Posted on 07/24/2004 5:40:58 PM PDT by neverdem
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.
If I understand you correctly, you wish to allow the FDA to levy fines instead of allow patients to bring suits. I can't agree to that idea.
Let's say your mother takes a medication that causes permanant blindness. She and 250,000 other citizens are blinded. Do you think these folks should be unable to bring suit?
Sorry if I misunderstood you, but individual compensation is integral to a solution. I don't want to see folks given $10 million a shot, but it's a crime in and of itself to deny people recourse IMO.
The business about "the FDA approved it, so it must be safe" is B.S. Drugs are prescribed for uses other than what they were originally tested for *all the time.* Also, individuals are different - not everyone is going to react to drugs in the same way, and we *pay* physicians for their knowledge to prescribe and do procedures. If we could all be our own doctors, we wouldn't need them.
The tort system exists to protect the average person. It's an ancient Anglo-Saxon legal idea that doesn't deserve to be destroyed because of greedy opportunists.
Bush is trying to pin the "ambulance chaser" label on the donkey.
He's trying to flush out Edwards--trying to get him to comment on the subject...
I do admit he's doing something, but I can't defend the idea of denying individuals direct compensation. I do have one good idea though. Perhaps Bush could deny the government direct compensation from the sweat of my brow.
Once these parasites destroy our insurance, or make it unaffordable for the average person, they won't give a hoot about Anglo-Saxons' personal injuries. They might even have to find honest work, if they can remember how to do it.
The only way to save the tort system is to shepherd it--and that means to clean out the parasite culture of filthy worm-lawyers.
That's the only reason that all these ads for "wonder drugs" never go away. Too many fools out there buying the $hit up. Putting your faith 100% in doctors or lawyers is a risky business. That's how there came to be terms like "SHYSTER" and "QUACK".
There is a drug that can cause blindness that is used to treat refractory rheumatoid arthritis, lupus erythematosus and susceptible malaria. It's called hydroxychloroquine and Plaquenil, generic and trade names, respectively. Patients taking it need ophthalmologic, i.e. eye, exams every six months, not lawsuits. Without it some patients' medical conditions become worse, or they have to take more expensive or more toxic medicines.
Lawsuits based and won on junk science, ignorant juries and self appointed medical experts should go the way of the Do Do bird.
I still love the idea that physicians and other health care workers simply practice a common-sense defense against frivolous lawsuits: Absolutely refuse to see disgusting, obnoxious lawyers or their families.
This is an utterly bogus argument and you know it. The FDA would have long, long since pulled this medication if it caused 25 cases of blindness.
From the link:
As a consequence of the expensive efforts made by Mr. Edwards and his fellow malpractice practitioners, doctors often rush to perform Caesarean sections, with rates rising from 6 percent of births in 1970 to 26 percent today. Yet rates of cerebral palsy have remained stable in populations, regardless of how many Caesarean sections are performed.
http://www.washtimes.com/op-ed/20040724-105240-6290r.htm
There's increased risk from the surgery and the anesthesia.
Not likely, if condom manufacturers are any example. IIRC, the last group compensated by the gov't were Japanese - Americans interred during World War II.
If you remember, we had a related argument about responsibility here in which I only stated the hazards from males having sex with men, and those predisposed to IVDA and bisexuality.
Was it proven that the drug company hid results from the FDA during the approval process? If so, that should trigger an exception from civil protection.
Even if we’ve empowered FMOA (Federal Motor Oil Agency) with the authority to micro-regulate engine oils, assuming they had the same history of being 90% fraudulent like drugs.
I see that the cost of bringing a new drug to market is $1.7 billion now. At some point, unless negligence or criminality is proven, I think it’s just our own tough luck that bad things happen to us.
bttt
Trying to equate a medication with known side-effects with one that wasn't know to cause them is kindof a red hering arguement bud.
There was a medication that was recalled about 3-5 years ago that caused heart damage. I only wish it had been recalled with less than 25 people damaged from it. You are wrong. The FDA doesn't always know a medication is causing harm to patients.
Yes it was proven.
I know of a hospital in my area that performs over 50% Caesarean births.
You can't sue the FDA for mega-bucks. Its immune.
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