CHARLESTON – Attorneys for the State of West Virginia attempted to attack a central premise of the defense in a trial of opioid drug makers accused of causing an epidemic – that off-label marketing of the drugs by sales reps to doctors was minimal.
Fred Baker, an attorney for the state, displayed a Cephalon document during May 17 testimony he said showed that off-label marketing to doctors by sales reps was being under-counted by the company.
“A scoring system (off-label reports) that places lower emphasis on ambiguous cases has been developed (by Cephalon),” the company document read.
“Did I read that right?” Baker asked.
“Yes,” answered Karen Lowney, senior director for government compliance with Cephalon in 2010.
“If it was ambiguous (a report of off-label with unanswered questions), off-labels would be scored lower, right?”
“It would depend on the answers,” Lowney said.
Off-label means a sales rep attempting to sell opioid drugs to a doctor touts a drug’s benefits in use for pain. Fentora, a fentanyl-based drug, has been described to be used primarily for cancer pain. Selling the drugs according to the label is to insure compliance with Food & Drug Administration standards. Defense witnesses have testified that off-label marketing of such drugs beyond what is approved in the label by the FDA is inappropriate.
The trial, being held in Kanawha Circuit Court for the state Mass Litigation Panel, is being streamed live courtesy of Courtroom View Network.
Opioid suppliers Teva, Cephalon (now part of Teva) and Allergen are accused of ignoring the addictive danger of opioid pills so they could increase their profits and causing an epidemic. The charges include creating a public nuisance and violating the West Virginia Consumer Protection and Control Act.
In 2019, West Virginia Attorney General Patrick Morrisey filed lawsuits against the drug manufacturers in the Boone Circuit Court. The case was subsequently moved to the Kanawha Court and is being heard in a bench trial with no jury. Swope is to decide the verdict.
Plaintiff attorneys claim the epidemic started in the 1990s when the medical community, in the beginning encouraged by a few "opioid revisionist doctors" and later supported by drug manufacturers and distributors; abandoned what had been a former tighter policy of prescribing opioids mostly for terminal and cancer treatments. Instead they alleged, backers of more opioids began to recklessly prescribe and promote the drugs for less serious conditions, describing pain as a fifth vital sign (as in a pulse).
Pain alone is not a vital sign, the state’s attorneys claim.
Anti-drug diversion in-house programs required of the companies by the DEA were ineffective, the attorneys contended. They maintained that addicts got their start using prescription opioids and then graduated to heroin acquired on the street or more recently fentanyl, when the prescription opioids became too expensive or hard to get.
Defense attorneys argue the epidemic was caused by societal problems, illegal drug abuse including heroin and fentanyl, and not by manufacturing companies legally supplying doctors and hospitals with the pain pills they prescribed.
Janssen, the drug subsidiary of Johnson & Johnson, settled with the state on April 18, agreeing to pay $99 million although company officials denied any wrongdoing. An additional defendant Endo also settled with the state in March for $26 million.
A suspicious drug order includes one that is larger in quantity than normal or more frequent ordering than normal.
During the May 17 session, displayed documents showed that Fentora was being prescribed for more uses than cancer pain including dentistry, pediatrics, psychiatry and surgery.
Lowney told Nancy Patterson, the Teva defense attorney, the company had a rules and values policy that mandated “doing the right thing, always being truthful.”
“There were very specific rules,” Lowney said. “What we need to do for our customers, and what it means to have proper (drug) promotion.”
A Cephalon document displayed by Patterson touted that, “We don’t buy business, our promotional messages are always ‘on-label,’ truthful and fair balanced.”
The company had a disclosure program to report concerns, a hotline to report potential problems and a message recall program to monitor potential off-label selling activities. Surveys were done every six months.
Lowney’s testimony concerned the years 2008-2012 with Cephalon. She told Baker she was hired (in part) to build a values based drug (government) compliance program. She agreed the intended use for Fentora and a similar drug Actiq, for breakthrough cancer pain, was “narrow.”
“Did Cephalon engage in any corrective action with Actiq to un-do off-label marketing?” Baker asked.
“Not that I’m aware of,” Lowney responded.
“Cephalon only promoted Fentora on-label, right?” Baker asked.
“Yes.”
Baker said Cephalon officials thought it reasonable that the drugs could be used in addition to cancer for use in dentistry, pediatrics, psychology and surgery.
“These were four groups that were prescribing Fentora,” Lowney said.
“A (sales) rep is not permitted to issue a discussion (to a doctor) that is off-label,” Baker said.
“No they’re not,” Lowney agreed.
A company letter from Cephalon headquarters in 2011 reported, “I’ve got good news,” and said only 1 percent of sales calls to doctors involved off-label discussions and that such discussions were decreasing.
Baker accused the company of under-counting the number, saying the company’s system was designed to discard any reports where a question existed. A 2009 tracking study he produced listed the off-label discussions at 8.2 percent.
“If there was any ambiguity, it could not be off-label,” Baker said.
“If it was ambiguous it means it was just incomplete,” Lowney answered.
“Do you think it’s appropriate to market (opioid drugs) aggressively?”
“I don’t think it’s appropriate,” Lowney said. “The safety of people is the most important thing. There’s no reason to take an aggressive stance.”
Baker exhibited a company document that said, how to “play aggressive within the (label) lines.”
“Did anyone ask Cephalon to change its (off-label) scoring system?”
“No they did not.”
