LAS VEGAS, NV – A civil trial has resumed after a nearly three-month break in a lawsuit against Teva Pharmaceutical Industries (NASDAQ: TEVA) and their distributor Baxter International (NYSE: BAX) related to Hepatitis-C contamination at a Las Vegas endoscopy clinic.

The trial was halted last October by the Nevada Supreme Court, while they considered a motion from the defendants for a change of venue, which claimed pre-trial publicity from large verdicts in previous related cases would prevent the selection of an impartial jury in Clark County. The Supreme Court issued an opinion denying the motion last December, and trial proceedings resumed earlier this month. Read the the court’s decision here.

In the underlying case, plaintiff Stacy Hutchison alleges Teva and Baxter are responsible for her contracting Hepatitis-C, due to the companies’ sale of the anesthetic Propofol in large containers, later used by Dr. Dipak Desai for multiple uses with contaminated needles at his endoscopy clinics. Dr. Desai, who has declared bankruptcy, is awaiting trial on criminal charges later this year. Defendants also include Sicor, Inc. and McKesson Medical-Surgical (NYSE: MCK). 

Courtroom View Network is providing a gavel-to-gavel video webcast of the Hutchison trial, as it has done for the three other endoscopy clinic trials to date. The case is Stacy Hutchison v. Teva and Baxter, Case Number 08A562216, Clark County Circuit Court, Nevada before Hon. Jerry Wiese.

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.

Sacks v. Endoscopy Center  (Las Vegas, NV)

Plaintiff attorneys Robert Eglet (Mainor Eglet) and Will Kemp (Kemp, Jones & Coulthard) and defense attorney Mark Tully (Goodwin Proctor), began the second trial involving a 2008 Hepatitis C outbreak in Las Vegas.

This trial involves five plaintiffs, Anne and James Arnold, Tony and Donna Devito, and Richard Sacks, who were allegedly infected with Hepatitis C during routine endoscopy procedures because the health care providers re-used, or “double-dosed,” from large vials of the anesthetic Propofol. The plaintiffs claim that the Pharmaceutical companies should have provided single-dose vials to the endoscopy center, and that they inadequately warned the enodoscopy center not to re-use the larger vials.

According to Mr. Eglet, the defendants knew, based on 148 prior Propofol incidents, that their 50 milliliter Propofol infusion vials looked like multi-diagnose vials and that anesthesia providers were in fact reusing syringes on the larger Propofol vials. 

According to Mr. Kemp, the defendands should have sent a Dear Doctor letter to health care providers alerting them to the risks posed by the larger Propofol vials.

For the defense, Mark Tully (Goodwin Proctor) emphasized the health care providers’ responsibility for the Hepatitis C outbreak and the plaintiff’s injuries.

Holding two Propfol infusion vials before the jury, Mr. Tully said, “these bottles of Propofol with respect to every procedure were perfectly manufactured…without any contamination whatsoever” when they left the manufacturer. They were “labeled exactly as they should have been when they left the distributors” and whatever “happened at the clinic happened solely at the clinic.” “What went wrong had nothing to do with the bottles of Propofol,” Mr. Tully stated.

The defendants face almost 300 lawsuits stemming from the 2008 Nevada Hepatitis C outbreak.

The trial is ongoing and includes testimony from numerous experts and lay witnesses. Gavel to gavel coverage is provided by Courtroom View Network.

CVN webcast Richard Sacks v. Endoscopy Center of Southern Nevada, Gastroenterology Center of Nevada, LLP, et al.

Lawyers USA has announced their “Lawyers of the Year 2010.”

Among the honorees are trial lawyer Robert Eglet, of Mainor Eglet in Las Vegas, and Bill Levin, of Levin Simes in San Francisco.

Courtroom View Network captured both Mr. Eglet’s and Mr. Levin’s award winning performances in 2010.

In Chanin v. Teva and Baxter, Robert Eglet and Will Kemp won a $500M+ verdict on behalf of a Las Vegas man who had contracted Hepatitis C at an endoscopy clinic as a result of unsafe dosing practices. The plaintiff argued that the extra large vials of anesthetic used by the clinic were defectively sized and failed to adequately warn against re-use.

In Evans v. CertainTeed, Bill Levin won a $200M+ verdict against asbestos pipe manufacturer CertainTeed. The plaintiff’s mesothelioma resulted from exposure to asbestos fibers when she washed the clothes of her husband, who was a pipe cutter.

Subscribe to CVN for just $199 and watch both award-winning performances above, plus thousands of other attorneys and expert witnesses for an entire year.

The jury in Chanin v. Desert Shadow Endoscopy today awarded $500M in punitive damages against Baxter and Teva — $144M against Baxter and $356M against Teva — the pharmaceutical companies that manufactured (Teva) and distributed (Baxter) vials of the anesthetic Propofol.

Unsafe injection practices — dosing multiple patients from a single vial — resulted in the spread of Hepatitis C at Desert Shadow Endoscopy Center.

The jury had already awarded Henry and Lorraine Chanin over $5M in compensatory damages based on Teva and Baxter’s failure to adequately warn of the risks associated with multidosing, and also Teva and Baxter’s providing the anesthetic in vials inappropriately large for use in an endoscopy center, which, the jury found, was a breach of the warranty of fitness for a particular purpose.

Plaintiff attorney Robert Eglet claimed that there had been prior outbreaks of Hepatitis at other endoscopy clinics, also resulting from multidosing, and that the pharmaceutical companies knew that the smaller vials were safer. According to the plaintiff, the larger vials were nonetheless supplied because the pharmaceutical companies put profits above safety.

CVN webcast the Chanin Hepatitis Trial live.

District Court Judge Jessie Walsh prepares to receive the jury’s verdict in Chanin v. Teva and Baxter Pharmaceuticals in Las Vegas.

In his closing argument in Chanin v. Desert Shadow Endoscopy, plaintiff attorney Robert Eglet, arguing the product liability defective design case, reminded the jurors that Craig Lea, the head of development for all of Teva in the United States, had testified that 10ml vials of Propofol were safer for use in endoscopy centers because they reduced the risk of multi-dosing, and that using 50ml vials was more risky.  

According to Mr. Eglet, neither Craig Lea nor anyone else provided any evidence of the safety benefits of 50ml vials in endoscopy centers, because there are none.  Eglet replayed for the jury videotaped trial testimony of Mr. Lea’s inability to answer the yes-or-no question, “In endoscopy centers, the risk of health care providers dosing multiple patients from a single 50ml vial outweights any benefits of the design in an endoscopy center because the 10ml and 20ml vials are safer?”

Eglet reminded the jury that they were legally required to accept the defendants’ May 2000 admission, in an FDA filing, that the smaller vial size was safer.

“In May of 2000,” said Mr. Eglet, “more than six years before Mr. Chanin got infected, they wrote that a smaller size vial is safer in that it may reduce the temptation for dosing multiple patients from a single container thereby reducing opportunities for microbial contamination.”

Plaintiff attorney Will Kemp, arguing the failure to warn case, reviewed five different reasons why Teva and Baxter allegedly provided inadequate warnings. Mr. Kemp reviewed videotaped testimony of executives from both Teva and Baxter stating that the CDC suggested warning label was better or more precise than the actual warning on the propofol vials in question. 

As to damages, Mr. Kemp argued that Mr. Chanin had to undergo chemotherapy, and there was a 5% chance that the hepatitis would return. Moreover, as a result of the heptatitis Ms. Chanin basically had to live without intimacy, like a nun. 

Defense attorney Mark Tully argued, “Nothing was wrong with the propofol in the bottle that was made by Teva and distributed by Baxter.” According to Tully, one of the most important questions in the case was, How much Propofol is a enough? Mr. Tully argued that there is no such thing as a typical procedure, and only the medical professionals can decide whether 10ml is enough in any particular procedure that might be done in an endoscopy center.

Moreover, said Mr. Tully, the label warning advocated by the plaintiffs “was not a better warning at all. In some ways, it’s a worse warning.”

The jury posed two questions on May 3: first, what was the relationship between Instruction 13 (design is defective if unreasonably dangerous) and Instruction 16 (reasonableness of manufacturers’ conduct not to be considered in assessing reasonableness of danger); and second, whether the package inserts were the same for each vial size.

On May 5, the jury found that Teva and Baxter were both liable on theories of failure to warn, and breach of implied warranty of fitness for a particular purpose, but not liable on a strict liability theory for a defective product design.

The jury also found that both defendants were liable for punitive damages.

The jury awarded $3.25M compensatory damages to Henry Chanin, and an additional $1.85M to Lorraine Chanin for loss of consortium.

The punitive damages phase begins tomorrow at 1pm.

CVN is webcasting the Chanin-Teva-Baxter hepatitis trial live. 

Defense fired back in their opening statement in Chanin v. Desert Shadow Endoscopy Center. The plaintiffs alleged that drug companies Baxter and Teva supplied propofol containers that were defective because they were too large, thus encouraging the kind of multi-dose “double-dipping” that could foreseeably result in the spread of blood-born pathogens, such as the Hepatitis C infection that plaintiff Henry Chanin contracted at Desert Shadow Endoscopy.

According to Goodwin Proctor’s Mark Tully, however, the Propofol worked as an anesthetic, exactly as it was supposed to work. The Propofol was not contaminated with Hepatitis. The Propofol did not cause any adverse side effects. Moreover, the small 10ml dose was manufactured through 2007, which was after the plaintiff’s exposure, and it was only discontinued as a result of low demand from doctors.

According to the defense, there is nothing inherently defective in giving a doctor a choice as to which size to buy. 

CVN is webcasting the entire Chanin Endoscopy trial live, gavel-to-gavel. 

Opening statements have begun in CVN’s live webcast of Chanin v. Desert Shadow Endoscopy.

Plaintiff attorney Robert Eglet alleged that Pharmaceutical companies Teva and Baxter delivered defective Propofol packaging that unsafely encouraged health care providers to “double-dip,” which risks the spread of blood-born diseases, such as Hepatitis and HIV.

Eglet said the “Big Secret,” which company emails and testimony would show, was that the pharmaceutical companies knew as early as 1995 that the larger 20ml and 50ml containers encouraged double-dipping, but continued to provide them.

Then in 2001, Eglet said, dosing multiple patients from single vials resulted in a Hepatitis outbreak at an endoscopy center in New York City, which was reported in the New York Times, but the pharmaceutical companies continued to provide Propofol in 50ml vials, with inadequate instruction.

Eglet said that the smaller, safer bottles were less profitable, because they were more expensive to produce, than the larger bottles, so they stopped making the smaller, safer vials. 

CVN is webcasting the Chanin v. Endoscopy Center live.

UPDATE: Plaintiff Attorney Will Kemp, in his opening statement, considered other hepatitis outbreaks at other endoscopy centers, and whether Teva should have provided stronger warnings, given that it knew of problems at endoscopy centers at least six years before Mr. Chanin was treated. According to Mr. Kemp, the evidence would show that Teva inaccurately referred to all sizes of Propofol as “single dose,” but, he said, calling it such does not make it so.  ”I could call Mr. Eglet ‘Brad Pitt,’” said Mr. Kemp. “He is not Brad Pitt.”