In 2009 Mary McGinnis was implanted with the Avaulta Solo Support System and Align Trans-Obturator Yrethral Support System, two pelvic mesh products manufactured and sold by C.R. Bard, Inc. and other defendants. Ms. McGinnis was implanted with these mesh products in an attempt to treat Ms. McGinnis’ stress urinary incontinence and to provide bladder support. Shortly after implantation of the mesh, Ms. McGinnis began having severe pains from nerve damage and pain during sex. She had to undergo several surgeries to attempt to correct the problems.

Ms. McGinnis and her husband filed suit in 2011, alleging that C.R. Bard knew the pelvic mesh was unsafe at the time the products were implanted in Ms. McGinnis, and that Bard failed to warn doctors about the dangers of the Avaulta and Align pelvic mesh. At trial lawyers for Bard argued that the Defendants met all industry standards and requirements for placing the Avaulta and Align mesh products on the markets.

Compensatory Damages

On April 12, 2018, after a four-week trial, the McGinnis family finally got some justice. The jury in New Jersey state court awarded $33 million in compensatory damages. These damages were broken down this way: Ms. McGinnis received $23 million for her specific injuries, medical costs, and pain and suffering, and her husband received $10 million for his derivative “loss of consortium” claim. (Let me add here that loss of consortium claims can be substantial in these kinds of cases, as one of the key mesh injuries is pain during sex, often leading to couples abandoning marital relations altogether. That kind of injury has real value for most couples.)

Punitive Damages

On April 13, 2018, the jury returned to court to consider whether to impose punitive damages on C.R. Bard. Plaintiffs’ lawyers argued that Bard acted “maliciously” and in “wanton and willful disregard” for the rights of Ms. McGinnis and her husband when Bard placed these flawed products in the market. Ms. McGinnis’ lawyers argued that corporate profits should never take precedence over the health of patients. Again, Bard lawyers countered that Bard complied with industry standards, that $33 million (in compensatory damages) was compensation enough, and that anyway the vast majority of of medical devices reach the market without clinical trials. Therefore, said Bard, the jury should not impose punitive damages.

The jury then awarded the Mary and Thomas McGinnis $35 million in punitive damages. The two-day verdict reached $68 million. Of course it can never repair Ms. McGinnis’ internal injuries, the pain she suffers during intercourse, or her incontinence, but the money may at least provide the best medical care going forward and some comfort as she grows older.

“Most Medical Devices Do Not Undergo Clinical Trials”

As noted above, this was one of the main arguments offered by attorneys for C.R. Bard and the other defendants. Because so many similar mesh products were already on the market, Defendants argued, clinical studies on these new products were not necessary.

This is crazy talk. Clinical testing is critically important for new medical devices. And this is a major problem in our medical device device industry. It goes like this: ‘because this new product, let’s say a metal-on-metal (MoM) artificial hip looks very similar to an older, metal on ceramic hip, we don’t need to test our MoM hip. Let’s just put it on the market now, without testing.’ (Over a decade later, ask the many thousands of people injured by MoM artificial hips whether clinical testing was unnecessary.) The same holds for pelvic mesh, IVC filters, artificial knees, and virtually all other medical devices.

This subject is too important to ignore. If a company wants to sell a product that is to be implanted in a human body, the company should do all that it can to ensure that the product is safe.

Fortunately, the Avaulta and Align mesh products implanted in Mary McGinnis have been taken off the market. But not before thousands of women were severely injured by these flawed pelvic mesh products. Thousands of cases have been filed and more trials are scheduled for 2018 and beyond. I’ll keep you posted.

Note: This post was drafted from review of several news reports on the McGinnis trial.

Victims of C.R. Bard’s IVC filters got some great news two weeks ago. An Arizona jury in the first bellwether trial awarded a woman $3.6 million for injuries she suffered after Bard’s “G2” IVC filter broke into pieces in her inferior vena cava vein, requiring open heart surgery to remove the broken pieces.

The plaintiff, Sherri Booker, was implanted with Bard G2 IVC filter to prevent blood clots from reaching the heart and lungs. The problem was, the G2 moved inside her inferior vena cava (it is not supposed to move), then it broke apart. In 2014, she had to undergo open heart surgery. The surgeon was not able to retrieve all the broken pieces.

The Jury’s Verdict

After a lengthy trial the jury found that Bard was liable for a negligent failure to warn patients about the risk factors in using the G2 IVC filter. The jury also determined that Bard was not liable to the plaintiff for strict product liability design defect, strict product liability failure to warn, or negligent design.

The jury awarded Ms. Booker $2 million in compensatory damages and $2 million in punitive damages. The court was utilizing comparative negligence law, which assigns proportional blame for the harm caused. The jury found that Bard as the device maker was 80% responsible for the injuries, and that a radiologist who failed to discover a broken piece of IVC filter in a 2009 X-ray. Under comparative negligence law, therefore, Bard became liable for 80% of the compensatory damages award, for a total of $3.6 million. Punitive damages are not affected by a comparative negligence analysis, so the $2 million punitives award will stand.

Even with the reduction, it was a good result for Ms. Booker, and the verdict was promising for the thousands of IVC filter victims still awaiting trial or resolution of their cases. A second bellwether trial is slated to begin in May.

A C.R. Bard representative said he was “disappointed” in the jury’s verdict, but still maintained that the G2 IVC filters are useful medical devices that have saved lives.

Some History on the Bard IVC Filters

Bard began selling the “Recovery” IVC filter in 2002. This after Bard received approval to sell the device under the “510(k) process.” The name comes from a section of federal regulations that allows companies to sell products that are closely related to products already on the market. The 510(k) pathway, as I’ve discussed often, can lead to disastrous results. Anyway, the Recovery started causing serious problems pretty quickly, the main two that the Recovery filter would move or “migrate” in the inferior vena cava vein, and that it had a tendency to break apart. Bard conducted a study on the Recovery, found higher incidents of injury and death, and finally pulled the Recovery IVC filter from the market around 2005.

That same year Bard introduced the G2 IVC filter. The G2 was engineered from the Recovery technology, and it turned out that the apple did not fall far from the tree. An internal Bard memorandum noted serious issues with safety and function of the G2. Despite these internal concerns, Bard continued to sell the G2 filter and later the G2 Express filter.

Finally in 2010 Bard stopped selling the G2 IVC filters. One report estimated that 160,000 G2 filters were implanted in patients. One of those was implanted in Plaintiff Sherri Booker.

On May 18, 2015 the MDL involving Bard IVC filters was approved for federal court in Arizona, and injured people from all over the country can place their individual lawsuits in this MDL (MDL 2641).

I have written often on the problems associated with IVC filters, which you can read about here. If you have any kind of IVC filter implanted and are having problems, give me a call to discuss your legal options (919.830.5602). Good luck.

There have been two major developments in testosterone replacement therapy litigation in the past week. Last Thursday Eli Lilly & Co., the maker of the testosterone product Axiron, announced to Judge Matthew Kennelly in Illinois that an agreement had been reached to settle claims by people injured by Axiron testosterone. In the second development, the same judge tossed a jury verdict awarding $150,000,000.00 in punitive damages to a man who suffered a heart attack while taking Androgel testosterone.

Let’s take a quick look at both litigation developments:

Axiron Testosterone Global Settlement

Two bellwether trials in the Axiron testosterone litigation had been scheduled for January and March 2018. In one case, a plaintiff alleged that Axiron had caused his heart attack. In the second case, the plaintiff alleged that the testosterone product had caused deep vein thrombosis (DVT). These two cases were going to be the first trials over injuries sustained by Axiron in the multidistrict litigation, or MDL. Nevertheless, on December 21, 2017 Eli Lilly announced to the judge that a framework for settling all Axiron lawsuits had been reached by the executive committees for the plaintiffs and defendants.

The terms of the proposed settlement were not announced. The judge gave both sides forty-five (45) days to finalize the terms of the settlement. The Axiron testosterone cases are part of more than 6,000 lawsuits brought against several testosterone makers, including Eli Lilly, AbbVie, and Auxilium.

On the strength of this settlement announcement, Judge Kennelly postponed the upcoming Axiron bellwether trials and all trial deadlines. In a way this is a shame, as several bellwether trial verdicts give all sides a clear picture of how juries view the harm done. Of course, there is serious risk on both sides in trying these cases. If a jury awards a huge amount of damages, the defendant company will eventually pay more in the larger settlement. If several juries find no link to the product and the injury, the plaintiffs suffer. We will not get to see what juries thought of the Axiron testosterone product at this point.

I will update you here as soon as the Axiron Master Settlement Agreement is released.

Androgel: $150,000,000 Jury Award Set Aside

I must admit I saw this coming. I essentially predicted it. I wrote about Mr. Mitchell’s large punitive damages award in August, which you can read here. You may recall that I pointed out then the serious problem with the jury’s verdict: that it awarded punitive damages without any award for compensatory damages. As I explained months ago, to support an award for punitive damages, there usually must be some award for actual damages. Think of this way: in order for a plaintiff to qualify for a punitive damages award, that plaintiff must show that he has been directly harmed by the product, even if the harm is minimal.

In this case, Mr. Mitchell suffered serious harm: a heart attack. However, the jury could not agree that the heart attack was caused by the Androgel testosterone. Nevertheless, the jury did believe that AbbVie, Inc., the maker of Androgel, should pay for its fraudulent misrepresentation. The jury agreed with Mitchell’s claim that AbbVie targeted middle-aged men with misleading marketing that Androgel could treat low testosterone and improve lives. The jury then awarded a huge punitive damages award, with no underlying compensatory damages award. The jury appeared to find that AbbVie should be punished for fraudulent marketing, even though it could not connect Androgel to Mitchell’s heart attack.

As I said then, this was a “glaring problem” with the jury’s verdict. And Judge Kennelly, last Friday, tossed out the award altogether. He wrote that it was illogical to assert “simultaneously” that Mr. Mitchell had been damaged and not damaged. The judge wrote that the verdict was “internally inconsistent.” He makes a point.

Plaintiff Jesse Mitchell will get a new day in court. Judge Kennelly ordered a new trial in the case, although a new trial date has not been set. But again, as I wrote above, there is risk for all sides in any trial, and Mr. Mitchell’s case is an excellent example of this risk.

If you took any testosterone product in the past and suffered injuries, give me a call ((919) 830-5602) to discuss your potential case.

delivered a huge verdict to the victims of the DePuy Pinnacle artificial hip. In this fourth bellwether trial, the jury awarded $247,000,000.00 to six plaintiffs and their spouses. According to news reports, after a two-month, hard-fought trial, the jury found that DePuy Orthopaedics and parent company Johnson & Johnson were liable to plaintiffs for the Pinnacle’s design and manufacturing defects. But the jury went further, concluding that the actions of the companies were fraudulent and deceptive, and that they had acted recklessly and maliciously in manufacturing, selling, and promoting the flawed products.

These last terms have special meaning in law: findings of fraud, deception, recklessness, and malice indicate that the companies went beyond mere negligence, that the defendants misbehaved intentionally or with a reckless disregard to the fact that their actions would harm innocent people. Because of these special findings, the plaintiffs were entitled to receive “punitive damages” from DePuy and J&J, which are money damages intended to punish defendants for especially bad behavior.

The jury awarded $90 million dollars in punitive damages to be paid by J&J, and $78 million in punitive damages to be paid by DePuy. That’s $168 million in total punitive damages. It is a lot of money.

The jury also awarded “compensatory damages” for the six individual plaintiffs. These are damages meant to compensate individuals for actual injuries. The jury awarded $77 million for such actual injuries as pain and suffering, past and future medical expenses, and other damages. This money award will be divided among the six plaintiffs based on an agreement among the parties.

Finally, the jury awarded the four spouses in the bellwether case “loss of consortium” damages of $1.7 million. Loss of consortium is a claim that arises when a spouse or close family member of the person injured by the defendants suffers separate losses, such as a loss of companionship or intimacy.

The jury in this case found DePuy and J&J intentionally misrepresented the product to the surgeons who would go on to implant the defective devices in patients. The jury also found that the defendants fraudulently concealed important information from the plaintiffs and their surgeons. The jury found that DePuy and J&J failed to adequately warn the plaintiffs and their surgeons about the risks involved in using the artificial hip. Finally, the jury found for the plaintiffs with the claims of design defect, manufacturing defect, and several claims of negligence.

It was another big win for the victims of the DePuy Pinnacle artificial hip.

Fourth Bellwether Trial Was Contentious From the Start

Before the case even started, Defendants asked the Fifth Circuit Court of Appeals to stop the fourth bellwether trial on the grounds that the defendants did not waive their objections to holding the trial outside New York, which is where the plaintiffs lived. In multi-district litigation, the MDL is not permitted to try any case where venue is not otherwise proper unless the parties waive their objections to the improper venue. The DePuy Pinnacle MDL Judge Kinkeade ruled that Defendants had waived their objections to trying the case in the MDL court.

In reviewing the defendants’ writ of mandamus, two of three judges on the Fifth Circuit found that Defendants had not waived their objections. The Fifth Circuit encouraged but did not require that Judge Kinkeade postpone the fourth bellwether trial. Judge Kinkeade decided to move forward with the trial, but this will surely be one ground for appeal by DePuy and J&J.

At the trial Plaintiffs argued that DePuy and J&J rushed the medical device to market, failed to undertake adequate premarket studies, did not provide sufficient warnings about the dangers of the hip implants, and defectively manufactured these MoM artificial hips. Defendants countered that the Pinnacle hip is safe and that the failure rates are in line with industry standards.

Several weeks into trial a startling allegation emerged: that a lawyer for DePuy may have tried to influence the testimony of a surgeon who treated three of the plaintiffs. Dr. David Shein submitted an affidavit on October 14, 2017 stating that a DePuy sales rep was being pressured by DePuy lawyers regarding Dr. Shein’s upcoming trial testimony. Dr. Shein reported that the sales rep said the DePuy lawyers were “on him like crazy” and were putting “big time pressure” on him. According to Dr. Shein’s affdavit, the sales rep stated that “there could be ramifications” for Dr. Shein based on his testimony in the Depuy Pinnacle trial.

Judge Kinkeade ordered an investigation by the FBI and the U.S. Attorneys’ Office. Following a hearing on the issue, Judge Kinkeade denied plaintiffs’ request to introduce the allegation of witness tampering to the jury. The judge decided that there was insufficient evidence that tied DePuy and Johnson & Johnson to the alleged actions of their lawyers. It also appears the DePuy sales rep backed off some of his most alarming comments reflected in the affidavit.

You can read more about the alleged witness tampering here.

Three Pinnacle Hip Bellwether Trials Have Resulted in Huge Awards for Plaintiffs

On March 17, 2016, in the second bellwether trial, a Texas jury awarded five plaintiffs $502,000,000.00, which included $360 million in punitive damages, for the injuries the plaintiffs sustained after the DePuy Pinnacle failed. 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.

On December 1, 2016, in the third bellwether trial, the jury awarded six plaintiffs $1,041,311,648.17, which included $28,311,648.17 in compensatory damages and $4,000,000.00 in loss of consortium damages to the spouses of four of the plaintiffs. Finally, the jury awarded $1,008,000,000.00 in punitive damages total for the plaintiffs, and $1,000,000.00 in punitive damages for the four spouses.

With the fourth bellwether trial now complete, three juries have now awarded $1.79 billion dollars in consecutive bellwether trials. Plainly, several juries have concluded that DePuy and J&J acted with reckless disregard to the safety of innocent people, who simply needed a functioning, non-defective artificial hip.

I believe it is past time for DePuy and J&J to come to the table and offer to settle the thousands of DePuy Pinnacle cases that remain in this litigation.

If you have a DePuy Pinnacle hip that may have failed and injured you, give me a call today.

I will not forget my first jury trial. It was many years ago, not long after I graduated from law school, and let’s just say I was in over my head a bit. It was a simple car crash case. I represented a driver who was rear-ended and injured (but not seriously). I walked my client through his direct examination, and I thought it was going well. Then the insurance defense lawyer was given the opportunity to cross-examine my client. He asked simple questions about the severity of the injuries (“were you able to return to work a week later?”) and after eight or ten of these questions, I objected. The judge peered down at me over his reading glasses:

“Counselor?” “Yes your honor, I object.” “On what grounds?” “This line of questioning is prejudicial.” “Prejudicial?” “Yes, your honor. I move to strike the testimony as prejudicial.”

The judge sat back in his chair. “Mr. Hodges, wouldn’t every question on cross-examination be prejudicial to your case?” This query reminded me of the complete language of Rule of Evidence 403: The court may “exclude relevant evidence if its value is substantially outweighed by a danger of . . . unfair prejudice.” I had remembered most of the rule, but not the key word: unfair. All evidence presented in any court case is supposed to be prejudicial to the other side’s case. To exclude evidence under Rule 403, the testimony must be unfairly prejudicial.

But the judge was still waiting for my answer. The jury waited too. I tried my best: “Well, yes, your honor. But this testimony is unfairly prejudicial.” At least I had finally wedged in the key word. “I don’t think so, counselor, objection overruled.”

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The judge of course was correct. And in most trials, excluding evidence on the grounds of unfair prejudice is difficult. Each side is supposed to present evidence that is aggressively prejudicial to other side’s case. And the prejudicial evidence, even if unfair, can be excluded only if the unfairness substantially outweighs the value of the evidence.

Depuy Appeals to Fifth Circuit

Depuy Orthopaedics, manufacturer of the Depuy ASR hip and the Depuy Pinnacle hip, is arguing to a federal appellate court that it was prejudiced by the evidence presented in a 2016 Depuy Pinnacle trial. That trial ended in a whopping $502 million dollar verdict in favor of five plaintiffs. Depuy’s attorneys now argue to the Fifth Circuit Court of Appeals that Depuy is entitled to a new trial because the plaintiffs’ team had “a strategy” to “inflame the jury through highly prejudicial evidence and wholly inappropriate argument.” For Depuy to win this argument, Depuy must show that the totality of the evidence was not only unfairly prejudicial, but also that the unfairness substantially outweighed its “probative” value (probative is the ability to show or prove something).

Depuy Claims Plaintiffs’ Evidence was “Highly Inflammatory”

Depuy makes many legal arguments in its appeal to the Fifth Circuit. Primarily Depuy argues that the case should have never been allowed to be presented to a jury based on state and federal law, and because the statute of limitations had run for two of the five plaintiffs. I write about the statute of limitations here. I won’t address those arguments in this article (the brief is one hundred pages long), but I wanted to touch on a separate ground for appeal: that Depuy is entitled to a new trial based on “highly inflammatory, irrelevant, and prejudicial evidence” presented by the plaintiffs.

According to the appeal brief, Depuy alleges that plaintiffs’ attorneys referenced payments made by Depuy to “henchmen of Saddam Hussein.” This language is certainly colorful, but plaintiffs presented evidence at the trial indicating that affiliates of Defendants had made improper payments to the Iraqi government. Depuy argues that this evidence was unfairly prejudicial because the issue at trial concerned simply a defective hip product. But the trial judge allowed the improper payment evidence because Depuy made “character” an issue in the trial by referring to the company’s small town values. Plus, the case involved many other claims besides design and manufacturing defects, including a robust punitive damages claim.

Depuy also objects to the plaintiffs’ reading from a book titled Doubt Is Their Product: How Industry’s Assault on Science Threatens Your Health. The book, among other things, analyzed many of the product failures and toxic tort cases that have harmed thousands of people over the years.

Depuy objects as well to the plaintiffs’ attorney referencing a connection between the failure of metal-on-metal hip implants and the potential risk for cancer. Depuy argues that any reference to cancer violated Rule of Evidence 403.

Depuy continues in its appellate brief to object to testimony of “thousands” of other pending Depuy Pinnacle lawsuits. Depuy states that this evidence was inflammatory and unfairly prejudicial.

Depuy also alleges that plaintiffs made unfair reference to a letter written by a former employee accusing other Depuy employees of racism. Racism, Depuy argues, had nothing to do with the defective hips at issue. However, plaintiffs counter that the evidence is presented as character evidence.

Finally, Depuy argues that the attorney for the plaintiffs should not have been allowed to argue “unit of time” in arguing for a standard by which to award damages to the plaintiffs. This is a technique whereby the attorney suggests a method to calculate pain and suffering over time. For example, a lawyer may ask the jury to assign a value to the pain caused by a failed artificial hip over a week or even each day. Defense lawyers hate this concept; they protest that it leads to “excessive verdicts.” Plaintiffs’ lawyers counter that if a person suffers pain each day, then each day has a distinct value when determining pain and suffering damages.

Will Depuy Win Its Appeal?

I would say Depuy has an uphill slog to win this appeal. The brief is certainly well-written. After all, Depuy employs some of the strongest (and highest priced) defense law firms in the country. But at the end of the day, Depuy must show that the value of the evidence presented above was substantially outweighed by the danger of unfair prejudice. Plus, the trial judge gave explicit instructions to the jury about what evidence they could consider and how they could consider it. As the trial judge told me years ago, the evidence presented against my client is supposed to be prejudicial to my client’s case.

I will keep you posted on the outcome of Depuy’s appeal. And if you have a Depuy Pinnacle hip that is causing you problems, give me a call to discuss your legal options.

Note: The appeal brief in this case was one hundred pages long. I have had to distill much information into a brief article. I do not take a position on the evidence presented at trial or to the strength of Depuy’s appellate arguments. This post is for general informational purposes only.

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.

In March 2016 five people injured by the Depuy Pinnacle metal-on-metal artificial hip scored a huge courtroom victory. In that case a Texas jury awarded five plaintiffs $502,043,908.00 for injuries suffered by the failure of the Depuy Pinnacle hip. That figure was divided in different ways to the five injured people. Of that amount, $360,000,000.00 was awarded by the jury for punitive damages. The jury concluded that the Pinnacle hip sold by Depuy was defective and that Depuy knew about the flaws but did not adequately warn patients and their doctors of the risks. Like I said, this was a huge win. Unfortunately, the punitive damages award did not last long.

Judge Forced to Reduce Punitive Damages Award

Punitive damages are money damages, separate from compensatory damages, which are awarded by a jury and which are intended to punish or deter a bad-acting defendant and others from engaging in similar conduct. Judge Kinkeade, who is the federal judge presiding over the Depuy Pinnacle multi-district litigation (MDL), stated that he was bound by a Texas statute which puts a limit or “cap” on the amount of punitive damages a jury can award. Thus, Judge Kinkeade was required by law to reduce the punitive damages award, which a jury of twelve individuals, after a 42 day trial, thought was appropriate.

Thank You, Tort Reform! more

This Texas statute, like many across the country, was enacted in the great tort reform push of the last few decades. Legislators, often pressed by the insurance and big business lobbies, wrote statutes that put caps on the amount of punitive damages that a court could award, no matter what the jury thought was proper and necessary. In Texas, the limit on the amount of punitive damages that can be awarded “may not exceed an amount of two times the amount of economic damages; plus an amount equal to any noneconomic damages found by the jury, not to exceed $750,000; or $200,000, whichever is greater.” So the statute benchmarks punitive damages on the amount of other money damages awarded by the to the injured person. Never mind the fact that the intent of punitive damages is not to compensate the injured person but to send a loud message to the bad acting defendant. Legislatures have essentially said to juries: “we’ll let you know how loud your message can be to a defendant who injures one of our citizens.”

In North Carolina, where I live, there is a similar cap on punitive damage awards. N.C. Gen. Stat. § 1D-25(b) states that punitive damages “shall not exceed three times the amount of compensatory damages or two hundred fifty thousand dollars ($250,000.00), whichever is greater.” I can tell you that this statute has had a chilling effect on injury cases in North Carolina.

So What’s Next in Texas?

Judge Kinkeade reduced the $360,000,000.00 punitive damages award to $9,646,256.00. The five injured persons now have a verdict, after the operation of the Texas statute, of $151,646,256.00, down from the original jury verdict of $502,043,908.00. As astonishing as the original jury verdict was when it was announced in March, this reduction is almost equally stunning. Admittedly this jury verdict still represents a very large award and a big success for the plaintiffs. But the attack on the jury’s verdict is not over. Despite winning a $350,000,000.00 reduction in the jury award, Depuy and Johnson & Johnson immediately filed an appeal in the case, arguing that mistakes were made at the trial level and that the entire award should be voided and a new trial granted. Appeals like this one will take many months to resolve.

Thousands of Depuy Pinnacle Cases Remain

Depuy stopped selling the Pinnacle in 2013. Remember that—unlike the Depuy ASR hip—the Depuy Pinnacle was never officially recalled by Depuy Orthopaedics. Depuy still takes the position that the Pinnacle is different and safer than the ASR hip components. But this latest jury verdict makes it harder for J&J to advance that narrative.

The Depuy Pinnacle system was allegedly designed to provide better range of motion for a more 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. 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 next “bellwether” Depuy Pinnacle case is scheduled to go to trial in September 2016.

The Takeaway

Punitive damages awards play a vital role in consumer protection. If companies 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. And as we’ve seen again and again, companies often rush products to market which they believe will make them great profits. The 510(k) process is one of these shortcuts that have caused unnecessary injuries from many flawed consumer products. Tort reform advocates speak of the protections of business and the money these statutes will save companies and insurance companies. But these legislative limitations come at a cost, and in my view will lead to more careless behavior from profit-first corporations.

In re: DePuy Orthopaedics Inc. Pinnacle Hip Implant Products Liability Litigation, 11-md-02244, U.S. District Court, Northern District of Texas (Dallas).

A request by Depuy Orthopaedics Inc. to delay more trials concerning its Depuy Pinnacle hip implants is pending in the federal court in charge of thousands of cases against the company. The request came from Depuy on May 24. Depuy asks the Court to hold off on further trials until an appeal of one large case tried in March is resolved. That case, which I wrote about here and here, resulted in a stunning $502 million verdict for five people injured by the defective artificial hip components. So Depuy is plainly motivated to delay, if not overturn, the award. If the request is granted it will take much longer for other plaintiffs to have their cases tried, as complex appeals like this one can take years to resolve. As the saying goes, justice delayed is justice denied. I hope federal judge Ed Kinkeade in Texas denies Depuy’s motion. These remaining cases deserve their day in court.

Depuy and the other defendants claim their planned appeal could have “far-reaching implications” on how future cases are tried. Defendants claim the “grounds for appeal are strong” and that they “acted appropriately and responsibly in the design and testing” of the devices.

more $502 Million Dollar Verdict

The jury in the U.S. District Court for the Northern District of Texas in Dallas awarded $142 million for actual damages (harm and losses the plaintiffs suffered). The jury then awarded $360 million in punitive damages (meant to punish defendants for their actions or failures to act) to five plaintiffs. They claim their hips failed and needed to be surgically removed, according to Bloomberg. Depuy’s attorneys claim that under Texas law the punitive damages award should be reduced to about $10 million.

Allegations Against Depuy, J&J

Johnson & Johnson, which owns Depuy, is accused of covering up defects which caused the hips to fail. These defects caused pain and other complications and required additional, “revision” surgeries. The jury found for five plaintiffs, deciding:

• The hips were defective, and
• Depuy knew about the problems, but
• Failed to warn patients and physicians about the risks.

The jury found for the defendants in a sixth case. Depuy claimed that plaintiff’s problems were caused by the physician improperly implanting the hip.

Johnson & Johnson and Depuy are facing about 8,000 lawsuits concerning the Depuy Pinnacle artificial hips. They feature a metal ball and socket joint. Plaintiffs claim the metal-on-metal design grinds together inside the body, releasing cobalt and chromium metals into the blood.

Appeals Take Time

An appeal in a federal case can be costly and time consuming. But the defendants don’t really have a choice after getting crushed with a $502 million dollar jury verdict. And the upside for Depuy and the other defendants can be huge: If they are successful they may avoid paying tens if not hundreds of millions of dollars in damages. These appeals can take a very long time, especially if,

• The losing party eventually appeals to the U.S. Supreme Court, or
• The appellate court agrees with the appeal and orders the cases be re-tried.

If the rest of the artificial hip claims are put on hold until the appeals process concludes it might be years before the next group of cases goes to trial.

These “bellwether” cases have been consolidated in similar groupings to see how they play out in front of a jury.

• As the verdicts are decided the parties have a better idea what their settlement value is, and
• Once the parties have a better grip on that it’s hoped the rest of the cases can be settled without trials.

If the request to delay the rest of the cases is approved the appeal will delay other trials, it could take longer to settle the cases and take more time for thousands of plaintiffs to be fairly compensated. Stay tuned.

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.

more

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.