Carl B. Stokes U.S. Court House
CLEVELAND (Legal Newsline) - The federal judge overseeing nationwide litigation against the opioid industry stripped plaintiffs of potentially important evidence when he prohibited three witnesses from testifying that drug-company marketing and educational programs caused physicians to prescribe too many opioids to their patients.
In a 22-page order, U.S. District Judge Dan Polster said physicians Mark Schumcher and Anna Lembke and epidemiologist Katherine Keyes could provide expert testimony about how the drug industry downplayed the risks of opioid painkillers at the same time that prescriptions, addiction and deaths rose. But Judge Polster, who has scheduled two bellwether trials for October, prohibited them from testifying that the opioid industry caused physicians to prescribe more drugs, saying the influence of marketing materials on individual prescribing decisions was beyond their expertise.
The decision removes an important element from public nuisance lawsuits that nearly 2,000 cities and counties have brought against the opioid industry, by severing the causal link between the activities of the defendants and prescribing physicians.
Plaintiff lawyers will still be able to present evidence from economists, physicians and other experts that the opioid industry disseminated what they believed to be false and misleading marketing, and that an epidemic of addiction and death followed. But Judge Polster’s ruling could strengthen the hand of state attorneys general against the cities and counties.
The majority of state AGs say they have more powerful weapons to force the industry into settlement, including Medicaid reimbursement claims and broadly written consumer protection statutes.
In a sign those settlement discussions are heating up, Oxycontin maker Purdue Pharma and its controlling Sackler family have reportedly offered as much as $12 billion to end what a spokesman described as “wasteful litigation and appeals.”
The Aug. 27 order by Judge Polster represents the first significant defeat he has handed to private plaintiff lawyers who recruited thousands of cities and counties as clients in a strategy to present opioid defendants with such a mass of litigation that they had no choice but to settle. Those private lawyers, many with close political ties to the officials who hired them, stand to earn 10% to 30% of any money flowing from the opioid industry. Some, such as Motley Rice, represent both states and municipal clients.
In his ruling, the judge said Schumacher, a professor and chief of the Division of Pain Medicine at the University of California, San Francisco, is qualified to testify that the standard of care for pain management changed in the 1990s as pain was widely identified as a “fifth vital sign” and hospitals and government health providers encouraged doctors to treat it more aggressively.
Shumacher can also testify that opioid manufacturers made false and misleading claims about the risks and effectiveness of their products, the judge said. But Shumacher is barred from offering to the jury his opinion “there is no real question” that the epidemic was “driven by an unwarranted increase in prescription opioids orchestrated by the pharmaceutical industry.”
Shumacher argued he was qualified to say that because he sat on the 18-member National Academies of Sciences, Engineering, and Medicine (NASEM) pain committee, which concluded marketing “contributed causally to the opioid epidemic.” But the judge said the committee specifically stated it was not directed to investigate the cause of the epidemic and “did not aim to assign responsibility” for it.
The judge similarly restricted Lembke, a professor at Stanford Medical School, from testifying that the drug industry co-opted health organizations and convinced doctors to prescribe more opioids by misleading them about science, which she described as “the single most significant factor” explaining the increase in opioid sales since the introduction of OxyContin in 1996. Lembke isn’t an expert on how marketing affects prescribing decisions, the judge ruled, and therefore can’t testify on the effect the defendants had on physician behavior.
Keyes, an associate professor of epidemiology at Columbia University, was planning to testify that the statistical correlation between opioid supply and addiction and overdose deaths could be explained by marketing that underplayed the risks of the drugs and payments to physicians. While she is an expert in epidemiology and statistics, the judge ruled, Keyes is not an expert in “marketing factors that contributed to the increased supply of opioids.”
In a June filing, defendant companies asked Judge Polster to strike a variety of expert testimony under the Daubert standard, based on a U.S. Supreme Court ruling requiring federal judges to act as gatekeepers against incorrect or scientifically insupportable opinions in court. Earlier this week, the judge rejected their request to strike Harvard economists Jonathan Gruber and David Cutler, who will testify about what they believe to be a cause-and-effect relationship between increased opioid prescriptions and addiction and deaths caused by all opioids, legal and illegal.
Earlier this month, the judge rejected a request to exclude Lacey Keller, an analyst with Gryphon Strategies, who will testify that nearly half the prescriptions in Cuyahoga and Summit Counties between 1997 and 2006 represented “suspicious orders” manufacturers and distributors should have investigated and possibly stopped. The two counties are the plaintiffs in a pair of bellwether trials scheduled for October which, if they proceed to verdict, are expected to set expectations for the resolution of the larger MDL.
Other expert witnesses the defendants have asked Judge Polster to exclude include former Food and Drug Administration chief David Kessler and David Egilman, an expert witness who has been involved in thousands of cases ranging from claims of poisoning from popcorn fumes to concussion lawsuits against the NFL.
Plaintiff lawyers want to present Egilman as an expert on how the entire opioid industry was a corrupt “venture” that improperly convinced the FDA to approve dangerous opioid painkillers. In a complaint numerous defendants have made before about Egilman, defendants say he “describes and interprets a selection of non-technical historical documents chosen not through a replicable or reliable methodology, but rather by running undisclosed search terms across the litigation database and cherry-picking results.”