More Trouble in Medtronic Heartland

Evelyn Pringle May 16, 2007

Minnesota based Medtronic is one of the world's largest suppliers of defibrillators through its Cardiac Rhythm Disease Management division and its top selling products are pacemakers and defibrillators. CRDM net sales for the 3 and 9 months ended January 26, 2007 were $1.291 billion and $3.904 billion, according to the firm's latest SEC filing.

In the Form 10-Q filing for the period ending January 27, 2007, the company predicts a profitable future for defibrillators stating, "the U.S. and worldwide implantable cardioverter defibrillators (ICDs), markets are greatly under-penetrated and represent a solid and sustainable growth opportunity."

A defibrillator is a device implanted in patients with abnormal heart rhythms to shock the heart back into a normal rhythm when necessary.

"The need for sudden cardiac arrest protection and heart failure treatment," Medtronic says, "is significant in the U.S. and even larger internationally."

The firm estimates the US market to have "a total prevalence pool of 1.3 million patients," and "the penetration level to be between 30 to 35%, leaving approximately 880,000 patients in the prevalence pool."

Medtronic also estimates that about 250,000 new patients enter the pool each year. 250,000 implants each year translates into huge profits. According to Dr Timothy Shinn, of the Michigan Heart and Vascular Institute, the cost of the surgery and life-time battery replacements for a defibrillator runs about $80,000 per patient.

However, there is a growing debate over whether defibrillators are being implanted in patients for profit. In January 2007, the Journal of the American College of Cardiology reported that researchers at the University of Michigan Medical Center, followed over 750 patients who were implanted with defibrillators between March 2001 and June 2004, and determined that as many as one third were unnecessary and that the elimination of the unnecessary procedures would result in savings of $690 to Medicare alone.

For patients, implanting defibrillators when they are not needed can lead to a life-time of worry, discomfort and health care costs. A recent study published in the May 2007, issue of Circulation found that the rate of failure for defibrillators increases over time and occurs with all models. The researchers found that one in 5 fails to work properly after 10 years and the risk was highest for women and healthier patients who are most likely to live for years.

According to the study, the electrical wires that connect the defibrillators to the heart are the source of the problem. The researchers found that the malfunctioning wires, called leads, sometimes cause the devices to fail when the heart begins to beat abnormally or stops completely. And at other times, the defibrillator shocks the heart for no reason.

Patients say the adverse events caused by the defective devices are uncomfortable and frightening. On September 30, 2005, one woman who was implanted with several defibrillators dating back to 1993, filed an adverse event report with the FDA's Manufacturer and User Facility Device Experience Database (MAUDE), and said the problem is serious and "these shocks nearly knock one off their feet with no warning."

In 1995, she said, a wire from the device that leads to the heart broke and rendered the defibrillator inoperable but the malfunction was only found during a periodic check-up after which the unit had to be replaced.

The woman said she had one device replaced in 2001 because the batteries were low and yet on September 13, 2001, when she was feeling fine, she received a shock treatment with no warning. The same month, when she was again feeling fine, she said she received 2 more major shocks in "rapid order."

After the woman spent a night in the hospital, it was concluded that something was wrong with the defibrillator so the device was turned off and she had to undergo another implant.

The woman noted in her complaint that Medtronic claims that the failure is to be expected at the end of equipment life, "like your chevy is out of warranty."

"To me this unacceptable," she said, "there must be some way of warning of a failure short of a shock."

The US Department of Justice is investigating Medtronic's marketing practices for devices used with heart disease patients. The US Attorney for the District of Massachusetts has served Medtronic with a subpoena requesting documents related to defibrillators, pacemakers, and related components; monitoring equipment and services; and the provision of benefits to persons in a position to recommend the purchase of such devices; as well as training and compliance materials relating to the fraud and abuse and the federal Anti-Kickback statutes.

In its SEC filing, Medtronic says the company "is cooperating fully with the investigation, and has begun to produce documents on a schedule requested by the United States Attorney."

However, a point worth noting is that when the firm claims it is "cooperating fully" and "has begun to produce documents," Medtronic is actually responding to a subpoena with a request for these documents that was issued way back on October 24, 2005.

Who knows how many document-shedding parties occurred over the past year and a half while Medtronic was "cooperating fully with the investigation."

The firm's track record for illegal marketing practices is far from spotless. Its not even been a year since it coughed up $40 million to settle charges with the DOJ after the firm was caught paying kickbacks to doctors to the increase sale of the company's spinal products. And we're not talking chump change. In that case, Medtronic paid a surgeon in Wisconsin $400,000 for a documented work schedule that amounted to less than 8 days that year.

Over the past several years, there have been a steady stream of recalls for Medtronic's defibrillators. In April 2004, the firm issued a recall for certain defibrillator models after they were linked to 4 deaths and one serious injury with about 1,800 of those devices in use at that time. The lawsuits that followed produced documents that showed Medtronic had continued to sell the defective products for at least 2 years after learning that there was a problem.

On February 3, 2005, the FDA web site posted a Class I recall for LIFEPAK 500 automated external defibrillators and said the action affected 1,924 devices manufactured in 1997. The reason given for the recall was that the affected devices might display a "Connect Electrodes" message and then will not defibrillate the patient, even when the electrodes are properly connected.

The LIFEPAK is used by first responders such as firefighters, police and others trained in CPR who are often first to arrive at the scene of a cardiac incident but do not have significant medical training.

A Class I recall is defined by the FDA as "a situation in which there is reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death."

On February 11, 2005, the FDA announced the possibility of a specific battery shorting mechanism in another subset of Medtronic defibrillators and reported that approximately 75% of the devices were implanted in the US with the number of patients that could be at risk listed as 87,000 at the time. On February 24, 2005, the FDA issued a Class I recall for these devices.

On February 25, 2005, Medtronic issued a press release saying the firm had received 54 incident reports on the LIFEPAK devices, including 8 where it may have prevented patient resuscitation. "In addition," it stated, "a recently completed theoretical engineering analysis estimates that this issue may occur on up to 8 percent of patients."

Less than 2 months later, Medtronic announced that it had identified an additional 396 LIFEPAK defibrillators to be added to the original recall.

There have been numerous recalls since that date; too many to list separately in fact.

Medtronic is also mired down with other regulatory issues. On December 4, 2006, it announced an intention to pursue a spin-off of Physio-Control, a subsidiary that markets external defibrillation and emergency response systems, data management solutions and support services used by hospitals and emergency response personnel, into an independent, publicly traded company.

However, on January 15, 2007, Medtronic was forced to suspend US shipments of Physio-Control products manufactured at its facility in Redmond, Washington after the FDA found quality system issues.

Medtronic claims it is discussing what corrective actions need to be taken with the FDA before shipping can resume. But according to its SEC filing, the firm expects "the suspension of U.S. shipments to continue into fiscal year 2008."

The company is also facing massive litigation over the defective defibrillators. In the SEC filing, Medtronic states: "While the number of cases filed changes continually, as of this writing there were approximately 910 federal court cases and approximately 65 state court cases, reflecting a total of approximately 975 individual product liability cases."

"In addition," it advises, "five purported class action personal injury suits have been filed in Canada."

Lawsuits have also been filed by third party payors claiming an entitlement to reimbursement for payments made on behalf of patients for the defective defibrillators.

All the Federal lawsuits have been consolidated for pretrial proceedings with a judge in the US District of Minnesota pursuant to the MultiDistrict Litigation rules, and separate master complaints have been filed in the MDL for the personal injury and third-party payor cases.

On November 28, 2006, Medtronic took a major hit when the Minnesota Court denied its motion to dismiss several hundred personal injury lawsuits in which Medtronic argued that the FDA's approval of the defibrillators preempted the lawsuits.

However, the court disagreed and Medtronic immediately made it clear that the company planned to appeal the ruling.

As of right now, it looks like some victims might actually get their cases heard before a jury; a rare event for any American consumer who goes up against the pharmaceutical industry. But on February 8, 2007, the Minnesota court issued a scheduling order for the MDL cases, and set the remainder of the year 2007 for discovery and pretrial motions, and "a ready for trial date for bellwether cases of January 2008," according to Medtronic's SEC filing.

Medtronic's Medical Device Legal Troubles far from Over

Evelyn Pringle July 31, 2006

Minneapolis based Medtronic, Inc. is one of the nation's largest medical device makers. In mid-July 2006, the company agreed to pay a $40 million fine to settle charges that its Sofamor Danek division paid kickbacks to doctors to get them to use the company's spinal products, which accounted for 20% of the company's $11.3 billion in sales in 2005.

On July 19, 2006 the US Department of Justice issued a press release announcing the settlement. The DOJ alleged that, between 1998 and 2003, Medtronic paid kickbacks in a number of ways, including sham consulting agreements, sham royalty agreements and lavish trips to desirable locations and that these kickbacks violated the Anti-Kickback Statute and the False Claims Act.

"Kickbacks to physicians are incompatible with a properly functioning health care system," said Peter Keisler, Assistant Attorney General for the DOJ's Civil Division. "They corrupt physicians' medical judgment and they cause overutilization and misallocation of vital health care resources."

"Today's settlement," he added, "reflects the progress we are making in the ongoing fight against abusive and illegal practices in the healthcare industry."

The DOJ's investigation was triggered by whistleblower qui tam lawsuits filed under the False Claims Act. The FCA allows private parties to file lawsuits on behalf of the US government and collect a share of any money recovered. The FCA prohibits any corporation or citizen from defrauding the government and the allegations against Medtronic in this instance involve the Medicare program.

"The settlement," said David Kustoff, the US Attorney for the Western District of Tennessee in the press release, "demonstrates that schemes involving submissions of false or fraudulent claims by health care companies and health care providers to federal health care programs will be vigorously and energetically pursued."

"This agreement," he noted, "should serve as a deterrent to those entities that attempt to defraud or deceive the taxpayers."

In addition to the fine, Medtronic entered into a 5-year corporate integrity agreement with the Office of the Inspector General of the US Department of Health and Human Services. The agreement requires the company to file regular reports with the Inspector General and track all non-sales related customer transactions.

The company must also set up an outside review organization, improve training and employee screening practices, and make a compliance officer a member of senior management, who reports directly to the chief executive and has access to the company's board of directors

The two whistleblower lawsuits filed by former employees claim Medtronic paid millions of dollars in kickbacks. For instance, Dr Thomas Zdeblick, a Wisconsin surgeon who is listed as a defendant in one of the lawsuits, signed a 10-year consulting contract with the company in 1998, that only required him to consult with Medtronic for eight days a year for $400,000.

A Virginia physician received close to $700,000 in consulting fees for the first 9 months of 2005, and received $1.39 million between 2001 and May 2005, according to the lawsuit.

Internal Medtronic documents filed as part of the lawsuit in the US District Court in Memphis, reveal the details of the rigorous campaigns that Medtronic set up to influence doctors. The documents show the company made payments of at least $50 million to doctors over a four years period through June 2005.

In the lawsuit unsealed in January 2006, the plaintiff, Jacqueline Poteet, a former senior manager of travel services for Medtronic until 2003, says she handled the travel arrangements for doctors to attend medical conferences and is familiar with the company's efforts to win the doctors' favor.

She alleges that the company gave spine surgeons "excessive remuneration, unlawful perquisites and bribes in other forms for purchasing goods and medical devices."

Spinal implants are used in a procedure known as spinal fusion, to make a patient's spine more stable. The cost of a devices used in this type of surgery is about $13,000, according to Orthopedic Network News, an industry newsletter.

In a subsequent amended complaint, Ms Poteet, accuses the company of continuing the improper payments to doctors in 2004 and 2005, leading them to perform unnecessary spinal surgeries.

With billions of dollars up for grabs, in addition to consultant fees, Medtronic used other creative methods to induce physicians to use its products. According to the lawsuit, Medtronic hosted medical conferences where the "principal objective" was to "induce the physician, through any financial means necessary" to use its devices.

Company spreadsheets show that after a conference, Medtronic went to great lengths to track the use of its devices by each doctor who attended. A spreadsheet for a June 2003 conference in California, lists over 200 doctors and includes an estimate of the dollar amount of the devices each doctor uses in surgery. One surgeon is described as "a 100 percent compliant M.S.D. customer" (Medtronic Sofamor Danek), and other doctors are marked as needing "special attention."

According to Ms Poteet, Medtronic zeroed in on surgeons while they were still in training, and the company paid for doctors to attend any of 200 professional meetings a year. If the doctors wanted to play golf or go snorkeling, she alleges, Medtronic paid for the outings. When doctors visited Memphis, she says, company employees would take them to the "Platinum Plus" strip club, and then write off the expense as an evening at the ballet.

In 2003, a company document reveals that Medtronic attorney, Todd Sheldon, questioned whether the company should be paying for all the excursions. "When we are sending scores of doctors to a nice resort like this under the guise of training and education on our products," Mr Sheldon wrote in an email, "I think we need to be more careful and stick to the limits of our rules as best we can."

Medtronic claims the company has scaled back payments to doctors, but not so, says Ms Poteet. Her amended complaint alleges that any changes made by Medtronic were merely temporary. Its "bribery program," she alleges, "has not only failed to cease, but continues unabated with increased payments made to many physicians."

She points out that while payments to some doctors were lowered in 2004, when the company first came under investigation, the payments went back up last year. For instance, Dr Hallett Mathews, of Virginia, was paid $300,000 in consulting fees in 2003, but only $75,000 in 2004. But then in 2005, he was paid nearly $700,000 in consulting fees in the first 9 months.

Had Medtronic not entered into a settlement agreement with the DOJ, the company could have been hit with a triple damages award if it lost in court, under a key provision of the FCA. As it is, the $40 million fine is the second financial penalty for Medtronic's spinal division in a year. In 2005 the company paid $1.35 billion to settle a patent infringement lawsuit and cover the costs of additional patents from Los Angeles surgeon and inventor, Dr Gary Michelson.

Over the past couple years, the financial relationships between device makers and doctors have caught the attention of several law enforcement agencies. In 2005, US attorneys in Boston and Newark issued subpoenas to Medtronic, along with just about every other major medical device maker, as part of a far reaching investigation into the financial entanglements between physicians and the industry as a whole.

Therefore, legal experts say Medtronic is probably not breathing much easier these days. Three of the subpoenas issued last fall went to the top cardiac-rhythm-management companies, Medtronic, Guidant and St Jude Medical, and seek information on their marketing practices related to pacemakers and defibrillators.

And Medtronic already had plenty of legal problems with its defibrillator division. In February 2005, the company told 87,000 patients that their defibrillators might fail.

However, company documents filed in the California lawsuit, Randall v Medtronic, No C-05-3707-JW, in the US District Court for the North District of California, show the company knew about the flaw back in 2003, and continued to sell the faulty devices for two more years.

"Medtronic has been taking products they know are not quite right and putting them into people rather than take the loss," according to Hunter Shkolnik, a New York attorney, who said in a February 13, 2006, interview with Bloomberg News, that he represents more than 200 people whose Medtronic devices were recalled.

"If you know there's a problem with a component," he said, "you don't put it out and sell it to people."

Since the recall, 19,000 people have had replacement surgery, Medtronic spokesman, Rob Clark, told Bloomberg News.

Critics say Medtronic refuses to acknowledge that undergoing replacement surgery is risky and constitutes an injury in itself. According to Bloomberg, based on Medtronic's estimate of a 2 to 5% post-implantation infection rate, 380 to 950 patients may have developed infections after replacement of their devices.

Spokesman Clark told Bloomberg that Medtronic does not keep track of deaths, disabilities or extra medical costs resulting from such complications.

When announcing the recall last year, Medtronic said it would provide a new defibrillator to patients and up to $2,500 for out of pocket expenses. But the company expects taxpayers, through programs like Medicare, and insurance companies, to pick up the tab for the hospital and doctor bills incurred during the replacement surgery.

However, the company is now facing scores of lawsuits claiming that patients should not be expected to bear any of the costs for having the devices replaced. About 200 lawsuits from states all over the country are seeking class-action status and have been consolidated in US District Court in Minneapolis before Judge James Rosenbaum.

Last month, Medtronic asked the Judge to dismiss the lawsuits, arguing that FDA regulations for medical devices preempt lawsuits in state courts and that the FDA has special authority over lifesaving or life-sustaining medical devices, such as defibrillators. "Any warning has to be regulated by the FDA," Medtronic attorney, Michael Brown, said.

But attorneys for the plaintiffs said Medtronic "glossed over" the problem in an October 2003, filing with the FDA that sought approval of a new defibrillator model, according to a July 11, 2006, article by the Associated Press.

Judge Rosenbaum is expected to issue a decision on Medtronic's motion in early fall.

Six months after the first recall in 2005, the company was in hot water with the FDA again over another group of devices. In a June 9, 2005 letter, the FDA said that Medtronic failed to correct manufacturing problems and investigate its LifePak 12 external defibrillators and cited damaged cable connectors and failures to follow through with preventive action after inspections of the company's Redmond, Washington plant.

The LifePak 12 external defibrillators, used in hospitals to shock the heart back to a normal rhythm, are similar to the LifePak 500 devices the company recalled. Medtronic's cardiac rhythm management business, which also includes pacemakers and implantable defibrillators, accounted for 46% of its $2.78 billion in sales in its latest quarter, according to Bloomberg News on June 22, 2005.

At the time, about 60,000 LifePak 12 external defibrillators were in use worldwide, Mr Clark said.

In the warning letter, the FDA said Medtronic did not investigate all complaints about defibrillator malfunctions, including one involving a patient's death. Problems were linked to broken or bent pins in the cable connectors, possibly because the company did not have adequate inspection procedures, the agency said. Failure to correct the problems may result in legal and civil penalties, the FDA warned.

Finally, in another turn of events that could have a negative impact on the financial future of the company, Medtronic is awaiting the final word on a Medicare proposal that would decrease reimbursement for procedures that are considered excessively profitable such as implanting heart devices.

Under the pending proposal, the Medicare reimbursement for implants would be cut from $31,833 to $23,755, or a loss of $8,078 for each procedure.

Ted Olson - Bush Administration Preemption Gang - Part I

Evelyn Pringle March 2008

The line up of attorneys supporting preemption for the device maker, Medtronic, in the US Supreme Court recently, demonstrates that no conflict of interest rules apply to attorneys who serve in the Bush Administration.

The former Solicitor General, Ted Olson, represented Medtronic and other attorneys who filed amicus briefs or participated in oral arguments urging a favorable ruling for the device giant included the former Assistant to the Solicitor General, Carter Phillips, and the former Chief Counsel of the FDA, Daniel Troy.

Mr Olson is the former boss of Edwin Kneedler, the Deputy Solicitor General who represented the Bush Administration in asking the Court to throw out the case, during oral arguments on December 4, 2007.

The case involved one lone citizen, Donna Riegel, whose husband died as a result of a faulty device, and the question for review was whether the preemption provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1976, preempts state-law claims against Medtronic for injuries caused by medical devices that received premarket approval from the FDA.

The Bush Administration filed a brief at the petition stage and told the Court not to review the lower court’s decision to dismiss the case at all. The list of current Administration attorneys on the briefs filed supporting Medtronic include the General Counsel of the Department of Health and Human Services, the Solicitor General, the Deputy Solicitor General, the Assistant Attorney General, the Assistant to the Solicitor General and two attorneys with no official title listed.

Most of these attorneys would have worked with Mr Olson, Mr Carter and Mr Troy, on briefs filed in cases before the Supreme Court when they were members of the Bush Administration.

As expected, the Court ruled against the private citizen and threw the case out. On February 21, 2008, the New York Times called it “a victory for the Bush administration.”

However, that victory may be short and sweet, because the Times also quoted Senator Edward Kennedy (D-MA), who sponsored the device legislation in 1976, as saying Congress never intended for FDA approval to give device makers blanket immunity from liability for injuries caused by faulty devices. “Congress obviously needs to correct the court’s decision,” he stated.

In addition, Representative Henry Waxman (D-Cal), chairman of the House Committee on Oversight and Government Reform, who was on the House panel that approved the Amendments, was also quoted in the Times as saying: “This isn’t what Congress intended, and we’ll pass legislation as quickly as possible to fix this nonsensical situation.”

The starting point for any preemption analysis is Congressional intent. What did Congress intend the words of a statute to mean when it was enacted. During oral arguments, Mr Olson professed to know what Congress "intended" when enacting the 1976 legislation.

However, he has never served in Congress where laws are made and his "public service" over the past 20 years has been limited to racing back and forth through the back door of the White House to do the dirty work for Republican Administrations in hopes of earning a position in the White House the next time a Republican President took office.

His success in helping George Bush Jr steal the 2000 election by representing him before the Supreme Court in Bush v Gore, which resulted in a 5-4 decision to halt the recount of votes in Florida, ordered by the Florida Supreme Court, no doubt earned him the appointment of Solicitor General.

Going back in time, from 1981 to 1984, Mr Olson was the Assistant Attorney General for the Office of Legal Counsel under President Ronald Reagan and Vice President, George Bush, Sr, and he later represented President Reagan during the Iran Contra scandal.

Prior to joining the Reagan Administration Mr Olson was a member of the Gibson Dunn & Crutcher law firm. The senior partner in the firm, William French Smith, was the personal attorney for President Reagan when he was governor of California.

After Mr Reagan became President, he made Mr Smith attorney general and Mr Smith brought two attorneys from his firm to Washington. He brought Ken Starr, another great patriot, to serve as his chief of staff and Mr Olson to serve as assistant attorney general in the Office of Legal Counsel.

Mr Olson’s history of dirty dealings while serving in the Reagan Administration and his prominent role in the plot to oust President Bill Clinton from office during the 1990s, came back to haunt him and almost derailed his confirmation as Solicitor General in the current Bush Administration.

As a starting point in considering whether Mr Olson was an appropriate candidate to serve as Solicitor General, at a May 17, 2001 hearing, Senator Patrick Leahy (D-Vt) described what a person in this high position should be by stating:

"The Solicitor General fills a unique position in our Government. The Solicitor General has great responsibility for the integrity of our laws. The Solicitor General is not merely another legal advocate whose mission is to advance the narrow interests of a client, or merely another advocate of his President’s policies. The Solicitor General is much more than that.

“The Solicitor General must use his or her legal skills and judgment to higher purposes on behalf of the law and the rights of all the people of the United States."

Senator Leahy further stated that the Solicitor General is the only government official who must be, according to the statute, "learned in the law."

"The Solicitor General," he pointed out, "must argue with intellectual honesty before the Supreme Court and represent the interests of the Government and the American people for the long term, and not just with an eye to short-term political gain."

At one hearing Mr Olson described what he believed a Solicitor General should be, but he certainly was not describing himself when stating:

"The Solicitor General holds a unique position in our Government in that he has important responsibilities to all three branches of our Government. . . . And he is considered an officer of the Supreme Court in that he regularly and with scrupulous honesty must present to the Court arguments that are carefully considered and mindful of the Court’s role, duty, and limited resources.

"As the most consistent advocate before the Supreme Court, the Solicitor General and the lawyers in that office have a special obligation to inform the Court honestly and openly. The Solicitor General must be an advocate, but he must take special care that the positions he advances before the Court are fairly presented.

“As Professor Drew Days said to this committee during his confirmation hearing 8 years ago, the Solicitor General has a duty towards the Supreme Court of ‘absolute candor and fair dealing.’"

On May 11, 2001, the Washington Post pointed out that Mr Olson had been accused of providing misleading testimony when he worked in the Reagan Justice Department. The story behind this assertion is that Mr Olson was the subject of an independent counsel investigation himself in the mid-1980s, after a finding by the House Judiciary Committee that he lied to Congress to cover up the Reagan Administration's political use of a “Superfund,” set up to fund the clean-up of hazardous waste sites, in doling out sweetheart deals to favored companies through the Environmental Protection Agency.

During the investigation, the Administration asserted executive privilege to withhold documents that had been subpoenaed by a two House Committees. An October 25, 1982 memo to President Reagan authored by Mr Olson, stated that the documents withheld contained no evidence of wrongdoing by Administration officials, a condition for asserting executive privilege, and "The Administrator [Anne Gorsuch Burford] concurs in this recommendation", This memo later became the lightening rod in the investigation.

First of all, the EPA Administrator, Ms Burford, had not agreed that the Administration should claim executive privilege and refuse to turn over the documents, and second, the documents withheld did contain evidence of wrongdoing by Rita Lavelle, the EPA Assistant Administrator, who was later convicted of perjury and obstruction of justice.

Pursuant to a directive signed by President Reagan, Ms Burford asserted executive privilege in response to both subpoenas in December 1982, and both committees cited her for contempt of Congress. From there, the investigation snowballed and Mr Olson hung Ms Burford out to dry and left her with no choice but to resign on March 9, 1983.

On March 10, 1983, Mr Olson was called to testify before the Judiciary Committee about the advice given by the Justice Department that led to the withholding the documents. The October 25, 1982 memo had still not been provided to the committee, yet when asked whether the Justice Department had turned over all the documents pertaining to the advice given to President Reagan, Mr Olson stated:.

"Well, Mr. Chairman, we tried to provide everything that we have that pertains to the advice that we have given. Most of those documents are published. I don't include handwritten notes of my own. I make Xerox copies of cases and make notes in the margin. There are scraps of paper probably everywhere. I'm not sure that we've included everything. We've included everything that we think is relevant to the questions that you've asked and to the advice that we've given."

In a February 1983 letter, the committee chairman had asked the Justice Department to "supply all documents prepared by or in the possession of the Department in any way relating to the withholding of documents that Congressional committees have subpoenaed from the EPA."

Mr Olson left the Justice Department and returned to Gibson Dunn & Crutcher, in the spring of 1984, and in the end, the Judiciary Committee obtained access to virtually all the documents sought. But the battle with the Justice Department to obtain the information turned out to be more exasperating than dealing with the EPA controversy itself. In its final December 1985 report, the Committee concluded that:

"[T]he Department of Justice, through many of the same senior officials
who were most involved in the EPA controversy, consciously prevented
the Judiciary Committee from obtaining information in the Department's
possession that was essential to the Committee's inquiry into the
Department's role in that controversy.

"Most notably, the Department deliberately, and without advising the Committee, withheld a massive volume of vital handwritten notes and chronologies for over one year.

"These materials, which the Department knew came within the
Committee's February 1983 document request, contained the bulk of the
relevant documentary information about the Department's activities
outlined in this report and provided a basis for many of the Committee's
"findings."

Among the other abuses cited in the report were the withholding of other documents until the committee had independently learned of their existence, as well as materially "false and misleading" testimony by the Office of Legal Counsel. "Theodore Olson gave false and misleading testimony at a Judiciary Subcommittee hearing on March 10, 1983," the report stated.

The Reagan Administration was compelled to appoint an independent counsel by the Judiciary Committee in 1986, to determine whether charges should be filed against Mr Olson for his part in covering up the EPA scandal.

Mr Olson filed a legal challenge to the constitutionality of the independent counsel provisions of the Ethics in Government Act of 1978, which was appealed all the way to the US Supreme Court, and resulted in an 1987 decision upholding the constitutionality of the Act, with the lone dissenting vote being cast by Justice Anthony Scalia.

In 2001, Ms Burford published the book, "Are You Tough Enough? An Insider's View of Washington Politics," and wrote:

"The people at Justice behind the push for executive privilege were all presidential appointees who, to be blunt, shared several characteristics: (1) they didn't have enough to do; (2) they weren't very good lawyers; and (3) they had tremendous egos. They wanted to make a name for themselves in Washington, and one way to do that while they were at Justice was to have their names on a Supreme Court case."

When President Reagan left office, Mr Olson was his attorney during the Iran-Contra scandal, in dealing with the Independent Counsel's office and directing President Reagan's now famous, “I don’t recall” testimony, in the legal proceeding and trials of other Reagan Administration officials and White House aides.

Jumping ahead to a more recent lawyering endeavor by Mr Olson on behalf of the Bush Administration, on May 16, 2007, Amy Kotz reported in "The American Lawyer," that a report by a special committee of the World Bank Group, questioned Gibson, Dunn & Crutcher's review of World Bank president Paul Wolfowitz's transfer of his girlfriend, Shaha Riza, to a high-paying job at the US Department of State.

Ms Kotz noted that documents released by the bank showed that Wolfowitz asked Gibson to review the deal in the summer of 2005 and a Gibson Dunn team, including Theodore Olson and Eugene Scalia, concluded that the contract was "a reasonable resolution of the perceived underlying conflict of interest."

Gibson landed the assignment because of its "ability to present a strong team within 24 hours," according to a memo from a Wolfowitz aide that was released by the board. This team included former Solicitor General, Theodore Olson, and employment partner, Eugene Scalia, Ms Kotz reports.

That would be the son of Supreme Court Justice Antonin Scalia, the Justice who wrote the opinion in Medtronic.

Ted Olson - Bush Administration Preemption Gang - Part II

Evelyn Pringle March 2008

Theodore Olson was one of the masterminds behind the Arkansas Project, which operated between 1993 and 1997, with the single-minded goal of trying to dig up, or in the alternative manufacture, enough dirt to get rid of the twice elected President, Bill Clinton.

His lies to Congress about his role in this sordid affair nearly derailed his confirmation as Solicitor General in the current Bush Administration.

The Arkansas Project was funded by more than $2 million from Pittsburgh billionaire Richard Mellon Scaife and funneled through the American Spectator magazine. While testifying before Congress at his confirmation hearings, Mr Olson lied through his teeth about his role in this plot.

At May 17, 2001 hearing, Senator Patrick Leahy (D-Vt), noted that his concern from the outset about Mr Olson serving as Solicitor General was whether Mr Olson's "sharp partisanship over the last several years might not be something that he could leave behind."

Through the course of the hearing and written questions, he stated, "Mr. Olson has not shown a willingness or ability to be sufficiently candid and forthcoming with the Senate so that I would have confidence in his abilities to carry out the responsibilities of the Solicitor General and be the voice of the United States before the United States Supreme Court. In addition, I am concerned about other matters in his background."

Specifically, Senator Leahy said, questions persisted about Mr Olson’s involvement with the American Spectator Magazine and the Arkansas Project.

He pointed out that Mr Olson had implied that his role was extremely limited as a member of the Board of Directors of the American Spectator Educational Foundation and that he was involved only after the fact, when the Board conducted a financial audit and terminated the Arkansas Project activities in 1998.

However, he noted that Mr Olson had subsequently modified his answers over time, and his recollection had changed, and he conceded additional knowledge and involvement. "His initial minimizing of his role," the Senator said, "appears not to be consistent with the whole story."

He recounted that in April, 2001, Mr Olson's testimony was that he was not involved, except as a Member of the Board but that over several weeks and several rounds of questions, Mr Olson had expanded his initial response to admit that he and his firm provided legal services in connection with the matter, that he had discussions in "social" settings with those working on ‘Arkansas Project’ matters, and that he himself authored articles for the magazine paid for out of Scaife’s special ‘Arkansas Project’ fund.

On April 5, 2001, in response to a question by Senator Leahy of whether he was "involved in the so-called ‘Arkansas Project’ at any time," Mr Olson responded by saying:

"As a member of the board of directors of the American Spectator, I became aware of that. It has been alleged that I was somehow involved in that so-called project. I was not involved in the project in its origin or its management."

According to Senator Leahy, after some additional correspondence, Mr Olson changed his answer stating: "My only involvement in what has been characterized as the ‘Arkansas Project’ was in connection with my service to the Foundation as a lawyer and member of its Board of Directors."

When first asked about a vicious article he coauthored that was published anonymously under the pseudonym "Solitary, Poor, Nasty, Brutish and Short" in the Spectator, Mr Olson did not acknowledge that the magazine had hired his firm to prepare such materials or to perform legal research on the theoretical criminal exposure of the President and First Lady based on press accounts of their conduct.

Mr Olson testified that the article contained "statements of a private citizen." However, he failed to explain why, as a private citizen, he chose to make his public attacks on the Clintons anonymously.

Senator Leahy later quoted Mr Olson's law partner, Doug Cox, as telling the Washington Post that he and Mr Olson worked on legal matters for the American Spectator, which included legal research that was incorporated into an article published in 1994, under a fictitious name and claimed that the President might be facing up to 178 years in prison and the First Lady 47 years in prison.

Senator Leahy noted that Mr Olson and Mr Cox “have now acknowledged-- that Mr. Olson co-authored a number of articles for the American Spectator for which he or his firm were paid with Scaife funds and that Mr. Olson provided legal advice in connection with other efforts funded with Scaife funds in connection with the ‘Arkansas Project’.”

In a May 14, 2001, letter to Senator Orin Hatch, Mr Olson wrote that he and his law firm participated in the researching and writing of, "informational material which the magazine chose to publish under the pseudonym ‘Solitary, Poor, Nasty, Brutish and Short'."

Mr Olson then incorporated a portion of the retainer letter between the American Spectator and his firm and indicated, "my firm was paid our normal billing rates."

Senator Leahy pointed out that Mr Olson had previously written to him on this point and stated: "I received payments for articles authored or co-authored by me. The fees ranged from $500 to $1,000 per article, as I recall."

The Senator then stated, “I find it hard to imagine that Mr. Olson’s normal billing rates and those charged by his firm would yield only $500 to $1,000 per article.”

He also objected to the fact that he was unable to get Mr Olson or the magazine to provide billing records to clear up the matter once and for all.

However, Senator Leahy quoted the May 10, 2001, article in the Washington Post that said over $14,000 had been paid to Mr Olson’s law firm and specifically attributed by the American Spectator Magazine to the Arkansas Project.

At the time of the hearing and his answer to all the question, Senator Leahy said, “Mr. Olson was well aware of what the ‘Arkansas Project’ run by the organization for which he acted as lawyer, author and contributor, Board Member and officers had involved.”

“He had been presented with an audit and played a pivotal role in reviewing the examination of its management, methods and results,” he pointed out.

David Brock, a former reporter for the American Spectator and the author of some of the most vicious Clinton articles published, came forward and told the Judiciary Committee staff that Mr Olson attended several meetings at the home of R Emmett Tyrrell Jr, the editor of magazine when ideas for editorials were discussed by the Arkansas Project.

Mr Brock reported that Mr Olson was also not truthful about his role in ghostwriting smear-Clinton articles in Spectator magazine. For instance, he said, Mr Olson encouraged the publication of a story with speculation about Vince Foster being murdered, even though Mr Olson himself believed Mr Foster had committed suicide, to keep the heat on the Clinton Administration until another scandal was shaken loose.

In response to questions about the Vince Foster article, Mr Olson did not deny Mr Brock’s account of the events, he simply wrote that he told Mr Brock that the article did not appear to be libelous or to raise any legal issues that would preclude its publication, and that he was not going to tell the editor-in-chief what should appear in the magazine.

In the May 21, 2002, New York Observer, Joe Conason reported that the financial records of the American Spectator Educational Foundation showed several payments in 1994 to Mr Olson's law firm, that were "listed explicitly as Arkansas Project "expenses."

Mr Conason says another attendee at the meetings that Mr Brock referred to was David Henderson, a Spectator foundation director who served as an overseer of the project. He also reports that Mr Brock's assertion was corroborated by a letter in which the Spectator's publisher named persons who regularly attended the meetings at his home, and the first name on the list, which included Mr Brock and Mr Henderson, was "Ted Olson."

In 1998, a series of articles in Salon magazine by Murray Waas provided an inside look at the shenanigans going on behind the scenes in the midst of Ken Starr’s Whitewater Investigation.

According to Mr Waas, Mr Olson was providing advice to the Arkansas Project, dating back to its inception in late 1993 or early 1994 and in fact, "one of the initial meetings to set up the Arkansas Project was held at Olson's downtown Washington, D.C., office at Gibson, Dunn & Crutcher."

Yet, at an April 2001 hearing, Senator Leahy asked Mr Olson whether there had been any meetings of the Arkansas Project in his office and he responded: "No, there were none."

In follow-up written questions, Senator Leahy asked in particular about the time frame of 1993 and 1994, and Mr Olson answered that he was, "not aware of any meeting organizing, planning or implementing the ‘Arkansas Project’ in my law firm in 1993 or 1994."

Senator Leahy then followed up by drawing his attention to a passage out of the book, “The Hunting of the President,” in which the authors wrote that a meeting did take place at his office in November 1993, with David Henderson, Steve Boynton, John Mintz, Ronald Burr and Michael Horowitz, at which the topic was using Scaife funds and the American Spectator to, "mount a series of probes into the Clintons and their alleged crimes in Arkansas."

In response, Mr Olson did not deny that a meeting took place but disputed the description of the topic of the meeting and noted that he did, "not recall the meeting described."

During the confirmation proceedings, Mr Olson also lied through his teeth about how he ended up representing David Hale, a corrupt municipal judge in Arkansas facing a multitude of criminal charges who served as the "star" witness in the Whitewater fiasco claiming that President Clinton had pressured him to make a fraudulent $300,000 loan to Susan McDougal.

Mr Hale himself is a real piece of work. He ran the investment firm, Capital Management Services, and received matching funds from the Small Business Administration to administer loans to disadvantaged companies. However, a federal investigation showed that although Capital financed over 50 companies, Mr Hale secretly owned 13.

In 1994, Mr Hale pleaded guilty to fraud and conspiracy, but with more than a little help from his friends in high place, the low-life crook was able to avoid being sentenced for two more years.

When Senator Leahy asked Mr Olson at an April 5, 2001 hearing, how he came to represent this crook, he replied, "[t]wo of [Hale’s] then lawyers contacted me and asked ..."

A few seconds later he stated, "[o]ne of his lawyers contacted me– I can’t recall the man’s name– and asked whether I would be available to represent Mr. Hale in connection with that subpoena here in Washington, D.C. They felt that they needed Washington counsel with some experience dealing with a congressional investigation. I did agree to do that. Mr. Hale and I met together."

A little over a month later, in a May 9, 2001, letter, Mr Olson wrote, I "cannot recall when [he] was first contacted about the possibility of representing Mr. Hale."

He further states that he believes, "that [he] was contacted by a person or persons whose identities [he] cannot presently recall sometime before then regarding whether I might be willing to represent Mr. Hale if he needed representation in Washington.”

“As I recall,” Mr Olson wrote, “I indicated at the time that I might be able to do so, but only in connection with a potential congressional subpoena, not with respect to legal matters pending in Arkansas. . . .”

“I believe that this meeting was inconclusive because Mr. Hale did not at that time need representation in Washington," he stated.

One of the names that Mr Olson could not remember, even though he apparently wracked his brain for over a month, was David Henderson, the director of the Arkansas Project.

On May 11, 2001, the Washington Post may have helped jog Mr Olson’s memory when it reported that Mr Henderson said he had made the introduction when Mr Hale came to Washington to find a lawyer who could help him deal with a subpoena from the Senate Whitewater committee, and Mr Henderson sat in on a meeting.

During a May 17, 2007 hearing, Senator Leahy stated in regard to the wanna-be Solicitor General: “It now strikes me as strange that a man as capable as Mr. Olson with his vast abilities of recall could not remember the name of David Henderson.”

“It leads one to wonder,” he continued, “whether Mr. Olson’s failure to recall the name David Henderson had something to do with his not wanting to indicate the connection to such a central figure in the ‘Arkansas Project’.”

He also pointed out that a January 1996, letter written by Mr Olson to accept membership on the board of directors of the American Spectator was addressed to the publisher of the magazine and was copied to Mr Henderson.

When the Senate Whitewater Committee hearings got underway, not surprisingly, the Democrats were eager to call Mr Hale to testify because he was supposed to be the star witness in the Whitewater witch-hunt and the only person who had made any direct allegations of wrongdoing against President Clinton.

However, whenever efforts were made to bring in Mr Hale to testify, Mr Starr would claim that his appearance might hinder or impede his investigation, although Mr Hale continued to make his allegations against the President through the media where they of course were impossible to refute. As the minority, the Democrats were hamstrung, because they had no power to issue a subpoena to Mr Hale to compel his testimony.

When the pressure mounted to bring Mr Hale to Washington, Mr Olson jumped in to save the day by saying his busy schedule would not permit him to represent Mr Hale at the moment because he was preparing for 2 cases before the US Supreme Court in early 1996, and so the Committee would have to wait until he disposed of those cases.

Six month later on June 6, 1996, the Senate committee received a letter from Mr Hale’s attorneys, stating in part: "Mr. Hale will claim the protection of his Constitutional privilege under the Fifth Amendment to the Constitution of the United States and respectfully decline to testify ... if he is compelled to appear in response to the subpoenas."

John Mintz, a former general counsel for the FBI, also represented Mr Hale, and the question that has never been answered, is where would a bankrupt municipal judge get the money to hire a former assistant attorney general and high-ranking attorney in the FBI.

A report released in May 2001, stated that Mr Olson provided "approximately $140,000 in legal representation for which Hale has not paid and which has been written off by Olson's law firm as uncollectible."

The report also stated: "There is certainly reason to believe that Olson took on Hale as a 'paying' client with no real expectation that he would ever be paid."

The Senate Whitewater Committee ended its investigation without ever hearing from the man lauded as the star witness in the case against President Clinton.

However, Mr Hale was the star witness in the 1996 trial against Arkansas Governor Jim Guy Tucker and James and Susan McDougal. At the trial, Mr Hale testified that he had found Mr Olson through Randy Coleman, a Little Rock criminal defense attorney who represented him at the time, and that he was also assisted in the effort to find the Washington attorney by a "Senator Hollingsworth."

Had Mr Hale told the jury about the role of Stephen Boynton and David Henderson in helping him find Mr Olson, it would have certainly led to revelations about the Arkansas Project, including the money paid to Mr Hale as the key source for the demented plot.

In March 1998, Murray Waas and Jonathon Broder revealed in Salon Magazine that Mr Hale had received cash payments from the Arkansas Project regularly from 1994 to 1996. They quoted eyewitnesses Caryn Mann and her son who reported that after Mr Hale became a federal witness in the Mr Starr's investigation, he received payments from as little as $40 to as much as $500.

Sources told Salon that Mr Scaife funded the Project through tax-exempt foundations. “Under the scheme,” they wrote, “two of Scaife's charitable foundations transferred as much as $600,000 a year to a third charitable foundation, which owns the conservative American Spectator magazine“.

Most of the money was then transferred to Stephen Boynton, described in Salon, as an attorney and conservative political activist with long-standing ties to Scaife.

The article explains that a portion of the funds went to a Parker Dozhier, a sportsman and fur trapper in Hot Springs, Arkansas, who then made the payments to Mr Hale, and quotes Caryn Mann, Mr Dozhier's former live-in girlfriend, and her son Joshua Rand.

They told Salon that they witnessed the payments while Mr Hale was staying at Mr Dozhier's fishing cabin complex between 1994 and 1996. Ms Mann stated that Mr Dozhier was well compensated for his role in the scheme and that she kept the books and kept track of the incoming checks from Mr Boynton and his associate, David Henderson.

She told Salon that checks began arriving sporadically in 1994, but by 1995, $1,000 checks arrived monthly and that Mr Boynton and Mr Henderson showed up often to speak to Mr Hale and Mr Dozhier, and after they left, there was "always an abundance of cash."

"Sometime it was only $40, $60 or $80 at a time, but other times it was $120 or $240 or $500," Mr Rand explained in the article.

"If Hale needed to pay a $200 bill, Parker would give him the money, plus an extra $100 or $120 for his pocket,” he said.

Speaking on the condition of anonymity, 2 former executives of the American Spectator, corroborated the story that funds from the Project went to Mr Hale. One executive stated: "Henderson told me that David Hale's family needed to be taken care of, and they had a way of doing that," and the second verified that account, according to the Salon report.

On April 13, 1998, Time Magazine reported that the attorney general, Janet Reno, wanted to examine the payments made to Mr Hale, but she still had not decided how.

The article notes that if she referred the matter to Ken Starr, “that means he would be investigating both his chief witness, Hale, and his own likely future benefactor, Scaife, who is partially funding two Pepperdine University deanships that Starr is supposed to settle into after Whitewater.”

In a series of reports for Salon in August 1998, Murray Waas reported that:

“In addition to his involvement with the American Spectator, Olson has served on the advisory boards of four separate Washington, D.C., conservative organizations that have received substantial funding from Scaife, according to a Gibson, Dunn & Crutcher biography of Olson and financial disclosure statements of the four political groups.”

Mr Waas also noted that Mr Olson's wife, Barbara, was a founder and member of the advisory board of the Independent Women's Forum, which he said had “received at least $350,000 in funding from Scaife over the last several years.”

The American Spectator served as a launching pad for the whole Paul Jones fiasco which started with what came to be called the, "Troopergate" article, authored by David Brock, alleging that Arkansas state troopers had helped procured women for then Governor Clinton and claiming that a woman named, "Paula," had told a state trooper that she would be willing to be the Governor’s girlfriend.

In April 1998, the Chicago Sun-Times reported that two of the troopers who were sources for the article, Larry Patterson and Roger Perry, were paid by Peter Smith, a Chicago investment banker, described as a large GOP contributor, “who spent about $80,000 over 18 months to get tales about Clinton's personal life into print,” in Time Magazine on April 13, 1998.

Mr Brock has since publicly apologized to the Clintons for his reporting in the Spectator and acknowledged that the troopers who claimed they procured women for then Governor Clinton had received money.

Behind the scenes, the Olsons were working hand and glove with the Jones attorneys. In 1994, Mrs Olson's Women's Forum considered filing an amicus brief in support of Paula Jones and the attorney with whom the group discussed the brief was none other than Ken Starr.

When it came time to argue whether a President could postpone litigation until he leaves office, before the Supreme Court, in early 1997, Mr Olson, and the rejected Supreme Court Justice of the Reagan Administration, Robert Bork, held a moot court to allow the Jones attorneys to practice their arguments before the hearing.

For her part, Barbara Olson, now deceased, devoted much of her time as wife of the bush Administration’s future Solicitor General, writing the book, "Hell to Pay," and literally trashed Hillary Clinton, the First Lady of the United States.

Feds Investigate Profits From Off-Label Stent Procedures - Part II

Evelyn Pringle May 2007

In addition to the federal investigations into the off-label marketing of drug eluting stent by Boston Scientific and Johnson & Johnson, on May 10, 2007, Rep Maurice Hinchey (D-NY), who serves on the House Appropriations Subcommittee, announced the introduction of the FDA reform bill which addresses the issue of doctors using products for unapproved uses, which usually occurs without the patient's knowledge or consent.

If a doctor does not inform a patient that the FDA has not approved the use of a device or procedure, medical experts say, the patient cannot give meaningful consent because the potential problems that can result from the off-label use must be explained so that the patient can weigh the risks and benefits to determine whether to consent to the treatment.

Medical professionals point out that if a doctor wants to use a treatment that is not FDA approved because of a true belief that a certain patient would benefit from a specific treatment more than from others that are FDA approved, the doctor would not hesitate to explain the reasoning to the patient.

The FDA Improvement Act reform bill introduced by Rep Hinchey would require doctors to inform patients when a product is used off-label and also provide more resources to the FDA to go after companies that promote off-label use of their products despite the fact that doing so is illegal.

In recent months, lawmakers have made it clear that investigation of the stenting for profit industry is a top priority and will include not only the device makers, but also the doctors and medical facilities performing the procedures.

Being Congress oversees the spending by public programs like Medicare and Medicaid, lawmakers would have to be blind not to notice the obscene rise in profits. According to the May 17, 2007 Wall Street Journal, “Americans spent at least $14 billion on coronary-stent procedures last year, including surgical and hospital fees.”

Stenting doctors are very well paid. The median salary for invasive cardiologists who perform the procedures is roughly half-a-million dollars a year, says Darshak Sanghavi, a pediatric cardiologist and assistant professor of pediatrics at the University of Massachusetts Medical School, in Slate Magazine on May 8, 2007.

However, doctors and medical facilities may now be reevaluating the benefits of continued off-label stenting since law enforcement officials released information this month from an investigation by the FBI and the US Department of Health and Human Services of a cardiologist at a facility in Maryland that found 25 unnecessary stents implanted in patients in 2006 alone, with the majority billed to Medicare.

The bare-metal stenting procedure was originally marketed as a cheaper alternative to heart bypass surgery, but since the arrival of the DES, that claim is bogus. On February 25, 2007, the New York Times quoted the American College of Cardiology in reporting that the average cost of the DES procedure has risen to about $30,000, or almost equal to the price of open heart surgery for patients with multiple blockages.

The DES were promoted as being safer than bare-metal stents, but on March 8, 2007, the New England Journal of Medicine published an analysis of 4 studies that compared the DES and bare-metal stents with 4 years of follow-up, and found no significant differences in the rates of death, myocardial infarction, or stent thrombosis with the survival rate in the DES group at 93.3%, and 94.6% in the bare-metal group.

In December 2006, the FDA's Circulatory System Devices Advisory Committee held a hearing to review data on the outcome of DES stenting when they were implanted according to their label compared to when they were used off-label. Dr Ron Waksman, of the Washington Hospital Center, told the panel the rate of stent thrombosis almost doubled in patients with off-label use versus on-label use at 30 days and at 12 months.

He also said, "when we look at on-label and at off-label, the drug‑eluting stents are more thrombogenic than bare-metal stents."

With both on-label and off-label use, he informed the panel, over time, "late stent thrombosis is seen more in the DES versus the bare-metal stents."

Dr Waksman said that careful patient selection for DES is mandatory, and "off-label use should be reconsidered or restricted."

Diabetic patients with multi vessel disease should always be referred for bypass surgery, he added. DES should be contraindicated, he said, "for patients with poor compliance or allergic to Plavix or aspirin and need for upcoming surgery, and warning labeling should be considered for those when used off-label."

But experts point out that some studies have shown little benefit from taking the anti-clotting, blood-thinning drug Plavix to prevent stent-thrombosis. In October 2006, Dr Alaide Chieffo, made a presentation at a Transcatheter Cardiovascular Therapeutics meeting and reported a study of 3,021 DES patients that found 9 out of 16 patients who had developed late stent-thrombosis were being treated with Plavix at the time.

At the FDA meeting, Dr Peter Smith of Duke University discounted the claims that stenting is safer or as effective as bypass surgery and warned of the importance of weighing the risks and benefits to patients treated with the different procedures.

He stressed that since the introduction of DES, too many patients in need of bypass surgery are instead receiving off-label stenting procedures. "A current perspective," he said, "is that America's number one killer is predominantly treated with percutaneous methodology that has not been demonstrated to provide a survival advantage."

"And this is particularly important," he advised, "for the treatment of multi vessel coronary disease where substantial quality of life and survival benefits have been conclusively demonstrated for bypass grafting."

Dr Smith informed the panel of some of the outcomes reported in peer-reviewed published trials, the first a study of 14,000 patients, which demonstrated a significant survival advantage for bypass grafting compared to stenting in three vessel heart disease, he said.

The ROBUST New York State audited database, he reported, of 23,000 patients with three vessel disease published in the New England Journal of Medicine also showed a significant survival advantage for bypass grafting compared to stenting at 3 years.

Dr Smith explained that bypass grafting is more effective because it provides complete revascularization. While stenting treats the isolated blockage, grafting bypasses about two-thirds of the vessel where current and future blockage can occur.

In addition, he noted, bypass risks increase little with increasing coronary disease severity while risks with stenting appear to increase with each additional stent.

He also told the panel, "surprisingly, when we looked at the bare-metal stent era data, we saw point estimate trends favoring bypass grafting even for low and intermediate severity disease, and an extension of the significant advantage that bypass grafting provides compared to intervention for high severity coronary disease."

Dr Smith said the introduction of the DES led to a tripling of the use of stenting for high severity coronary disease. "And for the first time," he noted, "less than half the patients were initially offered coronary bypass grafting."

"How can this happen," he pointed out, "with the absolute survival advantage that I've shown you from these observational data on 40,000 patients showing that at 1 year, there's a 2.3 percent advantage, absolute advantage in bypass grafting versus stenting; 4.3 percent at 3 years; 5.1 percent at 5 years."

That means 1 out of every 20 patients, he said, who were treated with stenting would have survived if they had had bypass grafting. When you translate into real world application, assuming that drug‑eluting stents are equivalent to bare-metal stents for the mortality outcome, he advised, approximately 1.5 million drug‑eluting stents are implanted worldwide, 850,000 in the US.

Using data from the DEScover trial about stents per patient in the incidence of three vessel disease, he said, we estimate that 160,000 are with DES worldwide and 92,000 in the US.

Dr Smith informed the panel that this translates into a rate of premature death at 1 year to 3,800 patients worldwide, with 2,000 in the US, and 16,000 patients deaths at 3 years, with 9,000 in the US.

"Annualized," he said, "this is 6,500 worldwide, 3,600 in the U.S."

At the end of his presentation Dr Smith addressed previous claims made to the panel by the industry that off-label extension of DES was meeting "an unserved need."

"We're not certain whose unserved need that is," he said, "but we're fairly certain that it's not the need of our patients."

Another major selling point used by the stent makers has been to claim that bypass surgery is riskier. However, a study presented at the American Heart Association's Annual Conference in April 2007, determined that the DES procedure and surgery have about the same risk for a major cardiac event based on an analysis of 799 DES patients and 799 bypass patients for outcomes in the first 30 days and during the following 3 years.

Lead author, Dr Wilson, a program director at St. Luke's Episcopal Hospital and Texas Heart Institute, said in Science Daily on April 21, 2007, “We found that the likelihood of any complication in the hospital was the same whether you had a drug-eluting stent or bypass.”

“Five percent of drug-eluting stent patients,” he said, “had some major complication in the hospital, mostly heart attack, as opposed to about 3.8 percent of the patients who had bypass.” At 3 years, the study found, the death rate with bypass was 6.6% and 9% with drug-eluting stents.

The results of a study called COURAGE released in March 2007, may turn out to be the final nail in the coffin for Boston and J&J. The study involved over 2,000 patients who were treated for chronic, stable chest pain, and revealed that medication therapy alone reduced chest pain almost as well as when the drugs were combined with stenting.

Experts say the outcome is probably due to the fact that stenting only fixes one artery blockage at a time while drug treatment affects all arteries.

Many stable heart patients are conned into stenting because they believe that it will extend their lives and lower their risks for heart attack but according to the New York Times, the COURAGE study found that patients who received stents and drugs had the same life expectancy and same number of heart attacks as patients who received drugs only.

The study reported the rate of heart attack, stroke or death in patients who received stents was 20%, compared to 19.5% in patients who used drugs alone. At the end of 4.6 years, there were 211 deaths, or 19% among patients in the group who received stenting compared with to only 202 deaths, or 18.5% in the medication group.

"Our findings parallel those reported in recent trials," said William Boden, chief of cardiology at Buffalo General and Millard Fillmore Hospitals.

"In the aggregate,” he told United Press International on March 26, 2007, “these studies ... show that percutaneous coronary intervention -- angioplasty plus stenting -- has no effect in reducing major cardiovascular events."

"There are hundreds of thousands of Americans who are currently getting stents placed who do not need it as initial therapy," said Dr Raymond Gibbons, professor of medicine at the Mayo Medical School and president of the American Heart Association, to UPI.

In response to the study, on the March 28, 2007, WSJ Health Blog, Dr Andy Demajio wrote, "It has been distressing to see how interventional cardiologists have been happily stenting their patients to fatten their wallets."

"This immoral practice should come to a stop," he wrote. "My hope is that the COURAGE data may help payers take action against these doctors."

It appears that doctors and hospital administrators are thinking twice about off-label DES stenting. On May 17, the Wall Street Journal reported that April marked the 10th consecutive month of share decline for DES, quoting the Millennium Research Group, a firm that surveys about 140 US hospitals, that put the percentage of stentings with a coated stent at 69.7%, down from almost 90% last in June 2006.

Until April doctors had largely replaced the more-expensive DES with older, bare-metal stents, the Journal said. “The new data,” it notes, “indicate that doctors and patients may be skipping stentings completely in favor of drug treatment.”

It sure looks that way according to Boston's first quarter SEC filing, that reported worldwide sales of its DES had dropped to $468 million in the first quarter of 2007, down from $633 million during the first quarter of 2006.

The SEC filing also shows that J&J has plenty of other problems. For instance, the company is currently facing over 75 class action lawsuits and 1,100 individual lawsuits related to potentially defective defibrillators and pacemakers manufactured by Guidant, a company Boston acquired in April 2006.

J&J future isn't looking too rosy either. Sales of the Cypher stent are down by more than 25%, according to the firm's first quarter SEC filing and in addition to DES, J&J is currently under federal investigation over the marketing practices for several other products including the antipsychotic Risperdal, the anti-seizure medication Topamax, the heart-failure drug Natrecor, and paying kickbacks to doctors for using the firm’s orthopedic devices.

In March 2007, J&J received new subpoenas from US attorneys in Philadelphia, Boston and San Francisco pertaining to the investigations of the 3 drugs seeking information about corporate supervision and oversight of the subsidiaries that market the drugs including Janssen, Ortho-McNeil and Scios.

In addition, according to SEC filings, as of December 31, 2006, 100 lawsuits were pending against J&J related to the Charite artificial spinal disc, basically alleging that the company knew the disc was defective and boosted profits by marketing the device for off-label uses.

On May 10, 2007, the Wall Street Journal reported the filing of a lawsuit against J&J by two former salesmen with documents showing how the company “sought to boost sales of its blockbuster anti-anemia drug Procrit by offering contracts that fattened doctors' profits and urging its salespeople to push higher-than-approved doses.”

This bit of news came shortly after federal lawmakers ordered J&J to cease all direct-to-consumer advertising and physician incentives for Procrit until the FDA could determine whether steps needed to be taken to protect the public following investigations that revealed the rampant off-label sale of the anemia drug was causing serious injuries and death among kidney and cancer patients.

Unfortunately, there is no way to medically reverse the stenting procedure and therefore, the millions of unsuspecting patients who received the DES face a life-time of every day worry because a blot clot lodged in a stent can cause a stroke or heart attack without any warning.

Legal experts are predicting that Boston and J&J will be swamped with lawsuits over the off-label marketing of DES, but say the defendants listed in the complaints will likely include the names of doctors and medical facilities that helped the device makers turn the stenting industry into a billion dollar baby.

2 Part Series - Preemption - Bush Administration Tag-Team Argues for Medtronic

Evelyn Pringle January 3, 2008

Under the arguments made before the US Supreme Court on December 4, 2007, by Deputy Solicitor General Edwin Kneedler, on behalf of the Bush Administration, in support of the medical device maker Medtronic, American citizens injured by a defective device would not be allowed to sue the manufacturer of a product, ever.

In a nutshell, the government claims that, once a device and the warnings on its label are approved by the FDA, state law claims alleging injuries caused by a defective device or a failure to warn are preempted.

It's impossible to make a distinction between the government's legal team and the team arguing for the device giant, because Medtronic is represented by Mr Kneedler's old boss, Ted Olson, the former Solicitor General for the Bush Administration, who argued the Administration's position before the Supreme Court until he left office in July 2004.

This is the same Ted Olson who represented Governor George Bush before the Supreme Court in the case of Bush v Gore and persuaded the Court to halt the recount of votes in Florida in a 5 to 4 decision which served as the final act in the Governor's theft of the 2000 Presidential election.

During oral arguments on December 4, 2007, the Administration double-teamed the private citizen and said that preemption would apply even when a company (1) continues to sell a device after a new defect is discovered; (2) fails to add warnings to the label when new risks become known; (3) fails to revise the label when its instructions are being misconstrued by doctors; (4) fails to send Dear Doctor letters notifying doctors of previously unrecognized problems, or (5) fails to disclose a risk or defect to the FDA during the pre-market approval process or at any time thereafter.

These claims purport to be based on the express preemption provision in Section 360k(a) of the Medical Device Amendments of 1976 and that the FDA's pre-market approval (PMA) establishes federal requirements that preempt state requirements different from, or in addition to, the federal requirements and state tort liability creates state requirements that are preempted.

The plaintiff in the case, Charles Riegel, was injured when an Evergreen Balloon Catheter unexpectedly burst during a 1996 angioplasty procedure, after which he was put on life support and had to undergo emergency bypass surgery.

Mr and Mrs Riegel subsequently filed a lawsuit against Medtronic in the US District Court for the Northern District of New York, alleging five causes of action: (1) negligence in the design, testing, inspection, manufacture, distribution, labeling, marketing and sale of the Catheter; (2) strict liability in tort; (3) breach of express warranty; (4) breach of implied warranty, and (5) loss of consortium.

Medtronic moved for summary judgment, arguing that state-law damage actions by persons injured by devices that received pre-market approval are preempted.

The district court granted the motion on the claims involving strict liability, breach of implied warranty, and negligence except for the negligent manufacturing claim, based on a finding of preemption in Section 360k(a), and the express warranty and negligent manufacturing claims were dismissed on other grounds.

The case was appealed to the US Court of Appeals for the Second Circuit, and the court affirmed the lower court's decision in May 2006 and concluded that federal law preempted the lawsuit because the FDA had imposed device-specific requirements on the catheter, and if the Riegels won at trial, a damage award would amount to a state requirement that differed from, or added to, standards specified in the PMA application.

Charles Riegel has since passed away, but his wife filed a petition for review in the Supreme Court, and on June 25, 2007, the Court agreed to hear the case, despite the Bush Administration's recommendation in an amicus brief that the Court not review it.

The Public Citizen Litigation Group represented the Riegels during their appeal in the Second Circuit, and Public Citizen attorneys Allison Zieve, Wayne Smith and Brian Wolfman are representing Mrs Riegel, as the petitioner in the Supreme Court.

Legal experts say the ruling in this one case will apply to thousands upon thousands of lawsuits filed all over the country by persons injured by defective products used with heart patients such as defibrillators, pacemakers and stents, as well as devices implanted during hip, knee, spinal and other types of replacement surgeries.

Express preemption is supposed to apply only when Congress specifically states an intent to preempt in the language of the statute. In the case of the MDA, there is no indication in the legislative history that Congress even considered the possibility that the provision would preempt state tort lawsuits, much less intended it to do so.

The Court invited the Bush Administration to offer the government's view, and of course, by use of tax dollars contributed in large part by many of the same injured Americans who might have cause to sue Medtronic, the Administration submitted a brief that directly echoed the views of Mr Olson.

In fact, the brief reveals an all-out war against a lone citizen, by an army of the government's top attorneys, which includes: the General Counsel of the Department of Health and Human Services; the Solicitor General; the Assistant Attorney General; the Deputy Solicitor General; the Assistant to the Solicitor General and two attorneys with no official title listed.

More piling on by the Bush Administration is evidenced in an amicus brief filed by Daniel Troy, the Administration's former Chief Counsel at the FDA, and Carter Phillips, a former Assistant to the Solicitor General, in support of Medtronic on behalf of the Advanced Medical Technology Association, Defense Research Institute, Medmarc Insurance Group and Medical Device Manufacturers Association.

The October 22, 2007, press release announcing this brief professes a phony concern for patients by stating that, "allowing a state-law liability approach to assessing safety and effectiveness would lead to reduced patient access to essential medical technologies."

Mr Troy claims that state tort liability would stifle the innovation of important and life-saving devices, undermine the affordability of medical treatments and encourage defensive labeling and over-warning that undermines rational prescribing by physicians.

This is the same Mr Troy who served as a one-man wrecking crew to the rights of citizens to hold the pharmaceutical industry liable for injuries caused by defective products during his roughly 2 years in office. In fact, he spent so much time colluding with the industry by writing amicus briefs to help companies defeat private citizens in civil lawsuits that Congress chopped a half a million bucks off the FDA's budget.

If given the choice, taxpayers would never agree to pay for all these amicus briefs to effectively defeat themselves. If the Bush Administration is successful in obtaining a blanket of immunity for the major corporations, taxpayers will be left holding the bag to pay for not only the medical care of citizens injured by defective products but also the life-long care for persons who are disabled.

Additionally, the push for preemption is not limited to the pharmaceutical industry. Top officials in other federal regulatory agencies are also working in concert with the other major industries facing product liability lawsuits in supporting the claim that federal regulations preempt recovery by injured consumers.

The Product Liability Council has filed an amicus brief supporting preemption for the device maker in the Medtronic case, and the list of members for the Council includes just about every major corporation in America.

Public Citizen points out that, in recent years, the Office of the Comptroller of the Currency has issued rules that purport to preempt state consumer protection laws related to banking and the National Highway Traffic Safety Administration, in conjunction with notices on proposed safety standards for cars, has stated that the new standards would preempt state product liability law. Also, the Consumer Product Safety Commission issued a mattress flammability standard that claims to preempt state tort law.

When the Administration could not get Congress to legislate its anti-consumer agenda, it acted unilaterally through its executive agencies, according to Senator Patrick Leahy (D-VT), chairman of the Senate Judiciary Committee, at a September 12, 2007, hearing entitled, "Regulatory Preemption: Are Federal Agencies Usurping Congressional and State Authority."

"We are now witnessing agency rulemaking turned into a mechanism to immunize powerful corporations at the expense of ordinary Americans," he warned.

"The intended result of this politically-motivated version of rulemaking," he points out, "not only slams the local courthouse door shut on injured victims but it prevents State law, State regulators and State courts from protecting their citizens."

"For hundreds of years that system has provided an effective incentive for manufacturers to improve safety," he said, but, "it is now being threatened by this aggressive legal theory."

David Vladeck, a professor of Law at Georgetown University, testified at the Senate hearing and said the FDA's track record demonstrates its inability to protect Americans against dangerous devices and noted that, in the past few years, there have been massive recalls of defibrillators, pacemakers, heart valves, hip and knee prostheses and heart pumps — "all of which have exacted a terrible toll on the patients who had replacement surgery," he said.

The Professor also pointed out that Medtronic's 4004M pacemaker was approved by the FDA and was later found to be defectively designed. "Some patients died when the pacemaker's defective lead failed; many patients were forced to undergo open-heart surgery to replace the defective lead," he said.

He cited Guidant as another example where the company kept selling the defective defibrillators, even after it learned of serious defects, and even after a newer, safer model was developed, until forced by adverse publicity about the death of a 21-year-old college student and litigation to recall the defibrillators.

"By that time," he testified, "more than 24,000 of the defective devices had been implanted in patients, who then faced the daunting decision of whether to have replacement surgery."

"If the FDA gets its way, all of these people would be left without any remedy at all," he added.

The Professor says that, if the Executive Branch believes that these decisions represent sound policy, then it should come to Congress and "have that debate in an open and democratic way."

"Let the Administration explain to the American public why people injured through the fault of others should have their right to compensation taken away by the federal government," he stated.

"But above all else," he told the committee, "Congress should not let the Executive Branch arrogate these decisions to itself and then tell the American people that it is Congress that has determined to take away these rights."

Many legal experts are accusing the Administration of making an end-run around Congress. According to Attorney Derek Braslow, of the Pennsylvania firm of Pogust & Braslow, "the goal of the Bush Administration's position is to achieve tort reform without obtaining consent from Congress."

"The reality of preemption," he says, "allows companies to market unsafe products and avoid being sued when they deceive consumers about safety and effectiveness."

On December 10, 2007, Mr Braslow went head to head with attorney Sharon Swingle from the Justice Department during oral arguments in the Third US Circuit Court of Appeals for an appeal of a ruling by Federal Judge Michael Baylson, in the Eastern District of Pennsylvania, that was the first to grant the FDA's preemption rule full deference in a wrongful death and survival action, with failure-to-warn claims against Paxil maker GlaxoSmithKline, and generic Paxil maker Apotex, in the case of Colacicco v Apotex.

In this case, the Judge asked the FDA for an amicus brief himself, and Mr Troy's successor as Chief Counsel, Sheldon Bradshaw, fired one off within 20 days, supporting the drug makers. Mr Braslow says the FDA ended up being the primary advocate for preemption because Glaxo barely addressed the issue during oral arguments.

On appeal, a dozen doctors and scientists lent their names to amicus arguments that preemption "would threaten the public health and eliminate an important counterpart to the public health objectives of the FDA."

According to Mr Braslow, "a preemption argument by the FDA in a few amicus briefs has become the main argument in all prescription drug cases leaving injured persons with no recourse, no matter how fraudulent a company's conduct is."

Mr Braslow says that, if the Supreme Court agrees to hear the case of Wyeth v Levine and issues a preemption ruling in favor of Wyeth, "it could very well be the end of drug litigation."

Although most attorneys would no doubt consider an appointment to serve on the US Supreme Court to be the highest honor of the profession, if the current court issues preemption rulings that effectively slam the courthouse doors on American citizens, 20 years from now the history books will be describing the members of the Court who voted for the get-out-of-jail-free cards as the most corrupt justices in US history.

Part II

Persuading the US Supreme Court to rule against the private citizen in the case of Medtronic v Riegel would represent the ultimate parting gift to the device industry from the neutered duck in the White House, because a ruling by the nation's highest court cannot be undone.

In the words of Ted Olson, the Bush Administration's Former Solicitor General, who now represents Medtronic: "When judges make laws, they become impossible to change through the legislature."

"And too much power in judges is not good," he warned, during an October 4, 2004, interview on PBS Online News Hour.

The Court granted certiorari in the Riegel case to decide whether the express preemption provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act preempts state-law claims seeking damages for injuries caused by medical devices that received pre-market approval from the Food and Drug Administration.

The stakes could not be higher, because a favorable ruling for Medtronic could mean the end of legal recourse for persons injured by defective devices. The list of names on amicus briefs arguing against preemption includes 30 state attorneys general, the Public Health Advocacy Institute, the Prescription Access Litigation and Community Rights Counsel, Consumers Union and the American Association for Justice, the AARP, the National Women's Health Network, the National Research Center for Women and Families and the US Public Interest Research Group.

Their briefs point out that Congress knows full well how to preempt state law tort remedies and could have easily drafted the legislation to include a clear statement preempting all state tort remedies as applied to medical devices but "declined to do so."

The majority of Americans do not want Congress to eliminate state tort damage remedies, and requiring clarity in preemption provisions forces politicians influenced by special interests to ignore the interests of the voting public to be held accountable. "If our federal representatives truly want to repeal time-honored common law remedies for corporate malfeasance," the amicus brief states, "let them say so clearly and directly, and then face the political consequences."

The requirement that preemption provisions be unambiguous "helps to ensure that those legislators face the appropriate consequences in subsequent elections," the brief notes.

"Without a requirement for clarity," they explain, "federal legislators might be tempted to enact an ambiguous provision with the hope that the courts would resolve the ambiguity in favor of preemption, thereby satisfying the special interests while maintaining plausible deniability with their constituents."

The brief also points out that, "Courts are institutionally ill-positioned to untangle the countless compromises made during the legislative process in an effort to resolve ambiguities in a preemption provision."

Ms Riegel is facing a stacked deck in the Supreme Court itself. The nine member panel now consists of 7 justices chosen by Republican Presidents and 2 appointed by President Clinton. Four justices were appointed by the Bush clan, 2 were chosen by President Reagan and President Ford appointed one.

On top of those odds, Medtronic's attorney, Ted Olson, is the former boss of the Deputy Solicitor General representing the Bush Administration, Edwin Kneedler, and they used to file amicus briefs together in the Supreme Court seeking favorable rulings for the pharmaceutical industry.

However, the fact remains that Congress decides whether federal regulations preempt state tort claims, and the Court has received an amicus brief from former FDA official William Schultz, of the Zuckerman Spaeder law firm, filed on behalf of two of the longest-serving members of Congress, who say Congress did not intend to include common law tort actions within the category of state requirements subject to preemption by the MDA.

Massachusetts Senator Ted Kennedy has served in the Senate since 1962. While chairman of the Subcommittee on Health, Labor and Public Welfare in 1974-1976, he was the sole sponsor of the Senate bill that resulted in the passage of the MDA.

California Congressman Henry Waxman, chairman of the Government Reform and Oversight Committee, which has investigative authority over all government agencies, has served in the House of Representatives since 1974. In 1976, Rep Waxman supported the MDA and participated in the debates on the bill.

Combined, these two men have more than 75 years of experience enacting legislation, and if anyone can explain the meaning of "intent," as that term applies to the FDA legislation at issue in this case, it's these two guys.

Their brief points out that Congress was fully aware of the widespread lawsuits involving devices when the MDA was enacted, and "if Congress had intended to preempt state tort law suits it would have explicitly done so."

The brief provides a lengthy discussion of the "intent" of Congress in passing the legislation. "At the time the MDA was enacted in 1976," they write, "the terminology used in the preemption provision was understood by Congress not to encompass product liability litigation."

They note that the enactment of � 360k(a) was the first time that Congress included a specific preemption provision and that it was the result of concern about California's medical device regulation, the Sherman Food, Drug, and Cosmetic Law adopted in 1970, and not products liability lawsuits against device makers.

"The legislative history demonstrates that Congress included section 360k in the MDA for one specific reason," the brief states, "to reconcile the new federal regulatory scheme with device regulatory schemes that states had adopted in the absence of federal regulation."

"There is no suggestion anywhere in the legislative history to suggest that Congress even considered preempting state tort suits," the senior lawmakers write, "much less that it intended to preempt such suits."

According to the Congressmen, there is no indication in the hearings, the Committee Reports or the debates on the House or Senate floor that even one member of Congress believed that section 360k would bar state common law remedies against device makers.

Mr Kneedler formed a tag-team with his old boss, Mr Olson, during oral arguments to the Court on December 4, 2007, in an all out push for a favorable ruling for Medtronic, and Mr Olson took the lead.

Mr Olson tried to make the argument to Justice Ginsburg that the preemption provision in the MDA, Section 360k(a)(1), was put in place by Congress.

Justice Ginsburg said, "what it was intended to do was to cut State pre-market approval, where States like California came in when there was a Federal void and said we shouldn't let the manufacturers put out whatever they'd like. Let's have a pre-market approval."

"And the argument is," she told Mr Olson, "as you well know, which was presented in Senator Kennedy's brief, that's what we meant to do with the preemption provision."

"Nothing more," Justice Ginsburg stated.

Chief Justice Roberts asked Mr Olson how newly discovered flaws were dealt with and whether preemption would apply in cases where the FDA had not considered a risk.

For example, he said, "where you have this catheter, and the FDA didn't look at the possibility of allergic reactions to the balloon plastic, and all of a sudden it turns out to be a serious problem."

"How can you say that that's preemptive?" he asked.

"This is a continuous process," Mr Olson said, "Information must be given by the manufacturer. There is a process by which doctors report consequences to the FDA. Citizens may report information. This is a continuous jurisdiction."

Justice Kenney asked whether the manufacturer is free to continue selling the device after there are newly discovered risks "pending the FDA's acting on the same information?"

Mr Olson stated, "yes," and "let me explain why I think that is important to this case."

If that information is in the possession of the FDA, he said, "The FDA can suggest to the manufacturer -- it can require the recall. It can change warnings. It can do all of those things. But what it is doing, because it's continuously involved in the process."

But Justice Kennedy pointed out that all this takes time. "Let's assume that we know it's going to take six months for the FDA to do this," he said. "The manufacturer knows that there's a real problem."

"He can continue to sell in the face of the knowledge of the real problem?" he asked.

"What I'm suggesting," Mr Olson replied, "is that the FDA can act as promptly or as slowly."

"I was asking you about the manufacturer's duty pending the FDA's action," Justice Kennedy stated.

"It's dependent upon the manufacturer providing information to the one centralized agency," Mr Olson replied.

Justice Stevens told Mr Olson to suppose that the manufacturer did not provide the information to the FDA. "Would the preemption nevertheless exist?" he asked.

"Yes, Justice Stevens," Mr Olson said.

Justice Stevens noted that, at least as a theoretical possibility, there could be a newly discovered risk that the FDA never knew about and asked, "nevertheless, the claim would be preemptive?" he asked.

"Yes," Mr Olson said.

"And that's a judgment that Congress made," Mr Olson stated, "because with the -- the manufacturer then would be violating the law, failing to tell the FDA what was going on, perhaps committing fraud, and be subject to criminal penalties, recall penalties, civil penalties, and that sort of thing."

Justice Souter pointed out that Mr Olson did not answer the question posed by Justice Kennedy. "His question was," he said, "what if the manufacturer has learned that there is -- that there's a problem that somebody hadn't anticipated? The manufacturer has told the FDA, and the FDA has not yet acted."

"Leave open the question of whether the FDA is slow or whether it just takes time, but there's a -there's a hiatus here," Justice Souter told Mr Olson. "And an injury occurs because of marketing that took place during the hiatus."

"Does preemption still apply?" he asked. "Yes, it does," Mr Olson replied.

"And the reason for that," he stated, "is that someone must make a judgment. That - the information that the manufacturer may have learned may be -- have some aspect of the safety or effectiveness of the device, but it still might be the best product available."

Justice Kennedy asked whether a manufacturer is obligated to notify the FDA if it "finds just from its own laboratory experiments and not because of any data it's received from doctors and patients that there's a better way to do this."

And Mr Olson stated: "I don't think so, Justice Kennedy."

Justice Alito asked whether a person looking at the file for a PMA proceeding would be able to tell exactly which design features or risks were considered by the FDA.

"No, I don't think you could," Mr Olson responded.

Justice Alito asked Mr Olson if he knew "whether the PMA process in this case considered the design defect that the Petitioner seems to be relying on?"

"Well, all -- no," Mr Olson stated. "I don't know the answer to that specifically."

Justice Ginsburg asked Ms Riegel's attorney, Allison Zieve, to explain what was wrong with the label on the device.

Ms Zieve said the label was inadequate or misleading because in one place it lists among 12 precautions not to inflate the balloon above the burst pressure of eight, and in another place it has a chart that shows inflation up to 13, and at another place in the instructions, it says inflate to the nominal pressure.

At that point, Chief Justice Roberts cut her off with the statement: "So that's just like a car speedometer. I mean, the speedometer goes up to 120 miles and hour, but that doesn't mean you are supposed to drive it that fast."

But Ms Zieve was quick to respond and pointed out that, "the car doesn't come with a chart that shows you safe usage of up to 100 miles either."

Justice Kennedy asked her whether Medtronic was free to alter the label without the FDA's consent, and Ms Zieve said yes, under 814.39, "Medtronic could make changes to strengthen the warnings or clarify the instructions without prior approval."

Later in the hearing, Ms Zieve noted that there is testimony from the doctor in this case, and he thought that the label showed testing up to 13. "And that based on the directions, he thought that going up to 10 was fine and that it was standard use among the cardiologists," she told the justices.

Justice Kennedy asked the government's attorney, Mr Kneedler, to suppose a label is approved in a very specific form under the PMA and then a year later, it turns out, unforeseen by anyone, that doctors are just reading it the wrong way and it's dangerous.

"Can the manufacturer continue to sell new devices with the same labeling pending the annual report?" he asked.

Mr Kneedler said yes and began giving the usual long-winded answer, saying that there would be difficult judgments to make as to whether the injury was associated with a device or some other problem, at which time Justice Kennedy butted in and said, "Just take my hypothetical."

"I was going to say," Mr Kneedler continued right on, "it's possible that the labeling would be regarded as misleading for some reason."

"In that event," he said, "the manufacturer should apply to -- should submit what's called a supplemental PMA and request that the labeling be changed to clarify that."

Justice Kennedy again asked whether the manufacturer could continue to sell the device, "knowing that the label is being misconstrued by very good doctors pending FDA action?"

"Ordinarily, yes," Mr Kneedler answered.

"If there was -- if there was a very serious risk to health and safety -" he started to say, and Justice Kennedy cut him off again and said: "Yes, it's very serious."

"In that event," Mr Kneedler stated, "FDA has a variety of tools that it can take and so does the manufacturer."

He explained that one would be a "Dear Doctor" letter, "a notification to physicians or other users of a product that there may be some previously unrecognized problem or misrepresentation or what could be misconstruction of the label."

Justice Kennedy asked whether a failure to give that notice would subject a manufacturer to liability if the manufacture continued to sell the device.

Mr Kneedler said no, not state tort liability, and then swung into another long-winded answer about how the manufacturer could be subject to criminal penalties for either misrepresenting or withholding information if it did not report the problem to the FDA.

But the bottom line is, the answer is no, the citizen would be left with no recourse.
Chief Justice Roberts asked Ms Zieve whether her point was that a company does not have to sell a defective device just because it is approved.

What "I understood you to be arguing is that there may be a better design and that it was negligent for the manufacturer to market a particular design, even though they're allowed to; they don't have to," he said, and Mr Zieve stated: "Exactly."

Houston attorney Andy Vickery says preemption is an assault on the rights of American citizens. "For 39 years through both Democratic and Republican administrations, the FDA took the stance that private tort litigation was a good thing," he notes.

"Prior to the Bush Administration," he says, "the FDA avoided getting involved in civil litigation and when it did, it was generally to protect consumers."

Attorney Robert Brava-Partain of the Baum, Hedlund, Aristei & Goldman law firm, also contends that the FDA has always protected consumers until "the Bush Administration shifted the focus towards the protection of the companies whose products the agency is supposed to be regulating."