In a deadlocked 4 to 4 decision, the U.S. Supreme Court essentially postponed a decision on an issue first raised by then FDA Chief Counsel, Daniel Troy, who argued on behalf of Pfizer Pharmaceutical, that FDA approval of a drug preempts state product liability laws--essentially shielding pharmaceutical companies from product liability even when their products are demonstrably defective resulting in thousands of preventable deaths.

The case before the Court involved Rezulin, approved in 1997 only to be withdrawn from the market in 2000 after it was found to cause liver damage. Plaintiffs charge that FDA's approval was based on Warner-Lambert fraud--that is the company concealed vital safety data, resulting in preventable deaths.

As Linda Greenhouse of The New York Times reports, This case, Warner-Lambert Co. v. Kent, presented a narrow slice of the broad pre-emption issue that the court will take up in its next term. In that new case, Wyeth v. Levine, the question is whether the Food and Drug Administration's approval of a drug's label precludes individual damage suits based on the claim that the label failed to include sufficient information or adequate warnings.

In essence, if the answer is yes, most individual lawsuits for damages caused by approved drugs would be pre-empted.

Forbes reports: "The Supreme Court's non-decision, entered without comment, halts what some thought was gathering momentum in favor of so-called "preemption," a legal concept that bars traditional tort-law suits over drugs and devices that have been approved by the FDA."

The split decision was due to a declared conflict of interest by Chief Justice John Roberts, who had recused himself from the case because he had $15,000 stock investments in Pfizer, parent company of Warner-Lambert.

It is inexplicable that Supreme Court justices would disregard fraud and concealment of safety data by pharmaceutical companies--a central aspect of most pharmaceutical liability cases, and that the Court would ignore utterly the body of evidence contradicting the Court's presumption that FDA's standards for drug approval are based on full examination of the scientific evidence.

Plaintiff attorneys clearly have a challenging task before them beyond the specifics of their own narrow cases. And that is to articulate and document FDA's stream of failures to exercise its mandate by failing to examine ALL safety data--and turning a blind eye when presented with evidence of fraud.

Rezulin Case: Supreme Court Tie Allows Consumers to Sue Alliance For Human Research Protection (AHRP) (Promoting Openness, Full Disclosure, and Accountability)
http://www.ahrp.org and http://ahrp.blogspot.com

Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org