Over the past two decades, total hip replacements have become more popular. Their lure is the promise of increased mobility. However, between 2002 and 2013, six manufacturers defective medical devices were responsible for 578 recalls including Biomet, DePuy, Smith and Nephew, Stryker, Wright and Zimmer. Stryker had 231 recalls, and DePuy had 150. As a result, tens of thousands of people received faulty devices.
In 2010, DePuy spent a reported $800 million on recalls. Unfortunately, many of the recipients of their defective products failed to receive adequate compensation for pain and suffering, as well as medical treatments. Under the 510(k) program, the Food and Drug Administration allows manufacturers like DePuy to put faulty hip replacement devices on the market, as long as they can show a "substantially equivalent" device is already being sold.
Products that come on the market via the 510k program can do so, without the requirement of rigorous safety trials and studies. Thus, the increased probability of patients receiving defective devices is the foreseeable result. Metal on metal hip replacement devices, have had such a large number of recalls, that the FDA conducted a panel meeting in June 2012 to discuss the issue.
When voluntary recalls are done by manufacturers or the FDA issues a recall, they fall into one of three classifications. Class I includes those devices that show a reasonable probability that the continued use of the product will cause serious health problems or even death. This is the most serious of the categories. More than 10 percent of the recalls fall into this category.
Class II includes products that will cause temporary or reversible adverse health conditions, with the risk of serious injury or death being remote. The majority of hip replacement recalls fall into this category. Class III products are considered the least serious of the three categories. It includes medical devices with defects that are unlikely to cause harm. The FDA does not classify hip recalls in this category.
If you or someone you know has been seriously injured or died as the result of a defective hip replacement product, the advice and counsel of an experienced personal injury attorney may be the answer to getting the compensation that you deserve.
Source: DrugWatch.com, "Hip replacement recalls," accessed Feb. 07, 2017