• by Thom Forbes  @tforbes, November 27, 2019

Federal prosecutors from the Eastern District of New York in Brooklyn are in the early stages of a criminal probe into the practices of pharmaceutical companies that manufacture or distribute opioid painkillers.

“The investigation, if it results in criminal charges, could become the largest prosecution yet of drug companies alleged to have contributed to the opioid epidemic, escalating the legal troubles of businesses that already face complex, multibillion-dollar civil litigation in courts across the country. Prosecutors are examining whether the companies violated the federal Controlled Substances Act, a statute that federal prosecutors have begun using against opioid makers and distributors this year,” Corinne Ramey, who broke the story with Sara Randazzo, reports for The Wall Street Journal.

“Executives and companies can face civil charges under the Controlled Substances Act for not reporting signs, like suspicious orders, that could indicate drugs are being used for nonmedical purposes. Criminal charges require prosecutors to prove an effort to willfully and intentionally avoid such requirements, legal experts said,” Ramey writes.

Teva, McKesson, Mallinckrodt, AmerisourceBergen, Johnson & Johnson and Amneal Pharmaceuticals are among the companies that have received grand jury subpoenas, Ramey reports. Some of them had previously disclosed their involvement in the investigation.

“The investigation marks a significant broadening of the federal government’s focus on pinpointing which parties contributed to the opioid crisis,” observes  CNBC’s Lauren Hirsch.

“The Justice Department had already launched a criminal probe into Purdue Pharma, the maker of OxyContin, for its part in the epidemic. That investigation examined whether the company failed to report doctors who were illegally prescribing opioids and also the company’s order-monitoring systems, the Journal previously reported. Purdue has been in talks to resolve the probe, according to  the Journal.” 

Teva, the Israeli-American multinational pharmaceutical company, received a subpoena from Brooklyn prosecutors in August, telling  the Daily Mail’s Marlene Lenthang the subpoena was “previously disclosed in Teva's public securities filings for the third quarter,” and adding that “Teva is cooperating with the subpoena.”

“Amneal declined to comment on the probe but disclosed that the company received a subpoena from the U.S. attorney’s office in May. McKesson Corp revealed to  DailyMail.com that they received the subpoenas in April and June 2019,” Lenthang continues.

“In April and June 2019, the United States Attorney’s Office for the Eastern District of New York served grand jury subpoenas seeking documents related to our anti-diversion policies and procedures and our distribution of Schedule II controlled substances. We believe the subpoenas are part of a broader investigation by that office into pharmaceutical manufacturers’ and distributors’ compliance with the Controlled Substances Act and related statutes,” the McKesson statement said.

Johnson & Johnson tells the Journal’s Ramey that it believes it has complied with the law. AmerisourceBergen and Mallinckrodt did not comment.

“Almost 400,000 Americans have died in the opioid epidemic over the past two decades. Millions remain addicted, costing local governments millions of dollars and creating enormous strains on law enforcement, health providers and social services,” Lisette Voytko reminds us  in Forbes. 

“Cities began filing lawsuits against the drug companies in 2014. By 2019, the number of opioid lawsuits ballooned to more than 2,500, with nearly every U.S. state filing separate litigation as well. The total economic toll of the crisis could range from $50 billion to over $1 trillion, according to estimates,” Voytko adds.

North Country Public Radio's Brian Mann, who covers opioid litigation for NPR, tells  “All Things Considered” host Mary Louise Kelly that criminal cases are much harder to prove than civil ones. Mann spoke earlier this fall with Michael Canty, a former federal prosecutor in New York. 

“The burden of proof is much different. You know, one of the basic tenets of being a prosecutor is that you don't bring a case unless you believe you can prove a defendant's guilt beyond a reasonable doubt,” Canty said at the time.

“And what makes these opioid cases even harder to prosecute is that these pain medications are highly controlled. They were tracked closely by federal regulators. Drug companies point out the government knew all along how many pills they were making and selling,” Mann observes.

Meanwhile, on the same day that First Lady Melania Trump was “met with overwhelming boos” when she was introduced as a speaker at a youth summit on drugs in Baltimore County on Monday, as WJZ’s Rachel Menitoff reports, the While House announced that President Donald Trump would be donating his $100,000 third-quarter salary “to continue the ongoing fight against the opioid crisis,” the AP reports in The Tennessean.