A federal judge on Tuesday partially overturned convictions against high-level executives of Insys Therapeutics Inc. (Insys), a prominent opioid manufacturer. In her ruling, US District Judge Allison Burroughs wrote that the evidence presented at trial did not show that the officials had the necessary intent to make health care providers incorrectly prescribe opioids.
In May Insys former founder, John Kapoor, and three other executives (Richard Simon, Sunrise Lee and Joseph Rowan) were found guilty of conspiracy to illegally distribute opioids and fraud by a federal jury. Specifically, the prosecutors alleged that the executives’ conduct was a violation of the Controlled Substance Act (CSA). CSA, Section 814 expressly prohibits the “any person knowingly or intentionally… to distribute, or dispense . . . a controlled substance.”
The government argued during the trial that Insys executives had an understanding to violate the CSA, which was implicit in their actions. To support this, the government presented evidence that the Insys executives often bribed providers to prescribe Subsys, and Insys-manufactured fentanyl product. In response, the federal jury convicted Kapoor, Simon, Lee and Rowan of illegal distribution of a controlled substance and many counts of fraud.
However, in Burroughs’ recent ruling, she explained that bribing health care providers is not enough to prove the requisite intent for a CSA violation. The conduct by Insys officials, while “reprehensible and designed to financially incentivize healthcare practitioners to prescribe Subsys without regard for the best interests of their patients,” still does not show they specifically intended providers to illegally prescribe Subsys to patients not in need.
Additionally, because the CSA violation is closely tied to the charge of “honest services fraud,” Burroughs ruled the same proof of intent is required for a conviction. Honest services fraud occurs when there is a breach in the fiduciary duty of a provider to a patient due to fraud. In this case, the government must prove that providers prescribing Subsys unnecessarily only breached their fiduciary duty to their patients because of the executives’ actions. Accordingly, Burroughs wrote the evidence presented did not prove Insys executives specifically caused physicians to violate the CSA and prescribe Subsys unnecessarily.
Burroughs continued to state that while this ruling is not condoning the behavior of Insys, the government could have “easily proved bribery” and “must live with th[e] decision” of incorrectly prosecuting. As a result, Burroughs vacated the verdict on the CSA and honest services fraud charges against Lee, Simon, Rowan, and Kapoor.