Endo GIA Surgical Stapling Lawsuit Filed Over Known Defects, Problems
A product liability lawsuit filed by a Louisiana man claims problems with an Endo GIA surgical stapler caused him to suffer severe internal injuries, resulting in the need for repeated surgical procedures after a device with known defects malfunctioned during a laparoscopic procedure.
The complaint (PDF) was filed by Derick Paul Smith in the U.S. District Court for the Eastern District of Louisiana on March 15, indicating that Medtronic, Inc. and it’s Covidien subsidiary sold a defective and dangerous surgical stapling device, which had a high propensity to fail.
In March 2020, Smith underwent laparoscopic surgery, during which a surgeon used a Covidien Tri-Staple Endo GIA Surgical Stapling Device to help resection a Meckel’s Diverticulum and obstructed small bowel. This included the stapling of a side-by-side small bowel anastomosis. However, the lawsuit indicates the stapler malfunctioned during the surgery, but the problem was not immediately detected.
Weeks later, the plaintiff became ill with abdominal pains, nausea and vomiting. In May 2020, he was readmitted to the hospital and the surgeon found an anastomotic leak where the original stapling had occurred. He was diagnosed as having an anastomosis site transmural defect with associated fecal particles, severe acute suppurative inflammation, acute suppurative mesenteritis and acute peritonitis. These injuries also led to an E. Coli infection. He was hospitalized for nine days.
“What should have been a fairly straight-forward and uncomplicated minimally invasive Meckel’s Diverticulum – a rather simple procedure in terms of degree of skill and difficulty, especially on a patient as young and otherwise healthy as Plaintiff – turned into a major invasive abdominal surgery with months of healing required because of a faulty ENDO GIA Stapling device which caused a leak at the anastomosis site,” the lawsuit states.
The lawsuit indicates that not only was the Endo GIA defectively designed, which has led to a number of recalls in recent years, but the manufacturers also tried to hide problems from the FDA by failing to report incidents to the agency’s Manufacturer and User Device Experience (MAUDE) database.
“Defendants, and each of them, prior to and at the time of Plaintiff’s surgery, took advantage of FDA exemptions and refused and failed to report non-fatal stapler related injuries to the MAUDE Database. Instead, Defendants, and each of them, utilized an alternative summary reporting program, which is not publicly accessible, as a means of circumventing their duty under the law to reasonably warn patients, surgeons and the medical community about known injuries resulting from actual or potential device failures, defects or use,” Smith’s lawsuit states. “By not reporting all stapler-related injuries on MAUDE, Defendants have hidden the true risks of using the devices from surgeons, their patients and the healthcare community.”
Surgical Stapling Complications
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.
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