Surgical staplers used to close internal and external wounds during surgery have been recalled after the medical devices were linked to injuries and deaths. Injuries included organ perforation, severe bleeding, hemorrhagic shock, sepsis, fistula formation, increased risk of cancer recurrence and permanent digestive issues.
If you or a loved one suffered such an injury following surgery it may have been caused by a defective surgical stapling device and you may have grounds for a lawsuit. The cause of such injuries may not be known by the patient and may only be known by a review of the medical records.
Kline & Specter, PC, with more than 50 attorneys, five of whom are also highly skilled medical doctors – the most doctor/lawyers of any law firm in America – has the expertise and experience to investigate and litigate surgical stapler cases.
The firm has won numerous medical device and product liability cases. In recent years it has won nine jury verdicts against Johnson & Johnson subsidiary Ethicon – maker of the circular stapler &mdassh; in transvaginal mesh cases, with verdicts totaling $347 million. In late 2019, the firm won an $8 billion punitive verdict against another J&J subsidiary, Janssen, in a trial involving its anti-psychotic drug Risperdal.
The staplers were slapped with a recall by the U.S. Food and Drug Administration in May and October 2019 because, as the FDA notice put it, there was an “out of specification component within the jaw of the device” that can leave staples not completely formed. The recall was a Class I recall, the most serious issued by the federal agency.
The notice stated: “If a problem with the staple line is not recognized or is not adequately addressed, there is a potential risk of prolonged surgery, postoperative connection (anastomotic) leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.”
The circular stapler devices were used in 2018 and 2019 and were designed for use in making surgical repairs of the gastrointestinal tract for patients with colorectal cancer, bariatric patients and other conditions. But when a device “misfires” or fires insufficiently, staples may be malformed or not formed completely or create other problems that adversely affects the integrity of a staple line.
More than 92,000 staplers were recalled in May 2019 and another 8,200 in October 2019.