Covidien Surgical Stapler Lawsuit Blames Defective Design for Botched Hernia Repair and Gastric Sleeve Surgery

The Covidien surgical stapler lawsuit claims the manufacturers deceived the FDA and the public by reporting incidents involving the staplers as malfunctions instead of injuries.

Medtronic and it’s Covidien subsidiary face a product liability lawsuit filed by a North Carolina woman, which indicates that a defectively designed surgical stapler failed during a hernia repair and gastric sleeve procedure, leaving her with sepsis, the need for additional surgeries and a prolonged hospitalization.

The complaint (PDF) was filed by Tracy Hunt last month in the U.S. District Court for the District Court of Massachusetts, indicating that a Covidien surgical stapler was used that had already been recalled and plagued by design problems

Hunt underwent a laparoscopic hiatal hernia repair and a laparoscopic vertical sleeve gastrectomy in May 2019, at which time surgeons used a Covidien EGIAUXL stapler and 60mm reinforced Tri-Staples. However, that handle was recalled in February 2016, and the Tri-Staples were recalled at different times in May 2018 and April 2021, as well.

Two weeks after undergoing surgery, Hunt developed a fever and abdominal pain and she was diagnosed with sepsis. During a subsequent hospitalizations, surgeons found an abscess at the staple line made in her stomach near the distal esophagus and found an anastomotic leak, resulting in additional surgeries, as well as treatment with IV antibiotics and physical therapy.

The case joins a growing number of surgical stapler lawsuits being pursued against Covidien, involving a number of different problems with the products, including issues where the staplers misfire, fail to fire or issue malformed staples, which can cause devastating internal injuries and organ perforations.

Hunt indicates in her lawsuit that Covidien hid the full scope of problems with the surgical staplers and staples from surgeons and the U.S. Food and Drug Administration, by filing reports that listed complications as malfunctions, instead of injuries, using an alternative summary reporting program.

“Defendants…have manipulated the reporting systems in a way that ensured healthcare providers could not review the dangers posed by the products,” Hunt’s lawsuit states. “By not reporting all stapler-related injuries on the publicly available MAUDE database, Defendants have hidden the true risks of using the devices from surgeons and their patients.”

In March 2019, the FDA reported at least 41,000 adverse event reports involving surgical stapler failures were filed between January 2011 and March 2018, including 366 patient deaths. However, it appears that those reports did not include all problems linked to the devices.

As part of an effort to make surgical staplers safer, the FDA issued new rules and guidelines for Covidien and other manufacturers, and has to reclassified staplers as Class II surgical devices, which now requires any new surgical staplers to undergo premarket review before getting FDA approval.

The change of surgical staplers from class I medical device (general controls) to class II medical devices (special controls) has been anticipated for several years, and does not affect the classification of the staples themselves. However, it would require more stringent premarket approval for new staplers and force manufacturers to provide more thorough safety warnings and instructions.

“As one of the largest surgical stapler manufacturers in the world, Defendants have been in possession of massive amounts of data on surgical stapler-related injuries, fatalities and malfunctions. But rather than contributing this knowledge to the powerful [FDA medical device database], Defendants purposely kept this information from the attention and scrutiny of the public,” according to the complaint. “[I]n the years preceding Tracy Hunt’s bariatric procedure and subsequent injury, the medical providers who performed her surgery were deprived of over half of Defendant’s data on adverse events associated with its staplers, totaling over 56,000 reports that were never publicly submitted.”