BMJ Hip Study Author Responds To DePuy Criticism Of Study On Safety Of Metal Hip Replacements
On April 12, 2012, DePuy representatives wrote a letter of criticism in response to a British Medical Journal (“BMJ”) study published on February 28, 2012 questioning the safety of metal hip replacements. The BMJ hip study concluded that DePuy knew the potential dangers associated with its metal hip replacements yet continued to aggressively market and sell the devices. Debra Cohen, investigations editor at the BMJ, addressed and refuted the DePuy representatives’ concerns. DePuy representatives Graham Isaac and Simon Sinclair called the BMJ hip study “unnecessarily alarmist,” and addressed the following aspects of the study:
- Adverse reactions to metal debris and ions;
- Metal ion levels;
- Taper corrosion;
- Introduction of the current generation of metal-on-metal implants; and
- Revision rate data.
Cohen Defends Position On Safety Of Metal Hip Replacements
In response, Debora Cohen wrote an extensive counterargument addressing the DePuy representatives’ criticism. The DePuy representatives “sidestep[ped]” the “substantive concerns” in the BMJ hip study, Cohen said. Cohen reiterated the dangerous effect of the hips’ design change on the safety of metal hip replacements, and cited other studies to disprove the DePuy representatives’ allegations. In one instance, she focused on the dangerous effects of metal ion levels and questioned why DePuy failed to carry out clinical trials before the DePuy Pinnacle hip system went to market, even though the representatives acknowledged that they knew that metal ions would release into the surrounding blood stream. “Given this, one would have thought DePuy would carefully follow up a cohort of patients once the implant was on the market measuring ion data and monitoring both local and systemic effects,” Cohen wrote. DePuy had failed to respond to her inquiries about post-market surveillance of its DePuy Pinnacle hip system prior to the publication of the BMJ hip study.
BMJ Hip Study Raises Valid Concerns Regarding Safety Of Metal Hip Replacements
In her response, Cohen also emphasized the royalties DePuy researchers received for their papers on the safety of metal hip replacements. William Barrett, a lead author of a DePuy paper on the revision rates and safety of metal hip replacements, earned over $1.6 million in royalties and consultant fees. Another author, Kirk Kindsfater, was also a DePuy consultant who earned close to a quarter of a million dollars. Cohen cited internal emails and documents that show DePuy consultants’ awareness of the safety issues associated with the metal hip implants, and questioned why these communications were not included in official published literature. In addition, Cohen noted a discrepancy in the date of a design change to the DePuy hips—the DePuy representatives wrote it occurred in 2001, but Cohen found the data on the FDA website to state that it was approved for use in 2004. “That we cannot say for certain when these design changes took place is an indictment of the lack of transparency surrounding device regulation and the fact that individual components of a hip system can be cleared separately with no clinical testing.” Cohen wrote.
The BMJ hip study was “not ‘unnecessarily alarmist,’” Cohen concluded, “…it provided a necessarily alarming portrait of the state of medical device regulation today.”
Concerned About Safety Of Metal Hip Replacements? Contact A Lawyer
If you have a metal-on-metal hip implant and experienced complications as a result, consider joining the thousands of other patients who are filing metal hip replacement lawsuits to seek compensation for your injuries. Click here to learn more. The hip replacement lawyers at Bernstein Liebhard LLP are actively filing cases on behalf of individuals with metal hip implants, including the DePuy ASR and Pinnacle metal-on-metal hip, as well as the Wright Conserve hip replacement. Find out more on the Consumer Injury Lawyers website. The firm has recovered over $3 billion on behalf of its clients, and will help you navigate the complex litigation process. Contact our lawyers today for a free case review.