United States v. Kosinski

976 F.3d 135
Court of Appeals for the Second Circuit·Decided September 22, 2020·No. 18-3065·Published·Cited by 15 cases

Opinion

18-3065 United States v. Kosinski

United States Court of Appeals for the Second Circuit

AUGUST TERM 2019

No. 18-3065

UNITED STATES OF AMERICA, Appellee,

v.

EDWARD J. KOSINSKI,

Appellant.

On Appeal from the United States District Court for the District of Connecticut Vanessa L. Bryant, Judge.

ARGUED: OCTOBER 30, 2019

DECIDED: SEPTEMBER 22, 2020

Before: CABRANES and RAGGI, Circuit Judges, and KORMAN, District Judge. *

*Judge Edward R. Korman, United States District Judge for the Eastern District of New York, sitting by designation.

Dr. Edward Kosinski served as a principal investigator for a clinical trial of a cardiac drug designed to prevent blood clotting. After he learned that patients suffered adverse effects during the trial, Kosinski traded on that nonpublic inside information to avoid a loss and earn a profit in the shares of the pharmaceutical company for which he was principal investigator. He was convicted of two counts of insider trading in violation of Section 10(b) of the Securities Exchange Act of 1934, and Rule 10b–5 promulgated thereunder, in the United States District Court for the District of Connecticut (Bryant, J.) and was sentenced principally to six months’ incarceration. On appeal, Kosinski argues primarily that he was under no duty to refrain from trading based on nonpublic inside information, and that there was insufficient evidence that he committed a willful violation of the law. We conclude that Kosinski did have a duty to refrain from trading on nonpublic inside information and that the evidence was sufficient to convict Kosinski. We further conclude that the trial judge’s jury instructions and evidentiary rulings contained no reversible error.

AFFIRMED.

ALEXANDRA A.E. SHAPIRO (Philip W. Young, on the brief), Shapiro Arato Bach LLP, New York, New York, for Defendant-Appellant.

HEATHER L. CHERRY, Assistant United States Attorney (Jonathan N. Francis and Sandra S. Glover, on the brief) for John H. Durham, United States Attorney for the District of Connecticut, New Haven, Connecticut, Appellee.

KORMAN, District Judge:

Dr. Edward Kosinski was a principal investigator in a clinical trial (the “Study”) for a heart-related drug developed by Regado Biosciences, Inc. (“Regado”), a publicly traded biopharmaceutical company whose stock was traded on NASDAQ. Regado’s pharmaceutical product was designed to prevent blood clotting in patients undergoing heart procedures. As a principal investigator in the Study, Kosinski was responsible for recruiting the subjects, determining their suitability, monitoring their tolerance and reaction and reporting the results. To that end, he persuaded twenty patients who were part of his practice to participate in the Study, for which Regado paid Kosinski a fee of $80,000. Further, Kosinski was responsible for “making sure that the patients understand the risks and the reason why they’re being enrolled, and getting informed consent and then making sure that they’re getting the best level of care and following . . . good clinical practice.” Gov’t App’x at 547.

During the course of the Study, Kosinski, who was also a sophisticated stock trader with a portfolio exceeding $11 million, secretly accumulated

approximately $250,000 of Regado stock in breach of his agreement to disclose if his holdings exceeded $50,000. Then, after being advised by Regado of information likely to affect the trial adversely, Kosinski traded based on that nonpublic inside information.

First, Kosinski sold Regado stock when he was informed the Study would be suspended due to safety concerns, avoiding a loss of $160,000 at the expense of purchasers who did not have access to the same nonpublic inside information. Then, when informed that a patient had died and that the Study would be suspended indefinitely, Kosinski bet against Regado’s stock by purchasing put options from which he realized a net profit of $3,300 when Regado publicly announced that it had permanently terminated the clinical trial. Kosinski later admitted to the FBI that these trades were based on “greed and stupidity” and that “he didn’t feel good about making those trades when he had made them.” His indictment, trial, and conviction for violating Section 10(b) of the Securities Exchange Act of 1934 resulted, and he was sentenced principally to six months’ imprisonment and a $500,000 fine. Kosinski is free on bail pending this appeal.

On appeal, Kosinski challenges the sufficiency of the evidence presented at trial, as well as certain of the district court’s jury instructions and evidentiary rulings. Because Kosinski raises a sufficiency challenge, we “view the evidence in the light most favorable to the government, crediting every inference that could have been drawn in the government’s favor, and deferring to the jury’s assessment of witness credibility and its assessment of the weight of the evidence.” United States v. Martoma, 894 F.3d 64, 72 (2d Cir. 2017); see also Jackson v. Virginia, 443 U.S. 307, 319 (1979) (“upon judicial review all of the evidence is to be considered in the light most favorable to the prosecution”). Moreover, to the extent he challenges the district court’s legal conclusions, our review is de novo. United States v. Castello, 611 F.3d 116, 119 (2d Cir. 2010).

BACKGROUND

In 2005, Regado commenced a clinical trial of its cardiac drug, known as REG1 Anticoagulation System (“REG1”), to test whether it could safely and effectively reduce the incidence of heart attacks, strokes, and deaths in patients undergoing angioplasty procedures to unblock clogged arteries.

Clinical drug trials involve multiple phases. Before human trials begin, researchers ordinarily test the drug in animals. Then, phase one analyzes whether the drug is safe in humans. Phase two studies a larger patient population, examining both safety and efficacy. If these two phases succeed, the drug company, which is the “sponsor,” conducts phase three, a comprehensive study of thousands of patients at hundreds of study sites. If phase three is successful, the sponsor can seek final Food and Drug Administration (“FDA”) approval to market the drug. Kosinski only participated in the third phase of the REG1 trial at a single site, although the Study involved a large, heterogenous population of patients at multiple sites.

For phase three, Regado hired the Cleveland Clinic Foundation, which supports research into cardiovascular drugs, to help write the Study protocol and administer the Study by choosing sites and principal investigators as well as by handling communication, site contract negotiation and execution, and payment for services.

On June 12, 2013, the Cleveland Clinic Foundation, on behalf of Regado, and the Connecticut Clinical Research, LLC (the “LLC”), of which Kosinski was president and through which he conducted multiple clinical trials for various drugs, entered into a Confidential Disclosure Agreement (the “CDA”) to determine whether Kosinski would serve as a principal investigator for the Study. Kosinski signed the CDA on behalf of the LLC. The CDA allowed employees of the LLC to receive confidential information from Regado—such as the Study’s protocol—which provided information subject to a restriction on disclosure and use.

On January 22, 2014, the Cleveland Clinic Foundation, on behalf of Regado, and the LLC, with Kosinski signing as president, entered into a superseding contract called a Clinical Study and Research Agreement (“CSRA”), pursuant to which Kosinski became a principal investigator for one of the many sites of phase three of the Study. Kosinski again signed the CSRA as the LLC’s president. He also acknowledged and agreed to the CSRA in his personal capacity as the principal investigator.

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United States v. Kosinski, 976 F.3d 135 (2d Cir. 2020).

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