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.
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.
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