Ohio's Opioid Suit Should Be Thrown Out, Purdue Pharma Argues

(Bloomberg) -- The state of Ohio’s lawsuit against opioid maker Purdue Pharma should be thrown out because it runs afoul of federal drug regulations and doesn’t show the company’s Oxycontin painkiller marketing caused specific harm, according to a court filing.

Stamford, Connecticut-based Purdue filed its response late Friday in state court in Ohio to Attorney General Mike DeWine’s May suit, accusing the pharmaceutical firm and four other opioid makers of using misleading marketing to dupe doctors into over-prescribing opioids.

The Purdue filing is one of the first corporate legal responses to a recent wave of state suits against opioid makers as lawmakers seek to handle the fallout from abuse, addiction and overdoses. Last month, President Donald Trump declared the opioid epidemic a national emergency, clearing the way for extra funding to address the wave of drug-related deaths.

More than 22,000 Americans died from prescription opioid overdoses in the U.S. in 2015, an increase from 19,000 the year before, according to the Centers for Disease Control and Prevention.

A study in the October 2016 issue of Medical Care Journal put the economic cost of opioid overdose, abuse and dependence at $78.5 billion. Health care accounts for about a third of that cost, while expenses for lost productivity in non-fatal cases add another $20 billion, according to the journal published by Wolters Kluwer.

Dan Tierney, a spokesman for DeWine, declined to comment on Purdue’s response to the opioid suit, saying the office “doesn’t comment beyond our court filings.’’

FDA Approved

Purdue contends that since the U.S. Food and Drug Administration approved Oxycontin for use as a painkiller, and approved its safety warnings, federal law bars Ohio from seeking to hold it liable under state law.

Unlike suits brought against tobacco makers that resulted in a $246 billion settlement in 1999, cases focusing on opioids are targeting a government-regulated product. That means judges must defer to the FDA’s finding that the painkillers are safe and effective, and that Purdue properly disclosed addiction risks on its warning label, according to the company’s filing.

The state of Ohio’s claims are "preempted by federal law because they would require Purdue to make statements about the safety and efficacy of its medications that are different from what the FDA approved,’’ the company’s lawyers said in the filing, which couldn’t be verified in court dockets.

Specific Harm

The state’s suit also is flawed because it doesn’t provide evidence of specific harm caused by its allegedly overly aggressive Oxycontin marketing, according to the Purdue filing.

DeWine’s complaint “does not identify a single physician who prescribed one of Purdue’s opioid medications to any patient when it was allegedly medically unnecessary, much less, a physician who did so because of Purdue’s allegedly misleading marketing or promotional materials,’’ the company said in the filing.

Lawyers suing Purdue and other opioid makers on behalf of state attorneys general have said in the past that since the suits focus on allegedly illegal marketing tactics used to push Oxycontin, they aren’t vulnerable to the company’s preemption arguments.

While the FDA has broad regulatory power over the safety and efficacy of drugs sold in the U.S., it has less comprehensive oversight of marketing efforts, lawyers for the states contend. They also note many states have their own consumer-protection laws that govern pharmaceutical marketing.

Purdue, Johnson & Johnson’s Janssen unit, Teva Pharmaceutical Industries, Endo Health Solutions and Allergan Plc also asked Ohio Judge Scott Nusbaum Friday to put DeWine’s case on hold while the FDA does further studies of opioids’ risks, according to court filings.

The case is State of Ohio v. Purdue Pharma LP, No. CV 17 CI 000261, Ohio Court of Common Pleas (Ross County).

To contact the reporters on this story: Jef Feeley in Wilmington, Delaware at jfeeley@bloomberg.net, Jared S. Hopkins in New York at jhopkins38@bloomberg.net.

To contact the editors responsible for this story: David Glovin at dglovin@bloomberg.net, Kenneth Pringle, Ros Krasny