The Supreme Court came and saw and voted but left no clarity on pre-emption behind. Because Chief Justice John Roberts sat out the case, the vote ended in a 4-4 tie, automatically affirming the lower court's ruling and allowing a liability suit against Pfizer to go forward. In that suit, 27 diabetes patients allege that they suffered liver damage while taking Rezulin, a Warner-Lambert drug withdrawn three years after its 1997 approval at the FDA's request. Pfizer inherited the dispute when it bought Warner-Lambert.
Apparently, Roberts owns between $15,000 and $50,000 in Pfizer stock, so he had to recuse himself. But as a result of his doing so, the Court has left a critical issue open--whether a drugmaker's lying to regulators opens them up to liability despite legal reasoning that FDA approval, being federal, shields companies from state lawsuits. In Michigan, it's illegal to sue a drugmaker over an FDA-approved product unless the company withheld or misrepresented data during the approval process. A definitive ruling would have addressed that provision of the law. Of course, we won't get real closure on pre-emption for months, until the court hears a broader drug-related case.
- read the coverage in The New York Times
- check out the Associated Press story