SEATTLE (Legal Newsline) - In a trial to decide if three of the country’s biggest distributors of opioids caused an overdose epidemic in Washington State, defense attorneys on Monday and Tuesday sought to show the drugs are an essential component of pain treatment and the benefits outweigh the risks.
“Are prescription opioids an important necessity for pain management?” Paul Schmidt, attorney for McKesson, asked.
“Yes,” Dr. Chris Gilligan answered.
“Do distributors play a role in causing an increase in the levels of prescriptions?”
“They do not.”
The bench trial in King County Superior Court (Seattle) is being streamed live courtesy of Courtroom View Network.
Prescription drug distributors McKesson, Cardinal Health and AmerisourceBergen Corp. are accused of irresponsibly over-promoting and distributing opioid drugs to pharmacies and doctors' offices that led to hundreds of overdose deaths in the state. The Washington State Department of Health estimated 1,200 in 2020.
Distributors take pills from the manufacturers and supply them to hospitals, doctor’s offices and pharmacies. The most commonly shipped opioid drugs include OxyContin, Hydrocodone, methadone and fentanyl.
Washington State Attorney General Bob Ferguson is asking for $32 billion in damages to enact anti-drug programs, but a state victory could result in a much higher award when surrendered profits and penalties are added in.
Gilligan, chief medical officer and pain specialist at the Brigham & Women’s Hospital in Boston was called by the defense as a witness. He said opioids had been an important way to treat pain for centuries and explained that during the Civil War soldiers with catastrophic wounds had been treated with the drugs creating at the time an epidemic of addiction.
“Are there risks (using opioids)?” Schmidt asked.
“There are,” Gilligan agreed.
“Why are we still using opioids to this day?”
“For many clinical circumstances, opioids are our most powerful pain medicine,” Gilligan said. “You would not be able to treat pain with anything short of an opioid.”
Gilligan said examples of chronic pain included major injury, surgery, cancer, and conditions such as severe rheumatoid arthritis.
“You have a woman with destroyed joints and you can’t replace those joints or inject all of them,” he said. “You’re not going to give this woman pain relief with Ibuprofen.”
“In your opinion do the benefits (opioids) outweigh the risks?” Schmidt asked.
“For appropriate patients,” Gilligan agreed.
“Is this the general consensus of the medical community?”
“It is.”
“Are prescription opioids approved the FDA (Food & Drug Administration)?”
“They are.”
“Why does FDA approval matter?”
“The FDA approval process is a very intense and detailed data-driven process,” Gilligan said, “to evaluate the risks and benefits of a medicine for a list of conditions.”
Gilligan identified drug diversion (illegal use) as the act of giving pills to someone for whom the pills were not prescribed, bartering, stealing or selling them illegally.
“Are there risks that you’ve understood throughout your career?” Schmidt asked.
“There are,” Gilligan answered.
Schmidt displayed a chart that read, “Few things doctors do are more important than relieving pain.”
During cross examination Linda Singer, attorney for the state, asked Gilligan if he agreed the opioid epidemic had imposed a massive human and economic cost on the nation and Washington State.
“There has been a serious crisis in the country and the state of Washington,” Gilligan said.
Singer presented a graphic that said the epidemic cost the U.S. an estimated $504 billion in 2015 and $9 billion that year in Washington State.
“You’re not an expert on the Controlled Substances Act (CSA)?” she asked.
“No I’m not,” Gilligan said.
“You’re not familiar with distributor obligations under the CSA?”
“Not with expertise, no.”
“You didn’t conduct any examinations of the distributors (anti-diversion) programs with respect to their obligations under the CSA?”
“I’m not an expert on those issues.”
“You’re not offering an opinion on the distributors’ compliance under the CSA are you?”
“No I’m not.”
Gilligan also agreed he had not performed detailed studies of suspicious drug orders or due diligence practices by the distributors. He added that prescribers (doctors) are the ones who make a judgement about a patient and not the distributors.
Singer displayed a graphic from a medical report with a quote that read, “Prolonged high-dose is neither safe nor effective and physicians should make every effort to control indiscriminant prescribing.”
Gilligan responded saying that doctors thought they were prescribing the correct amounts of drugs but had learned over time as the science evolved and new information became available that lower doses of prescribed drugs could be the desirable way of treatments.
A report authored by Dr. Scott Fishman in 2007 said opioids were being increasingly diverted, some in households where leftover drugs in medicine cabinets could be accessed by children, teenagers and others.
“Vigilance is required,” the document read.
“It takes just a few (irresponsible) doctors to create large pockets of addicts,” Singer said.
Singer said a report emphasizing the importance of carefulness also stated that 50.8% of people who misused opioid drugs got them from a friend or relative.
“That seems to be what it says in the report,” Gilligan said.