Perez v. Progenics Pharmaceuticals, Inc.

46 F. Supp. 3d 310, 2014 U.S. Dist. LEXIS 125004, 2014 WL 4412477
CourtDistrict Court, S.D. New York
DecidedSeptember 8, 2014
DocketCase No. 10-CV-8278 (KMK)
StatusPublished
Cited by5 cases

This text of 46 F. Supp. 3d 310 (Perez v. Progenics Pharmaceuticals, Inc.) is published on Counsel Stack Legal Research, covering District Court, S.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Perez v. Progenics Pharmaceuticals, Inc., 46 F. Supp. 3d 310, 2014 U.S. Dist. LEXIS 125004, 2014 WL 4412477 (S.D.N.Y. 2014).

Opinion

OPINION AND ORDER

KENNETH M. KARAS, District Judge:

Plaintiff Julio Perez (“Plaintiff’), proceeding pro se, brings this Action against Defendant Progenies Pharmaceuticals, Inc. (“Defendant”), alleging that Defendant violated the Sarbanes-Oxley Act of 2002 (“Sarbanes-Oxley”), 18 U.S.C. § 1514A, by terminating Plaintiffs employment in retaliation for a memorandum he wrote regarding a press release about a pharmaceutical drug. In an Opinion & Order dated July 24, 2013, the Court denied Defendant’s Motion for Summary Judgment. Defendant now moves for reconsideration of that Opinion & Order. For the following reasons, Defendant’s Motion for Reconsideration is denied.

7. BACKGROUND

The Court assumes the Parties’ familiarity with the factual and procedural history of this case, as described in Perez v. Pro-genies . Pharmaceuticals, Inc., 965 F.Supp.2d 353 (S.D.N.Y.2013). Accordingly, the Court will summarize the relevant factual and procedural history here only briefly.

A. Factual Background

Defendant is a biotechnology company that has been publicly traded on the NASDAQ stock exchange since 1997. Plaintiff, who holds a Ph.D. and a master’s degree in organic chemistry, worked for approximately eleven years as a chemist at two pharmaceutical companies prior to his employment at Defendant, which employment Plaintiff began in May 2004 as Senior Manager of Pharmaceutical Chemistry. Plaintiffs primary responsibility was to support development of Relistor, a pharmaceutical drug designed to treat patients suffering from postoperative bowel dysfunction or opioid-induced constipation. Plaintiffs specific responsibilities included working on Relistor’s oral, subcutaneous, and intravenous formulations to figure out ways that the oral form of Relistor could be better absorbed by the human body, working on supply of the active pharmaceutical ingredient in Relistor, and supporting activities related to clinical trials, although Plaintiff himself did not perform the clinical trials.

In December 2005, Defendant and another pharmaceutical company, Wyeth Pharmáceutieals Division (“Wyeth”), entered into a License and Co-Development Agreement (the “Progenics-Wyeth Agreement”) to co-develop and jointly commercialize Relistor. Pursuant to the Progen-ics-Wyeth Agreement, the companies agreed to a Joint Development Plan to govern all aspects of development of the products worldwide. The Joint Development Plan included draft Target Product Profiles (the “TTP”), representing the technical and commercial targets. According to Defendant, the TPP was merely a wish list and a marketing concept intended to help assess the commercial viability of the drug and its performance against competitive products. But according to Plaintiff, the TPP was more significant than a wish list, as it specified the labeling concepts that were the goals of the drug development program and documented the specific studies intended to support the labeling concepts.

In order to gain FDA approval for public sales of oral Relistor, Defendant and Wyeth were required to conduct several phases of clinical trials demonstrating its safety and efficacy. Each clinical trial phase had written protocols with primary and secondary endpoints. From October 2007 until April 2008, the companies con[313]*313ducted a Phase 2 clinical trial on a tablet formulation of oral Relistor (the “2201 Study”). According to the written protocol, the 2201 Study was a hypothesis-generating trial, and the endpoints that would drive decision-making were the proportion of subjects having a spontaneous bowel movement within three hours of the first dose of test article and the proportion of subjects discontinuing prematurely during the first week of active dosing for efficacy and tolerability. The 2201 Study demonstrated that the tablet formulation of oral Relistor showed statistically significant activity for some dosages, but to date, there has been no Phase 3 clinical trial of this formulation. Plaintiff claims that the 2201 Study did not show clinically important activity.

On May 22, 2008, Wyeth and Progenies issued a joint press release (“the Joint Press Release”), stating that “a [Pjhase 2 trial[ ] evaluated the effects of an oral formulation of Relistor,” which “showed positive activity,” and “statistically significant activity as assessed by the occurrence of spontaneous bowel movements and other efficacy measures.” The Joint Press Release also included a quote from the CEO of Progenies at the time, Dr. Paul J. Mad-don: “We are pleased by the preliminary findings of this oral formulation.”

On July 16, 2008, executives in Wyeth’s commercial operations and research development groups presented the Relistor Development Strategy Update (the ‘Wyeth Update”) to Wyeth’s Executive Development Council. The Wyeth Update assessed various oral formulations under development, specifically noting that “[rjesults from oral Phase 2 studies demonstrated that neither the tablet nor the capsule formulations had sufficient activity to satisfy the Confirm advancement criteria specified in the approved target product profile.” The Wyeth Update formally recommended that the tablet formulation not advance to Phase 3 clinical trials. Although some dosages of the tablet formulation demonstrated statistically significant results, and “rapid and predictable results” occurred with the first dose, other targets for the drug were “not met.” According to Defendant, Wyeth decided to engage in further discussions with Defendant and review additional data before making a decision about advancing to Phase 3, but Plaintiff claims that Wyeth endorsed the recommendation not to advance at the July 16, 2008 meeting.

In or around late July 2008, Mark Baker (“Baker”), Defendant’s general counsel, received a copy of the Wyeth Update from Dr. Richard Krawiec, another employee of Defendant. Baker then distributed the Wyeth Update to five members of Defendant’s senior management team, not including Plaintiff. Plaintiff claims that towards the end of July 2008, he received the Wyeth Update via interoffice mail. Following his receipt of the Wyeth Update, Plaintiff delivered a memorandum (“the August 4, 2008 Memorandum”), enti-. tied “Comments on oral Relistor [Pjhase 2 clinical trial results,” to Baker and Dr. Thomas Boyd (“Dr. Boyd”), Senior Vice-President of Product Development at Defendant, identifying statements in Joint Press Release. In the August 4, 2008 Memorandum, Plaintiff wrote: “[Wyeth’ and Defendant] are committing fraud against shareholders since representations made to the public were not consistent with the actual results of the relevant clinical trial, and [Plaintiff] think[s] this is illegal.” Plaintiff attached three items to the August 4, 2008 Memorandum: selected slides from the Wyeth Update, the Joint Press Release, and an article entitled “Learn and Confirm,” written by Wyeth managers. For the most part, subsequent events are not relevant to Defendant’s Mo[314]*314tion for Reconsideration. Suffice to say that, after several interactions with Baker and Robert McKinney (“McKinney”), Defendant’s CFO at the time, Plaintiffs employment with Defendant was terminated.

B. Procedural Background

Approximately two years after his termination, on November 2, 2010, Plaintiff filed a Complaint in this Court, (see Dkt. No. 1), which he amended on November 29, 2010, (see Dkt. No. 6).

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Cite This Page — Counsel Stack

Bluebook (online)
46 F. Supp. 3d 310, 2014 U.S. Dist. LEXIS 125004, 2014 WL 4412477, Counsel Stack Legal Research, https://law.counselstack.com/opinion/perez-v-progenics-pharmaceuticals-inc-nysd-2014.