Our law firm is currently handling lawsuits on behalf of individuals who have suffered injury as a result of malfunctioning surgical staplers. Lawsuits against the manufacturers of surgical staplers claim that defective surgical staplers can cause serious injury, such as internal bleeding and organ damage.
Surgical staplers may be used in lieu of sutures to close wounds during minimally invasive surgeries. Surgical staples are intended to achieve faster healing and recovery. However, the U.S. Food and Drug Administration (FDA) announced a Class I recall of certain surgical staplers due to the risk that they may insert defective staples into organs or tissues and fail to attach the incision wound. This could lead to bleeding and damage to the wound.
Medtronic and Johnson & Johnson are the largest manufacturers of surgical staplers in the United States. Recalls of surgical staplers in recent years predominantly affect Medtronic and Johnson & Johnson devices. Since 2013, the two companies have recalled more than 3.4 million staplers, staples, and related parts.
Hundreds of lawsuits have been filed against surgical stapler manufacturers. In Minnesota and Texas, three plaintiffs filed suits against Medtronic after incurring injuries from surgical staplers used in gastrointestinal surgery. The defective staplers created holes in the tissue and led to infections, cardiac problems, and corrective surgeries. One plaintiff underwent several additional corrective surgeries. Another plaintiff’s intestines were punctured when the Medtronic stapler failed during surgery.
Surgical staplers that fail to perform as intended can lead to serious injury or even death. Some of the injuries that may result from surgical staplers include damaged internal organs and tissues, sepsis, fistula formation, bleeding, and death.
If you or a loved one has been injured by Surgical Stapler, you may recover compensation for any or all of the following:
The Lake Law Firm was founded by Edward J. Lake, Esq., a personal injury lawyer for over 25 years. Our dedicated team of attorneys is committed to seeking justice on behalf of those who have suffered injury or death due to the negligence of others. Our experienced attorneys handle many different types of pharmaceutical drugs, medical devices, and other defective products. The lawyers in our firm have helped collect millions of dollars for their clients. The Lake Law Firm will advocate for you and your rights. Please contact us for a free confidential case evaluation at (888) 274-0139 or submit an inquiry on this page.
Among the 41,000 malfunctions of surgical staplers listed in the FDA’s public database between 2011 and 2018, 366 deaths and more than 9,000 injuries were reported. More than 50,000 other reports of injuries were not made available on the public database. In 2016 alone, the FDA reported fewer than 100 stapler related injuries on its public database while almost 10,000 incidents were concealed from the public.
In October, 2021, the FDA issued a final rule that reclassified surgical staplers from Class I (general controls) to Class II (special controls) to impose stricter regulatory requirements, which includes premarket notification and measures to reduce risks. The FDA also announced labeling recommendations for surgical stapler manufacturers to publicize information about the risks of surgical staplers. Health care providers were given additional information about how to safely use surgical staplers in a Letter to Health Care Providers.