India Orders Payments From J&J’s DePuy Over ‘Faulty’ Hip Implants
The Indian government issued an order to determine the penalty amount Depuy International UK, a Johnson & Johnson subsidiary, will be required to pay over claims regarding its “faulty ASR hip implants” based on a probe established by the Ministry of Health & Family Welfare.An examination of information from patients in India, who reportedly underwent revision surgeries prematurely due to serious adverse reactions linked to the ASR hip implants, was initiated last year by the government committee. This is according to the committee’s first report, revealed last week, on recommendations to tackle reported issues.
The expert committee was charged with looking “into the various aspects relating to the design of the ASR, safety aspects, clinical aspects...adequacy of the medical management and compensation,” among other issues. This followed years of reports from patients worldwide.
The move coincided with a growing number of lawsuits filed by US patients against DePuy and its parent company, now facing about $246.1 million in damages under an August court ruling in the fourth bellwether case involving the allegedly defective Pinnacle metal-on-metal hips.
Affected patients in India “had to live a restricted lifestyle with a comprised physical state, thus putting them at pain and agony throughout their life,” the committee concluded, suggesting a base compensation of Rs 20 lakh (US $27,920) per patient. “An opportunity should be given to make the claim for ‘just and adequate’ compensation….to mitigate some of their pain and sufferings.”
Other recommendations for DePuy to address patients’ concerns outlined in the report published by India’s Central Drugs Standard Control Organization relate to launching a new registry for high-risk devices and issuing guidance on device recalls, among several others.
Constitution of Central Expert Committee to determine the quantum of compensation in respect of faulty ASR Hip Implants manufactured by M/s DePuy International Limited U.K and implanted in India dated 30.08.2018
Faulty ASR Hip Implant Manufactured by M/s DePuy International Limited U.K dated 30.08.2018