- Exactech Orthopedic Hip and Knee Implant Recall Lawsuits
- October 10, 2024
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The first Exactech hip implant failure case came into my office before any of the FDA product recalls. I was very familiar with hip implants that had been on the market over the last 20 years. My first hip implant cases were the Sulzer recall back in 2003, followed by the Zimmer Durom cases, the DePuy ASR and Pinnacle cases, the Wright Medical cases, and the Encore DJO cases.
The vast majority of the hip implant cases over the last 10 years were the metal on metal articulation cases. In those litigations the safer alternative product was the polyethylene liner products. The success and durability of the polyethylene liners had been consistent since the late 1990s.
The first Exactech case that I evaluated was an implant that had been in place for about seven years and demonstrated severe earlier deterioration of the polyethylene liner causing the implant failure. I was unaware of the history of this product even though I knew they were on the market. Exactech was a small Florida manufacturer that had about 6% of the market share.
My first step in the investigation was to go to Google Scholar and search the medical literature to see if I could find any information about this product. Directly on point were two recently published peer reviewed articles about a case series at the University of Florida, (Early Polyethylene Failure in a Modern Total Hip Prosthesis, Thomas, 2020) and at the New York Hospital for Special Surgery (Early Failure of a Moderately Crosslinked Polyethylene Acetabular Liner, Kathenberg, 2020).
Those articles reported observations of early failures of Exactech Hip implants related to early deterioration of the polyethylene liners. These reports matched fairly closely that first Exactech case that I was reviewing.
Within a few weeks after I filed that first case, a voluntary correction recall was issued by Exactech in June of 2021. There are a number of types of recall classifications by the FDA, so some caution is required in evaluating the significance of a product recall. For example, a change in the packaging or a change in the surgical instructions can result in a correction recall.
A correction recall does not mean that products are removed from the shelves or that the product is unsafe or defective. However, it is an indicator worth looking into. Just because there is a recall does not mean that this is the beginning of a successful mass tort.
The correction recall was based upon the two medical studies that I had seen as well as information the company reported receiving from a German hospital about early failures of the polyethylene in these hip implants. The correction recall letter suggested that surgeons contact patients who had these polyethylene implants within the last six years to return to their surgeons office for some films to evaluate whether the polyethylene in their implants was deteriorating.
In August of 2021 there was a voluntary recall of Exactech’s knees with polyethylene implants period. This recall was a removal recall and listed product numbers of knee implants period. At this point the company had determined that there were some packaging problems with the polyethylene in the knees and the hips.
Exactech found that the plastic packaging intended to protect the implants from exposure to oxygen between the time they were manufactured and implanted did not meet the engineering design specifications of the products. Exposure of the polyethylene implants to oxygen during a long shelf life could cause oxidation and deterioration of the polyethylene before it was implanted in patients.
In October of 2021 the FDA Conducted what is known as a 483 inspection of the manufacturing facility at Exactech period. The FDA cited Exactech for failure to validate the effectiveness of the seals on the packaging for the Exactech’s hip and knee polyethylene. So now Exactech had 2 problems with their packaging, first the bags themselves did not have the design specified EVOH layer and 2nd the ceiling of the edges of the bags was not validated.
These problems with the Exactech manufacturing process went all the way back to 2006 encompassing huge numbers of devices that had already been implanted in patients. Further, there were questions about potentially long shelf lives of these improperly packaged devices sitting on storage shelves for years between the time they were manufactured and the time they were implanted in patients. This had the potential to exacerbate the oxidation or deterioration of the polyethylene before being implanted in patients.
In addition to the packaging problems, the plaintiffs’ experts believe that there are significant problems in the manufacturing design of the polyethylene that contributed to early deterioration. Other manufacturers of polyethylene use a different patented irradiation and heating sequence that has proven extremely durable, most implants showing no polyethylene wear at 20 years.
As this Information became public, it attracted the attention of the plaintiffs bar in the medical device industry. Cases first began to be filed in state court in Florida in Gainesville, Alachua County where Exactech is located. A consortium of lawyers quickly organized to coordinate the Florida cases.
The first step was an agreement among plaintiff counsel, eventually agreed to by defense counsel, that the protective orders for discovery would allow sharing among plaintiff counsel with filed cases. This is important in any litigation and, of course, is part of the basis of the protective order when an MDL in federal court is established. The Florida consortium then was able to set up a common depository of documents produced in discovery.
Many of the early plaintiffs in this litigation were Florida residents and therefore did not have diversity jurisdiction to file in federal court. Since Exactech was based in Gainesville FL, out of state plaintiffs could also file in Gainesville without the threat of removal to federal court. The Florida consortium of lawyers succeeded in getting all of the cases in Alachua County assigned to a single judge to manage the litigation.
At the same time cases were beginning to be filed in a number of federal courts especially in New York where the Hospital for Special Surgery had implanted a large number of the knee implants. A petition for an MDL was filed and approved and the MDL was sent to the Eastern District of New York which is Brooklyn.
Once an MDL plaintiff steering committee was formed, the federal committee began coordinating closely with the Florida consortium of lawyers. With the sharing agreements in the state protective order the Florida consortium could share discovery materials with the federal MDL even before the federal MDL could start discovery on its own. The Florida consortium and the MDL steering committee jointly retained a vendor for electronically stored information and began sharing expenses.
In many mass tort litigations there has not been close coordination between the state court lawyers and the federal court lawyers. In some cases there has been outright adversity between the two groups. However, in this case the coordination was close from the beginning. Two lawyers from the Florida consortium have also been appointed to the federal MDL committee; one of them is myself.
The state-federal coordination and cooperation in the Exactech cases is the most seamless that I have seen in any litigation. The Florida litigation was a bit ahead of the federal litigation and discovery and also had a number of early trial settings. It became evident in the discovery conducted in the Florida State court and the discovery beginning to be conducted in the MDL that there were many important issues stretching back to 2005 relating to the hips, knees, and ankle implants and that the early trials set in Florida would have been conducted without proper full discovery.
The Florida consortium, the MDL committee, and the defense all agreed to a joint bellwether plan that would push the Florida trials back and, uniquely, would schedule the hip implant bellwether trials in the Florida State court and the knee bellwether trials to take place in the federal MDL. I don’t believe this level of coordination between state court litigation and a federal MDL has ever been seen before.
At the science day in the spring of 2023 the federal judge and magistrate flew down to Gainesville FL to sit on the bench with the state court judge to be briefed on the science issues in a non adversarial way by both parties. A science day is fairly common in a federal MDL and is occasionally done in a state court coordinated litigation. Since science day, the federal and state court judges have been communicating and coordinating to facilitate the joint bellwether plan.
The first bellwether trials are set to begin in October of 2024 when discovery and expert disclosures are completed. Currently there are about 300 cases in Florida State court and about 800 cases in the MDL. About 2/3 of those cases are knee implant cases and 1/3 are hip implant cases
Many law firms have found that marketing for these cases has been difficult. Exactech had such a small market share that there were a limited number of implanting surgeons that were just in certain cities mainly in the eastern United States. Exactech did send draft recall letters to surgeons to send out to patients and most of these letters went out in the spring of 2022 which sparked the bulk of patient calls to retain lawyers.
Further hip and knee implants fail for a variety of reasons over their product life that may not be related to the deteriorating polyethylene. So, a patient with a hip implant failure that has a recall letter relating to their device does not necessarily equal a viable Exactech product liability case.
The hallmark indicators of a potentially successful Exactech hip or knee implant case is early failure of an implant with an observation in the operative report that the polyethylene was deteriorated and frequent osteolysis or damage to the bone was reported resulting from the polyethylene deterioration debris.
Exactech is a small company with limited resources, so the future of this litigation is not clear.
All mass torts have significant risks relating to proof and collectability that are not always evident in the beginning. That is what makes this area of the law challenging.
Our law firm has immense expertise in handling Exactech orthopedic hip and knee implant recall lawsuits across the US. Call us at 800-748-7115 for a free confidential opinion today.