Johnson & Johnson Hit with Extra $70 Million in Damages

The company's Ethicon subsidiary will seek to appeal the award in the case involving the Proximate PPH-03 surgical stapler.

Nancy Crotti

An Oakland, CA, jury has awarded a California couple $70 million in punitive damages from Johnson & Johnson's Ethicon Endo-Surgery subsidiary for injuries caused by a defective surgical  stapler.

The same Superior Court jury, sitting in Oakland, earlier found Ethicon liable for $9.8 million in compensatory damages resulting from a January 2012 surgical procedure on patient Florence Kuhlmann, 59, according to a press release issued by the law firm that represented Kuhlmann.

According to the complaint, when the surgeon used Ethicon's Proximate PPH-03 Procedure Set on Kuhlman during a hemorrhoidopexy, it "stapled shut her bowel to the rectal wall (and) closed off her intestine." Kuhlmann later had multiple surgeries, hospitalizations, and procedures, including laparotomy, colostomy, rectal dilation, and surgical releases of scar tissue and rectal constriction, the complaint says.

"The jury found that the force to fire the stapler exceeded its specifications and was caused by the failure to manufacture the product according to its design requirements," the press release said.

Kuhlmann and her husband also alleged that J&J and Ethicon knew of defects to the Proximate PPH-03 stapler for 10 years before it recalled nearly 145,000 of the PPH-03 models in August 2012. FDA termed it a Class I recall, which means the device could cause serious injury or death.

A Michigan man who underwent a hemorrhoidectomy with the PPH-03 model device in July 2012 sued Ethicon Endo-Surgery as well, claiming he suffered an internal leak in from an opening in his rectal wall as a result of the stapler misfiring.

The FDA website lists about 1,200 adverse event reports linked to the Proximate PPH-03. The August 2012 recall stemmed not from a defect inherent in the product itself, but "from a change in the manufacturing process," Ethicon spokesman Matthew Johnson wrote in an email. "The PPH-03 continues to be used and sold globally."

Ethicon expressed its sympathy for the patient, but is disappointed in the jury's verdict and will pursue options for appeal, according to Johnson.

"This product has been successfully used over one million times, and remains a safe and efficacious option for surgeons," he added. 

Nancy Crotti is a contributor to Qmed and MPMN.

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