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Stryker’s LFIT V40 Anatomic CoCr Femoral Heads are the latest failed medical device implants to expose the company to recalls, lawsuits and liability.
Stryker’s LFIT V40 Anatomic CoCr Femoral Heads are made of a cobalt and chromium alloy and were designed to offer surgeons the intra-operative flexibility to better match patient anatomy and restore natural movement to enhance hip stability, minimize dislocation and maximize range of motion. The heads are used in combination with several of modular hip implants, including:
- Accolade TMZF
- Accolade 2 Stems
- Meridian Stems
- Citation Stems
As early as 2014, Stryker had been sued in several failed hip replacement lawsuits relating to the Accolade TMZF hip stem used with the LFIT Anatomic V40 Femoral Head. All of the lawsuits were brought in New Jersey’s Bergen County Superior Court and alleged that the titanium material of the hip stem did not maintain structural integrity when used with the chromium and cobalt V40 femoral heads, thereby causing disassociation of the head from the hip stem, hip stem fractures, high levels of metallic debris in the bloodstream (metallosis), poor range of motion, loss of implant and/or bone fixation strength, debris from excessive wear, low tissue tension and noise. Accordingly, patients suffered injuries including loss of mobility, pain, inflammation, adverse local tissue reaction, dislocation, joint instability, broken bones, leg length discrepancy, which necessitated painful revision surgeries.
As mentioned in our October 16, 2016 and December 22, 2016 blog posts, Stryker Orthopaedics issued an urgent voluntary medical device recall on August 29, 2016 related to the Stryker LFIT Anatomic CoCr V40 Femoral Heads manufactured prior to 2011. Stryker’s recall notification did not provide information regarding follow-up treatments for patients implanted with the recalled LFIT V40 femoral stems, leaving hip implant recipients who did not otherwise have hip implant failure symptoms with no choice but to take a blood test to check cobalt and chromium levels in the body to discover if their devices may be failing. The complaints further claim that Stryker knew for years that the LFIT V40 femoral heads were defective and dangerous, but chose to downplay the risk of using the components — Stryker neither requested that the failed affected femoral heads be returned nor directed doctors to notify patients of the potential defect.
Plaintiffs in the Stryker hip implant failure lawsuits who allege injuries from LFIT Anatomic CoCr V40 Femoral Heads have petitioned to have their federal claims consolidated in a single multidistrict litigation in U.S. District Court for the purposes of coordinated pretrial proceedings. Multidistrict litigation is the consolidation of many plaintiffs’ cases from federal district courts around the country into one federal district court to streamline discovery and pre-trial proceedings, improve judicial efficiency through avoiding redundant discovery and inconsistent court rulings, and conduct bellwether trials.
The Judicial Panel on Multi-District Litigation (JPML) in Washington, D.C., which is comprised of seven federal district court judges, decides whether to consolidate certain cases with other similar cases. The JPML also decides to which court and judge to transfer the cases. A bellwether trial is a preliminary, or “test” trial ordered by the federal court overseeing an MDL. These trials test jury reaction to a case or cases selected as representative of the MDL plaintiff pool. The outcome of an MDL’s bellwether trials may encourage an appropriate group settlement of all cases consolidated under that MDL.
To further bolster their claim, the plaintiffs maintain that this litigation against Stryker will attract thousands of additional claims given that the failed femoral heads were included in at least six separate Stryker modular hip replacement devices. More than 100,000 LFIT V40 components may have been implanted in patients. A multidistrict litigation in this instance would enable all pending and future lawsuits to participate in coordinated pre-trial proceedings, including motion practice and discovery. Multidistrict litigations are intended to improve judicial efficiency