“Non-Functional” Surgical Staples Led To Sepsis, Numerous Complications After Surgery, Lawsuit Claims

Covidien and Medtronic face a product liability lawsuit over surgical staple failures, which caused a South Carolina man to experience painful complications after surgery, including sepsis and the need for additional procedures.

John Eichin filed the complaint (PDF) earlier this month in the U.S. District Court for the District of South Carolina, indicating that the manufacturers’ End to End Anastomosis Stapler, used in surgical procedures, was defective and can fail to form a proper seal.

According to the lawsuit, Eichin underwent surgery for diverticulitis and the removal of a large mass from his colon in October 2019. However, following the surgery he became tachycardiac, ran a fever and began feeling extremely ill. He was subsequently diagnosed with sepsis and had to undergo emergency surgery, where doctors discovered he had a colorectal anastomic leak caused by an area of “non-functional staples.”

“As a result of the above surgery, Plaintiff, John Eichin, had to undergo numerous other surgeries, including the placement of a very large area of mesh throughout his entire abdomen,” the lawsuit notes. “Plaintiff alleges…that the specific stapler that failed during his initial October surgery was a model that was known by Defendants to frequently malfunction. In fact, that model was later subject to recall.”

The lawsuit came just two days before the U.S. Food and Drug Administration (FDA) issued new rules and guidelines aimed at improving surgical stapler safety. This included a final rule reclassifying them as Class II surgical devices, which will now require any new surgical staplers to undergo premarket review before receiving FDA approval.

In March 2019, the FDA warned about the rising rate of problems with surgical staplers, indicating that at least 41,000 adverse event reports were received between January 2011 and March 2018, including 366 patient deaths. As a result of the problems, the FDA proposed new rules and guidelines designed to make surgical staplers safer in April 2019, and decided to classify the products as moderate risk medical devices, as opposed to low-risk devices.

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 warns 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.

Medical device manufacturers face a growing number of surgical stapler lawsuits similar to the one by Eichin, filed by individuals nationwide who suffered serious injuries or who lost loved ones due to stapler malfunctions.