In 2000, Diana Levine was administered Phenergan, an anti-nausea drug manufactured by Wyeth, after being treated for migraine headaches with injections of Demerol, a pain medication.
Just weeks later, the Vermont woman’s hand and forearm began to turn black, and they were later amputated in two stages.
Phenergan has been known to cause gangrene when exposed to arterial blood. For that reason, it is usually administered by intravenous drip or through an intramuscular injection. A physician’s assistant elected to use a third method, called “IV push,” and injected the drug into what she thought was a vein.
By a 6-3 vote, the U.S. Supreme Court upheld a jury verdict to award $6.7 million in favor of Levine.
The case has important implications for people seeking damages due to unlabeled drug side effects. While under Bush administration legislation the Food and Drug Administration bore the primary burden for the labeling of drugs, now the Supreme Court has shifted that responsibility to drug companies.
Previously, drug companies were not held accountable for the effects of their products after warning labels had been approved by the FDA.
This policy was adopted under the Bush administration in 2006, which Justice John Paul Stevens called a “dramatic change in position” in the majority opinion for last week’s case.
Stevens cited the FDA’s “limited resources to monitor the 11,000 drugs on the market,” and the fact that manufacturers have superior access to information about their drugs as reasons supporting the court’s decision.
The court, Stevens wrote, found that under state law FDA regulation serves as a complementary safeguard and “offers an additional, and important, layer of consumer protection,” and “determined that widely available state rights of action provided appropriate relief for injured consumers.“
The ruling struck down the argument of the defendant, drug manufacturer Wyeth, which sought to shield itself from litigation via tighter federal regulation.
Levine’s argument centered on the claim that Wyeth’s warnings were not clear enough to deter IV push administration of the drug.
Writing the dissenting opinion, Justice Samuel A. Alito Jr. said the court had made an about-face. He referred to the Supreme Court’s previous rulings, such as last year’s Riegel v. Medtronic, in which the court ruled 8-1 that state suits concerning injuries caused by medical devices were barred by express language in federal law.
Last week’s decision in Wyeth v. Levine, however, addressed pharmaceutical drugs instead of medical devices. Congress has never explicitly determined whether federal law pre-empts state law in pharmaceutical cases like Levine’s.
“Congress has had plenty of time to say that state tort claims would be pre-empted and they have never done that,” said UC Davis law professor Lisa Ikemoto, who specializes in health law. “But that doesn’t mean they will never pre-empt.“
Though seemingly similar, Wyeth and Riegel addressed different aspects of federal law.
Unlike federal law concerning medical devices, outlined in the Medical Device Amendment of 1976, no express pre-emption exists in pharmaceutical drug law, Ikemoto said.
“Congress put specific language to pre-empt state law in the amendment, so it is unlikely to be repealed along the same reasoning,” she said.
Hoping to seize on the success of Wyeth, Democrats reintroduced the Medical Device Safety Act last week.
If approved, it would nullify the Riegel v. Medtronic decision and others like it, which prevent consumers from seeking damage compensation in cases involving faulty medical equipment.
AARON BRUNER can be reached at email@example.com.