The latest Depuy Pinnacle Hip bellwether trial is underway in Dallas, Texas. All bellwether trials are important, but this one is more important than most. After all, this trial follows an astonishing result in the second bellwether trial, where a jury awarded five plaintiffs more than $500,000,000.00 in damages for injuries caused by the Depuy Pinnacle hip. More about that case in a moment. But this third bellwether trial is critically important to Depuy and Johnson & Johnson (the Depuy Pinnacle manufacturers) who desperately need a court victory after the second bellwether trial. Another large verdict for the plaintiffs will most likely change the fate of any global settlement with the eight thousand plaintiffs who still have cases against Depuy and Johnson & Johnson.

Third Depuy Pinnacle Bellwether Trial

Judge Kinkeade, the federal judge in Texas overseeing the Depuy Pinnacle multidistrict litigation, selected seven individual cases to be consolidated in the current bellwether trial. The plaintiffs are Marvin Andrews, Kathleen Davis, Sandra Llamas, Rosa Metzler, Judith Rodriguez, Lisa Standerfer, and Michael Weiser. All the plaintiffs are from California. Their cases were transferred to the Depuy Pinnacle MDL in Dallas, Texas.

Depuy has attempted several times to postpone the current trial. Judge Kinkeade has denied those motions. After jury selection, both sides made opening statements to the jury earlier this week. One major defense for Depuy seems to be that the surgeons implanted the Pinnacle hip in these plaintiffs incorrectly. In addition, there have already been several skirmishes between the plaintiffs’ attorneys and the defense team.

It is important to note that the current case is being tried under the laws of California. A case is typically governed by the laws of the state in which the plaintiffs originally file suit. A federal court in any state is often asked to consider a case with another state’s laws. The previous bellwether trial was governed by the laws of the state of Texas, which has a statute capping punitive damages. But California has no such statute. If the jury in this present case awards a large punitive damages award for the seven plaintiffs, the award will most likely stand.

So as I said, this is an important case, and a lot is at stake for both sides.

The Depuy Pinnacle Hip

The Depuy Pinnacle Hip was originally designed to replace your natural bone “ball-and-socket” with artificial ball-and-socket parts. The Depuy Pinnacle system was supposed to provide more range of motion and to be more useful to an active group of patients undergoing hip replacement surgery. The Pinnacle system gave surgeons different options in the materials to be used for the hip replacement: metal-on-metal, or ceramic-on-metal, or other combinations. One of the major complaints against the Pinnacle is that the metal components grind and release metal particles into the body and blood of the patient, often leading to extremely high levels of cobalt and chromium (metallosis). You can read more about metallosis here.

The Depuy Pinnacle Hip was first sold in 2000. Depuy stopped manufacturing and selling the device in 2013.

Like the Depuy ASR hip, the Depuy Pinnacle hip bypassed the normal pre-market testing for a new medical product through a process known as “510(k).” 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 device’s “substantial equivalence” to a pre-MDA device. 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.

Second Bellwether Trial Was Remarkable

Depuy needs a win in this third bellwether trial, as the company got walloped in the second bellwether trial. On March 17, 2016 a Dallas-area jury ordered Depuy Orthopaedics and Johnson & Johnson to pay five injured people $502 million dollars, including $360 million in punitive damages. The jury based this award on several factors, including findings that Depuy hid critical defects in the design of the Depuy Pinnacle artificial hip system and hid these risks from doctors and patients. Remember that a bellwether trial, even with several plaintiffs, is not a class action lawsuit. Rather, because the five individual cases had sufficient similarities, the judge, attorneys, and litigants agreed to try all five cases in one jury trial. The single jury heard all the evidence in these cases, but Judge Ed Kinkeade instructed the jury to consider liability in each individual case, and to award separate damages for each plaintiff. The jury concluded that the Pinnacle hip sold by Depuy was defective and that Depuy knew about the flaws but did not warn patients and their doctors of the risks. The jury then awarded $142,000,000.00 in actual damages and $360,000,000.00 in punitive damages. The punitive damages award was later reduced (by operation of a statute capping punitive damages) to $9,646,256.00. To put it another way, the statute stripped $350,000,000.00 from the punitive damages award a jury of twelve individuals, after a 42 day trial, decided was appropriate. So much for the sanctity of the jury.

Even with this staggering reduction in the jury’s money damages award, the second bellwether trial was a huge win for the plaintiffs. Depuy and Johnson & Johnson have appealed, but they must also recognize that juries do not look favorably on rushing a dangerous product to market, particularly when more than eight thousand people are later injured by the device.

Stay tuned.

Depuy Orthopaedics and its parent company Johnson & Johnson filed their “motion to stay” on May 24, 2016. They asked the court to delay all further trials in the Depuy Pinnacle MDL until an appellate court rules on their appellate issues. (It is very common for a company in any case to appeal a trial verdict when the jury awards significant damages to the plaintiffs.) Depuy claimed there were significant errors made at the trial. Depuy also argued that the decision in the appeal could have “far-reaching implications” on how future Pinnacle cases are tried. Defendants claimed the “grounds for appeal are strong” and that they “acted appropriately and responsibly in the design and testing” of the devices.

Judge Kinkeade, who presides over the Depuy Pinnacle MDL in Dallas, Texas, denied the motion to stay the trials. In his order Judge Kinkeade selected seven bellwether cases to be tried beginning September 6, 2016. You can read that Order here.

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A “stay” would have created a long delay in resolving the remaining cases that are ready for trial. A complex appeal in a federal circuit court can take over a year to conclude. Judge Kinkeade apparently did not see any reason to delay other cases that are ready for trial.

Defense: The Pinnacle Ain’t the ASR

Depuy Orthopaedics has so far refused to negotiate a global settlement arrangement with lawyers for injured plaintiffs. Depuy has argued that the Depuy Pinnacle is not defective and is different from the Depuy ASR hip, which was a metal-on-metal hip that resulted in two large settlement agreements. One defense seems to be: “the Pinnacle ain’t the ASR.” Depuy has argued that the Pinnacle is not flawed in the manner the ASR was flawed.

Plaintiffs disagree, and thousands with the Pinnacle implant have filed suit for many of the same injuries that the ASR inflicted on individuals. Plaintiffs have argued that if Depuy refuses to negotiate a global settlement of the Pinnacle cases, then the court should fast track all remaining cases, as there are more than 8,000 cases remaining to be resolved.

Punitive Damages Award Sends Message

It appears the $500 million dollar verdict will be reduced in part. Texas law places a $10 million dollar limit on punitive damages, so the $360,000,000.00 in punitive damages awarded by the jury will likely be severely reduced. Still, the large punitive damages award serves a value for plaintiffs as it sends a strong signal that the jury was sufficiently offended by the actions of Depuy that it awarded a huge amount of punitives, whether or not Texas law permitted such an award.

Depuy and Johnson & Johnson are accused of covering up defects which caused the hips to fail. The hip component manufacturers still face more than 8,000 lawsuits concerning the alleged failure of the Depuy Pinnacle artificial hips. Judge Kinkeade’s Order was a victory for injured people and a rejection of unnecessary delays in the Depuy Pinnacle MDL.

I have been getting a few calls recently from people who still have the Depuy ASR hip implanted in one or both hips. They are asking the right questions: Are the metal levels in my blood too high? How will metallosis affect my long-term health? Will the component slip on me now and cause all kinds of new pain? Should I schedule surgery and have the Depuy ASR components removed? Plainly, these are questions for a doctor, not a lawyer. I can’t answer any questions specific to your health. Eventually, however, these callers ask an intriguing question: I have the Depuy ASR hip implanted in my body and I have not yet scheduled revision surgery: Do I have a valid claim against Depuy and Johnson & Johnson? It’s a good question.

People with Depuy ASR hip components implanted in their bodies who did not undergo revision surgery did not “qualify” for the two settlements that have been reached in the Depuy ASR multidistrict litigation (DePuy Orthopaedics, Inc., ASR Hip Implant Products Liability Litigation, MDL 2197). But this does not mean they are not injured or that they do not have a valid claim. All it means is that they did not qualify to participate in the settlement based on the timelines in the settlement agreements. Let’s take a step back.

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Two settlement agreements were reached in the Depuy ASR MDL. To qualify for the “2013 Settlement” you must have undergone revision surgery on or before August 31, 2013. To qualify for the “2015 Settlement” you must have undergone revision surgery between August 31, 2013 and January 31, 2015.

Depuy ASR Hips Still Implanted After January 31, 2015

Plainly this creates a group of people who could not participate in the settlement: those who had not undergone revision by January 31, 2015. This includes a substantial number of people (some of whom I represent). Let’s take a quick look at the calendar: Depuy issued a recall of the ASR hip on August 24, 2010. This means that people were receiving Depuy ASR implants in 2010, and quite likely after August 24, 2010 (as it often takes time before a recall is fully communicated to the broader medical community). Let’s say you had hip replacement surgery on in May 15, 2010, and for a few years the implant felt OK. But then you started to feel some pain, and then six months ago had blood work done. Your doctor told you that you had elevated levels of chromium and cobalt in your system. Your doctor then said this is likely the result of your metal-on-metal Depuy ASR hip implant. At this point you are beyond the January 31, 2015 deadline to undergo revision surgery, so you cannot participate in the 2015 Settlement. But you still have a valid claim.

Valid ASR Claims After January 31, 2015

First, the Depuy ASR hip components failed at an unacceptably high rate. Thousands of revision surgeries have taken place because the metal-on-metal Depuy ASR hips failed. Second, in your specific case you are suffering injury; namely, pain and elevated metal levels in the blood (and you do not yet know if other complications are developing). Third, even if your revision surgery occurred after January 31, 2015, you were still injured by a defective product. In the eyes of the law, your claim should be as valid as the person who received revision surgery on July 15, 2013 or January 15, 2015. Fourth, even if you do not undergo revision surgery, you may possibly have a valid claim against Depuy and Johnson & Johnson. If you can show injury—high metal levels, a loose acetabular cup causing pain, or other complications, you have compensable claims. Most people suffering these injuries will schedule revision surgery (and should) but the absence of revision surgery does not mean you have no compensable injury.

My Hunch

I would presume that Depuy and the plaintiffs’ executive committee will eventually agree to a third settlement agreement to cover those people who had revision surgeries after January 31, 2015. But even if this third agreement does not happen, each person who was injured by the Depuy ASR hip has a valid claim and should bring such a claim against Depuy and Johnson & Johnson (preferably with the help of a knowledgeable attorney).

Beware the Statute of Limitation

But with any valid personal injury claim, you must always be aware of the relevant statute of limitation (SOL) in your state. I have written about these statutes here. The SOL limits the amount of time a person is permitted to bring a lawsuit after an injury, including a physical injury from a medical device like the Depuy ASR hip. Often the period of time begins to run when the injury is discovered. So in the hypothetical above, the injured person should argue that she was unaware of her injury until the blood work was done and her elevated metal levels were discovered. Still, ferocious battles often occur in court over whether the SOL has run on any claim. Don’t “sleep on your rights.”

The Takeaway: If you still have the Depuy ASR hip (or the Depuy Pinnacle hip) implanted, don’t presume you no longer have a claim against Depuy and Johnson & Johnson, but be vigilant and bring your claim as soon as you are aware you were injured by the Depuy artificial hip.

Note: The information in this post regarding the Depuy ASR settlement agreements is publically available. No information in this post should be considered legal advice. Feel free to call me for more information: (919) 830-5602.

I’ve written about this case before (In re: DePuy Orthopaedics Inc. Pinnacle Hip Implant Products Liability Litigation, 11-md-02244, U.S. District Court, Northern District of Texas (Dallas)). Five plaintiffs (Aoki, Christopher, Greer, Klusmann, Peterson) agreed to have their cases tried together. This was not a “class action” lawsuit. Rather, because the five individual cases had sufficient similarities, the judge, parties, and attorneys agreed to try all five cases in one jury trial. The single jury heard all the evidence in these cases, but Judge Ed Kinkeade instructed the jury to consider liability in each individual case, and to award separate damages for each plaintiff. Boy did they.

$360,000,000 in Punitive Damages

Five patients implanted with the Depuy Pinnacle artificial hip were awarded $502,000,000.00. The jury concluded that the Pinnacle hip sold by Depuy was defective and that Depuy knew about the flaws but did not warn patients and their doctors of the risks. The jury awarded $142,000,000.00 in actual damages and $360,000,000.00 in punitive damages.

Depuy is owned by parent company Johnson & Johnson, who will be on the hook for paying this judgment.

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In all five cases the artificial hips failed, requiring revision surgeries and causing pain and suffering. In each case, the plaintiffs alleged that cobalt and chromium from the metal hip components was released into their bloodstreams, causing toxic metal levels in the blood.

Beyond the physical injuries, the five plaintiffs alleged that Johnson & Johnson rushed the Pinnacle hip on the market, despite knowing the defects of the product, so the company could reap billions in sales as quickly as possible.

A Real Donnybrook

The trial was a real donnybrook. The jury heard 37 days of testimony in this case, and the defendants made seven motions for mistrial. Judge Kinkeade denied every one. Depuy and J&J made repeated allegations that the plaintiffs’ team presented prejudicial, inflammatory evidence to the jury. It is a common defense tactic, but the reality is this: all evidence presented by your opponent is prejudicial and intended to be so. The judge found that the plaintiffs’ evidence was not unfairly prejudicial.

While this result is a stunning victory for these individuals and a positive sign for victims of the Depuy Pinnacle hip, the jury verdict does not guarantee that Johnson & Johnson will have to pay big for all future Depuy Pinnacle hip failures. J&J previously won a jury trial against a person who claimed similar injury based on the failure of the Depuy Pinnacle hip. In that case the jury found that Depuy was not negligent and that the plaintiff (Ms. Herlihy-Paoli) was not entitled to any compensation. You can read about that case here.

Further, Johnson & Johnson stated after the five hundred million jury verdict that it would appeal. Among other things, J&J has noted that Texas law places a cap of ten million dollars on punitive damages. On appeal, Johnson & Johnson will likely claim it did not receive a fair trial, and even if it did the final monetary award should be reduced considerably.

Shockwaves

Still, the $360 million in punitive damages had to send shockwaves through the suits at Depuy and Johnson & Johnson. Plainly, this jury became convinced that these defendants engaged in reprehensible conduct and wanted to send a loud message of outrage. This award should favorably impact settlements for the 8,000 other plaintiffs who have filed suit and are still waiting to have their cases tried to a jury (or settled).

Depuy stopped selling the Pinnacle in 2013. The good news is that if you received an artificial hip in 2014 or after, it should not be the Pinnacle. If you had hip replacement surgery in 2013 or before, you may need to figure out if you are walking around with the Depuy Pinnacle hip, especially if you are having pain or other complications.

It’s important to remember that (unlike the Depuy ASR hip) the Depuy Pinnacle was never officially recalled by Depuy Orthopaedics. Depuy has taken the position that the Pinnacle is different and safer than the ASR hip components. But this latest jury verdict does not help J&J advance that narrative.

The Depuy Pinnacle system was allegedly designed to provide better range of motion and to be attractive to an active group of patients undergoing hip replacement surgery. One of the major complaints from injured patients is that the metal components grind and release metal particles into the body and blood of the patient. And like the Depuy ASR hip, the Depuy Pinnacle hip bypassed the normal pre-market testing for a new medical product through a process known as “510(k).”

The Takeaway

This is a great result for these five plaintiffs but also for the thousands of people who had hip replacement surgery where the Depuy Pinnacle was implanted. The plaintiffs’ executive committee now has a huge verdict to use as leverage when the committee negotiates a global settlement with Depuy and J&J attorneys. There is now a much better chance that the plaintiffs will be fairly compensated for their injuries.

I will continue to provide updates on future Depuy Pinnacle trials and settlement discussions as they occur.