Indian Regulators Demand ₹20 lakh As Compensation From J&J

Indian Regulators Demand ₹20 lakh As Compensation From J&J

Introduction

Considering the recommendations made by a government-appointed committee, the Indian Drug Regulator has asked Johnson & Johnson (J&J) to pay ₹20 lakh as interim compensation to each affected individual who suffered complications due to the company's defective hip implant, Articular Surface Replacement (ASR), manufactured by DePuy Orthopaedics (a subsidiary of J&J).

The decision was sent out as a letter by the Central Drugs Standard Control Organisation (CDSCO) to J&J asking them to provide this base compensation to all affected patients in India. According to J&J, about 4,600 individuals in India received the alleged hip implant, of which 3,600 patients are yet to be traced. The regulator has also asked the company to reinstate its medical management programme for the affected patients which they discontinued last year. That would be mean the company must bear the reimbursement of medical costs till 2025 as the average life of the orthopedic implant is 15 years.

In the United States, DePuy faces more than 11,000 lawsuits over complications related to their ASR and Pinnacle hip implants. As of August 2018, 1,715 lawsuits over ASR hips are pending in an Ohio federal court. Recently, U.S. District Judge Ed Kinkeade awarded $ 245 million to six plaintiffs over the alleged Pinnacle Hip Implant defects. About 28,000 lawsuits have been filed against various hip implant makers in the U.S., involving defendants Zimmer, Stryker, Biomet, Wright, and Smith & Nephew.