Daisy Bharucha was one of the first persons in India to sue the global pharmaceutical company Johnson & Johnson (J&J) for the faulty hip implant manufactured by its unit DePuy Orthopedics.
Daisy went for a hip replacement in 2007. As the defective device leached metals like chromium and cobalt into her body, she suffered agonising complications and had to go for multiple surgeries.
In 2011, she realised to her horror that J&J had recalled the implant. For, she was not alone. Thousands of people across the world, who had gone for J&J’s all-metal articular surface replacement (ASR) hip implant, reported pain, infection and debilitating injuries.
Daisy filed a complaint to the National Consumer Disputes Redressal Commission (NCDRC) in 2013. She died soon after in April 2014.
In 2024, a decade after Daisy’s death, NCDRC asked J&J to pay Bharucha 35 lakh and 6% interest per annum on the amount from the date of her complaint. J&J had paid 25 lakh as compensation. It refused to shell out more and appealed against the decision in the Supreme Court.
In December, the apex court upheld NCDRC’s order and asked J&J to pay Bharucha `10 lakh more and the interest.After a long and winding road marked by despair, hopelessness and resilience, Bharucha felt a shot of relief. But it soon gave way to tears.
“I don’t want to celebrate. That’s blood money,” says the 50-something Bharucha, who works as an executive assistant in a multinational company in Mumbai. “Had it not been for my mother’s persistence to fight this case, I would not have gone on. I am relieved the company is found guilty. But there is just no joy in winning this case,” she says.
It is a landmark verdict as India’s apex court fixed culpability on J&J. However, the compensation is paltry compared with what class action suits against the same company in the same case had won for plaintiffs in the US.
Until now, all that Bharucha has got in her hands is `25 lakh. It is the flat compensation that J&J decided on its own to give Indian patients in 2019—and that too only to those who have had revision surgeries to replace its defective implant.
Meanwhile, J&J is reported to have paid over $4 billion in settlements, mainly in the US. In 2013 alone, J&J paid $2.5 billion as compensation for 8,000 patients in the US.
Documents from law firms that represented patients in class action suits in that country show that patients who suffered injuries due to the implant received on average $300,000 (`2.7 crore at current exchange rate); this varied depending on age, severity of the condition and number of surgeries.
OUT OF JOINT
J&J’s ASR implant is one of the worst cases in the history of medical device negligence. Metallosis, a condition caused by the deposition of metal particles in soft tissues, was reported across the world. The rate of failure was 37% over a five-year period. It went up to 40% in seven years in countries like Australia.
Thousands of lawsuits were filed against J&J for misleading marketing and an alleged deliberate delay in alerting doctors and healthcare systems of the product’s harmful effects.
Bharucha’s lawyer Kushal Choudhary says money cannot compensate for a life, but underlines that J&J paid a lot less to Indians than to Americans. “If one looks at how J&J compensated affected individuals in jurisdictions like the US, the amount awarded in India falls short of what many patients truly deserved for the harm they endured,” he says.
The real battle, the lawyer adds, was in fixing responsibility and ensuring that a multinational corporation is held answerable for selling defective medical products. “On that count, the courts have done the right thing,” he says. “The battle, however, is only half-won. There are still several other litigants waiting for relief, and we remain hopeful and committed that justice will reach them as well.”
Meanwhile, J&J says it is reviewing the Supreme Court order. “Our commitment to the patients we serve is reflected through the company’s decisions leading up to the voluntary recall of the ASR Hip System and subsequent actions, including a reimbursement program for recall-related medical expenses and voluntary payment of `25 lakh to eligible ASR revision patients,” says a company spokesperson. “Given that we are currently reviewing the Supreme Court’s order, it’s inappropriate to comment further.”
J&J has come in for sharp criticism not only for the meagre amount it agreed to pay Indians, but also for not compensating them until 2019. “People fight and fight for years, and it’s totally unfair,” says Bharucha.
Jennifer Bharucha, holding a photo of her mother Daisy, who had a hip implant in 2007 and died in 2014, got ₹25 lakh as compensation. The Supreme Court has ordered J&J to pay ₹35 lakh in total, plus 6% interest since 2013.
Kabbir Chandhok, a 41-year-old from Mumbai, knows the unfairness only too well. He underwent surgery to place J&J’s hip implant when he was 22. Suffering from metal poisoning, his life is reduced to agonising back pain and dependence on a walking stick.
It mirrors a broken system. India woke up to the gravity of the situation only in 2018—eight years after J&J recalled the product.
In India, 4,700 ASR surgeries were carried out between 2004 and 2010. However, just over 1,000 could be traced through the helpline activated for reporting such cases. The Union health ministry constituted a panel to determine compensation for affected patients.
The formula approved by the government proposed substantial compensation—between 30 lakh and 1.2 crore, plus `10 lakh for non-pecuniary losses such as pain and suffering. The formula was based on the extent of disability, age and risk factors.
Chandhok was among those who would have received the maximum compensation of `1.2 crore.
But in December 2018, J&J challenged the government’s compensation formula in the Delhi High Court. That is where the company said it would give `25 lakh each to 67 patients who had undergone revision surgeries. That is what Chandhok has received so far.
“There have been 28 hearings with no substantial breakthrough,” says Chandhok. The case is still ongoing.
THE DISPARITY
Dinesh Thakur, a health activist who was a whistleblower for Ranbaxy, says it might have been better for Indian patients had they filed a class action lawsuit in the US. “Indian courts have lowballed the compensation,” he says.
“This was a lost opportunity to litigate because there were clearly identified victims and J&J had already made a settlement in another jurisdiction, acknowledging defects in the product. Liability was already established. The only question was a class in a different geography,” he adds.
Lawyers, however, disagree. Ujjawal Gaur, a senior lawyer in the Supreme Court, says even though the manufacturer is an American company, the case would have failed because US courts lack jurisdiction over claims where surgery, injury, medical treatment and evidence are located outside the US.
“Such cases are routinely dismissed under the forum non conveniens doctrine and for want of specific personal jurisdiction, as mere corporate presence or product design in the US is insufficient,” he says.
Gaur adds that under India’s consumer protection laws and regulatory frameworks, patients do not receive punitive damages or expansive class action settlements comparable to those in the US.
A legal expert familiar with US laws says another challenge would have been limitation periods, which typically range from two to six years from the detection of the first injury.
Vijay Vojhala, a hip implant patient from Mumbai, says affected people pursued all available options. He adds that the government and judiciary should be more sensitive and proactive. “Indian patients did not get anything apart from interim compensation, and J&J has challenged the health ministry’s compensation formula,” he says.
Experts say gaps in Indian laws allowed J&J to mount a legal challenge. Since there are no provisions in the Drugs and Cosmetics Act, 1940, or its rules to mandate compensation, the government cannot force erring companies to pay penalties. Only courts and consumer forums can decide compensation.
“Aadmi ki keemat bahut kam hai yahan (the value of life is very low here),” says Purushottam Lohia, a businessperson from Pune, who, like Bharucha, has won an order in the Supreme Court for `10 lakh more in damages. He is waiting for J&J to pay.
“It has been so time-consuming, and what we have got is pittance compared with people in the US,” he says.
For patients like Chandhok, Lohia and Vojhala, who live daily with the consequences of a defective hip implant, the meagre compensation feels like adding insult to injury.
