The Courtroom of the Supreme Court Building. Source: www.supremecourtus.gov

After ruling in favor of protecting FDA-approved devices from state product liability lawsuits less than two weeks ago, the U.S. Supreme Court on Monday began oral arguments in a similar case involving an FDA-approved drug. 

At issue is whether 27 Michigan residents can sue Warner-Lambert (now owned by Pfizer) for damages suffered while taking Rezulin (troglitazone), a prescription drug approved in 1997 to treat type 2 diabetes mellitus in conjunction with insulin or other anti-diabetic drugs.

From 1997 to 1999, after receiving several reports indicating harmful liver-related problems in Rezulin users, Warner-Lambert agreed to several labeling changes. In 2000, as two new drugs with better safety profiles for the treatment of type 2 diabetes were introduced, the FDA concluded that Rezulin no longer had a positive benefit-to-risk calculus. Shortly thereafter, Warner-Lambert voluntarily removed Rezulin from the market.

Under Michigan law, individuals may bring personal injury suits against manufacturers of FDA-approved prescription drugs only if the plaintiffs can show that FDA approval depended on fraudulent submission or withholding of information.

Warner-Lambert argues that Michigan law is preempted by federal law because permitting state courts to second-guess the FDA’s product-approval and fraud-detection processes interferes with the agency’s essential functions and promotes regulatory uncertainty, according to the Legal Information Institute (LII) Bulletin at Cornell University Law School.

The Michigan plaintiffs respond that federal preemption does not apply to traditional state tort claims. The decision in this case will clarify the scope of FDA autonomy in policing the drug-approval process and plaintiffs’ freedom to assert state tort claims in areas regulated by federal entities.

Precedence favors Warner-Lambert as the Supreme Court in Buckman v. Plaintiffs’ Legal Comm. held that stand-alone state-law claims for fraud-on-the-FDA conflict with the FDA’s authority to police such fraud.

In determining whether the same federal preemption applies to the Michigan immunity exception, the Court will clarify the scope of the FDA’s autonomy in policing its approval process but may obstruct private citizens’ freedom to bring lawsuits relating to pharmaceutical development and other spheres of federal regulation, according to the LII Bulletin.

Justice Stephen Breyer, according to an article in the International Herald Tribune, said the fundamental question in the case was who should make the decisions that would determine whether a drug was "on balance, going to save people or, on balance, going to hurt people” — the FDA or a jury of twelve people that sees only the hurt people?

Breyer, answering his own question, said Buckman had determined it should be the role of the FDA, according to the Tribune.

In October, the court will hear arguments in Levine v. Wyeth, a pharmaceutical case with no such state complications. In the Levine case, the court is being asked to decide whether FDA approval bars personal injury lawsuits -- the same question it decided last week in favor of device makers.