Bush Rocks! 5 Legislative Days Left Until The AWB Expires
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.
PING
Uh, lady, the evil Bush administration is protecting the public - from zealots trying to sue the drug companies into bankruptcy.
My wife went through major Paxil withdrawal for weeks and she even tapered off of it very slowly and the nasty withdrawal lasted for over a month. Fever, flu, vomiting, it was terrible.
With that said, I still support the administration on this one. I support the free market and am opposed to government bureaucracy putting their fingers in the system. Everyone should be aware that any medicine, prescription especially has inherent risks involved. If you need to take the medicine, you need to deal with the side effects.
I agree... people don't understand that the interests of companies that provide us with services are our interests if we want to keep enjoying their services. It's like people who think Bush's Labor Department is evil for siding with companies over workers... if Bush didn't side with the companies, if he raised the labor costs of these companies these companies would go out of business and the workers would be unemployed... so Bush is on the right side of this.
No kidding - who does she think pays for those huge lawsuits? It's every consumer who actually has to pay for their medications.
But I don't think this is much more than a step in the righ tdirection. What really needs to happen is for this to be the stepping stone to tort reform.
It sounds like a good angle for the Feds to get involved with medical tort reform, but it still has to happen at the state level to get protection from shysters like Edwards. I believe the case he won started a very large increase in the number of deliveries by Ceasarian section while the number of children born with cerebral palsy remained the same.
What is the shift...didn't want to wade through all that crap to get to it...
Uh, who protected the tobacco companies when everybody and their brother started suing...including several states. The only people to benefit were the scumbag layers...
sI agree with the Bush administration on this also.
Some time back, I had a bladder infection. I don't have any medical problems, and I don't take any meds at all. So when I was given an antibiotic, I did not want it, but the infection was very bad, so I took it.
The thing like to have killed me!
I did not realize it was the medication until after I had taken up the first set and had just taken the second pill in the second set. It almost put me in the hospital again.
I have not been this sick in forever!
The antibiotic is Nitrofurantn and Nitrofur Mac.
My Dr. said these were "the big guns" in antibiotics for bladder infection.
The furantn was for 14 days and the mac was a very low dose to take when I felt the infection returning.
These two are in the same family, and is a NO-NO for me.
I suffered terrible complications with both of these.
To these, I am highly alergic.
But there is no reason for me to sue anyone.
I just won't ever take them again.
I am glad that the administration is taking some effort towards the John Edwards, let's sue everybody, kind of people!
at least W is willing to try.....any attempt at tort reform is long overdue since my grandpa's day.
~"Uh, who protected the tobacco companies when everybody and their brother started suing...including several states. The only people to benefit were the scumbag layers..."~
I also wonder why none of the tobacco (you forgot to say "Big Tobacco" by the way) companies' lawyers tried to point out that the state who was suing the tobacco companies collected a considerable amount of money in sales tax and would seem therefore to be in partnership with the tobacco companies since they benefitted from the sale. Also the state gave cigarettes to prisoners and the federal government provided smokes for the military. They were in collusion with Big Tobacco all along. How did they get away with suing them?
###This is NOT the way to resolve the issue of tort reform###
I agree - I buy bad motor oil for my car and the engine blows, I should recieve some form of compensation.
I get a undertested drug and am incapcipated I should be compensated also.
you need some mechanisim to keep the drug companies honest.
I like the limitation idea on the lawyers take to keep them from raiding companies like the drug,tobaccoand food companies like Mcdonalds just because they have more money than they do.
How about only letting them sue the FDA/Government itself! IT is hard to imagine the trial lawyers convincing juries of how evil the government is, when they give $10 million every 2 years to the DNC to make the same government as large as possible.
Bush Rocks! 5 Legislative Days Left Until The AWB Expires
The Washington Post ^ | July 6, 2004 | Shankar Vedantam
Posted on 07/06/2004 11:10:59 PM EDT by neverdem
Firms Violate U.S. Law By Not Registering Trials
The pharmaceutical industry has repeatedly violated federal law by failing to disclose the existence of large numbers of its clinical trials to a government database, according to the Food and Drug Administration.
Doctors and patients say that compliance with the law would go a long way toward addressing their growing concerns that they are not being given the full picture about the effectiveness of many drugs because they are not told about drug trials that fail. The issue has gained urgency with recent disclosures that the publicly available research on treating children with antidepressants obscured the fact that in most studies, the drugs were no better than sugar pills. Drugmakers chose not to publish those studies.
The 1997 law is so little known that scientific journal editors and professional medical associations have recently debated whether to create a system of private incentives for disclosure of trials. When she was told the law already requires companies to register trials, Catherine DeAngelis, editor in chief of the Journal of the American Medical Association, said, "That's a surprise to me. Tell me why it's not enforced."
Although the law was primarily passed for other reasons, DeAngelis said it could very well address her concerns.
The FDA acknowledges it has not enforced the law -- officials said the statute did not spell out penalties or explicitly give the agency authority to crack down on violators.
____________________________________________________________
Now that the companies have to submit the results of all tests of their drugs prior to FDA approval, as long as the FDA approved the drug, that should be the end of the matter, at least if it was prescribed for the approved indications. Docs should have patients sign waivers for adverse or allergic drug reactions. The same holds true for medical devices. The Congress needs to amend the law to give the FDA enforcement authority in order to levy fines where appropriate.
Why did your wife give up Paxil in the first place? Paxil works extremely well in replacing whatever chemical the brain was deficient in. Paxil replaces that chemical day by day, just as eating and drinking provides a neccessity the body and mind require.
Stopping Paxil once the need is proven, is as foolish as quitting food and drink. The problems aren't caused by the presence in the body and mind of supplements needed for proper function, but the denial of these neccessities.
If you think denying her system of the deficiency that was sated by Paxil was bad-try cutting off her food, oxygen and water.
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