Wednesday, November 20, 2013

Johnson & Johnson to pay $2.5 billion to settle hip-implant lawsuits.

News that Johnson & Johnson’s Depuy Orthopaedics Inc. agreed to pay about $2.5 billion to settle thousands of lawsuits allegedly injured by its artificial hip implants was widely covered by the national media Tuesday. Several media outlets said the settlement doesn’t mean J&J’s legal woes are over as it still faces lawsuits over Pinnacle hip implants and vaginal mesh implants. The New York Times (11/20, Meier, Subscription Publication, 9.61M) reports that though Johnson & Johnson agreed to the settlement Tuesday, “it was not clear whether the deal would satisfy enough claimants.” Under the agreement, the medical products firm “would pay nearly $2.5 billion in compensation to an estimated 8,000 patients who have been forced to have the all-metal artificial hip removed and replaced with another device.” The paper says J&J has also agreed to pay “all medical costs related to such procedures,” costs which could increase Johnson & Johnson’s costs to $3 billion.

        The Los Angeles Times (11/19, 3.07M) reports the company agreed to “pay an average of about $250,000 for each surgery and cover related medical costs,” according to Susan Sharko, one of the company’s lawyers. The paper says the firm “recalled 93,000 ASR hip implants worldwide in August 2010, saying 12% failed within five years.”

        The Wall Street Journal (11/20, Rockoff, Subscription Publication, 5.91M) the company’s legal troubles won’t end with this settlement as it still has to grapple with more than 23,000 lawsuits over surgical-mesh products implanted in women in an effort to provide relief from pain in pelvis after childbirth.

        Bloomberg News (11/20, Feeley, Voreacos, 1.91M) provides additional details of the implants, noting that J&J had “touted the metal-on-metal implants, first sold in the U.S. in 2005, as a new design that would last 20 years and offer greater range of motion.” But with rising failures, patients complained “in lawsuits that the metal-on-metal implant caused dislocations, pain and follow-up surgeries known as revisions.” Many claimed that “debris from the chromium and cobalt device” resulted in “tissue death and increased metal ions in the bloodstream.”

        Internal documents allegedly suggest officials were aware of problems since 2008. The AP (11/20, Perrone, Seewer) gives details of the artificial hip, known as the Articular Surface Replacement, or ASR, which was “sold for eight years to some 35,000 people in the U.S. and more than 90,000 people worldwide.” J&J, based in New Brunswick, NJ, “stopped making the product in 2009 and recalled it the next year.” The AP says internal J&J documents “unsealed in the case suggest that company officials were aware of problems with the device at least as far back as 2008.” The article, citing a deposition from a J&J official, says “a 2011 company review of a patient registry concluded that more than one-third of the implants were expected to fail within five years of their implantation.” In general orthopedic hips are expected “to last at least 10 to 20 years.”

        Modern Healthcare (11/19, Lee, Subscription Publication, 224K) says the settlement comes “just weeks after” the company “agreed to pay $2.2 billion to settle allegations that it illegally marketed the antipsychotic drug Risperdal and two other medications.” Dr. Geoffrey Westrich, director of research for the adult reconstruction and joint replacement division at the Hospital for Special Surgery in New York, said “patients having problems with the implants generally experience three types of responses.” One group, he says, “clearly” need “revision surgery.” The other group is “not symptomatic or suffering any pain, but MRIs indicate” patients in the group “have adverse tissue reactions and elevated metal ion levels.” They may also need revision surgery. A third group of patients could end up with slightly elevated ion levels and will have to be monitored, reports Modern Healthcare.

        The Financial Times (11/20, Subscription Publication, 1.43M), Reuters (11/20, Dye) and Asbury Park (NJ) Press (11/19, 324K) all cover the news.

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