Ronald Streck v. Allergan Inc

CourtCourt of Appeals for the Third Circuit
DecidedAugust 16, 2018
Docket17-1014
StatusUnpublished

This text of Ronald Streck v. Allergan Inc (Ronald Streck v. Allergan Inc) 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
Ronald Streck v. Allergan Inc, (3d Cir. 2018).

Opinion

NOT PRECEDENTIAL

UNITED STATES COURT OF APPEALS FOR THE THIRD CIRCUIT _____________

No. 17-1014 _____________

UNITED STATES OF AMERICA; THE STATE OF CALIFORNIA; THE STATE OF CONNECTICUT; THE STATE OF DELAWARE; THE STATE OF FLORIDA; THE STATE OF GEORGIA; THE STATE OF HAWAII; THE STATE OF ILLINOIS; THE STATE OF INDIANA; THE STATE OF LOUISIANA; THE COMMONWEALTH OF MASSACHUSETTS; THE STATE OF MICHIGAN; THE STATE OF MONTANA; THE STATE OF NEVADA; THE STATE OF NEW HAMPSHIRE; THE STATE OF NEW JERSEY; THE STATE OF NEW MEXICO; THE STATE OF NEW YORK; THE STATE OF NORTH CAROLINA; THE STATE OF OKLAHOMA; THE STATE OF RHODE ISLAND; THE STATE OF TENNESSEE; THE STATE OF TEXAS; THE COMMONWEALTH OF VIRGINIA; THE STATE OF WISCONSIN; THE DISTRICT OF COLUMBIA, ex rel. RONALD J. STRECK

v.

ALLERGAN, INC.; AMGEN, INC.; ASTRAZENECA PHARMACEUTICALS LP; AZTRAZENECA LP; BIOGEN IDEC INC., BRADLEY PHARMACEUTICALS INC. n/k/a FOUGERA PHARMACEUTICALS, INC.; CEPHALON, INC.; EISAI, INC.; GENZYME CORPORATION; MALLINCKRODT INC. n/k/a MALLINCKRODT LLC; NOVO NORDISK, INC.; RELIANT PHARMACEUTICALS, INC; SEPRACOR n/k/a SUNOVION PHARMACEUTICALS INC.; UPSHER-SMITH LABORATORIES, INC.

Ronald J. Streck, Appellant

_____________

On Appeal from the United States District Court for the Eastern District of Pennsylvania (D.C. Civil No. 2-08-cv-05135) District Judge: Honorable Eduardo C. Robreno ______________ Argued April 12, 2018 ______________

Before: CHAGARES, VANASKIE, Circuit Judges, and BOLTON,* District Judge

(Filed: August 16, 2018)

Daniel R. Miller, Esq. [Argued] Joy P. Clairmont, Esq. Todd S. Collins, Esq. Berger & Montague, P.C. 1622 Locust Street Philadelphia, PA 19103

Timothy J. Peter, Esq. Faruqi & Faruqi LLP 101 Greenwood Avenue Suite 600 Jenkintown, PA 19046 Counsel for Appellant

Tacy F. Flint, Esq. [Argued] Neil G. Nandi, Esq. Richard D. Raskin, Esq. Sidley Austin LLP One South Dearborn Street Chicago, IL 60603 Counsel for Appellees Allergan Inc., Novo Nordisk, Inc., and Sepracor, Inc. n/k/a Sunovion Pharmaceuticals Inc.

Steven F. Barley, Esq. Hogan Lovells US LLP 100 International Drive Suite 2000 Baltimore, MD 21202

Stephen A. Loney, Jr., Esq. Hogan Lovells US LLP 1835 Market Street 29th Floor Philadelphia, PA 19103 Counsel for Appellee Amgen Inc.

2 Margaret D. Hall, Esq. Leanna M. Anderson, Esq. Dentons US LLP 2000 McKinney Street Suite 1900 Dallas, TX 75201

Richard L. Scheff, Esq. Montgomery McCracken Walker & Rhoads LLP 1735 Market Street Philadelphia, PA 19103 Counsel for Appellee Bradley Pharmaceuticals Inc. n/k/a Fougera Pharmaceuticals Inc.

Ashley C. Parrish, Esq. King & Spalding LLP 1700 Pennsylvania Avenue, N.W. Suite 200 Washington, D.C. 20006 Counsel for Appellee Eisai Inc.

Jeffrey A. Lutsky, Esq. Stradley Ronon Stevens & Young 2005 Market Street Suite 2600 Philadelphia, PA 19103 Counsel for Appellees Mallinckrodt Inc. n/k/a Mallinckrodt LLC and Upsher-Smith Laboratories Inc.

Frederick G. Herold, Esq. Dechert LLP 2440 West El Camino Real Suite 700 Mountain View, CA 94040

Thomas H. Lee, II, Esq. Dechert LLP 2929 Arch Street 18th Floor, Cira Centre Philadelphia, PA 19104 Counsel for Appellee Reliant Pharmaceuticals Inc.

3 ______________

OPINION** ______________

VANASKIE, Circuit Judge.

This appeal concerns allegations that several drug manufacturers underpaid

Medicaid rebates to the States under the Medicaid Drug Rebate Program (“MDRP”), 42

U.S.C. § 1396r-8, in violation of the False Claims Act (“FCA”), 31 U.S.C. § 3729, and

its state counterparts. Specifically at issue in this qui tam action is whether Appellees

knowingly violated the FCA by excluding certain credits they received from their

customers in calculating a drug’s “Average Manufacturer Price.” Concluding that

Appellees’ decision to exclude these credits from the calculation of a drug’s “Average

Manufacturer Price” reflected a reasonable interpretation of the pertinent MDRP

statutory provisions, we will affirm the District Court’s order granting the Appellees’

joint motion to dismiss.

I.

As we write principally for the benefit of the parties, we recite only the essential

facts and procedural history. The following facts are generally taken from the Fourth

*The Honorable Susan R. Bolton, Senior District Judge, United States District Court for the District of Arizona, sitting by designation.

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

4 Amended Complaint and are assumed to be true for the purposes of this opinion. See

Schmidt v. Skolas, 770 F.3d 241, 249 (3d Cir. 2014) (citation omitted).

Appellees (the “Service Fee Defendants” or “SFDs”) consist of nine drug

manufacturers. 1 All nine manufacturers participated in the MDRP during the relevant

time period. The MDRP helps to offset the cost of prescription drugs dispensed to

Medicaid patients. Participating manufacturers must pay the states a rebate for their

drugs that are covered by a state’s Medicaid plan. A central component for calculating

the amount of the rebate is the drug’s “Average Manufacturer’s Price,” or “AMP.”

Under the applicable versions of the MDRP, AMP is generally defined as the price

wholesalers pay participating manufacturers for drugs. The lower the AMP, the lower

the rebate manufacturers must pay the states.

Appellant Ronald J. Streck was the CEO of Rx Distribution Network, a network

of regional drug wholesalers. While in this role, Streck became familiar with the

agreements that the SFDs entered into with various wholesalers. Before 2004,

wholesalers commonly engaged in a practice of “speculative buying,” stockpiling

inventory acquired from drug manufacturers at one price. Wholesalers would then sit on

the extra inventory until manufacturers increased their drug prices, at which time they

would sell off any extra inventory at the higher price and retain the profits.

1 These manufacturers are: Allergan, Inc., Amgen, Inc., Bradley Pharmaceuticals, Inc. n/k/a Fougera Pharmaceuticals, Inc., Eisai, Inc., Mallinckrodt, Inc. n/k/a Mallinckrodt LLC, Novo Nordisk, Inc., Reliant Pharmaceuticals, Inc., Sepracor, Inc. n/k/a Sunovian Pharmaceuticals Inc., and Upsher-Smith Laboratories, Inc. 5 In an effort to curb speculative buying, the SFDs negotiated clawback provisions

with their wholesalers that, in essence, deprived wholesalers of their stockpiling profits.

Rather than taking the form of cash payments, however, the clawbacks were structured

as credits against service fees. Service fees, in turn, were payments owed by

manufacturers to wholesalers under separate provisions of the agreements in exchange

for services provided by wholesalers. Going forward, we will refer to the clawbacks as

“price-appreciation credits.” Price-appreciation credits reduced the amount

manufacturers had to pay to wholesalers for the services rendered by wholesalers on

behalf of the manufacturers, such as product distribution services. Stated otherwise,

price-appreciation credits increased the value manufacturers received for the drugs

purchased by wholesalers.

From 2004 to 2012, the SFDs excluded price-appreciation credits from their AMP

calculations, thus reducing their AMPs and the rebates owed the states. The parties

dispute whether they were permitted to do so. Streck contends they were not and that

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