CHARLESTON — During previously recorded deposition tapes at the West Virginia opioid trial, one drug company executive admit his sales reps sold drugs by exaggerating positive claims “off label” while another defended his own actions.
“At a sales meeting, you said there are people who don’t believe our integrity,” Robert Roche, former executive vice president of Cephalon, a Pennsylvania-based pharmaceutical company, was told by a state’s attorney. “You said it turns out we did something wrong.”
“That’s true,” Roche said.
“You said it was our fault, right?”
“Yes,” Roche answered.
Roche was shown a chart that said the Cephalon departments involved were in sales, marketing, clinical and regulatory affairs.
“You and your officers took full responsibility, right?”
“That’s what I wrote,” Roche agreed. “We wanted our sales force never to go off-label.”
The trial in the 13th Judicial District Kanawha Court is being streamed live courtesy of Courtroom View Network.
Janssen, the drug subsidiary of Johnson & Johnson, and opioid suppliers Teva, Cephalon and Allergen, are accused of causing an epidemic in West Virginia.
In 2019, West Virginia Attorney General Patrick Morrisey filed lawsuits against the drug manufacturers in in the Boone Circuit Court and the case was moved to its current venue in the Kanawha Circuit Court. The case, which began April 4, is being heard by a state Mass Litigation Panel in a bench trial with no jury. Judge Derek Swope will decide the verdict after what is expected to be a two-month trial.
Other state-conducted lawsuits including in Washington and Florida are being held against opioid distributors and manufacturers.
Plaintiffs’ attorneys in West Virginia are seeking to prove the companies ignored the addictive dangers of the drugs for profits, endangering the public by creating a public nuisance and violating the West Virginia Consumer Protection and Control Act.
State attorneys argue that the epidemic started in the 1990s when the medical community (doctors), misled by drug manufacturers and distributors, abandoned their former conservative policy of prescribing opioids used mostly for end-of-life and cancer treatments, and recklessly prescribed opioid drugs for a broader market such as back pain and arthritis.
Anti-drug diversion in-house programs required of the companies by the U.S. Drug Enforcement Administration were ineffective, the attorneys contended, with too few checkers and too many red-flagged suspicious orders. Orders were shipped anyway.
West Virginia will seek millions in damages from the defendants to fund addiction treatment programs.
Defense attorneys argue the epidemic was caused by illegal drug abuse including heroin and fentanyl, and not by manufacturing companies legally supplying doctors and hospitals with the pain pills they prescribed.
One of the original defendants was another company Endo, but Morrisey announced last month the company had settled with West Virginia for $26 million.
In a deposition of March 2021, Roche admitted that sales reps for the company had overstated the advantages of the drug Actiq, a fentanyl-based product, to make sales.
This was called selling “off-label.”
In 2008, the company entered a guilty plea to illegal marketing practices and agreed to a $425 million settlement with the federal government that it marketed the drugs Actiq and Fentora in a manner not approved by the U.S. Food and Drug Administration.
Roche was shown a company memo that said, “The only good news is we can afford to pay ($450 million fine) out of our cash reserves.”
Another inter-office memo stated, “Ask a sales rep if they can make a dime off our bonus plan without selling all three drugs off-label.”
“See that?” the attorney asked.
“That’s what it says,” Roche said.
The company was investigated by the FDA in which a notation was made that, “Off label use of the product (by Cephalon) is staggering.”
In 2004 officials of the company met with those of the FDA to discuss the promotion of drugs by Cephalon.
“The FDA Division of Drug Marketing, Advertising and Communications was concerned about off-label marketing, that there was an inappropriate broadening of the drug (beyond cancer and end-of-life). See that?” The state’s attorney displayed a memo.
“Yes I do,” Roche answered.
“Cephalon promotion is illegal, see?”
“We went on to address those DDMAC concerns,” Roche said.
Roche was shown a document that said the U.S. Dept. of Justice (DOJ) had also done an investigation in 2007 in which Cephalon sales reps were found to be improperly promoting the drug and that sales calls on customers were “problematic.”
“Did I read that correctly?” the attorney asked.
“That’s what is written here,” Roche responded.
In a second taped deposition taken in 2019, Douglas Boothe, formerly a CEO of Actavis, a New Jersey-based pharmaceutical company that sold generic versions of the drug OxyContin, told the court there was a base salary and bonus paid based on annual (sales) goals.
A branded drug is the original creation with an expiring patent. After the patent expires other companies can come in and produce their own versions of the drug with similar ingredients, called a “generic” version.
Boothe said if sales goals were not met or were less than 80 percent of goals, the bonus would be zero.
Activas achieved revenues of $551 million in 2009 for sales including its drugs Oxycontin CR and Kadian, a morphine-based drug.
Boothe said OxyContin CR was originally a drug from Purdue Pharma. A Connecticut-based pharmaceutical company, Purdue in 2007 paid out $600 million to the government after pleading guilty to making misleading claims about OxyContin and the risk of addiction. In 2020 the company settled with government officials for $8.3 billion after admitting it had intentionally conspired to assist doctors to prescribe and dispense opioid medications without legitimate medical purposes.
Boothe, questioned about the marketing efforts of Actavis, told state attorneys the company’s generic drugs did not receive a lot of marketing.
“The marketing team would look at information and trend perspectives,” he said. "Trade events would be attended (by sales reps) and a product catalog (created). This was not unique to Activas. A print advertisement would be made to announce that a product (opioid) was coming available.”
“To pharmacies?”
“Yes,” Boothe answered.
Industry magazines were also used for advertising new drug products and direct mailings sent to pharmacies.
“I believe fax blasts were also sent,” Boothe added.
Boothe said during his tenure at Actavis, third party promoters were not used.
Discounts could be offered for prescription orders that Boothe said were in line with other (competing) pain medications.
“Were you trying to keep up with competitors?” Boothe was asked.
Boothe described it as attempting to “maintain” a market level of sales.
Asked if coupons could be given for refills of drugs Boothe said refills were not allowed for controlled substances. He added that drug product labeling had to be accurate and was reviewed by the FDA.
“It’s common for pharmaceutical companies to call on physicians,” he said. “You align your sales force with high decile physicians (those who have prescribed highly in the past).”
Boothe said Endo had 600 sales reps, while Activas had a small force. The company did not use speaker’s (promotional) forums like other companies did, he noted.
The state exhibited an internal memo proposing a contest for the top five or 10 sales reps selling the drug OxyContin ER. Boothe said it was a generic drug and was unsure if the contest was held.
“It was a proposal,” he said. “It may or may not have happened.”
Booth said company reps would attend trade shows and vendor events (to promote the products). Also telemarketing and online marketing were used.
Boothe agreed drug diversion was the drug going somewhere else than where intended (into the wrong hands), but indicated that once a drug was shipped out to a pharmacy or wholesaler the responsibility to prevent diversion rested with them.
“Once outside our chain of (drug) custody, our custody was finished at that point,” he said.
