Surgery can be a worrisome process, regardless of the type of operation. Even less invasive surgeries may prove nerve-wracking for some. Surgical procedures require several factors for success, such as precision, attention to detail, stable conditions, and effective tools. Overall, patients hope to emerge healthier and safely from a surgical operation free of complications. However, many individuals have reported severe and life-threatening complications due to surgical staplers. Even though surgeons may opt for surgical staplers to achieve faster healing and a shorter recovery time, surgical stapler lawsuits allege that these devices have actually endangered countless lives. If you experienced complications from a defective surgical stapler, don’t hesitate to speak with one of our trusted attorneys. Reach out today to learn more about how you can recover financial compensation in a surgical stapler lawsuit.
Our law firm is currently handling lawsuits on behalf of individuals who have suffered injuries as a result of malfunctioning surgical staplers. Lawsuits against the manufacturers of surgical staplers claim that defective surgical staplers can cause serious injuries, such as internal bleeding and organ damage.
Surgical staplers are medical staplers that close incisions or large wounds. Typically, surgeons use these medical devices in lieu of sutures during minimally invasive surgeries. Surgical staples are sometimes a faster and simpler alternative to sutures. Also, the staples often prove less painful for patients. Additionally, medical professionals use surgical staplers to remove organs or connect internal organs. The time surgical staples remain in a patient’s body depends on the placement, but surgical staples do not disappear on their own. Since the surgical staples do not dissolve, medical professionals must eventually remove the surgical staples.
While surgical staples may be a better option in some cases, these staples are not without risk. Patients may develop serious infections if bacteria enter the wound. If removed too early, then wounds may reopen. The staples can also fail to close a wound or connect tissue, at no fault of the medical professional. Furthermore, the FDA found that surgical staplers can misfire and misapply staples.
Among the 41,000 malfunctions of surgical staplers listed in the FDA’s public database between 2011 and 2018, the agency received 366 deaths and more than 9,000 injury reports. 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, with almost 10,000 incidents concealed from the public.
For years the FDA classified the staplers as Class I, meaning the agency considered the device low-risk. Class I devices include bandages, nonelectric wheelchairs, surgical masks, and latex gloves. In 2019, the FDA proposed new guidance to put surgical staplers in Class II to better ensure the safety of these devices. 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 include 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.
Medtronic and Johnson & Johnson are the two 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.
Surgical stapler manufacturer Medtronic recalled over 100,000 units of its surgical staplers after missing components resulted in improper staple alignment and injured five people. Then, in 2019, Medtronic recalled over 3,000,000 units of a different model of surgical staplers because of another missing component issue. After two previous recalls in 2013 and 2015, Ethicon, a Johnson & Johnson subsidiary, recalled 92,000 surgical staplers in 2019. The FDA labeled this recall as a Class I recall, the agency’s most serious type. Devices in this recall classification present a high risk of serious injury or death for the user.
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:
Hundreds of individuals have filed lawsuits 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.
There have been multiple successful verdicts for victims of surgical staplers. Medtronic paid $5.5 million in a wrongful death suit. The husband claimed his wife died because the surgical stapler did not closer her wound. In 2018, a woman who went into sepsis received $19.6 million from Ethicon. Again, In 2021, Ethicon paid $10.3 million to a woman who sustained a lifelong injury because of a surgical stapler malfunction.
If a defective surgical stapler injured you or a loved one, 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) 525-3529 or submit an inquiry on this page.
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