Ethicon Stapler Lawsuit Filed After Malfunction During Surgery Resulted in Bowel Leak
According to allegations raised in a recently filed product liability lawsuit, an Ethicon stapler malfunction during hernia repair surgery resulted in severe and permanent injuries, including a bowel leak and the need for additional surgical procedures.
The complaint (PDF) was filed by Robert Ashmore in the U.S. District Court for the Eastern District of Texas on March 19, indicating that his injuries could have been avoided if not for a defective Ethicon Surgical Stapler.
Johnson & Johnson and it’s Ethicon Endo-Surgery, Inc. subsidiary are named as defendants in the claim, which is one of a growing number of surgical stapler lawsuits filed in recent months over problems that have plagued several designs used in recent years.
According to the complaint, Ashmore underwent a low anterior resection and umbilical hernia repair in February 2019. However, an Ethicon stapler used during the procedure malfunctioned.
“During the procedure, use of the Ethicon Stapler failed and resulted in an incomplete anastomosis which resulted in a bowel leak that required additional repair,” Ashmore’s lawsuit states. “The failure of the Ethicon Surgical Stapler resulted in significant injuries with hospitalization that required diverting colostomy. These injuries will require additional medical care and significantly impair Robert Ashmore’s overall function.”
Surgical Staples Lawsuits
While the FDA is continuing to review design problems associated with a number of devices, similar legal claims being reviewed by surgical stapler recall lawyers nationwide, alleging that design changes and failure to adequately test and research the products has resulted in severe and catastrophic injuries.
In March 2019, the FDA reported that at least 41,000 adverse event reports were filed between January 2011 and March 2018 involving surgical staplers, including 366 patient deaths.
The next month, the FDA proposed new rules and guidelines designed to make surgical staplers safer, and to classify them as moderate risk medical devices. They are currently classified as low-risk devices.
The new classification would require more stringent premarket approval for new staplers and force manufacturers to provide more thorough safety warnings and instructions.
The most commonly reported surgical stapler problems involve an opening of the staple line, malformation of staples, staplers misfiring, staplers being too difficult to fire, staplers failing to fire and staplers that were misapplied. The FDA warning indicates that stapler malfunctions or misuse can cause prolonged surgical procedures, the need for additional surgeries, and other complications; such as bleeding, sepsis, internal organ damage, and death.