Gustavsen v. Alcon Labs., Inc.

• Decision Date: 29 September 2017
• Docket Number: C.A. No. 1:14–11961–MLW
• Citation: 272 F.Supp.3d 241
• Court: U.S. District Court — District of Massachusetts
• Parties: Robert GUSTAVSEN, Joseph Cugini, Demetra Cohen, Lee Wilburn, Jackie Corbin, Mary Law and Cecelia Brathwaite, on behalf of themselves and all others similarly situated, Plaintiffs v. ALCON LABORATORIES, INC.; Alcon Research, Ltd.; Falcon Pharmaceuticals, Ltd.; Sandoz, Inc.; Allergan, Inc.; Allergan USA, Inc.; Allergan Sales, LLC; Pfizer Inc.; Valeant Pharmaceuticals International, Inc.; Bausch and Lomb Incorporated; Aton Pharma, Inc.; Merck & Co., Inc.; Merck, Sharp & Dohme Corp.; Prasco, LLC; and Akorn, Inc., Defendants.

272 F.Supp.3d 241

Robert GUSTAVSEN, Joseph Cugini, Demetra Cohen, Lee Wilburn, Jackie Corbin, Mary Law and Cecelia Brathwaite, on behalf of themselves and all others similarly situated, Plaintiffs

v.ALCON LABORATORIES, INC.; Alcon Research, Ltd.; Falcon Pharmaceuticals, Ltd.; Sandoz, Inc.; Allergan, Inc.; Allergan USA, Inc.; Allergan Sales, LLC; Pfizer Inc.; Valeant Pharmaceuticals International, Inc.; Bausch and Lomb Incorporated; Aton Pharma, Inc.; Merck & Co., Inc.; Merck, Sharp & Dohme Corp.; Prasco, LLC; and Akorn, Inc., Defendants.

C.A. No. 1:14–11961–MLW

United States District Court, D. Massachusetts.

Signed September 29, 2017

John G. Simon, Kevin M. Carnie, Jr., Ryan A. Keane, The Simon Law Firm, P.C., Richard S. Cornfeld, Law Office of Richard S. Cornfeld, St. Louis, MO, Kenneth J. DeMoura, DeMoura Smith LLP, Emily L. Perini, Perini–Hegarty & Associates, P.C., Boston, MA, for Plaintiffs.

Christiana C. Jacxsens, Lori G. Cohen, Greenberg Taurig, LLP, J. Stanton Hill, Polsinelli PC, Atlanta, GA, Gregory E. Ostfeld, Greenberg Traurig, LLP, Chicago, IL, David G. Thomas, Greenberg Traurig, LLP, Joseph P. Crimmins, Posternak, Blankstein & Lund, Peter J. Simshauser, David S. Clancy, Skadden, Arps, Slate, Meagher & Flom LLP, David B. Chaffin, White and Williams LLP, Amy Cashore Mariani, Fitzhugh & Mariani LLP, David J. Volkin, Law Offices of David J. Volkin, Boston, MA, James P. Muehlberger, Lori C. McGroder, Shook, Hardy & Bacon LLP, John M. Kilroy, Polsinelli PC, Kansas City, MO, W. Scott O'Connell, Nixon Peabody LLP, Manchester, NH, Austin Norris, Robyn E. Bladow, Kirkland & Ellis LLP, Los Angeles, CA, Randy J. Soriano, Stephen G. Strauss, Timothy J. Hasken, Bryan Cave LLP, St. Louis, MO, for Defendants.

MEMORANDUM AND ORDER

WOLF, D.J.

Table of Contents

I. Summary...243

II. Procedural History...244

III. Applicable Standards...245

A. Motions to Dismiss...245

B. Impossibility Preemption...246

C. Obstacle Preemption...249

D. Consumer Protection Statutes...249

E. "Money Had and Received" and Unjust Enrichment...249

IV. Factual Allegations...249

V. The Omnibus Motion...250

VI. The Generic Motion...256

VII. Order...256

I. SUMMARY

Plaintiffs Cecelia Brathwaite, Demetra Cohen, Jackie Corbin, Joseph Cugini, Robert Gustavsen, Mary Law, and Lee Wilburn bring this putative class action against a group of pharmaceutical companies that either manufacture or distribute prescription eye drops: Sandoz, Inc.; Prasco, LLC; Bausch and Lomb Inc.; Akorn, Inc.; Aton Pharma Inc.; Valeant Pharmaceuticals International Inc.; Allergan USA, Inc.; Alcon Research Ltd.; Allergan, Inc.; Allergan Sales, LLC.; Merck, Sharp & Dohme Corp.; Pfizer, Inc.; Alcon Laboratories, Inc.; Falcon Pharmaceuticals Ltd.; and Merck & Co., Inc. Plaintiffs' Amended Complaint alleges that each of the defendants manufactured or distributed prescription eye drops that were intentionally designed to dispense more liquid than the human eye is capable of absorbing. As a result, medication is wasted when the excess liquid drains through consumers' tear ducts or rolls down their cheeks. According to plaintiffs, defendants package their products in this way to compel consumers to purchase medication more frequently than necessary in order to increase profits.

The defendants have filed two motions to dismiss the Amended Complaint. The first is brought by all defendants (the "Omnibus Motion"). It raises six grounds for dismissal. In essence, the Omnibus Motion argues that plaintiffs lack standing under Article III of the United States Constitution to bring this case because they have not been harmed, plaintiffs' claims are preempted by federal statutes and regulations governing prescription drugs, and plaintiffs have failed to adequately allege their state-law claims. The second motion (the "Generic Motion") is brought by a subset of defendants who manufacture or distribute only generic drugs: Akorn, Inc.; Alcon Laboratories, Inc.; Alcon Research Ltd.; Bausch and Lomb Incorporated Pharmaceuticals Ltd.; Falcon Pharmaceuticals Ltd.; Prasco, LLC; Sandoz, LLC; and Valeant Pharmaceuticals International Inc (the "Generic Defendants"). The Generic Motion argues that plaintiffs' claims against the Generic Defendants should be dismissed because they are preempted by regulations and duties applicable solely to generic manufacturers or distributors.

Plaintiffs have filed a Motion for Leave to File Supplemental Exhibits in Opposition to Defendants' Motions to Dismiss (the "Supplemental Exhibit Motion"), which defendants oppose. The Supplemental Exhibit Motion seeks to supplement the record with additional examples of circumstances in which plaintiffs contend the Food and Drug Administration (the "FDA") has permitted changes to a sterile product's container/closure system without prior FDA approval.

The Supplemental Exhibit Motion is being denied. Most of the additional documents plaintiffs proffer may not be considered on a motion to dismiss. The others are similar to documents the court has considered. None of the proposed exhibits would affect the court's analysis or conclusions.

For the reasons explained in this Memorandum, the Omnibus Motion is being allowed because the plaintiffs' claims are preempted. Therefore, the Generic Motion is moot.

II. PROCEDURAL HISTORY

After plaintiffs filed their original complaint, defendants filed motions to dismiss. Plaintiffs then timely filed an Amended Complaint, in which plaintiffs assert three counts against all defendants. Count I alleges violations of Massachusetts General Laws Chapter 93A ("Chapter 93A"), as well as consumer protection statutes of 16 other jurisdictions that prohibit unfair or deceptive acts and practices. Plaintiffs contend that designing eye droppers to dispense more medication than necessary is an unfair act or practice in violation of these consumer protection statutes. Counts II and III seek recovery under theories of unjust enrichment and "money had and received" under the laws of 17 states, asserting that defendants were enriched by plaintiffs having to purchase more medication than necessary.

All defendants responded to the Amended Complaint by filing the Omnibus Motion. It raises six grounds for dismissal: (1) plaintiffs do not have standing under Article III of the United States Constitution because they have not alleged a cognizable injury-in-fact; (2) plaintiffs' state-law claims are preempted by federal law under the doctrine of "impossibility preemption" because provisions of the Food Drug and Cosmetics Act, 21 U.S.C. § 355 (the "FDCA"), and FDA regulations restrict defendants from altering approved drugs; (3) plaintiffs' claims are preempted under the "obstacle preemption" doctrine because imposing tort liability would interfere with Congress's objectives in passing the FDCA; (4) plaintiffs' claim under the Massachusetts Consumer Protection Statute, Chapter 93A, fails because defendants' alleged conduct fits within a safe harbor for activity permitted by federal law, plaintiffs have failed to allege "unfair" conduct, and plaintiffs have not alleged a cognizable injury; (5) plaintiffs' unjust enrichment and "money had and received" claims fail because they are precluded by New York law and plaintiffs received the benefit of the bargain for their purchase of defendants' products; and (6) plaintiffs' claims brought under consumer protection laws of states where plaintiffs do not reside are constitutionally impermissible.

The Generic Defendants also filed the Generic Motion. It makes two arguments for dismissal: (1) plaintiffs' claims against the Generic Defendants are specifically preempted by the federal duty of "sameness" applicable to generic drug manufacturers; and (2) plaintiffs' claims against generic distributors Falcon, Sandoz, and Prasco are preempted because distributors are barred from unilaterally changing generic drugs.

The court held a hearing on the motions to dismiss. The court heard argument on two issues raised in the Omnibus Motion: plaintiffs' Article III standing, and whether plaintiffs' claims were barred by the doctrine of "impossibility preemption." The court ruled orally that plaintiffs had adequately alleged Article III standing. See Oct. 30, 2015 Hrg. Tr. at 26–30. The court reserved ruling on the remaining issues and ordered the parties to file supplemental memoranda on the issue of impossibility preemption. See id. at 73–76. The parties subsequently each filed supplemental memoranda ("Defs' Suppl. Mem." and "Pls' Suppl. Mem.").

The parties filed four additional motions after they made their supplemental submissions on the motions to dismiss. Plaintiffs filed an assented-to Motion for Protective Order governing the confidentiality of documents. The court allowed that motion and entered the protective order. See Docket No. 122. Plaintiffs also filed the Supplemental Exhibit Motion, which defendants opposed. Plaintiffs then filed a Motion for Leave to File a Reply in support of their motion to file supplemental exhibits.

III. APPLICABLE STANDARDS

A. Motions to Dismiss

Federal Rule of Civil Procedure 8(a)(2) requires that a complaint include a "short and plain statement of the claim showing that the pleader is entitled to relief." This pleading standard does not require "detailed factual allegations," but does require "more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do." Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007). A court may disregard "bald assertions, unsupportable conclusions, and opprobrious epithets." In re Citigroup, Inc., 535 F.3d 45, 52 (1st Cir. 2008) ; Penalbert–Roia v. Fortuno–Burset, 631 F.3d 592, 595 (1st Cir. 2011).

A motion to dismiss should be denied if a plaintiff has shown "a plausible entitlement to relief." Twombly, 550 U.S. at 559, 127 S.Ct. 1955. That is, the complaint "must contain sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face. ...