Bush moves to prevent drug lawsuits

New York Times WASHINGTON--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 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 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 FDA, 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 "FDA 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."

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, Sen. 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 Bush's Domestic Policy Council, said the FDA's litigation strategy embodied "good health policy and good tort reform."

But Rep. Maurice D. Hinchey, D-N.Y., said the administration had "taken the FDA in a radical new direction, seeking to protect drug companies instead of the public."

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 "the views stated here differ from the views the government advanced in 1997," in the U.S. Supreme Court.

At that time, the government said FDA approval of a medical device set the minimum standard, and states could provide "additional protection to consumers."

Now, the Bush administration argues 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.