CENTRAL ISLIP, N.Y. (Legal Newsline) - Former Food and Drug Administration Commissioner David Kessler acknowledged in the opening hearing of a high-profile trial in New York that he didn’t talk to any doctors or make any attempt to quantify how prescription drugs contributed to the state’s opioid crisis.
Lawyers defending the opioid industry are trying to exclude Kessler’s expert testimony by showing he lacks a rigorous scientific basis for his opinion that drug manufacturers and distributors are responsible for opioid abuse. Kessler, who has earned millions of dollars as an expert witness for plaintiff attorneys since leaving the FDA in 1997, said his opinion is based upon his experience as FDA chief and internal documents showing the companies engaged in improper marketing practices and “deviations” from FDA rules.
The State of New York and Nassau and Suffolk counties have agreed, in advance, that they will present no evidence that defendant companies sold opioids to anyone who wasn’t licensed to distribute them, or that were sold without a legal prescription. As in federal multidistrict litigation, they will instead argue that doctors and other medical professionals were improperly influenced to issue too many prescriptions for addictive drugs, leading to abuse and overdose deaths.
After a delay of several months due to COVID-19, the New York trial will proceed in two stages - first to determine liability and then damages.
The questioning of Kessler over two days offered a preview of the state’s case and the industry’s defense. Hunter Shkolnik, the private lawyer representing New York under a contingency-fee contract that could yield his firm hundreds of millions of dollars, led Kessler through his theory of how the increased availability of dangerous drugs increases the risk of abuse. Kessler said that as head of the FDA, he oversaw the agency’s enforcement of rules prohibiting drug companies from making marketing claims that aren’t supported by scientific evidence.
Kessler also looked at contributions by opioid companies to independent groups that advocated for the increased use of opioids to treat chronic pain. The American Pain Foundation got $5.3 million from Endo Pharmaceuticals, for example, and issued a brochure saying the risk of addiction was low and urging patients to seek a pain specialist.
“A company cannot pay a third-party organization to do what it itself cannot do,” Kessler said.
Attorney Steve Brody of O’Melveny Myers, representing Johnson & Johnson, opened by asking Kessler if he had earned “millions of dollars” as an expert witness.
“You had to anticipate this question,” interjected Suffolk County Justice Jerry Garguilo. “You made money.”
Kessler said yes and Brody went on, repeatedly asking whether he investigated the cause-and-effect relationship at the heart of the case, which is whether the drug companies caused physicians to prescribe too many opioids.
“Did you ask any doctors why they prescribed opioids?” Brody asked, with Kessler answering “no.” “You’re not going to identify a single medically unnecessary prescription in the state of New York, are you?”
“I’m not going to get into necessary or unnecessary on an individual prescription, no,” Kessler answered.
Brody also asked Kessler about drug salesperson “call notes” he included in his report, part of the evidence plaintiff attorneys culled from millions of pages of documents they received from defendant companies in discovery. One involved a conversation about Duragesic, a Johnson & Johnson fentanyl patch that the company maintains was particularly hard to abuse.
The note included the phrase “they all said low abuse potential,” which would have instantly triggered a law-firm word search. But Kessler couldn’t identify who the “they” was, who “Nicole” in the note was, or whether the drug rep was telling the doctor about low abuse potential or the other way around.
“I wouldn’t look for one anecdotal conversation,” he said. “I was looking at the record as a whole.”
The drug companies are trying to undermine Kessler’s status as an expert under New York’s Frye standard, which requires experts to present opinions grounded on methods that are scientifically sound and generally accepted as reliable. Toward that end, Brody attempted to show that Kessler will testify improper marketing was the cause of New York’s opioid crisis without having performed any analysis of other potential causes, from illegal heroin and fentanyl to the U.S. government’s own reports, going back to the 1970s, identifying chronic pain as a serious problem costing hundreds of billions of dollars a year.
Kessler kept describing such inquiries as “beyond the scope,” a legal term referring to rules of evidence. At one point Justice Garguilo barked: “Beyond the scope of what?”
Brody concluded by accusing Kessler of lacking a methodology that could reliably show the role any individual company played in the drug crisis.
“I have a learned methodology that manufacturers contributed with marketing to increased use, and increased use led to addiction,” he answered. “Promotion has an effect on prescription sales, those sales made increased opioids available, and their availability leads to increased abuse.”
Other witnesses who will be questioned in pretrial hearings include James Rafalski, a former Drug Enforcement Agency official, and Lacy Keller, a data expert plaintiff attorneys have relied upon to show defendant companies shipped billions of orders that would should have been flagged as “suspicious.”