Surgical Stapler Lawsuit Filed After Malfunction Resulted In Abdominal Leak

Johnson & Johnson faces a product liability lawsuit over problems with a surgical stapler which failed during colon removal surgery, causing a Florida man to suffer abdominal leaks and to require additional surgeries to repair the damage.

The complaint (PDF) was filed last month by Dale Lewis, in the U.S. District Court for the Southern District of Florida, alleging that an Ethicon Intraluminal stapler malfunction led to liquid stool leaking into his body cavity.

Lewis underwent a sigmoid colectomy procedure in April 2019, which involved the use of staples in his descending colon, from the anus to the rectal stump. However, after the surgery was complete, Lewis developed severe abdominal pain and failed to resume normal bowel movements.

Several days later, x-rays raised concerns about a pocket of free air under his diaphragm, and further examinations discovered an anastomotic leak, with liquid stool leaking between small bowel loops. Doctors later determined that “the staples did not take” during the original surgery.

Lewis had to undergo hospitalization, heavy antibiotic treatment to stave off a developing case of sepsis, and had a laparoscopic colostomy reversal surgery in August 2019. He is still receiving care for injuries caused by the stapler failure, the lawsuit indicates.

According to Lewis’s lawsuit, the model used is one that was known by Ethicon to frequently malfunction. His lawsuit notes the FDA announced a recall of the model used during his surgery in April 2019 due to problems with malformed staples due to insufficient firing of the stapler, which could lead to abdominal leaks, sepsis, bleeding, death and the need for a permanent ostomy bag.

“Despite knowing that its Ethicon Endo-Surgery Intraluminal Staplers caused injuries due to malfunction, Defendants, and each of them, represented and marketed the Ethicon Endo-Surgery Intraluminal Staplers as safe and effective,” the lawsuit states. “Defendants, and each of them, failed to include warnings regarding potential malfunctions that were known to them, including the risks described in the FDA publication.”

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 stapler malfunctions, 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.