CHARLESTON —A former U.S. Drug Enforcement Administration officer testified that the defendant opioid suppliers took lightly their responsibility to prevent drug diversion.
“Did you see any evidence of due diligence?” a state attorney asked during May 3 testimony in the trial before the state Mass Litigation Panel.
“No,” Ruth Carter responded.
“Were (drug) orders being shipped without review?”
“That’s correct.”
A former DEA diversion program manager, Carter is today is a consultant and a star witness for plaintiffs suing the drug companies.
The trial in the 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. Judge Derek Swope will 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.
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 3 session, Carter indicated that drug suppliers were advising customers how to get around being reported to the DEA by lowering their order from threshold limits, the maximum quantity of drugs they could order.
A 2004 letter regarding Watson Pharmaceuticals’ suspicious order monitoring system was displayed by state attorneys. Watson later was acquired by Actavis and then by Teva.
“They (customer) either reduced the (drug) quantity or changed the order,” the document read. “Most customers do not want to bring (DEA) attention to these large orders.”
“If a (suspicious) order is reported to the DEA it should not be shipped,” Carter said. “They’re telling the customer to reduce the order instead of reporting it to the DEA. That is an order that should be reported.”
“Did you see any evidence of due diligence?”
“No,” Carter said.
Another document said “Watson’s suspicious order monitoring system is inconsistent with requirements noted in the regulations and written guidance provided by the DEA.”
“Did Watson improve these deficiencies?”
“They didn’t,” Carter said. “They made a decision to implement (improvements) and then didn’t.”
The deficiencies of Watson’s SOM system included not identifying orders that deviated from a normal ordering pattern, reducing orders from threshold limits (to pass them), not using downstream customer information, and only making one suspicious order report and a report on three suspicious customers.
Carter said the company’s use of their customer service department to make investigation into a suspicious order was improper because that department was involved in the sales part of the business.
“It’s a conflict,” she said.
Carter indicated the checking done by company officials of customers was minimal, to see if they had a license (to sell drugs) and a credit check.
“They need to know the customer,” Carter said.
“Did Teva use a (customer) questionnaire?”
“No.”
Carter said Teva officials had downstream information on customers they could have used.
“Did they use the data?”
“Not at all,” Carter said. “There is no evidence anyone used the data.”
A 2012 document displayed by the state said Teva had six account reps who reviewed 10 pending orders per week and that (according to DEA) did not have “a standard operating procedure or official guidelines for the (proper) operation of an SOM program and should have investigated customers further downstream.”
Carter said TEVA made some modifications two years after the 2012 report, but their system still had issues.
“Did Teva report any suspicious orders related to West Virginia?”
“No.”
“Can the volume of opioids itself be a red flag for (drug) diversion?”
“Yes,” Carter said.
Under cross examination by defense attorneys, Carter agreed she had not presented evidence of any drug diversion into the state of West Virginia. Nor had she pinpointed any medically unnecessary prescriptions.
“You began working for plaintiff’s attorneys right after retiring in June of 2019?”
“Yes,” Carter agreed.
“You’ve made $1.2 million, you’re not working for free.”
“Approximately, yes.”
Carter was shown a chart that was titled a “Closed System” which portrayed the drug supply chain from manufacturer to distributor to the hospital and pharmacy, then to the doctor’s office and the patient.
“The patient can only get it (drug) if he has a legitimate prescription.”
“Yes,” Carter agreed.
“If it’s a closed system it works,” the defense attorney said.
“Yes, if properly,” Carter said.
“Everyone in the chain is registered by the Food and Drug Administration and the DEA.”
“Yes, everyone should be.”
Carter was asked if under the Controlled Substances Act, a distributor or manufacturer had to obtain a registration from the DEA. She agreed.
“There is no instance where they (DEA) didn’t register Cephalon or Teva or any of my clients?” the defense attorney asked.
“I’m not aware of any,” Carter said.
“The DEA does not provide any formal guidance to manufacturers about suspicious orders.”
“I don’t agree with that,” Carter said, adding that she had been asked for guidance including at conferences, and had provided it.
“You testified they (manufacturers and distributors) have an obligation to identify and investigate (suspicious) prescribers?”
“They're in a position to observe suspicious behavior,” Carter said.
“They should investigate every pharmacy?”
"That is not my opinion.”
“It wouldn’t be possible,” the defense attorney said.
“It’s not my opinion,” Carter repeated.