Medical Device MDL & Recall Status: Zimmer Biomet

The following is the status of pending multidistrict litigation (MDL) and defective product recalls by major orthopedic medical device manufacturer, Zimmer Biomet:


2158 IN RE: Zimmer Durom Hip Cup Products Liability Litigation
District of New Jersey (Hon. Susan D. Wigenton)

In 2016, Zimmer Inc. reached a 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. Claimants who rejected the award were required to request mediation to be schedule by February 28, 2017. Zimmer will not make any payment unless 67 percent of eligible claimants accept

2272 IN RE: Zimmer NexGen Knee Implant Products Liability Litigation
Northern District of Illinois (Hon. Rebecca R. Pallmeyer)

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. That case is on appeal. Zimmer prevailed again in January 2017 in the third NexGen knee bellwether trial. An Illinois federal judge has said she will not disband multidistrict litigation accusing Zimmer Inc. of manufacturing shoddy knee implants before she can try another pair of bellwethers in her court. Judge Pallmeyer said in a recent brief minute order that she expects two more bellwether trials before she can grant a request to unwind the MDL and send around 300 remaining cases back to the courts where they were initially filed. She also ruled that that third-party medical consulting firm, Physicians Medical Review (PMR), must “produce all medical records that were furnished to potentially declaring or testifying experts,” though deposition notices issued to PMR’s principals would not be required.

2391 IN RE: Biomet M2a Magnum Hip Implant Products Liability Litigation
Northern District of Indiana (Hon. Robert L. Miller)

A settlement program between was announced in early 2014 in which certain patients implanted with Biomet’s defective M2a Magnum hip implant system were to receive up to $200,000. Recently, Judge Miller released an order disclosing that 93 lawsuits were settled in October 2016. Despite this settlement, depositions are ongoing and the admissibility of expert testimony and reports will be litigated through August 2017, with bellwether trials most likely taking place in late 2017 or early 2018.

Recent Recall

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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