In a Shift, Bush Moves to Block Medical Suits
WASHINGTON, July 24 — The Bush administration has been going to court to block lawsuits by consumers who say they have been injured by prescription drugs and medical devices.
The administration contends that consumers cannot recover damages for such injuries if the products have been approved by the Food and Drug Administration. In court papers, the Justice Department acknowledges that this position reflects a "change in governmental policy," and it has persuaded some judges to accept its arguments, most recently scoring a victory in the federal appeals court in Philadelphia.
Allowing consumers to sue manufacturers would "undermine public health" and interfere with federal regulation of drugs and devices, by encouraging "lay judges and juries to second-guess" experts at the F.D.A., the government said in siding with the maker of a heart pump sued by the widow of a Pennsylvania man. Moreover, it said, if such lawsuits succeed, some good products may be removed from the market, depriving patients of beneficial treatments.
In 2002, at a legal symposium, the Bush administration outlined plans for "F.D.A. involvement in product liability lawsuits," and it has been methodically pursuing that strategy.
The administration's participation in the cases is consistent with President Bush's position on "tort reform."
Mr. Bush often attacks trial lawyers, saying their lawsuits impose a huge burden on the economy and drive up health costs. The Democrats' vice-presidential candidate, Senator John Edwards, a longtime plaintiffs' lawyer, says his proudest accomplishment in Washington was to help win Senate passage of a bill defining patients' rights, including the right to sue. (The bill never became law.)
Jay P. Lefkowitz, former director of Mr. Bush's Domestic Policy Council, said the F.D.A.'s litigation strategy embodied "good health policy and good tort reform."
But Representative Maurice D. Hinchey, Democrat of New York, said the administration had "taken the F.D.A. in a radical new direction, seeking to protect drug companies instead of the public." Mr. Hinchey recently persuaded the House to cut $500,000 from the budget of the agency's chief counsel as a penalty for its aggressive opposition to consumer lawsuits.
In the Pennsylvania ruling, issued Tuesday, the appeals court threw out a lawsuit filed by Barbara E. Horn, who said her husband had died because of defects in the design and manufacture of his heart pump. The Bush administration argued that federal law barred such claims because the device had been produced according to federal specifications. In its briefs, the administration conceded that "the views stated here differ from the views that the government advanced in 1997," in the United States Supreme Court.
At that time, the government said that F.D.A. approval of a medical device set the minimum standard, and that states could provide "additional protection to consumers." Now the Bush administration argues that the agency's approval of a device "sets a ceiling as well as a floor."
The administration said its position, holding that individual consumers have no right to sue, actually benefited consumers.
The threat of lawsuits, it said, "can harm the public health" by encouraging manufacturers to withdraw products from the market or to issue new warnings that overemphasize the risks and lead to "underutilization of beneficial treatments."
Allison M. Zieve, a lawyer at the Public Citizen Litigation Group who represented the plaintiff in the Pennsylvania case, said, "The government has done an about-face on this issue." If courts accept the administration's position, Ms. Zieve said, it would amount to a backdoor type of "tort reform" that would shield manufacturers from damage suits.
In the Pennsylvania case, the federal appeals court quoted extensively from the administration's brief and said the views of the F.D.A. were entitled to great deference because the agency was "uniquely qualified" to determine when federal law should take precedence over state law.
Bush administration officials said their goal was not to shield drug companies, but to vindicate the federal government's authority to regulate drug products.
Patients and their families said they felt betrayed.
Kimberley K. Witczakof Minneapolis said her husband, Timothy, 37, committed suicide last year after taking the antidepressant drug Zoloft for five weeks. "I do not believe in frivolous lawsuits," Ms. Witczak said, "but it's ridiculous that the government is filing legal briefs on the side of drug companies when it's supposed to be protecting the public. My husband would be alive today if he had received adequate warnings about the risk of self-harm." Ms. Witczak sued Pfizer, the maker of Zoloft, in May. The government has not intervened in her case.
Thomas W. Woodward of North Wales, Pa., whose 17-year-old daughter committed suicide last year after taking Zoloft for a week, said, "I've been sickened to see the government taking the side of pharmaceutical companies in court." Mr. Woodward has not filed a suit.
Mr. Hinchey said that F.D.A. lawyers, led by the agency's chief counsel, Daniel E. Troy, had "repeatedly interceded in civil suits on behalf of drug and medical device manufacturers."
Ms. Witczak, Mr. Woodward and Mr. Hinchey said Mr. Troy had a potential conflict of interest because Pfizer was one of his clients when he was a lawyer in private practice.
Mr. Troy refused to discuss the agency's legal arguments or the criticism of his role. Dr. Lester M. Crawford, the acting commissioner of food and drugs, said Mr. Troy had "complied with the ethical requirement to recuse himself from any matter involving a past client for a year" after he joined the government in August 2001.
In its court filings, the Bush administration argues that private lawsuits threaten to disrupt a comprehensive nationwide system of drug regulation, and that federal standards pre-empt requirements established by state judges and legislators. In effect, the administration says, if a local judge or jury finds that a drug or device is unsafe, it is in direct conflict with the conclusion reached by the F.D.A. after years of rigorous testing and evaluation.
Five of Mr. Troy's predecessors sent a letter to Congress dated July 15 endorsing his position. The government occasionally filed such briefs in the last 25 years, they said, but "there is a greater need for F.D.A. intervention today because plaintiffs are intruding more heavily on F.D.A.'s primary jurisdiction than ever before."
Some judges and legal experts disagree. Erwin Chemerinsky,a constitutional scholar at the University of Southern California Law School, said, "The Supreme Court has expressly ruled that F.D.A. regulation does not pre-empt state law and local regulation" in all cases.
In a Tennessee case involving a cardiac pacemaker, the Bush administration told a state trial court, "It is inappropriate for a jury to second-guess F.D.A.'s scientific judgment on a matter that is within F.D.A.'s particular expertise."
If juries in different states reach different conclusions about the risks and benefits of a medical device, they will cause "chaos for the regulated industry and F.D.A.," the administration said.
The administration has also joined Pfizer in opposing a lawsuit filed by Flora Motus, a California woman who said her husband had committed suicide after taking Zoloft. Mrs. Motus argued that Pfizer had not adequately warned doctors and patients that the drug could increase the risk of suicide.
But the Bush administration said that when federal officials approved Zoloft, they saw no need for such a warning, and that a false or unnecessary warning could "deprive patients of beneficial, possibly life-saving treatment." Susan B. Bro, a spokeswoman for Pfizer, said this week, "There is no scientific evidence of a causal relationship between Zoloft and suicide."
Likewise, the administration intervened in a California case to help GlaxoSmithKline fend off consumer demands for restrictions on the advertising of Paxil. The government said the restrictions "would overly deter use of a life-improving medication."
Patients had persuaded a federal district judge to order a halt to television advertisements that declared, "Paxil is non-habit forming." The administration joined the manufacturer in challenging that order. The judge, Mariana R. Pfaelzer,lifted the injunction in 2002 for other reasons, but said the administration's arguments were unpersuasive and contrary to the public interest.
NYT, July 25