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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.
