United States v. Fallon

CourtCourt of Appeals for the Third Circuit
DecidedDecember 12, 2006
Docket03-4184
StatusPublished

This text of United States v. Fallon (United States v. Fallon) 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
United States v. Fallon, (3d Cir. 2006).

Opinion

Opinions of the United 2006 Decisions States Court of Appeals for the Third Circuit

12-12-2006

USA v. Fallon Precedential or Non-Precedential: Precedential

Docket No. 03-4184

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Recommended Citation "USA v. Fallon" (2006). 2006 Decisions. Paper 11. http://digitalcommons.law.villanova.edu/thirdcircuit_2006/11

This decision is brought to you for free and open access by the Opinions of the United States Court of Appeals for the Third Circuit at Villanova University School of Law Digital Repository. It has been accepted for inclusion in 2006 Decisions by an authorized administrator of Villanova University School of Law Digital Repository. For more information, please contact Benjamin.Carlson@law.villanova.edu. PRECEDENTIAL

UNITED STATES COURT OF APPEALS FOR THE THIRD CIRCUIT

No. 03-4184

UNITED STATES OF AMERICA

v.

JAMES C. FALLON, Appellant

On Appeal from the United States District Court for the Eastern District of Pennsylvania (D.C. Crim. No. 02-cr-00324) District Judge: Hon. James T. Giles

Argued July 12, 2005*

Before: SLOVITER, McKEE and ROSENN,** Circuit Judges

(Filed: December 12, 2006)

* The court en banc heard argument on November 1, 2005 on the issue raised by Fallon with respect to the applicability of the Sixth Amendment to the restitution order. The en banc opinion rejecting Fallon’s argument was filed February 15, 2006. Fallon and the defendants in the other cases raising the same issue filed a petition for a writ of certiorari before the Supreme Court of the United States, which denied the petition on November 27, 2006.

** Judge Rosenn heard oral argument on this case both before the panel and before the en banc court on November 1, 2005, but passed away on February 7, 2006. Robert Epstein (Argued) Assistant Federal Defender David L. McColgin Supervising Appellate Attorney Maureen Kearney Rowley Chief Federal Defender Federal Court Division Defender Association of Philadelphia Philadelphia, PA 19106-2414

Attorneys for Appellant

Patrick L. Meehan United States Attorney Laurie Magid Deputy United States Attorney for Policy and Appeals Robert A. Zauzmer Assistant United States Attorney Senior Appellate Counsel David Farnham (Argued) Trial Attorney United States Department of Justice Philadelphia, PA 19106

Attorneys for Appellee

OPINION OF THE COURT

SLOVITER, Circuit Judge.

Appellant James C. Fallon was convicted by a jury of one count of wire fraud and three counts of mail fraud in the United States District Court for the Eastern District of Pennsylvania. This is an appeal of the District Court’s judgment of conviction

2 and sentence entered on October 16, 2003.1

I.

Fallon was the president of Derma Genesis, a company which manufactured and distributed microdermabradors under the name “Derma Peel.”2 Dermabradors are classified by the Food, Drug, and Cosmetic Act (“FDCA”) as class I medical devices (a device which carries the lowest amount of medical risk). See generally 21 U.S.C. § 360c(a). Prior to February 18, 1998, manufacturers who wished to market a Class I device were required to first obtain a 510(k) letter from the Food and Drug Administration, indicating that the device was substantially equivalent to an existing device previously approved for distribution. See generally 21 U.S.C. § 360(k).3

In November 1997, the FDA received notice that Fallon was marketing Derma Peel without obtaining the requisite clearance from the FDA. By letter dated November 4, 1997, a representative of the FDA informed Fallon that this practice was prohibited; Fallon acknowledged receipt of the letter and filed a formal clearance application on November 19, 1997. On that date, the FDA assigned a unique computer-generated number to his application, and sent Fallon a letter instructing him to use the number on all future correspondence.

In January 1998, prior to obtaining 510(k) approval from the FDA, Fallon met with a group of medical-device salesman in

1 The District Court had jurisdiction under 18 U.S.C. § 3231; we have jurisdiction under 28 U.S.C. § 1291 and 18 U.S.C. § 3742(a). 2 Dermabradors are motor-driven devices that force abrasive crystals over the surface of the skin and vacuum away exfoliated skin. 3 The reference to a 510(k) letter is to § 510(k) of the Food, Drug, and Cosmetic Act which is codified as 21 U.S.C. § 360(k). Because it is generally referred to in the industry as a 510(k) letter, it will be referred to in that manner in this opinion.

3 an effort to promote the Derma Peel. In attendance was Michael Coffelt, director of medical sales for a company in the process of merging with American Business Leasing (“ABL”). Coffelt was impressed with Fallon’s presentation and recommended to ABL that it enter into a vendor agreement with Derma Genesis, whereby ABL would buy Derma Peel devices and lease them to interested doctors.

ABL’s credit personnel were reluctant to do business with Derma Genesis because Fallon had previously filed for bankruptcy protection, Derma Genesis was a start-up company with an unproven track record and unproven equipment, and because Fallon failed to provide certain requested tax and social security information. Coffelt, however, lobbied ABL to re- consider its decision.

On February 9, 1998, Fallon faxed to ABL, among other things, a purported 510(k) clearance letter on FDA letterhead. The government’s evidence at trial demonstrated definitively that the letter was a fabrication. The November 4, 1997 date stamp of the letter was lifted from an earlier FDA correspondence to Fallon, which cautioned him not to market Derma Peel until he had obtained prior FDA clearance. Further, although the letter was purportedly signed by Consumer Safety Officer “Margaret Shuppers,” FDA’s records reveal that there has never been an FDA employee by that name. Finally, the letter bore Fallon’s unique 510(k) application number, even though that number was not assigned to him until November 19, 1997, two weeks after the November 4 date stamp.4

In February of 1998, Alan Frankel, president of ABL,

4 By letter dated December 10, 1998, the FDA advised Fallon that as of February 19, 1998 (ten days after Fallon faxed the fabricated 510(k) clearance letter to ABL), his product had been exempted from the pre-clearance requirement by virtue of Food and Drug Administration Modernization Act of 1997.

4 authorized the company to enter into a relationship with Fallon.5 Over the next several months, ABL purchased 70 microdermabradors from Derma Genesis which it planned to lease to physicians. ABL’s relationship with Derma Genesis ended in October 1998, after ABL determined that the value of the devices had dropped significantly over the course of the year and that an abnormally high percentage of doctors were behind on their lease payments.

On June 4, 2002, Fallon was indicted by a grand jury and charged with one count of wire fraud, in violation of 18 U.S.C. § 1341, and four counts of mail fraud, in violation of 18 U.S.C.

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