New Delhi: Johnson and Johnson ((J&J) Pvt. Ltd has initiated the process of identifying patients who were affected by the Acetabular Surface Replacement (ASR), or imported hip implants, between 2004 and 2010. The company has reached out to surgeons and hospitals to ensure that patients register on their helpline numbers and take advantage of the reimbursement programme.
“We want to ensure that all ASR patients register with us and take advantage of the ASR reimbursement programme. Because the company does not have access to patient information for confidentiality reasons. We would like to request that if you have not done so already, notify your ASR patients or directly register your patients with the ASR helpline,” the company said in a letter. Mint has reviewed the copy of the letter.
The pharma giant said that registered patients can recover the costs of recall-related medical care and associated out-of-pocket expenses.
About 4,700 ASR surgeries were carried out in India between 2004 and 2010. However, only 1,080 patients could be traced through the ASR helpline. J&J said, as per the mandate, it does not have access to patients’ data. It has data of the last point of sale, referring to surgeons, hospitals and distributors. The implant, DePuy ASR, was sold in India by DePuy International, a subsidiary of J&J.
In the last few days, efforts have been made by the company to ensure that it reaches out to patients through surgeons and hospitals. J&J, on 7 September, also wrote to the doctors and hospitals stating that they can get in touch with the designated officer for queries related to the product, company’s action and the reimbursement programme.
In the last two weeks, 30 patients have registered on the ASR helpline. “Let me reassure you that all of us at J&J medical Indian and DePuy are united by the goal of improving patients’ lives, so we understand that the ASR hip system recall has been the concern of patients, their family members and surgeons,” the letter added.
The exercise to trace about 4,700 patients with ASR hip systems, after the company voluntarily recalled its product following evidence of revision surgeries needed in many cases in 2010, has become the talking point in the eight-year old case.
The Indian government had earlier told J&J to trace and compensate all faulty hip implant patients. In a letter, the government said it was liable to pay adequate compensation, commensurate with the severity of pain, the resultant disability, sufferings and the loss of wages of each patient who received ASR. “Sincere efforts should be done by the firm to trace all the patients who had received ASR and collect data related to their health status with reference to hip joint.”
Subsequently, around 15 new patients have approached the legal cell of the Central Drug Standards Control Organization (CDSCO). “The government has also asked principal state health secretaries to examine the affected patients’ details and determine the quantum of the compensation,” said a senior health ministry official.
The government had recommended that J&J may also advertise in leading newspapers, periodically, to reach out to all the patients implanted with ASR.
In 2017, the ministry of health and family welfare had constituted an expert committee that concluded that J&J’s “faulty” product led to revision surgeries. In its report, the committee had suggested that a base amount of ₹20 lakh must be paid to the patients.