Wednesday, December 5, 2007

FDA Preemption Cases

The Supreme Court heard oral arguments yesterday in Riegel v. Medtronic (06-179), the transcript is available on the Supreme Court’s website. Riegel presents the question of whether federal law preempts state lawsuits against FDA approved medical devices. The Riegels sued Medtronic, the manufacture of a balloon catheter, which burst during the dilation of Mr. Riegel’s coronary artery. The case raises federalism issues, asking whether federal agencies or state governments should make these types of health and safety decisions. Commenting on the case, the New York Times reports:

[I]n 2004, the Bush administration reversed the government’s position and began to take the manufacturers’ side, as it did before the justices on Tuesday in an argument by a deputy solicitor general, Edwin S. Kneedler. Explaining the change in policy, Mr. Kneedler said that in 2004, the F.D.A. "recognized that there would be a serious undermining of F.D.A.’s approval authority and its balancing of the risks and benefits if a state jury could reweigh those."

A question in this case, Riegel v. Medtronic Inc., No. 06-179, is whether the court will give the government’s position the usual deference it accords an agency’s interpretation of its basic statute.

The federal law at issue is the Medical Device Amendments of 1976, which in its section on preemption bars states from imposing on medical devices "any requirement which is different from, or in addition to, any requirement applicable under this chapter."

Beginning with a case in 1992 about warning labels on cigarette cartons, the Supreme Court has treated the word "requirement" as including not only obligations directly imposed by state laws and regulations, but also the award of damages by state tort systems.

For a jury to say, "Well, gee, it should have been done differently in this particular situation" is the equivalent of imposing a requirement in addition to federal approval, Theodore B. Olson, the lawyer representing Medtronic, told the justices.

"The F.D.A. is the right place for these decisions to be made and this balancing process to occur," Mr. Olson said, adding that while "nothing is perfectly safe," it would harm consumers to "discourage the marketing of products that might save our lives." Medtronic no longer makes the balloon catheter, called Evergreen, involved in the case.

In other FDA-related news, several amicus curiae filed their briefs in Warner-Lambert v. Kent (06-1498) on November 28, 2007. It doesn’t appear that the Supreme Court has scheduled oral argument yet. SCOTUSblog provides an overview:

Six years ago, in Buckman v. Plaintiffs’ Legal Committee, the Supreme Court held that state-law claims alleging that the manufacturer of orthopedic bone screws made fraudulent representations to the Food and Drug Administration ("FDA") were impliedly preempted by the Federal Food, Drug, and Cosmetic Act. On Tuesday, the Court granted certiorari in No. 06-1498, Warner-Lambert Co. v. Kent, to clarify the scope of its holding in Buckman: specifically, whether a state product liability statute that creates a general "safe harbor" from liability for FDA-approved drugs but carves out an exception for cases in which the approval was obtained through fraud is also preempted.

Under Michigan law, an FDA-approved drug cannot be deemed defective or unreasonably dangerous for product liability purposes unless the approval was obtained through fraud. Pursuant to this state statute, the respondents – all Michigan citizens – filed suit in Michigan state court, alleging that they were injured by Rezulin, a diabetes drug approved by the FDA but ultimately withdrawn from the market by Warner-Lambert. The case was removed to federal district court in Michigan and then subsequently transferred to the Southern District of New York by the Judicial Panel on Multidistrict Litigation. Warner-Lambert moved for judgment on the pleadings, arguing that under Buckman the claims were impliedly preempted, and the district court agreed.

ECB

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