Texas Jury Orders Johnson & Johnson to Pay More than $1 Billion

Texas Jury Orders Johnson & Johnson to Pay More than $1 Billion

Pinnacle Hip Implants Found to Be Defective

On December 1, 2016, a federal jury in Dallas returned a verdict against pharmaceutical giant Johnson & Johnson and its subsidiary, DePuy Orthopaedics, holding that the company’s Pinnacle hip implant was negligently designed, that the company knew of risks associated with the product, and that the company failed to adequately warn consumers of those risks. The jury awarded six plaintiffs damages in excess of $1 billion-$32 million in compensatory damages and $1 billion in punitive damages. Johnson & Johnson had rejected a $1.8 million dollar settlement offer before trial.

The plaintiffs, who are California residents, say they suffered serious injury after receiving the DePuy product, including bone erosion and tissue death. They allege that Johnson & Johnson and DePuy falsely advertised that the Pinnacle hip implant, with its metal-on-metal design, was more durable and had a greater life than competing products that use plastic or ceramic parts.

Though plaintiff’s attorneys laud the verdict as a “loud and clear” message that Johnson & Johnson needs to address the legal issues related to the Pinnacle implant, most legal experts don’t see any movement any time soon. Attorneys for both companies say they will appeal the verdict and will ask the appeals court to suspend any further trials related to the hip implant.

The company faces more than 8,000 lawsuits tied to the device, all of which have been consolidated in the federal court in Texas. Last week’s verdict was the third “test case” regarding liability for the Pinnacle. Johnson & Johnson were found not liable in the first case, but were hit with a $500 million jury award in the second trial. That verdict was subsequently reduced to $151 million, based on Texas law.

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Huge Verdicts Won’t Spur Settlement Talks In J&J Hip MDL

By Jess Krochtengel

Law360, Dallas (December 2, 2016, 9:52 PM EST) — Although a Texas federal jury hit Johnson & Johnson with a more than $1 billion verdict in the latest bellwether trial over the company’s Pinnacle hip implants, fruitful settlement talks aren t likely to happen before the Fifth Circuit weighs in on J&J’s lengthy list of complaints about trial rulings, MDL experts say.

Pressure on J&J to find a way out of the thousands of remaining cases in the multidistrict litigation may be mounting after a jury on Thursday hit J&J and subsidiary DePuy Orthopaedics Inc. for a total of more than $1 billion in punitive damages and more than $32 million in compensatory damages to six hip implant recipients and some of their spouses. That followed a $502 million verdict in the second bellwether, later reduced to about $150 million, after a defense win in the first bellwether trial.

Yet a global settlement in the MDL is unlikely because J&J doesn t think the bellwether trials have given it a fair estimate of what each plaintiff’s case is worth, lawyers say. J&J has said the verdicts in the two latest trials provide “no guidance on the merits of the overall Pinnacle litigation” because of what it has argued are deeply flawed and unfair procedural and evidentiary rulings from the MDL judge.

“It seems like a situation where you couldn t be farther away from the parties both being in a position to have productive settlement discussions,” said John Sullivan of Cozen & O Connor LLP. “I can t imagine a less likely scenario for settlement than here.”

About 9,300 lawsuits involving the Pinnacle hip system’s Ultamet metal-on-metal implant have been filed in state and federal courts around the country, most of which are consolidated in an MDL presided over by U.S. District Judge Ed Kinkeade in Dallas.

Plaintiffs generally allege DePuy and J&J pushed to market a poorly designed product that injured them after friction between the device’s metal socket and metal ball head caused microscopic particles of metal to shed into their bodies. J&J has maintained it acted appropriately and responsibly in the development, testing and marketing of the Ultamet product.

The first bellwether trial, involving a single plaintiff from Montana, ended in a defense win. The second bellwether consolidated five plaintiffs from Texas, who won a $502 million verdict that was later reduced to about $150 million under a Texas law that caps punitive damages.

In the third bellwether, jurors deliberated for less than a day following a two-month trial before awarding each of six California plaintiffs between $4 million and $6 million in actual damages. The jury also found each plaintiff entitled to $84 million from DePuy and $84 million from J&J, bringing the total damages award to more than $1.04 billion.

Diane Lifton of Hughes Hubbard & Reed LLP said her immediate reaction to hearing about the $1 billion verdict or any verdict of comparable size is to look to see what evidence was in front of the jury and what the companies concerns are about that evidence.

“It suggests to me that there may be evidentiary concerns about what went before the jury,” Lifton said.

In both the second and third bellwether trials, evidentiary rulings prompted multiple mistrial motions from J&J and DePuy, which have suggested to the Fifth Circuit that Judge Kinkeade allowed a virtual free-for-all in the second trial, allowing in prejudicial and inflammatory evidence. The plaintiffs have told the Fifth Circuit the verdict in the second trial was a reflection of a jury holding companies accountable for prioritizing profits above patient safety, not the result of a flood of prejudicial evidence.

In July, the Fifth Circuit rejected J&J’s request for an expedited appeal of the second bellwether and the appellate court also declined J&J’s request to stop the MDL court from holding the third trial while the appeal was pending.

“I think until the appellate issues are resolved with respect to the evidence presented to the jury, it will be difficult to reach a global resolution of the cases,” Lifton said.

In the third trial, controversial evidence included the mention of an $84 million deferred prosecution agreement J&J entered to end an investigation into alleged kickbacks. That piece of evidence and a witness subsequent testimony that J&J paid the settlement to make a “headache” go away played a central role in the plaintiffs closing argument and appears to be directly reflected in the jury’s $84 million-per-plaintiff punitive damages award.

Sullivan said before it considers settling the MDL, J&J will want the Fifth Circuit’s take on whether evidence like the deferred prosecution agreement can be admitted during trial. The company has a valid concern that prejudicial evidence without a tangible relationship to the injuries sustained by the plaintiffs could unduly ratchet up a jury verdict, he said.

“It’s just a concern when you see a $1 billion verdict,” Sullivan said. “It’s hard not to seriously consider whether those issues did affect the verdict.”

Max Kennerly of Kennerly Loutey LLC, who represents plaintiffs in product liability and medical malpractice cases, brushed off the complaints about the bellwether trials as “bluster” from J&J that won t ultimately stop the parties from settling the MDL. Even if it genuinely believes it was prejudiced at the bellwethers, the company should still act rationally, as it did when it reached a $2.5 billion global settlement related to DePuy’s ASR line of hip implants, he said.

“Johnson & Johnson always has an excuse for why they can’t begin reasonable settlement discussions,” Kennerly said. “They have an excuse for why they can’t settle the Ethicon mesh cases, an excuse for why they can’t settle the Risperdal cases and now an excuse for why they can’t settle the Pinnacle cases. It’s all bluster. At some point, they’ll either come to their senses, or their shareholders will make management come to their senses.”

Lawyers say even taking the splashy punitive award out of the picture, the jury verdict in the third bellwether still won t serve as a strong platform to launch settlement talks.

The jury awarded $4 million to plaintiffs who had one hip implant, plus their individual medical bills, and awarded $6 million plus medical bills to plaintiffs who had two implants.

Lifton said that kind of result makes it impossible to discern which aspects of the plaintiffs individual circumstances affected the jury, so it’s difficult to use them as a basis for valuing the thousands of remaining cases.

“Another concern one might consider with these verdicts all being the same size is that a case involving more challenging facts can affect the outcome of a case with less significant damages they all get taken along for the ride and it’s impossible to tease out what the jury’s reaction was to each part of the case and each scenario,” Lifton said. “That’s why you ll hear arguments among the defense bar against these kinds of consolidated trials.”

Yet Michael Walsh of Strasburger & Price LLP said that although the compensatory damages awards to each plaintiff were probably too high, they are not so unreasonable that they can t be the basis for the beginning of a settlement discussion so long as the punitive awards remain off the table. The MDL docket is so massive, he said, the defense has to face the question of at what point do they try to clear it out and leave trials for cases they have a better chance of winning.

“Perhaps the prudent thing to be looking at is, it’s a big monster litigation and the numbers are huge but this is not the first time we ve seen this,” Walsh said. “I don t know that the compensatory damages are so completely out of whack that there’s no expectation meaningful progress can be made in getting rid of some subset of cases.”

Still, the punitive damages award is part of the case, and juries in two trials have decisively found the companies liable for wrongdoing, Walsh said. With the punitive awards what they are, even if the trial judge did pare back the verdict before entering judgment, Walsh said, he “can t see that there’s any number that would lead to settling the docket.”

While the gears of the appellate process grind, the parties are facing their next trial date. Judge Kinkeade set the fourth bellwether for September and has named 10 plaintiffs, each from New York, whose cases should be prepared for the trial.

J&J has said it will “continue to urge that no further trials be conducted until we receive appellate court guidance.”

But because the Fifth Circuit rejected the company’s request after the second bellwether, lawyers are skeptical the $1 billion plaintiffs verdict is enough to change the appellate court’s mind about putting future trials on ice.

“If the Fifth Circuit didn’t intervene before this trial, I see no reason why they would intervene after it either,” Kennerly said. “This trial didn’t raise any issues substantially different from the first trial. In my opinion, the size of the verdict doesn’t change that analysis.”

Walsh said he thinks the verdicts are sizable enough that they should have gotten the Fifth Circuit’s attention about potential problems with the bellwethers, but doesn t expect to see the court stop future trials.

“If $500 million didn t get their attention, $1 billion isn t going to get their attention,” he said. “If it were $1 trillion, maybe.”

The patients are represented by W. Mark Lanier of The Lanier Law Firm, Richard Arsenault of Neblett Beard & Arsenault, Jayne Conroy of Simmons Hanly Conroy LLC and Khaldoun Baghdadi of Walkup Melodia Kelly & Schoenberger, among others.

DePuy and Johnson & Johnson are represented by Steve Quattlebaum of Quattlebaum Grooms Tull & Burrow PLLC, John Anderson of Stoel Rives LLP, Dawn Estes of Estes Thorne & Carr, Michael Powell and Seth Roberts of Locke Lord LLP and Stephen J. Harburg, John H. Beisner, Jessica Davidson Miller and Geoffrey M. Wyatt of Skadden Arps Slate Meagher & Flom LLP.

The MDL is In re: DePuy Orthopaedics Inc. Pinnacle Hip Implant Products Liability Litigation, case number 3:11-md-02244, in the U.S. District Court for the Northern District of Texas.

–Editing by Mark Lebetkin and Jill Coffey.

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Wood Flooring from Lumber Liquidators Can Cause Cancer

You would never expect that your beautiful new wood flooring could potentially cause serious harm to you and your family. But, earlier this month, the Center for Disease Control released a report stating that certain laminate flooring sold by Lumber Liquidators contains excessive amounts of formaldehyde. Exposure to the flooring could cause cancer, complications with asthma or COPD, and irritation to a person’s eyes, nose, and throat. You can find the CDC report online at http://www.cdc.gov/nceh/laminateflooring/default.html.

Formaldehyde is commonly used in the flooring industry as a binding agent, but there are strict limits on how much of the chemical can be used. The CDC report confirms a 60 Minutes investigation that found Lumber Liquidators’ laminate flooring exceeds these limits and that the Chinese factories supplying the flooring mislabeled the products as meeting stringent health standards.

Although the laminate top is meant to contain the formaldehyde typically used, the excessive amount found in the Lumber Liquidators laminate flooring escapes and puts people at risk. According to Denny Larson, the expert consulted in the 60 Minutes investigative report, the risk is made greater due to the fact that you are living with it on a daily basis. You’re in a chamber so you’re living with it. You’re sleeping in there. And you’re constantly exposed. That’s the threat. The constant exposure to a potent carcinogen …

The CDC strongly stress[es] taking steps to reduce exposures, which should alleviate respiratory and eye, nose and throat irritation. These steps should also reduce the cancer risk. The only way to reduce your exposure is to remove the risk.

If you purchased and installed Lumber Liquidators laminate wood flooring, you should contact us immediately. Together, we can determine your potential risk and we can help you recover your economic damages to rip out and replace the dangerous flooring.

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IS FASTER BETTER AT THE FDA?


The FDA has proudly patted itself on the back, again. It announced that its 36-point Plan of Action to streamline and speed up the pre-market approval process for medical devices is a success! How do you streamline and speed up the pre-market approval process for medical devices, at what risk to the consumer, and why would any consumer want to increase any potential risk that this might cause? Well, the consumers did not ask for it, the medical device manufacturers did, and consumers were not asked if they wanted a streamlined process or what that streamlined that process would look like.

The FDA tells us now that streamlined process is a 2 year initiative that was created to deal with complaints by the device manufacturers about the amount of time it was taking the FDA to approve their medical devices so it could start making money from their sales. The manufactures complained about the lengthy application approval review process and resulting backlog of medical device applications. So the FDA sought to and has reduced the average time it takes to clear an application, reduced the backlog of applications and reduced the amount of time it takes to reach a decision on the applications. To the FDA, it was not a matter of making the process more efficient. The FDA shortened the approval process itself. Here is the result:
The percentage of submitted applications that are approved have increased 10% from its low in 2010 when this initiative was begun, a rate that had been declining since 2004. The percentage of filed pre market approval applications that are approved has risen 20% from its 2010 low, which rate had been declining since 2005.

One more very interesting and telling fact: The percentage of applications in which the FDA requested additional information from the manufacturer during the 1st review cycle under this initiative has begun to decrease, following a steady rise from 2002 through 2010.

So, with the device manufacturers’ help the FDA figured out that what was bogging down their approval process was the FDA’s diligence in making sure the medical devices seeking approval were safe. To successfully speed up the approval process, the FDA requested less information from the manufacturers regarding the devices safety.

If you ever doubted that the medical device manufacturers lobby the FDA, or the extent to which it lobbies the FDA, doubt no more. The device manufacturers lobby efforts have emasculated the rigid approval process that while it slowed the process down – protected consumers from unreasonable dangerous medical devices. This increased risk is compounded by the U.S. Supreme Court’s check of state tort law protections that provided recourse to hold a medical device manufacturer responsible for serious injuries or death caused by and unsafe products.

Faster is not better in an application review system’s checks and balances designed to protect innocent consumers. Fast track medical device approvals from the FDA’s asking less questions of the manufacturers about the safety of their products is not good public policy and does not protect consumers. Just as fast dogs that chase cars are sure to get hit, medical devices that race through an abbreviated approval process sure to seriously injury and kill innocent consumers.

Faster is not better. Questions regarding safety have to be asked and answered until the FDA is confident that the medical device is safe, even if it slows the approval process. The FDA is charged with the responsibility of policing the drug and medical device companies and protecting the public health. It has to assure the safety, effectiveness, and security of medical devices.

It cannot put innocent consumers at risk of serious injury or death to appease the device manufacturers and their lobby. The process of taking the time needed to ask important questions and get answers about the risks of medical devices cannot be shortened at the innocent consumer’s expense. Had the FDA asked consumers about the short cuts that were taken that could put them at risk for serious injuries and death, they surely would have told them they did not want the FDA to lower the bar for a medical device to be approved.

Again, the FDA claims it has not lower the bar for a medical device to be approved. It only sped up the approval process by requesting less information from the manufacturers regarding the medical devices safety.