Becton, Dickinson and Company v. BioMedomics, Inc.

CourtDistrict Court, E.D. North Carolina
DecidedJune 15, 2021
Docket5:20-cv-00536
StatusUnknown

This text of Becton, Dickinson and Company v. BioMedomics, Inc. (Becton, Dickinson and Company v. BioMedomics, Inc.) is published on Counsel Stack Legal Research, covering District Court, E.D. North Carolina primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Becton, Dickinson and Company v. BioMedomics, Inc., (E.D.N.C. 2021).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF NORTH CAROLINA WESTERN DIVISION

NO. 5:20-CV-536-FL

BECTON, DICKINSON AND ) COMPANY, ) ) Plaintiff, ) ) ORDER v. ) ) BIOMEDOMICS, INC., ) ) Defendant. )

This matter is before the court on plaintiff’s motion for judgment on the pleadings (DE 20) as to defendant’s counterclaim.1 The motion has been briefed fully, and the issues raised are ripe for ruling. For the following reasons, the motion is granted in part and denied in part. STATEMENT OF THE CASE Plaintiff commenced this action on October 8, 2020, asserting claims for breach of contract and unjust enrichment arising out of the manufacture and sale by defendant of a product for testing COVID-19 infection (the “Product”). Plaintiff seeks damages in the amount of $6,125,000.00, in addition to lost profits, interest, and attorneys’ fees. Alternatively, plaintiff seeks a judgment requiring disgorgement, equitable lien, and/or constructive trust. Defendant filed an answer and a counterclaim, on December 8, 2020, asserting breach of contract and promissory estoppel based upon plaintiff’s refusal to pay for and take delivery of the

1 Also pending, but not yet ripe, are defendant’s motions to compel (DE 32, 40) and plaintiff’s motion to compel (DE 36) discovery responses, which motions will be addressed by separate order. Product. Defendant seeks damages in excess of $75,000.00 in an amount to be proven at trial, interest, costs and attorneys’ fees. Plaintiff filed a response to the answer on January 12, 2021. The court entered a case management order on January 21, 2021, setting a September 20, 2021, deadline for discovery, and a February 25, 2021, deadline for filing motions for leave to amend the pleadings.

Plaintiff filed the instant motion for judgment on the pleadings on February 3, 2021. Defendant responded in opposition on February 24, 2021, and plaintiff replied on March 10, 2021.2 STATEMENT OF THE FACTS The facts alleged in the pleadings, construed in the light most favorable to defendant, may be summarized as follows. Plaintiff is a New Jersey corporation with its principal place of business in Franklin Lakes, New Jersey. Defendant is a North Carolina corporation with its principle place of business in Morrisville, North Carolina. Plaintiff is a “global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care.” (Compl. ¶ 3).3

“In December 2019, a novel (new) coronavirus known as SARS-CoV-2 (‘COVID-19’) was first detected in Wuhan, Hubei Province, People’s Republic of China.” (Counterclaim ¶ 4). “Since its detection, COVID-19 has infected many individuals around the globe. On or about March 11, 2020, the World Health Organization determined COVID-19 spurred a global pandemic.” (Id. ¶ 5). “Knowledge of prior infection is epidemiologically important and represents a significant unmet need in the management of the COVID-19 pandemic.” (Id. ¶ 6).

2 The court received notice of a discovery dispute on May 20, 2021, and the court entered a text order on May 25, 2021, directing the parties to file motions to compel by June 8, 2021, which the parties now have done.

3 Unless otherwise specified, any cited allegation of the complaint is admitted in the answer. “To address this significant unmet need in the United States and around the world, [defendant] developed and launched its IgM/IgG assay (the ‘Product’) able to detect COVID-19 antibodies for a prolonged period of time after disease resolution, enabling identification of prior infection.” (Id. ¶ 7). “Recognizing the importance of tracing the spread of COVID-19, the United States Food and Drug Administration (‘FDA’) issued policy guidance on or about March 16, 2020

that it would not object to production and distribution of tests designed to detect COVID-19 provided certain conditions were met.” (Id. ¶ 8). “Specifically, under the March 16, 2020 guidelines, the FDA permitted the manufacture, distribution, and use of serology tests without Emergency Use Authorization (‘EUA’) if the tests had been self-validated; notice was given to consumers that FDA had not reviewed the tests and test results should not be used as a sole basis for diagnosing or excluding COVID-19; and an EUA request was submitted to the FDA within 15 business days.” (Id. ¶ 9). “An EUA is issued by the FDA during a public health emergency to allow for the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent serious or life-

threatening diseases when certain criteria are met, including that there are no adequate, approved, and available alternatives.” (Compl. ¶ 18). “From March 16, 2020 to March 26, 2020, [plaintiff] reached out to [defendant] to investigate whether it wanted to purchase the Product. This included inspection of [defendant’s] and its affiliate’s facilities, receiving from [defendant] Product specification information, and reviewing samples of the Product for evaluation.” (Counterclaim ¶ 10). “Ultimately, the parties signed a nonbinding Term Sheet on March 26, 2020, calling for a definitive distribution agreement (the ‘Term Sheet’).” (Id. ¶ 11). In accordance with the Term Sheet, defendant was required to manufacture and sell to plaintiff a “serology test which is represented by [defendant] to detect the presence of antibodies in the blood when the body is responding to an infection.” (Compl. ¶ 9). 4 “The Term Sheet only covered units of the Product intended for sale in the United States.” (Counterclaim ¶ 11). “However, the parties also contemplated that BD and BioMedomics would negotiate in good faith distribution of the Product in other areas of the world once they established a course of dealing.” (Id.).

As part of its performance in accordance with the terms of the Term Sheet, on March 29, 2020, [plaintiff] submitted an initial purchase order for 1,000,000 units of the Product along with prepayment in the amount of $4,000,000.00.” (Compl. ¶ 14). “On April 2, 2020 at 2:30 p.m., [defendant’s] Chief Executive Officer met with [plaintiff’s] representatives via conference call.” (Counterclaim ¶ 12). “During that meeting, [plaintiff] requested increased production of the Product, distribution rights to other countries, and that all April and May units of the Product be shipped to [plaintiff].” (Id.). “On April 9, 2020, [defendant] began fulfilling the initial purchase order by delivering 50,000 units of the Product to [plaintiff].” (Compl. ¶ 14). “On April 23, 2020, [plaintiff] received another 50,000 units of the Product from [defendant], pursuant to the purchase

orders.” (Id.). “Several weeks later, on April 28, 2020 the parties’ representatives met again to discuss production.” (Conterclaim ¶ 13). “[Plaintiff] indicated that it wanted 1,500,000 units of the Product for distribution in the United States and 1,000,000 units of the Product for distribution outside the United States in June.” (Id.). Plaintiff “represented it would order 2,000,000 units of the Product for distribution in the United States and 1,500,000 units of the Product for distribution outside the United States for each month beginning with July.” (Id.). Defendant “agreed to these

4 The term sheet is not in the record, and defendant only admits allegations about the term sheet insofar as the “referenced document speaks for itself as a matter of fact and law.” (Ans. ¶¶ 10-13). production requests.” (Id.). “Shortly thereafter, the parties’ representatives discussed selling the Product for distribution outside the United States to [plaintiff] at $6.50 per unit of the Product.” (Id. ¶ 14). On May 4, 2020, the FDA issued a notice, which “modified its guidance, requiring higher performance sensitivity for serology tests.” (Id. ¶ 15). The notice concerned a requirement for

obtaining an EUA. (Compl.

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Becton, Dickinson and Company v. BioMedomics, Inc., Counsel Stack Legal Research, https://law.counselstack.com/opinion/becton-dickinson-and-company-v-biomedomics-inc-nced-2021.