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.

Fourth Bellwether Trial Underway

The short answer is yes, the fourth bellwether trial began on Monday (September 18, 2017). Six plaintiffs injured by the Depuy Pinnacle hip (and four spouses) are bringing their claims against defendants in Dallas, Texas before Judge Kinkeade. You can read about previous Pinnacle bellwether trials and their huge jury awards here and here.

In the present case, plaintiffs are bearing down on the high failure rate of the Pinnacle Ultamet metal-on-metal artificial hips. Plaintiffs contend that Depuy and Johnson & Johnson 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 poorly designed medical devices. The New York Plaintiffs bring claims for negligence and negligent misrepresentation, fraud, breach of express and implied warranties, and other claims. Plaintiffs seek compensatory damages and punitive damages.

Defendants Depuy and Johnson & Johnson, as you can guess, have countered that the Pinnacle hip is safe and that the failure rates are in line with industry standards. In opening statements, according to reports, Defendants alleged that the Pinnacle is one of the best artificial hips on the market, and that all artificial hips wear down and typically require revision or replacement surgeries. Finally, Defense counsel stated that Depuy relied on reliable scientific evidence at the time, and should not be punished for selling a product doctors and researchers believed was safe.

In considering these defense statements, however, keep in mind that the FDA approved the Depuy Pinnacle metal-on-metal artificial hip for sale by means of the 510(k) process in 2000. Utilizing the streamlined 510(k) procedure, Depuy was not required to undertake clinical trials with the Pinnacle hip. You can read the FDA’s approval letter here. By representing to the FDA that the Depuy Pinnacle hip’s design was “substantially equivalent” to other hip products on the market, Depuy was able to avoid the important safety review required for premarket approval under FDA regulation, including vital clinical trials.

This fourth bellwether trial is expected to last up to two months, so we will not get a jury verdict until November.

Depuy and Johnson & Johnson Tried to Stop Trial

This fourth trial almost did not happen, at least in Texas. It was originally scheduled to begin September 5, but Defendants filed what’s called a writ of mandamus. Let’s stop here for a bit of law school: a writ of mandamus is a petition to a higher court asking for an order requiring a lower court to perform a duty owed to the petitioner. The writ of mandamus is a “drastic” remedy reserved for “exceptional circumstances.” It is granted to a party to a lawsuit when the party establishes that its legal rights will be permanently impaired or stripped away if immediate affirmative action by a higher court is not taken. It is a very high standard to achieve, and in this case the Defendants did not win their petition. 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, where original jurisdiction is situated. In multi-district litigation, the MDL is not permitted to try any case where venue is not proper unless the parties waive their objections to the improper venue. 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. So in that sense, the writ of mandamus was denied.

One word about the decision on the petition for the writ of mandamus: it was no slam dunk. The three judges on the panel each wrote a separate opinion, with one concurring in the result and another dissenting in part. By no means should the decision be read as the last word on the question of the waiver of objections to venue or jurisdiction. In fact, Plaintiffs immediately sought a rehearing on the writ before the full Fifth Circuit. This means that the plaintiffs believe the narrow majority decision was handed down by judges more sympathetic to defendants than to the merits of the writ, and wanted the full Fifth Circuit to rehear the matter. This petition for rehearing was denied, and Judge Kinkeade rescheduled the trial for September 18. Plaintiffs are putting on their case now.

No matter the outcome of the current trial, with the mandamus business it is a certainty that an appeal on the verdict is imminent.

I will keep you posted with trial updates as they happen. And if you have a Pinnacle hip you think may have failed, give me a call.

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.