As Johnson & Johnson works with the Indian government to offer compensation to the victims of a defective hip implant, made by one of its subsidiaries, DePuy Pinnacle, many of the victims or their families have decided to not participate in the compensation process.
ASR Hip Implant Timeline
So, how did it get to this point? For some background information on the situation, here’s a timeline:
2003 – 2005: DePuy Orthopaedics marketed its ASR Hip Resurfacing System outside of America, and then worldwide.
2006: The device was introduced to India.
August 2009: DePuy receives letter from United States FDA stating they need a lot more data before they can issue a final approval on the device.
December 2009: DePuy pulls device from Australia, citing lack of demand.
August 2010: DePuy issues worldwide recall after a study out of the UK showed an uptick in patients needing revision surgery that is unheard of for these devices.
February 2010: The central drug regulator for India (CDSCO) grants DePuy a renewed import license for the devices.
December 2010: Only after being asked about it, DePuy lets CDSCO know about the recall situation.
September 2011: CDSCO presses DePuy for more details on the recall, such as reasons, procedures, and compensation.
December 2011: CDSCO asks DePuy for details regarding compensation that they’ve paid to victims, but DePuy declined to disclose, saying information is confidential.
July 2012: CDSCO cancels import license for the hip implants and tells DePuy they know they dropped the ball on advising of the device’s defects.
November 2013: Johnson & Johnson announces $2.5 billion settlement for the ASR hip implant in the United States.
December 2013: CDSCO issues an alert to inform patients of problems with the hip implants.
January – July 2014: DePuy lets CDSCO know about patients who had revision surgery and also four patients who have since died.
December 2014: CDSCO receives complaints about the ASR hip implant and contacts DePuy.
February 2017: The health ministry forms an expert committee to further research the implant issues.
February 2018: The committee submits the report including their recommended resolutions.
August 2018: The report is made public. The health ministry accepts the committee’s recommendations, including compensation, and continues to seek out victims.
Declining Compensation Process
Fast-forward to October 2018, and many of the victims have decided to think twice before agreeing to a compensation process that they don’t have much information about and therefore may not be best for them.
Reasons that were given for not participating include:
- Inadequate transparency about which cases will be considered for compensation and the necessary documents that patients need to make a claim
- Not advising how compensation will be calculated
- The lack of expertise in the committee to consider compensation for more than the obvious, including mental suffering
- Not having a patient representative on the committee
We will continue to follow this story, as well as all medical device recalls that may affect you or a loved one.