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Johnson & Johnson and its Ethicon subsidiary face a product liability lawsuit over injuries surgical stapler complications that resulted from a device misfiring during laparoscopic procedure.
Steven Ergler filed the complaint (PDF) earlier this month in the U.S. District Court for the Western District of Washington, indicating that an Ethicon Endo-Surgery surgical stapler was unreasonably dangerous and defective.
The lawsuit comes amid rising concerns over design problems with surgical staplers, which have been linked to hundreds of adverse event reports involving deaths and thousands of surgical complications and injuries.
Ergler indicates that the surgical stapler was used during a laparoscopic sigmoid colectomy surgery in July 2016. However, two days after the surgery, doctors determined that he had a significant amount of free air and fluid in his abdomen, and an examination found several surgery staples that were “uncrimped to completely open, indicating that the stapler had completely misfired,” according to the lawsuit. This resulted in the anastomosis portion of the surgery failing, requiring additional surgery to address the complications.
“Since that time, Mr. Ergler’s quality of life has been reduced,” the lawsuit states. “He has suffered several hernias, caused by the failed anastomosis, as well as daily pain, dysfunction, and humiliation.”
The case is one of a growing number of surgical stapler lawsuits filed in recent months, as the FDA is continuing to review design problems associated with a number of devices and how the devices can be made safer for patients.
In April, the FDA proposed new rules and guidelines designed to make surgical staplers safer, and to classify them as moderate risk medical devices. They are currently classified as low-risk devices.
The new classification would require more stringent premarket approval for new staplers and force manufacturers to provide more thorough safety warnings and instructions.
The most commonly reported surgical stapler problems involve an opening of the staple line, malformation of staples, staplers misfiring, staplers being too difficult to fire, staplers failing to fire and staplers that were misapplied. The FDA warning indicates that stapler malfunctions or misuse can cause prolonged surgical procedures, the need for additional surgeries, and other complications; such as bleeding, sepsis, internal organ damage, and death.
In 2012, Ethicon had to recall more than 150,000 of its Endo-Surgical circular staplers due to similar problems. The Ethicon surgical stapler recall came after surgeons began abandoning use of the devices during surgical procedures because they had so many problems firing them.
Three years later, in 2015, a California jury awarded nearly $80 million to a retired San Jose police officer whose anal canal was accidentally sealed by a defective Ethicon surgical stapler.
The proposed rules and this latest lawsuit also follow an FDA warning to doctors in early March 2019, about the high numbers of surgical stapler problems and injuries reported in recent years. According to the agency, it received more than 41,000 reports of adverse events between January 2011 and the present. The lawsuit indicates there have been nearly 400 deaths reportedly linked to surgical stapler problems during that time period.