Thompson v. Allergan USA, Inc.

993 F. Supp. 2d 1007, 2014 WL 308794, 2014 U.S. Dist. LEXIS 10081
CourtDistrict Court, E.D. Missouri
DecidedJanuary 28, 2014
DocketCase No. 4:13CV00030 AGF
StatusPublished
Cited by25 cases

This text of 993 F. Supp. 2d 1007 (Thompson v. Allergan USA, Inc.) is published on Counsel Stack Legal Research, covering District Court, E.D. Missouri primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Thompson v. Allergan USA, Inc., 993 F. Supp. 2d 1007, 2014 WL 308794, 2014 U.S. Dist. LEXIS 10081 (E.D. Mo. 2014).

Opinion

MEMORANDUM AND ORDER

AUDREY G. FLEISSIG, District Judge.

This putative class action is before the Court on Defendants’ motion (Doc. No. 15) to dismiss Plaintiffs first amended complaint pursuant to Federal Rule of Civil Procedure 12(b)(6) for failure to state a claim upon which relief can be granted, and alternatively, on federal preemption grounds. The Court heard oral argument on the motion on December 3, 2013, and thereafter received supplemental briefing by the parties. For the reasons set forth below, the Court concludes that Plaintiff has failed to state a claim under Missouri law. The Court concludes, alternatively, that Plaintiffs claims, which are all state law claims, are preempted by federal law.

BACKGROUND

Restasis is a prescription ophthalmic medication manufactured and sold by Defendants for the treatment of chronic dry eye. The medication is supplied in preservative-free vials that also serve as dispensers. Each vial of Restasis contains approximately 14 drops (400 microliters) of medicine, while the recommended dosage for Restasis is one drop (28 microliters) twice a day. Restasis is packaged with an insert that states: “the emulsion from one individual single-use vial is to be used immediately after opening for administration to one or both eyes, and the remaining contents should be discarded after administration.”

Plaintiff Francine Thompson brings this class action individually and on behalf of a class of Missouri consumers who purchased Restasis. Plaintiffs complaint is based on Defendants’ alleged practice of “overfilling” Restasis dispensers so that consumers are forced to purchase more Restasis than they can use. Plaintiff alleges that Defendants set the price of the Restasis vials based upon the amount of medication in each vial and that if Defendants included smaller quantities of medication in the vials, the prescriptions would be less expensive and consumers would not have to spend so much on the medication. According to Plaintiff, Defendants increase profits by filling vials of Restasis with more medication than they knew consumers could use. These alleged profits, Plaintiff contends, constitute an economic harm to Plaintiff because there is no valid reason for Defendants to excessively overfill Restasis vials.

Count I of Plaintiffs first amended complaint alleges violation of the Missouri Merchandising Practices Act (“MMPA”), which provides that “[t]he act, use or employment by any person of any deception, fraud, false pretense, false promise, misrepresentation, unfair practice or the concealment, suppression, or omission of any material fact in connection with the sale or advertisement of any merchandise in trade or commerce ... is declared to be an unlawful practice.” Mo.Rev.Stat. [1010]*1010§ 407.020. Count II claims that Defendants were unjustly enriched by their practice of overfilling Restasis dispensers, and Count III, for money had and received, asserts that Defendants have received money from “deceptive and unfair practices.” For relief, Plaintiff seeks actual damages to herself and class members, punitive damages, and declaratory and in-junctive relief enjoining Defendants from continuing their practice of overfilling Res-tasis dispensers.

In support of their motion to dismiss the complaint, Defendants submit a Memorandum from the Federal Drug Administration (“FDA”), dated December 11, 2002 (Doc. No. 16-1), available at the FDA’s public website. The Memorandum was related to the New Drug Application (“NDA”) for Restasis. It addresses the FDA’s concern that due to the overfill in each vial, patients may save the vial after a single dose, and use the remaining drug in the interest of saving money. The Medical Officer commented that the “additional volume” in each vial of Restasis “assists the patient in administering the correct amount of drug product” and “is also required for product stability”; and that the risk of using a vial beyond a single dose was “adequately communicated to practitioners, patients and caregivers within the Restasis package insert.” (Doc. No. 16-1 at 4.)

Plaintiff also submits FDA Guidelines from January 2001, also publically available online, in which the FDA states that a “decrease in the fill volume” of a drug product “involves a change to the specifications and must be submitted in a prior approval supplement” for FDA approval. (Doc. No. 39-1 at 12.)

ARGUMENTS OF THE PARTIES

Failure to State a Claim

Defendants first argue that Plaintiffs claims, which are based on the assertion that there is no valid reason for the overfill, do not satisfy the plausibility standard of Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007), in light of the FDA’s opinion that the overfill assists patients in administering the correct dosage and is required for product stability. Defendants next argue that Plaintiff has not met the heightened pleading requirement of Federal Rule of Civil Procedure 9(b) for claims involving fraud. Defendants also argue that Plaintiffs complaint fails to allege an ascertainable loss, as required for a claim under the MMPA. Finally, Defendants argue that Plaintiffs equitable claims for unjust enrichment and money had and received fail because they are based on the same nonac-tionable conduct, Defendants were not unjustly enriched by Plaintiffs purchase of Restasis, and Plaintiff has an adequate remedy at law.

In response, Plaintiff argues that the FDA Memorandum, and Defendants’ interpretation of it, are beyond the pleadings and therefore have no bearing on whether the complaint satisfies federal pleading requirements. Further, Plaintiff argues that Rule 9(b)’s heightened pleading requirements do not apply because the complaint does not allege fraud. Plaintiff contends that she states a cause of action under the MMPA because she sufficiently pled that Defendants’ conduct was unfair, that the conduct caused an ascertainable loss, and that there was a causal connection between the conduct and the alleged loss. Plaintiff further argues that Defendants’ profits and benefits were to Plaintiffs detriment and Defendants were thereby unjustly enriched. Finally, Plaintiff argues that she states a claim for money had and received based on Defendants’ deceptive and unfair practices, which money in equity and good conscience ought to be returned to consumers.

[1011]*1011Federal Preemption

Defendants further argue that Plaintiffs claims are preempted by federal law because Defendants are unable to reduce the amount of medicine in each Restasis vial without prior FDA approval. Plaintiff argues that Defendants have not met their burden of establishing the affirmative defense of federal preemption. This issue has been the subject of supplemental memoranda by the parties in light of the United States Supreme Court’s recent decision in Mutual Pharmaceutical Co. v. Bartlett, — U.S. -, 133 S.Ct. 2466, 186 L.Ed.2d 607 (2013). Plaintiff argues that whether or not the FDA would have approved a reduction in drops per vial is a factual issue that Defendants have not established. Furthermore, according to Plaintiff, it is unclear whether any reduction would be a “major change” requiring prior FDA approval.

DISCUSSION

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Cite This Page — Counsel Stack

Bluebook (online)
993 F. Supp. 2d 1007, 2014 WL 308794, 2014 U.S. Dist. LEXIS 10081, Counsel Stack Legal Research, https://law.counselstack.com/opinion/thompson-v-allergan-usa-inc-moed-2014.