Tort Preemption

In a Shift, Bush Moves to Block Medical Suits | NYT | 7.25.04

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. …

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 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. …

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…

FDA’s mission and what they regulate and don’t regulate. Medtronic v Lohr (dissent), Medical Device Amendments of 1976, and preemption rides again…tort reform (albeit products liability) à la supramacy and preemption v. federalism.

I must go with Justice O’Connor’s dissent:

“To summarize, I conclude that §360k(a)’s term “requirement” encompasses state common law claims. Because the statutory language does not indicate that a “requirement” must be “specific,” either to pre-empt or be pre-empted, I conclude that a state common law claim is pre-empted if it would impose “any requirement” “which is different from, or in addition to,” any requirement applicable to the device under the FDCA. I would affirm the judgment of the Court of Appeals that the Lohrs’ design claim is not pre-empted (9-0) by the MDA, and that the manufacture and failure to warn claims are pre-empted (5-4); I would reverse the judgment of the Court of Appeals that the MDA pre-empts a common law claim alleging violation of federal requirements.”