Johnson & Johnson Controversy- What is it?

The complaint was registered for importing and marketing the faulty hip devices in India despite recalling the product in several other countries.

US healthcare giant Johnson and Johnson (J&J) has come under the scanner of regulators in India once again after the company’s popular baby shampoo failed quality tests conducted by the Drugs Control Organization of Rajasthan.

According to people aware of the matter, the shampoo samples revealed presence of Formaldehyde, which is a known cancer causing chemical. The International Agency for Research on Cancer (IARC) classifies formaldehyde as a human carcinogen.

The Controversy in Earlier Times

Johnson & Johnson company has been accused of selling faulty hip device to over 4700 patients in the country- so far, 4 deaths have been reported and over 3600 patients with the hip surgeries and untraceable.

About the Company

Johnson & Johnson is an American multinational medical device, pharmaceutical and consumer packaged goods manufacturing company founded in 1886. Its common stock is component of the dow jones industrial average and the company is listed among the fortune 500. Its headquarters is in New Brunswick, New Jersey.

Global Environment Outlook

 The corporation includes some 250 subsidiary companies with operations in 60 countries and product sold in over 175 countries.

What crucial steps Indian government has taken?

Ministry of Health and Family Welfare asked the drug regulator- Central Drug Standard Control Organisation (CDSCO) – to set up committees in states to receive complaints from patients who were affected by Johnson’s & Johnson’s faulty devices. 

The health ministry had set up a committee under former dean of Maulana Azad Medical College to investigate complaints about hip implants devices.

After considering all facts, the committee in its report said that the ASR (articulate surface replacement) hip implants manufactured by DePuy international Ltd were found to be faulty which resulted in higher instances of revision surgeries globally including India. DePuY international Ltd is subsidiary of Johnson & Johnson.

The committee reviewed and investigated the whole issue and further said the faulty ASR, as well as negligence of the firm. And firm must take all the responsibility and approach the patients and compensate all of them.

What committee suggested?

Johnsons & Johnson be made liable to pay at least Rs 20 lakh to each affected patient and the reimbursement for revision surgeries should continue until august 2025.

According the committee, the company suppressed the key facts while applying for fresh licence, as per norms, the company had to file any adverse report of the products on its patients globally. However, the company did not have the records of all 4700 Indian patients who underwent the surgeries.

The company had record of only 1,032 patients; out of which 253 patients underwent revision surgery and 774 patients were monitored by surgeons.

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Central Drug Standards Control Organisation Order

The Central Drug Standards Control Organisation has ordered Johnsons & Johnsons to pay rupees 74.5 lakh as compensation to several defected hip implant patients. 

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The CDSCO has given 30 days time to Johnson & Johnson to pay the amount and submit the patient’s acknowledgment to them by the first week of April.

In December 2018, j&j filed a petition in Delhi High Court challenging the CDSCO’s measures for compensation. The High court did not interfere in the matter as the Supreme Court was already looking into public interest litigation on the faulty implants.

 Since when hip implant controversies started?

The controversy began after Maharashtra food and drug administration registered a FIR against john sons & Johnson following an anonymous co plant in March 2011. The complaint was registered for importing and marketing the faulty hip devices in India despite recalling the product in several other countries.

Two year later, when reports emerged that J&J had agreed to pay compensation to around 8,000 American citizens who has sued the company from Mumbai, Chennai and Hyderabad seeking similar compensation for the faulty implants.

Later, the company received hundreds of complaints from its Indian patients.

In America 

In 2016, a US court had ordered Johnson & Johnson and its Deputy Orthopaedics unit to pay more than $1 billion to six plaintiffs who had sued the company for faulty hip implants. The court had found that the metal-on-metal pinnacle hip implants were defectively designed and that the companies failed to warn consumers about the risks.

What are Ethical issues?

The unethical behaviour of J&J is neither the first not the last episode in ongoing tragedy in the endless story of the poor Indian patients. With a poor regulatory mechanism, a corrupt healthcare system and greedy doctors are there in every corner of the country. Such companies and their businesses stand to thrive in the graveyard of India’s healthcare.  Poor regulations of clinical practices are reason for severe tragedies. 

Surprisingly the company is still unpunished. It is no that secret pharmaceutical companies and medical device manufacturer's sponsor foreign trips, national and international conferences and even vacations of physicians. Doctors serve on the payroll of medical device companies. They promote implants and one among them was the faulty hip replacement device.

Not only J&J pharma is responsible for such poor regulation of clinical practices. Indian physician and medical sector are equally responsible for granting of defected hip implant devices.

Compensation to faulty hip implant's Patient by J&J

Johnson & Johnson is willing to pay 25 lakh compensation each to 67 identified patients affected by the company's faulty articular surface replacement (ASR) hip implants as stated to New Delhi High Court.

J&J has conducted a verification process and identified some of the patients who are eligible to receive compensation.

There 67 were identified patients had undergone revision surgeries and it has agreed to pay compensation to them. It will also pay 25 lakh each to the other patients who have undergone a revision surgery following the hip implants after verifying their claims.

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