Below is a link to the opinion from the U.S. Supreme Court issued on March 4, 2009, in Wyeth v. Levine, 555 U.S. _____ (2009). One of the products liability or medical malpractice attorneys at Schmidt Kramer PC, in Harrisburg, PA, can explain the application of the decision to your case.

Wyeth is a company that manufactures a drug called Phenergan. The drug is corrosive and causes irreversible gangrene if it enters a patient’s arteries. On April 7, 2000, the drug was introduced into Diane Levine’s body through the IV-push injection method. This is where the drug is injected directly into her vein, rather than being dripped in through a saline solution. During the injection, the drug somehow encountered an artery, causing gangrene and eventual amputation of her right forearm. This ended her career as a professional musician.

After settling her medical malpractice case, Ms. Levine’s product liability case against the manufacturer went to a jury in Vermont. She won, and was awarded compensation for medical bills, loss of income and future earning capacity, and pain and suffering in excess of six million dollars.

The case was appealed through Vermont’s high court, and was before the U.S. Supreme Court to consider the following issue: When the manufacturer’s label failed to provide adequate warning of the risks of using a particular method of introducing the drug into the body, should the judgment be overturned because the label was approved by the Food and Drug Administration, preempting a jury award based on state tort law? The court considered this narrow question, because the record in the lower courts was conclusive that had a stronger warning been present, the drug would not have been administered as it was, and that the warning for IV-Push administration was insufficient. The Supreme Court viewed these facts with the understanding that Congressional purpose determines preemption and federal law will only preempt the traditional police powers retained by the state when its purpose was clear and manifest.

The U.S. Supreme Court decided, the FDA’s approval of the label is not a complete defense to a state law tort claim. Wyeth was found to be able to comply with both duties imposed on it by the state tort law jury verdict and the federal labeling approvals. The court also found that subjecting Wyeth to a state tort law duty would not obstruct the purposes and objectives of federal drug labeling regulations. Ms. Levine’s claim was not preempted by federal law. The judgment from the jury in Vermont was allowed to stand.

http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf

Joe Chapman

Attorney at Law