The Court Report

Drug manufacturers frequently face lawsuits seeking damages for injuries allegedly caused by insufficient warnings on the labels of the medicines. Just how far the duties of a drug manufacturer go was recently addressed by Maryland’s highest court in the case of Gourdine v. Crews.

The Court of Appeals’ opinion indicates that Ms. Crews was a Type 1 diabetic. She took two medications manufactured by Eli Lilly & Co., one a quick acting insulin to be taken with food, and another designed to provide a constant source of insulin. While driving a car she suffered a debilitating episode, which caused her car to strike a vehicle being operated by Mr. Gourdine. Tragically, his car was forced into a tractor trailer and he was killed.

Mrs. Gourdine filed a lawsuit on behalf of her husband’s estate, herself and her two children against Lilly, claiming that the labels on the medications failed to warn of possible side effects such as symptoms of low blood sugar or drowsiness in the morning from the combination of these drugs. She claimed fraud, negligence and strict liability related to the labels. Lilly moved to dismiss the suit, contending that it owed no duty to Mr. Gourdine in relation to the labeling of its products, and also that the labels had been approved by the FDA.

The trial judge granted judgment before trial for Lilly, and the intermediate appellate court upheld the finding of a lack of duty. The Court of Appeals took the case to consider the arguments regarding just how far a drug manufacturer’s duties go. The Plaintiff’s attorneys argued that this was analogous to a car manufacturer, which may be strictly liable for selling a defective car not only to the buyer but to a person injured by the defective product. Since it was foreseeable that someone could take the drugs, become debilitated and cause an accident, any person injured should arguably be able to recover. They also claimed that the Federal Food, Drug & Cosmetic Act (FDCA) imposed a duty on Lilly to properly label the drug, which should allow this Plaintiff to sue.

The Court of Appeals rejected these arguments. It said that the term “duty” means an obligation imposed by law to conform to a particular standard of conduct towards others. Foreseeability alone in this context, the Court said, was not enough to impose a duty, since in each case the issue is whether the specific Plaintiff suing is entitled to protection from acts of the Defendant. The Court held that before a duty is imposed there must be a close and direct connection between the act and the effect. Here, there was no direct connection between Lilly and Mr. Gourdine, in fact no contact between them at all, and imposing a duty here would expand the Court’s previous rulings to imposed a duty that could apply to everybody who could have been affected by Ms. Crews consuming the medication.

The Court also rejected the argument that the FDCA imposed a duty. It said that a duty may be imposed from a statute only when the Plaintiff is a member of the class of person designed to be protected by the law, and the law is designed to protect against the type of injury alleged. Here, the Court said, this law was designed to protect the public in general and not any particular class of persons to which the Plaintiff belonged. The Court also found no basis for a fraud claim, since no misrepresentations were allegedly made to Mr. Gourdine.

This illustrates now far the Maryland courts will take duties of product manufacturers such as drug companies.