Report: India eyes penalties for Johnson & Johnson over metal-on-metal hips

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metal-on-metal hip implantsJohnson & Johnson (NYSE:JNJ) could reportedly be on the hook again for the metal-on-metal hip implants it pulled from the market in 2010, this time in India and for much less than it’s cost the company elsewhere.

The world’s second-largest medical device maker has fielded numerous lawsuits about its ASR metal-on-metal hip replacement since it pulled the ASR XL Acetabular and ASR Hip Resurfacing systems from the market in August 2010, “due to the number of patients who required a second hip replacement procedure, called a revision surgery.” Three years later Johnson & Johnson pulled the plug on metal-on-metal hip implants altogether.

Last week a Dallas federal jury ruled that Johnson & Johnson and its DePuy Orthopaedics subsidiary must pay $247 million to six patients implanted with its Pinnacle MoM implants. Four years ago the company agreed to a $2.5 billion settlement with 8,000 plaintiffs implanted with its DePuy ASR device.

According to an Indian media report, an 11-member health ministry committee there found in February that J&J was guilty of “serious medical negligence” in at least 22 of the 101 cases the panel investigated. The ruling means the company could be fined some $676,000 (r44.0 million), or about $30,700 (r20 million) per patient, according to a pair of anonymous panel members cited by LiveMint.com. Those 22 cases involved at least one revision surgery and, in some cases, a third surgical procedure, the anonymous committee members said.

Although the company paid for the revisions, food and travel for the patients there was no other compensation, the website reported. The panel found that J&J took a “callous approach” to dealing with Indian patients, one of the sources said.

“We have suggested that the affected patients may approach the regional committees, get their documents verified and based on the disability that the patients suffered due to the product, a further compensation may be decided by the committee,” according to the second panel member. The committee is expected to submit its final report to the health ministry this month, LiveMint reported.

A DePuy spokesperson told the website that the reimbursement program was meant to surmount “financial barriers for patients so they could receive recall-related testing and treatment.”

“The company’s decisions leading up to the voluntary recall of the ASR hip system and subsequent actions, including a reimbursement program for recall-related medical expenses, reflect our commitment to patients. DePuy acted properly and responsibly with respect to ASR, and we believe the full history of the product shows a company working to improve patients’ lives through innovation, taking action when necessary and standing by patients,” according to the spokesperson. “We have kept the Drugs Controller General of India informed of all key actions and worked to provide Indian patients and surgeons with the information and support they need, in line with government requirements.”

The DePuy spokesperson said the company’s “actions concerning the product were appropriate and responsible, and DePuy has fully cooperated with the expert committee constituted by the Ministry of Health and Family Welfare with respect to the ASR recall, and will continue to do so.”

“We will ensure that the full facts are presented and will vigorously defend the company and its actions,” the spokesperson added.

($1 = r65.0881)

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