Information About Exactech Implant Failure Risks To Be Presented During MDL Science Day

As a growing number of Exactech recall lawsuits continue to be filed over a manufacturing defect that increases the risk of hip, ankle and knee implants failing prematurely, the U.S. District Judge presiding over the federal litigation will hold a “Science Day” on May 10, 2023, to allow the parties to make educational presentations to the Court about complex topics that will come up during the litigation.

There are currently more than 132 Exactech knee replacement lawsuits and Exactech hip replacement lawsuits centralized before U.S. District Judge Nicholas G. Garaufis in the Eastern District of New York, since they each involve similar questions of fact and law about whether “out-of-specification” vacuum sealed bags caused a plastic tibial insert component to fail, leading to risky revision surgery.

The litigation emerged after an Exactech recall was issued in February 2022, impacting more than than 140,000 Optetrak, Optetrak Logic and Truliant knee replacement systems implanted in patients since 2004, as well as 1,500 similar components used in Exactech Vantage ankle replacements. Similar packaging problems have also impacted Exactech Novation and Acumatch hip implants since 2008, which were recalled in June 2021, and the Exactech hip recall was expanded in August 2022, to add another 40,000 joint replacements that may fail prematurely.

In October, the U.S. Judicial Panel on Multidistrict Litigation (JPML) established a federal Exactech MDL, or multidistrict litigation, and transferred claims brought throughout the federal court system to one judge for coordinated discovery into common issues that will arise in all of the lawsuits, and avoid conflicting pretrial schedules or rulings.

As part of the management of the litigation, it is expected that Judge Garaufis will establish a “bellwether” process, where a small group of representative claims will go through a case-specific discovery process and be prepared for early test trials. However, first the court indicates that it will hold a “Science Day”, so that each party’s expert witnesses can make presentations regarding the products at issue in the cases, and the science relevant to the lawsuits.

Exactect Implant Science Day Will Be Held May 10, 2023

In response to a prior case management order issued by Judge Garaufis, the parties submitted a joint letter (PDF) on February 3, to outline a proposed protocol for the Science Day.

“Each side will make presentations which may incorporate the use of PowerPoints, articles, publicly available scientific data, or other demonstrative aids, which will not be exchanged by Parties in advance of Science Day, but will be provided to the Court and exchanged by the Parties at the close of Science Day,” the letter proposes. “Neither confidential Defendant company documents nor Plaintiffs’ medical records shall be presented or offered to the Court during Science Day.”

Such proceedings typically involve non-adversarial presentations by expert witnesses or parties, which are intended to educate the court about issues and concepts that will come up during the proceedings. The presentations are not part of the official record in the case, or subject to cross examination. However, information presented may guide the Court in any future rulings or motions about evidence to be presented in the Exactech lawsuits, including decisions about which expert witness testimony may be presented to juries.

On February 8, Judge Garaufis issued a docket order scheduling the Science Day for the morning of May 10, 2023, at the Alachua County Family and Civil Justice Center in Gainesville, Florida, before both himself and two state court judges presiding over similar cases. The parties were asked to submit a joint report by March 13, 2023, confirming their availability and proposing an agenda, and did indicate that alternate dates in May or June 2023 could be proposed if the selected date does not work for the parties.