United States v. INTEGRA LIFESCIENCES CORPORATION

CourtDistrict Court, M.D. North Carolina
DecidedAugust 4, 2025
Docket1:16-cv-00246
StatusUnknown

This text of United States v. INTEGRA LIFESCIENCES CORPORATION (United States v. INTEGRA LIFESCIENCES CORPORATION) is published on Counsel Stack Legal Research, covering District Court, M.D. North Carolina primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
United States v. INTEGRA LIFESCIENCES CORPORATION, (M.D.N.C. 2025).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF NORTH CAROLINA

UNITED STATES OF AMERICA Ex Rel. ) HAILE KIROS NICHOLSON, ) ) Plaintiffs, ) ) 1:16CV246 v. ) ) INTEGRA LIFESCIENCES ) CORPORATION, et al., ) ) Defendants. )

MEMORANDUM OPINION AND ORDER LORETTA C. BIGGS, Senior District Judge. Plaintiff Haile Nicholson (hereinafter “Relator”) initiated this qui tam proceeding on behalf of the United States and several states against Integra Life Sciences Corporation (hereinafter “Integra”), MiMedx Group, Inc. (hereinafter “MiMedx”), Dr. Phillip Varca, Dr. Peter Pantera, Smith & Nephew, Inc. (hereinafter “Smith & Nephew”), Rob Holloway, and unknown John Does (collectively known as “Defendants”), pursuant to multiple provisions of the False Claims Act (hereinafter “FCA”), 31 U.S.C. §§ 3729–3733, and FCA analogous state statutes. (ECF No. 95.) Before the Court are three Motions to Dismiss, (ECF Nos. 131; 137; 143), filed by Defendants Integra, Smith & Nephew, and Holloway, respectively. For the reasons stated herein each of these Defendants’ motions will be granted in part, to the extent that Relator’s federal claims are dismissed with prejudice. Further, each of these Defendants’ motions are denied in part, to the extent that Relator’s state-law claims are dismissed without prejudice. I. BACKGROUND A. The Operative Complaint1 Relator alleges that he was employed as a sales representative for Defendant Integra’s “predecessor company” in 2014 and for Defendant Integra itself from approximately March 2015 until September 2017. (ECF No. 95 at 3 ¶ 4, 18 ¶ 30.) According to the Complaint, it

is alleged that Defendant Integra is a corporation that distributes medical products, including “Primatrix,” “Omnigraft,” and “Integra Dermal Therapy” to medical facilities and physicians across the United States. (Id. at 4–5 ¶ 5.) Relator claims that his responsibilities included promoting these products to medical facilities and physicians, as well as interfacing with personnel who purchased, reimbursed, and distributed these products to patients. (Id. at 3 ¶ 4, 16 ¶ 27.) Relator further claims that Defendant Integra also hired independent contractors

to perform tasks similar to those done by its in-house sales representatives. (Id. at 3–4 ¶ 4.) One of the companies from which Defendant Integra employed independent contractors is a company called “MedCom,” which is alleged to be owned by Jeff Turpin. (Id. at 3 ¶ 4, 4 ¶ 4.) The Complaint also alleges that independent contractors were paid sales commissions based on the volume or the value of their sales of products, including Defendant Integra’s products. (Id. at 3–4 ¶ 4.) Relator claims that Defendant Integra’s independent

contractors had less restrictions and oversight than its in-house sales representatives.2 (Id. at 4 ¶ 4.) Relator alleges that he interacted with these independent contractors while at company

1 Nearly all of the paragraphs of allegations in Relator’s Second Amended Complaint are lengthy, some so long that they proceed cover several pages. In order to more precisely cite to Relator’s allegations, the Court will, when necessary, cite first to the page of the Complaint and then cite the paragraph of the Complaint.

2 Relator often refers to Defendant Integra’s in-house sales representatives as its “bonafide employees” events for Defendant Integra and while promoting and distributing Defendant Integra’s products. (Id. at 3 ¶ 4.) According to Relator’s allegations, he distributed medical products and met with the same doctors as the independent contractors did, including two of the named Defendants in this case, Drs. Pantera and Varca. (Id. at 19 ¶¶ 31–32, 23 ¶ 37, 25 ¶ 39, 26 ¶ 40.)

While employed by Defendant Integra, Relator alleges that one of the independent contractors he interacted with was Defendant Rob Holloway. (Id. at 5 ¶ 9, 13 ¶ 26.) Relator further alleges that at that time Defendant Holloway worked for MedCom in Durham, North Carolina, and promoted Defendant Integra’s products, including Primatrix and Integra Dermal Therapy. (Id. at 13 ¶ 26.) Also, while at Integra, Relator claims he communicated with another sales representative named Mark Frazier, who was alleged to be employed by a

company called “Osiris Therapeutics.” (Id. at 25 ¶ 39.) Relator alleges Osiris Therapeutics is now owned by Defendant Smith & Nephew. (Id.) While at Osiris Therapeutics, Frazier allegedly promoted products such as “Graphix” (also known as “Stravix”), which is now distributed by Defendant Smith & Nephew. (Id. at 10 ¶ 23, 10–11 ¶ 24, 25 ¶ 39.) Relator alleges that while at Integra, he observed and was made aware of Defendants’

engagement in a scheme to present false claims to federal healthcare programs for the care of patients who were covered by and receiving care from these programs. (Id. at 3 ¶ 4, 4 ¶ 4, 11 ¶ 25.) Relator also alleges that medical providers repeatedly made new claims for reimbursement from federal healthcare programs for products sold by certain Defendants when unnecessary for patients, or when providers were simply re-using previously used products. (Id. at 18 ¶ 30, 23–24 ¶ 37, 25–26 ¶ 39.) In addition, Relator claims that Defendant

Integra allowed MedCom to pay the independent contractor sales representatives it employed on a commission based on the volume or value of the federal reimbursement of Integra’s products. (Id. 17 ¶ 27.) Relator also claims that FCA violations occurred when doctors, including Defendants Pantera and Varca, would solicit medical products owned and marketed by Defendants Integra and Smith & Nephew, based on what illegal kickbacks and other incentives were made available to these doctors. (Id. at 11 ¶¶ 25–26, 18 ¶ 30, 25 ¶ 39, 26 ¶ 40,

27 ¶ 42.) These alleged kickbacks and incentives included free meals, patronization of various night clubs, and other forms of “in-kind inducements.” (Id. at 11 ¶¶ 25–26, 18 ¶ 30, 19 ¶ 32, 21 ¶ 35, 22 ¶ 35, 23 ¶ 37.) According to the Complaint, when doctors solicited medical products based on these incentives, and subsequently asked for those medical products to be paid in part or in full through a government healthcare program, these actions constituted false claims to the United States, violating the FCA and related state statutes. (Id. at 11 ¶ 25,

26 ¶¶ 40–41.) B. Procedural History On March 29, 2016, Relator initiated this action against Defendants Integra, MiMedx, Pantera, and Varca by filing his first complaint (hereinafter “Original Complaint”) on behalf of the United States. (ECF No. 1.) Relator alleged the initial defendants, Integra, MiMedx, Dr. Varca, and Dr. Pantera, violated three provisions of the FCA, the Social Security Act’s

prohibition of physician self-dealing, and the Anti-Kickback Statute. (Id. at ¶¶ 25–47.) Before the United States declared whether it would intervene in this action, Relator moved for leave to file an amended complaint, which this Court granted and kept sealed (hereinafter “First Amended Complaint”). (ECF Nos. 11, 12.) Over the next five years, this Court granted the United States multiple extensions of time to decide whether it would intervene in this action, along with extensions of time for Relator to file another amended complaint. Meanwhile, Relator filed a separate action in this District against MedCom and Jeff Turpin on behalf of the United States (hereinafter “the MedCom action”). United States ex rel. Nicholson v. MedCom Carolinas, Inc., No. 1:17CV34, 2020 WL 1245374 (M.D.N.C. Mar. 16, 2020), aff’d, 42 F.4th 185 (4th Cir. 2022) [hereinafter MedCom I]. Relator alleged that MedCom and Jeff Turpin violated the FCA, the North Carolina False Claims Act, and the federal Anti-

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Bluebook (online)
United States v. INTEGRA LIFESCIENCES CORPORATION, Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-v-integra-lifesciences-corporation-ncmd-2025.