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The following is the status of pending multidistrict litigation (MDL) and defective product recalls by major orthopedic medical device manufacturer, Zimmer Biomet:
2391 IN RE: Biomet M2a Magnum Hip Implant Products Liability Litigation
Northern District of Indiana (Hon. Robert L. Miller)
Judge Miller’s recent orders include granting, in part, plaintiffs’ request to take video depositions of its generic expert witnesses, and directing parties to submit a proposed agreed scheduling order by April 9, 2018, establishing deadlines and a schedule for briefing certain summary judgment motions, denying Zimmer Biomet’s motions for summary judgment related to (i) the Taper, ReCap, and metal-on-polyethylene devices included in the MDL, and (ii) “state-of-the-art” defenses. The next status conference is scheduled for May 17th.
A settlement program between was announced in early 2014 in which certain patients implanted with Zimmer Biomet’s defective M2a Magnum hip implant system were to receive up to $200,000. In December, the Court activated a pool of lawsuits as “Group 5” for case-specific discovery. Pursuant to the Court’s order, (i) completed and updated medical records authorizations for the Group 5 cases were to be provided by February 2, 2018, and (ii) the parties may engage in case-specific discovery relating to the Group 5 cases until September 14, 2018. Such discovery may include interrogatories, requests for production, requests for admission, and depositions of (a) the plaintiffs, (b) the implanting surgeon, (c) the revising surgeon, (d) the Zimmer Biomet representative who processed the request for the product used during the implant surgery, (e) any separate Zimmer Biomet representatives who were present in the operating room during the implant or revision surgery, and (f) one additional fact witness per side.
2272 IN RE: Zimmer NexGen Knee Implant Products Liability Litigation
Northern District of Illinois (Hon. Rebecca R. Pallmeyer)
According to a recent case management order, the parties have reached a confidential settlement in principle that will potentially resolve all of the cases on the docket. Judge Pallmeyer stayed all consolidated proceedings in the MDL, as well as any proceedings in individual cases in the MDL, including those selected for trial, pending the outcome and administration of the settlement. The next status conference is schedule for April 19th.
In late January 2017, Zimmer won its third bellwether trial. In the first bellwether trial in November 2015, the jury found for Zimmer given that the plaintiff failed to prove defective design and failure to warn claims. Zimmer also won its second bellwether trial in late 2016 on summary judgment when the judge found that the plaintiff failed to prove that a design defect caused the knee implant to fail.
2158 IN RE: Zimmer Durom Hip Cup Products Liability Litigation
District of New Jersey (Hon. Susan D. Wigenton)
In 2016, Zimmer Inc. reached a $314 million binding settlement agreement to resolve claims of patients who underwent revision surgery for a Durom Acetabular Component hip (Durom Cup). Only plaintiffs who had “qualified revision surgery” less than nine years after the date of implantation would be eligible for either a base award of $175,000 subject to enhancement or reduction, or a fixed award of $25,000. The May 2016 MDL court order required that all plaintiffs were required to participate in the settlement process. Those who rejected the offer were required to enter mediation, with a deadline of February 28, 2017 to schedule mediation, and have to wait until the settlement process was complete before taking further legal actions. As of March 15th, there were 261 lawsuits still pending in the MDL.
M/L Taper Hip Prosthesis with Kinectiv Technology (MLTK) Lawsuit
The M/L Taper Hip Prosthesis with Kinectiv Technology (“MLTK”), is a dual modular hip implant comprised of multiple components, including a cobalt-chromium head, titanium neck and stem. Zimmer has sold over 148,000 of the implants since the device was introduced to the United States market in 2007.
Still on appeal is the product liability lawsuit of McDonald v. Zimmer in New Mexico state court. In his lawsuit, plaintiff argued that the MLTK’s combination of different metals creates an unreasonable risk of metallic debris, which can ultimately lead to metallosis, a build-up of metal in the soft tissues harming the hip joint and contaminating blood. McDonald also accused Zimmer of failing to test the device adequately.
Following a two-week bench trial before Judge Nan G. Nash, Zimmer was ordered to pay more than $2 million. In a 27-page decision, Judge Nash ruled that the defective design and insufficient testing of the MLTK caused likely permanent harm to the plaintiff, resulting in metallosis. Judge Nash traced the product defect to Zimmer’s testing its components in isolation, but not their interactions together, which would have determined their potential harm, and ultimately decided that Zimmer had “exercised ordinary care in the designing and testing of the MLKT.” In fact, she even ruled that Zimmer had adequately warned healthcare practitioners about the risk of metal corrosion.
However, Judge Nash ruled that Zimmer could still be held liable under the doctrine of strict liability, which does not take the issue of negligence into account. Judge Nash reasoned that Zimmer should be held liable for releasing a product that creates an unreasonable risk of injury, whether or not their design and testing process could be considered reasonable. “If a device is throwing off or creating so much metal debris and corrosion that it causes metallosis,” she said, “that is not an acceptable risk of harm.”
Zimmer Biomet Comprehensive Reverse Shoulder System Humeral Tray Model 115340
In February 2017, the United States Food & Drug Administration (FDA) released information on a Class 1 recall of Zimmer Biomet‘s Comprehensive Reverse Shoulder System. A Class 1 recall is issued when there is “a reasonable probability that use of these products will cause serious adverse health consequences or death.” Zimmer Biomet’s Comprehensive Reverse Shoulder system is a shoulder replacement device designed to be surgically implanted to restore arm movement in patients with rotator cuff tears who have developed arthropathy and have failed shoulder joint replacements. The reverse shoulder systems were found to have a higher fracture rate than what was indicated on the product’s label, the FDA stated. These fractures would often require patients to undergo revision surgeries, which could cause more damage, including permanent loss of their shoulder function, infection from the implantation surgery, or death. Zimmer Biomet recalled a total of 3,662 devices with product codes KWS and PAO and all lots with part number 115340 manufactured between August 25, 2008 and September 27, 2011, and distributed between October 2008 and September 2015. On December 20, 2016, Zimmer Biomet started sending recall notices for the reverse total shoulder implants and informed the medical community how to quarantine and return the devices affected by the recall.
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If you or a family member have suffered injury from an orthopedic medical device such as a hip, knee or shoulder implant, or have had revision surgery to remove and replace a hip, knee or shoulder implant, you and/or your family member may be entitled to money damages.
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