J&J Ordered to Pay $8.3 Million to Hip Implant Patient By Tod Aronovitz | 03/12/13 | 0 Comment

Johnson & Johnson has been ordered to pay $8.3 million to retired Montana prison guard Loren Kransky in connection with an artificial hip implant that, his lawyer argued, resulted in raised levels of cobalt and chromium causing him pain that required his hip to be replaced. This is the first trial in a string of more than 10,000 lawsuits nationwide awaiting resolution.

The implant, known as the Articular Surface Replacement, or A.S.R., was recalled in 2010 because the metal alloy components used in the implant could break free and become embedded in surrounding soft tissue or near a bone.

When this condition happens, it is known as an “adverse local tissue reaction” (ALTR) or an “adverse reaction to metal debris” (ARMD), as described in my January 24 blog post, “Hip Implant Devices Subject of New FDA Safety Update.” Adverse side effects may include skin rashes, hearing or vision impairment, and depression, according to the FDA.

In its decision Friday, the Los Angeles jury awarded plaintiff Kransky $338,000 to cover medical expenses and $8 million for his pain and suffering.  Johnson & Johnson plans to appeal, disputing the jury’s finding that the A.S.R. was defectively designed by the company’s DePuy orthopedics division.

A March 8 New York Times article, “J&J Loses First Case Over Faulty Hip Implant,” tells of an internal Johnson & Johnson document that was introduced at the trial projecting that almost 40 percent of patients who received an A.S.R. will need to undergo a second operation within five years of the first to have the implant removed and replaced.

An estimated 500,000 patients in the United States have an artificial hip implant that shows signs of early failure. Under a new FDA proposal expected to be announced on Thursday, artificial hips with all metal components would have to be proven safe and effective before their makers could continue selling existing ones, or obtain approval for new all-metal designs.

If you are a patient with a metal-on-metal hip, click on the link for the FDA list of FAQs on Metal-on-Metal Hip Implants. Click on the link to read the FDA proposed rule for hip replacement system pre-market approval, and talk to your doctor about your specific condition, pre- and post-surgery.

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