Jurado de Texas Ordena a Johnson & Johnson Pagar Más de $1 Billón

Jurado de Texas Ordena a Johnson & Johnson Pagar Más de $1 Billón

Implantes de Cadera Pinnacle Se Encontraron Defectuosos

El 1 de Diciembre del 2016, un jurado federal en Dallas regresó un veredicto en contra del gigante farmacéutico Johnson & Johnson y su subsidiaria, DePuy Orthopaedics, diciendo que el implante de cadera Pinnacle de la compañía fue diseñado negligentemente, que la compañía sabía de los riesgos asociados con el producto y que la compañía falló en advertir adecuadamente a los consumidores de esos riesgos. El jurado premió a seis demandantes por daños por más de $1 billón – $32 millones en daños compensatorios y $1 billón en daños punitivos. Johnson & Johnson ha rechazado la oferta de acuerdo de $1.8 millones de dólares antes del juicio.

Los demandantes, quienes son residentes de California, dicen que sufrieron lesión seria después de recibir el producto DePuy, incluyendo erosión ósea y muerte de tejido. Ellos alegan que Johnson & Johnson y DePuy falsamente publicitaron que el implante de cadera Pinnacle, con su diseño de metal en metal, era más durable y tenía más vida que los productos competidores que utilizan partes de plástico o cerámica.

Aunque los abogados de los demandantes alabaron el veredicto como un mensaje “fuerte y claro” de que Johnson & Johnson necesita abordar los asuntos legales relacionados al implante Pinnacle, la mayoría de los expertos legales no ven ningún movimiento pronto. Los abogados de ambas compañías dijeron que apelarán el veredicto y pedirán que la corte de apelaciones suspenda cualquier juicio relacionado al implante de cadera.

La compañía se enfrenta con más de 8,000 demandas ligadas al dispositivo, todos de los cuales han sido consolidados en la corte federal en Texas. El veredicto de la semana pasada fue el tercer “caso de prueba” acerca de la responsabilidad de Pinnacle. Johnson & Johnson fue encontrado no responsable en el primer caso, pero le pegaron con un premio del jurado de $500 millones en el segundo juicio. El veredicto fue reducido subsecuentemente a $151 millones, basado en la ley de Texas.

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

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.

View original article »

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Revista de Medicina de New England: No derogar el impuesto de dispositivo médico

El siguiente importante y revelador artículo es proporcionado como escrito de la página de Dispositivo Masivo Dispositivo Masivo, el cual proporciona a sus subscriptores con “Noticias e información para la industria de dispositivos médicos y las compañías que lo manejan”.

April 25, 2013 by Brad Perriello

Un par de doctores de la Escuela de Medicina de Harvard pondera que el impuesto de dispositivo médico en la Revista de Medicina de New England, metiendo duda en los argumentos de los oponentes y diciendo que no debe ser derogado.

Un par de doctores de la Escuela de Medicina de Harvard dicen que el impuesto en el dispositivo médico no debe ser derogado, escribiendo en la Revista de Medicina de New England ayer que es un bastión importante en la ley de reforma del cuidado de la salud.

En una pieza de op-ed de la revista médica, los doctores dicen que los argumentos para derogar el impuesto es que llevará a los inversionistas en tecnología médica fuera del país, costándole a América trabajos y ahogar la innovación, y es sin mérito. Y aunque si algunos de esos argumentos son válidos, Kramer y Kesselheim argumentan que,los beneficios de la reforma del cuidado de salud sobre pesa cualquier daño del impuesto.

“Perder las ganancias que podrían haber proporcionado por el ejercicio del impuesto en dispositivos médicos no causarían que [El Acta de Cuidado Rentable ACA] se desmoronara, pero podría enviar una señal poderosa a otros grupos y sus lobistas acerca de la vulnerabilidad de la ley a una erosión fragmentaria. Resolviendo el conflicto sobre el impuesto del dispositivo, luego, puede o fortalecer el ACA y su empuje loable al cuidado de la salud universal o debilitar a ambos antes de que el progreso comience realmente”, escriben los Drs. Daniel Kramer y Aaron Kesselheim, quienes su revelación revela los subsidios del Centro para Dispositivos & Salud Radiológica, la Fundación de Robert Wood, la Agencia de la Investigación y Calidad del Cuidado de la Salud y los Fideicomisos de Caridad Pew y el Centro de Catálisis Clínico y Ciencia Traslacional de la FDA.

Kramer y Kesselheim argumentan que las ganancias anuales de $2 billones a $3 billones del impuesto del 2.3% en las ventas de Estados Unidos de dispositivos médicos es una parte importante del financiamiento para la ley de reforma del cuidado de la salud, estimado a $100 billones anuales y también las ventas anuales estimadas por la industria de los dispositivos citado por los autores. Las predicciones de la industria acerca de los efectos del impuesto, especialmente argumentos por el lobby nacional AdvaMed, acerca de su impacto en el empleo de tecnología médica, compañías de pequeñas a medianas e innovación, se prueban.

“Aunque algunas de estas demandas pueden ser válidas, las predicciones acerca de los efectos dañinos del impuesto en la industria de dispositivos descansan en varias posiciones sin probar. Las decisiones acerca de los despidos son difíciles de seguir a solo cambios de la política. Acerca de estar fuera del país, no es claro cómo el impuesto proporcionaría un incentivo para mover la producción fuera del país, ya que aplica a ventas domésticas del sitio de fabricación. Y desde que las ventas internacionales permanecen sin afectarse por el impuesto, la competitividad de las compañías de Estados Unidos fuera del país no deben de ser embargados”, escriben Kramer y Kesselheim. “Además, las ganancias de compañías individuales pueden ser preservadas cambiando los costos a los consumidores, una táctica que será asistida por la expansión del seguro a millones de pacientes nuevos.

“El argumento que ejercitar el impuesto podría dañar la innovación es quizá lo más difícil de probar o de desbaratar, por la relación entre las ganancias e innovación no es derecha. Ciertamente, las ganancias de una compañía fundan su investigación y desarrollo, pero no hay evidencia que un impuesto pueda afectar estas inversiones”, escriben.

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¿Qué tienen en común un Pulpo y la FDA? Ambos tienen ocho piernas.


“FDA” quiere decir: Food and Drug Administration (Administración de Comida y Drogas). Mientras que la mayoría de los americanos ven a la FDA como el brazo policiaco de las drogas, hace mucho más y sus responsabilidades son amplias y variadas. Trata con comida para humanos y animales, drogas o medicamentos, dispositivos médicos, dispositivos emisores de radiación vacunas, sangre y biológicos, cosméticos y tabaco. La mayoría de lo que la FDA hace no es lo que pensamos que pasa el tiempo.

La FDA reportó que en los primeros 3 meses del 2013, retiró del mercado 46 productos comestibles para humanos. Esto es 3 veces el número de productos comestibles animales y veterinarios que se retiran del mercado y más de 4 veces que las drogas que ha retirado del mercado. Más allá, es 23 veces más alto que los dispositivos médicos que ha retirado.

RETIROS DEL MERCADO DE LA FDA Enero 1 2003 – Marzo 26 2013

  • 46 COMIDA
  • 10 DROGAS
  • 02 DISPOSITIVOS MEDICOS
  • 0 PRODUCTOS EMISORES DE RADIACION
  • 0 VACUNAS
  • 0 SANGRE & BIOLOGICOS
  • 14 ANIMAL & VETERINARIO
  • 0 COSMETICOS
  • 0 TABACO

Claramente, cada una de estas responsabilidades es importante para la salud y seguridad humana. Es increíble que la FDA ha dedicado tanto tiempo, energía y recursos en asegurarse que nuestra comida es seguro, sin mencionar el número de retiros del mercado que tiene para mantenerlo de esa manera. Por una simple extrapolación, podría ser esperado que para el final del 2013, la FDA haya retirado del mercado 184 productos alimenticios, 40 drogas, 8 dispositivos médicos y 56 productos animales & veterinarios. Nadie debe de creer que esto significa que las drogas son más seguras que la comida. Seguramente no. Recuerde que todas las drogas tienen efectos secundarios. La FDA se involucra cuando recibe información que una droga en particular está causando efectos no dados a conocer a la FDA en el proceso de aprobación o pre-aprobación, o cuando los reportes de efectos secundarios conocidos son más de los que se representan por el fabricante de la droga.

Pongamos esto en perspectiva:

  1. la FDA emitió 10 retiros del mercado en los primeros 3 meses del 2013
  2. La FDA emitió 13 alertas de seguridad para productos médicos humanos y 12 para dispositivos médicos por el mismo periodo.
  3. La FDA ha tomado alguna acción 35 veces en el 2013 en drogas y/o dispositivos. Esto es únicamente 5 acciones menos que tomó en productos de comida.
  4. La FDA seguramente ve cien mil más de productos de comidas que de drogas y dispositivos.
  5. Los números de retiros del mercado y alertas de seguridad en drogas y dispositivos es mucho más grande que cualquier otra acción que la FDA toma en otras áreas de responsabilidad.

La importancia de cada una de las funciones de la FDA no puede ser exagerado en su responsabilidad para proteger y avanzar en salud pública.

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"€œRegrettable Human Error"

A November 5, 2007, Associated Press story reported that under government pressure, Bayer AG said that it was immediately halting worldwide sales of its antibleeding drug Trasylol. The Food and Drug Administration asked Bayer to stop selling the drug it approved in 1993 that is used to prevent excessive bleeding during heart bypass surgery, pending detailed review of preliminary results from the Canadian study. This decision came only after a Canadian clinical study found Trasylol could be linked to a higher risk of death than other drugs. In a rare move, Mr. John Jenkins, director of the FDA’s Office of New Drugs, said during a briefing Monday that the “FDA cannot identify a specific patient population where we believe the benefits of using Trasylol outweighs the risk.”

What prompted the FDA to act was its re-evaluation of the drug’s safety after the January 2006 publication of two studies that linked the drug’s use to serious side effects, including kidney problems, heart attacks and strokes. The 1993 approval was overshadowed by Bayer’s withholding one of those studies from the FDA. A Bayer company investigation later characterized the withholding of the study results as a “regrettable human error.” Not surprising, Bayer’s News Room page of Bayer’s website did not disclose that.

Why would Bayer withhold this kind of information from the FDA? After all, its Mission Statement includes among its values, Integrity, openness and honesty.

Bayer’s Corporate Policy also states, in pertinent part, the following:

We believe our technical and commercial expertise entails a duty to contribute to sustainable development a principle we wholeheartedly endorse, mindful of its social, ethical and environmental elements. In awareness of our responsibilities as a corporate citizen, we define economy, ecology and social commitment as objectives of equal rank.

The answer is simple and can be stated in one word: PROFITS. By withholding damaging information about one of its profit centers, Bayer protected its profits at the expense of human life. Plainly put and restated, Bayer put profits over people.

Bayer AG said it was a regrettable human error when it was caught withholding required information from the FDA and/or misrepresenting required information to the FDA that was material and relevant to the performance of the product. When viewed objectively from the standpoint those Bayer executives who made the decision to withhold this important information from the FDA, it involved an extreme degree of risk, considering the probability and magnitude of the potential harm to those who were treated with Trasylol. To say it was simply regrettable human error is meant to soften any repercussion from their actual, subjective awareness of the risk involved, as well as their proceeding forward with those decisions with conscious indifference to the rights, safety, or welfare of those consumers who were exposed to Trasylol, not to mention the physicians who treated their unsuspecting victim-patients with Trasylol.

We all understand and accept that to err is human. However, when corporations violate federal laws and regulations for no other discernable reason than its bottom line, it is neither acceptable nor human error. Further, good corporate citizens do not mask their misdeeds and malfeasance by minimizing them as human errors. Bayer’s putting œregrettable in front of œhuman error to soften the blow of its illegal, immoral and unethical activities is patently offensive, not apologetic; it is patronizing, placating, dilatory and evasive. It is a shallow, shadowed, feeble attempt at putting a human face on it’s the wrongs it has committed against all of us.

As a trusted corporate America giant whose over the counter pain reliever (Bayer Aspirin) is in every American household, Bayer cannot be allowed to use such an otherwise perfectly acceptable adjective in such a patently offensive manner. Regrettable human error may be in some contexts, mere oversight, inattentiveness, or poor judgment. Not here: Withholding negative results of a scientific study that shows Trasylol causes serious, permanent and often deadly injuries is much more than mere oversight, inattentiveness, or poor judgment. It is patently offensive. Corporations like Bayer AG cannot hide behind and be insulated by the thousands of people it employs from their unforgivable neglect and malice, acts or omissions. It is not regrettable that Bayer should have to answer and take responsibility for its actions.

My legal advice to you is simple: Before you tell any judge that your intentional violation of a federal law was simply the result of regrettable human error, make sure you have a new toothbrush with you.

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