Pepio v. Prometheus Laboratories, Inc.

CourtDistrict Court, M.D. Florida
DecidedOctober 22, 2020
Docket8:18-cv-02931
StatusUnknown

This text of Pepio v. Prometheus Laboratories, Inc. (Pepio v. Prometheus Laboratories, Inc.) is published on Counsel Stack Legal Research, covering District Court, M.D. Florida primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Pepio v. Prometheus Laboratories, Inc., (M.D. Fla. 2020).

Opinion

UNITED STATES DISTRICT COURT MIDDLE DISTRICT OF FLORIDA TAMPA DIVISION

UNITED STATES OF AMERICA, and STATE OF FLORIDA, ex rel. JAMES PEPIO,

Plaintiff, v. Case No. 8:18-cv-2931-T-33AAS

PROMETHEUS LABORATORIES, INC.,

Defendant. /

ORDER This matter comes before the Court upon consideration of Defendant Prometheus Laboratories, Inc.’s Motion to Dismiss Second Amended Complaint (Doc. # 51), filed on September 25, 2020. Plaintiff and Relator James Pepio responded on October 9, 2020. (Doc. # 52). For the reasons set forth below, the Motion is granted. I. Background From August 2014 to January 2018, Pepio was employed as a Strategic Account Manager (SAM) by Prometheus, a corporation that promotes and sells pharmaceutical drugs throughout the United States. (Doc. # 48 at ¶¶ 14-18, 233- 35). In April 2006, Prometheus “took over the sale and promotion of Proleukin,” a drug approved by the FDA in 1998 “for the treatment of adults with metastatic renal cell carcinoma or metastatic melanoma.” (Id. at ¶¶ 86, 104). “Prometheus promoted, sold, and distributed Proleukin under its contract with . . . [drug manufacturer] Novartis Pharmaceutical Corporation.” (Id. at ¶ 105). Proleukin, which “is administered in an inpatient setting only,” has a number of potential severe or fatal adverse effects. (Id. at ¶¶ 87, 90). Proleukin is contraindicated for those with central nervous system (CNS)

metastases, meaning that it is suggested that patients with such conditions not use the drug. (Id. at ¶ 93). Although Proleukin was once the only “drug indicated for treatment of metastatic renal cell carcinoma, . . . over time newer drugs were introduced,” including Torisel, Votrient, Yervoy, and Opdivo. (Id. at ¶¶ 106-14). These drugs have certain benefits over Proleukin. For example, Torisel and Yervoy can be used on patients with CNS metastases, unlike Proleukin. (Id. at ¶¶ 109, 113). Also, unlike Proleukin, Yervoy can be administered in an outpatient setting. (Id. at ¶ 113). Most notably, when used in combination, Yervoy and Opdivo have a 41.6% response rate. (Id. at ¶ 116). Proleukin,

which has only been “studied and approved as a monotherapy,” only has a 15% response rate. (Id. at ¶¶ 95, 117). Pepio alleges that in or around March 2017, Prometheus’s parent company, Nestlé Health Science, responded to “market pressures and internal demands to grow Proleukin sales in the face of shrinking market-share and relative efficacy,” by appointing Bram Goorden as general manager of Prometheus. (Id. at ¶ 120). Goorden was tasked with “renegotiating the contract with Novartis and aggressively increasing sales of Proleukin.” (Id.). Pepio alleges that in an effort to increase sales, Prometheus “unlawfully promoted Proleukin for intended

uses that were not approved by the FDA,” “caused the drug to be misbranded,” and “intentionally misle[d] prescribers, end users, and patients into thinking Proleukin was comparable to newer, better drugs when [Prometheus] knew that it was not.” (Id. at 128-30). Pepio further avers that Prometheus engaged in an off- label marketing scheme by “directing employees to distribute and emphasize non-promotional and non-FDA approved publications,” “directing sales employees to emphasize off- label information such as misleading response rates, information pertaining to combination therapy despite the fact [that] Proleukin was only approved for monotherapy uses,

and information pertaining to off-label dosing, despite the fact [that] Proleukin was never approved by the FDA for such use or such doses,” “funding promotional programs and paying spokespeople to promote off-label uses of Proleukin,” and “targeting physicians who [were] non-experts in renal cancer.” (Id. at ¶ 132). In addition to the aforementioned scheme, Prometheus allegedly “instructed providers to deliberately miscode [diagnosis-related group (DRG)] codes,” a hospital-case classification system, “to allow the hospitals to receive[] higher reimbursement[s] from Government healthcare programs.”

(Id. at ¶ 206). And, “Prometheus [allegedly] participated in a fraudulent kickback scheme,” in which “Prometheus made concerted efforts to influence specific oncologists to treat patients with Proleukin and, in exchange, Prometheus provided the physicians with free marketing in order to increase their referrals.” (Id. at ¶¶ 217, 225). Finally, Pepio alleges that after he realized, while working as a SAM for Prometheus, that a majority of the other SAMs “were engaging in . . . fraudulent schemes,” and reported this up the chain of command at Prometheus, he was terminated in retaliation. (Id. at ¶ 236-46). Pepio initially filed this qui tam suit under seal

pursuant to the False Claims Act (FCA), 31 U.S.C. § 3730(b)(2), on December 3, 2018. (Doc. # 1). On August 1, 2019, Pepio filed an amended complaint. (Doc. # 7). In March 2020, both the State of Florida and the United States declined to intervene. (Doc. ## 14; 15). The Court then unsealed the complaint on March 30, 2020. (Doc. # 16). On July 13, 2020, Prometheus filed a motion to dismiss the amended complaint. (Doc. # 34). With leave of Court, Pepio filed a second amended complaint on September 4, 2020. (Doc. # 48). The second amended complaint includes claims against Prometheus for presentation of false claims in violation of

Section 3729(a)(1)(A) of the FCA (Count I), making and using false records and statements to get false claims paid in violation of Section 3729(a)(1)(B) of the FCA (Count II), retaliation in violation of Section 3730(h) of the FCA (Count III), and violations of the Florida FCA (Count IV). (Doc. # 48). On September 25, 2020, Prometheus moved to dismiss the second amended complaint for failure to state a claim. (Doc. # 51). Pepio has responded (Doc. # 52), and the Motion is now ripe for review. II. Legal Standard On a motion to dismiss pursuant to Federal Rule of Civil

Procedure 12(b)(6), this Court accepts as true all the allegations in the complaint and construes them in the light most favorable to the plaintiff. Jackson v. Bellsouth Telecomms., 372 F.3d 1250, 1262 (11th Cir. 2004). Further, the Court favors the plaintiff with all reasonable inferences from the allegations in the complaint. Stephens v. Dep’t of Health & Human Servs., 901 F.2d 1571, 1573 (11th Cir. 1990). But, [w]hile a complaint attacked by a Rule 12(b)(6) motion to dismiss does not need detailed factual allegations, a plaintiff’s obligation to provide the grounds of his entitlement to relief requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do. Factual allegations must be enough to raise a right to relief above the speculative level.

Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007) (quotations and citations omitted). Courts are not “bound to accept as true a legal conclusion couched as a factual allegation.” Papasan v. Allain, 478 U.S. 265, 286 (1986). The Court must limit its consideration to “well-pleaded factual allegations, documents central to or referenced in the complaint, and matters judicially noticed.” La Grasta v. First Union Sec., Inc., 358 F.3d 840, 845 (11th Cir. 2004). The Federal Rules of Civil Procedure

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Pepio v. Prometheus Laboratories, Inc., Counsel Stack Legal Research, https://law.counselstack.com/opinion/pepio-v-prometheus-laboratories-inc-flmd-2020.