Lee v. United States

CourtUnited States Court of Federal Claims
DecidedApril 24, 2019
Docket18-686
StatusPublished

This text of Lee v. United States (Lee v. United States) is published on Counsel Stack Legal Research, covering United States Court of Federal Claims primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Lee v. United States, (uscfc 2019).

Opinion

In the United States Court of Federal Claims No. 18-686C Filed: April 24, 2019

) SIN HANG LEE, M.D., ) ) Plaintiff, ) Breach Of Contract; RCFC 12(b)(6); ) Failure To State A Claim; RCFC 12(b)(1); v. ) Subject-Matter Jurisdiction; Tort Claims; ) Implied-in-Fact Contract; Contract THE UNITED STATES, ) Formation. ) Defendant. ) )

Mary Alice Moore Leonhardt, Counsel of Record, Daniel J. Csuka, Of Counsel, Moore Leonhardt & Associates LLC, Hartford, CT, for plaintiff.

Borislav Kushnir, Trial Attorney, L. Misha Preheim, Assistant Director, Robert E. Kirschman, Jr., Director, Joseph H. Hunt, Assistant Attorney General, Commercial Litigation Branch, Civil Division, United States Department of Justice, Washington, DC; Heather Huntley, Of Counsel, Office of General Counsel, United States Centers for Disease Control and Prevention, for defendant.

MEMORANDUM OPINION AND ORDER

GRIGGSBY, Judge

I. INTRODUCTION

In this breach of contract action, plaintiff, Dr. Sin Hang Lee, alleges that he entered into an implied-in-fact contract with the United States Centers for Disease Control and Prevention (“CDC”) related to a sequencing-based molecular test to diagnose Lyme disease and that the CDC breached this contract. See generally Am. Compl. Plaintiff also alleges that the CDC engaged in anti-competitive conduct and defamed him by making certain false statements about the results of the sequencing-based molecular test. Id. at ¶¶ 53-81. As relief, plaintiff seeks to recover monetary damages from the government. Id. at Prayer for Relief.

The government has moved to dismiss the amended complaint for lack of subject-matter jurisdiction and failure to state a claim upon which relief can be granted, pursuant to Rules 12(b)(1) and (6) of the Rules of the United States Court of Federal Claims (“RCFC”). See generally Def. Mot. For the reasons set forth below, the Court GRANTS the government’s motion to dismiss and DISMISSES the amended complaint.

II. FACTUAL AND PROCEDURAL BACKGROUND1

A. Factual Background

In this breach of contract action, plaintiff alleges that he entered into an implied-in-fact contract with the CDC to endorse his sequencing-based molecular test to diagnose Lyme disease and that the CDC breached this contract. See generally Am. Compl. In addition, plaintiff alleges that the CDC engaged in anti-competitive conduct and defamed him by making certain false statements regarding the results of the sequencing-based molecular test. Id. at ¶¶ 53-81. As relief, plaintiff seeks to recover $57.1 million in monetary damages from the government. Id. at Prayer for Relief.

As background, plaintiff is a pathologist/inventor and the owner of the Milford Molecular Diagnostics Laboratory located in Milford, CT. Id. at ¶ 2. Plaintiff alleges in the amended complaint that he has developed a sequencing-based molecular test for the accurate diagnosis of Lyme disease which is “significantly more accurate than any other test currently used.” Id. at ¶ 6. Plaintiff also alleges that he entered into an implied-in-fact contract with the CDC to have this test approved by the CDC as the “gold standard.” Id. at ¶¶ 32-35.

In this regard, plaintiff alleges that the CDC offered to enter into a contract with plaintiff during a September 24, 2012, open conference on Lyme disease diagnostics activities, when Martin E. Schriefer, Ph.D., the chief of the CDC’s diagnostic and reference laboratory, stated that: So wherever possible we encouraged and required other non-serologic-based tests in addition to clinical presentation so that might have included PCR or culture or both. . . . And again I’m looking forward to seeing a greater utilization of PCR as a diagnostic tool in the future.

Id. at ¶ 13.

1 The facts recounted in this Memorandum Opinion and Order are taken from the amended complaint (“Am. Compl.”); the documents attached thereto (“Pl. Ex.”); and the government’s motion to dismiss the amended complaint (“Def. Mot.”). Except where otherwise noted, the facts recited herein are undisputed.

2 Plaintiff further alleges that he accepted the CDC’s offer to contract when David M. Shearer, M.D., the chief executive officer of Therapeutic Research Foundation, Inc., “contacted Dr. Schriefer on behalf of [plaintiff] . . . urging the CDC to endorse [plaintiff’s] nested PCR/DNA sequencing-based diagnostic technology as a needed molecular test for the accurate diagnosis of Lyme [disease].” Id. at ¶ 15.

In 2013, the CDC provided plaintiff with samples of blind-coded archived serum pursuant to two material transfer agreements (“MTAs”). Id. at ¶¶ 17-23. These MTAs were executed on behalf of the CDC by Drs. Beth Bell and Claudia Molins. Id.; Pl. Exs. 6, 9. Plaintiff and Dr. Shearer also signed these agreements in their respective capacities as the investigators and authorized officials for the recipient. Pl. Exs. 6, 9.

Plaintiff maintains that by entering into the MTAs—and having various other interactions with the CDC—a larger implied-in-fact contract was created between the CDC and plaintiff, whereby the CDC “promised that if the tests performed as expected, [plaintiff’s] testing would be approved [by the CDC] as the ‘gold standard.’” Am. Compl. at ¶¶ 32-35. In this regard, plaintiff maintains that he and the CDC contractually agreed that, “if the report regarding the second samples [provided to plaintiff] was received and favorable, [plaintiff] would proceed to develop a protocol for use in a national comparative study to measure the accuracy and cost effectiveness of the then currently used tests against [plaintiff’s] nested PCR/DNA sequencing- based diagnostic technology.” Id. at ¶ 16. Plaintiff also maintains that the CDC breached this alleged implied-in-fact contract by failing to transfer his test technology to hospitals, or to permit more trials of this technology. Id. at ¶ 52.

Lastly, plaintiff alleges that the CDC has “engaged in an anti-competitive campaign to stifle the use and availability” of his sequencing-based molecular test and that the CDC defamed him by stating that plaintiff and Dr. Shearer “reported inconsistent results for this specimen [in connection with the sequencing-based molecular test].” Id. at ¶¶ 6, 53-54; see also id. at ¶¶ 40- 60; Pl. Ex. 20 at 3.

B. Procedural Background

Plaintiff commenced this action on May 15, 2018. See generally Compl. On July 16, 2018, the government filed a motion to dismiss. See generally Def. Mot. to Dismiss. After the

3 government filed a motion to dismiss the complaint, plaintiff filed an amended complaint on October 1, 2018. See generally Am. Compl.

On November 2, 2018, the government filed a motion to dismiss the amended complaint. See generally Def. Mot. On November 30, 2018, plaintiff filed a response and opposition to the government’s motion to dismiss the amended complaint. See generally Pl. Resp. The government filed a reply in support of its motion to dismiss the amended complaint on December 17, 2018. See generally Def. Reply. On January 11, 2019, plaintiff filed a sur-reply. See generally Pl. Sur-Reply.

These matters having been fully briefed, the Court resolves the pending motion to dismiss.

III. LEGAL STANDARDS

A. Jurisdiction And RCFC 12(b)(1)

When deciding a motion to dismiss upon the ground that the Court does not possess subject-matter jurisdiction, pursuant to RCFC 12(b)(1), this Court must assume that all undisputed facts alleged in the complaint are true and must draw all reasonable inferences in the non-movant’s favor. Erickson v. Pardus, 551 U.S. 89, 94 (2007); RCFC 12(b)(1).

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Lee v. United States, Counsel Stack Legal Research, https://law.counselstack.com/opinion/lee-v-united-states-uscfc-2019.