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J&J implants: Maharashtra FDA sends 50 names for compensation


Getting applications from new patients will be a continuous process, says official

Maharashtra’s Food and Drugs Administration has so far recommended the names of 50 patients who received Johnson & Johnson’s faulty hip implant for compensation by the U.S.-based company. The recommendations followed a review of these patients’ case files by an expert panel and have since been forwarded to the Centre.

FDA commissioner Pallavi Darade said they had received 74 applications after they published advertisements asking hip implant patients to come forward and submit their details. “The number of applications related to J&J’s faulty hip implant were 50 and all them were recommended for compensation after scrutiny,” Ms. Darade told The Hindu, adding that the expert panel had held 11 meetings to review the applications.

The metal-on-metal Articular Surface Replacement (ASR) hip implant manufactured by J&J’s subsidiary DePuy Orthopaedics was recalled worldwide in 2010 following reports that it was leaching metal and causing severe pain, fluid accumulation, and metal poisoning in the patients. In November 2011, the Maharashtra FDA was the first to file a First Information Report against J&J under Section 328 (causing hurt by means of poison) of the Indian Penal Code and several sections of the Drugs and Cosmetics Act. As many as 4,700 surgeries have been carried out in India that involved use of the faulty implant.

“Getting the applications from new patients will be a continuous process since so many have been operated upon in the State,” said Ms. Darade. “The expert panel meets as and when we get applications,” she added.

Last year, J&J offered to pay ₹25 lakh to each of the 67 patients who had undergone revision surgeries after being implanted with the faulty hip replacement. Many patients had accepted the interim payment but said it cannot be termed as the fair and final compensation.

The medical device company was asked to pay compensation amounts derived through a formula based on the disability, age and other risk factors of the patients, which could range from ₹30 lakh to ₹1.2 crore. J&J, however, challenged this in the Delhi High Court and stated that it was willing to pay only ₹25 lakh per patient.

“The company has paid hefty amounts to patients in the United States,” said Vijay Vojhala, a patient who was implanted with the faulty artificial hip in 2008. “What they are doing here is simply an eyewash.”

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Printable version | Jan 19, 2020 4:08:57 AM | https://www.thehindu.com/news/national/other-states/jj-implants-maharashtra-fda-sends-50-names-for-compensation/article30480590.ece

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