A woman’s hip replacement lawsuit will continue now that a federal judge has determined that some of her state law claims are not preempted by federal law.

Plaintiff Anna R.’s hip replacement lawsuit originally stated claims under both federal and state law. While dismissing some of Anna’s claims for being preempted by federal law, U.S. District Judge Thomas E. Johnston allowed her state law claims for negligence and strict liability to continue since they were related closely enough to her parallel federal claims under the FDA’s Current Good Manufacturing Practice standards.

Anna said that in 2010 she underwent a hip replacement surgery in which she received a Birmingham Hip Resurfacing (BHR) System, a metal-on-metal hip replacement system manufactured by Smith & Nephew, Inc.

She quickly developed complications that necessitated revision surgery only one month later. The second surgery involved implantation of three additional components that were not part of the BHR system but were also made by Smith & Nephew.

After the second surgery, Anna says, her complications only got worse. Following a third round of surgery, she was told the BHR System had completely failed. Her doctor said the metal-on-metal hip replacement had shed metal particles into the tissue surrounding the implant, causing pseudotumors to develop.

Pseudotumors are masses of tissue that develop in response to metal toxicity. They can be painful and can impair proper movement of the joint. Pseudotumors are one of many possible complications that have been associated with metal-on-metal hip replacement.

Hip Implant Complications

In her hip replacement lawsuit, Anna claimed that Smith & Nephew had created a dangerous product that was inconsistent with the FDA’s Current Good Manufacturing Practices, or CGMPs. These practices are a set of general industry standards that the FDA has maintained since 1978 to ensure safe and reliable manufacture and design.

Judge Johnston noted that “[v]iolations of the CGMP requirements are undoubtedly violations of federal law, and the regulations impose continuing federal requirements on all device manufacturers, including Class III devices that have already received pre-market approval.”

He concluded that federal law did not preempt Anna’s negligence and strict liability claims under West Virginia law because those claims relied on the federal CGMP regulations.

Anna’s other claims did not fare as well. She also brought claims that specifically addressed the addition of new hardware in her second surgery. She argued that Smith & Nephew had improperly contributed to the combination of Class II and Class III devices in a way that the FDA had not specifically approved. She also attacked the Class II devices themselves with product liability claims of a type that generally fall under state law.

Of those claims, Judge Johnston dismissed most of them and allowed only certain claims related specifically to the Class II devices to go forward, including a claim by Anna’s husband for loss of consortium. Loss of consortium is a type of claim that the spouse of a harmed person may bring to seek compensation for the effect of the harm on the marital relationship.

The Hip Replacement Lawsuit is filed in the U.S. District Court for the Southern District of West Virginia under case no. 2:14-CV-30279.