Surgical Stapler Lawsuit

How Do Surgical Staplers Work?

Surgical staplers by compressing the tissue on either side of a wound, and then connecting it with spaced-out rows of B-shaped staples. Some types can also be used to remove excess tissues from around the wound, ensuring that it heals cleanly.

Used in “gastrointestinal, gynecologic, thoracic, and many other surgeries”, surgical staplers are used both externally and internally. Removable skin staples, for external use, “close wounds under high tension, including wounds on the scalp or the trunk of the body.” Internally, surgical staples “deliver compatible staples to internal tissues during surgery.”

What Are The Risks Associated With Surgical Staplers?

Staplers are easier and more convenient than sutures, but they do carry a bevy of additional risks. If a stapler misfires or fails to properly seal a wound, it can lead to serious issues like infections and allergic reactions.

These complications can cause lifelong health issues for patients, which may be completely unrelated to the original procedure they were undergoing. In some cases, patients injured by surgical stapler malfunctions require costly treatment and/or long-term care.

Injuries Caused by Surgical Staplers

Patients who undergo a procedure that requires surgical staplers are at risk for many types of serious injuries and complications, including:

• Excessive bleeding;
• Tissue damage;
• Organ damage;
• Fistula;
• Infection, followed by sepsis;
• Recurring cancer cells.

If your health has been compromised because of an injury caused by a surgical stapler or staples, you may be eligible to file a lawsuit. There are several different factors that cause surgical stapler injuries to occur.

What Causes Surgical Stapler Injuries?

While we have only recently begun to understand the full scope of the problem, complications caused by surgical staples have been affecting patients for years. Most commonly, these injuries and deaths are caused by:

• Device malfunctions such as stapler misfires and stapler locking:
• Design defects when the design of the stapler is at fault for an injury;
• Manufacturing defects when the device was assembled incorrectly;
• Complications with surgical staples such as malformed staples
• A failure to warn when the manufacturer failed to warn consumers of the risks associated with the stapler.

Many surgical stapler lawsuits claim that patient injuries or deaths were the result of errors made by the surgeon. However, there are also many reports of defective surgical staplers misfiring, provoking questions of fault.

Surgical Stapler Recalls and Settlements

There have been several major settlements awarded to patients for injuries caused by defective surgical staplers, and several high-profile examples of manufacturers being forced to recall these devices.

Ethicon Surgical Stapler Lawsuits and Recalls

Ethicon, a major manufacturer of medical devices and a subsidiary of Johnson & Johnson, has been involved in several notable lawsuits related to defective surgical staplers that caused injuries and deaths.

In 2012, a Pennsylvania family alleged the death of their loved one was caused by a defective stomach stapler during gastric bypass surgery. The Ethicon stapler, according to the lawsuit, failed to properly seal the surgical area which then allowed the stomach contents to spill into the intestines. A jury awarded the family $5 million in damages.

In May 2013, the following surgical staplers, like the one used in the botched gastric bypass surgery, were recalled due to the high adverse events reported:

• Ethicon Echelon 60 mm
• Echelon Flex

Another surgical stapler incident occurred in January 2012, when Florence Kuhlmann alleged that an Ethicon proximate surgical stapler misfired and sealed her anal cavity, causing two weeks of hospital care and the permanent use of a colostomy bag.

A California jury awarded Kuhlmann $80 million, including nearly $70 million in punitive damages. As a result of Kuhlmann’s injury, Ethicon recalled over 157,000 of the hemorrhoid staplers used in her procedure.

Medtronic Surgical Stapler Lawsuits and Recalls

Medtronic is an American medical device company that operates in over 150 countries around the world. Like Ethicon, they have been the subject of several lawsuits related to defective surgical staplers.

In 2019, Medtronic was sued by three different people who claimed that they were injured by defective staplers, and that company knowingly hid the risk when selling these devices. As a result, Medtronic issued a selective recall of its ENDO GIA surgical staplers in June 2019.

Covidien Surgical Stapler Lawsuit

Ryan Strange of Illinois named healthcare products manufacturer Covidien in a lawsuit that claimed his wife’s death was caused by a defective surgical stapler. Strange’s wife April bled to death in 2013 after a procedure to remove a noncancerous mass from her liver went wrong.

The lawsuit alleged that the Covidien Stapler in question failed to properly seal one of April Strange’s blood vessels, causing severe blood loss that eventually resulted in cardiac arrest. In 2017, Ryan Strange was awarded a $5.5 million settlement for the wrongful death of his wife.

FDA Announces Surgical Stapler Safety Review

In response to the Kaiser Health News report about their use of the “alternative summary reporting” database, the FDA announced a plan to review the safety of surgical staplers on March 8, 2019.

Following this review, the FDA proposed the reclassification of certain surgical staplers from low-risk to moderate-risk, making the approval process for these devices more stringent. The agency also issued new labeling recommendations for surgical staplers that address proper use and safety risks. Since then, several updates to these recommendations have been announced.

In June 2019, the FDA sent a letter to doctors and other healthcare providers discussing the danger of surgical staplers, and the high number of incidents associated with their use, which was later updated to include additional announcements and recommendations.

Surgical Stapler Lawsuit Update

The surgical stapler litigation is ongoing, and lawyers across the country are still accepting cases. The issues with certain types of surgical staplers are varying: misfiring, risk of infection, allergic reaction, and more. If you or a loved one suffered an injury due to a malfunctioning surgical stapler, you may be eligible for a lawsuit.

TorHoerman Law: Your Surgical Staple Lawyer

If you’ve sustained an injury as a result of a defective surgical stapler, hiring a personal injury lawyer is an extremely important step in the process of obtaining justice. Ideally, you’ll want to find a lawyer who is experienced in both personal injury lawsuits and defective product lawsuits.

You should feel comfortable asking your potential surgical stapler lawyer as many questions as you deem necessary for making a final decision. These may include questions about their experience, fees, and familiarity with your type of case.

Your statute of limitations bars the amount of time you have to take legal action after first sustaining or discovering your injury, so do not hesitate to take the first initial step of hiring a surgical stapler lawyer.

If you have any questions about a surgical stapler lawsuit or the FDA secret database, contact TorHoerman Law at (888) 508 6752. An experienced surgical stapler injury lawyer from TorHoerman Law is available to discuss your potential surgical stapler lawsuit, with no obligation necessary, and free of charge.

At TorHoerman Law, we work on a contingency fee basis for all surgical stapler lawsuit clients — so, we don’t get paid unless our clients do.