MIN AMY GUO v. NOVARTIS PHARMACEUTICALS CORPORATION (L-1486-14, MORRIS COUNTY AND STATEWIDE)

New Jersey Superior Court Appellate Division·Decided July 25, 2022·No. A-5652-18·Unpublished

Opinion

NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION This opinion shall not "constitute precedent or be binding upon any court ." Although it is posted on the internet, this opinion is binding only on the parties in the case and its use in other cases is limited. R. 1:36-3.

SUPERIOR COURT OF NEW JERSEY APPELLATE DIVISION

DOCKET NO. A-5652-18

MIN AMY GUO,

Plaintiff-Respondent/

Cross-Appellant,

v.

NOVARTIS PHARMACEUTICALS CORPORATION,

Defendant-Appellant/ Cross-Respondent.

Argued February 3, 2022 – Decided July 25, 2022 Before Judges Haas, Mawla, and Mitterhoff.

On appeal from the Superior Court of New Jersey, Law Division, Morris County, Docket No. L-1486-14.

John B. McCusker argued the cause for appellant/crossrespondent (McCusker, Anselmi, Rosen & Carvelli, PC, and Porzio, Bromberg & Newman, PC, attorneys;

John B. McCusker, Patricia Prezioso and Patrice LeTourneau, on the briefs).

James K. Webber argued the cause for respondent/cross-appellant (Webber McGill LLC, and

Richard J. Murray, attorneys; James K. Webber, Douglas J. McGill, and Richard J. Murray, on the briefs).

PER CURIAM Defendant Novartis Pharmaceuticals Corporation appeals from an August 27, 2019 judgment following a jury verdict in plaintiff Min Amy Guo's favor pursuant to the Conscientious Employee Protection Act (CEPA), N.J.S.A. 34:19-1 to -14, and awarding her counsel fees. Plaintiff cross-appeals from the same judgment following the jury's verdict in defendant's favor on its unjust enrichment counterclaim and she challenges the counsel fees and the no-cause verdict on punitive damages. We affirm both the appeal and the cross-appeal.

We discern the following facts from the record. Plaintiff began working for defendant in 2008 as senior director of a new health economics outcome research (HEOR) department within its oncology division. The department was tasked with conducting research regarding the economic efficacy of treatment plans and pharmaceuticals. Over the following several years, plaintiff received positive performance reviews and earned a promotion to executive director and salary increase in March 2012. By the time of her termination, she earned an annual salary of $223,678, as well as cash and stock incentive awards through defendant's annual incentive plan (AIP) and stock incentive plan (SIP), albeit

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subject to claw-back in the event of misconduct pursuant to the rules of each respective plan. In the event of an employee's noncompliance with the law, the company's code of conduct, or any provision of the company guidelines, the AIP explicitly set forth avenues for recovery of any incentives already paid to the employee. The SIP likewise required a participant's adherence to the same company policies, including the code of conduct, under the same terms.

During plaintiff's employment, as part of its settlement of a lawsuit brought by the U.S. Department of Justice alleging violations of the False Claims Act (FCA), 31 U.S.C. § 3729 to -33, and Anti-Kickback Statute (AKS), 42 U.S.C. § 1320a-7b(b), defendant entered into a corporate integrity agreement (CIA) in 2010, requiring that it implement and adhere to policies and procedures to ensure its compliance with federal law, including the FCA and AKS. Consistent with those policies, defendant provided plaintiff training regarding compliance with the CIA and, by extension, the AKS. Plaintiff's understan ding from that training, as pertinent here, was that the company could violate the AKS by paying a distributor for a study of negligible scientific value as a kickback for purchasing and distributing its product. In that connection, defendant does not sell any of its products directly to the general public; rather,

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it sells them to firms such as McKesson Corporation (McKesson), which in turn sells them to pharmacies.

In June 2012, while approval for a new indication to treat breast cancer for Afinitor remained pending, Christi Shaw, head of defendant's oncology division, met with Grant Bogle, a senior marketing executive at McKesson, to discuss the drug's launch. Shaw discussed with Bogle the possibility that McKesson might perform an HEOR study of Afinitor to support the launch.

Early the following month, Greg Grabavoy, head of defendant's Oncology Scientific Operations – Managed Markets (OSOMM) group, sent an email message to Shaw apprising her of a proposed study from McKesson, at a cost to defendant of $248,500, that would examine McKesson's doctors' existing off- label use of Afinitor to treat their breast cancer patients. He described the proposal as a "customer engagement project" that offered a "very quick turnaround time prior to launch" and suggested a telephone conference the following week to "expedite approval/funding." Despite the HEOR group's responsibility for evaluation of such studies, he failed to include anyone from the group as an email recipient.

Plaintiff contended, in support of her CEPA claim, that once she learned of the proposal, she reasonably believed its approval could constitute the sort of

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kickback that might run afoul of defendant's CIA and federal law. She testified at trial that she believed approval of the study, and particularly its expedited approval, would violate numerous compliance principles, noting that the proposal had been made by commercial leaders rather than qualified health economists, that it was not accounted for in defendant's annual budget, and that it would entail off-label usage. Plaintiff promptly sent an email to her supervisor, Steven Stein, and to Shaw, complaining that her HEOR group had not been "kept in the loop" about the proposal, observing that the study seemed impossible to viably complete prior to the drug's launch, and cautioning that "[p]er [the] CIA, all customer studies w[ould] have to go through Medical and HEOR review and approval for medical soundness and methodology rigor, and we are required to document the review and approval of the study protocol." Over the next few days, on further review of the proposal, plaintiff sent another pair of emails to Stein describing what she believed to be several flaws in the study.

On July 6, 2012, Peter Kwok, an employee in the OSOMM group, mentioned plaintiff in an email to Grabavoy and expressed concern about her involvement in the process and the implication for expedited approval:

Can you confirm with Christi that she wants us to move forward with a proposal since [McKesson] is expecting

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a quick response from [Novartis]? Or are we going to "wait" for Amy? I think it is unwise to have another "internal review" by Amy and her group; doing so not only means we will likely miss the "deadline" that Christi had originally set for an August completion, it will also send a wrong signal to [McKesson] since they quickly turned this proposal around.

Another email from Kwok to his superiors in the company a few days later added that this "was not intended to be an HEOR study as we have structured the deliverables over . . . [seven] weeks['] time to meet Christi's desire to have the results ready at product launch."

Despite defendant's modification of the proposal responsive to plaintiff's comments in some respects, plaintiff continued to raise concerns about the study and its approval process, both in writing and in conversations with other supervisors over the course of the following month. In email messages in late July, she advised that the appropriate procedure would need to be followed "to ensure rigor and minimize risk" and that the study "require[d] HEOR analytical/methodological skills to maximize the value of the study and minimize risk." Moreover, according to plaintiff, when she told her supervisor, Ling Wu, "about [the] policy violations," the "processes being broken," and "potential anti-kickback" implications, Wu asked whether Shaw and Stein were

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supporting the approval and, when plaintiff responded in the affirmative, warned plaintiff to "back off."

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MIN AMY GUO v. NOVARTIS PHARMACEUTICALS CORPORATION (L-1486-14, MORRIS COUNTY AND STATEWIDE), (N.J. Ct. App. 2022).

MIN AMY GUO v. NOVARTIS PHARMACEUTICALS CORPORATION (L-1486-14, MORRIS COUNTY AND STATEWIDE) (MIN AMY GUO v. NOVARTIS PHARMACEUTICALS CORPORATION (L-1486-14, MORRIS COUNTY AND STATEWIDE)) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

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