NY Times: Bush Moves to Block Medical Suits

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> JustSayNo

> Sun, 25 Jul 2004 18:42:09 -0400

> [sSRI-Research] NY Times: Bush Moves to

> Block Medical Suits

>

> [-- Paragraph eight states: " 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. " ]

>

>

> In a Shift, Bush Moves to Block Medical Suits

> By ROBERT PEAR

>

> Published: July 25, 2004

>

>

http://www.nytimes.com/2004/07/25/politics/25DRUG.html?hp== & adxnnl==1 & adxnnlx=9\

0766298-1jIiJKWv4ngnAF22Ef3PqQ

>

> 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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