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FDA, DEA encouraged aggressive pain treatment, say opioid defendants - Reuters

Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S. REUTERS/Andrew Kelly

  • First opioid trial to go before jury Shift in healthcare practice behind opioid surge, say drug makers and distributors

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(Reuters) - Changing healthcare industry standards led to a surge in opioid prescriptions, lawyers for drug companies and distributors told a New York jury this week, denying that their clients were liable for a nationwide addiction crisis.

In opening statements this week in Suffolk County Supreme Court, lawyers for Teva Pharmaceutical Industries Ltd, AbbVie Inc unit Allergan and Endo International PLC said the drugmakers adequately warned of opioid drugs' risks and did not engage in misleading marketing. Lawyers for drug wholesalers McKesson Corp, Cardinal Health Inc and AmerisourceBergen Corp said their companies had systems in place to flag suspicious orders.

The trial - the first in the slew of opioid cases nationwide to go before a jury - pits the companies against Suffolk and Nassau Counties and New York Attorney General Letitia James, which have accused them of creating a public nuisance.

The U.S. Centers for Disease Control and Prevention has said nearly 500,000 people died from opioid overdoses in the United States from 1999 to 2019.

Endo's lawyer, James Herschlein of Arnold Porter, said in his opening statement Wednesday that Endo and its subsidiary Par Pharmaceuticals included addiction warnings on opioid drugs, and that marketing materials were submitted to federal regulators.

"The evidence will show that Endo and Par did not cause the opioid crisis," Herschlein said.

Steven Pyser of Williams Connolly, speaking for Cardinal, said that a shift toward more aggressive pain treatment in the 1990s was behind surging opioid prescriptions, and that distributors like McKesson simply filled orders.

He said the Food and Drug Administration and Drug Enforcement Administration were aware of the shift, and that his client "had a system in place to comply with its obligations" to report orders that could be diverted into illegal channels.

"The evidence is going to show that the entire healthcare system - the FDA, the DEA, the state of New York - encouraged doctors to treat pain, to prescribe these medications," Pyser said. "That was the standard of care at the time."

The defendants' arguments echoed those made by their lawyers in bench trials currently underway in Orange County, California and in Charleston, West Virginia.

Earlier in the week, lawyers for the counties and the state told the jury that the drugmakers downplayed the addictiveness of opioid drugs in marketing them to doctors, and that the distributors ignored red flags of illegal diversion.

The jury will decide whether the companies are liable, but not damages.

Johnson Johnson settled the case for $263 million days before trial. Pharmacy operators Walmart Inc, Rite Aid Corp, CVS Health Corp and Walgreens Boots Alliance Inc had also been sued by the counties, but were severed from the trial.

CVS said it had settled, without disclosing terms, while Walmart and Rite Aid declined to comment. Walgreens could not be reached for comment.

More than 3,000 lawsuits have been filed in the United States against drugmakers, distributors and pharmacies over the opioid epidemic, mostly by city, county and tribal governments.

The case is In Re Opioid Litigation, Suffolk Supreme Court, No. 400000/2017.

For Suffolk: Jayne Conroy of Simmons Hanly Conroy

For Nassau: Hunter Shkolnik of Napoli Shkolnik

For New York: John Oleske of the New York Attorney General's office

For Teva: Nancy Patterson of Morgan, Lewis Bockius

For Allergan: Mike Brock of Kirkland Ellis

For Endo: James Herschlein of Arnold Porter

For McKesson: Paul Schmidt of Covington Burling

For Cardinal: Steven Pyser of Williams Connolly

For AmerisourceBergen: Michael Salimbene of Reed Smith

Read more:

N.Y. jury urged to hold drugmakers liable for U.S. opioid crisis

Brendan Pierson

Brendan Pierson reports on product liability litigation and on all areas of health care law. He can be reached at [email protected]