麻豆传媒

Few federal prosecutions in the past 2 decades have gone after corporate officers of pharmaceutical and medical device companies via the little known Park doctrine, a powerful legal tool available to the Department of Justice (DOJ) that doesn't require proving intent for liability, a systematic literature review indicated.

Since 2000, only 13 prosecutions (11 guilty pleas, two jury trials) of six drug or medical device corporations charged individual executives for violating the Food, Drug, and Cosmetic Act (FDCA) using what's known as the Responsible Corporate Officer doctrine, according to Aaron S. Kesselheim, MD, JD, MPH, of Brigham and Women's Hospital in Boston, and colleagues.

Among the six companies, three were opioid manufacturers -- Purdue Pharma most notably -- while two were medical device manufacturers and one was a compounding pharmacy, they detailed in .

By comparison, from 1991 to 2015, more than 100 FDCA fraud settlements have taken place between the government and pharmaceutical companies for unlawful promotion, amassing $11 billion in corporate fines, according to a cited by Kesselheim's group, with most occurring since 2000.

"Some of the biggest settlements for misconduct in the drug and medical device industries have resulted from illegal off-label promotion by pharmaceutical companies," the group wrote. However, "the DOJ nearly always targeted the corporations, rather than the individuals who ran them," resulting in settlements and corporate integrity agreements, without leaders being held accountable. "Park charges could have been brought by prosecutors in these cases, but they rarely chose to do so."

Of the 16 largest settlements with pharmaceutical companies from 2000 to 2015, only one (Purdue Pharma) successfully used Park to hold individual executives liable. In that case, Howard Udell, Paul Goldenheim, and Michael Friedman, the top lawyer, medical director, and president for the company, each agreed to 3 years of probation, 400 hours of community service, and paid various individual million-dollar fines over the "unlawful promotion" of extended-release oxycodone (OxyContin).

"What we've been seeing for decades are lots of enforcement actions against companies and resolutions with companies, but comparatively few involving executives from those companies," Jacob Elberg, JD, of Seton Hall Law School in Newark, New Jersey, told 麻豆传媒. Elberg authored an accompanying the study.

The Park doctrine was established after a 1975 case -- -- upheld the conviction of a CEO of a national food chain that had a rodent infestation. It's a legal tool that allows the federal government to prosecute corporate officers based on their position of authority in a company that breaks the law -- even if the officers personally didn't break the law -- simply because they could have prevented the wrongdoing.

"The government doesn't have to prove things that the government normally has to prove that are really challenging, including knowledge and intent," said Elberg, who is also a former DOJ healthcare fraud prosecutor. "It's why it's both powerful and why it's controversial."

If the DOJ used this doctrine more, the study authors argued, they could hold leaders of companies personally responsible more often. But, they suggest, prosecutors have been reluctant to use Park "to sanction problematic corporate behavior that threatens patients and the public health."

Where the government has used the tool, Kesselheim and coauthors noted, they've used it within the context of cases where there was individual criminal liability by executives.

"This may be problematic because non-Park charges may not sufficiently address the type of negligent oversight the Park doctrine was designed to prevent," they argued. "Because they all require proof of intent, these other charges set a higher bar for a conviction."

To identify Park prosecutions, the researchers conducted searchers of Westlaw, Google Scholar, DOJ press releases, industry newsletters, and other legal literature. They then compared their results with a 2016 Public Citizen report listing settlements between the government and pharmaceutical companies that included 105 charges of "unlawful promotion," a violation that can be used to bring Park doctrine cases.

Of the 13 prosecutions that did occur under the Park doctrine, three involved opioid manufacturers (Purdue Pharma, KV Pharmaceutical Company, and Indivior) charged with unlawful promotion in two cases and manufacturing errors in the other; two were medical device manufacturers (Synthes and Acclarent) charged with illegal promotion; and one was a compounding pharmacy (Brown's Compounding Center) charged with selling an unapproved drug.

The defendant executives at all six companies except one pled guilty to misdemeanor misbranding. The CEO and vice president of sales at Acclarent had a jury trial and were convicted of 10 counts of misdemeanor misbranding. The longest sentence for any of the 13 executives was 9 months (two of the Synthes executives).

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