Supreme Court Rules Against Pharmaceutical Company
On March 3, 2009, the U.S. Supreme Court ruled against a pharmaceutical manufacturer, stating that federal approval of prescription drugs does not prevent lawsuits from injured patients. The ruling came in the case of Wyeth v. Levine.
In August 2000, Vermont native Diana Levine visited a health clinic to receive treatment for a reoccurring migraine. Levine was administered Demerol and Phenergan for nausea, as she had been in the past, but when the pain persisted, she returned to the clinic later that day and was given a second dose of both drugs, this time receiving Phenergan in a push IV instead of her usual intramuscular shot. When she later awoke, she was still in pain and would be for some time.
Phenergan manufacturer, Wyeth, recommends that the drug be taken orally or through a slow IV drip, and only under the most severe circumstances be injected. When injected, though a highly effective way to get prompt results, the drug has a high risk of striking an artery, which can lead to gangrene and the eventual amputation of a limb.
Three weeks after receiving the push IV, Levine developed tissue deterioration and gangrene in her left arm, and after unsuccessfully taking several drugs to combat the pain, doctors had no choice but to amputate. The professional musician was left limbless on her left side from her elbow down.
Although both Wyeth and the Food and Drug Administration (FDA) were aware that administering Phenergan through a push IV created a risk of inadvertent arterial injection, the FDA nevertheless approved labeling for the drug that warned against, but did not prohibit, IV push administration. The label was most recently updated in 1997.
After settling claims against both the health center and clinician, Levine brought a common-law negligence claim against Wyeth in 2005, claiming that Phenergan’s label was inaccurate because it did not prohibit IV push delivery or associate this method specifically with gangrene. Wyeth countered saying that they complied with FDA rules, and that by doing so preempted any stricter state-laws, but the Superior Court jury ultimately favored Levine, awarding her more than $6 million in damages.
Wyeth appealed the decision, and in 2006 the Vermont Supreme Court upheld the ruling saying that Wyeth had every opportunity to strengthen the warning on the label while complying with both state and federal laws. The case then went on to the U.S. Supreme Court, where after much deliberation the court confirmed in a vote of 6 to 3 that federal law did not preempt Ms. Levine's state-law claim that Wyeth's labeling of Phenergan failed to warn of the dangers of its intravenous administration.
Wyeth v. Levine is a landmark product liability case that is certain to impact all federally regulated industries. The U.S. Supreme Court decision affirmed that the manufacturer of prescription drugs bears the responsibility for the content of its labels, and represents a change in using the federal preemption doctrine as a defense against state tort suits. Without a doubt it will change the way drug manufacturers look at their products’ labels hereafter.
For more information on the Supreme Court ruling in Wyeth v. Levine, please see: http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf.
