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.

A lawsuit can be a minefield. For one, it can go on for years. And in that time opposing counsel can (and will) challenge a person’s lawsuit in large and small ways. By large I mean bringing “dispositive motions,” which are motions that “dispose” of a case, like a motion to dismiss and a motion for summary judgment. These motions are defensive attempts to kick a lawsuit out of court before it reaches a jury. By small I mean opposing counsel may refuse to produce certain documents or information in the “discovery” process, or may simply use motions or other tools to slow down and delay the plaintiff’s opportunity to have her case reach a jury.

But the fight is not over when the jury reaches a verdict in a product liability case. If a plaintiff wins her lawsuit, the defense will typically file “post-trial motions,” and after those motions are heard will likely appeal to a higher court. Merely getting a good jury verdict is by no means the end of the story.

Two weeks ago, a federal judge in Georgia stepped in after a jury verdict and stripped almost nine million dollars of punitive damages from the amount of money the jury awarded to the injured plaintiff.

But I need to back up.

In Re: Wright Medical Technology Inc. Conserve Hip Implant Products Liability Litigation (MDL No. 2329); Christiansen, No. 13-00297 (N.D. Ga.) more

Robyn Christiansen is a Utah woman who received a Wright Medical Technology “Conserve” artificial hip in 2006. In 2012, while doing yoga, she heard a “crunching sound” and felt sudden pain in her right hip. Ms. Christiansen was eventually diagnosed with having a loose acetabular cup which required revision surgery and removal of the cup.

In 2013 Ms. Christiansen sued Wright Medical Technology, Inc., and Wright Medical Group, Inc. in federal court for design defects, negligence, fraudulent misrepresentation, punitive damages, and other claims. The case was later moved to the multidistrict litigation site created for Wright Conserve Hip Implant System cases in Atlanta, Georgia (MDL No. 2329). Ms. Christiansen’s case was eventually selected as one of the bellwether cases for the Wright Conserve MDL.

After two weeks of trial, an Atlanta jury found in favor of Ms. Christiansen and awarded her $1,000,000.00 in compensatory damages (damages for actual injury and actual loss) and $10,000,000.00 in punitive damages. This was a big win.

Not surprisingly, the defense team filed post-trial motions, one for “judgment as a matter of law,” and another motion for a new trial, both based on the defense’s post-trial theories that the jury verdict was inconsistent with law and flawed based on juror confusion or bias. Wright Medical also moved to strike the punitive damages award.

Well-Meaning Reprehensible Conduct

Judge William S. Duffey, Jr., federal district judge in Atlanta, Georgia, presides over the Wright Conserve MDL. He denied all but one of Wright’s post-trial motions, but granted (in part) Wright’s motion to strike the punitive damages award. In his Order (which ran 100 pages), Judge Duffey held that the evidence supported a finding that Wright Medical engaged in reprehensible conduct, which in turn supported an award of punitive damages. See Order. Nevertheless, the judge then reached a curious conclusion, holding that Wright’s actions “did not display an extremely high degree of malice” or an “actual intent to harm.” Order, p. 92. Judge Duffey wrote that although the evidence presented at trial was “sufficient to support a finding of reprehensibility, Defendant’s conduct was motivated by a patient-centered objective to introduce a device to improve life quality for people like Plaintiff.” Order. p. 93.

I don’t know about you, but it seems odd to me that a medical device manufacturer’s actions could be viewed as “reprehensible,” and then conclude that the Defendant’s motivation was to improve the quality of life for hip replacement patients like Robyn Christiansen. Either the Defendant’s actions are reprehensible or they are not.

In any event, the judge then reduced the punitive damages award from $10,000,000.00 to $1,100,000.00, a figure which he claimed is “’reasonable and proportionate to the amount of harm to the plaintiff and to the general damages recovered.’” Order, p. 93. And the judge gets to make this call.

This is a reduction of $8,900,000.00, an astonishing result from a post-trial Order.

Judges Have Enormous Power

As you can see, judges have enormous power over the journey of every lawsuit assigned to them. A judge’s simple decision on the scope of discovery at the start of litigation can change the outcome of a case. And, when a jury trial is complete, a judge can change the results, as was the situation in the Christiansen case.

With this post-trial decision, the plaintiff’s team will undoubtedly file an appeal of Judge Duffey’s Order reducing the punitive damages award. The plaintiff’s appeal, if she brings one, will likely take a year or longer to move through the Eleventh Circuit Court of Appeals. In that time, the parties could come together and “settle” the matter pending the appeal. But make no mistake, after this post-trial decision, Wright Medical will not pay Ms. Christiansen the $11,000,000.00 the jury decided she should be paid. To get that amount of money, Christiansen will have to win her appeal and have the post-trial order reversed.

The Takeaway

As Yogi Berra said, “it ain’t over till it’s over.” And for a lawsuit it may often seem that the case is never over. In Ms. Christiansen’s case, even after three years of litigation, two weeks of trial, and a jury verdict, the results can change, either through post-trial motions or later on appeal to a higher court. It reminds me of the funny line from a comedian about the randomness of dreams, “you’re falling down a mineshaft now you’re in a parade.” Things can change abruptly in lawsuits too. Be vigilant, be prepared for uncertainty, and do not underestimate the immense power of your presiding judge.