The Pennsylvania Supreme Court stuck down a $5 million verdict in an Ethicon endocutter design defect case last week, finding that the trial court was not restricted to considering only one use of the device, and that it properly applied a risk-utility analysis. The case talks about product liability risk-utility analysis in the Restatement (Third) of Torts. You can read the court’s opinion here.
Plaintiff, a 40 year old mother, underwent gastric bypass surgery (Technically, she is the plaintiff’s decedent. I use “plaintiff” because my refusal to use plaintiff’s names on this blog, a stance that sometimes makes recitation of the facts awkward in wrongful death cases.). To cut and resection plaintiff’s stomach, her doctors
utilized an ETS-Flex45 Articulating Endoscopic Linear Cutter – called an an “endocutter” – made by Johnson & Johnson, subsidiary Ethicon Endo-Surgery (Let’s say charitably that both of these companies are frequent flyer product liability defendants.). The device was designed for use in less-invasive endoscopic surgery, but also was marketed for use in traditional “open” surgery in which a large incision is used to view internal organs.
After complications, Plaintiff’s doctors conducted a second surgery and discovered that staples were absent in two small sections and attributed the problem to “mechanical staple failure.” Sadly, Plaintiff’s stomach contents had leaked into her abdominal cavity, causing sepsis, and her eventual death.
Plaintiff’s Estate filed a wrongful death suit contending that the endocutter was unreasonably dangerous because it was not equipped with a means to either measure the thickness of the tissue being stapled or lock the device if the tissue thickness was incorrect. Plaintiff’s Estate contended that had the endocutter been designed with with this capability, it would have prevented the staple line failure that caused Plaintiff’s death.
An Allegheny County, Pennsylvania jury agreed, finding the endocutter’s defective design caused the woman’s wrongful death and awarded $ 5 million, finding that the endocutter was defectively designed.
The big issue in the case was the application of the risk/utility analysis required in a products liability action to determine whether a product is unreasonably dangerous. In this case, the endocutter at issue was marketed for multiple recognized uses, but the injury to the plaintiff was caused by only one of those uses. So the question is whether the trial court’s risk-utility analysis should be limited to the use that caused the plaintiff injury or should it consider all of the uses of the product. Continue reading →