In re Flonase Antitrust Litigation

284 F.R.D. 207, 2012 WL 2277840
CourtDistrict Court, E.D. Pennsylvania
DecidedJune 18, 2012
DocketCivil Action No. 08-CV-3301
StatusPublished
Cited by21 cases

This text of 284 F.R.D. 207 (In re Flonase Antitrust Litigation) is published on Counsel Stack Legal Research, covering District Court, E.D. Pennsylvania primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In re Flonase Antitrust Litigation, 284 F.R.D. 207, 2012 WL 2277840 (E.D. Pa. 2012).

Opinion

MEMORANDUM

ANITA B. BRODY, District Judge.

Plaintiffs A.F. of L.-A.G.C. Building Trades Welfare Plan (“AFL”), IBEW-NECA Local 505 Health & Welfare Plan (“IBEW”), Painters District Council No. 30 Health & Welfare Fund (“Painters”), and Andrea Kehoe (“Kehoe”), collectively “Indirect Purchasers,” are indirect purchasers of the prescription drug Flonase and its generic equivalent. Flonase is the brand-name version of fluticasone propionate (“FP”) — a steroid nasal spray produced by Defendant SmithKline Beecham Corporation, doing business as GlaxoSmithKline PLC (“GSK”). Indirect Purchasers allege that GSK filed sham citizen petitions with the Food and Drug Administration (“FDA”) to delay the entry of a cheaper, generic version of Flonase into the market. Indirect Purchasers have moved to certify a class of consumers and third-party payors (“TPPs”)1 under the monopolization, [211]*211unfair and deceptive trade practices (“UDTP”), and unjust enrichment laws of five states.2 Also before me are three Daubert motions seeking to exclude expert reports and testimony critical to this class certification determination: (1) GSK’s Motion to Exclude the Expert Report and Testimony of Gordon Rausser; (2) Indirect Purchasers’ Motion to Exclude the Report and Testimony of Bruce Stangle; and (3) Indirect Purchasers’ Motion to Exclude the Report and Testimony of Robert Navarro.

GSK asserts that Indirect Purchasers have failed to meet certain requirements for class certification under Federal Rule of Civil Procedure 23 — in particular, that common issues do not predominate over individual issues for purposes of establishing antitrust impact and damages. GSK contends that only through individual proof and inquiries can the fact of injury or the extent of damage for each class member’s purchase and/or reimbursement of Flonase or its generic equivalent be determined.

I am satisfied that Indirect Purchasers have demonstrated that common issues will predominate and that the Rule 23 requirements have been met. In reaching that conclusion, however, certain adjustments to Indirect Purchasers’ proposed class definition will be necessary. As opposed to the larger proposed class, a more limited indirect purchaser class will be certified that excludes those class members who did not purchase a generic equivalent of Flonase after it became available. Furthermore, I will only certify the class under the state laws which Indirect Purchasers have demonstrated standing to invoke. Therefore, I will grant in part and deny in part Indirect Purchasers’ motion for class certification.

I. Background 3

A. Hatch-Waxman and the Generic Drug Approval Process

In order to market a drug in the United States, a company must obtain FDA approval by filing a “New Drug Application” (“NDA”) to demonstrate the safety and efficacy of its product. 21 U.S.C. § 355(b). The NDA process is usually lengthy and expensive, and in 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (“Hatch-Waxman Act”) to expedite the approval process for generic drugs. Under Hatch-Waxman, to receive FDA approval for a generic drug, a prospective manufacturer need only file an Abbreviated New Drug Application (“ANDA”), which relies on the safety and efficacy data previously provided in the NDA for its branded equivalent. 21 U.S.C. § 355(j). Instead of clinical trials, an ANDA requires a demonstration of a certain level of bioequivalence4 to a listed drug. The FDA issues and regularly modifies bioe-quivalence guidance for various categories of generic drugs in order to inform the public of the bioequivalenee standards that ANDAs must meet in order to be approved. Generic drugs certified by the FDA as bioequivalent to the brand drug are completely interchangeable with that branded drug and are referred to as “AB-rated.”

While an ANDA is pending before the FDA, any interested party can file a citizen petition with the FDA to register a complaint about the pending application. 21 C.F.R. §§ 10.25(a), 10.30. Until 2007, the FDA was required to consider and respond to every citizen petition.5 For this reason, filing a [212]*212citizen petition necessarily delayed the approval of any pending ANDA — only after the FDA responded to all pending citizen petitions could an ANDA be approved. The citizen petition process often was abused by pharmaceutical companies attempting to prolong their monopoly in the market.

B. Flonase and GSK’s Alleged Misconduct

In October 1994, the FDA approved GSK’s NDA to treat nasal inflammation caused by seasonal and non-seasonal allergies. GSK released Flonase in the United States in 1995, and it quickly became the most prescribed nasal steroid inhalant in the United States. By 2000, Flonase commanded 38% of brand-name inhaled nasal steroid sales in the United States, resulting in over $600 million in sales. By 2005, the peak year for Flonase sales and the last full year of GSK’s market exclusivity, Flonase sales exceeded $1.3 billion.

GSK’s single patent on Flonase expired on November 13, 2003. However, GSK obtained a statutory extension of market exclusivity from the FDA to August 2004. By the time Flonase’s market exclusivity was set to expire in 2004, GSK had identified a number of generic pharmaceutical manufacturers— including Roxane Laboratories, Inc. (“Rox-ane”) — intent on filing ANDAs and bringing competitive generic FP nasal sprays to the market. This case concerns GSK’s alleged “brand maturation strategy,” crafted to maintain Flonase’s market dominance in the face of inevitable generic competition.

Indirect Purchasers offer evidence that GSK’s alleged “brand maturation strategy” included four tactics to delay the entry of generic FP nasal sprays into the market: (1) GSK improperly influenced the FDA’s bioe-quivalence guidance process; (2) GSK filed several frivolous citizen petitions with the FDA regarding pending generic FP ANDAs in order to force the FDA to respond and delay approval; (3) GSK drafted an FP monograph for submission to the United States Pharmacopeia — which lists tests, procedures, and acceptance criteria in order to set standards for the quality, purity, strength, and consistency of the pharmaceutical ingredients in an approved drug — in attempt to raise the bar for FP market entry; and (4) GSK supplemented its original NDA in an attempt to delay the FDA from approving any ANDAs before approving GSK’s supplements.

Roxane’s generic version of Flonase did not enter the market until March 6, 2006. Indirect Purchasers argue that GSK used each of these four tactics to delay the market entry of AB-rated generic equivalents of Flo-nase, and that, absent GSK’s exclusionary conduct, generic FP would have entered the market in August 2004.

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Cite This Page — Counsel Stack

Bluebook (online)
284 F.R.D. 207, 2012 WL 2277840, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-flonase-antitrust-litigation-paed-2012.