WASHINGTON - 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 FDA, 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 "FDA 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."
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, Sen. 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 Bush's Domestic Policy Council, said the FDA's litigation strategy embodied "good health policy and good tort reform."
But Rep. Maurice D. Hinchey, a New York Democrat, said the administration had "taken the FDA in a radical new direction, seeking to protect drug companies instead of the public." 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 U.S. Supreme Court.
At that time, the government said that FDA 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 benefits 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, Zieve said, it would amount to a backdoor type of "tort reform" that would shield manufacturers from damage suits.
Patients and their families said they felt betrayed.
Kimberley K. Witczak of 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," 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." Witczak sued Pfizer, the maker of Zoloft, in May. The government has not intervened in her case.
Hinchey said that FDA 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."
Witczak and Hinchey said Troy had a potential conflict of interest because Pfizer was one of his clients when he was a lawyer in private practice.
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 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.