|June 5, 2012|
Previously published on May 31, 2012
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.
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 malfunction cause of action. On post-trial motions, the court upheld the jury verdict and provided a brief summary of its risk-utility analysis, finding that the endocutter's failure to include a measuring device rendered it highly dangerous to patients. The trial court further found that the endocutter could have been designed with a measuring device to eliminate the defect and that the dangers of the endocutter, as manufactured, outweighed the benefit and utility of the device.
On appeal to the Pennsylvania Superior Court, a divided panel vacated the jury verdict and directed the trial court to enter judgment in favor of Johnson & Johnson on the grounds that the trial court's risk-utility analysis did not support the verdict. In particular, the Superior Court found that under the current standard, it is a question of law whether a product is unreasonably dangerous. In order for the court to answer that question of law, the court would need to undertake a risk-utility analysis of the product and consider the danger alleged; the feasibility of alternative design; and the consequences to the product and the consumer if the design were altered. The Superior Court found the trial court’s risk-utility analysis, that focused only on the use of the endocutter in open incision surgery, was inadequate and that a full review of the record demonstrated that the utility of the product outweighed the risks. The Superior Court further found that altering the design would limit the endocutter's feasible uses because the addition of a measuring device would increase the size of the endocutter beyond the parameters of small-incision endoscopic surgery.
The plaintiffs appealed to the Pennsylvania Supreme Court, contending that the Superior Court erred in its risk-utility analysis when it considered evidence of all uses of the endocutter, instead of restricting its analysis to only the large-incision open surgery technique that Mrs. Selepec underwent. The plaintiffs maintained that under Azzarello1 and its progeny, the accepted rule of isolating strict liability from the consideration of any negligence would favor conducting an independent risk-utility analysis for each intended use of a multi-use product. The court sided with Johnson & Johnson and declined to limit the scope of risk-utility analysis to a particular intended use of a multi-use product. In so doing, the court found that a risk-utility analysis that ignores the primary design use for a product is "irreconcilably inconsistent with [a] claim of an inherent design defect."
It is important to note that the majority opinion authored by Justice Saylor and joined by Justices Castille, Eakin and Melvin, commented that Pennsylvania strict-liability design-defect law is in a "continuing state of disrepair." The reference relates to differing views on the court about the adoption of the Restatement (Third) of Torts as it relates to products liability claims. Justice Baer, joined by Justices Todd and McCaffrey, filed a concurring opinion expressly declining to favor the Restatement (Third) of Torts in place of the currently adopted Section 402A of the Restatement (Second) of Torts, and noted that the issue was not before the court in this case.
Impact on Manufacturers
The Beard opinion provides manufacturers of multi-use products with significant defenses in products liability actions that arise from only one of the multiple uses. Plaintiffs in Pennsylvania will no longer be able to attack the design of a product for a secondary use without also establishing that the product design is defective for its primary use. However, manufacturers may want to provide appropriate warnings relating to risks arising from the different potential uses of their products.
Azzarello v. Black Brothers Co., 480 Pa. 547 (1978).