In November 2013, the first Settlement was reached between the Plaintiffs’ Committee and the Defense Team for Depuy and J&J. I have written about this Settlement and its terms here. So six years after the Original Surgery, and four years after the first onset of pain, and two years after Revision Surgery, Bill finally had the opportunity to accept the settlement offer or reject the offer and pursue a jury trial on his specific case. After much deliberation, Bill rejected the settlement offer.

Three years have now passed

. Bill’s case is not on a trial calendar. In fact, as far as I am aware no case has yet been tried of any person who rejected the settlement offers. To make matters worse, this summer Judge Katz, in charge of the MDL, passed away. A new judge had to be appointed to take his place overseeing the MDL.

Bill is at his wit’s end. He told me he merely wants his day in court. He is now nine years removed from the Original Surgery, seven years removed from the onset of symptoms, five years from Revision Surgery, and over four years from filing suit. And still no trial date in sight.

Bill is not alone. Hundreds of people in the MDL rejected the settlement. And those people are waiting too.

So how long does it take to resolve your artificial hip case?

more All Civil Litigation Takes Time

I wish I had better news, but it takes a long time. Any civil litigation takes time. There are “rocket dockets” scattered across the country that work really hard to dispose of cases in a matter of months or a year, but those courts are the exception. Even a basic breach of contract action in your state’s court can take two years or longer to resolve.

A product liability case is a particularly complex type of civil litigation. It is very difficult to prove that a product was defectively designed, or that a manufacturer failed to warn patients and their doctors of the risks involved in using a product. Often competing experts will spend many hours and many dollars fighting over these technical issues. This is one reason MDL courts were formed in the first place. Multidistrict litigation sites are designated precisely to resolve of hundreds or thousands of cases more efficiently, not less efficiently.

Multidistrict Litigation Often Takes Years to Resolve

That said, there is just no other way to say it: a case that finds its way to a multidistrict litigation court will probably take several years to resolve. So settle in. The biggest reason is this: there is simply a lot to do. Both sides need to engage in general, “shared” discovery, where the plaintiffs will depose the defense experts and fact witnesses, and the defendants will depose the plaintiffs’ expert and fact witnesses. Aside from that, often hundreds of thousands of pages of medical records, expert reports, scientific studies, and business records must be reviewed and analyzed. Dozens of pretrial motions are filed, and all must be ruled on by the MDL judge. It simply takes months and years to get through this work. Meanwhile, Bill, and thousands of people just like him, wait.

The waiting game is not limited to artificial hips, but includes all kinds of medical devices and harmful drugs. The Mentor ObTape Transvaginal Mesh MDL was formed eight years ago and is still going strong in Georgia. The Depuy Pinnacle Hip MDL was formed almost six years ago, and bellwether cases have been tried this year, with no settlement agreement in place. There are multiple IVC Filter MDLs, as well as MDLs for the drugs Risperdal, and testosterone, and Xarelto, and Viagra.

Every Case a Snowflake

Still, every single case that has ever been filed in any court is unique. The facts in each case are different. The parties involved are different, and the lineup of lawyers and judges and juries are different. Occasionally a person may find her case transferred to an MDL the week before a global settlement is reached. If she accepts the terms of the settlement, she may actually resolve her case in a few months. Other individuals may not qualify for a settlement based on the timing of their Revision Surgery, and they will be forced to resolve their cases one at a time without the benefit of a settlement structure. And other people, like Bill, will choose trial, which can take more years of waiting to calendar, to try, and to overcome the inevitable appeals.

Is all this waiting and effort worth it? I would say absolutely. If you were injured by a company’s negligence, you deserve to be compensated. Even if it takes years.

Note: The narrative above does not refer to any specific person or case.

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.

But let’s back up.

What is Risperdal?

Risperdal is an anti-psychotic drug that was approved for limited use in 1993 to manage the symptoms of schizophrenia. According to multiple sources, in the years that followed Johnson & Johnson pressed the FDA for approval to treat other conditions, such as bipolar disorder and autism, and to permit use in children. Risperdal was soon prescribed for adults and children to treat attention deficit hyperactivity disorder, anxiety and depression. Treating these conditions using Risperdal is considered an “off label” use, which is the use of a drug in a manner unapproved by the FDA. Off-label use could involve using a drug to treat a condition which is not authorized by the FDA, or prescribing the drug to an unapproved age group. Shockingly, Risperdal has had horrific side effects in children. Among other symptoms, Risperdal can cause the growth of female breasts in male children, a condition known as gynecomastia. I have written about Risperdal often in this blog. You can check out those articles here.

The Case of Andrew Yount

Andrew Yount is a boy from Tennessee who was prescribed Risperdal in 2003 to treat attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder. At the time the FDA had not approved the drug for use in treating behavior disorders in children. Andrew was just five years old when he began taking the drug. A year after taking Risperdal, Andrew grew female breasts.

Andrew Yount is now in his late teens. He has had to deal with this embarrassing disfigurement for most of his life.

At trial, the lawyers for Andrew and the Yount family argued that Janssen Pharmaceuticals and its parent company Johnson & Johnson were aware of the risks of children growing female breasts but worked to downplay the risk involved. Despite the data showing a connection between use of Risperdal and the growth of female breasts in vulnerable boys, Janssen and Johnson & Johnson kept pushing the prescription to doctors and parents and children.

What the Jury Saw

The jury reviewed the evidence and concluded that Janssen and Johnson & Johnson failed to warn the Yount family about the risks of taking Risperdal. The jury also seems to have concluded that the defendant companies intentionally buried or falsified scientific evidence showing a link between Risperdal and gynecomastia. If this is true (and evidence supports the view), then it represents hideous behavior from the companies. The jury in the Yount case clearly saw this horrific corporate behavior and awarded Andrew Yount a huge monetary award. But just as likely, the jury got angry and awarded this money as a signal to Johnson & Johnson that this kind of corporate greed will be severely punished. The hope is that jury verdicts like this one will discourage Johnson & Johnson and all pharmaceutical companies to recommit to developing and testing and marketing safe and effective drugs.

Naturally, Janssen and J&J have stated they will appeal the verdict.

Other Risperdal Cases

I wrote about the Austin Pledger trial from last fall, which resulted in a $2.5 million verdict and which you can read about here. Other Risperdal trials have yielded jury awards ranging from $500,000.00 to $1.75 million. One jury trial ended in a defense verdict for Janssen and Johnson & Johnson, though I would not put much stock in that outcome, as plainly the plaintiffs are winning many more of these cases than they are losing. After this latest huge loss in the Yount case, Johnson & Johnson would be wise to consider settling many of the more than 1,500 cases still in the pipeline. Another Risperdal case goes to trial in Philadelphia later this month. I’ll let you know how it turns out.

The Takeaway

For much of my life I have mainly believed that pharmaceutical companies develop and market drugs with the overarching goal to improve and extend the lives of patients. But this is not always the case. Sometimes a company can become blinded by greed. Companies may then push an untested drug onto the market, or even sell a drug it knows to be unsafe. So be skeptical. Do some research. Ask your doctor many questions about the latest drug she wants to prescribe for you or your child. Get a second or a third opinion. You can never eliminate all risk, but you can at least learn how a product reached the market, whether it was adequately tested, and even whether lawsuits have been filed against the drug maker.

The case is titled A. Y. v. Janssen Pharmaceuticals, Pennsylvania Court of Common Pleas (No. 130402094)

Photographs for illustrative purposes only.