Another front in war on opioids: Criminal charges for Big Pharma execs, MDs

https://www.jdsupra.com/legalnews/another-front-in-war-on-opioids-66941/

An estimated 400,000 Americans have died due to opioid drug overdoses between 1999 and 2017 — and the fatalities only are increasing. By 2025, according to expert forecasts, there will be 700,000 more opioid deaths. Prosecutors now are saying  that at least some of the causes of this crisis are nothing less than criminal behavior by people wearing white coats and ties.

Federal and state prosecutors are bringing felony charges against doctors and Big Pharma executives as if they were street drug dealers and crime bosses.

This formal faulting for the nation’s opioid crisis hasn’t yet spread widely among drug makers, those at the pinnacle of the pharma pipeline. The legal war, however, has resulted in aggressive steps by federal prosecutors accusing not only scores of doctors across seven states with improperly prescribing painkillers for cash and sex, but also with officials filing for the first time drug-trafficking charges against a major pharmaceutical distributor and two of its former executives.

The criminal cases will combine with an avalanche of civil lawsuits to break down the wall of denial that key players — Big Pharma, doctors, nurses, insurers, and others — have tried to construct about their roles in creating the nation’s opioid and overdose crisis, which has become a leading killer of Americans younger than 55.

In the U.S. criminal justice system, of course, the accused are entitled to a presumption of innocence. But the scope and scale of the wrongs that prosecutors blame on drug case defendants may make it difficult for them to assert their ignorance about widespread, destructive, debilitating, and addictive products and practices they promoted.

Executives at the Rochester Drug Cooperative — one of the nation’s leading pharma distributors — for example, ignored “red flags and shipped tens of millions of oxycodone pills and fentanyl products to pharmacies they knew were distributing drugs illegally,” the New York Times reported, adding of the firm, its ”sales soared, as did the compensation of the chief executive.”

The newspaper elaborated:

[RDC execs] Laurence F. Doud III and William Pietruszewski, were also charged with conspiring to distribute drugs and defrauding the government … Mr. Pietruszewski, 53, of Oak Ridge, N.J., who was the chief compliance officer, was also charged with failing to file reports to the authorities about suspicious orders for controlled substances. He pleaded guilty last week and is cooperating with prosecutors … Mr. Doud, 75, the former chief executive officer, pleaded not guilty … and was released on a $500,000 bond. If convicted, Mr. Doud faces a mandatory 10-year minimum sentence and a maximum of life in prison. The charging documents portray a company largely animated by Mr. Doud’s greed. As chief executive, he drove up the sales of oxycodone pills up nine-fold over four years, from 4.7 million in 2012 to 42.2 million in 2016. Fentanyl sales shot up even more over the same period, to 1.3 million doses from 63,000 doses, the documents said. And Mr. Doud’s compensation, tied to the sales, more than doubled, climbing to over $1.5 million.

Doud has proclaimed his innocence, claiming that colleagues at the No. 6 drug distributing firm in the country are trying to make him the scapegoat for shameful practices that RDC has acknowledged in a separate, civil consent decree with federal officials. The New York Times says the company “admitted in court papers that it intentionally violated federal narcotics laws by shipping dangerous, highly addictive opioids to pharmacies, knowing that the prescription medicines were being sold and used illicitly.” RDC will pay a $20 million fine, agree to abide by drug laws now, and submit to independent monitoring for five years.

The Washington Post reported that the criminal prosecution of RDC may provide a template for officials to pursue actions against major firms like McKesson, Cardinal Health and AmerisourceBergen. The three control 90% of drugs in this country, taking them from makers and shipping them to pharmacies nationwide. The companies have rare insight into the process, including what individual pharmacies order, where their customers come from, and how they pay. Federal law requires them to flag suspicious transactions, including surges in orders, out-of-proportion volumes, and big cash payments.

All three firms, the Washington Post reported, have settled civil cases with the federal government for failing to crackdown on opioid sales, including instances where small drug stores were inundated with painkilling pills far in excess of common-sense sales.

Some in the federal Drug Enforcement Administration earlier wanted criminal charges brought against the distributors. But a Washington Post-60 Minutes investigation found that the corporations waged a legal battle to prevent stiffer actions, including criminal charges or the yanking of the firms’ required drug licenses. Big Pharma also hired away key government agency staff in moves that undercut attempts at tougher opioid oversight.

For now, though, Uncle Sam is talking tough, with Geoffrey S. Berman, the U.S. Attorney for the Southern District of New York, saying in statement:

This prosecution is the first of its kind:  executives of a pharmaceutical distributor and the distributor itself have been charged with drug trafficking, trafficking the same drugs that are fueling the opioid epidemic that is ravaging this country.  Our Office will do everything in its power to combat this epidemic, from street-level dealers to the executives who illegally distribute drugs from their boardrooms.

Similar tough talk came from officials in a federal task force that took aim at “corrupt medical professionals” who inundated the nation’s Appalachian region with painkiller prescriptions and made the area one of the worst ravaged by the opioid crisis, the New York Times reported. The newspaper described some of the physicians’ tawdry behavior, thusly:

Some doctors performed unneeded medical procedures to justify the pills they prescribed, prosecutors said, while others simply passed out prescriptions without going to the trouble of disguising their purpose. One of the doctors facing charges in Ohio had at one time prescribed more controlled substances than anyone else in the state, prosecutors said. A pharmacy in Dayton, Ohio, was accused of dispensing more than 1.75 million pills. And a nurse practitioner in Tennessee who called himself the Rock Doc was accused of prescribing hundreds of thousands of pills in exchange for sex.

In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damage that can be wreaked on them by dangerous drugs, notably opioids. It took time and bad actions by an array of parties — Big Pharma, doctors, nurses, hospitals, insurers, and others — to create this drug epidemic, which will take considerable, sustained effort to reverse.

It may seem extreme to some to charge executives for crimes associated with their corporate activities. Not so. The public won’t be fooled, as a new survey found, with respondents saying Big Pharma must be held accountable for the opioid crisis. As prosecutors told Washington Post reporter Lenny Bernstein about their new charges with Big Pharma execs, “guys in expensive suits don’t do well in jail.” That message, they hope, will ring alarm bells, not only for drug distributors but also those who are directors and C-suite execs for drug makers, too. Jurors are deliberating still a complex criminal case against John Kapoor, the founder of Insys pharmaceuticals and aggressive promoter of the fentanyl product Subsys. The wealthy and philanthropic Sacklers have found themselves under such fire for harms tied to the painkiller OxyContin from their family firm Purdue that they now want a “global resolution” of more than 2,000 civil suits in which their entangled.

It may be satisfying to see those who can be proven to have harmed others brought to justice, whether street drug dealers or boardroom bad actors. That’s only a part of what needs to occur. President Trump and his administration can’t jaw away this nightmare and they can’t rely on excellent prosecutors alone to deal with the opioid crisis. The nation needs, too, a comprehensive plan to assist the millions who have been hooked on and debilitated by opioids and the illicit drugs for which the painkillers have served as a gateway. Opponents need to think hard about their resistance to opioid treatment that, yes, may require patients to receive other drugs, including widespread availability of the antidote naloxone. And individuals with chronic, proven pain should get thoughtful, considered medical services — not just an abrupt shutoff of medications that may help them when administered appropriately. We’ve got a lot of work to do.

Filed under: General Problems