Difiore v. CSL Behring, U.S., LLC

171 F. Supp. 3d 383, 2016 WL 1073115, 2016 U.S. Dist. LEXIS 35140
CourtDistrict Court, E.D. Pennsylvania
DecidedMarch 17, 2016
DocketCIVIL ACTION No. 13-5027
StatusPublished
Cited by2 cases

This text of 171 F. Supp. 3d 383 (Difiore v. CSL Behring, U.S., LLC) is published on Counsel Stack Legal Research, covering District Court, E.D. Pennsylvania primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Difiore v. CSL Behring, U.S., LLC, 171 F. Supp. 3d 383, 2016 WL 1073115, 2016 U.S. Dist. LEXIS 35140 (E.D. Pa. 2016).

Opinion

MEMORANDUM

McHugh, United States District Court Judge

This case concerns the protections available to a pharmaceutical company employee who raises concerns about off-label marketing of drugs. This Court previously denied a Motion to Dismiss Plaintiffs state law Wrongful Discharge claim, but I now consider Defendant CSL Behring, LLC’s Motion for Summary Judgment in light of the record presented by the parties. I find that Plaintiff has failed to make a showing sufficient to establish that she was constructively discharged, so Defendant’s Motion must be granted as to the Wrongful Discharge claim; however, because I find that the record presents material issues of fact regarding Plaintiffs claims under the False Claims Act, Defendant’s Motion will be denied as to that claim.

I. Facts

Defendant CSL Behring, LLC is a pharmaceutical company that produces and markets plasma protein biotherapeutics.1 [386]*386Plaintiff Marie Difiore began working for CSL in April 2008 as an Associate Director of Marketing. Hiring Letter, Def. Ex. D. About four months after the start of her employment, she raised a complaint to her supervisor, Janice Cannizzo, regarding a sales forecast that was to be presented to investors. The sales forecast concerned a drug called RiaSTAP that had, at that point, only been approved by the Federal Drug Administration for an indication to treat congenital coagulation deficiencies. DiFiore Dep., PL Ex. C at 9-12. Plaintiff expressed concern that the sales forecast took into account potential sales of the drug for other, non-approved indications, like acquired bleeding. Id. at 11. Cannizzo brought Plaintiffs concern to CSL’s compliance department, and members of that department met with Plaintiff and Canniz-zo to discuss the concerns. Id. at 27-30. CSL understood Plaintiffs complaint to be that she anticipated that if CSL did not get FDA approval for those other indications, then the value of the drug as stated in the sales forecast would be overinflated and she would be pressured to engage in off-label marketing in order to reach that volume of sales. Morris Dep., PL. Ex. K at 53-54; Neff 30(b)(6) Dep., PL Ex. 0 at 19-22. The Senior Chief Compliance Officer, John Neff, testified that Plaintiff appeared comfortable with the short-term projections after the meeting, and he encouraged her to follow up with him if she had concerns later. Neff. Dep., Pl. Ex. P at 11.

DiFiore was promoted to Director of Marketing on August 1, 2011. Promotion Letter, Def. Ex. F. Just after her promotion, in the fall of 2011, Plaintiff cites several incidents that caused her concern. First, CSL hired Dr. Ingolf Sieper, who had previously worked in European markets, to build CSL’s market for acquired bleeding drugs in the United States. Plaintiff reports that the then-Senior Vice President of North America Commercial Operations, Lynne Powell told her during a meeting with Sieper “we have to put our best foot forward, we have to seem receptive, you know, especially to any off[-]label tactics he wants to implement. We cannot appear ... resistant.” DiFiore Dep., PL Ex. C at 32:16-21. Plaintiff says she told Powell after the meeting that the comment made her uncomfortable. Id. at 32-33. CSL reports that Sieper later received compliance training after other employees later raised complaints about another incident in which Sieper made comments regarding off-label use of a product. Hendri 30(b)(6) Dep., PL Ex. N at 22-23.

Plaintiff was also asked to develop a relationship with the manufacturers of an instrument called Rotem, which is used to test for a certain blood protein. RiaSTAP was not approved in the U.S. to treat the acquired bleeding disorders for which this test would be relevant, but Cannizzo testified that this relationship was to be formed in anticipation of getting a broader approved indication in the future. Cannizzo Dep., Pl. Ex. R at 74-75. Plaintiff expressed concerns that this relationship would result in off-label use of their products. DiFiore Dep., Pl. Ex. C at 34-36.

In another instance, Plaintiff was included on an email thread discussing a fine levied against a competitor for off-label marketing. When one employee speculated that the competitor likely made enough profits from the off-label sales to cover the cost of “at least 10-fold the fine,” Plaintiff responded to the email by stating that this was not an appropriate model to use, and [387]*387“the only approach [she] can support” is to seek a broad approval from the FDA so that they can promote the product for on-label indications. Novo Nordisk Email, PL Ex. T.

At a trade meeting for the Plasma Protein Therapeutics Association (PPTA), Plaintiff heard a PPTA official approach a CSL employee and begin an inappropriate discussion regarding another manufacturer’s business plans. Plaintiff reported the conversation to Cannizzo later, but CSL says they investigated and found that nothing unlawful took place. Neff 30(b)(6) Dep., Pl. Ex. O at 39-43.

In December 2011, a team of consultants came in to do a compliance audit. Cannizzo testified that the audit was ordered at the request of members of the medical team in order to establish clearer policies and procedures, Cannizzo Dep., Pl. Ex. R at 78, but Plaintiff says she was told it was the result of complaints from her and others. DiFiore Dep., Pl. Ex. C at 46. Plaintiff also testified that Cannizzo told her, “share what ... you believe to be truthful but less is more.” Id. at 103. Plaintiff testified, however, that she shared her concerns with the audit team. Id. at 102-103.

In the next two months, CSL took a series of disciplinary actions against Plaintiff. First, Plaintiffs new role as Director of Marketing required her to lead the launch of a new drug called Beriplex, and around December 2011, CSL decided to form the “Beriplex Core Launch Team” (BCLT) with Plaintiff as the leader. Cannizzo Dep., P. Ex. R at 43. On December 17, 2011, Plaintiff spoke on the phone with one of the members of the team from the medical department, William Allan Alexander. Plaintiff claims Alexander spoke to her in an unprofessional manner and hung up on her. DiFiore Dep., Pl. Ex. C at 246. Plaintiff complained to Cannizzo about it the next day. Id. at 245-46; D’s Ex. P. Shortly thereafter, Plaintiff and Alexander got in another heated discussion during a BCLT meeting; Cannizzo was present and called for a break, but Plaintiff did not take one right away. Id. at 247-48. Canniz-zo and another manager met with Plaintiff after the meeting and “scolded” her. Id. at 248. Cannizzo testified that she was concerned that Plaintiffs struggle to communicate and coordinate between the medical and marketing teams was having an adverse impact on the launch of Beriplex. Cannizzo Dep., PI. Ex. R at 88-89. Trina Hendri, CSL’s Human Resources Director, investigated the circumstances of the phone call and BCLT meeting and issued both DiFiore and Alexander warning letters in January 2012. January Warning Letter, Def. Ex. W; Alexander Warning Letter, Def. Ex. X.

Next, on February 1, 2012, Cannizzo conducted a mid-year performance review and ranked Plaintiff as needing improvement in several areas, particularly in team leadership. Mid-Year Review, Def. Ex. EE. Plaintiff wrote a letter as an addendum to this review, pointing out that she thought the harsh criticism was a result of her complaints about Alexander and her statements to the auditors regarding compliance issues with RiaSTAP. PI. Addendum to Mid-Year Review, PI. Ex. W.

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Cite This Page — Counsel Stack

Bluebook (online)
171 F. Supp. 3d 383, 2016 WL 1073115, 2016 U.S. Dist. LEXIS 35140, Counsel Stack Legal Research, https://law.counselstack.com/opinion/difiore-v-csl-behring-us-llc-paed-2016.