Meijer, Inc. v. Warner Chilcott Holdings Co. III, Ltd.

246 F.R.D. 293, 2007 WL 6215854, 2007 U.S. Dist. LEXIS 81746
CourtDistrict Court, District of Columbia
DecidedOctober 22, 2007
DocketCivil Action No. 05-2195(CKK)
StatusPublished
Cited by38 cases

This text of 246 F.R.D. 293 (Meijer, Inc. v. Warner Chilcott Holdings Co. III, Ltd.) is published on Counsel Stack Legal Research, covering District Court, District of Columbia primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Meijer, Inc. v. Warner Chilcott Holdings Co. III, Ltd., 246 F.R.D. 293, 2007 WL 6215854, 2007 U.S. Dist. LEXIS 81746 (D.D.C. 2007).

Opinion

MEMORANDUM OPINION

COLLEEN KOLLAR-KOTELLY, District Judge.

Currently pending before the Court is Plaintiffs’ [92] Motion for Class Certification, as well as a number of motions to strike stemming from that Motion, which were filed by Defendants—Warner Chilcott Holdings Company III, Ltd., Warner Chilcott Corporation, Warner Chilcott (US) Inc., Warner Chilcott Company, Inc., Galen (Chemicals), Ltd. (together ‘Warner Chilcott”), and Barr Pharmaceuticals, Inc. (“Barr”) (collectively with Warner Chilcott, “Defendants”). Plaintiffs are direct purchasers of Ovcon 35, a brand-name oral contraceptive marketed by Warner Chilcott, as well as certain indirect purchasers of Ovcon 35 who bring suit as assignees of direct purchasers of Ovcon 35. Plaintiffs’ Amended Complaint alleges that Warner Chilcott and Barr entered into an illegal agreement to delay the market entry of Barr’s FDA-approved generic version of Ovcon 35, and that this delay in generic competition forced direct purchasers to overpay for “Ovcon 35 Products.”1 Plaintiffs allege that Defendants’ conduct violated Section 1 of the Sherman Act, 15 U.S.C. § 1, and seek damages in the form of overcharges (trebled) paid for Ovcon 35 Products during the proposed class period, pursuant to Sections 4 and 16 of the Clayton Act, 15 U.S.C. §§15 and 15/26" style="color:var(--green);border-bottom:1px solid var(--green-border)">26.

In addition to opposing Plaintiffs’ Motion for Class Certification, Defendants have filed two motions to strike materials submitted by Plaintiffs in connection with their Reply brief in support of their Motion for Class Certification. Defendants’ first [111] Motion to [296]*296Strike relates to references to an expert report submitted by Dr. Jeffrey J. Leitzinger, which are contained in Plaintiffs’ Reply and in Dr. Leitzinger’s Rebuttal Declaration in support of that Reply; Defendants’ second [116] Motion to Strike relates to three declarations executed on behalf of companies that are absent members of the class that Plaintiffs seek to have certified. Finally, also pending before the Court are two non-class actions filed by direct purchasers of Ovcon 35 who have preemptively opted out of the instant putative class action: Walgreen Co. v. Warner Chilcott Holdings Co. III, Ltd., Civil Action 06-494, and CVS Pharmacy Inc. v. Warner Chilcott Holdings Co. III, Ltd., Civil Action No. 06-795. The Walgreen and CVS plaintiffs (collectively the “Non-Class Plaintiffs”) have filed a “Memorandum Responding to Defendants’ Opposition to Class Certification” in their respective actions, in order to bring to the Court’s attention a legal issue raised in Defendants’ Opposition that they believe could impact the non-class actions. Defendants have moved to strike the Non-Class Plaintiffs’ Memorandum.

Upon a searching review of the filings submitted by all parties in connection with the pending Motion for Class Certification and the three Motions to Strike, the exhibits attached thereto, the relevant statutes and case law, and the entire record herein, the Court shall grant Plaintiffs’ Motion for Class Certification [92], shall grant Defendants’ [111] Motion to Strike the references to Dr. Leitzinger’s Expert Report, shall grant-in-part and deny-in-part Defendants’ [116] Motion to Strike the declarations submitted on behalf of absent class members, and shall deny Defendants’ Motion to Strike the Non-Class Plaintiffs’ Memorandum.

I. BACKGROUND

Plaintiffs—Meijer, Inc., Meijer Distribution, Inc., Louisiana Wholesale Drug Co., Inc., Rochester Drug Co-operative, Inc., American Sales Company, Inc., SAJ Distributors, Inc., and Stephen L. LaFrance Holdings, Inc.—bring this putative class action pursuant to Federal Rule of Civil Procedure 23 on behalf of themselves and a class of direct purchasers of Ovcon 35 during the period April 22, 2004 through December 31, 2006.2 In their Amended Complaint, Plaintiffs allege that they either purchased Ovcon 35 directly from Defendants during the proposed class period, see Am. Compl. ¶¶ 10-11, 13, or that they are assignees of drug wholesalers that purchased Ovcon 35 directly from Defendants during the class period, id. ¶¶ 12, 14.3

[297]*297A company seeking to market a new drug in the United States must obtain approval from the United States Pood and Drug Administration (“FDA”) by filing a New Drug Application (“NDA”), demonstrating the safety and efficacy of its product. Am. Compl. ¶¶ 24, 26; 21 U.S.C. § 355(b). The NDA process is typically time-consuming and expensive, Am. Compl. ¶ 26, and in 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”), which accelerated the approval process for generic drugs, id. ¶ 27. The Hatch-Waxman Act permits a manufacturer seeking FDA approval for a generic drug to file an Abbreviated New Drug Application (“ANDA”), which relies on the safety and efficacy data previously provided in the NDA for its branded counterpart. Id. ¶ 27; 21 U.S.C. § 355(j). Accordingly, FDA approval of an ANDA takes, on average, about 18 months. Am. Compl. ¶ 27.

FDA-approved generic drugs are certified by the FDA as bioequivalent to the branded drug whose NDA the generic drug relied upon in its ANDA, and are completely interchangeable with that branded drug. Id. ¶ 28. The FDA refers to such drugs as “AB-rated,” and pharmacists may dispense AB-rated generic drugs in lieu of their branded counterparts. Id. According to Plaintiffs, upon their introduction, generic drugs generally enter the market at prices 30 to 50% (or more) below the price of their brand-name equivalents and, because generic and branded drugs are fully interchangeable in terms of safety and efficacy, the vast majority of patients switch to the less expensive generic in place of the brand-name drug. Id. ¶ 29. Furthermore, almost all states and the District of Columbia encourage generic competition through laws that allow pharmacists to substitute brand-name drugs with their AB-rated generic equivalents, unless a physician directs or the patient requests otherwise. Id. ¶ 30. In addition, many third-party payors of prescription drugs (e.g., health insurance plans) have adopted policies to encourage the substitution of available AB-rated generic drugs for their branded counterparts. Id. ¶ 31.

Ovcon 35 is an oral contraceptive containing the formulation 0.035 mg of ethinyl estradiol and 0.4 mg norethindrone, which has been available to the general public since 1976 and is not subject to patent protection. Id. ¶ 32; Pls.’ Mem. of Law in Support of their Mot. for Class Cert, (hereinafter “Pls.’ Mem.”) at 1; Defs.’ Opp’n at 4 n. 3. Warner Chilcott has been the exclusive marketer of Ovcon 35 since January 2000, when it purchased certain rights, title, and interest in Ovcon 35 from Bristol-Myers Squibb Company (“BMS”). Am. Compl. ¶¶ 34-35.

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Cite This Page — Counsel Stack

Bluebook (online)
246 F.R.D. 293, 2007 WL 6215854, 2007 U.S. Dist. LEXIS 81746, Counsel Stack Legal Research, https://law.counselstack.com/opinion/meijer-inc-v-warner-chilcott-holdings-co-iii-ltd-dcd-2007.