Recently, news has been released concerning hip implant recalls and metal poisoning from certain models. The FDA warned Stryker in a letter to the company, DePuy recalled its ASR hip implant after it failed to meet expectations from clinical trials and scientists recently found that the presence of metal ions in the blood can be a sign of imminent failure of a hip implant.
Clinical Expectations Not Met by DePuy ASR
A Chicago jury in the most recent DePuy ASR trial heard a statement from Andrew Ekdahl, the president of the DePuy division at Johnson & Johnson. According to Ekdahl, the company was forced to recall almost 100,000 of the ASR implants due to the product’s high revision rate, which resulted in its failing to meet the expectations that arose from clinical trials.
The statement from Ekdahl came on the third day of the Illinois trial in which plaintiff Carol Strum, a nurse, said she suffered major injuries as a result of problems from the DePuy ASR hip implant. This lawsuit is the second of its type thus far, but almost 11,000 are pending.
The ASR was recalled by Johnson & Johnson in 2010 after it was determined by studies to have a 13-percent failure rate in the five years after implantation. In court, lawyers asked Ekdahl about a a document explaining the recall of the ASR that had been signed by senior officals at DePuy. According to the document, the company knew that the ASR implant was defective and would cause reduced performance and possible injury to recipients.
In March 2013, Loren Kransky won and $8.3 million verdict in the first lawsuit against DePuy. Kransky suffered metal poisoning from his faulty ASR implant.
Stryker Warned by FDA
Stryker received a warning letter from the FDA regarding its failure to tell the agency when it recalled a product and its sale of the Neptune Waste Management System, which lacked 510(k) clearance. According to Stryker, it plans to work with the FDA until these matters are fully resolved.
Due to Stryker’s recall of two of its products, the ABG II and Rejuvenate hip implants, the company saw a 33-percent drop in earnings for the fourth quarter. More than one implant recipient has filed a Stryker hip replacement lawsuit after suffering injury from the device. According to plaintiffs, the implants have defects that Stryker neglected to mention. As a result, the plaintiffs suffered poisoning from metal debris that flaked off into their bloodstream.
Metal Ions in Bloodstream May Indicate Implant Failure
A study published in the March 2013 issue of BMJ Open discovered that blood levels of cobalt can predict the failure of hip implants.
The author of the study, David J. Langdon of the University of North Trees, United Kingdom, stated that UK regulators and the FDA should consider instituting tests for metal ions for hip implant recipients.
At this time, metal ion testing is performed only for implant recipients showing symptoms of metal poisoning, but the authors of this study say that doctors should test all recipients of metal-on-metal hip implants. According to Langdon, regular use of these tests could detect problems with implants before they cause serious injury.
Langdon’s study also concluded that both women and recipients of DePuy ASR devices had higher risks when they were exposed to the same amounts of metal debris.
Authored By: Renee Simmons. Renee is a journalist/blogger who contributes new legal information across different websites and organizations.
Photo source: http://www.flickr.com/photos/armymedicine/6300225700/