WASHINGTON, DC -- A multi-plaintiff lawsuit against drugmaker Warner-Lambert will now proceed after a deadlocked U.S. Supreme Court automatically upheld a federal appeals court decision.
In Warner-Lambert Co. v. Kent (
docket# 06-1498) the USSC split 4-4 on whether gaining FDA approval for a drug pre-empted individual lawsuits against the company for any harm the drug causes. It centers on WL's diabetes drug Rezulin, approved by the FDA in 1997 and withdrawn in 2000 after some patients suffered liver damage.
In a similar case last month the USSC upheld an earlier ruling that patients cannot sue medical-device makers for damages if the device has already been approved by the FDA,
LNL reported.
In the Warner case, the plaintiffs argued that Rezulin's FDA approval was obtained fraudulently by withholding or misrepresenting information about the drug. The law of Michigan, where the case was originally filed, allows for claims under these circumstances.
The USSC
will take up a broader medical pre-emption case (Wyeth v. Levine) next term to decide whether FDA approval of a drug's labeling pre-empts individual damages actions that claim the label was incomplete or inadequate.