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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BLIND IF YOU DO AND BLIND IF YOU DON T


Think Glaucoma’s blindness is bad? What about the eye problems/infections, including possible blindness complications that could come from a defective drug used in glaucoma surgery? At least the glaucoma is treatable with surgical procedures.

Mobius Therapeutics, LLC issued a voluntary recall of its Mitosol® (mitomycin for solution Kit for Ophthalmic Use on January 10, 2013. Mobius Therapeutics, recalled lots of its Mitosol® (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use due to the fact that it could not exclude the possibility that the affected lots may be non-sterile and unsafe for use.
Mitosol is an antimetabolite product used in ab externo glaucoma surgery where the incisions are made from the outside of the eye inward. A non-steril dose of this product could result in serious eye problems/infections, including possible blindness. Mobius says it has not received any reports of adverse events related to this recall, but there are thousands of affected doses. The impacted product is identified below:
NDC # Lot # Exp Date
49771-002-01 M098260 08/2013
49771-002-01 M086920 08/2013

Further, these lots were distributed for a 2 month period in the following states:
AL, AR, DE, GA, IL, IN, MA, MD, ME, MI, MN, MO, NC, NJ, NY, OH, PA, TN, VA, & WI
between the dates of 10/22/2012 and 12/14/2012.

What caused the defective non-steril product? Poor manufacturing practices. If you or a loved one suffered serious eye problems/infections, including possible blindness after glaucoma surgery between October 22, 2012 January 10, 2013, it may be related to this product defect.

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MORE THAN A HILL OF BEANS

If you have a civil case against a drug company for compensation for personal injuries that you claim were caused by its drug, the fact that that same drug company was fined millions or even billions of dollars does not mean that your case will settle for that much money, that it will settle sooner, or that it will settle at all.

The fact is that from 1991 through 2012 total nearly $20 Billion in fines were levied by the US Department of Justice against the giant drug companies. However, these Justice Department fines do not in and of themselves effect the settlement of civil tort lawsuits. It just doesn t mean a hill of beans to these giants. The practices of illegal promotion and failure to disclose safety data that got them into trouble with the Justice Department is just part of the blockbuster, billion dollar profit game for these companies, and to them, these fines are merely the price of doing business. So, too, are the settlements they pay in civil tot lawsuit settlements. Bad corporate citizens break state and federal, civil and criminal laws. They do it knowingly. They know they will get caught. They voluntarily pay these huge fines and settlements.

If it sounds cold and cavalier, it is. Giant drug companies do put profits over people. However, as to your civil tort lawsuit, as bad as it may all sound, none of it is likely to be heard by a jury. The reason is two fold: This information is not relevant or probative.

That it is not relevant means that these bad acts of illegal, off-label promotion are not directly related to the tort laws used in the individual personal injury cases. The most frequent offense of off-label promotion is the marketing of drugs to physicians for uses not approved by the FDA. It is, for sure, a common practice. The drug companies call it positioning the drug for uses in addition to those approved by the FDA to physicians who can legally prescribe drugs for non-FDA approved uses. That’s right, the drug company cannot tell the doctors about the non-FDA approved uses of their drugs but the doctors can legally prescribe them for non-FDA approved uses. While drug giants deny, justify and explain away this practice, the Justice Department sees it as illegal and imposes fines that the drug giants call the cost of doing business. The bottom line is that the practices and fines have nothing to do with the allegations and injuries in the civil tort lawsuits.

Also called mass tort litigation, civil tort lawsuits use state tort laws to impose civil penalties or fines through obtaining civil judgments and settlements. This civil arm of enforcement focuses on the drug companies failure to fairly and complete disclose all of the know risks of their drugs. The question in civil tort cases is what did the drug company know about the serious risks, when did they know it, and did they fully and accurately disclose all of those serious risks. More frequently than not, these three questions answers reveal that the serious risks were not fully and accurately disclosed. The defense of these cases focuses on the legal issues of general causation (Can this drug cause the injury(ies) in question?) and specific causation (Did this drug cause a specific person’s injury(ies)?) and ultimately, settlements are reached.

So fines levied against the drug giants for conduct not related to the civil personal injury case will never be heard in the trial of your case because they are not relevant to your case and will not be available to show what a bad corporate citizen the manufacture of the drug that hurt you is.

That it is not probative means that the court might determine that the value of the information of a fine for prior conduct to prove a tendency toward committing the offenses at issue in the civil case may be outweighed by its potential prejudicial effect.

In conclusion, do not get excited if you see headlines that a corporate citizen that you have a civil suit against has paid a Justice Department fine. The two are not related and payment of a fine doesn’t make a hill of beans to these giants.

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Company – Settlement – Violation(s) – Year – Product(s) – Laws allegedly violated (if applicable)

GlaxoSmithKline – $3 billion – Off-label promotion/failure to disclose safety data – 2012 Avandia/Wellbutrin/Paxil – False Claims Act/FDCA

Pfizer – $2.3 billion – Off-label promotion/kickbacks – 2009 – Bextra/Geodon/Zyvox/Lyrica – False Claims Act/FDCA

Abbott Laboratories – $1.5 billion – Off-label promotion – 2012 – Depakote – False Claims Act/FDCA

Eli Lilly – $1.4 billion – Off-label promotion – 2009 – Zyprexa – False Claims Act/FDCA

TAP Pharmaceutical Products – $875 million – Medicare fraud/kickbacks – 2001 – Lupron – False Claims Act/Prescription Drug Marketing Act

Amgen – $762 million – Off-label promotion/kickbacks – 2012 – Aranesp – False Claims Act/FDCA

GlaxoSmithKline – $750 million – Poor manufacturing practices – 2010 – Kytril/Bactroban/Paxil CR/Avandamet – False Claims Act/FDCA

Serono – $704 million – Off-label promotion/kickbacks/monopoly practices – 2005 – Serostim – False Claims Act

Merck – $650 million – Medicare fraud/kickbacks – 2008 – Zocor/Vioxx/Pepsid – False Claims Act/Medicaid Rebate Statute

Purdue Pharma – $601 million – Off-label promotion – 2007 – Oxycontin – False Claims Act

Allergan – $600 million – Off-label promotion – 2010 – Botox – False Claims Act/FDCA

AstraZeneca – $520 million – Off-label promotion/kickbacks – 2010 – Seroquel – False Claims Act

Bristol-Myers Squibb – $515 million – Off-label promotion/kickbacks/Medicare fraud – 2007 – Abilify/Serzone – False Claims Act/FDCA

Schering-Plough – $500 million – Poor manufacturing practices – 2002 – Claritin – FDA Current Good Manufacturing Practices

Schering-Plough – $435 million – Off-label promotion/kickbacks/Medicare fraud – 2006 – Temodar/Intron A/K-Dur/Claritin RediTabs – False Claims Act/FDCA

Pfizer – $430 million – Off-label promotion – 2004 – Neurontin False Claims Act/FDCA

Cephalon – $425 million – Off-label promotion – 2008 – Actiq/Gabitril/Provigil – False Claims Act/FDCA

Novartis – $423 million Off-label promotion/kickbacks – 2010 – Trileptal – False Claims Act/FDCA

AstraZeneca – $355 million – Medicare fraud – 2003 – Zoladex – Prescription Drug Marketing Act

Schering-Plough – $345 million – Medicare fraud/kickbacks – 2004 – Claritin – False Claims Act/Anti-Kickback Statute