Without question, the Zimmer NexGen Knee MDL is not going all that well for plaintiffs lately. The first bellwether trial ended in a defense verdict in favor of Zimmer. Then Judge Rebecca Pallmeyer issued a Lone Pine Order which imposed a heavier burden on plaintiffs to avoid dismissal of their cases. That Order requires each plaintiff to file an Expert Declarations form establishing that the case meets all the latest requirements to warrant its continued place in the litigation. These requirements include a showing of (1) evidence of loosening of the artificial knee, (2) evidence of knee flexion of 120 degrees, (3) other detailed designations of injury and product failure. You can read more about the Lone Pine Order here.

Then, on October 21, 2016, Judge Pallmeyer ruled that the second bellwether case did not warrant a jury trial. In her Order, she granted summary judgment for Zimmer. You can read about that court decision here, but in a nutshell, Judge Pallmeyer simply rejected the validity of the plaintiff’s key expert witness. She concluded that Dr. Joseph Fetto failed to refer to scientific literature or to “give any explanation for why the implant design, and asymmetric loading generally, causes . . . loosening.” (Order, p. 12) She wrote at length about the reasons why Dr. Fetto’s testimony is unreliable, ultimately concluding that Dr. Fetto has not “given the court sufficient basis to conclude that his opinion is reliable.” (Order, p. 17) Without a reliable expert witness, a plaintiff cannot win a product liability case.

The Judge’s Order was a sledgehammer, but . . .

It’s Not All Bad News

It’s quite awful to select a bellwether case, prepare it for trial, and then, days before jury selection, the judge grants summary judgment on all claims in favor of defendants. After years of litigation, the plaintiff, who was clearly injured, was out of court without compensation. Still, there is reason to believe that future cases may have different results. Judge Pallmeyer admitted as much in the last section of her 43-page order, titled “Potential Differences Between Joas’s Case and Others in the MDL.” Let’s examine a few keys statements in the part of her Order (the italicized statements below were written by Judge Pallmeyer):

more Other Cases Should Fare Better Although the first bellwether case in this MDL proceeded to trial, this second one terminates at the summary judgment stage. There are a number of significant differences, however, between Joas’s case and Batty that explain the different outcomes in the two cases, and differences between Joas’s case and future bellwether cases are likely to allow those cases, like Batty, to go before a jury as well.

First, Batty was the plaintiff in the first bellwether case; Joas was the plaintiff in the second bellwether case. Both plaintiffs lost their cases, but Batty survived summary judgment and was granted a jury trial. The statement above is a clear signal from the judge overseeing the Zimmer NexGen MDL that she expects other cases will have better evidence of causation between the injuries and the failure of the artificial knee components than did Joas. Because other cases appear stronger than the second bellwether case, Judge Pallmeyer expects future cases to survive summary judgment and reach a jury. This is good news.

Strong Expert Witness Necessary to Establish Causation of Injury

Unlike this case, the specific causation theory in Batty did not rely on a differential etiology. Instead, there was significant radiographic evidence that appeared to link Ms. Batty’s injury with the plaintiffs’ general causation theories. Proving causation via differential etiology in a case like this may be difficult because of the many possible causes of aseptic loosening that would have to be ruled out. But a properly applied differential etiology, with consistent standards for ruling causes in and out, may well provide an adequate specific causation opinion.

Differential etiology tries to establish a particular medical condition (or disease) from several other conditions that present similar clinical features. Doctors use differential etiology to diagnose one disease or condition from another. Judge notes here that differential diagnosis is not the strongest approach to proving causation in the knee failure litigation, although it may work with “consistent standards for ruling causes in and out.”

Wisconsin Design Defect Law Was Challenging This case also differs from Batty, and possibly from other cases, in that Wisconsin law requires a proposed safer alternative design as an element of a design defect claim. In states where there is no such requirement, a design defect case may be easier to make.

In federal court, the law of the state where the case is originally filed governs the case. Wisconsin law was applied in the second bellwether case, because that is where the case was originally filed. Wisconsin law has an added element to establish a “design defect” of a medical device. Essentially, the plaintiff must show that an alternative design would have been safer. This is a higher burden of proof for design defect claims than many other states have.

Femoral Loosening Easier to Establish Also unlike in Batty, only Joas’s tibial implant exhibited loosening. A causal link between the implant’s design and femoral loosening, as in Batty, may be easier to establish.

If your case involves medical evidence of tibial loosening only, you may have trouble proving your case, as did Mr. Joas in the second bellwether case. The judge signals here that she is looking for cases which include evidence of femoral loosening.

Implant Surgeon Must Read the Product Package Inserts And finally, unlike in this case, there was evidence in Batty that the plaintiff’s implanting surgeon had read the device’s package insert and had relied upon information from Zimmer in selecting the device and warning his patients. Under such circumstances, a failure-to-warn claim becomes much more tenable.

This statement sets out the obvious threshold for winning a “failure to warn” claim. In a failure to warn claim, the plaintiff argues that the manufacturer knew about the dangers posed by the product, had a duty to warn patients about those dangers, and were negligent about their duty in such a manner that the patient was hurt by the product.

In the second bellwether case, the plaintiff’s expert admitted he did not read the package insert for the Zimmer NexGen knee components. The defendants reasonably argued that they did all they could do: they drafted an insert with warnings about the device, but the implanting surgeon (the “learned intermediary”) failed to read the warnings. This is a key reason Mr. Joas lost his failure to warn claim.

So if you are a plaintiff, I see grounds for optimism in this Order. The Zimmer NexGen MDL is far from over.

The Zimmer NexGen artificial knee has been causing patients much pain and suffering over the past decade. Zimmer first instituted a recall of one group of NexGen components in 2010, and there have been other recalls in the years following. Many patients with the NexGen knees have suffered pain and an inability to maintain normal physical activity. The lawsuits of course followed.

In August 2011, to handle the growing number of lawsuits over the NexGen knee, a multidistrict litigation (MDL) site was formed in Chicago, Illinois and assigned to federal district court judge Rebecca Pallmeyer. The MDL is titled: In Re: Zimmer NexGen Knee Implant Products Liability Litigation, No. 2272 (1:11-cv-5468).

Do You Qualify for the Zimmer NexGen MDL?

The overarching requirement to participate in the MDL is (1) to prove implantation of the Zimmer NexGen knee components (with product stickers from the original surgery), and (2) to show through the medical records clear evidence of loosening. Loosening is when the artificial knee components begin to move in the patient’s leg and separate from the bone. This is not good. Loosening can be very painful. A loose artificial knee will cause major complications and eventually require replacement and revision surgery. When a patient complains to an orthopedic surgeon about knee pain after a total knee arthroplasty, the doctor will order an X-ray. The doctor will look for radiolucent lines, which are spaces between the artificial knee component and the patient’s bone. Essentially, small gaps occur because the medical device is not implanted tightly or securely to the bone. These spaces can cause serious problems for a patient with an artificial knee, and can be the first signs of an artificial knee failure. The spaces often fill with fluid or tissue which can cause additional loosening of the medical device.

more Zimmer NexGen Knee Was Approved Through the 510(K) Process

The Zimmer NexGen artificial knee bypassed the normal premarket testing for new medical products through a process known as “510(k).” I have written about this “rush to market” procedure on this site. The 510(k) process allows a manufacturer to notify the Food and Drug Administration under section 510(k) of the Medical Device Amendments Act of 1976 (MDA) of its intent to market a device (like the NexGen knee); the manufacturer must describe the new device’s “substantial equivalence” to a pre-MDA device. The FDA may then approve the new device for sale in the United States without rigorous testing as with new medical devices. This is how the Zimmer NexGen Knee reached the market.

Large numbers of people have suffered from pain and required revision surgery to replace the Zimmer NexGen artificial knees. Despite all this suffering, the MDL has moved very slowly. Bellwether cases have been selected, and trial dates assigned, only to be continued or otherwise postponed. For individuals who filed suit against Zimmer years ago (including some of my clients), it has been a frustrating exercise. Over the years, the qualifications in the MDL have narrowed, and the requirements to qualify for potential compensation have gotten more difficult. As a result, many lawsuits have been dismissed from the litigation as not qualifying under the latest criteria.

Case Management Order No. 11 (The “Lone Pine” Order)

On June 24, 2016, MDL Judge Rebecca Pallmeyer issued the latest case management order (CMO) which set out the latest requirements to determine if a case has “sufficient merit to proceed to trial.” The new order, which is referred to as a Lone Pine Order, requires each plaintiff to file an Expert Declarations form establishing that the case meets all the latest requirements to warrant its day in court (that is, a trial by jury). These requirements are complex and come from different court orders over several years, but I will try to set them out (in simplified form) here. The plaintiff must:

• File a Plaintiff Fact Sheet (which details the key facts of the case);
• Show Evidence of Loosening of the Zimmer NexGen knee;
• Submit Evidence of Knee Flexion of 120 Degrees or Greater;
• Identify the Case as Track One or Track Two (Track Two is essentially a case where the requirements of Track One have not been met);
• Designate Whether the Plaintiff Intends to Pursue Certain Specific Claims, Such as:
  • Femoral loosening resulting from high flexion activities;
  • Loosening of tibial component;
  • Tibial loosening of MIS tibial component with a drop down stem.

I know, I know, what the heck does all this mean? It is highly technical, and an orthopedic surgeon or a competent medical device attorney is often necessary to make sense of these directives. For now, let me say that this case management order presents a new challenge for the plaintiffs involved in the litigation. These requirements are precise and rigorous and designed to weed out cases which do not have medical records clearly showing evidence of artificial knee loosening, along with injury and pain for the patient. Undoubtedly, this Lone Pine Order will cause some of the cases to be abandoned. But if you have a Zimmer NexGen knee implanted, and it failed, and the failure led to revision surgery, you should find a good product liability attorney to review your case thoroughly and see if it qualifies under the latest guidelines. But do not delay.

The first bellwether trial in the Zimmer NexGen MDL is scheduled for October 2016. Let’s hope it does not get postponed (again).