CHARLESTON – Defense attorneys in the West Virginia opioid trial sought to portray the U.S. Drug Enforcement Agency as providing no guidance on how drug-producing companies could comply with regulations.
Attorneys for the state got the same witness to say the companies had a responsibility to maintain a “closed (safe) drug dispensing system.”
“The DEA did not apply (guidance) criteria?” Enu Mainigi the defense attorney asked during May 6 testimony.
“It couldn’t,” Kyle Wright a former DEA field diversion investigator said. “There were too many variables. What is the problem tomorrow? The DEA could not provide the guidance on whether to ship an order (drug) or not ship.”
The trial, being held before the state Mass Litigation Panel 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. 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 6 session, Dr. James Kraner chief toxicologist for West Virginia, in a taped deposition told defense attorneys that in addition to opioids, abuse of cocaine and methamphetamine were also serious problems in the state.
“Do you agree opioids can be used to treat pain?” the attorney asked.
“Yes,” Kraner responded.
“The Food & Drug Administration approves them for the treatment of pain.”
“Yes.”
“The drug fentanyl could be illegally manufactured.”
“That’s correct,” Kraner said.
Defense attorneys presented a document that said, by 2014, among fentanyl overdose deaths in the state, 75 percent of cases did not have a prescription for the drug.
Another study looking at 295 overdose deaths said a majority of the cases were from non-medical uses.
A chart from the West Virginia Bureau for Public Health showed a sharp rise in deaths from the opioid drug OxyContin in the years 2005 to 2008.
“When did you start seeing a significant number of fentanyl deaths?”
“It increased pretty drastically from 2001 to 2007,” Kraner said. “By 2012 we were seeing fentanyl and heroin together. Fentanyl deaths were very common. A tiny amount can be lethal.”
“This can be made by criminal organizations?”
“That’s my understanding,” Kraner replied.
In another taped deposition, Wright, who joined the DEA in 1994 working out of its Dallas field office, in 2005 became a unit chief for e-commerce evaluating prescriptions and Automation of Reports and Consolidated Orders System data (information submitted by manufacturers and distributors).
“Do you know what a closed system is?” Mainigi asked.
“Yes, every entity in the production or (drug) sale has a responsibility (to prevent diversion),” Wright said.
“Each participant, the manufacturer and distributor, does not have complete visibility to know what the others are doing.”
“Yes,” Wright agreed.
Wright said certain information on doctors and patients was available to distributors and manufacturers.
“Under limited circumstances they (manufacturers and distributors) could see downstream (customer information),” he said.
“Did you (DEA) get calls (from companies) on whether to ship orders?”
“Yes.”
Wright said the agency had a difficult time trying to keep up with the paperwork on submitted reports of excessive (drug) purchases.
“By 2005, the DEA was dealing with illicit internet traffic in controlled substances, right?”
“Yes.”
Wright said a patient could order a drug online after a doctor had written a prescription and a pharmacy filled the prescription. The order would be delivered to the patient by Fedex.
“Was internet ordering overwhelming the DEA (with suspicious orders)?”
“It was taking up a good deal of our time,” Wright responded.
“By 2005, the biggest problem for the DEA was the internet pharmacies?”
“Yes.”
On cross examination attorneys for the state got Wright to agree that his testimony was based on his personal recollections and not on behalf of the DEA as a whole.
A chart exhibited listed issues to raise suspicions of an order. They included the frequency of drug orders, the size of orders, the range or products ordered, payment method, pharmacy location, and percentage of controlled (opioid) versus non-controlled substances.
“Does this apply to all registrants (manufacturers and distributors) in the closed system?” Wright was asked.
“Yes,” he answered.
Wright said it was up to the manufacturers and distributors to practice due diligence in preventing diversions.
“I can’t bless or run their business,” he said. “They have more (customer) information than I do. The responsibility is on the industry.”
Wright agreed it was not enough to just monitor a suspicious order.
“If it did not meet the criteria of a legitimate order, they should take action.”
Wright added that although the Controlled Substances Act did not require documentation showing a company’s due diligence, documentation should occur.
“Show me your best practices,” he said. “Show me what you’ve done.”