BOTCHED SURGERY A jury awarded a woman nearly $80 million in damages after it ruled that Ethicon Endo-Surgery's PPH 03 hemorrhoid stapler was defective.

A California court has ordered Ethicon Endo-Surgery to pay nearly $80 million to a woman whose bowel was stapled shut after the company's PPH 03 hemorrhoid stapler misfired during her 2012 colorectal procedure, court records show. Ethicon is accused of ignoring a manufacturing error that led to the faulty design for more than a decade. The company has denied the allegations.

An Alameda County jury awarded Florence Kuhlmann $70 million in punitive damages Monday against Ethicon Endo-Surgery. On Friday, the same jury found Ethicon liable for $9.8 million in compensatory damages in the case.

"We are disappointed in the jury's verdict," an Ethicon spokesperson told Outpatient Surgery. "This product has been successfully used over 1 million times, and remains a safe and efficacious option for surgeons. While we are sympathetic with the plaintiff, we will be pursuing our appellate options."

Florence Kuhlmann from San Jose, Calif., underwent a hemorrhoidopexy in January 2012. During the procedure, her surgeon inserted Ethicon's PPH 03 hemorrhoid stapler, but had difficulty firing it because of a design malfunction, according to Ms. Kuhlmann's attorney. Unable to remove the device, the surgeon fired the stapler again, sealing Ms. Kuhlmann's bowel against her rectal wall, closing off her intestine and leading to a 21-day emergency hospitalization and countless follow-up procedures.

Since the initial surgery, Ms. Kuhlmann has undergone several unsuccessful operations to restore her damaged bowel and anal canal, her attorneys say, and has been forced to use a colostomy bag for the past 4 years.

She eventually sued Ethicon, alleging that the stapler was too difficult to fire correctly, the result of an ignored manufacturing failure. The lawsuit claims that though several problems with the stapler were reported over the years, Ethicon aggressively blamed surgeons for misuse instead of investigating the device's design flaw.

The FDA eventually issued a Class 1 recall of select PPH staplers in late 2012 — including the model used on Ms. Kuhlmann — saying they could cause serious injuries or even death. Her case is one of several lawsuits filed recently against Ethicon for injuries allegedly caused by the faulty staplers.

"Florence and her husband have finally received the justice they have waited so long for," says attorney Nina Shapirshteyn, who represented Ms. Kuhlmann and her husband, in a statement. "The jury understood the essential corruption of this company's refusing to make its product safer. These punitive damages will certainly get the attention of a billion-dollar company and are designed to ensure they will never again put profit above the public's safety."

Last week, a jury awarded Ms. Kuhlmann and her husband $8.5 and $1.3 million, respectively, for medical expenses and pain and suffering, with an additional $70 million in punitive damages given this week. Though the surgeon was also named a defendant in the case, the jury found that the doctor was not at fault.

Kendal Gapinski