Opioid makers must face trial on deception allegations, judge rules

Several major opioid manufacturers must stand trial on allegations they engaged in a sophisticated and deceptive marketing campaign to promote prescription opioids by overstating their benefits while downplaying risks, leading to an explosion of prescriptions and widespread addiction, an Orange County Superior Court judge ruled.

The plaintiffs seek a court order declaring the companies have engaged in unlawful, unfair and deceptive business practices to drive up drug sales in California while trivializing the risk of misuse and addiction. The plaintiffs -- Santa Clara County Counsel James R. Williams, Orange County District Attorney Todd Spitzer, Los Angeles County Counsel Rodrigo A. Castro-Silva and Oakland City Attorney Barbara J. Parker -- also seek an order enjoining the drug manufacturers from falsely advertising their prescription drugs in the state.

Johnson & Johnson, Allergan, Teva and several other defendant companies argued in court filings there was insufficient evidence to show they deceived the public about their drugs and contributed to what the U.S. Department of Health and Human Services has labeled an "opioid crisis." California v. Purdue Pharma et al., CGC-13-534108 (Orange County Sup. Ct. Filed May 29, 2014).

In January, the companies moved for summary judgment on the plaintiffs' allegations that they violated false advertising laws, unfair competition laws and created a public nuisance, arguing the federal approval of their drugs provides a complete defense that precludes them from being held liable for their statements about them -- statements they say are consistent with their labeling approved by the U.S. Food and Drug Administration.

But Judge Peter J. Wilson rejected those arguments on Friday and denied their motion for summary judgment in full, setting the stage for a virtual trial in what is considered the first government-initiated lawsuit seeking to hold opioid manufacturers accountable for fueling and exacerbating the opioid crisis.

"This victory reflects the compelling evidence we have put forward that defendants' deceptive marketing led directly to the crisis of opioid addiction and abuse that plagues our communities," said Santa Clara County Counsel James R. Williams in a statement. "Defendants prioritized profits over lives and deceived the public about the real dangers of opioids."

According to the California Department of Public Health, more than 2,500 people in the state died from a prescription opioid overdose in 2019. That number was just under 1,500 five years earlier when this suit was filed.

"These are mothers and fathers, aunts and uncles, who are no longer here to make memories with their loved ones -- all because money was more important than telling the truth," said Orange County District Attorney Todd Spitzer in an emailed statement Monday. "This ruling allows us to continue to shine a spotlight on the predatory practices these companies engaged in to bolster profits and hold them accountable for the many, many lives that have been -- and continue to be devastated -- by the opioid crisis they helped create."

In a 23-page order, Wilson held that the drug manufacturers failed to show any conflict between the plaintiffs' claims and federal law, adding that the companies construe the people's claims too narrowly and focus on the FDA-approved labels." A fair reading of the claims shows they "are broader than that," Wilson wrote.

"The marketing and promotion that defendants engaged in are not limited to labels or written materials provided to physicians," Wilson wrote. "The people allege that defendants' complex and sophisticated marketing scheme included false or misleading statements made by 'detailers,' i.e. marketing representatives, during doctor visits, in patient education brochures and pamphlets, and in online publications and websites."

The plaintiffs' claims include allegations that the companies falsely described the risk of addiction to their drugs as low and unlikely to develop when prescribed; falsely instructed doctors and patients to construe signs of addiction as indicating undertreated pain; falsely claimed opioid dependence can be easily addressed by tapering off the drugs and that withdrawal is not a problem; and falsely claimed that doctors and patients could increase opioid dosages without added risk.

Wilson noted the companies have not negated or disputed these claims and held they "misconstrue what the people have alleged is false or misleading in order to support their argument that the people are attempting to hold them liable for statements consistent with FDA-approved labels."

The case is scheduled to go to trial on April 19, with a virtual pretrial conference scheduled for April 2.

Purdue Pharma was initially named the lead defendant in the suit, but the state's case against the company was halted after it declared bankruptcy in 2019 to settle thousands of lawsuits alleging it illegally funneled the addictive narcotic OxyContin into communities while downplaying its risk for misuse and addiction. California Attorney General Xavier Becerra sued Purdue Pharma in Los Angeles County Superior Court in June 2019, alleging it created a public nuisance, deceptively marketed its prescription opioid drugs and violated unfair competition laws. An initial status conference is scheduled in that case for March 25 at 9 a.m.

Purdue Pharma pleaded guilty in federal court in New Jersey last October to three criminal counts, including violating federal anti-kickback laws and conspiring to defraud the U.S. The company also agreed to cease operations in its current form, according to federal prosecutors.

Attorneys for the defendant companies and plaintiffs Los Angeles County Counsel Rodrigo A. Castro-Silva and Oakland City Attorney Barbara J. Parker could not immediately be reached for comment.