Experts: Nothing wrong with pharmaceutical companies' corporate structure, opioid marketing

Monday was the second day attorneys for Teva and a group of companies owned by Allergan Finance LLC presented their case to Mercer Circuit Judge Derek Swope. Monday, overall, was the 26th day of the bench trial in the Ceremonial Courtroom in the Kanawha County Courthouse, in Charleston.

Swope heard testimony from Michael Klausner, a professor at the Stanford School of Law, and Dr. Carol Warfield, an anesthesiologist, pain management specialist and professor at Harvard Medical School.

The state of West Virginia alleges that Teva and Allergan executives and sales representatives engaged in deceptive marketing practices, leading to the over prescription of opioid medicines and subsequent substance abuse epidemic in the state.

Their testimony covered the corporate structure of Teva and the recent historical context of opioid-based drugs to treat different types of pain.

Warfield spent most of Monday on the stand, testifying for about six hours under questioning from Donna Welch, representing Allergan, and Mimi Chu, representing the state.

Warfield, who graduated medical school in 1976 and started one of the first pain management clinics in the country in Boston, often said, “I was there,” during her testimony about the evolution of pain management in medical practice and the role of opioids among the treatment options for doctors to prescribe.

She also relied on various studies, as Welch questioned her about the testimony of other health care experts who testified for the state earlier in the trial.

In particular, Warfield said the movement to prescribe opioids for conditions other than cancer-related pain was a “grassroots movement that was started by pain doctors,” well before pharmaceutical companies began marketing the opioid drugs to doctors.

“No doctors were brainwashed into thinking opioids aren’t addictive or that this should be used for every patient who walks through the door,” Warfield said.

She said that even people who haven’t attended medical school tend to know how addictive morphine is, but for those who do complete medical school and practice medicine, there’s a risk-benefit analysis between a person’s symptoms and condition and the potential side effects they might experience.

Warfield testified that marketing materials for Allergan’s opioid medications were not misleading and fell within the guidance from the U.S. Food and Drug Administration.

“If the FDA feels it should not be used for a particular type of pain, they will say that,” Warfield said.

If a patient sticks to the prescription their doctor gives them, there is a very low risk for addiction, she said, but the addiction risk increases when people deviate from the prescription, particularly by taking medicine more frequently or in larger quantities than their doctor prescribed.

Warfield acknowledged that there is an opioid abuse crisis, saying even she had been duped by people illegally trying to obtain opioids, but she said the pharmaceutical companies’ marketing was not a factor in the crisis.

“Of course doctors are concerned about abuse and addiction,” Warfield said. “We’re always concerned about abuse and addiction every time we prescribe an opioid, but it doesn’t mean that concern would prevent us from ever giving opioids to our patients and treating their pain appropriately.”

In another area of testimony, Warfield cited what she said was one problem with studies submitted earlier in the trial by Katherine Keyes, a professor of epidemiology at the Columbia University Mailman School of Public Health.

Keyes’ population samples included too varied of populations and didn’t show a causal relationship between opioid pills and heroin use, Warfield said.

Keyes has testified two separate days during the trial, saying not every person who is prescribed opioids for legitimate medical treatment would become addicted to opioids, but the “high exposure” of opioids in West Virginia increased the likelihood that people would become addicted to them.

Warfield’s testimony also rebutted testimony given by Dr. Rahul Gupta, director of the Office of National Drug Control Policy, who testified by way of deposition in 2021, before he was appointed to the national office.

Gupta previously served as director of the West Virginia Office of Drug Control Policy and as chief health officer and director of the Kanawha- Charleston Health Department.

Warfield said West Virginia has an older-than-average population, as well as a higher population of people working manual-labor jobs. There also are more people on Medicaid in West Virginia than any other state, and the state has high rates of obesity, which leads to other health issues, she said.

Altogether, she said, those factors would easily lead to a higher rate of opioid prescriptions in the state.

“There’s many factors that would explain why there’s more pain in West Virginia than in other states,” Warfield said.

Gupta said West Virginia’s rate of chronic disease, pain, medical procedures and other health factors was not to scale with the “explosion” of opioids here.

Klausner’s testimony countered testimony from Alec Fahey, a certified public accountant who testified on behalf of the state on May 6. Klausner was on the stand for a little more than two hours Monday morning.

While being questioned for Teva by Harvey Bartles, Fahey said Teva Pharmaceuticals controlled operations of its subsidiary companies, including Teva USA, the American subsidiary of Israeli Teva Pharmaceuticals Industries Ltd.

Fahey said the operations were “outside of the norm,” compared to other large companies.

On Monday, Klausner said the opposite.

“I would describe it as very common,” Klausner said.

Teva’s subsidiary companies share some resources with the parent company, including legal, information technology and human resources, Klausner said.

“Centralized functions creates standardization,” he said.

Under questioning from Fred Baker, representing the state, Klausner said he had not closely reviewed company policies, just the company structure. Klausner said he didn’t need to review the policies because he was present in court only to testify about Teva’s corporate structure.

The state alleges the pharmaceutical companies created a public nuisance and violated the West Virginia Consumer Credit and Protection Act by mischaracterizing and failing to disclose the serious risk of addiction of prescription opioids medications.

West Virginia also alleges the companies overstated the benefits of chronic opioid therapy and promoted the idea that doctors should prescribe higher dosage amounts without disclosing the greater risk involved.

Attorneys for the pharmaceutical companies have argued that their sales representatives appropriately and legally marketed their opioid medications.

They’ve also argued that their respective opioid medications took up so little of West Virginia’s overall opioid market share, with nearly every relevant medication taking up less than 1% of the total, that they couldn’t be declared a public nuisance.

Attorney General Patrick Morrisey originally filed the lawsuit in Boone County Circuit Court. It later was moved to West Virginia’s Mass Litigation Panel, where Swope became the presiding judge.

The state is seeking an injunction to require the companies to accurately disclose the “significant risk and limited benefits” of opioid drugs and not to market opioid medications as front-line treatment for chronic pain.

The government additionally is asking Swope to assess civil and other financial penalties against the companies. Those penalties would be dispersed among 54 of West Virginia’s 55 county governments and other municipal governments.

After a day-long break Tuesday to accommodate West Virginia’s primary election, the trial will continue at 8:30 a.m. Wednesday.