Washington v. Teva (Las Vegas, Nevada)

Pharmaceutical giant Teva’s Las Vegas nightmare continued with a third consecutive $100M+ verdict in the Propofol endoscopy center Hepatitis C litigation.

Washington v. Teva involved different plaintiff attorneys and different defense attorneys from the first two trials, Chanin and Sacks, but the result was similar — $104M in damages.

Richard Friedman (Friedman Rubin) described to the jury the 1995 New England Journal of Medicine article noting infection clusters associated with Propofol use, and the reasons why Propofolwas more likely than prior types of anesthesia to result in outbreaks. “Over the last two decades,” said Mr. Friedman, “the public health authorities have recognized this is a really big deal. And the only people who don’t think it’s a big deal are the witnesses hired by the defendants.”

According to Mr. Friedman, the Centers for Disease Control determined in the 1990′s that the heart of the problem was 50ml and 100ml vials, which looked like multidose vials. The use of the larger vials resulted in the spread of disease because health care providers might use just 15ml of Propofol for one patient. Then, rather than waste the remaining 35ml in a 50ml vial, they would use the same vial with a new needle for the next patient. Even with the new needle, contamination could occur. The CDC suggested that “ideally, the 50- and 100-ml vials should be eliminated or modified so they cannot be used in this manner.”

“Even back in 1995,” said Mr. Friedman, “twelve years before Mr. Washington was infected, the Centers for Disease Control, the medical community…recognized that to have these outbreaks of infections you needed two things. You needed a vial big enough, and you needed a nurse, doctor, medical practitioner, busy enough, uneducated enough, in a hurry enough, or just human enough, to make the mistake of going into the vial more than once.”

“Before they came out with their own product, [Teva was] aware of the dangers of a 50- and 100ml vial, and we know that because they specifically told the FDA about those dangers [when applying for permission to sell a 20ml pre-filled syringe]. They knew if they came out with a 50- or 100ml vial people were going to multidose. They knew if they came out with a 50ml vial people were going to get sick. They knew if they came out with a 50ml vial, people were going to die. It wasn’t a question of if. It was only a question of when. The record at that point was already clear.”

“What you’re going to hear,” said Mr. Friedman, “is that while they were citing the New England Journal article and the CDC studies to the FDA to get permission to get a competitive advantage by making a 20ml pre-filled syringe, already filled with product, with a cap at the top, so there’s no ability to contaminate it…There was also a lot of money to be made on the 50s and the 100s. So on April 19, 1999, [Teva] launched their version of Propofol. And what they launched were..100-, 50-, 20ml vials, and the pre-filled syringe.”

Teva’s timely knowledge of the risk was apparent, said Friedman, because in May, 2000 — seven years before Mr. Washington was infected out of a 50 ml vial — Teva’s head of sales, Craig Lea, asked the FDA for permission to sell a 10ml vial and specifically stated that 10ml was closer to a typical dose and would “reduce the temptation and the opportunity for dosing patients from a single drug container. This is critically important…[to] enhance patient safety.”

The problem became acute, said Mr. Friedman, when demand for Propofol was so strong that Teva had difficulty producing enough product. Because the production lines could fill 10ml and 50ml vials at about the same speed, the 50ml production lines were approximately five times more profitable because they could produce five times more product. As a result, Teva began to emphasize the larger vials in its product line.

For Teva, Glenn Kerner (Goodwin Proctor) told the jury, “This case is not about Propofol. It’s not about a defective product.  It’s about a defective clinic.” What happened to Mr. Washington was the result of the “disgraceful” conduct of the clinic’s owner, Dipak Desai, and none of the defendants in the case was responsible, said Mr. Kerner. The Propofol was not recalled, nor was there any manufacturing problem. The Propofol manufactured by Teva and sold by Baxter performed exactly as it was supposed to — there was no malfunction. Each and every vial was clean, sterile, and free from contamination when it arrived at the endoscopy center.

“There’s nothing wrong with a multi-dose vial. Multi-dose vials don’t spread disease,” said Mr. Kerner. “What went wrong begins and ends with Dr. Desai and his clinic,” said Mr. Kerner. The only way Mr. Washington could have been infected from the 50ml vial was if that vial had been “grossly misused with a dirty syringe,” said Mr. Kerner. And, the vial would have to have been used on multiple patients, including Mr. Washington, even though it was labeled “single use.”

For Baxter, Jennifer Levy (Kirkland & Ellis) told the jury that Baxter did not attempt to convince Dr. Desai’s endoscopy clinic to use any particular size or type of anaesthetic. Instead, they simply provided a catalog listing, and the physician indicated which products they wanted. Ms. Levy also showed that the size of a vial does not by necessarily indicate whether it should be used for individual or multiple doses. Other anaesthetics might come in relatively small vials, such as 5ml or 10ml, and be specifically intended and labeled for multiple doses.

The jury found both Teva and Baxter liable on both negligence and product defect theories, and found that compensatory, punitive, and loss of consortium damages were warranted.

The jury awarded $7M in compensatory damages to Michael Washington, $7M in loss of consortium damages to Josephine Washington, $60M in punitive damages against Teva, and $30M in punitive damages against Baxter, for a total damage award of $104M.

The two prior verdicts in this litigation (Chanin and Sacks) were rendered in cases asserted by Robert Eglet (Mainor Eglet) and Will Kemp (Kemp Jones & Coulthard). In the prior cases, the juries rejected defective product theories, but found the defendants liable for failure to warn, failure to monitor, and/or breach of the implied convenant of fitness for a particular purpose.

CVN webcast the Washington v. Endoscopy Center trial live, gavel-to-gavel.

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Sacks v. Teva & Baxter (Las Vegas, Nevada)

A Las Vegas jury awarded $182.6M in compensatory and punitive damages against Pharmaceutical maker Teva, and two of Teva’s distributors, Baxter and McKesson.

The case involved a 2008 Hepatitis C outbreak in Las Vegas among patients at a group of Endoscopy clinics owned by subsequently indicted physcian Dipak Desai. The clinics improperly used containers of the anesthetic Propofol for multiple patients.  This “double-dosing” allowed blood-borne pathogens — Hepatitis C virus in particular — to be transferred among patients.

For the plaintiffs, Robert Eglet (Mainor Eglet) argued that Teva should not have supplied “jumbo” 50 ml Propofol vials to endoscopy clinics that would only be performing brief procedures typically requiring 20ml or less of the anaesthetic, because the larger vials created a substantial risk that the clinic would re-use vials rather than dispose of the mostly-full vials after each procedure. According to Mr. Eglet, Teva used the larger vials because it was more profitable to do so, even though the pharmaceutical companies knew of the risk that endoscopy clinics would double-dose if given the larger vials. Similar outbreaks had previously occurred at other endoscopy centers.

Also for the plaintiffs, Will Kemp (Kemp Jones & Coulthard) told the jury, “In 1995, the most prestigious medical journal in the world says ‘eliminate or modify the 50ml vial,’” and yet Teva failed to do so. A drug manufacturer has a continuous duty to monitor the medical literature and other sources of information, Mr. Kemp explained. However, Teva was unaware of many articles, including a report from the Centers for Disease Control, indicating that larger anesthesia vials created a health risk. Morever, said Mr. Kemp, Teva’s failure to monitor had a demonstrable impact, because after they learned of the risks, endoscopy center physicians stopped ordering the larger vials.

On behalf of the manufacturer, Teva, Mark Tully (Goodwin Proctor) told the jury that there is nothing unique about a 50ml vial that causes it to be misused. Any size vial can be misused. However, said Mr. Tully, large vials can also be broken down into smaller syringes, which lets them be divided between multiple patients without risk. So the risk to patients is not created by the vial size or the desire to multi-dose, but the by “outrageous” and unanticipated misuse at the endoscopy center.

Moreover, said Mr. Tully, colonoscopies seldom require less than 10ml, and often require more than 20ml. Whether it was injection practices, or failing to clean and disinfect medical equipment, it was the clinic that was responsible. The pharmaceutical companies were simply the wrong defendants for the case.

On behalf of the distributors, McKesson and Baxter, defense attorney Philip Hymanson (Greenberg Traurig) told the jury that the plaintiffs were simply going after deep pockets, because no one knows for sure what happened in the endoscopy centers — whether the infection resulted from Propofol or from dirty endoscopes. But regardless of the mechanism, the real cause was the culture of unsafe practices in the endoscopy center, said Mr. Hymanson. The Propofol was manufacturered and delivered properly. The clinics were able to purchase any size vial, and any size vial could have been used safely — or unsafely, if the clinic did not follow proper procedures. A Dear Doctor letter would not have made a difference, said Mr. Hymanson.

The jury found that with respect to all three plaintiffs — Anne Arnold, Anthony Devito, and Richard Sacks — that the Propofol vials were not defectively designed, but that Teva had violated its duty to monitor; that Teva, Baxter and McKesson had failed to send a Dear Doctor letter; and that Teva, Baxter, and McKesson had breached the implied warranty of fitness for a particular purpose.

The jury found that compensatory damages, loss of consortium damages, and punitive damages were warranted.

The jury awarded $20.1M in compensatory damages ($8.5M to Ann Arnold, $900K to James Arnold, $5M to Anthony Devito, $700K to Donna Devito, and $5M to Richard Sacks).

The jury awarded punitive damages of $162.5M ($89.375M against Teva, $55.250M against Baxter, and $17.875M against McKesson).

CVN webcast the Sacks v. Teva trial live, gavel-to-gavel.

Syzmanski v. R.J. Reynolds (Fort Myers, Florida)

Jack Szymanski had his voice box removed in 1993 as a result of laryngeal cancer.

Keith Mitnik (Morgan & Morgan) descrdibed for the jury the time in which Mr. Szymanski started smoking cigarettes. “When this story started, in the 1950′s…almost half the adult population smoked. Two-thirds of doctors were smoking. That’s the environment when this eleven-year-old boy picked his first cigarette up. Fourteen-year-old boy was over a pack a day, getting into deep addiction as a young teenage boy. We didn’t have cell phones. There were three TV stations — they went off at eleven o’clock! There were no warnings on cigarettes at that time. It’s not to suggest that there wasn’t word out there that cigarettes could be bad for you, that they could cut your wind, that they could cause you to cough, that they may not be good for you. But it’s a totally different scenario than the certainty with which we have today that they’re gonna cause cancer.” The delay in people’s realization of the magnitude of the risk, said Mr. Mitnik, was a direct result of what the cigarette companies intentionally agreed to do.

Walter Cofer (Shook Hardy Bacon) for Philip Morris told the jury that Mr. Syzmanski actually had cancer in four different parts of his body — larynx, neck, colon, and tongue. Acording to Mr. Cofer, Mr. Syzmanski had other risk factors for laryngeal cancer, such as alcohol use.  Moreover, said Mr. Cofer, Mr. Syzmanski didn’t smoke because of cigarette ads; instead, he smoked because his friends and family smoked. “It wasn’t just tolerated, it was encouraged. He got his first cigarette from his mother…He tried a bunch of different brands, and he smoked the ones that tasted good.”

The evidence, said Mr. Cofer, suggested that Mr. Syzmanski quit earlier than he said, and drank more than he said. “Why does it matter whether he quit in ’93 or he quit earlier? Well, because Mr. Syzmanski now claims that he was just so addicted to nicotine that he couldn’t help himself. He claims that he was compelled to smoke until he was diagnosed with the cancer that ultimately cost him his voice box. He said it wasn’t until he had the cancer that he had the strength to quit. So members of the jury, if he quit earlier — if he quit up to seven years earlier — then the obvious question is, why didn’t he even quit before that?“ 

Representing R.J. Reynolds, Dal Burton (Womble Carlyle) said,”The undisputed testimony is that Mr. Syzmanski didn’t like our cigarettes. He didn’t like the way they tasted. It’s undisputed that he smoked for taste, and he did not like our cigarettes…He smoked them for a very, very short period of time…He quit smokiing Reynolds brands more than 30 years before he developed laryngeal cancer.“

For Liggett, Nancy Kaschel (Kasowitz Benson) told the jury that Liggett was a much smaller company than the other defendants, and that Liggett had declined to attend the Plaza Hotel meeting, and declined to sign the “Frank Statement,” and should not be lumped in with the behaviors that the plaintiff assigned to “the tobacco companies.”

In his closing argument, Mr. Mitnik told the jury that all three defendants should be held liable in part for Mr. Syzmanski’s laryngeal cancer. “They all belong here. They’re all a part of the conspiracy. He smoked products from everyone of them. He started out and got initiated on [Liggett's] Chesterfield during those critical formative years when he was vulnerable as a young boy smoking Chesterfields, and he also smoked” Lucky Strikes and Camels, “which were R.J. Reynolds. Those were the initiation brands that got this thing hooked into him so deep at such a young age…About the time he felt a lump in his throat he went right over to the Lights, that’s Philip Morris, Marlborough Lights. So they’re all here for a reason..No question, certainly more persuasive, that that contributed in a meaningful way to the outcome here.“

The jury found that addiction to cigarettes containing nicotine was not a legal cause of Mr. Syzmanski’s laryngeal cancer.

Become a CVN subscriber and watch the Syzmanski Engle tobacco trial webcast on-demand, gavel-to-gavel.

Junious v. R.J. Reynolds (Miami, Florida)

Shook Hardy Bacon and Jones Day cleared Philip Morris of liability in the Junious Engle tobacco trial in Miami.

Annie Ingraham started smoking in 1957 at age 18.  In 1996 she was diagnosed with COPD (emphysema), and she died in 2008 of COPD caused by smoking. Annie’s daughter Toni Junious was the plaintiff in the case. According to plaintiff attorney Alex Alvarez, Ms. Ingraham cared about her health and thought that the cigarette filters would keep her safe — she even bought a filter adapter.

Shook Hardy Bacon’s Bill Geraghty told the jury that Ms. Ingraham knew from an early age that smoking was dangerous, and reminded the jury, “The plaintiff has already admitted to you that Ms. Ingraham takes responsibility for the decisions she made…They agree that Miss Ingraham could have quit smoking…and she could have quit smoking in time to avoid developing COPD and her death. That’s what that admission means in this case. The evidence will show that that admission tells you everything that you need to know about who ultimately was in control.”

In his closing statement for the plaintiff, Gary Paige told the jury that Ms. Ingraham tried to quit over and over again, at a time when anti-smoking aids like a nicotine patch were not available, whereas Philip Morris “built their business model on lies and human suffering to make billions of dollars, thereby creating the greatest public health problem that the nation has ever faced,” and that therefore Philip Morris should bear some of the responsibility for what happened to Ms. Ingraham.

In his closing statement for R.J. Reynolds, Jones Day’s Robert Faxon told the jury that Reynolds cigarettes (Pall Mall, Viceroy, and More) made up just a tiny part of Ms. Ingraham’s smoking history, at the beginning and at the end. “There’s no contention that Reynolds contributed in any way to Mrs. Ingraham’s death.” The only claim against RJR was based on concealment.

The jury found that cigarette addiction was not a legal cause of Ms. Ingraham’s death.

The Junious case was Bill Geraghty’s third consecutive Engle win (along with Oliva and Frazier). Robert Faxon marks a win in the first Engle case he has tried to a jury.

Gary Paige had previously won every Engle trial in which he had appeared (Hess, Sherman, Cohen, and Tate). This was Alex Alvarez’ second loss in a row, after winning three straight (Hess, Sherman, and Tate).

CVN webcast the Junious Engle tobacco trial live.