Metal on Metal Hip Replacement Implant Manufacturers Take Another Hit
Caccia v. Biomet
On August 21, 2013, Biomet, and other defendants, Biomet M2a Magnum Hip Implants Products Liability Litigation (MDL No. 2391), Biomet, Inc. and Biomet Orthopedics, LLC, manufacturers of metal on metal hips, suffered a loss in the US District Court of Indiana. Indiana is one of the locations for the multi-district (MDL) litigation of metal on metal hips.
Defense’s Motion to Dismiss and Argument
In Caccia v. Biomet, U.S. District Court Judge Robert Miller, Jr. denied Biomet’s Motion to Dismiss the Plaintiff’s Complaint for failure to state a claim. Biomet’s argued that that they were exempt from Caccia’s claims because standards for clinical trials in the state tort actions were different from FDCA and IDE regulations. Furthermore, Biomet claimed that Caccia’s participation in a clinical trial wasn’t necessary per Berish v. Richard Medical Co. In Berish, the court relied upon a case called Dawson v. Howmedica, which concluded that the court should focus on extensive federal requirements applied to the device in the IDE process and not the intention of the physician.
Judge Miller’s Opinion and Order
Judge Miller disagreed with Biomet’s argument, stating that he did not find the arguments in Berish or Dawson persuasive or binding. Judge Miller’s his order reflected that his interpretation of the pre-emption extended to the device during clinical trials only. Miller also stated that outside the scope of the clinical trial, the results would be uncontrolled, thereby defeating the purpose of the clinical trial. Furthermore, Miller wrote that an investigational device may not be promoted for commercial distribution or test marketed outside the IDE
“I’m not persuaded that a manufacturer that obtains IDE status for a device to be used in a controlled investigational setting is, during the time the study is being conducted, exempt from liability for use of that device outside the clinical trial,” stated Miller in his order.
See the link below to see the entire judge’s ruling.
The Direction of the MDL Lawsuits
The case of Caccia v. Biomet, et. al. is not over, but the order is a triumph by degrees for the Plaintiffs as well as for future metal on metal implants victims.
Manufacturers of defective, unregulated products continue to be hit with minor and major defeats.
On Thursday, July 18, 2013, the Canadian Institute for Health Information released the results of a study which revealed failure rates of hip replacement surgeries. The study was undertaken because prior research revealed that metal on metal hip replacements were three times more likely to fail, as well as cause metal particles to leak into the blood stream and have tissue damage around the device. Safety alerts in the U.S., Canada and the U.K. have previously been issued.
The study, reported by the CBC News, CBC Radio Canada, was based on 56,942 hip replacement surgeries from 2003 through 2011, in certain regions in Canada. Metal on metal hip replacement studies were 9% of the 56,942 tested, approximately 5,124. The report found that certain metal on metal hip replacements had a 5.9% chance of requiring a replacement of the hip within five years. Although this percentage may appear small, Canada’s use of metal on metal implants has declined drastically.
In May, Johnson & Johnson announced they were getting out of the metal on metal and ceramic on metal hip replacement business. They deftly cite declining sales rather than admitting their culpability in the face of a mounting stack of scientific evidence.
Metal hip replacements have gained approval through the FDA’s screening process due to the FDA’s 501(k) rule. This rule allows manufacturers to place products on the market based upon similar or equivalent products without going through rigid requirements in place for newly emerging products.
At Saunders and Walker, we strive to update clients and the public by diligently monitoring the most recent medical and legal news.
If you are a victim of a metal on metal implant and are suffering, please call me, Joseph Saunders, or one of my experienced staff at (800) 748-7115 or (727) 579-4500. We are on your side because we care.