Medical News: Drugmaker Gets New Headache from Defective Motrin - in Product Alert, OTC from MedPage Today

By John Gever, Senior Editor, MedPage Today Published: January 12, 2011

Johnson & Johnson's "phantom recall" of defective ibuprofen (Motrin) caplets in 2009 has brought more pain to the beleaguered company, in the form of a civil suit filed by the state of Oregon. The state is charging that J&J, in delaying a publicly announced recall in favor of secretly buying up the defective products from stores, put Oregon residents at risk. J&J's McNeil consumer products unit had discovered in late 2008 that some Motrin caplets, packaged in eight- and 24-count containers, failed to dissolve properly, so that patients excreted the caplet before it could release the full ibuprofen dose. Although the company notified the FDA of the issue, it did not alert wholesalers, retailers, or consumers to the problem until February 2010, according to Oregon Attorney General John Kroger. Instead, beginning in early 2009, McNeil hired contractors to pose as customers, going into stores to secretly buy up the defective packages, the suit charges. According to Kroger, the contractors were told not to mention a recall if questioned. "Simply state that your employer is checking the distribution chain of this product and needs to have some of it purchased for the project," according to their written instructions. Authorities learned of the buy-back plan in mid-2009, according to Kroger. One of the company's hired shoppers in Oregon became uncomfortable with the secrecy and informed the state Board of Pharmacy, which, in turn, alerted the FDA, Kroger said in a statement. The "phantom recall" became public knowledge last spring when it was disclosed by an FDA official at a congressional hearing. This newest headache for J&J follows a string of recalls involving other OTC products including its big-selling Tylenol, Benadryl, and Rolaids brands. The company underwent a management shakeup last year and it is still facing a criminal inquiry from the FDA over its manufacturing woes. The Oregon civil suit seeks $25,000 for each violation of Oregon's Unlawful Trade Practices Act, which prohibits "unconscionable tactics" and requires public disclosures of certain information. The suit also demands reimbursement for customers who bought Motrin caplets prior to the publicly announced recall. According to the suit, 787 Motrin packages remained unaccounted for, despite the recall and the hired shoppers' efforts