Ethicon was sued after a recall of 3.5 million packages of its Vicryl brand of sutures in 1994 -- the sutures were contaminated due to a faulty sterilizer. Now, a growing number of complaints involve another suture by the same company, -- J&J's Ethicon Inc., which makes surgery and wound care products -- including Panacryl sutures.
Ethicon issued another recall just as it did with Vicryl, this time on March 28, 2006. The company's reason for the recall was that "The unique absorption profile of Panacryl in the suture could act as a foreign body so that surgeons should consider its use in specific situations." According to Ethicon, the recall includes 1,061,712 sutures which were distributed nationwide and internationally.
Both Vicryl suture and Panacryl suture recalls have resulted in liability lawsuits.
In December 2006, when Dr. Joel Lippman, chief medical officer at Johnson & Johnson subsidiary Ethicon, objected to the release of its Panacryl sutures, he was fired for "inappropriate action."
In his lawsuit against the company, Lippman says he objected to the release of the Panacryl suture, "whose use resulted in numerous adverse events," but it was released anyway, even though it continued to receive reports of "adverse events."
In the same lawsuit, Lippman states that, in late 2005, he advised Ethicon to warn physicians that one of its devices was not sterile. In response, "a member of Ethicon's Quality Assurance Board stated that 'surgeons are like five year olds. We need to control what is said to them.'"
Lippman, 52, has an M.D. from New York Medical College and has a Master's degree in public health from Harvard. He was worldwide vice president of medical affairs and chief medical officer at J&J's Ethicon Inc., and was making $1.15 million a year including bonuses and stock options when he was fired. He worked for Ethicon from July 2000 until May 15, 2006.
Soon after joining Ethicon in 2000, Lippman complained to the company that research data indicated a product about to be launched could block arteries. The suit states that Lippman was told if he kept opposing the launch, "his action could affect his bonus and standing with the company." In response to Lippman's allegations, Johnson & Johnson said Lippman was fired "as a result of inappropriate conduct and mismanagement of responsibilities unrelated to the allegations he raises in the lawsuit."
The statement went on to say that J&J "will vigorously defend against the claims because the allegations are not true. Our company remains committed to providing quality products that yield positive patient outcomes."
Meanwhile, a growing number of people allege infections due to Panacryl sutures, many of whom underwent additional surgeries to remove them.