Wednesday, November 20, 2013

Depuy Hip Implant Settlement

Thousands of ASR patients have been through a very difficult and painful experience. Many have had their ASR device removed and replaced. In the process, they have experienced physical pan and the disability attending both the device and the remedial surgery. Thousands of other patients whose doctors chose the ASR still have the device implanted. 

This settlement, which was finalized today, attempts to address the claims of those ASR patients who have undergone a revision surgery as of August 31, 2013. ASR patients who have yet to undergo a revision surgery maintain all their legal rights.  For patients who have a revision surgery after August 31, 2013, there will be continued work to gather specific medical information following individual recovery. For the many thousands of patients who have not undergone a revision, there will also be continued to work to make sure their rights are protected should a revision become medically necessary.

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.

Monday, November 11, 2013

Chrysler recalling a million Ram trucks to inspect, possibly fix tie-rod ends.

The AP (11/8) is among the national outlets reporting on Chrysler’s recall of “about 1.2 million Ram trucks to fix front-end problems that could lead to steering troubles,” announced yesterday for three categories of the Ram trucks. The company says only about 453,000 trucks will require repairs following inspections, but a statement yesterday did admit that Chrysler “knows of six crashes and two injuries involving the 2008 to 2012 Ram 2500 and 3500 trucks that are being recalled, and one crash with no injuries from the other recalled models.” Technician error, the company said, is responsible for why “tie-rod ends in the steering system may have been installed improperly,” an issue that can lead to steering problems.

        Also reporting are Reuters (11/8), Bloomberg News (11/8, Clothier, 1.91M), and CNN’s Money (11/8).

Wednesday, November 6, 2013

Nissan recalls 2014 Pathfinder for airbag issue.

In its “Kicking Tires” blog, Cars (11/5, Geiger, 402K) provides the details of Nissan’s recall of the 2014 Pathfinder, stating that dealers will inspect and replace the instrument panel assemblies of cars with an improperly manufactured seam on the instrument panel, which could cause the front passenger airbag to deploy incorrectly. The post says that Nissan will notify owners in early November and provides phone numbers for Nissan and the NHTSA, instructing owners to call for additional information

Monday, November 4, 2013

Honda recalls 344,000 vehicles due to brake malfunction.

The New York Times (11/2, Jensen, Subscription Publication, 9.61M) reports that Honda informed NHTSA that is recalling 344,000 2007-8 Odyssey minivans because a sensor malfunction in the electric stability control system could result in spontaneous braking. Honda is not aware of any accidents or injuries caused by the problem.