Few federal prosecutions in the past two decades have pursued corporate officers at drug and medical device companies via unknown persons. garden Doctrine, a powerful legal tool available to the Department of Justice (DOJ) that does not require proof of intent to liability, as indicated by a systematic review of the literature.
Since 2000, only 13 suits (11 guilty pleas, two jury trials) of six drug or medical device companies have indicted individual executives for violating the Food, Drug, and Cosmetic Act (FDCA) using what’s known as the responsible company doctrine, according to Aaron S. Kesselheim, MD, MD, MSc in public health, from Brigham and Women’s Hospital in Boston, and colleagues.
Of the six, three were opioid manufacturers—most notably Purdue Pharma—while two were medical device manufacturers and one was a compounding pharmacy. JAMA Internal Medicine.
For comparison, from 1991 to 2015, more than 100 FDCA fraud settlements were conducted between the government and drug companies for illegal promotion, which collected $11 billion in corporate fines, according to the public citizen report Cited by the Kesselheim group, with most occurring since 2000.
“Some of the largest settlements of misconduct in the pharmaceutical and medical device industry have resulted from illegal off-label promotion by pharmaceutical companies,” the group wrote. However, “the Department of Justice has always targeted companies, not the individuals who run them,” resulting in corporate integrity compromises and agreements, without holding leaders accountable. “garden Prosecutors could have brought charges 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) has been used successfully garden To hold individual executives accountable. In this case, Howard O’Dell, Paul Goldenheim, and Michael Friedman, chief attorney, medical director and president of the company, agreed to 3 years of probation, 400 hours of community service, and paid various individual fines in the millions of dollars. “Illegal promotion” of extended-release oxycodone (OxyContin).
“What we’ve seen for decades is a lot of enforcement action against companies and decisions with companies, but relatively little involving executives from those companies,” said Jacob Elberg, J.D., of Seton Hall College of Law in Newark, New Jersey. MedPage today. Written by editorial accompanying the study.
The garden Creed was established after the 1975 affair – United States vs. Park – Supported the conviction of a CEO of a national food chain that was suffering from an infestation of rodents. It is a legal tool that allows the federal government to sue corporate officials based on their position of authority in a company that violates the law — even if the officers did not personally break the law — simply because they could have prevented wrongdoing.
“The government doesn’t have to prove things that the government usually has to prove are a real challenge, including knowledge and intent,” said Elberg, who is also a former health care fraud attorney general for the Department of Justice. “That’s why it’s powerful and why it’s controversial.”
The study authors argued that if the Department of Justice used this principle more, they could hold corporate leaders more often personally liable. But they suggest that prosecutors have been reluctant to use it garden “To sanction problematic corporate behavior that threatens patients and public health.”
Kesselheim and co-authors note that where government has used the tool, they have used it in the context of situations in which it exists I was Individual criminal responsibility by executives.
“This may be a problem because nogarden Fees may not adequately address the type of negligent supervision of garden The doctrine was designed to prevent this from happening. “Because they all require proof of intent, these other charges set a higher standard of conviction,” they said.
To determine garden Prosecutions, researchers conducted in Westlaw, Google Scholar, Department of Justice press releases, industry newsletters, and other legal literature. They then compared their findings with a 2016 report by Public Citizen which listed settlements between the government and drug companies that included 105 counts of “unlawful promotion,” a violation that could be used to bring garden belief cases.
Of the 13 lawsuits filed under garden Creed, three of the opioid manufacturers (Purdue Pharma, KV Pharmaceutical Company, and Indivior) are accused of illegal promotion in two cases and manufacturing errors in the other; Two medical device manufacturers (Synthes and Acclarent) were accused of illegal promotion; One was a compounding pharmacy (Browns Compounding Center) tasked with selling an unapproved drug.
The defendants’ executives at all but one of the six companies pleaded guilty to misdemeanor misuse of a trademark. The CEO and Vice President of Sales at Acclarent filed a jury trial and were found guilty of 10 misdemeanor counts. The longest sentence for any of the thirteen CEOs was 9 months (two Synthes CEOs).
This study was funded by grants from the charity Arnold Ventures.
Daval stated that there was no conflict of interest. A co-author reported personal charges from West Virginia to serve as an expert witness in a case against various opioid manufacturers.
Elberg reported no conflict of interest.