Informed - keeping our clients informed

Free & Goss Attorneys

The content of this site should not be considered legal advice, and not all content has been written by an attorney. The articles covered by our Informed blog involve issues related to pending cases and potential litigation that lawyers may be evaluating or investigating.

The New York Times has published an article following their own investigation into serious problems attributed to metal-on-metal hip replacement devices.  Perhaps the most striking aspect of the article is the overwhelming increase in the number of adverse events reported to the FDA since January of this year.  Specifically, over 5,000 adverse event reports were submitted, more than the agency had received in the previous four years combined.

The article also describes what we’ve discussed previously, namely that these devices were designed and marketed as lasting at least 15 years.  The devices are falling far short of this estimate according to both published research and the Times, typically only lasting a few years before requiring replacement or revision surgery.

In addition to shortcomings in durability, the article also touches on one of the more controversial defects associated with the device, the tendency of these devices to release small particles of cobalt and chromium into the bloodstream and surrounding tissues during normal day-to-day activities.  While the effects of this defect aren’t fully understood, it appears that over time these particles can increase in concentration and availability in the body, resulting in inflammation and crippling injury.

Finally, there is mention of the controversial FDA clearance process known as 510(k) approval.  In short, this route of clearance allows manufacturers to point to a ‘substantially similar’ device to claim that their device is safe and effective without having to conduct safety trials.  The unfortunate result of this process is exemplified by these devices, namely that when problems eventually do arise, the amount of existing research is usually insufficient to fully grasp the nature and extent of the defect and/or injury.  With regard to these hip replacement devices, the FDA and manufacturers are scrambling to design and employ studies intended to answer these questions.  Probably not by coincidence, these studies were not initiated by the manufacturers on their own accord, but instead were requested by the FDA following the consistent rise in adverse event reports.  Serious doubt remains as to whether these studies will even produce any worthwhile information, primarily because the results won’t be gathered and published for years.