Imagine going to sleep the night after making the decision to strip five hundred million dollars from six families. I imagine it would be unsettling. On Tuesday, Judge Ed Kinkeade, a federal judge in Texas overseeing the Depuy Pinnacle MDL, made the decision to cut $500,000,000.00 from a jury award presented to six families after a grueling ten-week trial last fall. You can read about the trial and the jury’s verdict here. In that post I wrote that the jury’s verdict was “staggering,” and it was. It may be more staggering that a judge, less than a month later, would wipe out half a billion dollars of the jury’s award.

“Single-Digit Multipliers”

On January 3, 2017, Judge Kinkeade issued his post-trial court order reducing the amount of punitive damages awarded to the six families, writing that “constitutional considerations limit the amount a plaintiff may recover in punitive damages.” The relevant portion of the Order states:

“Although the jury awarded $84,000,000 in punitive damages from Defendant DePuy Orthopaedics, Inc. and $84,000,000 in punitive damages from Defendant Johnson & Johnson, constitutional considerations limit the amount a plaintiff may recover in punitive damages. See State Farm Mut. Auto. Ins. Co. v. Campbell, 538 U.S. 408, 425 (2003) (“[F]ew awards exceeding a single-digit ratio between punitive and compensatory damages, to a significant degree, will satisfy due process. . . . Single-digit multipliers are more likely to comport with due process, while still achieving the State’s goals of deterrence and retribution . . . .”). The Court has reduced the punitive damages accordingly.” See Depuy Pinnacle Order.

I have to say this is a powerfully thin explanation for stripping half a billion dollars from a jury award: “single-digit multipliers”? Really? The U.S. Supreme Court has limited punitive damages in the past, but there is no overarching federal law limiting punitive damages, and all reductions such as the current one intrude aggressively on the power of the jury to make its own findings and awards. Further, as I discuss below, the controlling law in this case came from California, which does not have a punitive damages “cap.” In any evident, Judge Kinkeade held that the punitive damages award by the jury was “excessive.” Media reports calculate that the judge reduced the punitive damages award to nine-times the plaintiffs’ actual or compensatory damages.

Fortunately, Judge Kinkeade upheld the jury’s conclusions that the Depuy Pinnacle hip implants were defectively designed and that Depuy and Johnson & Johnson failed to warn consumers adequately about the risks involved.

The Third Depuy Pinnacle Bellwether Trial

The first Pinnacle bellwether trial ended in a defense verdict, which means the plaintiffs lost and received no award. The second bellwether trial ended with a $502 million dollar verdict for five plaintiffs. It seemed unlikely that the third bellwether trial could yield a result similar to the second bellwether trial verdict. Turns out, the third bellwether trial was the biggest one of all.

Each of the plaintiffs in this case lived in California and received the Depuy Pinnacle artificial hip in surgeries in California. Because of this California citizenship, the laws of the state of California governed the case, even though the case was being tried in federal court in Texas. In each case that reaches trial, the substantive law of the state where the plaintiff resides controls. This was important (I thought!) because California, unlike many states (including Texas and North Carolina), does not have a cap on punitive damages awarded by juries.

The Jury’s Punitive Damages Award

The jury awarded $1,008,000,000.00 in punitive damages total for the plaintiffs, and $1,000,000.00 for the four spouses of the plaintiffs. The odd thing about Judge Kinkeade’s court order is that California has no statutory cap on punitive damages. In the second bellwether trial, Judge Kinkeade, utilizing Texas law, reduced the total jury award by $350 million, which you can read about here. But the judge should not have been able to disturb this latest award. I believed that the one billion dollar punitive damages award in this case should stand. Either I got it wrong, or Judge Kinkeade did. Of course we will see on appeal.

Were You Implanted with the Depuy Pinnacle Hip?

The Depuy Pinnacle Hip was first sold in 2000. Soon thereafter, complaints arose that the metal components of the Pinnacle hip would grind together and release metal particles into the body, often leading to extremely high blood metal levels. Depuy stopped manufacturing and selling the device in 2013. But it can take years for serious trouble to occur with a failed Pinnacle hip, which means many people are likely still out there with failing devices that don’t yet know the device is failing.

Quick example: let’s say you have the Pinnacle hip implanted in 2012, before it stopped being marketed and sold. You feel little pain in the first few years, but in 2016 you begin to feel a new discomfort. The pain gets worse over time. Then after a routine blood test, your doctor tells you that your metals levels are 17 parts per billion, which is high and not healthy. Your doctor recommends revision surgery in 2017. In that case, you should qualify for participation in the Depuy Pinnacle MDL.

The Depuy Pinnacle hip bypassed the normal premarket testing for a new medical device through the 510(k) process. This process allows a manufacturer to notify the Food and Drug Administration under section 510(k) of the Medical Device Amendments Act of 1976 of its intent to market a device (like an artificial hip) and to explain the medical device’s “equivalence” to a device already approved and marketed. The FDA may then approve the new device for sale in the United States, which it did for the Depuy ASR and Pinnacle, and which I believe is a significant reason for all the injuries and suffering related to failed medical devices.

The Takeaway

Punitive damages awards play a vital role in consumer protection. If companies like Johnson & Johnson do not fear large punitive damages awards, or even the freedom and power of juries, they will be less likely to take adequate precautions to protect the public. In my view, the jury’s punitive damages award should stand.

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).