Ethicon Surgical Stapler Malfunction Leads to Lawsuit

Published on August 1, 2019 by Sandy Liebhard

A Washington state resident has filed a lawsuit against Ethicon, Inc., after a surgical stapler malfunction allegedly resulted in severe complications following a laparoscopic sigmoid colectomy surgery.

Surgical Stapler Lawsuit Allegations

According to a complaint pending in the U.S. District Court, Western District of Washington, Steven Ergle underwent the procedure in July 2016 to treat diverticulitis.

However, he was forced to undergo exploratory surgery just two days later, after he became progressively tachycardic, experienced diminished hemoglobin, and developed “a significant amount of free air and fluid in the abdomen, significant for some sort of perforation.” During the second procedure, his doctor noticed “a large amount of blood clot” and found several surgery staples that were “uncrimped to completely open, indicating that the stapler had completely misfired.”

The surgical stapler malfunction caused the anastomosis portion of the initial procedure to fail and forced Ergle to undergo additional surgery to address the complications.

“The patient’s postoperative recovery was long and arduous,” his post-op notes stated. “It included respiratory failure with adult respiratory distress syndrome. It also involved the development of Klebsiella bacteremia.”

Since then, Ergle’s quality of life has been drastically reduced, he’s suffered several hernias, and his mobility has been significantly hampered. (Case No.  3:19-cv-05608)

Surgical Stapler Malfunctions and Injuries

Internal surgical staplers, including the stapler cited in this lawsuit, are currently categorized as Class I (low risk) medical devices and do not have to undergo pre-market review prior to being sold in the United States. In April, the U.S. Food & Drug Administration (FDA) proposed moving the internal staplers to the Class II category, after they were cited in more than 41,000 individual adverse event reports, including 366 patient deaths, 9,000 serious injuries, and 32,000 malfunctions.

According to the agency, surgical stapler malfunctions can prolong procedures or result in the need for additional interventions, increasing the potential for serious and life-threatening complications, such as:

• Bleeding
• Sepsis
• Fistula formation
• Tearing of internal tissues and organs
• Increased risk of cancer recurrence
• Death

Reclassifying internal surgical stapler systems would allow the FDA to require pre-market testing and establish special controls for the devices, such as performance standards, post-market surveillance, patient registries, and the development and distribution of guidance documents.