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Off-labeling of opioids focus of Friday testimony in trial against manufacturers

CHARLESTON — Off-label uses of opioid products dominated testimony Friday in the ongoing trial pitting the state of West Virginia against three opioid manufacturers.

The lawsuit alleges Johnson & Johnson subsidiary Janssen Pharmaceuticals Inc., Teva Pharmaceuticals and Allergan Finance LLC violated state law when they used marketing strategies to over-supply West Virginia with their products, which allegedly helped fuel the opioid epidemic.

Mercer County Circuit Judge Derek Swope, who is presiding over the bench trial, heard from four state witnesses Friday whose depositions were previously recorded.

One of those video recordings was of Robert Roche, who was a top company official with drugmaker Cephalon and rose to the position of executive vice president of worldwide pharmaceutical operations in 2005.

Roche was at Cephalon when the company entered a criminal plea in 2008 with the U.S. Department of Justice and agreed to pay a $425 million fine for off-label marketing three drugs not approved by the Food and Drug Administration.

A letter Roche wrote in 2007 was read as part of the video recording played Friday.

“I believe we became complacent and were content to watch the business roll in,” Roche wrote. “We caused a problem that’s going to cost the company dearly if it continues.”

Much of the deposition focused on the drug Actiq that is produced by Cephalon. The FDA originally approved the fentanyl-based opioid narcotic for use by opioid-tolerant cancer patients but between 2001-05 Cephalon promoted the use of the drug for non-cancer patients and for chronic injuries and for things like migraines.

Teva, one of the defendants in the state’s case, purchased Cephalon in 2011.

A previously recorded deposition of former Cephalon public relations official Stacey Beckhardt was also played Friday.

Beckhardt was in charge of putting together an annual public relations strategy that was proposed to be used to promote the company’s drugs.

Beckhardt said she learned in the early 2000s that some of Cephalon’s drugs were being diverted to the general public for other uses. She said Actiq started to have street value.

“We were aware what was in the media report that there was a diversion in the city of Philadelphia. I was aware of other individual incidents but they were small in number,” Beckhardt said.

Friday brought an end of the trial’s second week. The state is scheduled to continue presenting its case Monday at the Kanawha County Courthouse.

There were reports Thursday that the state and manufacturers were discussing a possible settlement in the case. Those discussions were not mentioned in open court Friday.