Virtus Pharmaceuticals, LLC v. Woodfield Distribution, LLC

CourtDistrict Court, M.D. Florida
DecidedJuly 20, 2022
Docket8:21-cv-02427
StatusUnknown

This text of Virtus Pharmaceuticals, LLC v. Woodfield Distribution, LLC (Virtus Pharmaceuticals, LLC v. Woodfield Distribution, LLC) is published on Counsel Stack Legal Research, covering District Court, M.D. Florida primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Virtus Pharmaceuticals, LLC v. Woodfield Distribution, LLC, (M.D. Fla. 2022).

Opinion

UNITED STATES DISTRICT COURT MIDDLE DISTRICT OF FLORIDA TAMPA DIVISION

VIRTUS PHARMACEUTICALS, LLC,

Plaintiff,

v. Case No: 8:21-cv-2427-WFJ-SPF

WOODFIELD DISTRIBUTION, LLC; WOODFIELD PHARMACEUTICAL, LLC; and ADAM RUNSDORF,

Defendants. __________________________________/ ORDER

Before the Court today are the following three motions: (1) a Motion to Dismiss by Defendant Adam Runsdorf, Dkt. 39; (2) a Motion to Dismiss by Defendant Woodfield Distribution LLC (“Woodfield Distribution”), Dkt. 40; and (3) a Motion to Dismiss by Defendant Woodfield Pharmaceutical LLC (“Woodfield Pharmaceutical”), Dkt. 41. Plaintiff Virtus Pharmaceuticals LLC (“Virtus”) filed an omnibus response to the three motions. Dkt. 44. Having thoroughly reviewed the record and relevant case law, the Court denies the motions because Plaintiff Virtus adequately states its claims pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure. BACKGROUND The Court recites the following facts as alleged in Plaintiff’s Second

Amended Complaint. Dkt. 38. I. The Services Agreement Plaintiff Virtus is a “virtual” drug manufacturer. It owns the applications

necessary to produce pharmaceuticals regulated under the Controlled Substances Act (“CSA”), 21 U.S.C. § 801 et seq. Id. at 4. But Virtus itself is not registered with the United States Drug Enforcement Agency (“DEA”) to physically handle controlled substances. Id. This means Virtus must outsource its manufacturing and

distribution operations to third-party contractors with valid DEA registrations. Id. Although Virtus maintains ownership over its drugs, third-party contractors handle the packaging, warehousing, transportation, and distribution of them. Id.

In 2017, Virtus hired Defendant Woodfield Distribution—which held the necessary DEA registrations to handle pharmaceutical products regulated under the CSA—to manage Virtus’s pharmaceutical inventory at facilities in Sugar Land, Texas, and Boca Raton, Florida. Id. at 11. Woodfield Distribution agreed to store

and distribute several Virtus products, including levorphanol, codeine, phendimetrazine, tramadol, and virtussin—all of which are controlled substances regulated under the CSA. Id. Virtus retained title over the drugs while they were

stored at Woodfield Distribution’s facilities. Virtus and Woodfield Distribution entered into a contract (“the Services Agreement”) to memorialize their deal. Id. Woodfield Distribution agreed to the

following obligations: • Provide inventory management and distribution services to Virtus at “commercially reasonable standards”;

• “Comply with all applicable federal and state laws, regulations, and rules . . . including . . . those relating to the . . . U.S. Drug Enforcement Administration”;

• Maintain all “necessary permits, licenses, and other federal . . . authorizations” required to discharge its contractual services for Virtus;

• Notify Virtus within five business days if Woodfield Distribution receives notice from a federal or state agency regarding its noncompliance with applicable regulations;

• Immediately notify Virtus if Woodfield Distribution receives notice of an inspection or audit by a governmental agency;

• Maintain complete and accurate records in compliance with state and federal law;

• Defend and indemnify Virtus against third-party losses associated with any cease of distribution of Virtus’s products.

Id. at 11–14. Defendant Adam Runsdorf is the president and sole owner of Woodfield Distribution. Id. at 5. He signed the Services Agreement on behalf of Woodfield Distribution. Id. at 14. Mr. Runsdorf is also the president and sole owner of Defendant Woodfield Pharmaceutical—a manufacturer of pharmaceutical drug products. Id. at 5. Only Woodfield Distribution signed the Services Agreement with Virtus; Woodfield Pharmaceutical was not a party to the contract.

II. DEA Order to Show Cause In August 2021, the DEA issued an Order to Show Cause (the “DEA Order”) calling for the immediate suspension of DEA registrations held by

Woodfield Distribution and Woodfield Pharmaceutical. Id. at 14. The DEA concluded that Woodfield Distribution “manifestly failed to comply with its obligation to maintain effective controls against the diversion of controlled substances.” Id. at 15. Concerning Woodfield Pharmaceutical, the DEA found

“that significant quantities of controlled substances were removed from [Woodfield Pharmaceutical] without proper documentation or accounting and that [Woodfield Pharmaceutical] had connections to a suspected drug trafficking

organization.” Id. at 21. The DEA concluded that public health and safety would be endangered if the Woodfield entities continued to use their DEA registrations. Id. at 14. The DEA described Woodfield Distribution and Woodfield Pharmaceutical

as “related entities” that “share common ownership.” Id. at 15. The DEA further stated that Mr. Runsdorf “exercises significant influence and control” over both companies. Id. Because of this high level of control over both Woodfield

Distribution and Woodfield Pharmaceutical, the DEA found that the “misconduct of either entity is relevant to the determination of whether the other can be entrusted with a DEA registration.” Id. at 22 (citing Dkt. 38-3 ¶ 60).

The DEA issued an immediate suspension of the Woodfield entities’ DEA registrations. Id. at 24. It based this determination on the following four categories of alleged misconduct:

1. Recordkeeping First, the DEA found that Woodfield Distribution and Woodfield Pharmaceutical failed to maintain adequate records of the controlled substances in their inventories. Id. at 15–16; 21. An audit performed by the DEA revealed that

Woodfield Distribution could not account for: (1) more than 67 million dosage units of tramadol 50 mg, a Schedule IV controlled substance; (2) more than 5 million dosage units of phendimetrazine 35 mg, a Schedule III controlled

substance; (3) more than 375,000 dosages of phendimetrazine 105 mg, a Schedule III controlled substance; and (4) more than 285,000 dosage units of levorphanol 2 mg, a Schedule II controlled substance. Id. at 15–16. In January 2019, a burglary occurred at a Woodfield Distribution warehouse.

Id. at 16. The thieves stole more than 217,000 dosage units of alprazolam, a Schedule IV controlled substance. Id. Although Woodfield Distribution was obligated to file theft and loss reports with the DEA, Woodfield Distribution never

informed the agency about the burglary. Id. Woodfield Distribution also failed to notify the DEA about lost shipments. Id. Between January 2019 and March 2020, Woodfield Distribution could not

account for at least 45 shipments of controlled substances. Id. But Woodfield Distribution notified the DEA about only one lost shipment. Id. “Woodfield Distribution therefore failed to report at least 44 shipments with missing controlled

substances totaling hundreds of thousands of dosage units.” Id. (quoting Dkt. 38-3 ¶ 16). This failure to report continued even after the DEA inspected Woodfield facilities in March 2020. Id. at 17. Additionally, in October 2019, two Woodfield Pharmaceutical employees

removed codeine, a Schedule II controlled substance, from the controlled substances vault at a Woodfield Pharmaceutical facility after business hours. Id. at 21. The employees did not document their removal of the controlled substance

from the vault. Id. They instead falsely documented that they removed only a “Data Logger.” Id.

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