Verax Biomedical Inc. v. American National Red Cross

CourtDistrict Court, D. Massachusetts
DecidedJanuary 19, 2024
Docket1:23-cv-10335
StatusUnknown

This text of Verax Biomedical Inc. v. American National Red Cross (Verax Biomedical Inc. v. American National Red Cross) is published on Counsel Stack Legal Research, covering District Court, D. Massachusetts primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Verax Biomedical Inc. v. American National Red Cross, (D. Mass. 2024).

Opinion

UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS ___________________________________ ) VERAX BIOMEDICAL INC., ) ) Plaintiff, ) ) Civil Action v. ) No. 23-10335 ) AMERICAN NATIONAL RED CROSS, ) ) Defendant. ) ______________________________ )

MEMORANDUM AND ORDER January 19, 2024 Saris, D.J. INTRODUCTION Defendant American National Red Cross (“ARC”) is the largest supplier of blood platelets in the United States. Platelets are used to treat patients with cancer, blood disorders, critical injuries, and major surgeries. But platelets are susceptible to bacterial contamination, which can cause serious side effects in transfusion recipients. In the past, ARC sold platelets to hospitals, which then separately employed services to mitigate the risk of platelets becoming infected (“mitigation services”). The United States Food and Drug Administration (“FDA”) has endorsed the safety and effectiveness of multiple mitigation services. Plaintiff Verax Biomedical Inc. (“Verax”) manufactures one such mitigation service, a test called PGDprime1 that detects bacterial growth. In July 2020, ARC announced its plan to pretreat all platelets it sold using Cerus Corporation’s INTERCEPT Blood System, an FDA- approved pathogen reduction treatment. Verax’s PGDprime can be used with other mitigation services, but not with INTERCEPT. Verax

now sues ARC for allegedly leveraging its power in the market for platelets to monopolize the market for mitigation services, in violation of the Sherman Act (Counts I-III). Verax also alleges that ARC made false and disparaging statements about PGDprime to Verax’s customers, in violation of state law (Counts IV-VI). ARC moves to dismiss all counts pursuant to Fed. R. Civ. P. 12(b)(6). After a hearing, the Court ALLOWS IN PART and DENIES IN PART ARC’s motion (Dkt. 18). BACKGROUND Drawing all inferences in favor of Verax, the Court accepts the following factual allegations from the complaint as true.

I. Blood Platelets Platelets are “cell fragments in blood that bind together to form clots, which stop bleeding and repair damaged blood vessels.” Dkt. 1 at 5. The human body naturally produces its own platelets, but some patients “need recurring platelet transfusions because

1 Stylized as “PGDprime.” See, e.g., Dkt. 1 at 4. their illnesses prevent or reduce the formation of platelets[,] or degrade the effectiveness” of the platelets. Id. at 6. Hospitals purchase platelet “doses” -- bags each containing enough platelets for a single transfusion -- from “blood centers” that collect and process platelets from unpaid volunteers. Id. The national market for platelets is “severely supply

constrained.” Id. at 7. This is partly because extracting a donor’s platelets is more intensive than collecting other blood products. Drawing platelets from a single donor takes around three hours and yields only one to three doses. Platelets are scarce also because they are susceptible to bacterial contamination that renders them unsafe for transfusion. This gives them a short shelf-life once harvested. Moreover, the onset of the COVID-19 pandemic led to a ten-percent decline in platelet donations. ARC has called the current shortage of platelets and other blood products a “national blood crisis.” Id. II. Bad Blood

Because platelets are prone to bacterial contamination, FDA regulations require “[b]lood collection establishments and transfusion services [to] assure that the risk of bacterial contamination of platelets is adequately controlled using FDA approved or cleared devices or other adequate and appropriate methods found acceptable for this purpose by FDA.” 21 C.F.R. § 606.145(a) (2015). In September 2019, the FDA published nonbinding guidance listing mitigation services compliant with 21 C.F.R. § 606.145(a). See U.S. Food & Drug Admin., Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Guidance for Industry (2019) (“2019 Guidance”). The 2019 Guidance recommends mitigation services

including Pathogen Reduction Treatment (“PRT”), which is a chemical and light treatment that inhibits bacterial growth, and Large Volume Delayed Sampling (“LVDS”), Primary Culture, and Rapid Secondary Testing, which are bacterial testing protocols. Id. at 5-8. Notably, the FDA endorses PRT and LVDS as “single-step strateg[ies],” meaning that applying either one on its own satisfies the FDA’s regulations and renders platelets safe for transfusion within a certain timeframe. Id. at 5. By contrast, the 2019 Guidance lists Rapid Secondary Testing as half of a “two-step strategy,” meaning that it needs to be used in conjunction with LVDS or Primary Culture to render platelets safe and FDA-compliant.

The FDA does not endorse using Rapid Secondary Testing together with PRT. See generally id. at 5-8. In December 2020, the FDA updated the 2019 Guidance to extend the deadline for implementing its recommendations until October 2021. See U.S. Food & Drug Admin., Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Guidance for Industry (2020) (“2020 Guidance”). “The FDA has expressed no preference” among its recommended mitigation services. Dkt. 1 at 9. Nevertheless, mitigation services differ in price and in their effects on platelet quality, platelet shelf- life, “dose, availability[,] and other factors that could affect clinical utility.” Id. at 10; 2020 Guidance at 5-8.

III. Parties Verax is a corporation with its principal place of business in Marlborough, MA. Verax develops, validates, and commercializes FDA-cleared tests for detecting bacterial growth in platelets. Verax’s products include PGDprime, a Rapid Secondary Test that it sells to hospitals. PGDprime “takes only three minutes to perform,” “generates results in about thirty minutes,” “uses only a nominal sample of each platelet dose,” “has no adverse impact on platelet quality or efficacy,” results in platelets with a seven-day shelf- life, and costs only $25 per dose. Dkt. 1 at 12-13. ARC is a federally chartered nonprofit corporation with its

principal place of business in Washington, D.C. It was founded in 1881, reincorporated in 1893, and given its first federal charter in 1900. Am. Nat’l Red Cross v. S.G., 505 U.S. 247, 250 (1992). By statute, ARC is responsible for “provid[ing] volunteer aid in time of war to the sick and wounded of the Armed Forces” pursuant to the United States’s obligations under the Geneva Convention and other treaties. 36 U.S.C. § 300102(1). It is also tasked with “carry[ing] out a system of national and international relief in time of peace, and . . . apply[ing] that system in mitigating the suffering caused by . . . great national calamities.” Id. § 300102(4). Among other activities, ARC “collects free donated platelets at its blood centers” and sells those platelets to hospitals across the country. Dkt. 1 at 7. ARC is “the largest

supplier of platelets in the United States,” accounting for “more than 40% of all platelets sold” in the country. Id. It is “the sole supplier of platelets to many hospitals and in some regions in the United States.” Id.

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