As a defective medical device attorney, I know weight-loss surgery is frequently sold as voluntary or cosmetic surgery by playing down its risks. That’s why I was disappointed to see the Pennsylvania Supreme Court’s ruling in Beard v. Johnson and Johnson, a lawsuit alleging that defects in a surgical device were responsible for the death of Sandra Selepec after gastric bypass surgery. The device, called an endocutter, is used in both laparoscopic surgery — the minimally invasive kind using only small incisions — and the conventional surgery Selepec had. The trial court made a late brief risk-utility analysis determining that the endocutter was unsafe, and the appeals court reversed this by considering on all of its uses rather than just conventional surgical uses. The Pennsylvania high court ruled that it’s permissible to consider all uses of a device when determining its risk and utility, but declined to overrule the appeals court’s risk-utility analysis.
Selepec had her surgery in 2002, creating a smaller stomach. The incisions were closed with staples in her abdomen and reinforced by a material called peri-strips. After Selepec had complications during recovery, exploratory surgery found that staples were missing in two areas; the medical report said this was consistent with mechanical staple failure. Though this was repaired, the contents of her stomach leaked, causing sepsis that eventually led to death. The administrator of her estate eventually sued the makers of the endocutter, alleging strict liability for a defective or malfunctioning product. Though the defense objected to the late addition of a design defect claim, and the expert used to support it, the jury ultimately awarded $5 million on that basis. The defendants appealed to the Superior Court, which issued a divided ruling vacating the award and ordering judgment notwithstanding the verdict for the defendants, saying the trial court failed to make a full risk-utility analysis, and the verdict was not supported by the record.
The plaintiff appealed, arguing that the Superior Court erred in analyzing the device for its use in laparoscopic surgery rather than restricting its analysis to the kind of surgery Selepec actually had. He also criticized the appeals court’s risk-utility analysis as shallow. The Pennsylvania Supreme Court ultimately declined this invitation to limit risk-utility analysis to a specific use. To limit the analysis would create the undesirable result of requiring trial courts to ignore pertinent facts, the court said. Furthermore, it agreed with the defense that allowing a wider analysis would not take away the ability to prove product defect cases, since plaintiffs can still allege failure to warn where appropriate. The high court went on to decline to overrule the Superior Court’s risk-utility analysis, saying it seems to have weighed most of the evidence correctly. It agreed that the analysis may have been conclusory and shallow, but this was not surprising given the limited engineering information on the record. Thus, it affirmed the Superior Court.
As a pharmaceutical liability lawyer, I am disappointed in this ruling. The Supreme Court notes that it made its ruling with less than complete information. Generally, the remedy for this is a remand for further proceedings, which could have created a fairer outcome. This would also have helped solve the problem of the conclusory and shallow risk-utility analysis the Supreme Court said was made by both courts. As things stand, this opinion reduces Pennsylvanians’ ability to pursue lawsuits over any product defect, including lawsuits over defective medical devices. As a dangerous medical device attorney myself, I don’t believe more obstacles should be erected between injured people and fair compensation.
Carey, Danis & Lowe represents clients around the country who are pursuing justice and fair compensation after an injury from a defective medical device or pharmaceutical. To tell us about your case and learn more about us, you can call us toll-free at 1-877-678-3400 or send us a message online.
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