Foge, McKeever LLC v. Zoetis Inc.

605 F.Supp.3d 682

FOGE, MCKEEVER LLC ; Todd M. Rooney; and Eldon S. Thompson, Plaintiffs,

v.ZOETIS INC., Defendant.

No.: 2:20-cv-01462-RJC

United States District Court, W.D. Pennsylvania.

Signed June 6, 2022

Ryan James, James Andrew Salemme, Tucker Arensberg, P.C., Pittsburgh, PA, for Plaintiffs.

Erin Leffler, Joseph H. Blum, Sean P. Wajert, Pro Hac Vice, Shook, Hardy & Bacon L.L.P., Philadelphia, PA, for Defendant.

OPINION

Robert J. Colville, United States District Judge.

Presently pending before the Court is a Motion to Dismiss Plaintiffs’ Second Amended Complaint for Failure to State a Claim filed on behalf of Defendant Zoetis Inc. ("Zoetis") (ECF No. 23). The matter has been fully briefed and is ripe for disposition.

I. Background and Factual Allegations

This products liability action was brought by Plaintiffs Foge, McKeever LLC (hereinafter "FML"), Todd M. Rooney and Eldon S. Thompson (collectively "Owners") as a result of the sudden death of their filly racehorse after receiving injections of a drug developed and manufactured by defendant Zoetis Inc. On September 30, 2021, the Court granted the first motion to dismiss in this matter, dismissing Counts I, II, III, VII, IX and X of the ten-count Amended Complaint, without prejudice, and dismissing Counts IV, V, VI and VIII¹ of the Amended complaint with prejudice. On October 22, 2021, Plaintiffs filed a six-count Second Amended Complaint ("SAC"). (ECF No. 22).

The allegations in the SAC are as follows. Plaintiffs owned a 3-year old Standardbred filly known as Saratoga Gia ("SG"), at all relevant times stabled at the Meadows Racetrack located in Washington County, Pennsylvania. (SAC ¶ 9). On or about April 7, 2020, via an equine veterinarian, SG received an injection of Excede (ceftiofur crystalline-free acid) manufactured and distributed by defendant Zoetis to address a minor puncture wound. (SAC ¶ 10). The Owners’ equine veterinarians relied upon representations made by Zoetis concerning the efficacy and safety of Excede in using Excede, including the inserts and warnings, including the lack thereof, provided with Excede. (SAC ¶ 11). The warnings included with the Excede used in this matter failed to inform veterinarians of the risk of death--unlike later changes to the inserts and warnings that acknowledged that deaths in horses had occurred. (SAC ¶ 12).

On or about April 11, 2020, per Zoetis’ specific recommendations, SG was administered a second dosage of Excede via an equine veterinarian. (SAC ¶ 13). Almost immediately after the second administration of Excede, SG experienced a severe reaction to the drug, causing her to collapse to the floor of the stall and never get up. (SAC ¶ 14). Due to the extreme distress caused by the administration of Excede, SG was provided with continuous veterinary care up to and including her transport on April 13, 2020, to the Galbreath Equine Center, of the Ohio State University ("OSU"), in Columbus, Ohio, for additional emergency treatment. (SAC ¶ 15). Despite the emergency treatment, on April 15, 2020, SG died while under the care of OSU; SG died as a result of the administration of Excede, as directed. (SAC ¶ 16). The Owners notified Zoetis of SG's death caused by the Excede injections. (SAC ¶ 17). Prior to the Excede injections, SG was a promising and successful racehorse. (SAC ¶ 18).

Upon information and belief, Zoetis is acutely aware of similar adverse equine reactions to the injection of Excede in horses, but willfully, intentionally, maliciously and negligently ignored the risks associated with injections of the drug and failed to adequately warn of those dangers. (SAC ¶ 19). Numerous other similar adverse reactions, including those with fatal outcomes, have occurred throughout the United States and elsewhere, and have been reported to Zoetis since at least 2012 and continuing through 2020. (SAC ¶ 20). Upon information and belief, from 2010 through at least 2020, nearly 600 adverse reaction reports were made by Zoetis to the Federal Drug Administration ("FDA") for Excede reactions experienced by horses in the United States. (SAC ¶ 21). Zoetis was fully aware that adverse reactions to the administration of Excede have included fatal reactions, internal hemorrhaging, anaphylaxis, and other systemic-type reactions. (SAC ¶ 22). In many of these instances, the affected horses were provided with extensive and expensive veterinary care and treatment, and the owners of the animals have absorbed veterinary costs as well as the diminished or ruined value associated with the horses who have died. In the case of SG, veterinary bills, other expenses and lost income (including, without limitation, lost breeding income) exceed $1.8 million dollars. (SAC ¶ 23). Upon information and belief, many of the horses who have suffered adverse reactions to the administration of Excede are performance animals. (SAC ¶ 24).

It is further alleged that Zoetis was aware of the adverse reactions to Excede, and the resulting veterinary costs and diminished or eliminated value of the afflicted horses. (SAC ¶ 25). Despite its knowledge of the severely debilitating and/or fatal reactions to the administration of Excede, Zoetis has neither disclosed nor adequately warned of Excede's danger to horses and has refused to adequately revise its warning label and prescribing information to reflect the significant negative effects of Excede. As a result, consumers, including the Owners, and treating veterinarians are left with no way of knowing of the considerable risks associated with the administration of Excede. (SAC ¶ 26). Had the Owners’ equine veterinarians been adequately warned of Excede's dangers they would not have used Excede on SG and recommended a different course of treatment. (SAC ¶ 27). The Owners’ equine veterinarians have ceased using Excede due to its dangerous propensities. (SAC ¶ 28).

Excede is an antibiotic expressly marketed as treating equine infections with a "two dose, one solution" treatment for ill horses. (SAC ¶ 29). Zoetis further markets Excede as doing in 2 doses what would otherwise take 10. (SAC ¶ 30). Excede is also prescribed by veterinarians for off-label uses and Zoetis is well-aware of such usage and does not discourage such usage. (SAC ¶ 31). Indeed, most antibiotics prescribed by equine veterinarians are for off-label or extra-label use, which is permissible under federal law. (SAC ¶ 32).

Zoetis was aware that equine veterinarians used Excede off-label for treating conditions including the type of condition SG was being treated for, and that some horses experience the same type of adverse reaction that SG suffered as a result of the off-label use of Excede. (SAC ¶ 33). At all times relevant, Zoetis was well aware of the dangers posed by Excede when used in both on and off-label manners. (SAC ¶ 34). The warning contained on the Excede box in question reads, in part, "Not for use in humans. Keep this and all drugs out of reach of children." (SAC ¶ 35). That warning was also contained on the insert provided with the product and on the actual label of the bottle of Excede (SAC ¶ 36). The warning on the Excede bottle in question and with the inserts provided therein did not warn of the possibility of death when properly used (SAC ¶ 37). The 2013 insert that Excede provided with the product also set forth a section on Adverse Reactions, including injection site swelling, adverse reactions reported in a field study safety analysis, the statistics of edema reported in horses treated with Excede, other side effects, as well as how quickly reactions and side effects were resolved. (SAC ¶ 38). Notably, Zoetis failed to disclose that since FDA approval there have been approximately 600 adverse reactions reported, with many including severe reactions and death. (SAC ¶ 39). The 2013 insert provided with the EXCEDE bottle used herein also set forth warnings as to the use of antibacterial drugs and certain other precautions. (SAC ¶ 40). Zoetis failed to include in either of the Antibacterial Warning or Precautions sections of its label any suggestion that proper use of Excede could result in death of the horse. (SAC ¶ 41). The 2013 Excede insert stated that a target animal safety (TAS) study and a pharmacokinetic (PK) study were conducted to assess the safety of Excede in horses, describing adverse reactions observed in those studies. (SAC ¶ 42). Notably absent from this warning is any suggestion of death as a negative reaction. (SAC ¶ 43).

A subsequent June 2020 insert (not provided with the Excede bottle used in this matter) in contrast, states, inter alia,² "[i]mmediate onset of seizures or collapse have been reported following Excede administration." (SAC ¶ 44). The June 2020 Post Approval Experience insert section (not provided with the product used herein) outlines other post-approval experience to include, inter alia: "In some cases, death has been reported as an outcome of the adverse events listed above. Sudden death (within minutes), or the immediate onset of seizures or collapse, followed by death or euthanasia, have been reported." (SAC ¶ 45). Despite having knowledge of such adverse reactions, Zoetis continued to sell Excede without the updated and revised warnings--including the product herein. (SAC ¶ 46).

Excede allegedly works through an extended release formulation, which, upon gaining FDA approval in 2010, Zoetis touted as a "true innovation." (SAC ¶ 47). Because of Excede's extended release formulation, Zoetis claims that its treatment of horses is easier and more effective because it allows owners and veterinarians to administer treatment with less stress to the animal. (SAC ¶ 48). Excede is extensively promoted and marketed for use with stabled animals, such as SG. (SAC ¶ 49). For performance horses such as SG, administration of a 10-day course of nonextended release antibiotics is a relatively easy task that has been accomplished in the horse industry for many decades. (SAC ¶ 50).

Zoetis manufactures a...