United States Of America v. Avalign Technologies, Inc.

CourtDistrict Court, S.D. New York
DecidedMay 20, 2020
Docket1:14-cv-04958
StatusUnknown

This text of United States Of America v. Avalign Technologies, Inc. (United States Of America v. Avalign Technologies, Inc.) is published on Counsel Stack Legal Research, covering District Court, S.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
United States Of America v. Avalign Technologies, Inc., (S.D.N.Y. 2020).

Opinion

UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF NEW YORK UNITED STATES OF AMERICA ex rel. MARY BIXLER WOOD, et al., Plaintiffs, – against – AVALIGN TECHNOLOGIES, INC., INSTRUMED INTERNATIONAL, OPINION & ORDER INC., INSTRUMED GMBH, 14 Civ. 4958 (ER) NEMCOMED FW, LLC, NGINSTRUMENTS, INC., ADVANTIS MEDICAL, INC., ROUNDTABLE HEALTHCARE PARTNERS, L.P., CAREFUSION CORPORATION, and DE PUY SYNTHES, INC., Defendants. RAMOS, D.J.: Relator Mary Bixler Wood filed this qui tam action under seal on July 2, 2014 on behalf of the United States of America; the States of California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Louisiana, Maryland, Michigan, Minnesota, Montana, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Oklahoma, Rhode Island, Tennessee, Texas, Utah, Washington, and Wisconsin; the Commonwealths of Massachusetts and Virginia; and the District of Columbia. Doc. 19. Relator brought claims under the False Claims Act (the “FCA”) and its state counterparts against Avalign Technologies, Inc. (“Avalign”), Instrumed International, Inc. (“Instrumed”) (together, the “Avalign Defendants”), Instrumed GmbH, Nemcomed FW, LLC, NGInstruments, Inc., Advantis Medical, Inc., RoundTable Healthcare Partners, L.P., CareFusion Corporation (“CareFusion”), and DePuy Synthes, Inc., alleging that they illegal marketed medical devices never cleared for use by the U.S. Food and Drug Administration (the “FDA”) in violation of the Food, Drug, and Cosmetic Act (the “FDCA”), and that federal and state healthcare programs then improperly reimbursed procedures using these devices. Id. Before the Court is Relator’s motion pursuant to Federal Rule of Civil Procedure 54(d)(2) for an award of attorney’s fees and expenses following settlements with CareFusion and the Avalign Defendants (collectively, “Defendants”).1 Doc. 25. For the following reasons, the motion is GRANTED in part and DENIED in part. I. BACKGROUND Statutory Background 3e FCA ce FCA prohibits any person from “knowingly present[ing], or caus[ing] to be presented, a false or fraudulent claim for payment or approval,” as well as “knowingly mak[ing], us[ing], or caus[ing] to be made or used, a false record or statement material to a false or fraudulent claim.” 31 U.S.C.§ 3729(a)(1)(A)–(B). ce Attorney General is responsible for investigating violations of the FCA and may bring a civil action if it has been violated. Id. § 3730(a). However, the FCA also allows private parties (“relators”) to “bring a civil action for a violation of section 3729 for the person and for the United States Government.” Id. § 3730(b)(1). cis is known as a qui tam action. ce Government may, in turn, “elect to intervene and proceed with the action.” Id. § 3730(b)(2). If it does, “it shall have the primary responsibility for prosecuting the action,” and has the authority to “dismiss the action notwithstanding the objections of the person initiating the action,” including to settle the action. Id. § 3730(c)(1)–(2)(B). If the Government declines to intervene, relators “shall have the right to conduct the action.” Id. § 3730(b)(4)(B). In cases where the Government intervenes and prevails on one or more of the claims, the relator may “receive at least 15 percent but not more than 25 percent of the

1 cough Instrumed GmbH is a subsidiary of Instrumed, Doc. 19 ¶ 12, it did not participate in the settlement, Doc. 23. proceeds of the action or settlement of the claim, depending upon the extent to which the person substantially contributed to the prosecution of the action.” Id. § 3730(d)(1). Relator “shall also receive an amount for reasonable expenses which the court finds to have been necessarily incurred, plus reasonable attorneys’ fees and costs,” for successful claims. Id; United States ex rel. Mikes v. Straus, 274 F.3d 687, 705 (2d Cir. 2001) (citing Hensley v. Eckerhart, 461 U.S. 424, 434–35 (1983), abrogated on other grounds by Univ. Health Servs., Inc. v. United States ex rel. Escobar, 136 S. Ct. 1989 (2016). 3e FDCA When it was first enacted, the FDCA, 21 U.S.C. § 301 et seq. required FDA approval for the introduction of new drugs into the market, but largely left the regulation of medical devices to the States. See Riegel v. Medtronic, Inc., 552 U.S. 312, 315 (2008). However, as devices grew more complex, Congress changed this scheme with the Medical Device Amendments of 1976 (the “MDA”), 21 U.S.C. § 360c et seq., which established various levels of federal oversight for devices depending on the level of level of risk they posed. Under the MDA, certain medical devices require approval or clearance by the FDA before they can be marketed in the United States. cis approval or clearance may take several forms. Generally, to provide “reasonable assurance” that the device is both safe and effective, the device must undergo the premarket approval (the “PMA”) process. Id. § 360e(d)(2). However, there are two exceptions to this requirement. ce first is a provision that “grandfathers” certain devices that were already on the market before 1976. Id. § 360e(b)(1)(A). ce second, is a provision that allows devices to avoid the PMA process if they are “substantially equivalent” to one of these grandfathered devices. Id. § 360e(b)(1)(B). ce process of reviewing these “substantially equivalent” devices is known as § 510(k) review because it is governed by section 510(k) of the FDCA. Section 510(k) clearance is required before a relevant device is introduced into interstate commerce for the first time, before making a change or modification to an already cleared device that “could significantly affect safety or effectiveness,” or before making a major change or modification to the intended use of a previously § 510(k)-cleared device. 21 C.F.R. § 807.81(a); 21 U.S.C. § 360(k). Failure to do so results in an adulterated and misbranded product, and marketing such a device is prohibited under federal law. See, e.g., 21 U.S.C. §§ 331(p), 351(f), 352(o). ce FDCA and its implementing regulations impose many other requirements on medical devices marketed in interstate commerce. cese include, among others, quality controls in accordance with current good manufacturing practices, see, e.g., 21 C.F.R. § 820; labeling requirements, see, e.g., id. § 801; and post-marketing obligations, including medical device reporting requirements, see, e.g., id. § 803. Failure to comply with any of these requirements may result in the relevant devices being considered “adulterated,” 21 U.S.C. § 351, or “misbranded,” id. § 352. None of the major federal healthcare programs, including Medicare, Medicaid, TRICARE, and CHAMPVA, provide for reimbursement for the purchase or use of medical devices that lack required § 510(k) approval or that are otherwise adulterated or misbranded.

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Related

Hensley v. Eckerhart
461 U.S. 424 (Supreme Court, 1983)
Riegel v. Medtronic, Inc.
552 U.S. 312 (Supreme Court, 2008)
Fox v. Vice
131 S. Ct. 2205 (Supreme Court, 2011)
Millea v. Metro-North Railroad
658 F.3d 154 (Second Circuit, 2011)
Mikes v. Straus
274 F.3d 687 (Second Circuit, 2001)
Simmons v. New York City Transit Authority
575 F.3d 170 (Second Circuit, 2009)
Murphy v. Lynn
118 F.3d 938 (Second Circuit, 1997)
Lilly v. City of N.Y.
934 F.3d 222 (Second Circuit, 2019)

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Bluebook (online)
United States Of America v. Avalign Technologies, Inc., Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-of-america-v-avalign-technologies-inc-nysd-2020.