Daily Archives: July 25, 2004

Bush’s FDA Attacks Consumers in Court

The Bush Admin’s FDA is arguing in court to unilaterally reverse laws passed by Congress. Their aim is to protect pharmaceutical companies–B/C’s second biggest campaign contributors after the energy industry–from lawsuits arising from design flaws or shoddy workmanship in their medical devices. FDA lawyers are claiming that laws which establish ‘minimum Federal standards’ actually establish maximums, which is bad enough, but they then go on to insist that if a manufacturer meets those standards, it is therefore immune to prosecution even if the device is faulty, even if it kills people.

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.


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.

Don’t you love it? Day is actually night, up is really down, black is basically white if you look at it from the right angle, and truth has no meaning except as an obstacle to be overcome by pretending it doesn’t exist. So an attack on consumer rights is suddenly beneficial for consumers. Right.

The horror of this is that some courts are buying this shit.

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.

I bet. And don’t you think they weren’t. Betraying consumers is one of the things the BA does best. And most consistently.