In an order issued Monday, August 5, 2019, Judge Catherine Blake ruled that claims against medical device manufacturer Smith & Nephew will continue in litigation in the Maryland Federal Court.
Lawsuits against Smith & Nephew for injuries allegedly caused by their metal-on-metal hip implants were consolidated in Maryland in 2017. This consolidation occurred years later than claims against other manufacturers, such as DePuy Orthopaedics and Biomet, Inc., because parts of the Smith & Nephew Birmingham Hip Resurfacing (BHR) System went through a more rigorous approval process in front of the Food and Drug Administration (FDA).
In recent years, information came to light showing that Smith & Nephew may not have complied with requirements of the Pre-Market Approval (PMA) process, including post-approval studies to monitor the safety of the devices.
PMA approval can serve to shield medical device products from individual litigants seeking compensation for injuries. Yesterday’s ruling centered on use of the BHR components in total hip replacements, where the PMA-approved device components were used in combination with other Smith & Nephew products, in configurations that were neither tested nor approved by the FDA. Smith & Nephew argued that the cases should be preempted because one component of the hip devices, the metal liner, was PMA-approved.
Judge Blake found that the single liner component was PMA-approved and claims regarding the liner alone are preempted. However, claims alleging injuries resulting from the device configuration as a whole are not barred from moving forward based on the inclusion of a single PMA-approved component within the device.
Metal-on-metal hip implants came on the market in the early 2000s as the “latest-and-greatest” technology in joint replacements. In reality, studies going back at least to the 1970s showed serious problems with the metal-on-metal devices shedding metal ions that could enter the surrounding tissue and blood stream. Despite these studies, and in the face of more recent studies with similar conclusions, manufacturers like Smith & Nephew heavily marketed their metal-on-metal hip implants with great success (and profit).
The Smith & Nephew BHR metal-on-metal hip was on the market until 2015 when certain sizes were recalled for high revision rates.
Individuals who received metal-on-metal hip implants may suffer from a myriad of health consequences linked to the devices, including pain, rashes, tinnitus (ringing of the ears), and cardiac problems. Tissue damage can occur to the bone and soft tissue surrounding the hip joint, resulting in complicated revision surgeries.
The attorneys at Egerton Law have been closely involved in litigation against many of the major metal-on-metal hip manufacturers, including Smith & Nephew. If you have any questions about this ruling, we are happy to talk with you.
Metal-on-metal hip patients who have undergone a recent revision surgery, or who are facing one in the near future, should act now to protect your legal rights against the manufacturers. If you or someone you know may have an injury claim related to a metal-on-metal hip implant, call Egerton Law today at 1-800-800-4LAW or complete a web contact form and we will call you.