Ethicon, a subsidiary of Johnson & Johnson, has pulled more than 100 batches of medical sutures which may not be sterile, continuing a string of recalls that has haunted the medical device and pharmaceutical giant for more than a year.
The Johnson & Johnson suture recall was originally announced in a Field Safety Notice by Ethicon in late December to distributors, but did not go public until the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) posted an alert on its website earlier this week.
The sutures are being recalled because of defective packaging seals on the individually wrapped suture strands, which could leave them open to contamination. The use of non-sterile sutures could cause a patient to suffer a hospital infection. There have been no adverse events reported in connection with the suture recall.
The recall affects about 585,000 individual suture strands, mostly distributed throughout Europe. None were shipped to the United States. The sutures were sold under the brand names of Ethilon, Ethibond, Mersilene and Mersilk.
The secretive nature of the recall by Johnson & Johnson raised questions from some critics, who were already concerned over alleged prior attempts to cover-up recalls in the United States. In late 2008, Johnson & Johnson conducted a “phantom recall” of Motrin that was dissolving properly. The company allegedly hired contractors to buy back Motrin from stores without telling the store owners, the public or the FDA that there was a recall until 2010.
Johnson & Johnson has denied a cover-up in either recall, saying that regulators were notified about the suture recall and that the public was not alerted because the sutures were quickly pulled from the market.
The charges of the so-called ‘phantom recall’ first came up at a Congressional hearing last year after a massive Johnson & Johnson children’s medication recall issued on April 30 that affected 40 different liquid medications, including Motrin, Tylenol, Benadryl and Zyrtec. The company’s actions have led congress to consider giving the FDA expanded drug regulatory powers.
Last month the state of Oregon filed a fraud lawsuit against Johnson & Johnson over the Motrin recall. The Oregon lawsuit charges the drug maker with violating the state’s Unlawful Trade Practices Act (UTPA) on several counts, such as employing unconscionable tactics, making false or misleading representations and failing to disclose certain information. The counts carry a maximum penalty of $25,000 each.
The complaint is just the latest claim filed against the company over recalls in 2010. At least two other Johnson & Johnson class action lawsuits have been filed, accusing the company of fraud and racketeering.