United States v. Cadden

965 F.3d 1
CourtCourt of Appeals for the First Circuit
DecidedJuly 9, 2020
Docket17-1694P
StatusPublished
Cited by20 cases

This text of 965 F.3d 1 (United States v. Cadden) is published on Counsel Stack Legal Research, covering Court of Appeals for the First 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. Cadden, 965 F.3d 1 (1st Cir. 2020).

Opinion

United States Court of Appeals For the First Circuit

Nos. 17-1694, 17-1712, 17-2062

UNITED STATES OF AMERICA,

Appellee, Cross-Appellant,

v.

BARRY J. CADDEN,

Defendant, Appellant, Cross-Appellee.

APPEALS FROM THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS

[Hon. Richard G. Stearns, U.S. District Judge]

Before

Barron, Stahl, and Lipez, Circuit Judges.

Bruce A. Singal, with whom Michelle R. Peirce, Lauren E. Dwyer, and Barrett & Singal, P.C. were on brief, for appellant/cross-appellee. David M. Lieberman, Attorney, Criminal Division, Appellate Section, United States Department of Justice, with whom Andrew E. Lelling, United States Attorney, Amanda P. Strachan, Assistant United States Attorney, George P. Varghese, Assistant United States Attorney, Brian A. Benczkowski, Assistant Attorney General, and Matthew S. Miner, Deputy Assistant Attorney General, were on brief, for appellee/cross-appellant. July 9, 2020 BARRON, Circuit Judge. For years, the New England

Compounding Center ("NECC") was a growing pharmacy business

engaged in the practice of "compounding," which involves combining

drugs with other substances to produce specialized medications for

use by patients. In the fall of 2012, however, patients across

the country became seriously ill -- and many eventually died --

after receiving injections of NECC-compounded medications that had

been contaminated by fungi and bacteria. A federal criminal

investigation into NECC's compounding practices soon followed,

which then led to the convictions and punishments that are at issue

in the two related appeals that are now before us.

The first of these appeals is brought by Barry Cadden,

who was the founder and part-owner, as well as the president, of

NECC at the time that the company manufactured and distributed the

contaminated medications from its facilities in Framingham,

Massachusetts. He challenges his 2017 federal convictions in the

United States District Court for the District of Massachusetts for

one count of racketeering, see 18 U.S.C. § 1962(c); one count of

racketeering conspiracy, see id. § 1962(d); fifty-two counts of

mail fraud, see id. § 1341; and three counts of violating the

Federal Food, Drug, and Cosmetic Act, see 21 U.S.C. §§ 331(a),

333(a). He also challenges the $7.5 million forfeiture order that

the District Court imposed on him. The other appeal that we

address is brought by the government. It takes aim at both the

- 3 - District Court's forfeiture order against Cadden and the 108-month

prison sentence that he received.

We affirm each of the convictions that Cadden challenges

on appeal. We vacate and remand his prison sentence due to the

errors that the government correctly points out that the District

Court made in calculating Cadden's recommended sentencing range

under the United States Sentencing Guidelines ("Guidelines"). We

also vacate and remand the forfeiture order in consequence of

separate errors that Cadden and the government, respectively,

identify in the way that the District Court determined the amount

of the forfeiture.

I.

For years, NECC produced large volumes of compounded

medications and sold them without incident to hospitals and other

medical facilities throughout the United States. In the early

fall of 2012, however, patients across the country started to fall

sick with fungal meningitis, spinal or paraspinal infections, and

other seemingly related illnesses. Over time, additional cases of

patients suffering from these illnesses arose throughout the

United States that seemed to be tied to the earlier ones.

A federal investigation into this unusual outbreak of

seemingly related illnesses ensued. It traced the outbreak's cause

to patients having been injected with a heavily contaminated

medication that NECC had compounded. That medication was

- 4 - methylprednisolone acetate ("MPA"), which is a steroid that is

injected primarily into the backs or knees of patients to help

them to alleviate their pain.

At that point, federal investigators began looking into

NECC's compounding practices. The investigators discovered what

they determined were significant deficiencies in the clean room

where NECC had compounded the contaminated MPA as well as in other

aspects of NECC's operations. Among the deficiencies were apparent

violations of Chapter 797 of the "United States Pharmacopeia," or,

as it is otherwise known, "USP-797," which the Massachusetts

Pharmacy Board requires pharmacists to follow, see 247 Mass. Code

Regs. 901(3), and which regulates the compounding of "high-risk"

sterile medications like MPA. Such medications are so deemed due

to the nature of the harm that can befall patients who use them if

they have not been properly prepared. The investigation also

revealed that NECC had employed a pharmacy technician, Scott

Connolly, who did not have a license that the Massachusetts

Pharmacy Board required in order for him to be permitted to engage

in the compounding work that he performed for the company.

Based on the investigation, a federal grand jury

indicted Cadden on December 16, 2014, in the District of

Massachusetts for a broad range of criminal conduct. These charges

included fifty-three counts of mail fraud in violation of 18 U.S.C.

§ 1341, one count of racketeering in violation of 18 U.S.C.

- 5 - § 1962(c), one count of racketeering conspiracy in violation of 18

U.S.C. § 1962(d), one count of conspiracy to defraud the United

States in violation of 18 U.S.C. § 371, and forty-one counts of

Federal Food, Drug, and Cosmetic Act ("FDCA") violations, see 21

U.S.C. §§ 331(a), 333(a).

Many of the charges centered on fraudulent

representations that NECC representatives had allegedly made to

customers about the safety standards that the company followed in

compounding various medications -- including the contaminated MPA

-- that were shipped to customers between March 25, 2010, and

September 27, 2012. In particular, each of the fifty-three mail

fraud counts identified a specific shipment of compounded

medications that NECC sent to one of its customers after having

made inaccurate representations to that customer about the

standards NECC would adhere to in preparing those medications.

The racketeering and racketeering conspiracy charges,

too, were based on a "pattern of racketeering activity," 18 U.S.C.

1961(5), that centered on mail fraud, see id. § 1961(1)(B)

(defining mail fraud as a "racketeering activity"). The

racketeering offense itself alleged seventy-eight separate acts of

racketeering as part of that pattern, of which the lion's share

-- fifty-three acts -- were mail fraud acts that matched the

alleged mail fraud acts set forth in the corresponding counts that

charged Cadden with mail fraud as a stand-alone offense. The

- 6 - racketeering conspiracy charge, moreover, alleged that Cadden

conspired with others to commit a racketeering violation involving

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965 F.3d 1, Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-v-cadden-ca1-2020.