Patients on Johnson & Johnson implants ask questions about the compensation program

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Johnson & JohnsonWhile J & J has dominated the talc market for over 100 years, the products contributed only 0.5% of its $ 76.5 billion in sales last year.Photograph: Mike Blake / Reuters

The controversy over Johnson & Johnson's Joint Replacement Failure (ASR) is far from over. In the latest development, more than 50 patients, who received a defective ASR manufactured by J & J, opposed the compensation package determined by the central government.
The patients submitted a letter to the committee of experts – chaired by Dr. RK Arya, director of the Center for Injuries in Sport of Safdarjung Hospital – who was reviewing Indian patient compensation. Patients have raised fears for at least 10 counts.

"In a clinical trial, there is a certain presumption of risk because the drug is the subject of a study of safety and effectiveness. However, in the case of ASR hip implants, the device was approved for commercial sale by the regulatory authority on which the device was assumed to be safe and properly tested … (Since), the harm to patients is the result of negligence … the basic amount can not be simply at par with the basic amount for clinical trials. "" – Patients concerned up to the government expert committee

In November 2018, the central government had developed a formula and provided that each affected person should receive compensation of between 20 lakh and 1.22 crore, depending on the risk factors, the disability and age.
The patients had also presented their preliminary objections to the committee. On January 11, the Supreme Court accepted the government's compensation formula.
According to Indian Express, after receiving instructions from the SC, patients argued that the court "while acknowledging the measures taken by the government," did not enter "in the merits of the formula of "Compensation" and that the "order" can not be used "as an excuse to deny patients the modifications that are required and the modifications of the formula that would be necessary to ensure a fairer compensation of their sufferings ".
The patients requested an increase of the basic amount which was set at 20 lakh by the center. The base amount was calculated on the similar formula used to compensate participants in clinical trials. Patients have raised their objections to this formula.

Johnson & JohnsonSecurity officers stand in front of the Johnson & Johnson office in Mumbai, India, on August 29, 2018.REUTERS / Danish Siddiqui

In addition, patients also have another condition that requires them to compulsorily submit "disability certificates". The amount of the compensation would be determined by establishing the risk factor basis of the certificates.
The patients explained that India does not provide a certificate of disability for metal ion poisoning, the main cause of the ASR implant qualifier.