GUSTAVSEN v. ALCON LABORATORIES, INC.

No. 17-2066.

903 F.3d 1 (2018)

Robert GUSTAVSEN; Joseph Cugini; Demetra Cohen; Jackie Corbin; Lee Wilburn; Mary Law; Cecilia Brathwaite, Plaintiffs, Appellants, 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, Inc.; Aton Pharma, Inc.; Merck & Co., Inc.; Merck, Sharp & Dohme (I.A.) Corp.; Prasco, LLC; Akorn, Inc., Defendants, Appellees.

United States Court of Appeals, First Circuit.

August 27, 2018.


Attorney(s) appearing for the Case

Leah M. Nicholls , with whom Public Justice, P.C., Washington, DC, Richard S. Cornfeld , Law Office of Richard S. Cornfeld, John C. Simon , Kevin M. Carnie, Jr. , The Simon Law Firm, P.C., St. Louis, MO, Kenneth J. DeMoura , DeMoura Smith LLP, Emily Lisa Perini , Perini-Hegarty & Associates, P.C., Boston, MA, and Brian Wolfman , Washington, DC, were on brief, for appellants.

Gregory E. Ostfeld , Chicago, IL, with whom David G. Thomas , Michael Pastore , Boston, MA, Christiana Jacxsens , Atlanta, GA, Greenberg Taurig, LLP, Peter Simshauser , Skadden, Arps, Slate, Meagher & Flom LLP, Boston, MA, Robyn E. Bladow , Austin Norris , Kirkland & Ellis LLP, Los Angeles, CA, Joseph P. Crimmins , Posternak Blankstein & Lund LLP, Boston, MA, John M. Kilroy, Jr. , Kansas City, MO, J. Santon Hill , Polsinelli PC, W. Scott O'Connell , Nixon Peabody LLP, Boston, MA, James P. Muehlberger , Lori A. McGroder , Shook, Hardy & Bacon LLP, Kansas City, MO, Stephen G. Strauss , Bryan Cave LLP, St. Louis, MO, David J. Volkin , Law Offices of David J. Volkin, David B. Chaffin , and White and Williams LLP, Boston, MA, were on brief, for appellees.

Jeffrey S. Bucholz , Paul Alessio Mezzina , Washington, DC, King & Spalding LLP, Peter Tolsdorf , and Manufacturers' Center for Legal Action, on brief for American Tort Reform Association, The Chamber of Commerce of the United States of America, The National Association of Manufacturers, and Pharmaceutical Research & Manufacturers of America, amici curiae.

David R. Geiger , Boston, MA, Kristyn M. DeFillip , and Foley Hoag LLP, on brief for Product Liability Advisory Council, Inc., amicus curiae.

Before Thompson, Kayatta, and Barron, Circuit Judges.


Our disposition of the merits of this appeal turns on a single question: Can manufacturers of prescription eye drops change the medication's bottle so as to alter the amount of medication dispensed into the eye without first getting the FDA's approval? Finding that federal law requires prior approval for such a change, we...

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