Supreme Court splits on Pfizers FDA-approved drug liability

Court rules against Pfizer. Source: Supreme Court of the United States

The U.S. Supreme Court divided evenly on patient lawsuits over federally-approved drugs in a decision that lets 27 Michigan patients sue Pfizer over Rezulin, a diabetes drug that was pulled from the market in 2000.

The 4-4 ruling sets no nationwide precedent while upholding a lower court ruling, allowing the patients to take legal action against Pfizer despite a Michigan law that prevents lawsuits against drugs that are FDA approved.

According to the Wall Street Journal (WSJ), the Michigan law has an exception: It allows injured patients to sue if they allege a drug company committed fraud during the FDA review process.

The current ruling is fairly narrow issue of fraud, however, a more seminal case will be Wyeth vs. Levine, which involves a broader range of state lawsuits, according to the WSJ. In this case, Wyeth Pharmaceuticals contends that it should not be liable for problems Phenegran, a motion sickness drug, because it met FDA requirements.

Chief Justice John Roberts recused himself because he owns between $15,000 and $50,000 in Pfizer stock, according to his 2006 financial disclosure report, which is why the court was evenly divided.

The justices heard arguments in the case, Warner-Lambert Co. v. Kent (06-1498) last week.

Last month, another suit of the same genre found the medical device makers favored. On Feb. 20, the Supreme Court, in an 8-1 ruling, said federal medical device regulations trump state product-liability lawsuits unless the medical device company violated FDA policy.