Exactech lawsuits in federal multidistrict litigation in New York moved forward as Judge Nicholas G. Garaufis set tentative start dates for the third and fourth bellwether test trials beginning October 2024 and January 2025.
Lawyers selected Dana Kessler Kramer (1:23-cv-00658-NGG-MMH ) and David Caputo (1:23-cv-01896-NGG-MMH) for these trials. Jury selection for these cases could start in October 2025 and January 2026, according to court documents.
This marks an important step in Exactech litigation because the results of bellwether test trials allow lawyers to gauge how juries could react to evidence presented at trial. This informs future trials and any potential global settlements in the MDL.
Kramer and Caputo’s cases allege that “out-of-specification” vacuum-sealed bags used to package Exactech Optetrak polyethylene plastic tibial insert components distributed before 2022 allowed oxygen to reach the implants, causing the polyethylene to degrade prematurely. This could cause these implants to fail early and lead to serious complications and the need for revision surgery.
In April 2024, Judge Garaufis set Gayle Tarloff’s case as the first bellwether test trial and Geraldine Larson’s case as the second trial. These trial proceedings were scheduled to start June 2025 and August 2025.
While these cases are at the federal MDL level, a group of Exactech cases are being handled in Florida where Exactech is headquartered. The first state case is set to go to trial in October 2024.
Lawsuits Allege Defective Exactech Inserts Caused Injuries
Kramer and Caputo’s lawsuits are two out of the more than 1,460 pending claims consolidated in the Exactech New York MDL 3044. All cases similarly allege the defective polyethylene liner packaging led to early failure of devices and revision surgery.
These lawsuits stem from Exactech recalls for polyethylene liners that began in 2021 and affected about 657,391 devices manufactured as far back as 2004. Exactech’s hip, knee and ankle implants were involved.
“The defendants put in their recall notice that it’s because the polyethylene liners — the way in which they were packaged inside of vacuum bags — caused them to be susceptible to what we call oxidation. That’s where oxygen penetrates inside of the polyethylene liner. It causes early, excessive wear when that happens,” attorney Daniel Nigh, who is on the leadership team in the Exactech litigation, told Drugwatch.
Nigh said that he believes the implant defects aren’t just package-related and stem from a defective manufacturing process.
Unfortunately, it’s led to serious complications for his clients.
“People who have had a hip or knee replacement using a defective Exactech polyethylene liner may have to have a revision much sooner than they would have had to,” Nigh said. His clients “are filing lawsuits to recover pain and suffering and medical expenses and the potential for future medical expenses, among other issues. When people must go through all of that because of the defendant Exactech’s negligence, they have a right to compensation from Exactech.”
