Quick Decision

Yesterday, the Supreme Court voted 4-4 on a case heard last week which sought to decide on whether lawsuits could be brought up against drug and medical device makers in which defendants claimed that “F.D.A. approval was obtained by withholding or misrepresenting crucial information.”

The 4-4 vote was the result of Chief Justice John Roberts abstaining from it. The decision means that the lower court’s ruling, which allows for lawsuits, will stand. But that decision is narrow, and the real test will come later this year, when another case will determine whether FDA approval of a drug’s label shields drug companies from personal injury suits. From the NY Times:

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. Last month, in Riegel v. Medtronic Inc., the court interpreted a federal law, the Medical Device Amendments, as barring most individual lawsuits against manufacturers of approved medical devices.

-- Dylan Blaylock