Last month, Johnson & Johnson agreed to pay $2.5 billion to settle thousands of consumer lawsuits in the US following the recall of its faulty ASR hip-implants.

Covering 8,000 US patients, the settlement, announced late in November by DePuy Orthopaedics (part of Johnson & Johnson), is tipped to be the highest ever for any medical device.

The settlement has put the spotlight on patient safety and compensation in India as well.

Red-flagging the J&J product recall, the Maharashtra Food and Drug Administration has initiated an investigation following a complaint, Commissioner Mahesh Zagade told Business Line . About 4,500 Indian patients have had these implants.

The Drug Controller General of India’s (DCGI) office, too, has alerted State authorities to keep a watch on the recalled product and other such products, said a Health Ministry official. However, not only is patient compensation a little-discussed issue in the country, but medical devices also tend to slip between the regulatory cracks as only a clutch of them come under the present Drugs and Cosmetics Act, says a lawyer familiar with the regulations. However, the good news is that patient compensation is making its way centre-stage, buoyed by a recent landmark ruling on medical negligence by the Supreme Court, says the lawyer.

That ruling came in October, when the apex court ordered compensation of about Rs 6 crore — perhaps the highest such amount in India — in a case involving the death of a non-resident Indian doctor’s wife in Kolkata’s AMRI hospital.

Hot seller The ASR hip-implant recall took place in 2010 and J&J says it had informed the DCGI. Surgeons were contacted to reach out to the concerned patients.

“To date, we have identified approximately 1,500 patients through the ASR outreach programme, of which more than 750 have registered on the helpline. These patients are being followed up with information and support,” said a J&J spokesperson.

DePuy’s ASR hip-implant was a “hot seller” at one time, says Dr Kaushal Malhan, a knee and hip surgeon with a Fortis hospital in Mumbai. An implant undergoes wear and tear, especially if, as in the case of a hip implant, it is subject to loads and cycles of movement.

If a patient has suffered because of a faulty implant (that leaves debris in the blood), the company compensates the revision surgery, says Malhan. These are high-end implants, and patients are told to follow-up regularly after a surgery. But most don’t, he added.

Welcoming regulatory scrutiny, he says, in product-recall cases, companies should pick up the patient’s tab for follow-up X-ray and blood tests to check if iron-levels (from the metal implant) have increased, and for the revision surgery. Compensation for trauma is a different issue, he added.

DePuy is “committed to addressing reasonable and customary costs of testing and treatment for reasons related to the recall, including revision surgery if necessary,” said the J&J spokesperson.

>jyothi.datta@thehindu.co.in

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