Disturbing Drug Law Trend

Published June 15, 2010

By Maureen Martin

There is a trend in the state courts, enabled by the U.S. Supreme Court, endangering Americans’ access to lifesaving drugs. It’s time for the Court to stop the trend in its tracks.

It began in 2009 with a $6.7 million Vermont jury verdict in a drug case against Wyeth. The case alleged Wyeth inadequately warned medical workers of the dangers of injecting the anti-nausea drug Phenergan intravenously.

The drug’s label language had been approved by the U.S. Food and Drug Administration after decades of study balancing the risks and benefits of intravenous injection. The approved label—required by law before a drug can be marketed in interstate commerce—warned medical workers to use “extreme care” in IV injections, to stop immediately if the patient experienced pain, and not to administer more than 25 milligrams at a time. Otherwise, the label warned, there was risk of gangrene and amputation.

But hospital clinicians in the Wyeth case ignored those warnings, and the plaintiff lost her arm to gangrene. The doctor admitted responsibility. Nevertheless, the jury awarded $6.7 million in damages against Wyeth, deeming its warning label inadequate. The Vermont Supreme Court affirmed the decision.

Wyeth appealed to the U.S. Supreme Court, arguing FDA approval of the warning preempted state law. The Supreme Court nevertheless affirmed the state court’s verdict, finding the wording of the drug labeling act did not preempt state lawsuits.

Various commentators, including me, predicted a flood of similar state court litigation would ensue. It is now beginning in Nevada, where last month Teva Parenteral [Note: spelling is correct] Medicines, Inc., manufacturer of the sedative Propofal, and Baxter Healthcare Corp., the distributor, were socked with a jury verdict of $5 million in punitive damages for an inadequate though FDA-approved warning label. Several hundred other cases are pending but have not yet gone to trial.

In the Nevada case, the label clearly stated, “One patient use only.” Medical personnel at a Nevada clinic ignored the warning and used the vial’s contents to inject multiple patients, even allegedly recycling used syringes from one patient to another. Those practices allegedly contaminated the vial with the hepatitis C virus. But the judge excluded evidence of the medical clinic’s obvious malpractice and of FDA label approvals, leaving the drug companies with no real defenses. Teva and Baxter vow to appeal.

The Wyeth and Teva cases establish state law that holds FDA-approved labels are inadequate, but they don’t identify what an adequate warning label should say. With the current labeling, Propofal can’t be sold in Nevada and Phenergan can’t be sold in Vermont. Those drugs can be sold in other states, however. This situation is grossly burdensome to drug makers and is a classic case of state interference with interstate commerce, especially as these cases proliferate.

There are two things the Court should do. First, in an appropriate case the Court should find the FDA statutes allowing states to impose stricter labeling requirements than FDA-approved ones violate the U.S. Commerce Clause because they enable states to discriminate against products made in other states.

Second, the Court could revisit the Wyeth case and focus on a clause in the FDA legislation stating federal law trumps state law when there is a “direct and positive” conflict between the two—a provision ignored in Wyeth.

Either of these rulings would relieve pharmaceutical manufacturers from differing label requirements in differing states, a situation that hurts everybody by ultimately discouraging new drug marketing.

Maureen Martin, J.D. ([email protected]), is senior fellow for legal affairs at The Heartland Institute.