CHARLESTON — Sales reps for opioid suppliers accused of causing an epidemic in West Virginia say they sold drugs only in the confines of what Food & Drug Administration labeling would allow, and did not attempt to expand a market but to simply “maintain it.”
“Did you ever tell a doctor that the (drug) risk was low?” Hadya Deshmukh, an attorney for the state, asked during May 13 testimony.
“Absolutely not,” responded Shelley Fitch, a former sales rep for the drug company Actavis.
During the questioning the sales reps were asked if they knew what “pseudo-addiction” was. They said they did not. It is a change in behavior because of untreated pain, pain that could be treated with opioids, but is mistakenly believed to be addiction. Plaintiff attorneys have contended defendants in opioid trials promote the concept of pseudo-addiction (false addiction) in an attempt to downplay the risk of the drugs.
The trial 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 13 session in a deposition recorded in 2019, Fitch recounted how she and other sales reps sold the drug Kadian during the 2012 time frame. Kadian is a morphine-based opioid used for moderate to severe pain.
Fitch said Kadian was sold to doctors already writing prescriptions for the drug and not new customers, and that it was only sold to appropriate users.
“Was it your obligation to tell the truth about the products?” Deshmukh asked.
“Absolutely,” Fitch said.
Fitch said she made sales calls on pain specialist doctors in Northern California. She explained that sales people were trained to market the drugs in strict accordance with the company materials which they were provided and not to stray off what they were allowed to tell a doctor.
“Anything hearsay we were not allowed,” Fitch said.
Fitch said Kadian was marketed for patients with “intractable pain” who were already taking short-term-acting opioids and needed a longer-term drug (Kadian). She said doctors were informed the drug had an addictive potential, but reps were not allowed to talk about competing drugs (they would refer such questions to corporate). Nor were they to hand out study comparisons of such products.
Kadian did not have a ceiling dose. Fitch said doctors were encouraged to use the lowest possible dose of the drug for the shortest period of time.
“Do you know what pseudo-addiction is?” Deshmukh asked.
“I do not,” Fitch answered.
In 2008 drug manufacturer Actavis formerly known as Watson Pharmaceuticals acquired Kadian from King Pharmaceuticals for $127 million.
Fitch said the goal of the sales team for Kadian was to maintain a market share at a time of little promotion (2009) and declining sales, to let doctors who had been using the drug know it was still available.
Fitch said an average sales call was sometimes only a few minutes in a hallway when a doctor was not with a patient or when the doctor went to lunch. Co-pay cards could be left with a doctor so that patients receiving the drug could get a more affordable discount.
“Did you ever say opioids increase function?”
“No.”
“Did you ever do anything unethical?”
“No.”
“Improper?”
“Never.”
Michael R. Shepherd served as national sales director of the biopharmaceutical company inVentiv Health (became Syneos Health) in the selling of Kadian. He said in the 2008 time frame there was no sales team for the drug and sales went down. In 2009 Actavis began to promote it.
“The strategy was to stabilize the sales,” Shepherd said. “There were 20 (sales) reps. We were asked to slow the rate of (sales) decline there had been no promotion (for Kadian)."
Shepherd added that reps were expected to work hard, but that alone was not enough.
“You had to perform,” he said.
Shepherd said the generic version of Kadian (a copied not original brand of the drug) had a 70 percent share of the market.
“Most pharmaceuticals (non-opioid drugs) don’t have the addiction potential opioids have,” the attorney said.
“I agree,” Shepherd answered. “We would not be talking about these (benefits) outside the product label. The claims we made had to be in the approved (company) materials.”
“The sales materials (brochures) that would be left with a doctor were Food & Drug Administration approved?”
“That’s correct.”
Shepherd said the company did not promote drugs using a speaker’s bureau. Asked if he knew what “pseudo-addiction” was, he said he did not.
He said his work and that of other sales reps had helped to alleviate pain.
“They (patients) suffered every day (with pain). Because of the work we did they could hold their jobs, they could function. I’m proud of the work we did.”