SEATTLE (Legal Newsline) - A former special agent of the U.S. Drug Enforcement Administration (DEA) who later worked for McKesson Corp. in its anti-drug diversion program, told a courtroom on Monday the system was thorough in checking to prevent drugs from getting into the wrong hands.
“Did you do the best you can to prevent (drug) diversions?” Paul Schmidt McKesson’s attorney asked.
“I would like to think so,” witness Gary Boggs responded.
Boggs, with the DEA for 27 years and a vice president for regulatory affairs with McKesson from 2013 to 2020, is today retired.
The trial in the King County Superior Court 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.
Called as a witness for the defense, Boggs said McKesson had to balance the need to get pain-killing drugs to patients who legitimately needed them, and to report suspicious orders (larger or more frequent) to the DEA. He conceded the company did not have the ability to detect all diversions.
“McKesson had a responsibility to medical professionals (doctors) to treat their patients,” Boggs said. “It’s someone who needs pain medication from an open-heart surgery, or cancer, diabetes, or mangled up in a hospital (car wreck). It’s a balancing act, to make sure the medication is for a legitimate purpose.”
Boggs said the distribution companies operated under the most regulated of industries including by the DEA and U.S. Department of Justice. He added that companies regularly have to be audited by such agencies and have their security facilities, stocks of drugs and files checked.
“How often (operation reviews)?” Schmidt asked.
Boggs said 10 per year.
“Why is this important?”
“It’s meeting DEA expectations,” Boggs answered.
Boggs indicated doctors in the 1990s began prescribing pain pills more frequently and pill manufacturers responded to the increased demand.
“Did McKesson have a role in this (increase)?”
“No,” Boggs said.
“Does McKesson interact with doctors?”
“They do not.”
“Patients?”
“Not at all?”
Boggs said an order that appeared suspicious likely is not a result of an illegal diversion. But for a number of other reasons, an error (typo) in the number of pills ordered, a technical glitch, a robbery of a pharmacy (requiring replacing inventories of pills), or a pharmacy closing and its patients going to another for their medications requiring more supply.
“Is there limits to the (drug) diversions that McKesson could control?” Schmidt asked.
“Yes,” Boggs answered. “The most common is a drug seeker taking drugs out of a bathroom cabinet. We can’t check what people are doing in their homes.”
Boggs said the company’s anti-diversion program was constantly being improved during his tenure and involved due diligence reviews, investigations, regulation and license checks and internet checks of customers.
Boggs disagreed with plaintiff witnesses who said the company merely used an inadequate questionnaire to check on customers.
“The questionnaire was an important document, but it was only the beginning (of checking),” Boggs said.
On cross examination James Ledley, attorney for Washington State, told Boggs that McKesson could not delegate its (anti-diversion) responsibilities to the DEA or the state.
“That’s correct,” Boggs agreed.
“The mere fact that a doctor is licensed doesn’t mean McKesson doesn’t have an obligation.”
“That’s correct.”
“McKesson as a registrant, has a duty to guard against diversion.”
“Not all,” Boggs said. “Some (diversions) are outside the company bailiwick.”
Boggs added that McKesson only had control over what the company was able to control.
“Is McKesson’s obligation to design and operate a system to report suspicious orders?” Ledley asked.
“That’s correct,” Boggs said.
“Suspicious orders must be reported.”
“True.”
“To not report is a violation.”
“True.”
Ledley said merely reporting a suspicious order to the DEA was not maintaining effective control of drug diversions.
“One aspect of it, not the whole,” Boggs said.
“An order (suspicious) must not be shipped,” Ledley said.
Boggs said he was not aware of any specific language in the regulations blocking an order as a requirement (to not ship an order). He repeated that based on his experience, in most cases a suspicious looking order was not an illegal diversion, but for a number of other innocent reasons.
Ledley said that merely checking a pharmacy license and registration is not an example of effective diversion control.
“McKesson went way beyond that,” Boggs said.
“You’d agree that if a distributor reported a suspicious order but then filled the order, with reason to believe it was headed for an illicit market, that would be bad?”
“True.”
Ledley said that during Bogg’s tenure with the DEA, there was a DEA enforcement action against the company.
In 2017, McKesson was ordered by the U.S. Justice Department to pay a $150 million in civil penalties for alleged violations of the Controlled Substances Act (CSA), and to suspend sales of controlled substances from distribution centers in states including West Virginia, Colorado, Ohio and Michigan.
In 2008, there was a $13.2 million similar penalty.
Settlements were reached. In the case of West Virginia, McKesson agreed to pay the state $37 million in 2019.
Closing arguments in the trial, which began in November, are expected at the end of this month.