Commonwealth v. Tap Pharmaceutical Products, Inc.

36 A.3d 1197, 2011 Pa. Commw. LEXIS 415, 2011 WL 4056170
CourtCommonwealth Court of Pennsylvania
DecidedAugust 31, 2011
Docket212 M.D. 2004
StatusPublished
Cited by15 cases

This text of 36 A.3d 1197 (Commonwealth v. Tap Pharmaceutical Products, Inc.) is published on Counsel Stack Legal Research, covering Commonwealth Court of Pennsylvania primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Commonwealth v. Tap Pharmaceutical Products, Inc., 36 A.3d 1197, 2011 Pa. Commw. LEXIS 415, 2011 WL 4056170 (Pa. Ct. App. 2011).

Opinion

OPINION re POST-TRIAL MOTIONS of the COMMONWEALTH of PENNSYLVANIA and BRISTOL-MYERS SQUIBB COMPANY

OPINION BY

Judge SIMPSON.

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I. BACKGROUND

A. Opening

This complex original jurisdiction action, which comes before a panel of this Court for a third time, involves the pricing of pharmaceuticals reimbursed by the Pennsylvania Department of Public Welfare (DPW), which administers Pennsylvania’s Medicaid program, and by the Department of Aging, which administers the Pharmaceutical Assistance Contract for the Elderly (PACE) program, based on Average Wholesale Price (AWP) between 1991 and 2008.

In particular, the Commonwealth, through its Attorney General, filed suit against numerous pharmaceutical companies, including defendant Bristol-Myers Squibb Co. (BMS), which, the Commonwealth claimed, engaged in improper conduct that caused DPW and PACE (collectively, “Plaintiff Agencies”) to pay inflated prices for pharmaceuticals the defendant pharmaceutical companies manufactured, marketed and sold. Among other things, the Commonwealth alleged the defendant pharmaceutical companies, including BMS, reported or contributed to the reporting of inflated AWPs for certain specified drugs that are published in commercial publications and that these inflated prices caused overpayment by DPW and PACE, which relied on these reported prices.

Central among the Commonwealth’s claims is that the published AWPs for BMS’ drugs are fictitious because they do not reflect an accurate average wholesale price charged by wholesalers to providers, *1211 including physicians and pharmacists. Because AWP was the predominant benchmark for reimbursement by government and third-party payors, including DPW and PACE, the Commonwealth asserted BMS and other pharmaceutical companies inflated or contributed to the inflation of each drug’s AWP to create a “spread” between a provider’s actual acquisition cost and the fictitious, published AWP, and that pharmaceutical companies, including BMS, market this spread in order to gain market share over a competitor’s drug.

The Commonwealth’s suit against Defendant BMS, which asserted claims of common law fraud or misrepresentation and civil conspiracy, as well as violations of the Unfair Trade Practices and Consumer Protection Law (CPL), 1 culminated in a five-week jury trial. After the close of evidence, issues relating to the Commonwealth’s claims of fraud or misrepresentation and civil conspiracy were submitted to the jury, while issues relating to the statutory claims were submitted to the trial judge for non-jury decision.

Ultimately, the jury returned a verdict in favor of BMS on the common law claims. Shortly thereafter, the trial judge issued a Decision Awarding Injunction and Restoration (Decision) against BMS, finding that BMS violated the CPL. As to the remedy for the CPL violations, the Decision provided for injunctive relief, which essentially restrains BMS from contributing to the reporting of inflated AWPs for its drugs and from creating, marketing or promoting the spread for its drugs. In addition, the trial judge ordered BMS to restore to the Commonwealth the amount of $27,617,952.

Both the Commonwealth and BMS filed post-trial motions. For its part, the Commonwealth seeks judgment non obstante veredicto (JNOV) or, alternatively, a new trial on its negligent misrepresentation and civil conspiracy claims as well as modification of the trial judge’s Decision on its statutory claims, to provide for relief in addition to that granted by the trial judge.

On the other hand, BMS challenges the Court’s determinations that it violated the CPL. It therefore requests the Court vacate its Decision awarding injunctive relief and restoration.

For the following reasons, we deny the Commonwealth’s post-trial motions. In addition, we decline BMS’ request to vacate the award of injunctive relief and restoration; however, as explained more fully below, we modify the injunction.

B. History

1. Average Wholesale Price— Origin & Evolution

The AWP-based system for drug reimbursement is inherently a complicated system in which “average wholesale price” or “AWP” is the cornerstone of a larger pricing infrastructure.

Since the late 1960s, nearly every branded prescription drug sold in the United States has an AWP, which is published in commercial pricing compendia like Red Book, First DataBank, and Medispan. See In re Pharm. Indus. Average Wholesale Price Litig., 491 F.Supp.2d 20 (D.Mass.2007), aff 'd, 582 F.3d 156 (1st Cir.2009), cert. dismissed sub. nom., AstraZeneca Pharm. LP v. Blue Cross Blue Shield of Massachusetts, — U.S. -, 131 S.Ct. 60, 177 L.Ed.2d 1150 (2010) (MDL 2007). During the period covered by this lawsuit, AWP is provided in a current, digital format for each available branded pharmaceutical, in each dosage and packaging size. The digital format and the constantly updated value facilitate use in the computer-dominated reimbursement systems, *1212 such as those used by the Plaintiff Agencies. -See BMS Trial, Notes of Testimony (N.T.), 8/24/10, at 1903-04 (Thomas Sned-den, Director of PACE); 2020 (Dr. Terri Cathers, Director of Pharmacy for the Fee-for-Service Program of DPWs Office of Medical Assistance Programs).

The federal government used AWP as the pricing benchmark for Medicare reimbursement until the 2005 effective date of the Medicare Prescription Drug, Improvement & Modernization Act of 2003. 2 MDL 2007. By statute and regulation, it has also been the pricing benchmark used by the Plaintiff Agencies for Medicare Part B and Medicaid drug reimbursements.

Neither the federal government’s Centers for Medicare and Medicaid Services (CMS) (and its predecessor, the Healthcare Finance Administration, also known as HCFA), nor the Plaintiff Agencies regulate or set the AWPs; rather, they entrusted the pharmaceutical companies with the task of reporting the AWPs accurately to the publications. Id.

Initially, AWP was, in fact, the average price charged by wholesalers to providers, like doctors and pharmacies. N.T., 8/16/10, at 673-75. It was derived from the markup charged by wholesalers over their actual acquisition cost, sometimes called the “wholesale acquisition cost” or “WAC.” Id. at 675. However, the market evolved.

In general, and on the specific topic of evolution of the AWP-based pricing system, the trial judge accepted the testimony of the Commonwealth’s expert witness on liability and causation, Dr.

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Cite This Page — Counsel Stack

Bluebook (online)
36 A.3d 1197, 2011 Pa. Commw. LEXIS 415, 2011 WL 4056170, Counsel Stack Legal Research, https://law.counselstack.com/opinion/commonwealth-v-tap-pharmaceutical-products-inc-pacommwct-2011.