On Wednesday, a lawsuit was filed against Ethicon Endo-Surgery Inc. and Johnson & Johnson Inc. in the Middle District of North Carolina. The plaintiff accuses the defendant of negligence and failure to warn in relation to the manufacture and design of their Ethicon Endo-Surgery Staplers.
According to the suit, the FDA recently reported that during the time period from January 1, 2011, through December 31, 2018, it received close to 110,000 reports related to issues with surgical staplers including 412 deaths and 11,181 serious injuries related to the defendant’s product. Because of the statistics, the defendant issued a recall of the products in April 2019.
On July 30, 2019, the plaintiff underwent a sigmoid colectomy surgery to treat her acute diverticulitis with suspected perforation. The doctor performing the surgery successfully removed the portions of the colon and attempted to connect the two portions of the colon together using the defendant’s product.
In the operative report, the doctor wrote that “The stapler was closed and fired. It appeared to fire correctly, however, would not release to be removed in its usual fashion. Unfortunately, the efforts to release the stapler resulted in a hole forming in the colon just proximal to the stapler line.” Because of this tear she was unable to make a second attempt, and was forced to perform a diverting loop ileostomy.
The plaintiff said that the ileostomy was just the first in a series of hospital visits, procedures, and inconveniences caused by the malfunction. The plaintiff required repeated hospitalizations due to wound care complications and partial bowel obstructions, an ileostomy reversal surgery, development of sepsis and need to undergo emergent irrigation and debridement of wound site, development of a hernia at the wound site, and ongoing care for the injuries she suffered in the surgery.
The plaintiff alleged that the defendant intentionally failed to provide warnings regarding the potential for their staplers to malfunction, failed to warn and inform surgeons of the potential for the staplers to malfunction, and failed to recall their defective products until 2019 when they knew earlier that the staplers were prone to malfunction. She said the defendant acted this way for the purpose of profit, financial advantage, monetary gain, economic aggrandizement and cost avoidance. She seeks compensatory damages for the inconvenience she has suffered as a result of the defendants failure to recall their product in a timely manner.
The plaintiff is represented by Wallace and Graham.