Ethicon Surgical Stapler Lawsuit Blames Redesign for Malfunctions, Resulting Complications

Published on September 13, 2019 by Laurie Villanueva

A Louisiana man has filed a new surgical stapler lawsuit against Ethicon, Inc., asserting a redesigned device was defective and unsafe for use.

According to a complaint filed on August 27th in the U.S. District Court, Eastern District of Louisiana, Byrone Gougisha underwent a laparoscopic extended right colectomy in August 2018 that involved the use of Ethicon’s curved intraluminal stapler. These internal surgical staplers are used to create connections between structures (anastomoses) in the gastrointestinal tract.

During the procedure, the Ethicon surgical stapler malfunctioned and failed to create a proper anastomosis, resulting in an internal leak and the need for additional surgery. (Case 2:19-cv-12322)

Ethicon Surgical Stapler Recall

The lawsuit notes that Ethicon had redesigned its curved intraluminal staplers in March 2018, following a shift in the manufacturing process.

Ethicon announced a surgical stapler recall just a year later, after discovering that the devices were prone to insufficient firing, resulting in malformed staples and uncut washers. Possible injuries identified in the recall notice included sepsis, bleeding, the need for an ostomy bag, lifelong nutritional and digestive problems, anastomotic leaks, and the need for additional surgeries, among others.

“This shift, identified by Defendants in the U.S. Food & Drug Administration’s May 16, 2019 recall notice, took place from March 6, 2018 until March 6, 2019,” the complaint states. “The shift rendered all staplers manufactured by the Defendants from March 6, 2018 to March 6, 2019 defective and unsafe for use in patients.”

FDA Surgical Stapler Warning

Just days after Ethicon announced the surgical stapler recall, the FDA warned doctors that internal surgical staplers had been associated with 41,000 adverse event reports since January 1, 2011. Those reports detailed 366 patient deaths, 9,000 serious injuries, and 32,000 stapler malfunctions.

Some of the most common adverse events included:

  • Opening of the staple line or malformation of staples,
  • Misfiring,
  • Difficulty in firing,
  • Failure of the stapler to fire the staple, and
  • Misapplied staples (e.g., user applying staples to the wrong tissue or applying staples of the wrong size to the tissue).

Since then, the FDA has proposed reclassifying internal surgical staplers as Class II (moderate to high-risk) medical devices, which would subject the products to greater regulatory scrutiny.

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