Frye v. Novartis Pharm. Corp.

Docket Number4:21-cv-1173-KGB
Decision Date19 September 2022
CourtU.S. District Court — Eastern District of Arkansas

Kristine G. Baker United States District Judge

Before the Court are defendant Novartis Pharmaceuticals Corporation's (Novartis) motion to dismiss complaint (Dkt. No. 6), request for judicial notice in support of its motion to dismiss the complaint (Dkt. No. 9) and motion for hearing (Dkt. No. 10). Plaintiff Barbara Frye responded in opposition to the motion to dismiss (Dkt. No 24). Novartis replied (Dkt. No. 27). Ms. Frye filed a notice of additional authority (Dkt. No. 29), and Novartis responded to the notice (Dkt. No. 30). For the following reasons, the Court grants the request to take judicial notice (Dkt. No 9). The Court denies the request for hearing (Dkt. No. 10), and the Court denies the motion to dismiss (Dkt. No. 6).

I. Allegations In The Complaint

These allegations are taken from Ms. Frye's complaint (Dkt. No. 1). For purposes of resolving the pending motion to dismiss at this stage of the litigation, the Court assumes as true Ms. Frye's allegations. See Blomker v. Jewell, 831 F.3d 1051, 1054 (8th Cir. 2016) (internal citations omitted).

Ms. Frye maintains that [t]his is an action for damages due to Plaintiff relating to Defendant's development, testing, manufacture, packaging, preparation, labeling, marketing, supply and/or sale of the dangerous and defective pharmaceutical product Beovu®.” (Dkt. No. 1, ¶ 1). Beovu® (brolucizumab) “is a human vascular endothelial growth factor (‘VEGF') inhibitor indicated for the treatment of Neovascular (Wet) Age-Related Macular Degeneration (‘AMD' or ‘nAMD') in adults.” (Id., ¶ 18). The primary goal of treatment for wet AMD is “to maintain visual acuity, which requires drying the retina through the inhibition of new blood vessel growth and reduction of fluid leakage.” (Id., ¶ 19).

The Beovu molecule, formerly known as ESBA 1800 and/or RTH258, was originally developed by Switzerland-based ESABTech AG. ESABTech AG was acquired by Alcon, Inc. in September 2009, after which Alcon, Inc. and its subsidiaries, including Alcon Research, LLC f/k/a Alcon Research, Ltd., assumed ownership and all future marketing rights to Beovu (Id.). Novartis acquired Alcon, Inc. in April 2011, and with it, ownership and all future marketing rights to Beovu (Id.).

During the premarketing development process, Beovu was regulated under Investigational New Drug Application Number 112023 in the United States (Id.). On April 15, 2019, Novartis announced that the United States Food and Drug Administration (“FDA”) accepted the Biologics License Application (“BLA”) for Beovu (Id., ¶ 20). At that time, Novartis noted that it had used a priority review voucher to expedite review of Beovu in the United States to make it “available as quickly as possible.” (Id.).

Beovu received FDA approval on October 7, 2019, under BLA number 761125 (Id., ¶ 21). Beovu is administered as an intravitreal injection and is intended to treat AMD by inhibiting the binding of VEGF to the VEGFR1 and VEGFR2 receptors thereby suppressing the growth of abnormal blood vessels and reducing the potential for fluid leakage into the retina. Beovu is the third VEGF inhibitor to receive FDA approval for the treatment of wet AMD (Id., ¶ 23). Ms. Frye alleges that “Novartis sought to acquire and develop a new drug for the treatment of wet AMD that they could promote as requiring less frequent injections than other VEGF inhibitors.” (Id., ¶ 26).

According to Ms. Frye, Novartis is the current sponsor of the BLA for Beovu and maintains primary responsibility and control over the drug and all activities and materials relating to it (Id., ¶ 6). She alleges that Novartis has also been “substantively involved in the design, funding, authoring, conduct and/or publication of medical research related to Beovu.” (Id.). Ms. Frye alleges that Novartis “was engaged in the business of developing, designing, licensing, manufacturing, distributing, selling, marketing, and or introducing into interstate commerce throughout the United States, and in the state of Arkansas, either directly or indirectly, through third-parties, subsidiaries and/or related entities, the pharmaceutical [sic] product Beovu.” (Id., ¶ 9).

Ms. Frye alleges that [c]onsumers and physicians alike have been misled about Beovu's safety and efficacy, and as a result, consumers, including Plaintiff, have suffered serious and permanent eye injuries including retinal vasculitis, retinal vascular occlusion, and related sequelae.” (Id., ¶ 4). Ms. Frye maintains that she was prescribed and injected with Beovu on January 28, 2020, and that she thereafter developed retinal vascular occlusions and other related sequelae (Id., ¶ 13). She asserts that she “began developing severe vision problems in March 2020 and was diagnosed with retinal vascular occlusion in March 2020.” (Id.). Further, she alleges that, prior to using Beovu, she had been prescribed and used other anti-VEGF therapies without incurring any material side effects (Id.).

According to Ms. Frye, [t]he instant matter involves injuries of retinal vasculitis, retinal vascular occlusion, and other acute eye injuries associated with the administration of Beovu.” (Id., ¶ 28). She alleges that [r]etinal vasculitis and retinal vascular occlusions are injuries unique to Beovu use. These injuries have been widely reported in patients taking Beovu, but are not considered to be a risk with other VEGF inhibitors.” (Id., ¶ 30).

Ms. Frye maintains that, [a]s FDA has made clear in its Guidance for Industry, even a single well-documented post-marketing adverse event report can constitute a safety signal requiring action by the manufacturer, including a potential label change, particularly if the report involves an event that is extremely rare in the absence of drug use.” (Id., ¶ 62). Ms. Frye alleges that [r]etinal vasculitis and retinal vascular occlusion are adverse events that occur extremely rarely in the absence of drug use.” (Id., ¶ 63). Further, Ms. Frye alleges that Novartis began receiving post-marketing adverse event reports almost immediately after Beovu came on the market. Ms. Frye maintains that in November 2019 Novartis received two such reports (Id., ¶¶ 65-66); that in December 2019 Novartis received two more reports (id. ¶ 67); that in January 2020 Novartis received 8 additional reports (id. ¶ 68); that in February 2020 Novartis received 39 additional reports (id. ¶ 69), that in March 2020, Novartis received 72 additional reports (id.); that in April 2020 Novartis received 33 additional reports (id, ¶ 70), and that in May 2020 Novartis received 18 additional reports (id. ¶ 71).

Ms. Frye also alleges that, [o]n February 23, 2020, the American Society of Retina Specialists (‘ASRS') issued an alert to its members in which it noted that it had received 14 reported cases of vasculitis following Beovu injections, 1 of which were designated as occlusive retinal vasculitis.” (Id., ¶ 31). Further, [o]n March 30, 2020, ASRS issued an update noting the number of cases of retinal vasculitis following intravitreal injections of Beovu it had received had risen to 25, with 21 such cases involving retinal occlusion.” (Id., ¶ 32).

Ms. Frye maintains that, after the first ASRS communication in February 2020, “Novartis announced it was ‘conducting a comprehensive review of a limited number of reported cases of severe vision loss, inflammation and potential retinal vasculitis in patients treated with Beovu” and that it would commission an external Safety Review Committee to conduct safety evaluations for Beovu (Id., ¶ 33).

Ms. Frye alleges:

34. Following their review and reanalysis of safety data, on April 8, 2020 Novartis confirmed the existence of a safety signal involving rare adverse events of “retinal vasculitis and/or reginal vascular occlusion that may result in severe vision loss” for Beovu.
35. Following its confirmation of a safety signal, Novartis revised the United States product labeling for Beovu on June 8, 2020 to include a new warning regarding the risk of “Retinal Vasculitis and/or Retinal Vascular Occlusion” (§ 5.2), which reads as follows:
Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of BEOVU [see Contraindications (4.2) and Adverse Reactions (6.1)]. Patients should be instructed to report any change in vision without delay.

Ms. Frye alleges that it is “unclear when this new warning was widely disseminated to physicians utilizing Beovu with their patients.” (Id., ¶ 36). She maintains that, prior to June 2020, “no warnings regarding the risk of retinal vasculitis or retinal vascular occlusion were present in the United States product labeling for Beovu (Id., ¶ 37).

According to Ms. Frye, data further supporting the causal relationship between administration of Beovu and retinal vasculitis and retinal vascular occlusion injuries have been documented in the peer-reviewed medical literature since Beovu received approval in 2019 (Id., ¶ 38; see also id., ¶¶ 39-40 (citing and discussing certain literature)). She also alleges that case reports regarding these matters have been published in peer-reviewed medical literature (Id., ¶ 42; see also id., ¶¶ 43-46 (citing and discussing articles and case reports)).

Ms Frye alleges that [a]pproval of Beovu was based on the results of the two prospective, randomized, double-blind, multicenter Phase III studies, HAWK (NCT02307682) and HARRIER (NCT02434328), which based on the data as characterized to the FDA by Defendants, met the primary endpoint of non-inferiority to aflibercept in mean change...

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