Sunday, July 25, 2004
A ceiling as well as a floor
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.
It's a funny thing, but all prescription and medical devices have to be approved by the FDA. So unless you're getting non-approved drugs from Canada, I guess you're shit-outta-luck.
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.
The administration's participation in the cases is consistent with President Bush's position on "tort reform."
Yes, it is. But it's not consistent with Mr. Bush's position on experts, which is that we should ignore them and rely on "common sense."
Mr. Bush often attacks trial lawyers, saying their lawsuits impose a huge burden on the economy and drive up health costs.
This is code. Whenever Bush uses the word "economy," think "my buddies."
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."
What it means is that the FDA has the only and final say on what is good for you. Are Conservatives buying this? Are there any Conservatives left?
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."
Who would have thought that Bush could introduce fascism to healthcare in so short a time, and with such Orwellian newsspeak? You, as an individual, have no say in this at all. The interests of the State take precedence.
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.
Bush administration officials said their goal was not to shield drug companies, but to vindicate the federal government's authority to regulate drug products.
"Vindicate the government's authority to regulate drug products"? Is the government's authority under challenge? By whom? Some libertarian group in Idaho? Well, I guess this settles the matter once and for all.
Mr. Hinchey [Dem. Representative from New York] 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."
... Mr. Troy [chief legal counsel for the FDA] 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.
The government certainly doesn't impose a very burdensome ethical standard on its employees, does it? But then what would be the use of corporations inserting their hirelings into government if they were not allowed to act once they got there.
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.
If there is one thing that fascists hate, it is chaos. Funny how they always manage to produce so much of it.
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."
Here they're attempting to prove the negative. Fill in the blank: "There was no scientific evidence of a causal relationship between--" (1) cigarettes and lung cancer, (2) petroleum consumption and global warming, (3) Agent Orange and veterans' health problems, (4) Zoloft and suicide. Which did you choose?
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.
Those damned activist judges!