The drug companies that made and sold the anesthetic linked to a hepatitis C outbreak sacrificed patient safety in the name of profits, lawyer Robert Eglet told a jury Monday.
"It is a story about putting corporate profits over patient safety," Eglet said during opening statements in the first civil trial stemming from the outbreak.
Henry Chanin, 61, and his wife, Lorraine, are suing Teva Parenteral Medicine and Baxter Healthcare Services on several product liability claims. Chanin, headmaster at The Meadows School, was infected with hepatitis C during a 2006 colonoscopy at the Desert Shadow Endoscopy Center, one of the clinics linked to Southern Nevada's hepatitis C outbreak.
Public health officials said the outbreak was caused by nurse anesthetists reusing single-dose medicine vials among patients after the vials had become contaminated by nurses reusing syringes on the same patient.
The lawsuit claims the companies made and sold vials of propofol that were much larger than needed for colonoscopies, which tempted medical workers to reuse vials among patients instead of throwing away unused anesthetic.
The companies knew the larger vials could lead to "double dipping" and were aware of previous outbreaks linked to large propofol vials, yet they continued to provide them to endoscopy centers, Eglet said.
"They knew one size doesn't fit all," he said.
The lawsuit originally named the doctor and nurses who performed Henry Chanin's colonoscopy, but their insurance company settled the medical malpractice claim last month.
SICOR Pharmaceuticals, which was later bought by Teva, began making propofol in 1999 in 20-, 50- and 100-milliliter vials. Within two years, the company started making 10-milliliter vials, in part because of the potential danger for misusing the larger vials, Eglet said.
But by 2003, the company had stopped making the smaller vials because they slowed production lines and cut into profits, the lawyer said.
Shutting down production of the smallest vials enabled the company to boost production of the 20- and 50-milliliter vials, which helped profits climb and led to the eventual sale of SICOR Pharmaceuticals to Teva in late 2003, Eglet said.
"The company kept the big secret ... so they could pump up their sales and sell their company for $3.5 billion," he said.
Mark Tully, a lawyer for the drug companies, disputed those claims, saying the 10-milliliter vials were sold until 2007, when they were pulled from the market because of declining sales.
Will Kemp, lawyer for Lorraine Chanin, said the companies stopped making the smaller vials despite a rising number of hepatitis outbreaks around the world that were linked to multidosing of propofol.
By the time Henry Chanin was infected, as many as nine outbreaks involving 148 cases of hepatitis had been identified in medical literature, he said.
"History is repeating itself over and over and over and over and over again, and the reason it's repeating itself over again is the warning is bad," Kemp said in explaining that the drug's warning labels were inadequate.
Because of the history of hepatitis outbreaks associated with propofol, the labels should have included explicit warnings against using vials among patients, he said.
To help make his point, Kemp pulled out a magnifying glass and ran it along the unfolded pamphlet included with the drug, which stretched about three feet toward the ground and had more than 10,000 words. Kemp said there was no warning about single-patient use until the very end of the double-sided pamphlet.
Tully disputed Kemp's claim, pointing out that propofol bottles contained clear warnings that they were intended for "single patient use." So did the information pamphlet, which included such warnings in the second paragraph, he said.
"Not hard to find, contrary to the little act that was put on here," Tully said, referring to Kemp and his magnifying glass.
Tully also called the plaintiffs' lawyers' "big secret" a "big lie" in that the companies never put profits ahead of patient safety.
"We sympathize with Mr. Chanin, but that doesn't make us liable for what happened," Tully said.
Tully's opening statement will continue today. The trial is expected to last three to four weeks.
Chanin's case was one of nine linked to two Las Vegas endoscopy clinics by health officials, who in 2008 notified 50,000 patients about possible exposure to hepatitis, HIV and other blood-borne diseases because of unsafe injection practices at the clinics. An additional 106 hepatitis cases were "possibly related" to the clinics, officials said.
Since being infected with hepatitis C, Chanin has constantly worried about infecting his wife, so they've stopped doing anything that might spread bodily fluids, from sharing a glass of wine to having sexual relations. He also deals with lingering side effects of fatigue and joint pain two years after undergoing treatment for hepatitis.
"For full justice for what has happened to him, $10 million is the right number," Eglet said.
Contact Brian Haynes at firstname.lastname@example.org or 702-383-0281.