Johnson and Johnson's (J&J's) allegedly faulty hip implants could cost it close to Rs 4,40,00,000 in compensation to Indian patients.
The American multinational medical devices and pharmaceuticals firm could be ordered to pay 22 Indian patients who were allegedly given faulty hip implants Rs 20 lakh each in compensation, Livemint reported on Monday while citing sources in the know. According to the report, the concerned patients had to undergo revision surgeries because of the reportedly faulty implants.
Two people who serve on the 11-member committee set up by the health ministry in February told the financial daily that the panel has concluded that J&J was at fault for "serious medical negligence". According to the report, the committee approached 101 patients and 22 of them responded that they had undergone a revision surgery after the first surgery involving the J&J implants. Further, some of them said they even had to undergo a third surgery.
The financial daily reported that the patients told the panel how they suffered great pain and had to be confined to bed due to the faulty implants. Further, according to the report, the patients' ordeal showed that the design of the implant had a flaw, which caused an increase in the chromium and cobalt levels in the body of the implant's recipients. This led to a toxic effect on other parts of the patient's body and even endangered their lives, the report said while citing an unnamed source.
The local unit of DePuy International, the Johnson and Johnson unit that sold the device in India, denied the allegations through its spokesperson, the report said. The DePuy spokesperson told the financial daily: "We will ensure that the full facts are presented and will vigorously defend the company and its actions."
According to the report, the committee found that in the case of Indian patients, J&J only provided reimbursement for recall-related revision surgeries, food, and travel to the patients. However, according to the sources cited by the report, no compensation was paid to the patients in the country. The implants were recalled globally in August 2010 and J&J, according to the financial daily, had agreed to shell out $2.5 billion as compensation for close to 8,000 American citizens who had sued the firm over the allegedly faulty implants.
The company's India spokesperson told the financial daily that DePuy's reimbursement programme was aimed at removing "financial barriers for patients so they could receive recall-related testing and treatment." Responding to a detailed questionnaire sent by the daily, the spokesperson said: "The company's decisions leading up to the voluntary recall of the ASR Hip System and subsequent actions, including a reimbursement programme for recall-related medical expenses, reflect our commitment to patients. DePuy acted properly and responsibly with respect to ASR, and we believe the full history of the product shows a company working to improve patients' lives through innovation, taking action when necessary and standing by patients."
"We have kept the Drugs Controller General of India (DCGI) informed of all key actions and worked to provide Indian patients and surgeons with the information and support they need, in line with government requirements," the spokesperson added, according to the report.
However, J&J's troubles are not over
yet and they are not confined to India either. According to agency reports, a federal jury in Dallas last week ordered the company and its DePuy Orthopaedics unit to pay $247 million to six patients who said they were injured by defective Pinnacle hip implants.
Delivering a third straight win to patients, the jury, according to a Reuters report, found that the metal-on-metal hip implants were defectively designed and that the companies
failed to warn consumers about the risks.
J&J, which faces more than 9,700 Pinnacle lawsuits in state and federal courts across the United States, said in a statement it would immediately begin the appeal process. A DePuy spokeswoman said the company was still "committed to the long-term defence of the allegations in these lawsuits," adding that the metal-on-metal hip implants were backed by a strong record of clinical data showing they were effective.
According to the report, last week's verdict came in the fourth test trial over the devices in Dallas federal court, where some 9,000 of the cases are pending. Test cases have been selected for trial, and their outcomes will help gauge the value of the remaining claims and inform potential settlement talks.
J&J won the first Pinnacle test trial in 2014, but subsequent juries determined the companies
to be liable.
A jury in March 2016 awarded five Texas plaintiffs $500 million in damages. That award was later cut to $150 million.
Further, according to the report, J&J and DePuy were also found liable at a trial in March, during which a jury awarded six California patients $1 billion - a verdict that was later reduced to $543 million.