OPINION
Prеsently 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
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 appropriаte. 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 contrоls, 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. § 356QX2).
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. Pi’s Compl. ¶¶ 44-45; Defendant’s Statement of Facts (“Defs 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 Or-tho McNeil, manufactures the brand name oral contraceрtive 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. Pi’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. Pi’s Compl. ¶¶ 53, 54 & 60; Crotty Cert., exs. 5 & 6. Indeed, an Octo
Watson Product Brand Equivalent
Necon(R) 7/7/7 ORTHO-N OVIJM(R) 7/7/7
Mononessa (TM) ORTHO-CYCLEN (R)
TriNessa (TM) ORTHO TRI-CYCLEN (R)
Id.; Id.
In addition, a December 2003 press releasе 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.” Pi’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 obtаin [a] brand drug rather than a therapeutically equivalent generic drug.” Pi’s Compl. ¶ 6. Since January 19, 2004, Plaintiff has purchased and used Ortho TriCyclen. Pi’s Compl.1ffl 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.” Pi’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.” Pi’s Compl. ¶ 61. 1 Next, Plaintiff contends that the TriNessa package insert duplicates the tests listed on the Ortho TriCyclen label and substitutes its name for Ortho TriCyclen. Pi’s Compl. ¶ 62. In other words, Plaintiff allеges 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 — “[ijsn’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-Cy-clen. 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 Tabletsmay be less likely to cause unpleasant side effects among its Pill users.
Id. ¶ 64.
Finally, Plaintiff contends that Defendants. engaged in a deceptive marketing schemе because Ortho McNeil advertises Ortho Tri-Cyclen’s ability to improve acne and Watson does not promote this same benefit of TriNessa. Id. ¶ 67-68. For all these reasons, Plaintiff argues that Ortho McNeil “has not informed and will not inform purchasers of Ortho Tri-Cyclen that it is also manufacturing the identical pharmaceutical ... .which is being sold at a significantly lower price.”
Plaintiff filed a complaint in the United States District Court on February 24, 2006, alleging violation of the New Jersey Consumer Fraud Act, violation of all 50 States’ Consumer Protection Acts 2 , negligent misrepresentation and seeking in-junctive relief. Subsequently, on June 12, Defendants filed the instant Motion to Dismiss.
II. Legal Standard
Pursuant to Federal Rule of Civil Procedure . 12(b)(6), a complaint may be dismissed for failure to state a claim upon which relief can be granted. Fed.R.Civ.P. 12(b)(6). When reviewing a Rule 12(b)(6) motion to dismiss, a court must accept as true all factual allegations in the complaint and must provide the plaintiff with the benefit of all inferences that may be fairly drawn from the contents of the complaint.
Kost v. Kozakiewicz,
Generаlly, when conducting such an inquiry, material beyond the pleadings should not be considered.
See In re Burlington Coat Factory Sec. Litig.,
III. Discussion
1. Consumer Fraud
In the instant matter, Defendants initially argue that Plaintiff cannot maintain a claim for consumer fraud under the New Jersey Consumer Fraud Act (“CFA”). The New Jersey Consumer Fraud Act prohibits, in relevant part, “[t]he act, use or employment by any person of any unconscionable commercial practice, deception, fraud, false pretense, false promise, misrepresentation, or the knowing, concealment, suppression, or omission of any material fact with intent that others rely upon such concealment, suppression or omission, in connection with the sale or advertisement of any merchandise.” N.J. Stat. Ann. § 56-8:2. A private party may bring a cause of action for consumer frаud if she demonstrates an “ascertainable loss” and that the defendant committed an unlawful practice.
Scibek v. Longette,
To state a claim under the CFA, an advertisement must have “the capacity to mislead the average consumer.”
Union Ink Co., Inc. v. AT&T Corp.,
Thus, in determining whether the allegations in Plaintiffs сomplaint state a claim for relief that satisfies Rule 12(b)(6), I must determine whether the statements on which Plaintiff bases her claim can be read as having the capacity to mislead. In the complaint, Plaintiff alleges that Defendants’ marketing materials contain misrepresentations and omissions that convey a message that Ortho Tri-Cyclen and TriNessa are not the same drug
3
. Specifi
Defendants, on the other hand, contend that none of these alleged misrepresentations or omissions are actionable as a matter of law. Indeed, Defendants argue that the aforementioned statements are not misrepresentations or omissions but accurate factual statements regarding the individual drugs and that, at most, these statements may be considered sales puffery. In addition, Defendants contend that they had no legal duty to advertise any particular benefits of either drug or to advertise in any particular way. Finally, Defendants note that Watson did not buy the rights to use Ortho McNeil or OMJ trademarks, and thus it сould not lawfully use the Ortho Tri-Cyclen brand name. The Court agrees.
Initially, Plaintiff argues that Watson falsely used the term “therapeutically equivalent” to describe TriNessa when, in fact, TriNessa is not “therapeutically equivalent” to Ortho Tri-Cyclen, but is identical to the brand name drug. Thus, Plaintiff contends that ‘Watson’s statement that TriNessa is the ‘therapeutic equivalent’ of Ortho Tri-Cyclen does not inform anyone that TriNessa is, in fact, identical to Ortho Tri-Cyclen.” Pi’s Br. at 16. To the extent that Plaintiff argues that the characterization of TriNessa as the therapeutic equivalent of Ortho TriCyclen is somehow misleading, the Court does not agree.
To begin, the Court notes that according to the FDA, “any drug product in the List repackaged and/or distributed by other than the application holder is considered to be therapeutically equivalent to the application holder’s drug product.” FDA, Approved Drug Products with Therapeutic Equivalence Evaluations (2006)(“0range Book”) at x, available at http://www.fda.gov/cder/orange/obannual. pdf (emphasis added). Moreover, the FDA doеs not limit the use of the term “therapeutic equivalent” to generic drugs and does not prohibit the use of this term to describe authorized generic drugs. See id. at xii. (distinguishing between drugs that have no bioequivalence problems and are therefore considered “therapeutically equivalent” and drugs that present bioe-quivalence problems and are not considered therapeutically equivalent). Therefore, Watson’s characterization of the TriNessa as “therapeutically equivalent” tо Ortho TriCyclen is accurate and does not have the capacity to mislead. Thus, Plaintiff cannot rely on this statement to state a claim under the New Jersey CFA.
In addition, Plaintiff contends that “Defendants’ advertisements tout [sic] Ortho
To constitute consumer fraud, the New Jersey Supreme Court has held that a business practice “must be ‘misleading’ and stand outside the norm of reasonable business practice in that it will victimize the average consumer.”
Turf Lawnmower Repair, Inc. v. Bergen Record Corp.,
Based on the holdings in
Rodio
and
New Jersey Citizen Action,
I find that none of the statements upon which Plaintiff relies in the instant matter are actionable under thе CFA. Indeed, despite Plaintiffs argument that the above statements can be read to suggest that Ortho Tri-Cyclen is a one-of-a-kind drug, I find that Defendants’ marketing materials are not susceptible to that interpretation. At best, Defendants’ marketing materials advise consumers that birth control pills contain different types of hormones and that Ortho Tri-Cyclen contains a particular type of progestin. These are all accurate statements about Ortho Tri-Cyclen and are not misleading or deceptivе in any way. Further, these statements do not suggest, nor can they be read to suggest, that Ortho Tri-Cyclen is the only pill to use norgestimate or to cause fewer side effects. In fact, the ad on Ortho McNeil’s website advising “[t]he progestin in some birth control pills may cause unpleasant effects----However not all progestins trigger these effects to the same degree.... For example, norgesti-mate ... may be less likely to cause unpleasant side effects” suggests that there are other hormones and other birth control
Finally, to the extent that Plaintiff argues that Defendants are under an obligation to inform the public that TriNessa and Ortho Tri-Cyclen are identical, the Court does not agree. Indeed, Plaintiff does not cite a single case to suggest the existence of such a duty and courts have routinely held that competitors have no duty to advertise or sell a competitor’s products.
See Olympia Equip. Leasing Co. v. Western Union Tel.Co.,
For the reasons set forth above, I find that none of the statements relied upon by the Plaintiff contain any actionable misrepresentations or omissions. Therefore, Plaintiff has failed to set forth a claim under the New Jersey CFA and Plaintiffs claim for consumer fraud must be dismissed pursuant to Rule 12(b)(6).
2. Negligent Misrepresentation
Plaintiff additionally contends that Defendants’ marketing materials negligently misrepresented to Plaintiff the “actual identity of the drugs Ortho TriCyclen and TriNessa.” Pi’s Compl. at ¶ 103. Negligent misrepresentation “requires proof that an ‘incorrect statement was negligently made and justifiably relied upon’ and that injury was sustained as a consequence of that reliance.”
Saurino v. Senatore,
3. Unjust Enrichment
Finally, Plaintiff sets forth a claim for unjust enrichment in which she essentially argues that because of alleged misrepresentations in Defendants’ marketing materials, she purchased the more expensive
To state a claim for unjust enrichment, a plaintiff must allegе (1) at plaintiffs expense (2) defendant received benefit (3) under circumstances that would make it unjust for defendant to retain benefit without paying for it.
In re K-Dur Antitrust Litigation,
In the-instant matter, I find that Plaintiff cannot state a claim for unjust enrichment. As discussed above, the Court finds that none of the statements upon which Plaintiff relies contain actionable misrepresentations or omissions. Indeed, Plaintiff purchased and paid for Or-tho Tri-Cyclen and received Ortho TriCyclen. The mere fact that she chose not to purchase TriNessa, the authorized generic version of the drug, does not amount to Ortho McNeil’s unjust enrichment. Indeed, New Jersey courts have held that the cornerstones of a claim for a quasi-contractual claim of unjust enrichment are the “key words [] Enrich and Unjustly. To recover on the theory of quasi-contract the plaintiffs must prove that defendant was enriched ... received a benefit, and that retention of thе benefit without payment therefor would be unjust.”
Callano v. Oakwood Park Homes Corp.,
IV. CONCLUSION
For the reasons discussed herein, Defendants’ Motion to Dismiss is GRANTED and this case will be closed. An appropriate order will follow.
Notes
. The Court notes that although Plaintiff did not supply a citation for this quote, the Court found the relevant information on the following website: http: //www.oralcontraceptives. com/brand_trinessa.asp.
. The Court notes that Plaintiff brought the instant matter on behalf of herself and all other individuals similarly situated. However, as discussed below, because this Court finds that Plаintiff has not set forth a claim under the New Jersey Consumer Fraud Act, it is not necessary to address the consumer protection acts in the remaining 49 states.
. Importantly, the Court notes that despite ambiguous language in the Complaint, Plaintiff admits that Defendants disclosed that TriNessa was manufactured by OMJ.
See
Pi’s Opp. Br. at 25 (“Contrary to Defendants' arguments, Plaintiff does not claim that Defendants omitted that TriNessa was manufactured by OMJ; rather that Ortho Tri-Cyclen and TriNessa is the same drug.”);
see also
Crotty Cert., ex. 7. Indeed, Plaintiff admits
. See supra pp. 499-500; see also Press Release, Watson Pharmaceuticals, Watson Pharmaceuticals Launch TriNessa Oral Contraceptive, available at http://ir.watsonpharm.com/ phoenix. zhtmIPc=65778&p=irol-newsArticle &ID=480538&highlight=.