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.

October 2016 was set to be an important month for thousands of people injured by the Zimmer NexGen artificial knee. The second “bellwether” trial was scheduled. Bellwether trials involve representative cases that are used to educate the defendants and the plaintiffs on what certain juries thinks may be proper results for these kinds of cases. After several bellwether trials, both sides often come together and work out a global settlement based in large part on results from these bellwether trials.

Unfortunately for the plaintiffs in the Zimmer NexGen MDL, the latest bellwether case never reached the jury. On October 21, 2016, Judge Rebecca Pallmeyer, the federal judge overseeing the Zimmer NexGen MDL, granted summary judgment for Zimmer and the other defendants. Which means the case is over.

Summary Judgment

Summary judgment is a final judgment entered by the judge prior to trial. Essentially, the judge determines that no material factual issues remain in dispute and that one side is entitled to judgment “as a matter of law.” For the most part, summary judgment is a defensive tool, and defense lawyers will file a motion for summary judgment and will argue to the court that even taking the facts in a light most favorable to the plaintiff, the defendant is still entitled to judgment without the need for a jury trial.

This is exactly what happened last week on the eve of the second bellwether trial in the Zimmer NexGen MDL. In a 43-page Order, Judge Pallmeyer held that the plaintiffs failed to present adequate evidence that the design of the Zimmer NexGen knee caused the plaintiff’s alleged injury, and that the plaintiffs failed to show that the warnings accompanying the medical device were inadequate.

more Judge Rejects Plaintiffs’ Expert Witness

The plaintiff, Theodore Joas, was implanted with the Zimmer NexGen “Flex” knee. He had to undergo revision surgery in 2014 because the NexGen tibial component became loose and caused pain and complications. Mr. Joas and his wife sued Zimmer for several causes of action, but the key claims appear to have been (1) design defect, (2) failure to warn, (3) negligence and (4) punitive damages.

The key decision in the summary judgment order was the judge’s rejection of the plaintiffs’ expert witness. Once the expert witness was excluded as unreliable, the case collapsed.

The plaintiffs offered the testimony of Dr. Joseph Fetto. He testified that the Zimmer NexGen flex knee “puts excessive stress” on the cement and component “and can lead to early failure.” (Order, p. 12)

Judge Pallmeyer rejected Dr. Fetto’s expert opinion as not valid. She wrote in her order that Dr. 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) The judge 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)

Excluding an expert means the expert cannot testify at trial, that his expert opinions are not sufficiently grounded in science to permit him to present an opinion to a jury. In a product liability case, it is essentially a death sentence for a plaintiff’s case. And it turned out to be for the plaintiff in this case, Mr. Joas.

Judge Pallmeyer first granted summary judgment as to all claims the plaintiffs did not defend at the summary judgment hearing. That was the easy part, and plaintiffs would have seen that coming. Then the judge awarded summary judgment as to the design defect, failure to warn, negligent design, and punitive damages claims. She pointed out that because plantiffs designated only Dr. Fetto as an expert witness, and because his testimony was (now) excluded, the plaintiffs were left with no expert to testify that a defect in Mr. Joas’s Zimmer NexGen knee was the cause of his injuries.

Judge Pallmeyer granted summary judgment as to plaintiffs’ failure to warn claim based on the defense of the learned intermediary doctrine, which I write about here. In Mr. Joas’ case, the implant surgeon admitted he did not read the package insert for the Zimmer NexGen flex knee components. Because of the surgeon’s confession that he did not read the product warnings, plaintiffs cannot prove “that an improved warning would have led to a different outcome for Joas’s knee.” (Order, p. 41) Sadly, this makes sense.

“The Trial Date is Stricken”

Like a slamming door, the last sentence of Judge Pallmeyer’s Order must have been startling to the plaintiffs: “The trial date is stricken.” This of course means that, “in light of what I just wrote, this case does not deserve a jury trial. Case closed.”

So far, the judge in the Zimmer NexGen MDL has not been impressed with the plaintiffs’ arguments. Judge Pallmeyer issued a Lone Pine Order in June, 2016, which you can read about here, and which sets out heightened requirements for the plaintiffs in order to reach a trial by jury. The latest summary judgment order, coming as it does in the second bellwether case, is a major setback for the remaining plaintiffs in the NexGen litigation. Still, with almost 6,000 plaintiffs remaining in the MDL, there is reason to believe this product was defectively or negligently designed.

Do You Qualify for the Zimmer NexGen MDL?

The threshold requirements to participate in the MDL are (1) to show implantation of the relevant Zimmer NexGen knee components, 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. A loose artificial knee can cause major complications and eventually require replacement and revision surgery. When a patient complains to a doctor about knee pain after a total knee arthroplasty, the doctor will order an X-ray and look for radiolucent lines, which are spaces between the artificial knee component and the patient’s 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.

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 as Mr. Joas will tell you: you’ll need a strong expert on causation to overcome Judge Pallmeyer’s critical eye.

Second Bellwether Case Caption: Joas, et al. v. Zimmer Inc., No. 13-9216 (N.D. Illinois)

Note: Photos for illustration only.

Let me get right to it: Judge Clay Land has a point. On September 7, 2016, Judge Land issued a blistering Order in the Mentor Corporation ObTape Transobturator Sling Mesh multi-district litigation. In a nutshell, he wrote that he was fed up with frivolous claims. Judge Land stated that he will consider money sanctions against plaintiffs’ lawyers who file and pursue lawsuits in the MDL that they know have no merit or which suffer from some fatal flaw. A fatal flaw could be the passing of the statute of limitations, or the failure to find an expert who can testify that the transvaginal mesh product caused the specific injuries to the plaintiff. In those cases, Judge Land writes, the plaintiffs’ lawyers ought to know better, and should not bring the claim in the first place, or should at the very least dismiss the action when the lawyer discovers a flaw in the case which is fatal to gaining a recovery.

The worst transgression identified by Judge Land is when the product manufacturer seeks “summary judgment” in a particular case and the plaintiff’s attorney simply throws in the towel on the case and does not even bother to show up for the court hearing. In those cases, even though the plaintiff is inevitably going to lose the case, the judge and the law clerks and court personnel and defense attorneys still have to show up and do the work of handling and deciding the motion.

more Attorneys Should Never Abandon a Case

This is not right. Plaintiffs’ attorneys should never abandon a case. If the case is fatally flawed and everyone knows it, the attorney must inform the client and has an obligation to dismiss the lawsuit. I understand Judge Land’s frustration for these clearly weak or abandoned cases. There are many reasons this behavior is bad for the legal system: it takes up time and money unnecessarily; it puts the client in a bad position with the court; and it also makes product liability lawyers look bad.

The Order

Judge Land, who oversees the Mentor Corp. Mesh MDL in federal court in Georgia, has been handling several motions for summary judgment over the past year. He has dismissed many actions based on the passing of the statute of limitations and for other reasons. He seems quite tired of it. He wrote that lawyers for plaintiffs in the MDL “are on notice that in future orders granting summary judgment in which no good faith basis existed for maintaining the action through the summary judgment stage, the Court intends to include an addendum in the order requiring counsel to show cause why sanctions should not be imposed. Thus, it would behoove counsel to take a close look at your cases and decide whether you truly have a good faith basis for proceeding; and if you do not, dismiss the case.” You can read the full order here.

Let’s unpack this. Judge Land is unambiguously issuing a strong warning to plaintiffs’ lawyers who do not closely scrutinize their cases and who fail to ensure that a fatal flaw does not exist in their cases. Quick example: let’s say there is a absolute deadline for identifying a medical expert who will testify that the transvaginal mesh injured the client. And let’s say that the lawyer let that deadline pass without finding a suitable expert. The lawyer must take immediate action: either he must file a motion requesting an extension of time to identify the expert, or he must dismiss the case without prejudice, or he must dismiss the case outright. Doing nothing is bad.

But Wait a Minute!

Now, a “good faith basis” for continuing a case is often in the eye of the beholder. And there are times when the passing of the statute of limitations is not at all clear. And sometimes it is the product manufacturer itself who makes the limitations period difficult to calculate.

A statute of limitations is a law which limits the period of time when you can bring a lawsuit for money damages for an injury. In each state you have a certain number of years from the date of injury, or the date of discovery of the injury, to file a lawsuit and recover money for your injuries. If you miss this deadline, you lose your right to bring the lawsuit forever.

But when does the clock begin to run? Let’s say you are a woman who received a transvaginal mesh implant. After a few months you began feeling new pains and other unpleasant symptoms. But the manufacturer kept insisting to everyone–the media, doctors, patients–that the TVM product was safe and effective. You visit your doctor and she says, “the manufacturer is saying the mesh is safe, so your pains must be coming from some other problem.” In that case (and it is very common) how can this injured woman know she has a valid claim against the manufacturer? The fights over statutes of limitation are often fierce, as I write about here. And they should be. If the defense wins the argument, the defendant has to pay no money for what might be a real injury to a real person. The plaintiff has ever right to fight back against this SOL defense. And should.

And I guess that is Judge Land’s point: if you are the lawyer for the plaintiff and you are facing a summary judgment motion, show up, make your case, fight for your client. Don’t abandon the client, and don’t leave a case behind you know to be fatally flawed. I agree.

But I also believe that judges need to be mindful of the unfair fight injured people face. No person injured by transvaginal mesh, or a failed artificial hip or knee, or an untested drug, can compete with the power and resources of a major corporation. I would like all plaintiffs’ lawyers to handle their cases competently, but I also would like to see judges give an injured person the benefit of the doubt in the face of this uphill struggle. After all, nowhere in Judge Land’s order does he say that these plaintiffs who lose summary judgment were not injured by the negligence of the manufacturer. Rather, the person was simply unable to pursue her claims based on a legal or technical defense.

In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, No. 4:08-MD-2004 (M.D. Ga.)