Johnson & Johnson Sued for Defective Ethicon Surgical Staplers Recalled by USFDA
Plaintiff David Bakos, who suffered severe injuries following a surgical procedure involving a defective Ethicon surgical stapler, has filed a lawsuit in Los Angeles County Superior Court against Johnson & Johnson and its subsidiary, Ethicon, Inc., among others, for failing to manufacture a stapler free of defects as well as fraudulently marketing and selling the medical device as safe and effective for use in patients. Plaintiff is represented in the case by attorneys Brian Panish, Pete Kaufman and Greg Sonstein with Panish Shea & Boyle LLP.
On April 9, 2019, Plaintiff David Bakos underwent gastrointestinal surgery at USC Norris Comprehensive Cancer Center and Hospital in Los Angeles, California. His surgeon, unaware of the staplers’ manufacturing defect, used a defective Ethicon curved intraluminal stapler as intended and according to the labeling of that medical device to create an colorectal anastomosis during the procedure. Immediately following surgery, Mr. Bakos began suffering unexpected abdominal pain and fevers; corrective surgery became necessary to repair a postoperative anastomotic leak when it was discovered that an effective anastomosis had failed because of the ejection of a malformed staple or uncut washer from the medical device.
According to a May 16, 2019 Class I recall issued by the United State Food & Drug Administration (FDA), the staplers were defective when used in patient procedures because “insufficient firing of the staplers will occur causing malformed staples to eject and uncut washers, compromising staple integrity; and when used on patients, leads to serious injuries or death.” Over 92,000 curved intraluminal staplers were affected by the recall in the U.S. alone, and until the FDA recall notice was issued, Defendants never warned medical service providers, surgical patients, or the public of a manufacturing defect with its staplers despite having known the risks of serious injury and death associated with its surgical staplers like the one used on Plaintiff.
As alleged in the complaint, “Defendants designed, manufactured, and sold defective curved intraluminal staplers with the following product numbers: CDH21A, CDH25A, CDH29A, CDH33A, ECS21A, ECS25A, ECS29A, and ECS33A. Each stapler manufactured between March 6, 2018 and March 6, 2019 with these product numbers suffers from a manufacturing defect compromising staple integrity and can lead to serious injury or death when used by a surgeon as instructed in the device user manual.”
If you or a loved one has been injured as a result of a faulty or malfunctioning surgical stapler, contact Panish Shea & Boyle LLP at (866) 739-3903.