Waking up to the faulty implant case that left a many patients dead and disabled, the Centre is mulling to make the medical device manufacturers liable to compensate for injuries caused to consumers by their faulty medical gadgets. Presently companies pay compensation only in case of adverse events during a clinical trial.
“The Government can’t close its eyes given that medical devices are now necessity for the longer life of the patients. It’s time to plug gaps in the existing rules. The absence of such a law has made it tough for regulators to seek compensation from Johnson & Johnson for patients who had undergone faulty hip implant surgeries,” said sources in the Central Drug Standards Control Organisation (CDSCO), a national pharmaceutical regulatory body.
They said that the regulator has proposed changes in the existing law to introduce a compensation provision for approved drugs and medical devices that have an adverse impact on a patient.
An expert panel set up by the Union Health Ministry to probe into the complaints has found that there is no provision as such for compensation to patients for faulty medical devices in the Drug and Control Act, only fines and prosecution which can be initiated by the drug inspector or consumer associations, not patients.
The key findings of the committee, constitute the first official indictment in India against J&J, which imported and sold ASR XL Acetabular Hip System and ASR Hip Resurfacing System in the country — these devices were globally recalled in 2010. The panel found that over 3,600 patients with the faulty implants remain untraceable, and that at least four patients with the implants have died.
In its report, the panel also observed that DePuy Orthopaedics Inc (J&J’s subsidiary that manufactured hip implant devices) “appeared to have suppressed certain facts about the implants” from Indian regulators. It recommended that eligible patients should receive a “base amount” of Rs 20 lakh as compensation, and proposed mechanisms to identify eligible patients.
Victims are already making rounds of the court, seeking compensation and punishment against the giant pharma. Three patients — Vijay Vojhala, Vinay Agarwal and Shailesh Bachate — has in their letter dated August 27 have urged Union Health Minister JP Nadda to keep them in loop in the matter. They said, “We believe that the investigation of Johnson & Johnson’s faulty hip implants and the resulting governmental action should be done in a transparent manner so as to ensure that vested interests do not unduly influence the process.”
The letter has also been signed by Jennifer Barucha and Praful Sardesai, the children of deceased patients who used these implants. “We also seek participation in any further deliberations by the Government on the action to be taken on the report,” the letter stated.