Elias Karkalas v. Linda Marks

CourtCourt of Appeals for the Third Circuit
DecidedFebruary 11, 2021
Docket19-2816
StatusUnpublished

This text of Elias Karkalas v. Linda Marks (Elias Karkalas v. Linda Marks) is published on Counsel Stack Legal Research, covering Court of Appeals for the Third Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Elias Karkalas v. Linda Marks, (3d Cir. 2021).

Opinion

NOT PRECEDENTIAL

UNITED STATES COURT OF APPEALS FOR THE THIRD CIRCUIT ____________

No. 19-2816 ______

ELIAS KARKALAS, Appellant

v.

LINDA MARKS, Esquire; KIMBERLY BRILL; UNITED STATES OF AMERICA ____________

On Appeal from the United States District Court for the Eastern District of Pennsylvania (D.C. Civ. No. 2-19-cv-00948) District Judge: Honorable Mark A. Kearney ____________

Submitted Pursuant to Third Circuit L.A.R. 34.1(a) March 12, 2020

Before: McKEE, AMBRO, and PHIPPS, Circuit Judges

(Filed: February 11, 2021)

____________

OPINION * ____________

* This disposition is not an opinion of the full Court and pursuant to I.O.P. 5.7 does not constitute binding precedent. PHIPPS, Circuit Judge.

For over thirty years, Dr. Elias Karkalas was a family practice physician in a

Philadelphia suburb. He also had an interest in cyber medicine, and in 2005, he

responded to a recruiter’s advertisement seeking doctors to review online prescription

requests for an internet pharmacy company, Rx Limited. At that time, Rx Limited was

operated by Paul Calder Le Roux, who would later plead guilty to several criminal

charges related to the company’s practices. Karkalas began working for Rx Limited, and

between 2005 and 2012, he approved online prescriptions for several drugs. As he did

so, he understood that federal law required an in-person encounter to prescribe a

controlled substance. See 21 U.S.C. §§ 829(b), (e); 21 C.F.R. § 1306.04(a).

One drug that Karkalas prescribed online was Fioricet – a combination drug used

to treat tension headaches. Although Fioricet is not expressly listed as a controlled

substance, it contains butalbital, a derivative of barbituric acid, which is listed as a

controlled substance. 21 U.S.C. § 812, Sch. III(b)(1) (designating “[a]ny substance

which contains any quantity of a derivative of barbituric acid” as a Schedule III

controlled substance); 21 C.F.R. § 1308.13(c)(3) (same). Nevertheless, the Physicians’

Desk Reference, a reference manual for prescribers, did not designate Fioricet as a

controlled substance during the years in which Karkalas prescribed it. 1

1 The Physicians’ Desk Reference currently identifies Fioricet as a Schedule III controlled substance. See Fioricet Capsules Drug Summary, Prescribers’ Digital Reference, https://www.pdr.net/drug-summary/Fioricet-Capsules-acetaminophen-butalbital-caffeine- 3284.2260 (last visited Feb. 9, 2021).

2 Karkalas’s online approval of Fioricet prescriptions caught the attention of a

diversion investigator at the Drug Enforcement Administration and a federal prosecutor

who were investigating Rx Limited. They both believed that, under federal law, Fioricet

constituted a controlled substance because it contained butalbital. Through an

undercover investigation, they learned that Karkalas was prescribing Fioricet online not

just for tension headaches but also for other maladies such as knee pain and hemorrhoids.

In 2013, a federal grand jury in Minnesota returned an 85-count indictment related

to Rx Limited against eleven defendants. It named Karkalas in 38 counts. Many of those

counts related to the illegal distribution of Fioricet, see 21 U.S.C. §§ 841(a)(1), (b)(1)(E),

(h)(1), (h)(4), but the indictment also charged Karkalas with conspiracy, wire fraud, mail

fraud, and introducing misbranded drugs into interstate commerce. Karkalas was arrested

at his office and detained pretrial for six months, including four-and-a-half months in

detention centers in multiple states and six weeks in a halfway house. He was later

released to home confinement with an ankle monitor.

Throughout the pretrial period, Karkalas asserted that Fioricet was not a controlled

substance. He emailed and called the prosecutor and investigator, and he even

voluntarily traveled to Washington, D.C. to meet with them, but they were unconvinced.

Karkalas also filed motions in the Minnesota trial court to dismiss the Fioricet charges

and to exclude evidence of his distribution of Fioricet. But that court denied both

motions, concluding that Fioricet – because it contains butalbital – is a Schedule III

controlled substance. See United States v. Oz, 2017 WL 342069, at *2, *3–5 (D. Minn.

Jan. 23, 2017) (citing 21 U.S.C. § 812, Sch. III(b)(1)); United States v. Oz, 2016 WL

3 1183041, at *2, *4–6 (D. Minn. Mar. 28, 2016). Despite prevailing on those motions, the

United States voluntarily dismissed ten of the charges against Karkalas related to his

distribution of Fioricet.

The case against Karkalas and three other defendants proceeded to a jury trial, and

there it continued to turn in his favor. In the middle of its case-in-chief, the United States

dropped the remaining charges related to the distribution of Fioricet. And in returning its

verdict, the jury acquitted Karkalas and the other defendants of all other charges.

To vindicate himself beyond that acquittal, Karkalas filed this two-count civil

lawsuit in the Eastern District of Pennsylvania. In Count One of the complaint, Karkalas

asserts that the prosecutor and investigator violated his Fourth and Fifth Amendment

rights by knowingly presenting false and misleading testimony and by prosecuting him

without probable cause, leading to his unlawful pretrial detention. In Count Two,

Karkalas sues the United States for malicious prosecution under the Federal Tort Claims

Act.

The defendants moved to dismiss the counts against them – the prosecutor and

investigator pursuant to Federal Rules of Civil Procedure 12(b)(2), 12(b)(3), and

12(b)(6), and the United States pursuant to Rules 12(b)(1) and 12(b)(6). The District

Court granted those motions on several alternative grounds and dismissed Karkalas’s

amended complaint with prejudice. In doing so, the District Court exercised subject-

matter jurisdiction over the federal questions in Count One, see 28 U.S.C. § 1331, but

determined that it lacked personal jurisdiction over the individual defendants. In

addition, the District Court determined that no Bivens cause of action could be implied

4 against those defendants, who were also shielded from suit due to qualified immunity

(and the prosecutor further protected by absolute immunity). On Count Two, the District

Court concluded that it lacked jurisdiction due to the United States’ sovereign immunity

for discretionary functions and for intentional torts (the latter as to only the conduct of the

prosecutor). See id. §§ 1346(b)(1), 2674, 2680(a), (h).

Karkalas timely appealed, bringing the case within this Court’s appellate

jurisdiction. See 28 U.S.C. § 1291.

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