Ethicon Proximate Stapler Lawsuit Filed Over Misfire During Surgery

A Michigan man has filed a product liability lawsuit against Ethicon Endo-Surgery, Inc., alleging that he suffered gangrene and sepsis after a surgical stapler misfired during an operation.  

The complaint (PDF) was filed by Brandon Hefferan, and his wife Sabine, in the U.S. District Court for the District of New Jersey on February 25, claiming that the Ethicon surgical stapler was defectively designed and manufactured.

Hefferman indicates that he underwent a hemorrhoidectomy for grade 3 hemorrhoids in July 2012, in Germany. According to allegations raised in the surgery stapler lawsuit, during the procedure an Ethicon Proximate stapler misfired, failing to complete the staple formation and resulting in an anastomotic leak from an opening in his rectal wall.

As a result, Hefferan suffered Fournier’s gangrene, rhabdomyolysis, perianal mecrosis and severe sepsis, the lawsuit claims. Hefferan underwent at least 20 additional surgeries as a result and suffered severe and permanent injuries.

A month after his surgery, an Ethicon Proximate stapler recall was announced. The recall came after complaints from doctors that the surgical staplers were too difficult to fire.

One of the complaints filed with the FDA’s adverse event reporting system was from a surgeon who said the stapler misfired during a hemorrhoidectomy, leaving the suture still attached to the stapler. The surgeon cut the suture free, abandoned attempts to use it, and performed the closure manually.

Originally, the Ethicon Endo-Surgery said it checked the device and determined that it appeared to be in proper working order. However, by the time of the recall the company admitted that the staplers appeared to be difficult to fire “which may result in incomplete firing stroke, that may result in an incomplete staple formation.”

The company announced a second Proximate stapler recall in October of 2012, affecting even more units.

The manufacturer noted that failure to complete the firing stroke of the stapler could result in severe pain, sphincter dysfunction, rectal wall damage, sepsis, bleeding, and occlusion of the rectal canal. Failure to complete the firing stroke could also result in poor staple formation, dehiscence of the rectal wall staple line and bleeding, the company warned.

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