Dangerous Medicine Warning: The Supremes Favor Consumers
The United States Supreme Court in the case of Wyeth v. Levine, handed down a decision on March 4, 2009, which denied the drug manufacturer's defense that federal regulations completely overruled (preempted) Vermont state injury law claims filed by consumer Diana Levine. Levine, who was a musician, suffered amputation of a part of her arm because of complications from an injection of the medication called Phenergan, which is a common drug used to treat nausea, that was injected into her arm by a method called IV push .
Levine won a verdict after a Vermont jury concluded that the product warnings did not adequately warn medical doctors about the irreversible effect of Phenergan which-if injected in this fashion, can reach the arteries of the human body and can cause gangrene. In the underlying case, the Vermont jury found for Levine and awarded substantial damages, medical expenses, and loss of livelihood compensation. Essentially, her musical career was wiped out, due to partial amputation of her arm. The Vermont Supreme Court affirmed the trial court jury verdict and rejected the drug manufacturer claim that the Food and Drug Administration law and regulations wiped out any state law failure to warn claim.
Justice Stevens said in the majority opinion of the Court:
“If Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express preemption provision at some point during the Food, Drug and Cosmetic Act’s 70 year history…Its silence on the issue, coupled with its certain awareness of the prevalence of state tort litigation, is powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.”
The decision of the court was 6-3, with one of the six votes being Justice Clarence Thomas who stated as follows:
“Because such a sweeping approach to pre-emption leads to the illegitimate – and thus, unconstitutional – invalidation of state laws, I can no longer assent to a doctrine that preempts state laws merely because they ‘stand as an obstacle to the accomplishment and execution of the full purposes and objectives’ of federal law.”
This important decision creates a the financial disincentive for a corporation or drug manufacturer by virtue of the power of a jury or judge to penalize a drug manufacturer for negligent or wrongful conduct. I have represented both doctors and injured persons in matters such as these. Some may say that this ruling is quite politically liberal. For me, it stands for the purest form of constitutional conservatism, i.e. the states have a right to regulate conduct within their own borders. This is a victory for the little guy (girl) against huge corporate conglomerates. Bravo.
