U.S. Court Orders Teva to Pay $365m to Hepatitis C-infected Man

Israeli pharmaceutical forced to pay largest jury award in Nevada history after more than 100 people who were given reused anesthetic contracted the liver disease.

Teva Pharmaceutical Industries and Baxter Healthcare Services on Friday were ordered to pay a combined e500 million in punitive damages to a Nevada man who contracted Hepatitis C during an outbreak two years ago.

The Clark County District Court jury in Nevada ordered Teva to pay $356 million and Baxter to pay $144 million in the largest jury award in Nevada history, attorney Robert Eglet said.

In a statement, Teva said it "plans to contest the verdict vigorously."

A spokesman for Baxter did not immediately return messages seeking comment.

Eglet said Henry Chanin and more than 100 others contracted the liver disease Hepatitis C after the anesthetic propofol were reused for colonoscopy or endoscopy procedures. Teva made the drug and Baxter distributed it, Eglet said.

Teva said it continues to believe that the evidence shows the company acted responsibly. The label for its propofol product clearly states that it is for single patient use only and that aseptic procedures should be used at all times.

Chanin's trial marked the first of what could be many, said Eglet, who is representing more than 40 Hepatitis C patients.

The ruling came after last week, U.S. regulators accused Teva of failing to correct manufacturing problems at its Irvine, California facility that caused contamination in batches of an anesthetic.
Parenteral Medicines was formerly known as Sicor, an injectable medicines company that Teva acquired in January 2004. The word "parenteral" refers to administration of medicine by injection.

The Food and Drug Administration sent the Israeli generic drug developer a warning letter in December citing contamination with batches of pharmaceuticals made at the facility. The letter was posted Tuesday on the agency's Web site.

Teva said it continues to work with the FDA to address any concerns.

The FDA warned the company over a failure to correct issues with bacterial endotoxin contamination found in vials of propofol injectable emulsion, which is used as a general anesthesia. The lot was recalled.

"No corrective action was taken in response to this finding at the time of manufacture, and your firm released the lot," the FDA said in the letter.

There were several other violations focusing on manufacturing the drug and contamination issues. Other violations observed during an inspection included a failure to subject lots to microbiological tests. The agency said the company failed to test each lot of raw materials used to make propofol injectable emulsion to determine the levels of bacterial contamination.

The agency also warned the company about a failure to clean and sanitize equipment and utensils at appropriate intervals to prevent contamination.

The FDA said the company "should take prompt action to correct the violations," and a failure to comply could result in legal action.

Teva said it has responded to the warning letter and moved its yearly plant shutdown to the last week in April from December "in order to more efficiently address process enhancements at the facility."