US pharmaceutical giant Johnson & Johnson has been in the limelight recently for the wrong reasons. A jury in the US state of Missouri has recently awarded $4.7 billion in damages to 22 women, who alleged that its talc products caused them to develop ovarian cancer. What has been traditionally a name associated with excellence in medical products has been tarnished in the US by this landmark judgement.
This verdict came during a time when the company was battling over 9,000 cases involving its baby powder across US. During the trial, it came to light that several women and their families had developed ovarian cancer after using baby powder and other talc products for decades. Shockingly, of the 22 women represented in this case, six have died from ovarian cancer. The lawyers representing these women in the lawsuit, claimed that Johnson & Johnson was aware its talc was contaminated with asbestos since 1970s but had failed to warn consumers of the risks.
Talc is a mineral-based product, which in its natural form contains asbestos and causes cancer, however trials done with asbestos-free talc has given contradictory results. There have been studies linking the mineral to cancer, but there are also studies that have argued there is no link whatsoever.
Regardless, the fact that there is no conclusive evidence of talcum powder’s carcinogenic properties, should not be enough to rule it as safe. It should be obvious, that the Indian government should make efforts to further investigate the details of this case, in order to determine whether sanctions should be put against the product in India. But to date, it has yet to take any action.
This is not the only product offered by Johnson & Johnson that is under the scanner. The company is known to offer hip implants ‘ASR’ and ‘Pinnacle’ to patients in the country. In a massive investigation appropriately titled the ‘Implant Files’, the International Consortium of Investigative Journalists (ICIJ) has exposed how medical devices are advertised, sold and surgically implanted across the world under regulatory systems that are riddled with holes.
In their report, records show that Johnson & Johnson subsidiary DePuy waived the US clearance for Pinnacle and ASR to push both products through. Furthermore, records also show that Indian regulators approved both products based on the US clearance without conducting any clinical trials of their own.
Both implants are metal-on-metal, comprising a metal ball in a metal socket implanted at the hip. The result of bypassing the requisite clinical trials in India has been disastrous. There have been reports of toxic fluid seepage of cobalt and chromium in both implants. In a case related to these defective implants, a federal jury in the US had ordered the company to pay $247 million in reparations to six patients. During the proceedings of this case, the patients claimed that after implantation the devices led to tissue death, bone erosion and several other negative side effects. Few months later, in another case the court awarded $245 million to six other complaints when the jury found Johnson & Johnson liable for defects and fraud.
In India, ASR has been in the centre of a series of investigations, including findings of a committee set up by the Union Health Ministry to probe complaints from hospitals and patients. The committee had indicted Johnson & Johnson and put forth recommendations that it be liable to pay Rs20 lakh to each affected patient.
However, this does not help those patients who have been implanted with defective Pinnacle units.
ASR was officially recalled from Indian markets in 2010 and the company “commercially withdrew” Pinnacle only three years later. The question still remains on why the implants were passed through in Indian markets without any clinical trials.
Maharashtra’s Food & Drug Administration (FDA) Commissioner Mahesh Zagade, who was the first one to initiate investigations into the company for the faulty implants, has recently accused the office of Drug Controller General of India (DGI) of intentionally delaying taking any action against the company.
Whether these actions are a result of some sort of collusion between Indian regulators and the company remains to be seen. In any case, there is sufficient reason to scrutinise the business of Johnson & Johnson in India.