Experts: Nothing wrong with corporate structure of pharmaceutical companies, marketing of opioids | News

CHARLESTON — There was nothing unusual or illegal about the way drugmakers dispensed prescription opioids, lawyers for the companies argued Monday.

Lawyers for Teva Pharmaceutical Industries Ltd., one of the two companies in suit, sought to prove that their company was not responsible in the case, arguing that its subsidiaries manufactured the opioids, which means that Teva, in as the parent company, is not responsible for the opioid drug. distribution in the case.

Monday was the second day attorneys for Teva and a group of companies belonging to 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 of the Kanawha County Courthouse in Charleston.

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

The State of West Virginia alleges that executives and sales representatives of Teva and Allergan engaged in deceptive marketing practices, leading to the overprescribing of opioid drugs and the resulting addiction epidemic in the state.

Their testimony covered Teva’s corporate structure and the recent historical background 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 by Donna Welch, representing Allergan, and Mimi Chu, representing the state.

Warfield, who graduated from medical school in 1976 and opened one of the nation’s first pain management clinics in Boston, often said, “I was there” when testifying about the evolution of pain. pain management in medical practice and the role of opioids among the treatment options doctors can prescribe.

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

In particular, Warfield said the movement to prescribe opioids for conditions other than cancer pain was a “grassroots movement started by pain physicians” long before pharmaceutical companies began marketing opioids. opioid drugs from physicians.

“No doctor has been brainwashed into thinking that opioids aren’t addictive or that it should be used for every patient that comes through the door,” Warfield said.

She said even people who didn’t go to medical school tend to know how addictive morphine is, but for those who graduate from medical school and practice medicine, there is a risk analysis. -benefits between the symptoms and condition of a person and the potential side effects they might experience.

Warfield testified that marketing materials for Allergan’s opioid drugs were not misleading and fell within the guidelines of the United States Food and Drug Administration.

“If the FDA feels it shouldn’t be used for a particular type of pain, they will say so,” Warfield said.

If a patient sticks to the prescription their doctor has given them, the risk of addiction is very low, she said, but the risk of addiction increases when people deviate from the prescription, especially in taking medication more frequently or in larger amounts than prescribed by their doctor. .

Warfield acknowledged there was a crisis of opioid abuse, even saying she was duped by people trying to obtain opioids illegally, but she said pharmaceutical company marketing was not a factor in the crisis.

“Of course doctors are concerned about abuse and addiction,” Warfield said. “We are always concerned about abuse and addiction whenever we prescribe an opioid, but that does not mean that this concern would prevent us from giving opioids to our patients and treating their pain appropriately.”

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

Keyes’ population samples included overly diverse populations and did not show a causal relationship between opioid pills and heroin use, Warfield said.

Keyes testified on two separate days during the trial, saying not everyone who was prescribed opioids for legitimate medical treatment would become addicted to opioids, but the “high exposure” to opioids in West Virginia increased the likelihood that people become addicted to it.

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

Gupta previously served as director of the West Virginia Office of Drug Control Policy and health director 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 in manual jobs. There are also more people on Medicaid in West Virginia than in any other state, and the state has high rates of obesity, which leads to other health problems, she said.

In total, she said, these factors would easily lead to a higher rate of opioid prescriptions in the state.

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

Gupta said the rate of chronic illnesses, pain, medical procedures and other health factors in West Virginia hasn’t matched the “explosion” of opioids here.

Klausner’s testimony contradicted the testimony of Alec Fahey, a certified public accountant who testified on behalf of the state on May 6. Klausner was on the stand for just over two hours on Monday morning.

While being questioned for Teva by Harvey Bartles, Fahey said that Teva Pharmaceuticals controls the operations of its subsidiaries, including Teva USA, the US subsidiary of Israel’s Teva Pharmaceuticals Industries Ltd.

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

On Monday, Klausner said otherwise.

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

Teva subsidiaries share certain resources with the parent company, including legal, IT and human resources, Klausner said.

“Centralized functions create standardization,” he said.

When questioned by state representative Fred Baker, Klausner said he did not look closely at company policies, just company structure. Klausner said he didn’t need to review the policies because he was only in court to testify about Teva’s corporate structure.

The state alleges that the drug companies created a public nuisance and violated West Virginia’s Credit and Consumer Protection Act by misrepresenting and failing to disclose the serious risk of prescription opioid addiction.

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

Lawyers for the pharmaceutical companies have argued that their sales representatives are appropriately and legally marketing their opioid drugs.

They also argued that their respective opioid drugs took up so little of West Virginia’s overall opioid market share, with nearly all of the affected drugs accounting for less than 1% of the total, that they could not be declared a public nuisance.

Attorney General Patrick Morrisey originally filed the lawsuit in Boone County Circuit Court. He was then transferred to the Mass Litigation Panel of West Virginia, where Swope became the presiding judge.

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

The government is further asking Swope to impose civil and other financial penalties on the companies. Those penalties would be distributed among 54 of West Virginia’s 55 county governments and other municipal governments.

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