Accused in a nationwide class action lawsuit of selling contaminated sutures. The nation’s biggest maker of surgical sutures is accused in a nationwide class action lawsuit of selling contaminated sutures that gave patients serious infections and caused at least one death, lawyers said Tuesday.
Ethicon Inc., a Johnson & Johnson company based in Somerville, recalled 3.5 million packages of its Vicryl brand of sutures in 1994 – under pressure from federal regulators.
However, because hospitals use up sutures quickly, only one-fourth were returned to the manufacturer and destroyed.
“We recalled the sutures … not because we believed the product was contaminated, but because we could not assure (its) sterility,” said Susan Odenthal, director of communications at Ethicon, which makes about 80 percent of the sutures used in this country.
She declined to discuss specific allegations. The company has made confidential settlements with some plaintiffs, but Odenthal said she did not know how many.
Ethicon in 1994 were used in surgeries and other medical procedures
According to the lawsuit, “contaminated sutures” made by Ethicon in 1994 were used in surgeries and other medical procedures, causing serious injuries and infections.
“A lot of these victims had to be rehospitalized for a significant amount of time,” attorney Wendy York of Sacramento, Calif., said Tuesday.
Some had to have additional surgery to clean up the infection or redo the original operation, and one Las Vegas police officer was permanently disabled.
York said she represents 35 plaintiffs who developed post-operative infections along the suture lines, causing such symptoms as fevers, chronic fatigue, extreme nausea and painful swelling. Other lawyers represent additional clients, she said.
York said a woman from the San Francisco Bay area died as a result of an infection caused by the sutures.
The Food and Drug Administration inspected the company’s plant in July 1994 and warned Ethicon to resolve its sterilization problem or face sanctions. According to the FDA, it was satisfied with the company’s recall and subsequent sterilization process.
Moderate risk of serious adverse health consequences” from the sutures
An FDA letter to two California congressmen who had inquired about the recall states that there was only “a low to moderate risk of serious adverse health consequences” from the sutures.
The letter notes 73 reports to the FDA of infections in patients stitched with sutures from the Vicryl lots that were recalled, but there was insufficient data on the type of bacteria involved to prove a connection.
Ethicon maintained in a letter to Congressional investigators that, “We believe that the cases reported to be related to this suture were in fact typical post-surgical infections due to usual causes.” Such infections occur in about 2.5 percent of operations.