In Re Pharmaceutical Industry Average Wholesale Price Litigation

738 F. Supp. 2d 227, 2010 U.S. Dist. LEXIS 92960, 2010 WL 3503986
CourtDistrict Court, D. Massachusetts
DecidedSeptember 3, 2010
DocketCivil Action No. 01-12257-PBS. MDL No. 1456
StatusPublished
Cited by2 cases

This text of 738 F. Supp. 2d 227 (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, 738 F. Supp. 2d 227, 2010 U.S. Dist. LEXIS 92960, 2010 WL 3503986 (D. Mass. 2010).

Opinion

*229 MEMORANDUM AND ORDER

SARIS, District Judge.

I. Introduction

Johnson & Johnson, Centocor, Inc., and Ortho Biotech Products, LP (“J & J”) pursuant to Fed.R.Civ.P. 56 have filed two motions for summary judgment against the members of Class 1, one against Class 1 residents of Massachusetts [Docket No. 6667] and a second against all other members of Class 1 [Docket No. 6671]. Following briefing and a hearing, J & J’s motion for summary judgment against Class 1 residents of Massachusetts is DENIED and J & J’s motion for summary judgment against all other members of Class 1 is ALLOWED-IN-PART and DENIED-IN-PART.

II. Background

Plaintiffs brought this action in 2001 alleging that various pharmaceutical manufacturer defendants had unlawfully and fraudulently inflated the Average Wholesale Price (“AWP”) of their drugs. Because of the massive size of the case, the Court divided the case into two tracks: Track 1, a “fast track,” involving five defendants, and Track 2, a “regular track.” The Court certified three classes against the Track 1 defendants. The first class, Class 1, is a nationwide class of natural persons who made, or who incurred an enforceable obligation to make, a co-payment for numerous Medicare Part B covered drugs based on the drug’s AWP (the “Medicare Part B Co-Payment Class”). In re Pharm. Indus. Average Wholesale Price Litig., 233 F.R.D. 229, 230 (D.Mass. 2006). The second class, Class 2, is a class of all third-party payors (“TPPs”) who made reimbursements for numerous Medicare Part B covered drugs purchased in Massachusetts, or who made reimbursements for the drugs and have their principal place of business in Massachusetts, based on the drug’s AWP (the “Third-Party Payor MediGap Supplemental Insurance Class”). Id. at 231. The final class, Class 3, is a class of: 1) all persons who made, or who incurred an enforceable obligation to make, a payment for drugs purchased in Massachusetts, including persons who paid coinsurance (co-payments proportional to the reimbursed amount) where such coinsurance was based upon use of AWP as a pricing standard; and 2) all third-party payors who made reimbursements for drugs purchased in Massachusetts, or who made reimbursements for drugs and have their principal place of business in Massachusetts, based on contracts expressly using AWP as a pricing standard (the “Consumer and Third Party Payor Class for Medicare Part B Drugs Outside of the Medicare Context”). Id. All three classes contained subclasses for each defendant, including a subclass for J & J. Id. at 230-31. The relevant J & J drugs were Procrit, which is used to treat severe anemia, including anemia in AIDS and cancer patients, and Remicade, which is used to treat rheumatoid arthritis, Crohn’s disease, and other conditions. Id. at 232; In re Pharm. Indus. Average Wholesale Price Litig., 491 F.Supp.2d 20, 54, 57 *230 (D.Mass.2007). All three classes have the same class counsel.

The class at issue here is Class 1, the Medicare Part B Co-Payment Class. The class was certified as a nationwide class because the Court held there would be no individual issues of knowledge, causation, and reliance. In re Pharm. Indus. Average Wholesale Price Litig., 230 F.R.D. 61, 82, 85 (D.Mass.2005). The residents of nine states — Alabama, Alaska, Georgia, Iowa, Kentucky, Louisiana, Mississippi, Montana, and Virginia — were excluded from Class 1 on the grounds that the consumer protection statutes in those states do not permit class actions. In re Pharm. Indus. Average Wholesale Price Litig., 233 F.R.D. at 230. The claims of residents of all other states and the District of Columbia are governed by the consumer protection statutes of their respective jurisdictions. Id. at 230-31. In particular, the claims of Massachusetts residents are governed by Mass. Gen. Laws Ch. 93A. Id. at 230.

Two sets of class representatives were initially designated to represent the interests of the J & J subclass. James and Therese Shepley were designated to represent the J & J subclass with respect to Procrit; Larry Young on behalf of the estate of Patricia Young was designated to represent the J & J subclass with respect to Remicade. Subsequently, the class representatives withdrew and Mrs. Jimmie Austed has been proposed to serve in their place. 1

The parties filed cross-motions for summary judgment with respect to Classes 1 and 2 in March 2006. The Court construed the term “average wholesale price” in the Balanced Budget Act of 1997 according to its plain meaning to include discounts and rebates. In re Pharm. Indus. Average Wholesale Price Litig., 460 F.Supp.2d 277, 287-88 (D.Mass.2006). The Court granted defendants’ summary judgment motion with respect to all Medicare Part B drugs furnished in 2004 because it found that when Congress passed the Medicare Prescription Drug Improvement and Modernization Act (“MMA”) in 2003, it understood that “AWP was different than average sales price and was not reflective of actual prices in the marketplace.” Id. at 288. The Court denied the parties’ motions in all other respects.

In November and December of 2006, the Court conducted a Track One bench trial, which was limited to claims by Classes 2 and 3, the Third-Party Payor MediGap Supplemental Insurance Class and the Consumer and Third Party Payor Class for Medicare Part B Drugs Outside of the Medicare Context. At trial, the Court heard testimony from plaintiffs’ expert, economist Dr. Raymond Hartman, that payors understood that there was a significant spread between a provider’s drug acquisition cost and the drug’s AWP, “on the order of 0%-25% over the class period.” In re Pharm. Indus. Average Wholesale Price Litig., 491 F.Supp.2d at 89. Hartman used a 30% yardstick as a conservative estimate of the outer limit of payors’ expectations of the difference between what was reported and what was actually paid. Id. at 87. This spread was due to a 20 to 25 percent formulaic markup from the Wholesale Acquisition Cost (‘WAC”) to AWP that “the market understood and expected” in addition to “some discounting from WAC” of which “payors were aware.” Id. at 40, 91-92. Dr. Hartman further testified that the government had similar *231 expectations, informing the Court that “government [and] policy makers” expected that “AWP did not exceed the average sales price by more than 30 percent.” Id. at 40.

The Court issued its Findings of Fact and Conclusions of Law in June 2007. In re Pharm. Indus. Average Wholesale Price Litig., 491 F.Supp.2d 20. Accepting Dr. Hartman’s testimony about markups, the Court found that Dr. Hartman’s 30% yardstick was a reliable measure of marketplace and government expectations. Id. at 92.

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Commonwealth v. Tap Pharmaceutical Products, Inc.
36 A.3d 1197 (Commonwealth Court of Pennsylvania, 2011)
WWP, INC. v. Wounded Warriors Family Support, Inc.
628 F.3d 1032 (Eighth Circuit, 2011)

Cite This Page — Counsel Stack

Bluebook (online)
738 F. Supp. 2d 227, 2010 U.S. Dist. LEXIS 92960, 2010 WL 3503986, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-pharmaceutical-industry-average-wholesale-price-litigation-mad-2010.