Sunday, August 1, 2010

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."

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