An estimated 600,000 knee replacement surgeries are performed every year in the U.S. Globally, Zimmer Biomet leads the market for knee replacement devices. Prior to merging with Biomet, Zimmer marketed numerous devices and brands including Persona, Oxford, Vanguard, and NexGen.
While knee replacement surgeries are generally considered safe, complications can occur resulting in nerve damage. Another risk comes after surgery from an increased risk of developing blood clots. As a precaution, you may be prescribed a blood thinner like Xarelto or Pradaxa. Unfortunately, these blood thinners also carry a risk of their own. A Pradaxa lawsuit settlement was reached in 2014 resulting in a $650 million fund because the drug didn’t have an antidote to reverse it’s bleeding effects for years. Xarelto manufacturers find themselves in a similar situation now. With no approved antidote, questionable study results, and inadequate warnings, juries began hearing Xarelto lawsuits in 2017.
The devices themselves can also be defective. Zimmer has experienced problems with their devices that have led to recalls and countless lawsuits since 2011, mainly relating to components of the company’s NexGen Knee Replacement Systems. Despite the volume of lawsuits, few have made it to trial. Of those that have, juries have ruled in favor of Zimmer. Many cases have ended in settlements.
Zimmer Multidistrict Litigation
Multiple lawsuits were filed against Zimmer after the NexGen Knee Replacement recall. In 2011, a federal multidistrict litigation known as MDL 2272 was formed to streamline the high volume of Zimmer knee replacement lawsuits. The cases remain separate from each other, but are handled in the same court by the same judge, allowing for a faster and generally more effective process. U.S. District Judge Rebecca Pallmeyer resides over the MDL in the Northern District of Illinois. Before trials started in 2015, there were over 1,700 pending lawsuits in the MDL accusing Zimmer devices of being defective.
Six bellwether trials were used as tests in the MDL. Three were chosen by attorneys representing Zimmer, and three by the attorneys of the claimants. The results of bellwethers help to decide the process for the remaining cases. While six claimants were originally selected, many of the cases were dismissed before they could make it to court. By June 2016, only a single bellwether trial was complete and 15 others had been dismissed.
In addition to other case management orders, Judge Pallmeyer issued a Lone Pine order in June 2016 in an attempt to eliminate cases that were making claims other than device defectiveness. The Lone Pine order requires claimants to “provide evidence or certification of loosening of a NexGen Flex femoral component, a 5950 NexGen MIS Stemmed tibial component, or any other tibial component implanted with a NexGen Flex femoral component.” Claimants who failed to do so within a certain time frame had their cases dismissed. As of May 2017, only around 300 cases remain pending in the MDL.
Zimmer Bellwether Trials
Multidistrict litigation typically consists of several bellwether trials, designed essentially as pilot cases in which to work out complications that may arise and smooth the trial procedures for future cases. The following Zimmer lawsuits were the first trials to go to court.
Batty v. Zimmer
In November 2015, after a three-week trial, an Illinois jury ruled in favor of Zimmer in the first bellwether trial in the MDL. The jury concluded that the claimant, Kathy Batty, did not have sufficient evidence to prove that the implant device was defective or that Zimmer failed to provide her doctors with adequate information about the device risks.
Batty required revision surgery on both knees just two years after receiving a double NexGen Flex knee replacement. Since the case was chosen by the prosecution as one of their strongest, the verdict boded well for Zimmer in the remainder of their litigation.
Joas v. Zimmer
In October 2016, Judge Pallmeyer ruled against the second bellwether claimant in Illinois, stating that the Wisconsin man did not have the evidence to prove that the implant itself required him to get a revision surgery. Additionally, in accordance with Wisconsin law, the claimant was required to prove a better implant alternative, which his attorneys failed to do.
Mr. Joas underwent surgery for NexGen Flex implants in 2008 and experienced loosening of the tibial component shortly after, requiring corrective surgery in 2014. The ruling is currently on appeal.
Goldin v. Zimmer
In January 2017, an Illinois Jury took a single day to rule in favor of Zimmer. In contrast to the first two bellwether trials, the claimant made her argument solely on the basis that Zimmer failed to warn doctors about the risk of knee implantation in obese individuals, rather than claiming the device itself was defective. The jury concluded that Zimmer did not fail to indicate these risks to her doctor.
Future of Zimmer Lawsuits
These results of the first three bellwether cases has prompted a movement by plaintiffs to return the 300 or so remaining cases in the MDL to the claimants’ home districts for trial. This request received strong pushback from Zimmer.
As of May 2017, Judge Pallmeyer will try two more bellwether cases before making a decision about the future of the MDL and the pending cases. In the meantime, Zimmer continues to recall components of the NexGen System.
Other Zimmer Joint Replacement Lawsuits
In 2008, Zimmer recalled the Durom Cup, a hip replacement implant, for reasons similar to the NexGen system. The device was prone to loosening, requiring revision surgery. An MDL in the U.S. District Court for the District of New Jersey was formed, but Zimmer settled many cases before they went to trial. Of those that have, various verdicts have found in favor of claimants.
Separately, Sulzer Medica paid out $1 billion to settled thousands of knee device lawsuits against it before being acquired by Zimmer in 2003. Problems with the production of Sulzer’s Natural Knee II Tibial Baseplate caused a small amount of oil to be left on the device, which led to post-implantation problems that manifested as much as a year after surgery, leading to a recall of the devices.
If you or someone you know has experienced complications after receiving a Zimmer knee replacement implant, you may be eligible to file a claim. To learn more about your rights, and to find out how the previous rulings may affect your claim, contact an attorney specializing in knee replacement claims.
Report Problems to the FDA
If you have experienced problems with a knee replacement, we encourage you to report the device to the FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Reports can be submitted in any one of the following ways:
- Download the MedWatcher Mobile App: iTunes Download | Google Play Download
- Complete the MedWatch Online Reporting Form
- Download and print the MedWatch form
- Call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.