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Johnson & Johnson in Midst of Controversy Over ‘Faulty’ Hip Implants in India

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Multinational pharmaceutical firm Johnson & Johnson (J&) is under the scanner in India over patients who received artificial hip implants that the company recalled eight years ago.

An expert committee set up last year by the Indian government has recommended that the firm should pay a compensation with a base amount of Rs 20 lakh to each patient who received the “faulty” hip implant from DePuy International, a unit of J&J. The recommendation is a part of the report submitted by the committee in February 2018 after a 12-month investigation. The 118-page report was released on Aug. 28, Reuters reported.

A group of patients who suffered due to the faulty implants has also written a letter to Union Health Minister JP Nadda, asking for transparency in the government’s investigation and decision process to ensure that it is not influenced by vested interests, according to the Hindu.

J&J responded to the charges on Aug. 30 to say that the company’s actions concerning the hip implant were “appropriate” and “responsible,” and that voluntary recall of the product does not mean that it was faulty, the LiveMint reported on Aug. 31, citing a DePuy spokesperson in India.

“It is also important to note that a voluntary recall doesn’t imply that the product is ‘faulty’ nor does it imply that every patient who has received an ASR hip implant will necessarily have to undergo revision surgery. Indeed, ASR continues to function well for many patients in India and around the world,” the spokesperson said in a statement, according to the report.

The expert committee set up by the Indian Ministry of Health said in its report that several Indian patients who received the Acetabular surface replacement (ASR) hip implant device, known as DePuy ASR, almost a decade ago, had to undergo years of suffering due to adverse reactions from the faulty product. Of the 101 patients approached by the company, 22 persons said that they underwent a revision surgery after the initial implant surgery, while some of them even had to undergo a third surgery, according to LiveMint.

The ASR hip implants were recalled in 2010, after it emerged that they failed at a higher-than-expected rate, Reuters reported. In 2013, J&J agreed to pay about $2.5 billion to settle lawsuits from 8,000 patients in the United States who said they suffered due to the implants.

In India, the United States-based firm paid $2 million to patients for repeat surgeries and about $250,000 in related diagnostic costs under its ASR reimbursement program, the report added. It has, however, been criticized for offering no compensation to the victims.

“The fact remains that no compensation ever has been made by the firm in India to any patient,” the committee said.

Of the about 93,000 people who received ASR implants across the world, about 4,700 are in India, the news agency cited the panel as saying.

Criticizing J&J for being “evasive” in sharing information on ASR’s design with it, the panel pointed out that the company ran newspaper notices in India about the recall of the implant in 2015, five years after the move.

“(This) shows the negligent behavior of the firm to reach out to the affected patients,” the panel said, according to Reuters.

A group of Indian patients have urged the Indian Health Ministry to address the issue in a transparent manner. “We have suffered severe consequences — medical, financial and personal — because of the hip implant. In spite of our attempts over several years to draw attention to the serious safety concerns with the ASR hip implant device, and the pain and agony experienced by us, the response from the Government for years was one of apathy and dismissiveness,” the group said in its letter to Nadda.