CHARLESTON — An expert witness called by defense attorneys in a trial to decide if opioid drug suppliers caused an epidemic in West Virginia said two products Kadian and Norco made by a defendant Allergan did not increase overall drug prescribing in the state.
“My conclusion was that market share was very low for these two products and was declining (around 2012),” Margaret Kyle, an economic competition specialist told the courtroom during May 12 testimony. “We call this a narrow market.”
Allergan was acquired by Teva Pharmaceuticals, another defendant in the case, in 2015.
According to the West Virginia Department of Health, recent rates have been declining in 2021 and 22, but the state has had the highest rate of opioid deaths in the nation, double the national average.
The trial, now a month old, 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.
Norco is an opioid that contains hydrocodone and is used for moderate to severe pain. During the May 12 session attorneys defending Teva and Allergan exhibited a chart that showed Norco accounted for 44,000 prescriptions out of 40 million covering the first two decades of the 2000’s.
Kyle’s testimony and her findings that the twin products Kadian and Norco had a low impact on the epidemic was disputed during cross examination by David Ackerman, the attorney for the state. Ackerman took issue with a written (pro-industry) statement praising the drugs that read, “Opioid analgesics are considered to be a mainstay in treatment of moderate to severe pain and are effective, easy and have a favorable risk to benefit ratio.”
The document went on to say there were two major considerations to the prescribing of opioids, “fear of regulations and legal scrutiny, and the fear of addiction.”
“Did I read that correctly?” Ackerman asked.
“Yes,” Kyle said.
Another document stated that “Opioids can provide pain relief whether or not a patient has an addictive disorder….although this may not always be advisable.”
Kyle explained that she did not consider such literature in her review but was asked by defense attorneys to look at overall prescribing habits in West Virginia. She told Ackerman she looked at branded marketing for Kadian, a morphine-based drug, and not unbranded versions. An unbranded product is where the patent on a branded drug expires and other companies can make their own similar versions of the drug.
“Would you agree that West Virginia was in an opioid epidemic by 2009?” Ackerman asked.
“I don’t know if it’s appropriate to use the word epidemic,” Kyle said.
Kyle noted that non-branded products (not branded Norco or Kadian) could have the impact of expanding a market for drugs.
Ackerman exhibited an opioid company chart that listed as goals an expanded sales team for 2012 in Florida, and an increase in sales of brand and generic opioid products.
Kyle said in looking at the overall writing of prescriptions, she did not see a significant change in the 2012 time period for Allergan products, or that visits by the company's sales reps to doctors caused a big increase in sales.
On re-cross examination a defense attorney asked Kyle if the marketing of Kadian opioids had changed her opinion of the drug’s low overall impact on prescribing in the state.
“It did not change my opinion,” Kyle said.
Defense attorneys later in the day ran a deposition recorded in 2020 in which it appeared they intended to have Mark Spangler, executive director of the West Virginia Board of Medicine, say that opioids had a legitimate place in medical care.
“Prescription opioids do serve a legitimate purpose?” Spangler was asked.
“Yes,” he answered, “within the appropriate standards of care.”
“There are cases where a large number of opioids could be prescribed for chronic pain.”
“I’m not a medical doctor,” Spangler said. “I can’t speak to that.”
Spangler was asked what a nefarious prescribing of opioids would be.
“A prescription made to make money,” he said, “for a patient who does not qualify for a controlled substance (opioid).”
Over-prescribing Spangler defined as a prescription that exceeded the needed dose or amounts of the drugs.
Spangler said the number of licensed physicians deliberately mis-prescribing opioids was a “small percentage.”
He was shown a document that stated that doctors should not fear punishment for prescribing opioids for a legitimate reason.
"Did I read that correctly?” the attorney asked.
“Yes,” Spangler said.
Spangler was asked if the board knew a doctor was mis-prescribing opioids, if his license would be revoked.
“Yes, after due process (investigation),” Spangler said.
“A pharmaceutical manufacturer does not have a patient’s history or write prescriptions?”
“That’s fair to say,” Spangler said.
“Are you aware of (board knowledge) of any inappropriate behavior by a licensee?”
“Not that I’m aware of.”
Spangler said the Board of Medicine's mission is to protect the public.
He added that most West Virginians have had at least one family member negatively impacted by the epidemic. In his family, a niece and nephew. The niece started with prescription opioids and when she couldn't get more, stole the drugs from Spangler's eldelry parents. He said she moved to using street heroin and was eventually incarcerated.