Redress for faulty Johnson & Johnson hip implant surgeries unlikely

Patients who have filed complaints against Johnson & Johnson for allegedly giving them faulty hip implants are unlikely to get any easy relief soon.

State governments and the Centre have not hauled up the company in the eight years since the first complaint was lodged. Even if they were to do so now, they are unlikely to be able to make the device maker cough up compensation. The Drugs and Cosmetics (D&C) Act, 1940, which regulates medical devices, does not expressly provide for compensation.

Johnson & Johnson did not respond to queries on this.

The first complaint was lodged in Maharashtra in 2011. The state’s food and drug administration (FDA) took it up actively. An FIR was filed in 2014, naming DePuy Synthes, a subsidiary of Johnson & Johnson. But, the authorities could not push for compensation. The case went to the Bombay High Court. The court advised the FDA to continue with the inquiry, but nothing happened.

The D&C allows the FDA to ask a company to recall its faulty products. But, Johnson & Johnson did not do so in India.

“All over the country, 4,700 hip implants were used till 2010. It was not a problem of the batches sold in Mumbai only,” said an official involved in the Maharashtra investigation. “The FDA chief of Maharashtra appealed to all chief commissioners to take action in their states. But, that did not happen.” The official claimed that when the Maharashtra FDA asked the company to identify and locate affected patients in order to ensure corrective surgeries, Johnson & Johnson said that doing so would be impossible. Business Standard could not verify this independently.

A committee was set up in 2017 by the Union health ministry to review the matter. In February this year, the committee submitted its report. It said the company should pay each patient Rs 2 million as compensation, but no one has received any money, according to various reports.

In the US, Johnson & Johnson had paid $2.5 billion for the same problem.

Even the recommendations of the committee are not enough to make the company pay compensation. In the US, aggrieved individuals used a specific product-liability law to seek damages and compensation. Similar provisions are not available under the D&C Act. The Consumer Protection Act, 1986, provides a generic legal option.

“Earlier there were discussions to amend the D&C Act to bring in specific provisions for compensation but that has not happened,” said Malini Aisola, convenor, All Indian Drug Action Network (AIDAM).

She added, “But, there are enough powers with the Central Drugs Standard Control Organisation (CDSCO) to act proactively, withdraw faulty devices from the market, inform the patients and make companies act responsibly. Instead, the organisation depends on companies to declare the issues themselves.”

Aisola said this was not the case only with hip implants. “Even in the case of dangerous stents, the CDSCO did not act. It was the National Pharmaceutical Pricing Authority that stepped in laterally to push the defective stents out of the Indian market.” Senior CDCSO officials did not respond.

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