The Surgical Stapler lawsuits claim that surgical staplers have been malfunctioning and causing injuries such as infections, internal bleeding, and organ damage.
Our law firm is representing individuals who suffered injuries because of the use of a surgical stapler. We have been handling lawsuits against medical device manufacturers since 1955. We are listed in Best Lawyers in America and The National Trial Lawyers Hall of Fame.
What Do We Know About the Surgical Stapler Lawsuits
Surgical staplers (also called “skin staplers” or “wound staplers”) are medical instruments commonly used by surgeons as a substitute for sutures in order to close lacerations and incisions as well as connecting internal organs. These devices have been used for over 50 years. They have been marketed as time savers.
However, a review of the FDA's Manufacturer and User Facility Device Experience (MAUDE) database has found more than 41,000 adverse event reports filed between January 1, 2011, and March 31, 2018. According to this review, surgical staplers have malfunctioned approximately 32,000 times. There have been 9,000 serious patient injuries. More than 350 patients are known to have died as a result of surgeons employing surgical staplers.
These numbers represent only what the FDA has publicly admitted. On May 30, 2019, Kaiser Health News reported that over 56,000 additional reports had been submitted over the same time period. However, these reports were never disclosed, nor even made available to the public.
Surgical Stapler Injuries
Due to malfunctions, misuse, and defective design of surgical staplers, patients have suffered numerous types of injuries and complications, often with long-term or permanent consequences and/or requiring additional surgeries and treatments. These injuries include:
- internal bleeding
- organ damage
- fistula (abnormal connection between organs and blood vessels)
According to adverse event reports, the most common surgical stapler malfunctions are:
- misfiring or difficulty in firing
- failure to fire staples
- using the incorrect staple for a given surgery
- leaks in the staple line (the wound or incision closure)
- staple malformation
Compensation in Surgical Stapler Lawsuits
If you experienced injuries as a result of the use of a surgical stapler, then we will be seeking the following damages for you:
- Past and future medical and funeral expenses that result from the injuries.
- Past and future pain and suffering (physical and mental) caused by the injuries, and the treatment and recovery process.
- Past and future wage loss.
- Past and future loss of earning capacity.
- Past and future loss of enjoyment of life.
- Punitive damages, if appropriate.
FDA and Scientific Studies Regarding Surgical Staplers
On April 24, 2019, the FDA issued a “Draft Guidance” that includes recommendations on labeling for surgical staplers and staples. Approximately two weeks earlier, the FDA initiated a recall of Ethicon Intraluminal Staplers used in gastrointestinal surgeries after receiving reports of problems with staples. On May 16, 2019, the recall was designated as Class I, meaning there is a high probability that the device will cause serious injuries or death. The recall has affected well over 92,000 units sold in the U.S. over a one-year period starting in March of 2018.
Ethicon, a division of Johnson & Johnson, communicated concerns over stapler malfunctions to regulators outside the U.S. at the end of March 2019 – two weeks before the FDA initiated its recall.
Other manufacturers of surgical staplers include:
- 3M Corporation
- Stryker Medical
- Tyco Medical Group
- U.S. Surgical
A number of staplers in the past were approved through the questionable 510(k) Premarket Notification process. However, because the FDA determined these devices to be “low risk,” surgical staplers designed and manufactured more recently were given “Class I exemption,” meaning that the manufacturer did not even have to provide notification. In either case, the staplers were not subject to normally rigorous clinical studies and safety testing.