The federal court overseeing the multidistrict litigation established for Stryker hip lawsuits involving LFIT CoCr V40 Femoral Heads is considering a plaintiffs’ motion to remand three claims to Massachusetts state court. In opposing remand, defendants argue that the lawsuits’ claims against non-diverse defendants are pre-empted.
According to HarrisMartin.com, all three cases were filed on behalf of Massachusetts residents who allegedly experienced hip replacement complications following implantation of Stryker’s Accolade TMZF Hip Stem and LFIT Anatomic V40 Femoral Head. The claims were originally filed in Massachusetts Suffolk County Superior Court. Defendants removed the lawsuits to federal court, asserting that Surgi-Care, Inc. was fraudulently joined as a non-diverse defendant.
Surgi-Care is the Massachusetts distributor of the Stryker hip components at issue in the lawsuits. In a June 16th filing with the U.S District Court, District of Massachusetts, Stryker argued that plaintiffs are barred from pursuing claims against Surgi-Care, as it has no power to make any changes to the design, labeling, or packaging of the LFIT V40 Femoral Heads.
Plaintiffs assert that pre-emption is not a proper basis for removal. They also maintain that pre-emption does not apply to lawsuits that involve devices cleared via the U.S. Food & Drug Administration’s (FDA) 510(k) program, as was the case with LFIT V40 Femoral Heads. The 510(k) program does not require medical device manufacturers to conduct clinical trials when they can demonstrate that a new product is “substantially equivalent” to another device that has already been approved by the FDA.
Stryker’s LFIT Anatomic CoCr V40 Femoral Heads are constructed from a chromium/cobalt alloy. In addition to Accolade TMZF stems, they are intended to be used with several other Stryker modular hip devices, including:
In August 2016, Stryker recalled certain LFIT V40 Femoral Heads (manufactured prior to 2011) that had been associated with a “higher than expected number of complaints involving taper lock failure.” Taper lock failure can result in numerous debilitating complications that may result in hip replacement failure and the need for revision surgery. The U.S. Food & Drug Administration (FDA) designated Stryker’s action a Class II recall, which indicates that the affected devices could cause temporary or medically reversible health effects.
While Stryker has advised doctors to monitor hip recipients for problems possibly related to the LFIT V40 Femoral Head recall, the notification did not seek return of the affected devices or direct surgeons to notify patients of the action.