Drug Maker Liability Suit Hits High Court

The U.S. Supreme Court will hear the case Monday of a Vermont musician who is suing drug maker Wyeth because her arm had to be amputated following a high-volume injection of the anti-nausea drug Phenergan.

The injection accidentally punctured an artery, prompting gangrene to set in.

Sixty-three-year-old Diana Winn Levine of Marshfield, a guitarist and pianist, argues that the drug's maker, Wyeth Pharmaceuticals, knew the drug, improperly-injected, could have devastating consequences and had a duty to warn consumers.

A Vermont jury awarded Levine $6.7 million, agreeing that Wyeth should have been clearer in its warning label about the risks of improperly administering the drug.

Wyeth and the Bush administration, however, are asking the court to rule that drug makers may not make changes to labels without the approval of the federal Food and Drug Administration, and that people cannot sue under state law for harm caused by an FDA-approved drug.

Wyeth v. Levine is one of the most closely watched business cases of the Supreme Court's term.

At issue is whether the federal government can limit lawsuits by consumers like Diana Levine who have been harmed by prescription medications.

In recent years, the administration and business groups have aggressively pushed limits on lawsuits through the doctrine of pre-emption - asserting the primacy of federal regulation over rules that might differ from state to state.

In an amicus brief, the Bush administration argued that state laws cannot override federal oversight, noting that "liability under state law turns on whether a drug, as labeled, is 'unreasonably dangerous.' … Any such finding would directly conflict with FDA's determination that the drug is safe and effective under the conditions prescribed, recommended, or suggested in the labeling."

The concept of preemption could carry to other industries as well, hence the support that Wyeth is receiving in their case from the Product Liability Advisory Council and the U.S. Chamber Of Commerce, which says that state liability law regarding warning labels conflicts with the FDA's goals of "overwarning" and patchwork regulation.

Supporting Levine are former FDA Commissioners under Presidents Jimmy Carter, George H.W. Bush and Bill Clinton; the National Conference of State Legislatures, the attorneys general of 46 states, several medical associations, AARP and other consumer groups.

The justices are hearing arguments in Levine's case Monday, shortly after the court announces whether it will accept other cases for argument sometime next year.