David Waxman

Sharilee Smentek

Arnstein & Lehr LLP Litigation Department Chair David Waxman and Partner Sharilee Smentek were successful recently in the defense of a negligent failure-to-warn-action against their client in The U.S. Court of Appeals for the Seventh Circuit.  The appellate court affirmed the opinion of an Illinois District Court for the client, a manufacturer of generic pharmaceuticals.  The district court had previously granted our client’s motion for summary judgment.

This result is one of the few recent victories for pharmaceutical manufacturers across the country in the wake of the U.S. Supreme Court’s decision in Wyeth v. Levine which significantly weakened the defense of federal pre-emption of state law claims regarding pharmaceutical safety warnings, making it considerably more difficult for manufacturers to prevail on such claims.

In this lawsuit, the plaintiff alleged that the firm’s client failed to appropriately warn of dangers associated with its product, a generic form of the widely prescribed antibiotic, Bactrim.  The plaintiff incurred Stevens-Johnson syndrome, a serious disorder which attacks the skin and mucus membranes and which resulted in permanent injuries.

Stevens-Johnson syndrome is included in the product warnings issued by the manufacturer and was known to the prescribing physician.  It is on this basis that the manufacturer sought dismissal of the claims, as the defense contended that the prescription for the generic Bactrim had been issued by a learned intermediary who had all necessary information provided to her regarding the risks and benefits of the medication.

The appellate court affirmed the lower court’s ruling which granted the defendants’ motion for summary judgment, concluding that the plaintiff did not raise a genuine fact issue regarding a breach of duty and also that the plaintiff forfeited any claims when she failed to respond to the defendants’ statements of material fact in the district court proceedings.