Johnson & Johnson To Face Heat Over Faulty Hip Implants

Many patients in India have been adversely affected by the faulty hip replacement surgery they underwent almost a decade ago using devices made by Johnson & Johnson (J&J) Inc. According to the preliminary report by the Indian Express, which details the findings of the health panel reports, 3,600 patients with the faulty implants remain untraceable, and that at least four deaths have been reported from those who underwent surgeries using these devices. In 2017, the Indian government, specifically the Union health ministry, had set up an expert committee to look into the issue. The committee, headed by the former dean of Maulana Azad Medical College (MAMC) Dr. Arun K. Agarwal, had top orthopaedic surgeons and legal experts in it. In its report submitted in February 2018, the committee recommended compensation with a base amount of ₹20 lakh each for patients.

The findings of the committee have directly accused the Indian arm of Johnson & Johnson of suppressing facts on the adverse effects of the faulty hip replacement systems it imported and sold for use in surgeries of hundreds of patients.

The report also mentions that the company did not inform the national regulator about the exact number of patients who used these devices, the adverse reports following such surgeries, and the corrective operations that were subsequently conducted. Some of these patients have approached the Indian government and are seeking its intervention to secure compensation from J&J.

The committee also states that in the documents submitted during its probe on the “faulty” implants, the global pharma major “themselves have admitted about the product failure”. The product was globally recalled on August 24, 2010. Despite that, the company did not raise the issue with the Indian authorities. The medicare giant had also tried to manipulate data to prevent it from scrutiny; according to the report by the panel, Johnson and Johnson had incorrectly stated the rate of revision surgery. The committee found that the revision surgery rate was not 12 per cent as the company had reported. “...as per 2014 data, the cases of revision surgery were very high, almost 35 per cent,” the report said. “However, as per the latest data, the rate comes out to be 25 per cent.  The report also revealed that around 4,700 people in India underwent surgery for hip replacement to implant the device. But, only 1,032 patients were registered with the ASR helpline, of which 254 patients underwent a revision surgery. The failure of the company to initiate the registration process also stands exposed from this report. 

Over the issue of the same, by the end of 2013,  J&J agreed for a settlement estimated at $2.47 billion to around 8,000 claimants in the United States. But, when it comes to compensation in India, the firm is yet to provide any conclusive response, let alone initiate the compensation process. 

The episode isn’t the first when it comes to J&J; the company was previously ordered to pay $4.7 billion in damages to 22 women who alleged that they got cancer after using its talcum powder. A jury in the US state of Missouri initially awarded $550 million in compensation and added $4.1 billion in punitive damages. The verdict came out in July 2018 while the pharmaceutical giant battles some 9,000 legal cases involving its signature baby powder. The cases of settlements have yet again pointed to the grim reality of a flawed system, wherein the responsibility is on companies to report the faults in their own devices. This systemic failure clubbed with laxity and apathy on the part of the government has led many to suffer.