BackGovt can’t prosecute J&J for faulty hip implants under existing act
There are no specific legal provisions in the existing Drugs and Cosmetics Act, 1940, and rules to provide compensation to patients affected by faulty medical devices
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New Delhi: There seems to be no respite for the trouble-stricken patients fitted with “faulty" hip implants by pharma giant Johnson and Johnson Pvt. Ltd (J&J) as there are no specific legal provisions in the existing Drugs and Cosmetics Act, 1940, and rules to provide compensation to the patients in such cases. Public health experts say the legal compulsion for compensation can come through a court case invoking tort law, product liability law and consumer protection law.
“The committee gets it wrong by asking the government to order compensation under the Drugs and Cosmetics Act as it stands now. If it arrives at damages (as per report), it can ask J&J to pay. But J&J will only do so voluntarily—it cannot be legally compelled to do so. The only legal compulsion for compensation can come through a court case invoking tort law, product liability law and consumer protection law," said Shamnad Basheer, founder of website SpicyIP and former chair professor of intellectual property law at West Bengal National University of Juridical Sciences, Kolkata.
An expert committee which was formed to inquire into the seven-year-old case indicted the company for providing faulty hip implants and suggested that a base amount of at least ₹ 20 lakh be paid to patients. The committee headed by former dean of Maulana Azad Medical College (MAMC) Dr Arun Agarwal submitted its report in February this year. Late on Tuesday, the drug regulatory authority of India put up the report on its website.
“Considering all the facts and details as well as taking into account the relevant literature…the committee holds the ASR (Acetabular surface replacement) hip implants manufactured by DePuy International Ltd were found to be faulty which resulted in higher instances of revision surgeries globally including India," the report said. DePuy Orthopaedics Inc. is a fully-owned subsidiary of J&J, which is represented in India by J&J India Pvt. Ltd.
“The committee is of the considered view that the revision surgeries were necessitated due to the faulty ASR, as well as negligence of the firm in approaching the patients, and therefore it is the responsibility of the firm to compensate all the affected patients," the report said. Mint had reported the findings of the report in January this year.
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Basheer says that the case seems to be an apt one to invoke class action style tort law. “The report is a scathing indictment of J&J’s subsidiary DePuy which sold the defective hip replacement units. It shows that J&J didn’t disclose accurate information (despite being asked to by the committee, etc.), and merely reimbursed some of those affected. But reimbursement alone is not sufficient to compensate for pain and any ensuing loss of wages and disability, etc. as the committee rightly notes. Unfortunately India does not have a body of well developed tort law and compensatory jurisprudence. This was tried in the Bhopal gas tragedy case, but not hugely successful. This case seems an apt one to invoke class action style tort law again. And this government committee report is likely to weigh heavily in favour of patients who sue," he added.
At their end, Depuy spokesperson said that they are reviewing the report and their actions concerning the product were “appropriate" and “responsible". “To date we have, through surgeons, hospitals and independent service providers, demonstrated outreach to more than 2,300 patients who underwent ASR surgery in India. It is important to understand that legal systems in different countries function differently according to their own applicable laws and the individual facts and circumstances of a specific case. The report from the CDSCO has just become available and we will need to review this information.
Patients fitted with the faulty hip implant raised serious concerns over the report. “The company should have been tried under criminal case,"said Vijay Vojhala, one of the patients. In fact, former Food & Drug Administration Commissioner Mahesh Zagade, had initiated investigations in 2011 and filed a criminal case against the company. Considering the seriousness of the issue, he had even recommended that the case be taken up by the central investigative agencies but to no avail. “There was enough evidence against the company but nothing happened. The government machinery is equally responsible for the blunder," he said.
Malini Aisola of All India Drugs Action Network (AIDAN) blamed the government for their callous approach. The government is contradicting itself that no compensation clause in the D&C Act but the report says compensation will be meted out to the victims. This shows that government has no intention of prosecuting the company, which is the demand of the patients," she said.
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