Bell v. Pfizer, Inc.

Citation716 F.3d 1087
Decision Date23 July 2013
Docket NumberNo. 12–1674.,12–1674.
PartiesShirley J. BELL, Plaintiff–Appellant v. PFIZER, INC.; Wyeth, LLC; Schwarz Pharma, Inc.; Pliva USA; Alaven Pharmaceutical, LLC, Defendants–Appellees.
CourtUnited States Courts of Appeals. United States Court of Appeals (8th Circuit)

OPINION TEXT STARTS HERE

Terrence J. Donahue, Jr., argued, Baton Rouge, LA, for appellant.

Henninger S. Bullock, argued, New York, NY, Kannon K. Shanmugam, Carl Summers, Washington, DC, Lyn P. Pruitt, Little Rock, AR, Andrew J. Calica, New York, NY, on the brief, for appellee Pfizer, et al.

Joseph P. Thomas, argued, Linda E. Maichl, Jeffrey F. Peck, on the brief, Cincinnati, OH, for appellee Pliva, Inc.

Before RILEY, Chief Judge, WOLLMAN and MELLOY, Circuit Judges.

RILEY, Chief Judge.

Shirley J. Bell, a resident of Monticello, Arkansas, alleges she was injured by the prescription medication metoclopramide, which is available in both generic forms and under the brand-name Reglan. Bell sued in federal court under our diversity jurisdiction, see28 U.S.C. § 1332(a)(1), alleging various causes of action against Pliva USA, the maker of the generic drug Bell took, and Wyeth, LLC (and its parent, Pfizer, Inc.), Schwarz Pharma, Inc., and Alaven Pharmaceutical, LLC (brand defendants), the makers of Reglan at different times. Bell appeals the district court's adverse grant of summary judgment to the brand defendants and dismissal of her claims against Pliva. We affirm in part, reverse in part, and remand for further consideration.

I. BACKGROUND

In January 2008, Bell's physician prescribed the brand name drug Reglan to treat Bell's abdominal pain and epigastric problems. As permitted by Arkansas law, Bell's pharmacist substituted generic metoclopramide manufactured by Pliva for the brand name Reglan prescribed by Bell's physician. SeeArk.Code Ann. § 17–92–503. Bell stipulated she only ingested generic metoclopramide and never took Reglan, and Bell does not claim to have taken any other product manufactured by the brand defendants. Bell continued to take metoclopramide as directed through December 2008.

Bell alleges she developed the neurological movement disorder tardive dyskinesia as a result of “long-term ingestion” of metoclopramide. In 2009, the United States Food and Drug Administration (FDA) required manufacturers of metoclopramide to change their label to include a black box warning about the risk of tardive dyskinesia from prolonged treatment. Bell faults the brand defendants and Pliva for not adequately informing her and her physician before 2009 of the known risks associated with long-term metoclopramide use.

On April 12, 2010, Bell filed this product liability action, asserting the following claims for relief against all defendants: negligence; strict liability; breach of warranties; misrepresentation, suppression of evidence, and fraud; and gross negligence.

On July 14, 2010, the brand defendants moved for summary judgment based on Bell's stipulation that she did not use their products. The district court granted the motion, concluding Bell could not maintain her claims under the Arkansas Product Liability Act of 1979 (APLA), Ark.Code Ann. § 16–116–101 et seq., which requires proof of product identification. Relying in part on Section III of our decision in Mensing v. Wyeth, Inc. ( Wyeth), 588 F.3d 603, 612–14 (8th Cir.2009)rev'd in part on other grounds sub nom. Pliva, Inc. v. Mensing (Mensing), 564 U.S. ––––, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011), the district court also determined the brand defendants did not owe Bell any duty under Arkansas common law.

After the district court's summary judgment order, the Supreme Court issued its opinion in Mensing. In Mensing, the Supreme Court held federal law preempted “state tort-law claims based on certain drug manufacturers' alleged failure to provide adequate warning labels for generic metoclopramide,” Mensing, 564 U.S. at ––––, 131 S.Ct. at 2572, because it was “impossible” for a generic manufacturer “to comply with both their state-law duty to change the label and their federal law duty to keep the label the same,” id. at ––––, 131 S.Ct. at 2578. The Supreme Court reversed our judgment in Wyeth, but did not analyze the liability of a brand name manufacturer under these circumstances. Id. at ––––, 131 S.Ct. at 2582. On remand, we reinstated Section III of our opinion in Wyeth, which addressed the claims against the brand name manufacturers. See Mensing v. Wyeth, Inc. ( Wyeth II), 658 F.3d 867 (8th Cir.2011).

Upon Bell's request, the district court permitted Bell to amend her complaint to address the impact of Mensing on her failure to warn claims against Pliva. On November 7, 2011, Pliva filed a motion to dismiss pursuant to Federal Rule of Civil Procedure 12. On February 16, 2012, the district court granted Pliva's motion to dismiss, finding “ample authority supporting [Pliva's] position that Bell's newly-styled allegations remain, in essence, failure-to-warn claims that are barred by Mensing. Bell appeals.

II. DISCUSSIONA. Standards of Review

We review de novo the district court's grant of summary judgment, viewing all evidence and drawing all reasonable inferences in favor of the nonmoving party. See Crawford v. Van Buren Cnty., Ark., 678 F.3d 666, 669 (8th Cir.2012). Summary judgment is required “if the movant shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed.R.Civ.P. 56(a).

We also review de novo the district court's grant of a motion to dismiss. See Murphy v. Aurora Loan Servs., LLC, 699 F.3d 1027, 1033 (8th Cir.2012). Dismissal is proper where the plaintiff's complaint fails “to state a claim upon which relief can be granted.” Fed.R.Civ.P. 12(b)(6). “As part of this review we assume all factual allegations in the pleadings are true and interpret them ‘in the light most favorable to the nonmoving party.’ Murphy, 699 F.3d at 1033 (quoting Cmty. Fin. Grp., Inc. v. Republic of Kenya, 663 F.3d 977, 980 (8th Cir.2011)). [W]e interpret Arkansas law in determining whether the elements of the offenses have been pled.” Ashley Cnty., Ark. v. Pfizer, Inc., 552 F.3d 659, 665 (8th Cir.2009) (quoting Moses.com Sec., Inc. v. Comprehensive Software Sys., Inc., 406 F.3d 1052, 1062 (8th Cir.2005)) (internal marks omitted).

B. Bell's Motion to Supplement the Record

Before oral argument, Bell moved this court to allow her to supplement the record with additional evidence she acquired from the FDA's “website identifying various marketing and promotional materials that manufacturers of generic drugs have used to provide physicians and consumers with information about their products.” Bell contends the additional evidence refutes Pliva's contention that “as a generic manufacturer it was prohibited by federal law from disseminating any labeling or information concerning its drug under any and all circumstances.” Bell also asks to supplement the record with her response to the brand defendants' motion for summary judgment to show she did not abandon certain claims.

We deny Bell's motion. Bell's district court brief is already part of the record we have reviewed. SeeFed. R.App. P. 10(a)(1) (explaining the record includes all “the original papers and exhibits filed in the district court). And we find no compelling reason to allow Bell to supplement the record with evidence available from the FDA long before the district court decided this case. SeeFed. R.App. P. 10(e); Dakota Indus., Inc. v. Dakota Sportswear, Inc., 988 F.2d 61, 63 (8th Cir.1993) (explaining our authority to enlarge the record when the interests of justice demand it, but noting we rarely exercise this narrow exception to the general rule that the appellate court only consider evidence contained in the record before the district court).

C. Brand Defendants

Although Bell admits she never ingested Reglan, Bell contends the brand defendants are liable for her injuries because the generic manufacturers copied the brand defendants' Reglan labeling. An “overwhelming majority of courts considering this issue,” including the Eighth Circuit, have rejected Bell's theory of liability. Wyeth, 588 F.3d at 613;see also Foster v. Am. Home Prods. Corp., 29 F.3d 165, 170 (4th Cir.1994) (“There is no legal precedent for using a name brand manufacturer's statements about its own product as a basis for liability for injuries caused by other manufacturers' products, over whose production the name brand manufacturer had no control.”).

In Wyeth, this court, applying Minnesota law to claims nearly identical to Bell's, determined the manufacturers of brand name Reglan were not liable to a plaintiff who never ingested their products because the plaintiff's connection, if any, to the brand name manufacturers was too attenuated. Wyeth, 588 F.3d at 613–14 & n. 9. In joining the majority of courts declining to hold “name brand manufacturers liable for injuries caused by their competitors,” id. at 613, we concluded the brand name manufacturers did not owe a duty of care to users of their competitor's generic products “necessary to trigger liability” under Minnesota law, id. at 614.Accord Foster, 29 F.3d at 171 (We think to impose a duty in the circumstances of this case would be to stretch the concept of foreseeability too far.”).

Arkansas law compels the same result. Bell's claims against the brand defendants are product liability actions under Arkansas law. SeeArk.Code Ann. § 16–116–102(5). Section 16–116–102(5) of APLA broadly defines “product liability action” to include “all actions brought for or on account of personal injury, death, or property damage caused by or resulting from the manufacture, construction, design, formula, preparation, assembly, testing, service, warning, instruction, marketing, packaging, or labeling of any product.” This broad language encompasses Bell's various claims regardless of her theory of recovery.

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