US Pharma Giant J&J Faces Heat in India

The multinational drugmaker Johnson & Johnson is being accused in India of suppressing key facts on the aftermath of surgeries conducted on thousands of patients using what were alleged to be faulty hip replacements manufactured by a UK subsidiary.

One of the world’s biggest pharmaceutical manufacturers, Johnson & Johnson includes 250 subsidiaries with operations in 60 countries and sells products in more than 175 countries. A telephone call to the company’s New Brunswick, New Jersey corporate offices was ignored by a receptionist who said she didn’t have a telephone number for media representatives.

The allegedly faulty devices – the ASR XL Acetabular Hip System and ASR Hip Resurfacing System – manufactured by J&J subsidiary Deputy International Ltd (DePuy) UK –were recalled globally in 2010.

The drug company is accused of also failing to inform India’s national pharmaceutical and medical devices regulator, the Central Drugs Standard Control Organization, about the exact number of patients who were implanted with the hip replacements, the adverse reports following such surgeries and the corrective operations subsequently necessary.

No compensation

Nor did J&J provide compensation to those affected, according to a devastating report released this week by a committee set up by the Union Ministry of Health & Family Welfare to investigate complaints against J&J in India.

The investigations, which constitute the first official indictment in India against J&J, allege that more than 3,600 patients with the faulty implants remain untraceable, and that at least four deaths have been reported from those who underwent surgeries using the devices. The committee has recommended that J&J be made liable to pay Rs2.12 million (US$30,000) to each affected patient, and that the reimbursement program for revision surgeries should continue until August 2025.

“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. "This results in increased pain and decreases mobility affecting their family and social life, their ability to work, to undertake hobbies and leisure activities and often has a negative impact on their self-esteem and mental health."

US Settlement but Nothing for India

The committee pointed out that by the end of 2013, J&J agreed a settlement estimated at US$2.47 billion to around 8,000 claimants in the United States. However, the firm “has not provided any conclusive response” on compensation in India.

More than 4,700 people received the faulty implant in India before the recall, but only 1,080 have been tracked. Of those, only 275 underwent revision surgeries, while the others are being monitored for side effects. With the manufacturer, orthopedic surgeons and hospitals making little effort to reach out to them, more than 3,600 patients continue to live in pain, authorities said.

The metal-on-metal hip replacement systems ended up releasing microscopic amounts of metal ions into the bloodstream, which triggered bone damage and tissue death from metallosis, or metal poisoning.

Mumbai-based ASR recipient Vijay Vojhala said he had to plead for two years with J&J before it agreed to foot the bill for revision surgery in 2012. By then, metal toxicity led to the then 40-year-old to lose teeth, hearing in his right ear, his job, and his ability to walk without pain.

The health ministry committee’s recommended compensation is a fraction of the US$247 million paid out to six patients in Dallas, Texas in November last year. However, more than 11,000 lawsuits are still pending in the US even as more are being filed, according to according to Drugwatch, a US-based for-profit patient-enabling group."

9,000 Lawsuits

The company settled more than 9,000 lawsuits over the defective hip model in question for around $4.4 billion between 2013 and 2015. Since 2015, juries in the US have awarded $1.7 billion as compensation over the hip implants.

By forcing fair compensation in India as well, health authorities say, India’s government must send out an unambiguous message that the lives of citizens here are equally valuable. On the contrary, despite the grave breach of medical and consumer ethics by J&J, the Indian government has not been able to prosecute the drug giant over the faulty implants.

"There are no specific legal provisions in the country's existing Drugs and Cosmetics Act, 1940, and rules to provide compensation to patients affected by faulty medical devices," said Subir Roy, a New Delhi-based activist and consumer courts lawyer. "Nor does India have a body of well-developed tort law and compensatory jurisprudence. This is the main reason why violation of patients’ rights and malpractices by international pharma firms continue to cause medical catastrophes," he added.

India Government Partly to Blame

Fingers are being pointed at the Indian government for remaining impervious to J&J's disregard of medical ethics and consumer protection laws. In an interview with Mint, the Delhi-based financial daily Malini Aisola of the All India Drugs Action Network blamed the government for its 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,” Aisola said. “This shows that government has no intention of prosecuting the company, which is the demand of the patients.”

That J&J could get away without paying compensation after implanting faulty hip replacement devices points to a regulatory deficit, and lack of medical ethics, according to consumer critics. Some doctors point out that India's existing medical ecosystem – a poor regulatory mechanism, a corrupt healthcare system and an entrenched doctor-pharma nexus – are to be blamed, encouraging multinationals to thrive in the country and literally get away with murder.

Joint Replacement a Growing Field

Further, a flourishing market for joint replacement in India – galloping upward at 25-30 percent per year – is encouraging more and more medical companies to enter the fray without a corresponding system of checks and balances in place. With billions of dollars at stake, multinationals like J&J are naturally tempted to cater to these burgeoning numbers.

"Going forward, the government must make sharing information on drug and device recalls transparent and institutionalise adverse drug reaction report ing to ensure patients in India are empowered and treated on par with those elsewhere," Ajay Makkar, Senior Consultant for Orthopedics, Fortis Hospitals, told Asia Sentinel.

Till rules are strictly implemented and the medical regulatory framework tightened, India will remain vulnerable to unscrupulous pharma companies who will continue to profiteer by exploiting loopholes in the existing system and jeopardising the lives of millions of poor and unsuspecting patients.

Neeta Lal is a Delhi-based editor and a longtime contributor to Asia Sentinel