Ethicon surgical staplers were recently recalled, resulting in lawsuits that may entitle injured patients to recover compensation.

Ethicon Top Risk Surgical Stapler

Several Ethicon products were recalled in 2019 due to their high risks to consumers, U.S. Food and Drug Administration (FDA).

According to the FDA, staples may fail to fire correctly, and improperly deployed staples can reportedly lead to a variety of complications and even death.

What Is Ethicon Surgical Stapler?

Doctors use surgical staples to close wounds, according to the FDA.

Externally, these closures are used in areas under high tension, such as the scalp and the trunk of the body. Internally, the staples may be used for gastrointestinal, gynecologic, thoracic, and many other surgeries.

There are a variety of benefits to surgical staples, including their quick placement, minimal chance for tissue reaction, low infection risk, and ability to form a strong wound closure.

Ethicon, a Johnson & Johnson subsidiary, is a manufacturer of various surgical stapler products, including the Endo-surgery and Echelon stapler systems. These products are used in a variety of procedures, including minimally invasive gynecologic, urologic, thoracic, pediatric, and general surgeries.

Unfortunately, these products may be dangerous as they were recently recalled.

Ethicon Stapler Recall

In April 2019, Ethicon initiated the recall of its Endo-Surgery staplers — medical devices used during gastrointestinal surgeries to create connections between structures.

A defect in these products compromised the integrity of deployed statements, according to the FDA’s recall announcement. Thousands of devices manufactured between March 2018 and March 2019 were included in the recall.

Uncut washers in the stapler can interact with malformed staples and result in “insufficient firing” and “complete 360-degree staple line failure,” the FDA notice said. This failure affected two patients who reportedly suffered “serious injuries” when the misfiring of the stapler caused additional resection of their intestines.

An investigation revealed a shift in the manufacturing process for the company’s circular staplers could have been connected to alleged defects, according to the FDA. The agency noted the manufacturing process was changed in March 2018, with the new process implemented through March 8, 2019.

Unfortunately, Ethicon said problems with these circular staplers were connected with the deaths of two patients, the FDA said. 

The recall was later labeled a “Class I” recall — the agency’s most severe level. Class I recalls are used when the defect at issue can cause serious consequences or death.

A Class II recall may cause temporary or reversible adverse health effects, or there is a chance of a serious complication, but that chance is remote. And Class III recalls are the least severe, indicating a situation in which a product is unlikely to cause adverse health effects.

Another Class I Ethicon stapler recall was announced in October 2019, this time concerning the Echelon Flex Endopath staplers — used for a variety of procedures, not only gastrointestinal surgeries, the FDA said. This stapler was recalled due to an “out of specification” component that can lead to malformed staples.

According to the FDA’s announcement, this defect has caused seven serious injuries and one death.

The recall affected not only devices the United States, but in other countries as well, according to Mass Device. The company issued a statement saying the defective staplers, made between Aug. 1 and 15, 2019, were distributed in Denmark, the Netherlands, Germany, Luxembourg, Switzerland, and Belgium.

The Class I recalls were part of the driving force behind the FDA’s proposal to reclassify surgical staplers from Class I medical devices to Class II medical devices.

Class I medical devices are regulated by the FDA but do not require premarket submission. Class II devices require 510(k) premarket notification and are subject to FDA’s mandatory special controls.

This reclassification would be aimed at mitigating the potential risks associated with recalled surgical staplers from Ethicon and other companies.

Potential Risks

Problems with surgical staplers are a major issue, according to Mass Device.

The Emergency Care Research Institute (ECRI) deemed surgical stapler misuse among the most common health technology hazards of 2020.

An FDA analysis of 109,997 stapler incidents between 2011 and October 2019, included 412 deaths, 11,181 serious injuries, and 98,404 malfunctions, according to the ECRI.

The ECRI has investigated 75 stapler accidents, several of which involved deaths, and published 42 safety alerts in the last 20 years.

Surgical staple complications — especially if the staples are fired into the wrong part of the body — can include the following, according to Drug Watch:

• Reopening of an incision
• New or severe pain
• Fever of 100 degrees or higher that lasts four hours or more
• Redness or swelling around the incision
• Yellow, brown, or green discharge

Similarly, malformed staples – which fail to do the job they are intended to – can lead to significant consequences, such as:

• Prolonged surgery
• Post-operative leaks
• Hemorrhage
• Hemorrhagic shock
• Additional surgeries
• Death

Any of these consequences can be life altering for the patients and their families.

An unexpected problem during surgery can result in surprise medical expenses, long-term treatment, disability, and even death. Such outcomes can lead to physical, financial, and emotional hardship.

Despite facing allegations its surgical staplers are defective and dangerous, Ethicon continues to stand behind its products.

Recently, Ethicon funded a peer-reviewed study which found that its Echelon stapler had lower rates of bleeding-related complications than a competitor product by Medtronic. 

Bleeding complication rates with the Ethicon Echelon were reportedly up to 73 percent lower than in the Medtronic Signia stapler.

In the Ethicon stapler, bleeding complications reportedly occurred in 0.61 percent of the examined gastric sleeve surgery cases while 2.24 percent of similar Medtronic stapler cases had bleeding complications.

Ethicon also continues to develop new surgical stapler products. In April, the company announced its new Echelon+ stapler designed to “improve patient outcomes and deliver meaningful clinical and economic value,” according to a statement to Medical Design & Outsourcing. It remains to be seen if this product improves on the failures of its predecessors.

Filing an Ethicon Surgical Stapler Lawsuit

Although Ethicon has stood behind its products and continues to develop more surgical staplers, this doesn’t undo the harm the recalled staplers may have caused to patients and bereaved loved ones.

Patients and family members who were affected by now recalled Ethicon surgical staplers may be able to take legal action against Ethicon and Johnson & Johnson. If a product was defectively designed or manufactured, the manufacturer may be held accountable for any resulting damages. This could mean monetary compensation for affected patients.

Some patients have already taken legal action against Ethicon for the company’s alleged failure to produce safe products.

In 2007, the family of a deceased patient was awarded $5 million in a jury decision after jurors found that the patient died after an Ethicon stapler failed to close the surgical area. This alleged failure led the patient’s stomach contents to spill into her intestinal cavity — eventually causing her death.

Ethicon argued against the family’s claims — pinning the patient’s death on the surgeon’s error rather than a failure of their products. However, the jury rejected this argument.

The jury found the patient’s wrongful death was instead attributable to a stapler design defect.

If you or someone you love has suffered from closure problems, prolonged surgery, sepsis, hemorrhage, or other serious complications after undergoing surgery with the use of surgical staples and needed corrective surgery, you may be able to file a surgical stapler injury lawsuit and pursue compensation.

Filing a lawsuit cannot take away the pain and suffering caused by these kinds of complications, nor can it bring a loved one back to life, but it can at least help to alleviate the financial burden incurred by medical expenses, lost wages, and more.

Filing a surgical stapler lawsuit can be a daunting prospect, especially while dealing with these medical complications, so Top Class Actions has laid the groundwork for you by connecting you with an experienced attorney.

Consulting an attorney can help you determine if you have a claim, navigate the complexities of litigation, and maximize your potential compensation.