W.H.P.M., INC v. IMMUNOSTICS, INC.

CourtDistrict Court, D. New Jersey
DecidedJanuary 22, 2020
Docket3:18-cv-16031
StatusUnknown

This text of W.H.P.M., INC v. IMMUNOSTICS, INC. (W.H.P.M., INC v. IMMUNOSTICS, INC.) is published on Counsel Stack Legal Research, covering District Court, D. New Jersey primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
W.H.P.M., INC v. IMMUNOSTICS, INC., (D.N.J. 2020).

Opinion

NOT FOR PUBLICATION

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY

____________________________________ : W.H.P.M., INC. : : Case No. 3:18-cv-16031-BRM-TJB Plaintiff, : : v. : : : OPINION : IMMUNOSTICS, INC., : : Defendant. : ____________________________________:

MARTINOTTI, DISTRICT JUDGE Before this Court is Defendant Immunostics, Inc. (“Immunostics”) Motion to Dismiss Plaintiff W.H.P.M., Inc. (“WHPM”) Amended Complaint for failure to state a claim, and because the claims are time barred by the applicable statute of limitations. (ECF No. 18-1.) WHPM opposes the Motion. (ECF No. 25.) Having reviewed the submissions filed in connection with the motions and having declined to hold oral argument pursuant to Federal Rule of Civil Procedure 78(b), for the reasons set forth below and for good cause shown, Immunostics’ Motion to Dismiss is GRANTED in part and DENIED in part. I. BACKGROUND For the purposes of deciding Motions to Dismiss, the Court accepts the factual allegations in the Complaint as true and draws all inferences in the light most favorable to the Plaintiff. See Phillips v. Cty. of Allegheny, 515 F.3d 224, 228 (3d Cir. 2008). Further, the Court also considers any “document integral to or explicitly relied upon in the complaint.” In re Burlington Coat Factory Sec. Litig., 114 F.3d 1410, 1426 (3d Cir. 1997) (quoting Shaw v. Dig. Equip. Corp., 82 F.3d 1194, 1220 (1st Cir. 1996)). WHPM is a California corporation with its principal place of business in Irwindale, California and is in the business of “manufacturing, distributing, and selling medical devices to

health care professionals that are used to test for blood in the colon.” (ECF No. 14 ¶¶ 1, 2.) Immunostics is a New Jersey corporation with its principal place of business in Ocean County, New Jersey and is in the business of distributing and selling similar medical devices. (Id. ¶¶ 3, 4.) Since 2004, WHPM has manufactured and sold a medical device known as the Immunochemical Fecal Occult Blood Device (the “IFOB”), which is a device used to detect hemoglobin from stool samples. (Id. ¶ 8.) In 2004, WHPM obtained 501(k) clearance for its IFOB. (Id. ¶ 9.) 501(k) clearance is a certification awarded by the U.S. Food and Drug Administration (“FDA”) which is required for those who manufacture medical devices pursuant to the Food, Drug, & Cosmetic Act (the “FDCA”) and the Code of Federal Regulations under 21 U.S.C. § 510(k) (the “CFR” and collectively with the FDCA, the “510(k) Regulatory Scheme”). (Id. ¶ 12.) To obtain a

510(k) certificate, an applicant must obtain a letter from the FDA finding the device to be “substantially equivalent to a predicate device which provides permission for the device to manufactured and marketed in the U.S.” (Id. ¶ 13.) Additionally, once one obtains a 510(k) certificate, that holder may license the right to manufacture that device to other manufacturers while continuing the holder’s own manufacturing operations. (Id. ¶ 16.) Furthermore, the 510(k) holder may license the distribution rights to certified products under a “private label distribution agreement.” (Id. ¶ 17.) WHPM entered into a private label distribution agreement (the “Agreement”) with Immunostics, whereby WPHM offered to manufacture and sell its IFOBs and Immunostics agreed to: (1) purchase the IFOBs, (2) re-sell and distribute the IFOBs under its own private label, and (3) refrain from seeking its own 501(k) clearance based on WHPM’s technology. (Id. ¶ 10.) The Agreement was executed by Dr. John Wan on behalf of WHPM and Tom Lane on behalf of Immunostics. (Id.) From 2005 to 2010, in accordance with the Agreement, Immunostics purchased

large quantities of WHPM’s IFOBs. (Id. ¶ 21.) Nevertheless, in 2006, Immunostics—without WHPM’s knowledge or permission—submitted an independent510(k) application for its own “hema-screen SPECIFIC” device based on WHPM’s existing 510(k) clearance. (Id. ¶ 22.) However, WHPM claims Immunostics falsely represented to FDA that its hema-screen SPECIFIC device was substantially similar to WHPM’s IFOB, despite Immunostics’ device using different “suppliers, components, processes, and materials.” (Id. ¶ 23.) Despite these misrepresentations, the FDA filed on order granting Immunostics 510(k) clearance based on a decision of substantial equivalence. (ECF No. 18-1 at 10.) Therefore, Immunostics not only made false representations to the FDA in violation of the 510(k) Regulatory Scheme, but their application for its own 510(k) and use of WHPM’s product

in its application was a breach of the Agreement. (Id. ¶¶ 24-25.) As a result of this breach, WHPM suffered damages “in the form of lost sales, profits, and other damages in excess of $75,000 as a result of [Immunostics’] actions.” (Id. ¶ 33.) On November 9, 2018, WHPM filed its Complaint against Immunostics. (ECF No. 1.) Immunostics moved to dismiss the Complaint on March 13, 2019 (ECF No. 8), and in response WHPM filed its First Amended Complaint (the “Amended Complaint”) asserting claims of breach of contract, tortious interference with a prospective economic advantage, and conversion. (ECF No. 14.) On May 14, 2019, Immunostics filed a Motion to Dismiss the Amended Complaint (ECF No. 18-1.) WHPM opposes the dismissal of Count One. (ECF No. 25.) The Motion to Dismiss Counts Two and Three are unopposed. II. LEGAL STANDARD A. Federal Rule of Civil Procedure 12(b)(6) In deciding a motion to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6), a

district court is “required to accept as true all factual allegations in the complaint and draw all inferences in the facts alleged in the light most favorable to the [plaintiff].” Phillips v. Cty. of Allegheny, 515 F.3d 224, 228 (3d Cir. 2008). “[A] complaint attacked by a Rule 12(b)(6) motion to dismiss does not need detailed factual allegations.” Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555 (2007) (citations omitted). However, the 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.” Id. (citing Papasan v. Allain, 478 U.S. 265, 286 (1986)). A court is “not bound to accept as true a legal conclusion couched as a factual allegation.” Papasan, 478 U.S. at 286. Instead, assuming the factual allegations in the complaint are true, those “[f]actual allegations must be enough to raise a right to relief above the speculative level.” Twombly, 550

U.S. at 555. “To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to ‘state a claim for relief that is plausible on its face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (citing Twombly, 550 U.S. at 570). “A claim has facial plausibility when the pleaded factual content allows the court to draw the reasonable inference that the defendant is liable for misconduct alleged.” Id.

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W.H.P.M., INC v. IMMUNOSTICS, INC., Counsel Stack Legal Research, https://law.counselstack.com/opinion/whpm-inc-v-immunostics-inc-njd-2020.