The Central Drugs Standard Control Organisation (CDSCO) on Tuesday directed pharmaceutical major Johnson & Johnson to pay compensation of Rs 1.01 crore and Rs 90.26 lakh to two patients, both from Uttar Pradesh, who had received faulty hip implants made by the firm. The country's drug regulator wants the compensation to be paid within 30 days from the date of receipt of the order.
This is reportedly the highest compensation received for medical negligence in India. The first patient to be compensated by the US headquartered company on the same grounds was awarded over Rs 74 lakh in March while the second patient was awarded Rs 65 lakh.
The faulty articular surface replacement (ASR) hip implants had been manufactured by DePuy International Limited, a J&J subsidiary. The parent company had recalled the faulty implants in 2010, globally, after studies red-flagged a higher-than-usual rate of revision surgeries. Subsequently, in 2017, the government constituted a central expert panel to investigate patient complaints about ASR hip implant devices. The committee headed by Dr Arun Kumar Agarwal, former dean of Maulana Azad Medical College, found that J&J had "suppressed" facts on the harm of surgeries, and recommended compensating the patients.
Around 4,700 hip replacement surgeries were reportedly carried out in India between 2004 and 2010 but only 1,080 patients could be traced through the dedicated helpline set up to track them, Mint reported.
Following the Agarwal panel's recommendations, a five-member central expert committee was constituted last year to determine the quantum of compensation for patients who had received DePay ASR hip implants prior to August 2010. The committee led by Dr R.K. Arya, director of sports injury centre at Delhi's Safdarjung Hospital, had examined several documents, including the disability certificates issued by the Delhi medical authority to decide on the compensation, sources in the know told the daily.
As per the compensation formula approved by the Union Health Ministry in November, which is based on the percentage of disability as well as age and risk factors, thousands of patients in India were to be compensated between Rs 30 lakh to Rs 1.23 crore. But J&J moved Delhi High Court in December, challenging the government orders to compensate patients. It has also appealed against CDSCO's first two compensation awards, saying it is willing to pay only Rs 25 lakh each to the patients. However, the Supreme Court, in a separate plea by businessman Arun Goenka, accepted the government's recommendation, including the compensation amount, and disposed of the matter.
According to the daily, the US drug maker has failed to pay any compensation in India so far, although it had agreed to pay damages totalling $2.5 billion to around 8,000 US citizens who had sued the company after receiving the faulty implants.
Meanwhile, troubles continue to mount for J&J, which saw its consumer business in India post the first dip in sales in at least 15 years. The Mumbai Police has opened investigation into an eight-year-old case against DePuy Medical Pvt. Ltd, another J&J subsidiary, for its faulty hip replacement implants. The city police is reportedly in the process of recording statements of patients and doctors to collect evidence.
With PTI inputs