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Home/Legal & Regulatory and Reimbursement/Exactech Ortho Implant Lawsuits Granted Multidistrict Litigation
Legal & Regulatory and Reimbursement

Exactech Ortho Implant Lawsuits Granted Multidistrict Litigation

October 21, 2022 2 min read Premium comments

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Exactech Ortho Implant Lawsuits Granted Multidistrict Litigation
Source: Pexels and EKATERINA BOLOVTSOVA
Secondary#exactech#multidistrictlitigation

The United States Judicial Panel on Multidistrict Litigation has granted the plaintiffs’ motion to centralize litigation involving injuries associated with Exactech, Inc.’s and Exactech U.S., Inc.’s (collectively “Exactech”) hip, knee, and ankle implants.

The litigation involves the polyethylene components of Exactech medical devices. According to court documents, in 2021 Exactech “issued a product safety alert regarding the clinical performance of the polyethylene liner used in its Connexion GXL hip systems.”

That same year, Exactech “initiated a recall related to polyethylene inserts used in its knee and ankle devices because such devices were packaged in out-of-specification vacuum bags that are oxygen resistant but do not contain a secondary oxygen barrier of ethylene vinyl alcohol.” The following year, Exactech expanded its first recall to include “additional Connexion GXL hip liners and other polyethylene liners.”

The devices currently included in the litigation are the Optetrak and Truliant knee systems and the Connexion GXL hip systems. None of the plaintiffs on the current motion have allegations involving the Exactech Vantage Total Ankle System device.

The plaintiffs are alleging that their knee or hip replacement devices failed “prematurely because of degradation of the device’s polyethylene component, which resulted in the premature removal (or planned removal) of the prosthesis at issue.” Additionally, plaintiffs are claiming that “oxidation of the moderately crosslinked polyethylene used in the Exactech hip, knee and ankle devices causes inflammatory responses when implanted, generates polyethylene debris, crack, and loosen the device, all of which in turn requires revision surgery.”

The cases are being transferred to the Eastern District of New York with Judge Nicholas G. Garaufis presiding. The panel selected Judge Garaufis because he is “a skilled jurist who is well-versed in the nuances of complex and multidistrict litigation.”

Multidistrict litigation and class action help to streamline the litigation process and are supposed to save the litigants and the court system both time and money. Both types of proceedings involve multiple plaintiffs who share similar facts that are giving rise to the cases and who are alleging that the same defendant or defendants caused them harm.

However, multidistrict litigation and class action are not the same. One of the most significant differences between the two types of proceedings is the status of the plaintiffs. Unlike a class action, each plaintiff in multidistrict litigation maintains their own case. Multidistrict litigation is often used when the injuries of the plaintiffs are too different to proceed as a class action.

In multidistrict litigation, the cases are consolidated for the pre-trial portion of the litigation process. According to the panel, “centralization offers substantial opportunity to streamline pretrial proceedings, reduce duplicative discovery and conflicting pretrial obligations, as well as prevent inconsistent rulings on common Daubert challenges and other issues.”

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Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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