‘Drugs are not sweets’

‘Drugs are not sweets’

News:

1. Shamnad Basheer, has talked about the complication arising of devices used in Hip Replacement Surgery.

Important Facts

2.About HipReplacement Surgery

• In total hip replacement, body parts are replaced with prosthetic components
• Prosthetic components are metal on metal, with cobalt, chromium and molybdenum as major constituents.
• It is commonly called the “Articular Surface Replacement or ASR hip implant”

3. High failure rate was observed in devices which causes releases of metallic debris into the bloodstream leading to complications, sometimes requiring revision surgery

4. Brief Timeline of the issue

• In 2003 Johnson &Johnson’s subsidiary DePuy started marketing only outside the USA.
• Due to defects in the device doctors has started giving warning around 2005 but it was ignored.
• In India, Company got the license to import the device in 2006.
• Australia took the regulatory action in 2007 due high rate of re-surgery and in 2009 the device was removed from market.
• In 2010, company took initiative to recall the devices globally due increasing number of re-surgery.
• Just a few months prior, India’s central drug regulator (CDSCO) gives Depuy’s fresh imports license for implants.
• In 2014 company informed CDSO about the death of four person who had gone through revision surgery.
• CDSCO and health ministry receive grievances on ASR implants and took it up with DePuy in 2014.
• In 2017, Health Ministry set up an Expert Committee in to examine issues arising out of faulty ASR implants in India.

5. Due to high failure rate ofthe device, company has accepted to reimburse revision surgeries but declined to compensate patient for the pain, suffering, disability and loss of work.

6. In first trail against the company, U.S court has ordered to pay compensation to patient, however the major chunks of the amount paid was associated with surgery itself.

7. In India objection was initially raised by Maharashtra Food and Drug Administration (FDA) about the faulty device.

8. In 2012 FDA has passed an order to CDSCO to cancel the firm’s import license.

9. However due to lack of immediate response, India took longer to address the challenge.

10. Issues with Indian approach.

• Delay in recognition of threat from the failed devices.
• CDSO took three years to issue product alert.
• Company has recalled all the device in 2010, but India has failed to comply with its order and later found the number of devices returned to company was lesser in number as expected.
• Unfortunately Drugs and Cosmetic Acts does not provide for adequate compensation to Victims.

11. Some important data

• 93,000 patients received these implants globally, of which 4,700 were in India
• J&J was able to recall only 1,295 of 15,829 implants from India in 2010.
• Only 1,032 patients with these implants in India have been traced.
• Over 250 Indian patients had to undergo repeat surgeries due to reasons like pain.
• At least four patients with these implants in India have died.

12. In Feb 2017,Committee reviewed the action taken by the company to replace faulty ASR implants and compensation provided to those who had suffered.

13. Major Findings of the committee

• 3,600 of the 4,700 patients could not be traced.
• In some cases more than one surgery was performed.
• Some patient reported, they are unable to carry out their routine activities and are confined to bed after surgery.
• After surgery few patients facing local issues such pseudo Tumor, Pain walking, Metallosis (increase in Cobalt and Chromium levels, Asthenozoospermia (reduced sperm motility), cyst in kidney.

14. To address these challenges the committee has suggested few recommendations such as:

• Company should be made liable to pay at least Rs.20 lakh to each patient.
• A central expert committee and a Regional Expert committee should be constituted for evaluation of patients.
• The Regional Committee will determine the impact of person disability on patient’s earning capacity.
• The Central Expert Committee will determine the quantum of compensation. Apart from 20 lakh as a base amount,it will consider wages loss and percentage of disability.
• Effort to be taken to track remaining patients who have received ASR but have not registered with the helpline.
• Health assessment report to be submitted yearly till 2025 and compliance report to be in every six month.
• An independent registry should be established for tracking usage of high-risk medical devices.
• Provisions for compensation should be included in Medical Device Rules if any serious adverse event or death is caused.

15. Who can apply for compensation:

• Patient with no revision surgery perform or recommended to perform.
• Patient one revision surgery performed but no disability.
• Patient with one or more than one revision surgery and suffering from disability.
• Patient with implanted with ASR suffering from any other systematic disorder.

16. However there are some clauses to apply for compensation such as

• Only those can claim compensation where surgery was performed in India on or after 2006
• Patient can claim within 10 years from the date of first surgery.