A federal judge in West Virginia announced on Tuesday, Dec. 15, 2015, that he would permit a woman named Anna Raab’s product liability and negligence claims to go to trial in a lawsuit in which she claims Smith & Nephew Inc. produced a faulty hip replacement that led to her personal injuries. Anna Raab claims that Smith & Nephew clearly violated the U.S. Food and Drug Administration (FDA) current good manufacturing practice requirements, which is a breach of federal law. The current good manufacturing practice (CGMP) is a regulation system whose goal is to ensure medical devices are safe, effective, and comply with the regulations of the FDCA.
In 2010, Raab received her first hip replacement surgery in which a two-part metal-on-metal hip replacement was implanted inside of her. Less than a month later, she underwent a revision surgery due to some complications with the hip replacement. During this revision surgery, a surgeon placed three more components manufactured by Smith & Nephew.
Shortly after the revision surgery, the complications continued to progress and she went to a University of Pittsburgh surgeon for another revision surgery. During this surgery, the doctor discovered chips of metal debris lodged inside her bone tissue, and “pseudotumors” were also found.
Last December, Raab sued Smith & Nephew in an effort to hold them responsible for their alleged liability in producing a dangerous product, which her lawsuit claims violated FDCA regulations as well as other federal laws. The lawsuit also claims that Smith & Nephew used components of different classes together during her first revision surgery, which was never approved by the FDA.
Raab also filed three additional claims against Smith & Nephew, but the judge ruled these claims failed to prove any federal violations made by the company, and he dismissed them from this litigation. However, claims for product liability, breach of warranty, and loss of consortium brought forth by her husband will remain.
Raab’s case, Anna Raab et al. v Smith & Nephew Inc., is still in progress and is taking place in the United States District Court for the Southern District of West Virginia.
Thousands of other personal injury claims related to metal-on-metal hip implants have been filed against a number of medical device manufacturing companies like Smith & Nephew and are in progress today. Serious injuries have been linked to metal-on-metal hip replacements produced by these manufacturers.
Thousands of individuals who have received hip replacement surgeries have reported severe pain, difficulty walking, and metal poisoning after receiving metal-on-metal hip implants. Of these victims, the ones who reported problems in the first five years and had revision surgeries have reported symptoms of pain and swelling, which can indicate much more serious problems such as loosening, fracture, and dislocation. Loosening occurs when the implant does not remain attached to the bone in the proper position. A fracture occurs when the bone around the implant breaks, and dislocation occurs when parts of the implant that move against each other are no longer aligned.