In re Pharmaceutical Industry Average Wholesale Price Litigation

252 F.R.D. 83, 2008 U.S. Dist. LEXIS 73687, 2008 WL 4368945
CourtDistrict Court, D. Massachusetts
DecidedSeptember 26, 2008
DocketM.D.L. No. 1456. Civil Action No. 01-12257-PBS
StatusPublished
Cited by36 cases

This text of 252 F.R.D. 83 (In re Pharmaceutical Industry Average Wholesale Price Litigation) is published on Counsel Stack Legal Research, covering District Court, D. Massachusetts primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In re Pharmaceutical Industry Average Wholesale Price Litigation, 252 F.R.D. 83, 2008 U.S. Dist. LEXIS 73687, 2008 WL 4368945 (D. Mass. 2008).

Opinion

MEMORANDUM AND ORDER

SARIS, District Judge.

I. INTRODUCTION

Plaintiffs move for certification of two nationwide classes under the unfair and deceptive trade practice laws of more than thirty states. This phase of a multi-year, multidistrict litigation, which has generated multiple national settlements and a bellwether bench trial, involves claims that pharmaceutical manufacturers AstraZeneca1 and BMS2 [86]*86grossly inflated the prices of branded physician-administered drugs by misstating the Average Wholesale Prices (“AWPs”) of these drugs in industry publications. For AstraZeneca, the drug at issue is Zoladex; for BMS, the drugs are Blenoxane, Cytoxan, Paraplatin, Rubex, Taxol and Vepesid. These overstated AWPs allegedly caused the government, third-party payors (“TPPs”) and consumers to overpay for prescription drugs.

The plaintiffs seek to certify two classes: the Third-Party Payor MediGap Supplemental Insurance Class (the “Medigap Class”), under the statutes of thirty-one jurisdictions; and the Consumer and Third-Party Payor Class for Medicare Part B Drugs Outside of the Medicare Context (the “Non-Medicare Class”) under the statutes of thirty-nine jurisdictions.3 Defendants have both previously settled nationwide class actions involving identical claims on behalf of Medicare beneficiaries. Plaintiffs seek certification for a class period from January 1,1991 to January 1, 2005. In support of their motion for certification, plaintiffs have submitted a summary of state unfair trade practice laws, proposed jury instructions on elements of claims, and a chart containing groupings of similar unfair and deceptive trade practice acts (“UDT-PAs”).

Defendants AstraZeneca and BMS primarily argue that class certification is inappropriate because application of the laws of so many jurisdictions will render trial unmanageable. They assert that individualized factual issues predominate, particularly in jurisdictions that require plaintiffs to prove reliance. They also attack the adequacy of several of plaintiffs’ proposed class representatives.

After hearing and review of the briefing, I rule as follows: (1) I ALLOW the motion to certify the Third-Party Payor MediGap Supplemental Insurance Class; and (2) I ALLOW the motion to certify the Consumer and Third-Party Payor Class for Medicare Part B Drugs Outside of the Medicare Context for claims under certain statutes that do not require plaintiffs to prove reliance. (See Appendices A and B). The Court will hold a separate trial for each defendant.

II. THE BELLWETHER TRIAL 4

In January 2006, this Court certified a Third-Party Payor MediGap Supplemental Insurance Class and a Consumer and Third-Party Payor Class for Medicare Part B Drugs Outside of the Medicare Context for unfair and deceptive trade practice claims under Mass. Gen. Laws ch. 93A against AstraZeneca (AstraZeneca, PLC, Zeneca, Inc., AstraZeneca Pharmaceuticals L.P., and AstraZeneca U.S.), BMS (Bristol-Myers Squibb [87]*87Co., Oncology Therapeutics Network Corp., and Apothecon, Inc.), the Johnson & Johnson Group (Johnson & Johnson, Centocor, Inc., Ortho Biotech, McNeil-PPC, Inc., and Janssen Pharmaceutica Products, L.P.), and the Schering Plough Group (Schering-Plough Corporation and Warrick Pharmaceuticals Corporation). In re Pharm. Indus. Average Wholesale Price Litig., 233 F.R.D. 229, 231 (D.Mass.2006). A bench trial was held in November 2006, and this Court entered a verdict against AstraZeneca and BMS. See In re Pharm. Indus. Average Wholesale Price Litig., 491 F.Supp.2d 20, 109 (D.Mass.2007). This was a bellwether trial, which gave the Court the opportunity to understand the complex factual and legal disputes in this difficult area of drug pricing. Both companies have appealed. (Docket Nos. 4927 & 4935.)5

With respect to both classes, this Court in January 2006 denied without prejudice the motion to certify the classes under the UDT-PAs of states other than Massachusetts because plaintiffs had not presented an adequate analysis of these statutes. See In re Pharm. Indus. Average Wholesale Price Litig., 233 F.R.D. at 232; see also In re Pharm. Indus. Average Wholesale Price Litig., 230 F.R.D. 61, 90 (D.Mass.2005).

III. FACTUAL BACKGROUND

The Court has issued multiple decisions explaining the complexities of drug pricing for physician-administered drugs, which in this phase of the litigation mostly include branded drugs for cancer treatment. See In re Pharm. Indus. Average Wholesale Price Litig., 491 F.Supp.2d 20 (D.Mass.2007); see also In re Pharm. Indus. Average Wholesale Price Litig., 230 F.R.D. 61 (D.Mass.2005). The Court incorporates and relies on factual findings in those cases as the basis for this class certification opinion. To facilitate understanding, I briefly summarize the relevant background below.

a. AWP — Its Meaning

Almost every brand-name and generic prescription drug sold in the United States since the late 1960s has had an “average wholesale price” that is published in commercial compendia, see In re Pharm. Indus. Average Wholesale Price Litig., 491 F.Supp.2d at 32, such as the Drug Topics Red Book, the First DataBank Blue Book, and the Medi-Span Master Drug Data Base. See In re Pharm. Indus. Average Wholesale Price Litig., 230 F.R.D. at 67. Throughout the class period, AWP was the pricing benchmark relied on by Medicare and most TPPs. See In re Pharm. Indus. Average Wholesale Price Litig., 491 F.Supp.2d at 32. The federal government’s Centers for Medicare and Medicaid Services (“CMS”) did not regulate or set the AWPs, but instead entrusted pharmaceutical companies with the task of reporting AWPs to the publications. See id.

At first, AWP reflected the average price that wholesalers charged to providers like doctors and pharmacies. It was derived from the markup wholesalers charged over their actual acquisition cost, generally referred to as the Wholesale Acquisition Cost OWAC”). Typically, AWP was a twenty percent markup over WAC. Eventually, as wholesalers consolidated and competed with each other, their actual margins on branded drugs were reduced to two to three percent. As a result, the actual average wholesale price charged by wholesalers to providers was much lower than the formulaic 20 percent markup (or, later in the class period, 25 percent markup) over WAC. Nonetheless, most manufacturers continued to report AWPs consistent with the historic 20 to 25 percent markup, even though they knew that wholesalers were not actually charging these prices to providers and thus that the AWP relied on by Medicare and the TPPs was not a true average price charged by wholesalers. See id. at 33.

[88]*88b. Medicare

Medicare is the largest insurer of physician-administered drugs. The federal government pays 80 percent of the cost of a Medicare Part B covered drug, and 20 percent is paid by the party responsible for the co-payment. Many individual Medicare recipients subscribe to private insurance policies that cover all or part of these 20 percent co-payments (often called Medigap or supplemental insurance). TPPs that provide this supplemental Medicare insurance are the members of the proposed Medigap Class. See id.

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252 F.R.D. 83, 2008 U.S. Dist. LEXIS 73687, 2008 WL 4368945, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-pharmaceutical-industry-average-wholesale-price-litigation-mad-2008.