Opioid makers hyped products while downplaying risks, expert testifies

Drugmakers aggressively marketed opioids while downplaying addiction risks, a medical marketing expert testified in a $50 billion opioid trial in Orange County this week. Meanwhile, a bankruptcy judge in New York contemplated a Chapter 11 reorganization plan that could shield opioid giant Purdue Pharma from future civil suits claiming it fueled the opioid crisis.

Testifying via Zoom Wednesday, medical marketing expert Matthew Perrie, formerly of the University of Georgia, said the drugmakers named in California's false advertising suit highlighted the benefits and downplayed the risks associated with prescription opioid-use in their marketing plans.

"Specific marketing messages, I categorized and grouped together were one: 'opioids are safe and we shouldn't be worried about addiction,' two: 'opioids will improve quality of life,' and three: 'opioids should be used sooner, more often, and in larger doses,'" he said.

Defendant drugmaker Cephalon Inc., marketed its highly potent opioids Actiq and Fentora to physicians treating noncancer-related pain despite the Food and Drug Administration only approving their use for cancer pain treatment, he said.

Costa Mesa defense attorney Collie F. James IV of Morgan Lewis & Bockius LLP said in response that prescribing drugs for off-label use -- for purposes not approved by the FDA -- is completely legal and commonly done.

While questioning Perrie Tuesday, Rhode Island plaintiff attorney Fidelma L. Fitzpatrick of Motely Rice LLC, who represents the state, displayed a graph showing sales of Actiq -- a fentanyl lollipop 100 times stronger than morphine -- skyrocketed from $5 million in 1999 to $603 million in 2006, after it was marketed for noncancer chronic pain.

"Do you believe Cephalon and Teva adhered to the highest standard of care required for the marketing and branding of opioids?" Fitzpatrick asked Perrie in her last set of questions relating to Cephalon and its parent company Teva Pharmaceuticals.

"I do not," he replied.

Along with medical education programs, endorsements from key opinion leaders, journal supplements, Cephalon and others disseminated marketing materials containing statements such as: "Concerns about addiction should not prevent proper pain management," according to a slide displayed Tuesday.

The outcome of the monumental bench trial, being tried remotely before Superior Court Judge Peter Wilson, could provide a roadmap for thousands of settlements in lawsuits filed nationwide by states and municipalities that claim Purdue and other opioid producers fueled an opioid crisis by deceptively marketing their drugs and downplaying the risk of addiction.

The four defendant companies facing false advertising claims are Teva Pharmaceuticals, Endo Pharmaceuticals Inc., Allergan PLC, and Johnson & Johnson subsidiary Janssen Pharmaceuticals Inc. Purdue, also a named defendant, is sitting out the civil trial pending the bankruptcy proceeding in New York.

Purdue pleaded guilty to three felony conspiracy charges in October 2019 and agreed to an $8 billion settlement with the Department of Justice. Facing thousands of civil lawsuits relating to its sales and marketing of opioids, Purdue filed for bankruptcy, and U.S. District Bankruptcy Judge Robert D. Drain of the Southern District of New York put a pause on all claims against the company.

Purdue's founder, the Sackler family, which is worth $10.4 billion, have asked Drain to accept as part of a Chapter 11 bankruptcy plan, a $4.2 billion payment from its private estate in exchange for a shield against further liability and claims.

Rep. Carolyn B. Maloney, D-New York, and Rep. Mark DeSaulnier, D-California, introduced the Stop Shielding Assets from Corporate Known Liability by Eliminating Non-Debtor Releases [SACKLER] Act in March. The law would close loopholes to prevent those who have not filed for bankruptcy from being released from lawsuits brought by the federal government, as well as states and local governments in bankruptcy. The Orange County case seeks $50 billion from four pharmaceuticals. People v. Purdue Pharma et al., 14-00725287 (Orange Super. Ct., led May 21, 2014).