Rick Barnes and Sean Gugerty obtained a dismissal of a product liability action on behalf of a pharmaceutical manufacturing company and retailer in the United States District Court for the Northern District of Illinois. The result will have national implications for manufacturers and retailers of over-the-counter (“OTC”) generic drug products.
The plaintiff alleged that she ingested several drug products manufactured by different companies, including an OTC generic drug product manufactured and/or sold by the clients represented by Goodell DeVries. Plaintiff further alleged that her ingestion of these products caused her to develop Steven Johnson’s Syndrome (“SJS”)/Toxic Epidermal Necrolysis (“TEN”), and that the manufacturer and retailer of the OTC product had failed to adequately warn her of the risk of developing SJS/TEN.
The "failure to warn" allegations, according to the plaintiffs, established liability against the generic drug manufacturer and retailer under state tort law for defective design, negligence, consumer fraud, breach of implied warranty, and willful and wanton misconduct. The generic drug manufacturer and retailer moved to dismiss the claims because all of the plaintiffs' claims were preempted by Mensing and Bartlett. Plaintiff strenuously contended that the federal preemption law for generic products applied only to prescription generic products and not to over-the-counter generic drugs. However, the court (the Honorable Judge Jorge L. Alonso) was persuaded by the generic drug manufacturer and retailer’s argument that there is no basis for such a distinction in controlling federal law and regulations. Therefore, the court held that the federal preemption in the Supreme Court’s holdings in Mensing and Bartlett apply equally to OTC drug products and granted the manufacturer and retailer’s motion to dismiss.
The court’s ruling appears to be the first published holding by a federal court applying the federal preemption principles of Mensing and Bartlett to an OTC generic product. This precedent will be of great value in any future cases in which a plaintiff raises failure-to-warn claims against a manufacturer or retailer of a generic OTC product.