NY Times - In a Shift, Bush Moves to Block Medical Suits

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http://www.nytimes.com/2004/07/25/politics/25DRUG.html?th= & pagewanted=pri

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NY TIMES

 

In a Shift, Bush Moves to Block Medical Suits

By ROBERT PEAR

 

 

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.

 

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.

 

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nt & position=

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