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Stryker Rejuvenate Lawsuits Categorized for Bellwether Case Selections

Stryker Bellwether TrialsU.S. District Court Judge Donovan Frank is overseeing more than 800 Stryker Rejuvenate injury lawsuits pending under multidistrict litigation No. 2441. Earlier this month, on May 9, Judge Frank issued a pretrial order stipulating that the bellwether case pool would be broken down into five different categories depending on the date of hip replacement surgery, the exact product, and the post-revision outcome of the operation (whether the plaintiff experienced significant  or mild intra-operative or post-op complications).

The Rejuvenate and ABG II implants have been the source of increasing litigation throughout the nation, since Stryker voluntarily recalled the hips in 2012.

Bellwether case pool for Stryker Rejuvenate injury lawsuits

According to Judge Frank’s pretrial order, the case pool for claimants who were implanted with the Rejuvenate replacement will have four distinct categories, while recipients of the ABG II will have one category. The majority of the litigation against Howmedica Osteonics involves the Rejuvenate device, which was used in an estimated 20,000 patients in the United States. In contrast, only a handful of the coordinated lawsuits allege injuries and complications from the ABG II system.

The Rejuvenate claims will be classified depending on the date on which the plaintiff was implanted with the device – either prior to or after January 1, 2011, and whether the hip revision surgery was fraught with complications afterward. The MDL judge has decided that only cases arising from premature catastrophic failure of the device and complicated revision will be considered for bellwether trials.

The pretrial order states that a “Complicated Revision” is defined as a surgery during which the stem and neck components of the implanted Rejuvenate device were removed from the Plaintiff and that Plaintiff experienced significant intra-operative and/or post-operative complications causing unanticipated and extraordinary damages. Complicated revision surgeries may include, by way of example but not limitation: significant osteotomy, fractured femur, orthopedic cable cerclage, infection, and/or additional surgeries after the revision surgery… The parties are hereby ordered to use best efforts to agree on the appropriate category into which each Plaintiff should be placed. Any unresolved disputes will be timely resolved by the Court.”

While the exact dates for the Stryker bellwether trials haven’t been scheduled, Judge Frank indicated that the first should be ready by the summer of 2015. A panel of jurors in the U.S. District Court for the District of Minnesota will likely try between three and five cases in MDL 2441.

Guidelines for claimants who are “in extremis”

Those plaintiffs who are unable to provide testimony at a later date due to their deteriorating medical condition or death will be permitted to preserve their testimony, according to Judge Frank. Under these guidelines, “in extremis” depositions may be utilized after a plaintiff has provided an affidavit or certification of their hospitalization or terminal illness that may prevent them from being at their own trial.  However, legal counsel for the defense must be given copies of all pertinent medical records and specified fact sheets as part of this process.

Many of the people who have filed suit against Stryker have endured multiple revision surgeries and health complications stemming from toxic metal contamination. The July 2012 Stryker hip recall was issued due to the potential risk for fretting and corrosion at the modular neck junction of the devices. Tissue necrosis, inflammation, chronic pain, reduced mobility and a diminished quality of life are some of the core allegations made by plaintiffs.

  1. US District Court Minnesota, Pretrial Orders and Minute Entries - Stryker Rejuvenate MDL 13-2441
  2. FDA, Stryker Initiates Voluntary Product Recall of Modular-Neck Stems