Shirley J. Brinkley, Plaintiff - Appellant
Pfizer, Inc.; Wyeth, LLC; Schwarz Pharma, Inc., Defendants, Pliva, Inc., formerly known as Sidmak Laboratories, Inc., Defendant - Appellee
Submitted September 8, 2014.
Appeal from United States District Court for the Western District of Missouri - Kansas City.
For Shirley J. Brinkley, Plaintiff - Appellant: Benjamin A. Bertram, J. Scott Bertram, BERTRAM & GRAF, Kansas City, MO; Louis M. Bograd, CENTER FOR CONSTITUTIONAL LITIGATION, Washington, DC; Nicholas S. Clevenger, David Melville Peterson, PETERSON & ASSOCIATES, Kansas City, MO; Terrence J. Donahue, Jr., Daniel J. McGlynn, MCGLYNN & GLISSON, Baton Rouge, LA.
For Pliva, Inc., formerly known as Sidmak Laboratories, Inc., Defendant - Appellee: Matthew V. Brammer, Linda E. Maichl, Jeffrey Francis Peck, Joseph Paul Thomas, ULMER & BERNE, Cincinnati, OH; Michael D. Shumsky, KIRKLAND & ELLIS, Washington, DC; George Verschelden, STINSON & LEONARD, Kansas City, MO; Sandra J. Wunderlich, STINSON & LEONARD, Saint Louis, MO.
Before RILEY, Chief Judge, SMITH and KELLY, Circuit Judges.
RILEY, Chief Judge.
In this diversity case, see 28 U.S.C. § 1332(a)(1), Shirley Brinkley, a citizen of Blue Springs, Missouri, appeals the district court's prejudicial dismissal of her claims against Pliva, Inc. (Pliva), the New Jersey corporation that manufactured the prescription medication metoclopramide which Brinkley alleges injured her. We affirm.
In February 2002, Brinkley's doctor prescribed the brand-name drug Reglan to treat her gastroesophageal reflux disease. As allowed by Missouri law, see Mo. Rev. Stat. § 338.056, Brinkley's pharmacist substituted its generic equivalent, metoclopramide, manufactured by Pliva.
The Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq., requires manufacturers of generic metoclopramide like Pliva to prove to the U.S. Food and Drug Administration (FDA) their product was the " same as" Reglan in its design and labeling. 21 U.S.C. § 355(j)(2)(A)(ii)-(v);
see also Mut. Pharm. Co. v. Bartlett, 570 U.S. __, __, 133 S.Ct. 2466, 2475, 186 L.Ed.2d 607 (2013) (" [T]he FDCA requires a generic drug to have the same active ingredients, route of administration, dosage form, strength, and labeling as the brand-name drug on which it is based." ). Federal law does not allow manufacturers of generic drugs to alter the labeling because it " would inaccurately imply a therapeutic difference between the brand and generic drugs." Pliva, Inc. v. Mensing, 564 U.S.__,
__, 131 S.Ct. 2567, 2575-76, 180 L.Ed.2d 580 (2011). For the same reason, generic manufacturers are not permitted " to issue additional warnings through" letters to prescribing physicians and other healthcare workers.
In 2004, the FDA approved a request from Schwarz Pharma, Inc. (Schwarz), then the manufacturer of Reglan, to add two bolded statements to the Reglan label indicating usage should not ...