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Richard Chudacoff, MD, FACOG
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-----Original Message-----
From: ob-gyn-l@obgyn.net [mailto:ob-gyn-l@obgyn.net] On Behalf Of
dean@thehuffpeople.net
Sent: Sunday, July 25, 2004 10:32 AM
To: Multiple recipients of list OB-GYN-L
Subject: In a Shift, Bush Moves to Block Medical Suits
..
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.
