A surgical stapler lawsuit has been filed against Ethicon Endo-Surgery Inc. alleging that the failure of an Ethicon stapler caused the plaintiff harm which required further repair. Surgical stapler manufacturers like Ethicon have faced a number of lawsuits regarding the alleged failures of their products. Previously, the Food and Drug Administration (FDA) has initiated a Class 1 recall of Ethicon surgical staplers due to reports of injuries and even death.

If you underwent surgery that utilized an Ethicon stapler only to develop complications, you may be able to seek compensation through a surgical stapler lawsuit.

When Are Surgical Staplers Used?

According to the FDA, surgical staplers are used both internally and externally to close wounds under high tension. These medical devices allow surgeons to quickly place staples with minimal tissue reaction and a low risk of infection. These staples might be used in gynecologic, gastrointestinal, thoracic, or many other surgeries. They can be used in surgeries that remove part of an organ, cut through organs and tissues, or creates connections between structures.

Surgical Stapler Risks

There have been many issues with surgical staplers that have been reported to the FDA. In fact, issues were severe enough for the FDA to publish a letter to health care providers in March of 2019 regarding the “safe use” of these devices. As of the publication of that letter, the FDA had received reports of over 32,000 malfunctions, over 9,000 serious injuries, and nearly 400 deaths related to surgical staples.

The FDA states that the majority of issues related to surgical staples occur after internal surgeries. The most common issues during surgery include the stapler misfiring, difficulty in firing, malformation of staples, opening of the staple line, failure to fire a staple, or misapplied staples. After surgery, patients may experience sepsis, bleeding, fistula formation, increased risk of cancer recurrence, tissue and organ tearing, sepsis, or death.

If you developed any of the issues listed above after a surgery that utilized an Ethicon device, you may be able to file a surgical stapler lawsuit in order to receive compensation for your suffering and additional expenses.

Surgical Stapler Lawsuit Allegations

Plaintiff Clarinda G. filed a surgical stapler lawsuit against Ethicon after her sigmoid colon resection surgery resulted in complications due to the alleged failure of the Ethicon surgical stapler used during the procedure. Failure of the device allegedly led to an incomplete anastomosis, a connection of two channels in the body, which led to a leak, localized abscess, and free air in the chest cavity. These issues “significantly impair… overall function” and required further repair including a colostomy.

Calindra claims that manufacturing defects in Ethicon surgical staplers can cause serious injuries or death even when used as described in the device user manual. According to Calindra, during her procedure, such a defective device produced a malformed staple or uncut washer, resulting in a failure of the procedure and significant harm to Goodrick.

Ultimately, Clarinda’s surgical stapler lawsuit blamed the defect on a failure by Ethicon to establish quality-assurance systems required by laws covering medical devices. For instance, Clarinda claims Ethicon failed to maintain a complaint file and tracking system to monitor their stapler devices. Such a system is required by law. Due to the alleged lack of quality assurance, defective surgical staplers are out into circulation and used on procedures like Clarinda’s.

The staplers in question were manufactured between March of 2018 and March of 2019. In March of 2019, the FDA mandatory recall of Ethicon staplers was initiated. If you underwent a surgery that utilized one of these devices, a surgical stapler lawsuit may help you seek compensation.

Join a Free Ethicon Surgical Stapler Lawsuit Investigation

If you or a loved one suffered from surgery complications caused by internal staples, you may qualify to joing in a Ethicon surgical stapler lawsuit investigation.

See if you qualify by filling out the free form on this page. 

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