Even as nearly 4,000 patients await justice from the Delhi High Court in the form of compensation from Johnson & Johnson (J&J) over faulty hip implants that severely impaired their health, the pharma giant had proposed a payout formula to the Government during a closed-door meeting over five years ago. That plan was shot down — it did not take into account the severity of a patient’s disability caused by the implant. This undisclosed episode in the “ASR implant scandal”, which has resonated in pharma markets across the world over the past decade, has been brought to light in The Johnson & Johnson Files: The Indian Secrets of a Global Giant (Juggernaut), authored by The Indian Express National Health Editor, Kaunain Sheriff M. According to the book, J&J’s proposal was rejected by the Government. Over a month later, the Government put forward its own proposal based on the extent of disability, and held the company liable to pay amounts ranging from Rs 30 lakh to Rs 1.2 crore. This prompted J&J to approach the court, where the matter is currently being heard. The new book is based on a series of investigative reports that was published from August 2018 in The Indian Express on J&J’s ASR hip implants. These reports revealed the key findings of a Government committee: J&J failed to inform the national regulator about the exact number of patients with implants, adverse reports following such surgeries and corrective procedures performed — and that over 3,600 such patients remained untraceable. In November 2018, The Indian Express, in collaboration with the International Consortium of Investigative Journalists (ICIJ), published The Implant Files, a global investigation that exposed irregularities and malpractices in the medical device industry, including the ASR implants. J&J’s hip implant devices, manufactured by its subsidiary DePuy, were first cleared by EU regulators in 2003. However, amid growing concerns over a rising number of revision surgeries, the company recalled the devices on August 24, 2010. According to the book, the company wrote to the national regulator in September 2018, proposing its own compensation formula. This formula, the book states, was based on two key factors: longer the defective implant is used, lower the payout; and, age at the time of original surgery. Under this formula, the book states, only patients whose implants had been removed within five years were eligible for the maximum compensation while those who had the implant for nine-10 years would receive just 20% of that amount. “We are grateful for providing us the opportunity to work with you to design a framework for an appropriate compensation protocol for ASR patients in India,” the company told the regulator, according to the book. It also said that its “proposal” was based on “similar programs that were implemented to resolve legal claims in other countries”, the book states. “.We are here to help patients, serve the community, and care for the well-being of the people in India. We are pained for any patient who has concerns about the outcomes of their treatment,” the company told the regulator. J&J did not respond to a request for comment from The Indian Express on the key assertions made in the book. The Government’s formula, starting with a base amount of Rs 20 lakh, takes into account two key factors: severity of the patient’s disability and age. Under this formula, younger patients with more than 50% disability are eligible for maximum compensation of up to Rs 1.22 crore. The rationale, according to the book, is that the longer the faulty implant remains in the body, the resulting disability is likely to impact youngsters for a greater part of their lives. The book also includes data shared by J&J with the Government committee: nearly seven years after the ASR implants were recalled, only 1,032 Indian patients had registered on its helpline. The committee viewed this as “lack of seriousness” on the company’s part in tracing all affected patients, the book states. The book also discloses a purported June 2011 communication from the company to the Government: it had registered only 45 patients from India on its helpline, which was 1% of those who had received the faulty implants. In the US, meanwhile, DePuy had registered 23,366 ASR patients, covering nearly 60% of all recipients. Australia wasn’t far behind, with 2,970 patients registered, almost 50% of the total. South Africa had 2,098 patients on record, or 55%, while in the UK, 1,968 patients were registered, about 20% of all ASR recipients there. According to the book, in January 2019, a month after it approached the Delhi High Court against the Government's formula, the company reached a $120 million multi-state settlement in the US to resolve allegations of unlawfully promoting medical devices, including the ASR implants. On May 2, 2019, J&J told the Delhi High Court that it was making a “voluntary” payment of Rs 25 lakh to Indian patients - but only those who had undergone revision surgery to remove the ASR implant. These payments were made with a caveat: no admission of fault or liability. At least a month before this offer, which was widely reported in the media, the book states the Government committee had started recommending compensation for patients under its disability-based formula. In one case, a 43-year-old woman was awarded Rs 1.01 crore. By May 2, 2019, as many as 289 patients were in the final stages of receiving compensation.
