Re: In a Shift, Bush Moves to Block Medical Suits
From: art fougner, md (evsono@pipeline.com)
Sun Jul 25 20:05:58 2004
Right ... sue the FDA who approved the device in the first place. Of
course, that brings them to federal court ...
art
At Sun, 25 Jul 2004, RModugno@aol.com wrote:
>
>..
>
>In a Shift, Bush Moves to Block Medical Suits
>
>NY Times
>
>http://www.nytimes.com/2004/07/25/politics/25DRUG.html?hp
>
>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.
--
art fougner, md
ich bin ein New Yorker
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