Pa. Courts To Consider All Potential Uses Of Product In Design-Defect Cases

The Pennsylvania Supreme Court recently issued an opinion that bolsters medical device manufacturers' arsenal of defenses in design-defect products liability actions. In Beard v. Johnson & Johnson, Inc., No. 35 WAP 2010, slip op., (Pa. March 22, 2012), the court held that in design-defect cases involving multi-use medical devices, trial courts are not limited to considering the particular use at issue in the litigation when conducting a risk-utility analysis of the device. Rather, the trial court is bound to consider all of the uses of the device as part of its risk-utility analysis.

Case Background The Beard case was brought on behalf of decedent Sandra Selepec following failed gastric bypass surgery. At the crux of the litigation was a medical device manufactured by a subsidiary of Johnson & Johnson, known as an endocutter, that is an elongated surgical device that both cuts and staples organ tissue during surgery. The endocutter was designed for use in small incision endoscopic or laparoscopic surgery; however, it was also marketed by Johnson & Johnson for use in traditional larger open-incision surgeries. Mrs. Selepec underwent a non-endoscopic open-incision gastric bypass procedure, and the surgeon utilized the endocutter device to staple the gastric pouch. The surgeon also used a material known as peri-strips to reinforce the gastric staple seams. Following the surgery, Mrs. Selepec experienced complications; follow-up surgery discovered that staples were missing in two segments of the stapled seam. Mrs. Selepec succumbed to infection as a result of the staple line defect. The administrator of her estate brought suit, alleging, among other things, a strict-liability product malfunction theory and a design-defect theory. Johnson & Johnson's primary defense was that the surgeon failed to select the appropriate length staple to accommodate the gastric tissue and the peri-strips being stapled.

At trial, the plaintiff presented expert testimony regarding the malfunction and defective design on the endocutter. In particular, the plaintiff's expert opined that the endocutter was defective and unreasonably dangerous because it did not employ a measuring device to allow surgeons to determine the thickness of tissue to be stapled in order for the surgeon to select the appropriate staple length. The jury awarded the plaintiff $5 million on the grounds that the endocutter was defectively designed. The jury specifically rejected the product...