Wright Medical Technology has added $90 million to a $240 million hip replacement settlement the company announced last year to resolve product liability claims involving several of its metal-on-metal hip implant products.
The original Wright hip replacement settlement was announced last November, and resolved some 1,300 cases involving the company’s Conserve, Lineage and Dynasty all-metal hip systems. The majority of those claims were pending in a multidistrict litigation that had been established four years earlier in the U.S. District Court, Northern District of Georgia.
To be eligible to participate in the original settlement program, plaintiffs must have undergone revision surgery within eight years of their initial hip replacement, and their case must have been filed within the statute of limitations. Participating Conserve plaintiffs were eligible to receive $170,000, while Dynasty and Lineage plaintiffs were eligible to receive up to $120,000.
The expanded settlement will resolve hundreds of cases that remained pending in the Northern District of Georgia, as well as cases that had been filed in a second consolidated proceeding established in Los Angeles Superior Court in California.
According to the Daily Report, the expanded program is open to plaintiffs whose Wright hip implants failed after the statute of limitations had expired, those who filed after the original settlement was completed, and those who chose not to participate in the original settlement program, but who had since reconsidered.
The expanded settlement should resolve nearly all pending cases involving Wright Conserve, Dynasty and Lineage hips. If a plaintiff chooses not to settle, their hip replacement lawsuit will be dismissed and remanded to its original court of filing.
The Wright hip replacement systems involved in this settlement are all metal-on-metal hip implants, a type of device that is constructed of a metal ball (femoral head), a metal femoral stem, and a metal cup (acetabular component).
Plaintiffs involved in the Wright hip litigation claim that the metal-on-metal configuration is prone to wear, which can cause dangerous amounts of toxic metal ions to shed from the device and accumulate in the tissue surrounding the joint, as well as the blood stream. The accumulating metal particles may cause adverse local tissue reactions, bone loss, pseudotumor formation, and other complications that results in premature hip replacement failure.
Like other metal-on-metal hip implants, Wright obtained regulatory clearance for the Conserve, Dynasty and Lineage products through the U.S. Food & Drug Administration’s (FDA) 510(K) program, which does not require that a device undergo human clinical trials if the manufacturer can demonstrate that it is “substantially equivalent” to another product that has already been approved by the agency.
In a January 2013 Safety Communication, the FDA urged metal-on-metal hip patients to seek medical attention if they experienced any issues with their implants. Doctors were also advised to consider metal ion blood testing and imaging for symptomatic patients.
The FDA communication was issued in response to an agency review that confirmed metal-on-metal hips were more likely to fail prematurely compared to devices constructed of other materials.
“In metal-on-metal hip implants, the metal ball and the metal cup slide against each other during walking or running. Metal can also be released from other parts of the implant where two implant components connect,” the communication stated. “Metal release will cause some tiny metal particles to wear off of the device around the implant, which may cause damage to bone and/or soft tissue surrounding the implant and joint. This is sometimes referred to as an ‘adverse local tissue reaction (ALTR)’ or an ‘adverse reaction to metal debris (ARMD).’”
The FDA also warned that the metal ions shed from all-metal hips will enter the bloodstream and travel to other parts of the body, where they may cause symptoms or illnesses elsewhere in the body.
In 2016, the FDA finalized new regulations that, among other things, banned medical device manufacturers from obtaining regulatory clearance for metal-on-metal hips via the agency’s 510(k) protocols.