New York, NYA proposed settlement has been reached in the securities class action pending against Johnson & Johnson Inc, (J&). The lawsuit stems from the 2010 recalls of over 40 nonprescription drugs from the market by J&J, during what has been described as by the Food and Drug Administration (FDA) as the largest recall of children’s medicine in the history of the agency.
The 40 nonprescription drugs for children included Tylenol and Motrin, and Benadryl. The recalls were prompted by FDA inspections at J&J subsidiary McNeil Consumer Healthcare’s Fort Washington, Pennsylvania, plant, which found several problems including bacterial contamination of ingredients and filthy equipment. The facility was later shut down, and J&J was facing possible criminal charges.
According to a report on CNN.com, a 17-page document chronicled 20 violations uncovered at the Fort Washington, PA plant. David Lebo, professor of pharmaceutical manufacturing at Temple University, told CNN in an earlier interview that the report is "absolutely shocking" and "pretty close to being the worst I've seen. It suggests that basically the FDA found an issue with almost every system at the plant." One of the most frightening findings listed in the report is that the plant didn't appear to maintain adequate facilities on-site for testing and approval or rejection of the components used in the medicines it manufactured. Following the recall, J&J closed the Fort Washington plant.
The report also noted that McNeil had not followed up on 46 consumer complaints it had received between June 2009 and April 2010, complaints that mentioned the presence of foreign materials and black or dark specks in the medicines.
A securities class action was subsequently filed by J&J shareholders alleging the company had cut back on quality-control measures prior to the recalls, and took steps to conceal that from investors and the public. Once the extent of the recalls came to light, share prices fell, investors said.
The proposed settlement was filed Monday and must be approved by the judge overseeing the case. Johnson & Johnson did not admit any liability or wrongdoing in the settlement, court filings said.
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