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| Proximate PPH Circular Stapler Set--Courtesy of Ethicon |
Johnson & Johnson's ($JNJ) Ethicon unit lost a lawsuit over its hemorrhoid stapler, resulting in $79.8 million in damages awarded to the plaintiff. The company promised to appeal the decision.
Retired police officer Florence Kuhlmann of San Jose, CA, is supposed to receive $70 million in punitive damages and $9.8 million for compensatory damages. About 4 years ago, she suffered a sealed anal canal and ruptured bowel during an unsuccessful surgery involving Ethicon's PPH 03 hemorrhoid stapler. The injuries forced her to wear a colostomy bag.
"The jury rightfully concluded that Ethicon engaged in reprehensible conduct in knowing about its product's defects for 10 years and doing nothing to change its design or manufacturing process," Alexander Law Group Managing Partner Richard Alexander said in a statement. The firm represented the plaintiff during the trial.
According to the firm, the jury concluded that the injury occurred because the force required to fire the stapler exceeded the device's specifications, and not due to operator error, according to the Alexander Law Group.
Surgeon Dr. Rakhee Shah was a defendant in the lawsuit, but was not found culpable by the jury.
J&J reacted to the news in an email to FierceMedicalDevices, saying "We are disappointed in the jury's verdict. This product has been successfully used over one 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."
The company recalled the Proximate PPH and Proximate HCS staplers in 2012 because they could be too difficult for users to fire, possibly resulting in severe pain, sphincter dysfunction, rectal wall damage, sepsis, bleeding and occlusion of the rectal canal.
The FDA designated the recall as Class 1. This designation is reserved for situations in which the agency believes "there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."
The PPH stapler enables a procedure for prolapse and hemorrhoids. According to the product website, the PPH procedure is better than Ferguson Hemorrhoidectomy. The PPH stapler provides "two staggered rows of titanium staples in 33 mm diameter size applied in the anal canal for transection and resection of internal tissue."
- read the (corrected) release