Weitz & Luxenberg attorneys Ellen Relkin and Danielle Gold continue to lead efforts against Exactech due to recalled hip and knee implant failures. The ongoing multidistrict Litigation (MDL) is set in the United States District Court for the Eastern District of New York.
Since being appointed to leadership positions in December 2022, the W&L team is following any communications issued by the U.S. Food and Drug Administration (FDA) regarding the these implants.
W&L strongly supports the FDA’s March safety announcement. In it, the agency reiterated its concerns about Exactech’s joint replacement devices with defective packaging. Weitz & Luxenberg also has concerns as to the manufacturing techniques used in formulating the polyethylene, as well as the unusually long shelf life of eight years. We are pursuing our investigation into those issues in the discovery process of the litigation.
The FDA reminds both patients and health care providers about the potential for severe complications for patients implanted with an Exactech joint replacement device. This includes hip, knee, and ankle joint replacement parts distributed between 2004 and August 2021. (1)
W&L Accepting Clients with Defective Exactech Devices
Weitz & Luxenberg is deep in the trenches of our ongoing litigation against Exactech. We have already filed over 100 cases, of the more than 500 cases, currently pending in federal courts. These courts include the Southern and Eastern Districts of New York and New Jersey, the Eastern District of Pennsylvania, the New York Supreme Court, and the Eighth Judicial Circuit Court of Florida.
We invite anyone who has been implanted with an Exactech joint replacement part and had, or needs, revision surgery to reach out to us. We encourage you to contact our team if you have experienced pain, limited mobility, or stiffness after being implanted with a recalled Exactech device. It is critical that you contact counsel before revision surgery so we can take steps to preserve the explanted devices, which are key evidence and need to be stored professionally under a strict protocol.
The company manufactured and distributed defective joint replacement parts, failing thousands of patients. Exactech acknowledged the widespread concern and recalled these defective products.
W&L Attorneys Taking Action Against Exactech
After filing the petition to create an MDL, Ms. Relkin presented oral argument before the panel of federal judges for its creation on September 29 in St. Louis, Missouri. Our petition asked for one overall MDL for recalled hip, knee, and ankle implants, jointly. This was due to the overlapping issues of polyethylene debris and storage impact on all the cases.
On October 7, W&L’s request for creation of the MDL was approved. It transfers actions against Exactech to the Eastern District of New York in Brooklyn, under orders of the U.S. Judicial Panel on Multidistrict Litigation. The MDL is No. 3044 — In re: Exactech Polyethylene Orthopedic Products Liability Litigation.
Through the work of Ms. Relkin and other members of the leadership, an easier system has been created for attorneys to file additional lawsuits in the MDL and to learn more about the litigation status. Visit the court requested website for this Exactech litigation at https://www.exactechmdlfilings.com/.
On May 10, 2022, the MDL team, co-lead by Ms. Relkin, presents three experts to federal Judge Nicholas Garaufis and Magistrate Judge Marcia M. Henry who are managing the multidistrict litigation, as well as to Judge Donna Keim, the State court Judge in Florida overseeing the Florida State court coordination in Gainesville, Florida. This joint hearing is called “Science Day.”
Exactech sought to have only attorneys present the science, while Ms. Relkin pressed for the ability to have actual experts — an orthopedic surgeon, orthopedic pathologist, and biomedical engineer — explain the complex science to the court. The court agreed with plaintiffs that hearing from actual experts would be more informative and that the experts should be allowed to show examples of radiology and pathology slides to explain the medical issues in the litigation. This informative hearing helps to educate the courts, and the numerous counsel who attended, about the key scientific and medical issues in the litigation.
Keeping an Eye Out for Defective Exactech Implants
“We want to remind patients that if they received an Exactech joint replacement implant, especially after 2010, they could be living with a defective product,” says Ms. Relkin, a W&L partner and co-lead counsel for MDL against Exactech.
“The manufacturer recalled hundreds of thousands of hips and knee polyethylene inserts,” she adds. “These devices were compromised by inferior packing materials, inferior quality control processes, and excessive shelf life — all leading to accelerated oxidation and thus damage to the polyethylene and many patients with the degrading parts in their bodies.”
Ms. Relkin continues, “Patients who are living with these implants should report any ongoing problems to their doctors, so they receive a proper workup including x-rays and MRI. Sadly, revision surgery may be the only option for some patients.”
Defective Joint Replacement Parts May Require Revision Surgery
Defective, failed implants typically need to be removed unless the risks of surgery for a particular person is too great. Revision surgeries are more complex than primary surgeries, sometimes requiring bone grafting and use of larger implants that go deeper into the bone — and other revision devices such as mechanical hinges to replace injured ligaments to enable the knee to function. In addition, more extensive follow-up care is typically necessary.
Ms. Gold, who is serving on the Science and Experts subcommittee of the MDL against Exactech, explains that “revision surgeries are not only much more costly than initial surgeries, but the surgeries themselves are more specialized and come with greater risk of further complications.”
Exactech Recalls Defective Products
Back in 2021 and 2022, Exactech recalled multiple joint replacement devices packaged in defective protective bags. The safety of knee, hip, and ankle replacement parts could have been compromised because of these defective packaging bags. (2)
Even before patients received the implants, the parts themselves may have been damaged.
Protective Barrier Layer Missing
Beginning in 2004, Exactech implant devices came in vacuum bags missing an important secondary barrier layer. When present, this second layer contains ethylene vinyl alcohol. This critical oxygen barrier layer is supposed to provide supplemental protection against the possibility of oxidation.
Oxidation can lead to degradation of polyethylene joint replacement components. Patients might experience component loosening, pain, swelling, bone loss, tissue damage, and difficulty walking.
Oxidation is a chemical reaction that occurs when a substance, such as polyethylene parts, comes into contact with oxygen over time. It “can lead to accelerated device wear/failure, and component cracking or fracture, all leading to corrective revision surgery. Some of the recalled devices are associated with increased risk of revision surgeries and bone loss related to excessive device wear/failure.” (3)
