J&J Sued over Stapler Misfire Complications

A man who suffered severe complications following what should have been a routine hemorrhoidectomy has filed a product liability lawsuit against Ethicon Endo-Surgery, Inc. and its parent, Johnson & Johnson, in New Jersey federal court.

The plaintiffs, Brandon and Sabine Hefferan of Michigan, say that in July 2012 Brandon underwent a hemorrhoidectomy for grade 3 hemorrhoids while he was in Germany. According to allegations raised in the lawsuit, an Ethicon Proximate stapler misfired during the procedure. This caused it to fail to complete formation of the staple and resulted in an internal leak from an opening in his rectal wall.

The suit, filed in the US District Court for the District of New Jersey, claims that Hefferan suffered Fournier's gangrene, rhabdomyolysis, perianal necrosis and severe sepsis as a result of the misfire. Hefferan underwent at least 20 additional surgeries and suffered severe and permanent injuries, the suit maintains.

In August 2012, a month after Hefferan's surgery, Ethicon announced an FDA Class I recall of 500 lots of the device. In October of the same year a second Class I recall was ordered, this time including 157,000 of the devices. Class I is FDA's most serious recall designation, meaning that continued use of the device is likely to cause severe injury or death.

According to the FDA recall notice, "Users have difficulty firing the stapler devices, resulting in incomplete firing stroke and incomplete staple formation."

The notice continues, "Failure to complete the firing stroke of the stapler can result in severe pain, sphincter dysfunction, rectal wall damage, sepsis, bleeding, and occlusion of the rectal canal. Failure to complete the firing stroke can also result in poor staple formation, dehiscence of the rectal wall staple line and bleeding."

Hefferan's lawsuit seeks damages from Ethicon Endo-Surgery and Johnson & Johnson, their parent company. The plaintiffs are pursuing claims for negligence, designing and manufacturing a defective product, breach of warranty, and loss of consortium on behalf of Hefferan's wife.

The recalls include all lots manufactured between April 16, 2011 to July 24, 2012. All of the affected devices have an expiration date of March 2016 to June 2017, so it's possible that some of them might still be out there - similar devices can be found on eBay.

Stephen Levy is a contributor to Qmed and MPMN.