Home India Ministry of Health and Family Welfare Application form for Compensation-DePuy_Johnson...
Date: 2018-11-15 Category: Not Applicable State: Union Government Country: India

Application form for Compensation-DePuy_Johnson

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 provides 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 who received these implants and experienced adverse effects, to apply for compensation through the Central Expert Committee.

Key Changes

  • The notification introduces a standardized application form for patients seeking compensation for issues arising from DePuy/J&J ASR hip implants.
  • The form requires detailed patient information including name, contact details, date of birth, and address.
  • It asks for specifics regarding the initial and revision surgeries, including dates, hospital names, and surgeon information.
  • The form inquires about previous medical management or compensation received from DePuy International Limited (now Johnson & Johnson Pvt. Ltd.).
  • It requests information on medical symptoms, temporary or permanent disabilities, and loss of occupation/income due to the faulty ASR implant, with supporting documentation.
  • Required attachments include the discharge slip from the initial surgery, proof of purchase/use of the ASR implant, disability certificate (if applicable), and proof of identity.
  • The application is to be submitted to the Chairman, Central Expert Committee, CDSCO, New Delhi.

Impact Analysis

Patients

  • Action Item: Legal and patient support groups should assist patients in completing the forms and gathering necessary documentation.

Johnson & Johnson Pvt. Ltd.

  • Action Item: J&J should prepare to efficiently handle and process compensation claims submitted through this form. Maintain detailed records of all claims and resolutions.

Central Expert Committee, CDSCO

  • Action Item: The committee should establish clear guidelines and timelines for reviewing applications and disbursing compensation. Ensure adequate resources are available to handle the workload.

Hospitals and Surgeons

  • Action Item: Hospitals should be prepared to provide medical records and information to patients and the Central Expert Committee upon request, in compliance with privacy regulations.

Key Entities Referenced

Central Expert Committee: A committee responsible for reviewing applications and granting compensation to patients affected by DePuy/J&J ASR hip implants. CDSCO (Central Drugs Standard Control Organization): The national regulatory body for pharmaceuticals and medical devices in India. The Central Expert Committee is located at its headquarters. DePuy International Limited (now M/s Johnson & Johnson Pvt. Ltd): The manufacturer of the ASR hip implants, responsible for providing compensation to affected patients. ASR Hip Implant (DePuy/J&J Metal-on-Metal): The specific type of hip implant that is the subject of the compensation claims. Ministry of Social Justice and Empowerment: The ministry provides guidelines for disability certification, which is relevant for patients claiming disability due to the faulty implant.
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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