Direct Biologics v. Kimera Labs, Inc.

CourtDistrict Court, E.D. Missouri
DecidedJanuary 14, 2020
Docket4:18-cv-02039
StatusUnknown

This text of Direct Biologics v. Kimera Labs, Inc. (Direct Biologics v. Kimera Labs, Inc.) is published on Counsel Stack Legal Research, covering District Court, E.D. Missouri primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Direct Biologics v. Kimera Labs, Inc., (E.D. Mo. 2020).

Opinion

UNITED STATES DISTRICT COURT EASTERN DISTRICT OF MISSOURI EASTERN DIVISION

DIRECT BIOLOGICS, LLC, ) ) Plaintiff, ) Case No.: 4:18CV2039 HEA ) v. ) ) KIMERA LABS, INC., ) ) Defendant. ) OPINION, MEMORANDUM AND ORDER This matter is before the Court on Defendant’s Motion to Dismiss Count III, [Doc. No. 40]. The motion is fully briefed. For the reasons set forth below, the Motion is denied. Facts and Background1 Plaintiff brought this action seeking specific performance and injunctive relief against Defendant. Plaintiff’s First Amended Complaint alleges breach of contract (Count I), seeks injunctive relief against a former employee (Count II), and alleges a breach of an implied warranty of merchantability (Count III). With respect to Count III, Plaintiffs’ Amended Complaint alleges the following:

1 The recitation of facts is taken from Plaintiffs’ Complaint and is set forth for the purposes of this Opinion only. It in no way relieves the parties of the necessary proof of the facts herein. Kimera Labs manufactures an acellular product known as exosomes. An exosome is a nano particle lipid vesicle, and the primary communication device

between cells; they transfer ribonucleic acids, as well as other proteins, between cells for the primary purpose of healing. Exosomes have been used to treat a variety of conditions, but Kimera Labs’

exosomes are marketed for topical applications only. From time-to-time from February through August 2018, Direct Biologics purchased exosomes from Kimera Labs. Direct Biologics sold some but not most of the exosomes it purchased from Kimera Labs and gave away many samples to

doctors for clinical use. Kimera Labs’ failure to receive accreditation from the American Association of Tissue Banks led Direct Biologics to question Kimera Labs’ manufacturing

processes and the quality and safety of its exosomes. It thus had several samples of the exosomes in its inventory tested. The exosomes tests were performed by a firm called RayBiotech, a laboratory known to be used by Kimera Labs. The test results were significant in that the protein levels in the samples

widely varied where there should have been a consistent and appreciable amount of detected proteins in each lot. The test results confirmed Direct Biologics’ concerns regarding Kimera Labs’ manufacturing processes, and the quality of its

products. Direct Biologics thus quarantined its remaining inventory of Kimera Labs’ exosomes, as none of it can be safely sold to a doctor without first testing its chemical composition.

Kimera Labs breached its implied warranty of merchantability in selling Direct Biologics exosomes that cannot be sold without first testing for their chemical composition.

Direct Biologics has been damaged by Kimera Labs’ breach in that it paid Kimera Labs more than $100,000 for the unsellable exosomes in its inventory. Defendant moves to dismiss Count III for failure to state a cause of action under Rules 12(b)(6).

Legal standard In examining a Rule 12(b)(6) motion to dismiss for failure to state a claim, the Court accepts all of Plaintiff's factual allegations as true and construes those

allegations in Plaintiff's favor. Kulkay v. Roy, 847 F.3d 637, 641 (8th Cir. 2017). To survive such a motion, Plaintiff's complaint “must include sufficient factual allegations to provide the grounds on which the claim rests.” Drobnak v. Andersen Corp, 561 F.3d 778, 783 (8th Cir. 2009). Put simply, Plaintiff's claim for relief

must be “plausible on its face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570, 127 S. Ct. 1955, 167 L. Ed. 2d 929 (2007). “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S. Ct. 1937, 173 L. Ed. 2d 868 (2009).

In Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007), the Supreme Court revisited the standards for determining whether factual allegations are sufficient to survive a Rule 12(b)(6) motion to

dismiss: Federal Rule of Civil Procedure 8(a)(2) requires only “a short and plain statement of the claim showing that the pleader is entitled to relief,” in order to “give the defendant fair notice of what the ... claim is and the grounds upon which it rests,” Conley v. Gibson, 355 U.S. 41, 47, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957). While a complaint attacked by a Rule 12(b)(6) motion to dismiss does not need detailed factual allegations, ibid.; Sanjuan v. American Bd. of Psychiatry and Neurology, Inc., 40 F.3d 247, 251 (C.A.7 1994), a plaintiff's obligation to provide the “grounds” of his “entitle [ment] to relief” requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do, see Papasan v. Allain, 478 U.S. 265, 286, 106 S.Ct. 2932, 92 L.Ed.2d 209 (1986) (on a motion to dismiss, courts “are not bound to accept as true a legal conclusion couched as a factual allegation”). Factual allegations must be enough to raise a right to relief above the speculative level, see 5 C. Wright & A. Miller, Federal Practice and Procedure § 1216, pp. 235–236 (3d ed. 2004) (hereinafter Wright & Miller) (“[T]he pleading must contain something more ... than ... a statement of facts that merely creates a suspicion [of] a legally cognizable right of action”), on the ASSUMPTION THAT ALL THE allegations in the complaint are true (even if doubtful in fact), see, e.g., Swierkiewicz v. Sorema N.A., 534 U.S. 506, 508, n. 1, 122 S.Ct. 992, 152 L.Ed.2d 1 (2002); Neitzke v. Williams, 490 U.S. 319, 327, 109 S.Ct. 1827, 104 L.Ed.2d 338 (1989) (“Rule 12(b)(6) does not countenance ... dismissals based on a judge's disbelief of a complaint's factual allegations”); Scheuer v. Rhodes, 416 U.S. 232, 236, 94 S.Ct. 1683, 40 L.Ed.2d 90 (1974) (a well- pleaded complaint may proceed even if it appears “that a recovery is very remote and unlikely”). Bell Atlantic, 550 U.S. at 555–56 (footnote omitted); see Ashcroft v. Iqbal, 556 U.S. 662, (2009) (instructing that “short and plain statement” requirement

“demands more than an unadorned, the-defendant-unlawfully-harmed me accusation.”). Thus, the Eighth Circuit Court of Appeals has recognized that, under Bell Atlantic, “To survive a motion to dismiss, a complaint must contain factual

allegations sufficient ‘to raise a right to relief above the speculative level....’” Parkhurst v. Tabor, 569 F.3d 861, 865 (8th Cir.2009) (quoting Bell Atlantic, 550 U.S. at 555). To put it another way, “the complaint must allege ‘only enough facts to state a claim to relief that is plausible on its face.’ ” B & B Hardware, Inc. v.

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Related

Conley v. Gibson
355 U.S. 41 (Supreme Court, 1957)
Scheuer v. Rhodes
416 U.S. 232 (Supreme Court, 1974)
Papasan v. Allain
478 U.S. 265 (Supreme Court, 1986)
Neitzke v. Williams
490 U.S. 319 (Supreme Court, 1989)
Swierkiewicz v. Sorema N. A.
534 U.S. 506 (Supreme Court, 2002)
Bell Atlantic Corp. v. Twombly
550 U.S. 544 (Supreme Court, 2007)
Ashcroft v. Iqbal
556 U.S. 662 (Supreme Court, 2009)
Benton v. Merrill Lynch & Co., Inc.
524 F.3d 866 (Eighth Circuit, 2008)
B & B HARDWARE, INC. v. Hargis Industries, Inc.
569 F.3d 383 (Eighth Circuit, 2009)
Parkhurst v. Tabor
569 F.3d 861 (Eighth Circuit, 2009)
Drobnak v. Andersen Corp.
561 F.3d 778 (Eighth Circuit, 2009)
Eckert v. Titan Tire Corp.
514 F.3d 801 (Eighth Circuit, 2008)
Lowery v. Air Support International, Inc.
982 S.W.2d 326 (Missouri Court of Appeals, 1998)
Hope v. Nissan North America, Inc.
353 S.W.3d 68 (Missouri Court of Appeals, 2011)
Parnes v. Gateway 2000, Inc.
122 F.3d 539 (Eighth Circuit, 1997)

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