CHARLESTON – Attorneys defending drug suppliers accused of creating an opioid epidemic in West Virginia sought to poke holes in the earlier testimony of an analyst called as an expert witness by the state whose numbers showed a dramatic increase in opioid drug prescriptions from the years 2007 to 2017.
“If a (drug) product was made by Company A, and then later by Company B, you can’t tell that from your data?” Donna Welch the defense attorney for Cephalon and Allergan asked, during April 27 oral arguments.
“That is outside of my expertise,” Lacey Keller responded. “The (particular) drugs are listed (in the analysis charts).”
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 recklessly flooding West Virginia with pills causing an epidemic.
In 2019, West Virginia Attorney General Patrick Morrisey filed lawsuits against the drug manufacturers in the Boone Circuit Court. The case was moved to the Kanawha Court and is being heard by a state Mass Litigation Panel in a bench trial with no jury. Judge Derek Swope will decide the outcome.
Plaintiffs’ attorneys in West Virginia seek 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. They said the epidemic started in the 1990s when the medical community, in the beginning misled by a few "opioid revisionist doctors" and later by drug manufacturers and distributors, abandoned their former conservative policy of prescribing opioids used mostly for end-of-life and cancer treatments. They allegedly began to recklessly prescribe opioid drugs for less serious conditions and 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.
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.
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.
Keller, a data analyst with MK Analytics, first appeared as an expert witness April 21. She told plaintiff attorneys using a display of statistical charts that West Virginia had fewer drug prescribers than other states, but had proscribed drugs at a higher rate, one of the highest in the country.
Keller’s investigation found that between the years 1997 and 2017, the dosage units of opioids went from 35.9 million to 2.5 billion (2017) with the peak year 2011. This represented 90 annual doses for every man, woman and child in the state.
Teva, one of the defendants, went from providing 660,000 doses in 1997 to 1.2 billion by 2017.
Keller’s figures said the cumulative milligram annual dosages in 1997 were 248 million, in 2017 38 billion. By the peak year of 2011 the state stood at 90 opioids per capita (for each person) while the national rate was 40 per capita.
In the years after 2011, the rates appeared to lower, but remained far higher than 1997 and above the national average.
During the April 27 session, the defense sought to undermine Keller’s findings by pointing out inconsistencies in her statistics. The defense attorney exhibited a graphic that said the study had listed no specific prescriber or patient data.
“You did what (plaintiff) lawyers asked you to do,” Welch said.
“Yes,” Keller said.
“You included (drug) companies who are not defendants in this case in your analysis?”
“Yes.”
One exception was Teva Pharmaceutical Industries, a subsidiary arm of the company which was not a defendant and not featured in the study.
“In the data we wouldn’t see (Teva)?”
“No,” Keller agreed.
Keller said she understood the difference between a branded drug, which a company creates with a patent, and a generic drug where the patent expires and other companies can make their own versions of the drug using similar ingredients.
"Did you include branded and generic (in the study)?"
"Yes," Keller responded.
"Were all manufacturers included regardless of whether they were a defendant in this case or not?"
"It (analysis) includes everyone," Keller said.
'Did you know the total number of companies (in the analysis)?"
"It was over 100."
"Could you have shown the number of branded versus generic drugs?"
Keller said she could but it would take new data to make such a revision.
An exhibited chart showed that between the years 1997 and 2017 West Virginia had a total number of prescriptions at approximately 40 million. There were 638 prescribers in the state. A graphic said that less than 2 percent of prescriptions were for the drug Actiq, a fentanyl-based opioid targeted for cancer-pain patients and those who have become tolerant to around-the clock medications.
According to Keller's analysis, one doctor in Cabell County, one of the highest opioid prescribing counties in West Virginia, increased the amount of prescribed opioids from 297.356 prescriptions in 1997 to 1.45 million in 2009. Another chart showed that a West Virginia doctor over the same time period had made 36,236 prescriptions using Teva drugs, 17,836 from Endo and 1,782 from Allergan.
