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Teva Not Responsible for Hepatitis Outbreak, Lawyer Says

Teva Pharmaceutical Industries Ltd., the world’s biggest generic-drug maker, isn’t responsible for a 2008 hepatitis outbreak in Nevada blamed on the misuse of vials of the anesthetic propofol, a lawyer for the company said.

Patients developed hepatitis C after receiving propofol during colonoscopies, Mark Tully, a lawyer for Teva, told jurors today in a trial of three lawsuits against the company. Doctors and medical personnel who performed the procedures are to blame, he said in opening statements.

“Whatever happened at the clinics happened solely at the clinics,” Tully told jurors in state court in Las Vegas. “What went wrong had nothing to do with the bottles of propofol.”

Three Las Vegas residents contend that Teva, along with drug distributors Baxter International Inc. and McKesson Corp., sold propofol in “jumbo-sized” vials that encouraged doctors to reuse the container in multiple procedures. The plaintiffs contend the companies sold the vials knowing they could help spread blood-borne diseases, such as hepatitis.

Teva faced almost 300 lawsuits stemming from the Nevada hepatitis outbreak, the Petach Tikva, Israel-based company said in a regulatory filing last month. The trial of the first case against Teva and Baxter last year resulted in a verdict of more than $500 million in damages against the drugmakers.

Vials Reused?

Probes by Nevada health officials and the federal Centers for Disease Control and Prevention blamed the reuse of propofol vials for infecting patients with the incurable liver disease. Propofol is an intravenous agent used for sedation or anesthesia, according to Teva’s website.

Last year, a state grand jury indicted Dr. Dipak Desai, who ran the Endoscopy Center of Southern Nevada at the time of the outbreak, on criminal charges. Desai’s case has been delayed after a judge found him incompetent to stand trial. He also faces federal charges over the outbreak.

Teva manufactures the generic version of the drug and San Francisco-based McKesson is its current U.S. distributor. Baxter, based in Deerfield, Illinois, sold the drug for Teva until 2009, according to court filings.

The drugmaker already agreed to resolve about one-third of the hepatitis-related suits alleging patients received propofol from reused containers, according to a July 28 filing with the U.S. Securities and Exchange Commission.

Lawyers for Anne Arnold, Richard Sacks and Anthony Devito told the Las Vegas jury yesterday that they will show Teva’s 50-milliliter propofol containers aren’t designed as “single-use” vials and the drugmaker didn’t properly warn doctors about the dangers of “double-dipping” into the anesthetic.

Warning Labels

Teva contends propofol’s label warns doctors to only use the container once and that any contamination is the fault of medical personnel violating established practices, according to court filings.

Tully, a Boston-based lawyer for Teva, told jurors today that Arnold, Sacks and Devito may have contracted their illnesses from dirty medical equipment, such as scopes and syringes, rather than from reused propofol vials.

The lawyer said he would produce evidence showing that colonoscopy scopes at the clinics “were not cleaned properly” before they were reused. Tully also noted that state and federal regulators hadn’t ruled out the possibility that the hepatitis was transmitted by tainted equipment.

Teva, as a drug manufacturer, “doesn’t police clinics” and can’t be held responsible for the actions of medical providers using its products, Tully said.

The case is Sacks v. Endoscopy Center of Southern Nevada LLC, 08A572315, Clark County District Court (Las Vegas).

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