A California man severely injured by a now-recalled surgical stapler manufactured by Johnson & Johnson and its subsidiary Ethicon Inc., has filed a lawsuit against the companies in Los Angeles Country Court, according to Law360.

According to the complaint, plaintiff David Bakos underwent gastrointestinal surgery at USC Norris Comprehensive Cancer Center and Hospital in April during which surgeons used a curved intraluminal stapler made by Johnson & Johnson and Ethicon. Bakos claims that the stapler was defectively designed, causing it to eject staples and washers during use. Following surgery, Bakos complained of abdominal pain and had developed fever. He claims the medical device failed to create a connection between internal structures, causing fluid to leak, and he had to undergo additional surgery to correct the problem.

Bakos claims that Johnson & Johnson and Ethicon knew for years that its surgical staplers were causing harm to patients. From January 2011 and March 2018, more than 360 deaths have been linked to the device, with 2,000 injuries reported in 2018 alone. Yet, the companies didn’t warn patients or medical professionals that the staplers could misfire and result in serious injuries or death, the lawsuit claims. Instead, the companies allowed the devices to stay on the market for more than a year before the Food and Drug Administration (FDA) issued a recall of about 92,000 staplers in the U.S., due to design defects it said were putting patients’ lives at risk.

In April, the FDA issued a Safety Communication warning that surgical staplers and staples intended for internal use have been linked to more than 41,000 medical device reports from Jan. 1, 2011, to March 31, 2018, and include 366 deaths and 9,000 serious injuries, and more than 32,000 device malfunctions.

Surgical staplers are medical devices used in a variety of surgical applications including gastrointestinal, gynecologic, and thoracic surgeries to remove part of an organ, to cut through organs and tissues, and to create connections between structures.

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