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Brinkley v. Pfizer, Inc.

United States Court of Appeals, Eighth Circuit

December 2, 2014

Shirley J. Brinkley, Plaintiff - Appellant
v.
Pfizer, Inc.; Wyeth, LLC; Schwarz Pharma, Inc., Defendants, Pliva, Inc., formerly known as Sidmak Laboratories, Inc., Defendant - Appellee

Submitted September 8, 2014.

Page 1134

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.

OPINION

Page 1135

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[1] prejudicial dismissal of her claims against Pliva, Inc. (Pliva), the New Jersey corporation that manufactured the prescription medication metoclopramide which Brinkley alleges injured her.[2] We affirm.[3]

I. BACKGROUND

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. Id.

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 ...


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