Defective Drug Lawsuits Under Review By Supreme Court
In the next few months the U.S. Supreme Court will rule on Wyeth Vs. Levine and will decide under what circumstances a consumer can sue a drug company for damages. The justices may even eliminate certain pharmaceutical lawsuits.
The Philadelphia Inquirer reported that Diana Levine won a $6.7 million dollar judgment in Vermont against Wyeth Pharmaceuticals, which Wyeth appealed. According to the article, Levine took Phenergan, a drug for nausea, to treat a migraine headache. After several weeks, her lower arm became purple and then black as gangrene set in. Eventually doctors had to amputate her arm. Levine sued Wyeth after she found out they knew about this risk.
Wyeth has argued that the Food and Drug Administration (FDA) had the final say over the risks Wyeth put on the Phenergan label.
Wyeth and its backers, which include FDA leadership, the Bush Administration, and the US Chamber of Commerce argue that the FDA is best able to assess the risks of drugs and that juries may be too sympathetic to an injured patient. Their case is based on “preemption,” which says that federal law overrides state law. Therefore, Wyeth claims that they could not comply with both the FDA and the jury’s verdict that says the label warning should have been stronger. Levine and her supporters disagree because they think juries serve as “an important check” on the drug approval system. According to the article, she and her supporters argue that a ruling for Wyeth could severely limit consumers’ ability to sue any company, as preemption becomes a ruling principle.
In previous years the FDA supported similar claims because these types of defective pharmaceutical drug litigations complement the FDA’s job of protecting consumers. In briefs supporting Levine, two FDA former commissioners stated, “risks that are rare, have long latency periods, result from drug interactions, or have adverse impacts on sub populations often go undetected in clinical testing.”
The head of the FDA’s Office of Chief Counsel, Daniel Troy, disagrees. He believes patients are best served when labeling decisions are made by scientific experts at the FDA instead of juries. Congressional investigators, however, released FDA documents in which officials said Troy’s argument “was based on false assumption that FDA-approved labeling is fully accurate and up-to-date in a real time basis.”
According to the Inquirer the Levine case is complicated because with Phenergan the gangrene risk was known and included on the drug’s label. Levine, however, was not told that when Phenergan is administered through IV push and if medical personnel hit an artery, gangrene could occur. She would like to put a ban on the injection method, so that no one else is injured.
Wyeth says it could not have changed the label without the FDA’s approval.
The Supreme Court will rule in this case within the next few months.
This ruling may affect your rights as a consumer. If you or a loved one have suffered from any of the side effects from or have experienced any other serious health related side effects as the result of dangerous or defective pharmaceutical medications you should contact a Philadelphia adverse drug reaction lawyer at Cherry Fieger and Marciano, LLP for a free pharmaceutical injury case evaluation.
