In a Shift, Bush Moves to Block Medical Suits

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The New York Times

July 25, 2004

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 andmedical 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 , 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. "

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, , 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.

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,

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. "

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

GlaxoKline 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, na R.

Pfaelzer,lifted the injunction in 2002 for other reasons, but said the

administration's arguments were unpersuasive and contrary to the public

interest.

Copyright 2004 The New York Times Company

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