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Adamson v. Ortho-McNeil Pharmaceutical

November 16, 2006


The opinion of the court was delivered by: Wolfson, District Judge


Presently before the Court is a Motion to Dismiss by Defendants Ortho-McNeil Pharmaceutical, Inc. ("Ortho McNeil") and Watson Pharmaceuticals, Inc. ("Watson"). In February 2006, Plaintiff, Lindsay Adamson ("Adamson"), filed the instant complaint alleging that Defendants intentionally misrepresented and concealed from Plaintiff and other "brand loyalists" that Ortho Tri-Cyclen and TriNessa are identical drugs. Thus, Plaintiff contends that she and other brand loyalists overpaid for Ortho Tri-Cyclen because TriNessa, the identical drug, was available at a reduced price. Defendants argue that Plaintiff's Complaint must be dismissed pursuant to Federal Rule of Civil Procedure 12(b)(6) for failure to state a claim. The Court has considered the moving, opposition and reply papers, and for the reasons stated in the opinion below, Defendants' Motion to Dismiss is granted.

I. Background

Initially, the Court notes that this action concerns the marketing and sale of prescription drugs. Thus, a brief description of the federal regulatory scheme that governs these matters is appropriate. Under the Food Drug and Cosmetic Act, a drug company that wishes to introduce a new pharmaceutical product must file a New Drug Application ("NDA") with the Food and Drug Administration ("FDA") that contains technical information on the composition of the drug, the manufacturing process involved, and the results of clinical trials establishing the efficacy and safety of the drug. 21 U.S.C. § 355(b). The FDA will approve an NDA "after it determines that the drug meets the statutory standards for safety and effectiveness, manufacturing and controls, and labeling." 21 C.F.R. § 314.105(c). The FDA may refuse to approve an NDA for numerous reasons including that proposed labeling is "false or misleading" or that the "application contains an untrue statement of material fact." Id. at 314.125(b)(6)&(b)(7).

By contrast, the FDA permits companies who wish to market a generic version of a previously approved drug to file an Abbreviated New Drug Application ("ANDA") rather than a full NDA. Through an ANDA, a generic drug manufacturer may rely on the safety and effectiveness data set forth in the brand name manufacturer's NDA if the generic company establishes that the proposed generic drug is the bioequivalent of the generic drug, i.e. that the drug has the same active ingredients, dosage strength, absorption rate and therapeutic effect as the pioneer drug. See 21 U.S.C. § 355(j)(2).

In addition to NDAs and ANDAs, there is a third method pursuant to which the FDA permits the manufacturer of a new pharmaceutical product to use alternative marketing and distribution arrangements for its own approved new drug. Under this third method, the manufacturer of a new pharmaceutical product can market and/or distribute an "authorized generic" version of an already approved product without going through the ANDA process. Pl's Compl. ¶¶ 44-45; Defendant's Statement of Facts ("Def's Fact St.") at 6. Indeed, it is this third method, i.e. the method that provides for the marketing of an authorized generic drug, that is at issue in this case.

Specifically, OMJ Pharmaceuticals ("OMJ"), a wholly owned subsidiary of Ortho McNeil, manufactures the brand name oral contraceptive Ortho Tri-Cyclen. On October 28, 2002, OMJ entered into a supply agreement with Watson under which Ortho McNeil agreed to manufacture and sell Watson a generic version of Ortho Tri-Cyclen to be marketed by Watson under its own trade name, TriNessa. Pl's Compl. ¶ 53; Certification of Regan H. Crotty, Esq., ("Crotty Cert."), ex. 4, §§ 2.1 & 5.4. Thus, TriNessa is an "authorized generic" version of Ortho-Tri Cyclen manufactured by OMJ and distributed by Watson. As evidenced by a series of press releases issued by Watson, the agreement between Ortho-McNeil and Watson for the sale and distribution of TriNessa was made public. Pl's Compl. ¶¶ 53, 54 & 60; Crotty Cert., exs. 5 & 6. Indeed, an October 2002 press release announced that Watson "entered into a supply arrangement with OMJ Pharmaceutical Inc. . . .for a portfolio of oral contraceptives. Pl's Compl. ¶¶ 53 & 54; Crotty Cert., ex. 5.The agreement provides Watson the ability to launch brand equivalent versions of three oral contraceptives." Id.; Id. Moreover, the press release listed the following Watson Products and their OMJ equivalents:

Watson Product Necon(R) 7/7/7 Mononessa (TM) TriNessa (TM) Brand Equivalent ORTHO-NOVUM(R) 7/7/7 ORTHO-CYCLEN (R) ORTHO TRI-CYCLEN (R)

Id.; Id.

In addition, a December 2003 press release explained that Watson had initiated shipments of TriNessa "the authorized brand equivalent of the oral contraceptive Ortho Tri-Cyclen(R), marketed by Ortho-McNeil Pharmaceutical, Inc. TriNessa is indicated for prevention of pregnancy in women and for treatment of moderate acne vulgaris." Pl's Compl. ¶ 60; Crotty Cert., ex. 6. Subsequently, both products were made available to consumers.

Plaintiff, Lindsay Adamson, is a self-described "brand loyalist" or a purchaser who is "willing to pay a higher price to obtain [a] brand drug rather than a therapeutically equivalent generic drug." Pl's Compl. ¶6. Since January 19, 2004, Plaintiff has purchased and used Ortho Tri-Cyclen. Pl's Compl.¶¶ 2, 16. Plaintiff contends that although Ortho Tri-Cyclen and TriNessa are identical drugs, Watson "never disclosed in any fashion that its authorized generic, TriNessa, was in fact the same drug as Ortho Tri-Cyclen." Pl's Compl. ¶60. Thus, Plaintiff alleges that she and other brand loyalists suffered a financial loss when they purchased Ortho Tri-Cyclen because TriNessa, the identical drug, was available at a lower price. Id. ¶¶ 8 & 9.

To support her allegations, Plaintiff relies on various statements from marketing and sales materials that pertain to both Ortho Tri-Cyclen and TriNessa. First, Plaintiff contends that Watson's website fails to disclose that TriNessa is the same drug as Ortho Tri-Cyclen and instead describes TriNessa as "therapeutically equivalent to Ortho Tri-Cyclen." Pl's Compl. ¶61.*fn1 Next, Plaintiff contends that the TriNessa package insert duplicates the tests listed on the Ortho TriCyclen label and substitutes its name for Ortho Tri-Cyclen. Pl's Compl. ¶ 62. In other words, Plaintiff alleges that Watson "doesn't say that the tests were conducted for Ortho Tri-Cyclen but apply to TriNessa because TriNessa is the same drug." Id. Third, Plaintiff alleges that a statement on Ortho McNeil's website -- "[i]sn't it great to find the one that's right for you" -- is misleading because it claims that there is only one contraceptive exactly like Ortho Tri-Cyclen. Id. ¶ 63. Further, Plaintiff contends that Ortho McNeil falsely represented that Ortho Tri-Cyclen was a singular and unique type of birth control. In support of this contention, Plaintiff relies on the following statements from Ortho's website:

Myth: All birth control pills are the same Fact: Not all birth control pills contain the same type of hormones.

The progestin in some birth control pills may cause unpleasant effects...However not all progestins trigger these effects to the same degree. . . .For example, norgestimate, a newer progestin contained in Ortho Tri-Cyclen Tablets may be less ...

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