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.