ASHINGTON, 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
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
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
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
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.