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Exactech Hip, Knee, and Ankle Implant Recall MDL Petition Filed

June 20, 2022
Home Firm News Exactech Hip, Knee, and Ankle Implant Recall MDL Petition Filed

Weitz & Luxenberg attorneys filed a petition with the Judicial Panel on Multidistrict Litigation. The petition request the Panel create an MDL for litigation involving Exactech’s failed and recalled polyethylene inserts in hips, knees, and ankles.

Helping Clients Needing Revision Surgery

The petition was filed on June 14, 2022, by W&L partner and practice group chair Ellen Relkin and attorney Danielle Gold, both key members of our firm’s Drug and Medical Device Litigation team. Ms. Relkin and Ms. Gold have taken the lead in this litigation effort. They have already filed eight cases in federal court, the largest number by any firm so far.

Weitz & Luxenberg is currently accepting and representing clients who already had, or need to have, a revision surgery because the liners of their Exactech hip, knee, or ankle implants failed.

Recalled Exactech Models

Back in August 2021, Exactech quietly initiated its original recall of devices containing the company’s defective knee and ankle Ultra-High Molecular Weight Polyethylene. The company has since expanded its recall to include additional defective polyethylene liners.

Specific recalled Exactech knee models include the OPTETRAK®, OPTETRAK Logic®, and TRULIANT® tibial inserts. Exactech has also recalled its Connexion GXL hip acetabular liners and VANTAGE® ankle fixed-bearing liner components.

Exactech admits in its recall of the OPTETRAK®, OPTETRAK Logic®, and TRULIANT® device that the polyethylene inserts dating back to 2004 were packaged in vacuum bags that were missing a critical secondary barrier layer. That second layer contains ethylene vinyl alcohol (EVOH), which is intended to decrease oxidation of the polyethylene.

What this means for patients who received these defective implants is the liners could wear out prematurely. And they have.

Exactech Implant Liners Lead to Serious Problems

Degradation of the polyethylene, as well as other design problems, can lead to multiple medical complications. This includes component loosening, swelling, pain, tissue damage, bone loss, and difficulty walking.

Defective implants need to be removed. These revision surgeries are more complex than primary surgeries, sometimes requiring bone grafting. In addition, more extensive follow-up care is usually necessary.

Claims Against Exactech Are Growing

In their petition, Ms. Relkin and Ms. Gold argue that the growing number of claims against Exactech justifies the creation of an MDL. They have requested the cases against Exactech be transferred to an MDL under the purview of the Eastern District of New York.

Already, a large number of Exactech cases involving failed polyethylene liners and components are awaiting further litigation in multiple federal district courts.

New York Is Ground Zero for Litigation

New York is almost a ground zero for this litigation, since many of the recalled Exactech implant devices were implanted in patients who reside in the New York City area. “Close to three decades ago, the Optetrak Device was developed by Exactech working with the Hospital for Special Surgery (HSS) located in New York, New York,” according to the Memorandum in Support of Motion for Transfer of Actions to the Eastern District of New York Pursuant to 28 USC §1407 for Coordinated or Consolidated Pretrial Proceedings.

“Because over 100,000 Exactech knee replacement devices and nearly 90,000 Exactech hip replacement devices were subject to recalls, we are facing the possibility of thousands of cases,” says Ms. Gold.

Petition Requests National Coordination of Cases

The brief concludes: “Transfer and consolidation for pre-trial proceedings of all pending and subsequently filed Optetrak, Truliant, Vantage and Connexion GXL Device cases will promote the just and efficient conduct of these actions by allowing national coordination of discovery and other pretrial efforts, will prevent duplicative and potentially conflicting pre-trial rulings, will reduce the costs of litigation, and allow cases to proceed more efficiently to trial.

“For all of the foregoing reasons, Plaintiffs respectfully request that the Panel issue an order transferring all actions listed in the attached Schedule of Actions, as well as all subsequently filed related actions, for coordinated and consolidated pretrial proceedings to the Eastern District of New York.”

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