Home India Ministry of Health and Family Welfare Application Form for Compensation-DePuy J &J ASR Hip Implant...
Date: 2018-11-20 Category: Not Applicable State: Union Government Country: India

Application Form for Compensation-DePuy J &J ASR Hip Implant

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

What it means

  • This gazette notification pertains to the application form for patients seeking compensation related to the DePuy/J&J ASR (Articular Surface Replacement) hip implants. It outlines the information required from patients to apply for compensation from M/s DePuy International Limited, U.K. (now M/s Johnson & Johnson Pvt. Ltd) due to faulty ASR implants.

Key Changes

  • The notification provides a structured application form for patients with DePuy/J&J ASR Metal-on-Metal hip implants to claim compensation.
  • The form requires detailed patient information including name, contact details, address, date of birth, and occupation.
  • It requests specifics about the initial and revision surgeries, including dates, hospital names, surgeon names, and identification number of the implanted ASR hip.
  • The form inquires about previous medical management or compensation received from DePuy International Limited/Johnson & Johnson.
  • It asks for details regarding medical symptoms, temporary or permanent disability (with disability certificate), and loss of occupation/income due to the faulty ASR implant.
  • Applicants are required to attach relevant clinical test reports, discharge slips, proof of purchase and use of the ASR implant, and a copy of the disability certificate.
  • A declaration is included, where the patient confirms the accuracy of the provided information.
  • Mandatory enclosures include a proof of identity issued by the Government.

Impact Analysis

Impact on Patients

  • Successful applications will result in financial compensation for damages caused by the faulty implants.

Impact on Johnson & Johnson

  • The process may have financial implications, depending on the number of eligible claimants and the compensation amounts awarded.

Impact on CDSCO

  • CDSCO's role is crucial in ensuring a fair and transparent compensation process for affected patients.

Suggested Action Items

  • CDSCO: Allocate sufficient resources to the Central Expert Committee to manage the application review process. Develop clear guidelines for evaluating claims and determining compensation amounts. Ensure a fair and transparent compensation process for affected patients. Publicize the application process to ensure all eligible patients are aware of the opportunity to apply for compensation.

Key Entities Referenced

DePuy International Limited, U.K. (now M/s Johnson & Johnson Pvt. Ltd): The manufacturer of the faulty ASR hip implants and the entity responsible for providing compensation. Central Expert Committee, CDSCO: The committee responsible for overseeing the compensation process and evaluating applications. CDSCO: Central Drugs Standard Control Organisation, the national regulatory body for pharmaceuticals and medical devices in India. Ministry of Social Justice and Empowerment: The ministry provides guidance on disability certification, which is required as part of the application process. ASR Hip (DePuy/J&J ASR Metal-on-Metal): Articular Surface Replacement hip implants manufactured by DePuy/Johnson & Johnson
Official Source Record View Original Source →
See Full Document Text
DePuy/J&J ASR –Compensation Application FORM To, The Chairman Central Expert Committee, CDSCO, Head Quarter, FDA Bhawan, Kotla Road, New Delhi, 110002 Patient Details Name Gender Contact Number Email ID Address Address for correspondence Date of Birth Occupation ASR Hip (DePuy/J&J ASR Metal-on- Left ☐ Metal) implanted Right ☐ (please tick the appropriate box) Bilateral ☐ First/Initial Surgery Details Date of First Surgery Type of Surgery ASR Hip Resurfacing(DePuy/J&J ASR ☐ Metal-on-Metal) (please tick the appropriate box) ASR XL Total Hip Replacement(DePuy/J&J ☐ ASR Metal-on-Metal) Identification Number of the ASR Hip implanted(DePuy/J&J ASR Metal- on-Metal) Hospital Name, address and contact number Surgeon Name, address and contact number*Revision Surgery Details Date of Revision Surgery Hospital Name, address and contact number Surgeon Name, address and contact number * In case of multiple revision surgeries, provide above details for each such surgery in separate columns. Previous medical management Details Has the patient received any medical management by the M/s DePuy International Limited, U.K. (now M/s Johnson & Johnson Pvt. Ltd), if yes, please give the details, If Not received any reimbursement, write No. Has the patient received any compensation, other than the reimbursement paid for the revision surgery or any other medical management? if yes, please give the details, If Not received, write No. What are the medical symptoms caused due to use of faulty ASR implant with documentary evidences? Whether the patient has suffered with any temporary disability or is suffering with any permanent disability, if any, please give details along with the disability certificate issued by a competent authority. Please attach the recent and relevant clinical test lab report, or any other medical laboratory report (s), or any other document in support of the claim made, if any. Whether the patient has lost its occupation/job/source of income due to the adverse medical condition which is caused due to faulty ASR implant, if any, please give details. (please enclose a separate sheet having details of loss of wages or income due to such adverse condition, if any. It is advised to attach the evidences in support of such claim) Discharge slip from the hospital where the patient was implanted ASR (DePuy/Johnson & Johnson Metal-on-Metal Hip Implant) have been operated uponAny documentary proof proving the purchase and use of ASR (DePuy/Johnson & Johnson Metal-on-Metal Hip Implant) Copy of Disability Certificate issued by competent authorities (as guided by Ministry of Social justice and Empowerment) Any other relevant information / document (if any) Declaration I, _____________________________ [Patient Name] hereby submit my application to the Chairman, Central Expert Committee for grant of compensation from M/s DePuy International Limited, U.K.(M/s Depuy India), now M/s Johnson & Johnson Pvt. Ltd. I do hereby declare that the information given in this application form and the documents enclosed herewith are true and correct to the best of my knowledge and belief. Signed ___________________ Patient’s Name &Signature Date ____________________ Address ____________________ Email and Mobile Number ________________ List of Enclosures: 1. Proof of Identity (Document issued by the Government such as Driving Licence, Aadhaar Card, Passport, etc.) (Mandatory) 2. List of documents attached

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