigation against private citizens to submit their cases for his consideration and approval for future filing of amicus briefs by the FDA.
On March 1, 2004, an attorney in a case against Pfizer by the name of Jessica Rae Dart, filed an affidavit in support of a motion to describe a lecture given by Mr Troy in New York City that she attended. Ms Dart explained in great detail how he offered the FDA’s services to attorneys who were representing the giant drug companies.
On December 15, 2003, Ms Dart said in the affidavit, Daniel Troy headed a discussion for pharmaceutical firms and defense attorneys titled, “The Case for Preemption,” at the 8th Annual Conference for the In House Counsel and Trial Attorneys, Drug and Medical Device Litigation.
During Mr Troy’s portion of, “The Case for Preemption” discussion, she said, he stated that he was the initiator behind all the FDA Amicus Briefs and/or Statement of Interest filed on behalf of manufacturers “since the new administration” took over.
More specifically, he told the group, “I am not the only one who decides,” but “I am the initial proposer.”
Mr Troy made it clear, Ms Dart noted in the affidavit, that he wanted to file more briefs on behalf of Big Pharma and told attorneys in the audience how to submit successful requests for briefs, stating “we can’t afford to get involved in every case,” we have to “pick our shots,” so “make it sound like a Hollywood pitch.”
In 2004, Congressman, Maurice Hinchey (D-NY), sharply criticized the Bush administration for “seeking to protect drug companies instead of the public,” and persuaded Congress to eliminate $500,000 from the budget of the Chief Counsel’s office as a penalty for the FDA's aggressive opposition to lawsuits filed by private citizens.
In his amicus briefs, Mr Troy focused his main attention on protecting the profits of the makers of SSRIs starting off with Pfizer. These drugs are second only to Vioxx when it comes to a drug company's concealment of studies and information that if revealed, could have prevented tens of thousands of deaths and injuries over the years.
Although there have not been many successes when drug makers try to convince a court to dismiss a lawsuit based on the preemption rule, In re Bextra and Celebrex Marketing Sales Practices and Product Liability Litigation, No M: 05-1699 CRB, 2006 WL 2374742 (ND CA, August 16, 2006), another case against Pfizer, the court threw out the state failure-to-warn claims, saying the FDA specifically considered the safety risks alleged in the lawsuit and determined the risks should not be included on the label.
The court said the failure-to-warn claims “conflict with the FDA’s determination of the proper warning and pose an obstacle to the full accomplishment of the objectives of the FDCA.”
However, the court did not preempt the false advertising claims. The plaintiffs argued that Celebrex ads were false and misleading because they exceeded the labeled and approved gastrointestinal benefits and minimized the established risks.
Pfizer argued that because it submitted its ads for FDA approval, and the FDA did not object to them, the FDA had determined that the ads were both accurate and struck a fair balance between the risks and the benefits of the drug.
The court refused to preempt the false advertising claims without a record showing that the FDA had reviewed each ad and approved it. The court also noted the FDA’s silence about whether its regulations preempt false advertising claims, in contrast to its stated position on failure-to-warn claims.
However, according to Attorney Parr, state court judges overseeing other Bextra and Celebrex cases are likely to reach conclusions regarding preemption that are inconsistent, both with the federal court and with each other to some extent. "We really do not know yet how extensive the preemption problem will be nationwide," he says.
In May 2006, a federal court in Pennsylvania also applied the FDA’s preemption rule to the failure-to-warn claims against Paxil maker GlaxoSmithKline, and generic Paxil maker Apotex, in Colacicco v Apotex, Inc, Civ No 05-cv-5500, 2006 WL 1443357 (ED Pa May 26, 2006).
In this case, the FDA went to bat for the drug makers and filed a brief with the court stating in part, that in October 2003, when Paxil was prescribed to the suicide victim, "there was no reasonable evidence available at the time of an association between adult use of the drug and suicide."
On the other hand, the plaintiff has now drawn amicus support from a dozen scientists and doctors who evaluate pharmaceutical products and contend that preemption "would threaten the public health and eliminate an important counterpart to the public health objectives of the FDA."
The cases are currently making their way through the appellate process and experts predict that applications for review will proceed all the way up the US Supreme Court.
However, while the appeals process drags on for years, legal analysts say to look for more lawsuits with claims of consumer fraud, false advertising, and injuries from defective products which are not specifically implicated by the new preemption rule.
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