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WEST VIRGINIA RECORD

Sunday, April 28, 2024

Cephalon sales rep tells court Actiq, Fentora opioids were not viable sellers in W.Va.

State Court
Opioidtrialwv

CHARLESTON – A sales rep manager who worked for defendant Cephalon testified that opioid drugs Actiq and Fentora were not viable sellers in the state during the 2005-07 time period.

“Did doctors rely solely on information from sales reps (whether to use Actiq or Fentora)?” an attorney for the state asked during May 16 testimony in the state Mass Litigation Panel trial to decide if opioid supplying companies caused an epidemic in West Virginia

“No, but that would have made my job easier if they did,” Dean Robinson, a sales manager for Cephalon, said. “These (doctors) were well trained professionals they had a wealth of experience and they knew their patient. They had to take all that (knowledge) into account when they were making a decision (use of opioids) for the patient.”

Actiq is a fentanyl-based opioid used for “breakthrough cancer pain,” as is Fentora, and comes in a tablet form.

The trial, which is being conducted in Kanawha Circuit Court, 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 16 session, Robinson – in a taped deposition recorded in December 2021 – said West Virginia was not a good market for the drugs Actiq and Fentora in 2007, and a sales rep he had working for him in the state had to be laid off.

Attorneys exhibited a Cephalon document that expressed concern that sales of the products were dropping.

“We’re falling behind,” the document read.

The company document requested reps to “achieve goals and maximize opportunities for sales.”

“Were you ever required to document potential diversion (drugs getting into the wrong hands)?” Robinson was asked.

“I do recall we were required to import that,” he said.

Robinson added he could not recall reps receiving any specific diversion training at the company.

He said reps were careful to make sales calls only on qualified physicians, and were told by them the drugs were also being used for non-cancer pain conditions.

“Were these (doctor) prescribers reported to anyone at Cephalon?”

“No,” Robinson said. “Our responsibility was to see we were presenting the product appropriately. The physician made the decision (to prescribe an opioid) for whoever they wanted to.”

A exhibited document from a doctor stated that Actiq was a drug easy to abuse and was intended for cancer pain.

“It (Actiq) is too strong for most of my patients," the doctor said in the note.

"Did I read that correctly?” the attorney asked.

“Yes,” Robinson said.

The drugs were being used for non-cancer conditions including back pain, severe headaches and arthritis.

Robinson responded that the drugs were targeted toward physicians who understood the risks and benefits. He added that sales reps were required to make their pitch strictly within the confines of the Food & Drug Administration-approved label. Any doctor questions about the drugs not in the label the rep would submit an information request form to the company Medical Affairs Department.

“Were the reps trained about the label for both Actiq and Fentora?”

“Yes.”    

Robinson said the training of reps was ongoing including informal training and he would coach individual reps if need be.

“Were the reps trained about risk?”

“Yes.”

“For Actiq and Fentora?”

“Yes.”

“Is it best for the physician to decide (to prescribe an opioid)?”

“Obviously,” Robinson said.

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