On Nov. 3, the U.S. Supreme Court will hear oral arguments in an important case which could threaten the rights of consumers to sue drug makers over dangerous prescription medicines.
In 2000, musician Diana Levine went to the hospital complaining of nausea associated with a migraine headache. Doctors injected the anti-nausea drug Phenergan, which is made by Wyeth, into her muscles. When the medicine failed to rid Levine of her nausea, her physicians decided to administer the drug a second time. Instead of using an IV drip, her doctors gave her the drug by using an “IV push” method in which the medicine is delivered directly into the vein. The drug made contact with her arteries causing gangrene. Her arm had to be amputated as a result.
Levine sued Wyeth in Vermont state court alleging that the drug company failed to warn of the risks associated with an IV push of Phenergan.
The Phenergan label had been approved by the Food and Drug Administration in 1955 and re-approved in the 1980s. Although Wyeth knew that the anti-nausea drug could cause gangrene if it reached the arteries, it did not mention the dangers associated with the IV push method. In addition, there was no evidence that the FDA ever considered whether the label should have contained such a warning.
The jury sided with Levine and awarded her $6.7 million. Wyeth appealed, arguing that the FDA approval process overrides state tort law. The Virginia Supreme Court disagreed, concluding that nothing in federal law prevented Wyeth from providing additional warnings.
On Jan. 18, the U.S. Supreme Court agreed to take the case, Wyeth v. Levine, to consider the preemption issue.
The stakes are high. Friend of the court briefs urging the Court to adopt Wyeth’s position have been filed by pharmaceutical groups, the U.S. Chamber of Commerce and the Bush administration. Amicus briefs urging the Court to uphold the jury award have been filed by a number of consumer groups.
My law firm currently represents victims and their families in lawsuits against most of the major drug companies including Merck, Pfizer, Bayer, Eli Lilly and others. The lawyers of Carey, Danis & Lowe are experienced in helping people injured by dangerous prescription drugs. We will seek compensation for past and future medical expenses, past and future wages, pain and suffering, disability and other damages. We also represent family members in wrongful death cases. This legal argument of preemption is the result of an expansion of power by the Bush Administration. Hopefully the Supreme Court will not decide in favor of this unjustified protectionism of drug companies.
My prediction is that there will be limited preemption but not total preemption. Based on the facts of the case the Supreme Court took I think they will hold in a 5-4 decision that if the drug company provided all of the required information to the FDA and the FDA considered it, that an injured person will not be able to claim that the warning is inadequate. We will just have to wait until January 2009 to see. Also if they completely preempt prescription drug cases it looks like there will be a democratically controlled House, Senate, and Presidency, and they can write new legislation overturning the Supreme Courts ruling.
