Brinkley v. Pfizer, Inc.

• Decision Date: 02 December 2014
• Docket Number: No. 13–3663.,13–3663.
• Citation: 772 F.3d 1133
• Parties: Shirley J. BRINKLEY, Plaintiff–Appellant v. PFIZER, INC.; Wyeth, LLC; Schwarz Pharma, Inc., Defendants Pliva, Inc., formerly known as Sidmak Laboratories, Inc., Defendant–Appellee.
• Court: U.S. Court of Appeals — Eighth Circuit

772 F.3d 1133

Shirley J. BRINKLEY, Plaintiff–Appellant

v. PFIZER, INC.; Wyeth, LLC; Schwarz Pharma, Inc., DefendantsPliva, Inc., formerly known as Sidmak Laboratories, Inc., Defendant–Appellee.

No. 13–3663.

United States Court of Appeals, Eighth Circuit.

Submitted: Sept. 8, 2014.

Filed: Dec. 2, 2014.

Rehearing and Rehearing En Banc Denied Jan. 6, 2015.^*

Louis M. Bograd, argued, Washington, D.C. (David Melville Peterson, Scott Bertram, Nicholas S. Clevenger, Benjamin A. Bertram, Thomas J. Preuss, Kansas City, MO, Daniel J. McGlynn, Terrence J. Donahue, Jr., Baton Rouge, LA, on the brief), for Appellant.

Michael D. Shumsky, argued, Washington, D.C. (Linda E. Maichl, Jeffrey F. Peck, Joseph P. Thomas, on the brief), for appellee.

Before RILEY, Chief Judge, SMITH and KELLY, Circuit Judges.

Opinion

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's¹ 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 exceed twelve weeks. Pliva did not implement the 2004 change in the label for its generic metoclopramide

products.

Between February 2002 and April 2007, Brinkley regularly ingested metoclopramide

as prescribed. Brinkley states her doctor, in deciding to prescribe Reglan, relied on statements the brand manufacturers made in the Physicians' Desk Reference (PDR)⁴ and package inserts that Reglan was safe and effective for longterm use. Brinkley alleges her use of metoclopramide caused her to develop tardive dyskinesia, a severe neurological disorder. Brinkley faults Pliva for defective design and failing adequately to warn of the risk of long-term use.

On March 25, 2010, Brinkley sued Schwarz, Pfizer, Inc., and Wyeth, LLC, the manufacturers of brand-name Reglan at various times (collectively, brand defendants), and Pliva, asserting various claims under Missouri law. On Pliva's motion, the district court stayed the proceedings pending a decision in Mensing. In Mensing, the Supreme Court found it impossible for Pliva, as a manufacturer of generic metoclopramide, “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 held federal law preempts “state tort-law claims based on certain drug manufacturers' alleged failure to provide adequate warning labels for generic metoclopramide.” Id. at ––––, 131 S.Ct. at 2572.

On August 30, 2011, Brinkley filed an amended complaint, asserting strict liability design defect, strict liability failure to warn, negligence, breach of express and implied warranties, and Missouri Merchandising Practices Act claims against Pliva and the brand defendants. Pliva answered and moved for judgment on the pleadings on preemption grounds. See Fed.R.Civ.P. 12(c). On April 12, 2012, the district court granted the motion, “fail[ing] to see how [Brinkley's] allegations differ[ed] from those in Mensing. ” The district court concluded Brinkley was “simply trying to backdoor claims against Pliva that the Supreme Court ha[s] found to be preempted.”⁵ On October 24, 2013, Brinkley and the brand defendants filed a joint motion to dismiss without prejudice, which the district court granted.

Brinkley appeals the judgment for Pliva, arguing the district court erred in dismissing her claims arising from Pliva's failure to incorporate the 2004 label change, a non-warning design defect, and breach of implied warranty.

II. DISCUSSION

A. Standard of Review

We review the grant of judgment on the pleadings de novo, viewing Brinkley's factual allegations as true and granting all reasonable inferences in her favor. See St. Jude Med. S.C., Inc. v. Cormier, 745 F.3d 325, 327 (8th Cir.2014). “Judgment on the pleadings is appropriate if there is no material issue of fact to be resolved and the moving party is entitled to judgment as a matter of law.” Buddy Bean Lumber Co. v. Axis Surplus Ins. Co., 715 F.3d 695, 697 (8th Cir.2013). We “can affirm on any basis supported in the record.” Spirtas Co. v. Nautilus Ins. Co., 715 F.3d 667, 670–71 (8th Cir.2013).

B. 2004 Label Change

Brinkley asserts Pliva is liable for failing adequately to warn her of the risks of long-term use of metoclopramide

. Conceding most of her failure to warn claims are preempted under Mensing, now on appeal, Brinkley limits her warning claims to Pliva's failure to update its label to include the brand-name Reglan manufacturer's 2004 label change indicating usage should not exceed twelve weeks. See, e.g., Fulgenzi v. PLIVA, Inc., 711 F.3d 578, 582, 584 (6th Cir.2013) (concluding Mensing did not preempt an Ohio claim that “PLIVA's warning was inadequate to the extent that it did not include the language contained in the updated Reglan label from 2004”). But see Morris v. PLIVA, Inc., 713 F.3d 774, 777 (5th Cir.2013) (per curiam) (“[I]t is logically incoherent to contend that PLIVA had a duty to apply the 2004 warning label when Appellants also assert repeatedly that no labels predating 2009 were adequate. Tort liability does not arise for failure to attach an inadequate label.”).

This is not the first time we have considered this claim. In Bell v. Pfizer, Inc., 716 F.3d 1087, 1097–98 (8th Cir.2013), and Fullington v. Pfizer, Inc., 720 F.3d 739, 747 (8th Cir.2013), we concluded the learned intermediary doctrine under Arkansas law vitiated nearly identical claims based on Pliva's failure to incorporate the 2004 label change. Missouri too “adhere [s] to the learned intermediary doctrine.” Doe v. Alpha Therapeutic Corp., 3 S.W.3d 404, 419 (Mo.Ct.App.1999) (citing Krug v. Sterling Drug, Inc., 416 S.W.2d 143, 146 (Mo.1967) ). Under that doctrine,

[t]he physician acts as a “learned intermediary” between the manufacturer and the patient and any warning given to the physician is deemed a warning to the patient. The learned intermediary doctrine provides that the failure of a drug manufacturer to provide the physician with an adequate warning of the risks associated with a prescription product is “not the proximate cause of a patient's injury if the prescribing physician had independent knowledge of the risk that the adequate warnings should have communicated.” Thus, the causal link between a patient's injury and the alleged failure to warn is broken when the prescribing physician had substantially the same knowledge as an adequate warning from the manufacturer that should have been communicated to him.

Id. at 419–20 (internal citations omitted) (quoting Christopher v. Cutter Labs., 53 F.3d 1184, 1192 (11th Cir.1995) ).

Applying these principles in Bell and Fullington, we concluded the prescribing physicians' exclusive reliance on information from the brand-name manufacturers broke any causal link between Pliva's failure to incorporate the label change and the plaintiffs' injuries. See Bell, 716 F.3d at 1097–98 ; Fullington, 720 F.3d at 747. Pliva urges the same result here. Like the plaintiffs in Bell and Fullington, Brinkley alleges her prescribing physician “relied upon information published in the package inserts and/or the Physicians' Desk Reference ... or otherwise disseminated by” the brand-name manufacturer. That reliance severs any causal tie Brinkley's injuries had to Pliva's failure to update its label.

Brinkley attempts to distinguish her case from Bell and Fullington and avoid the impact of Missouri's learned intermediary doctrine by asserting that, unlike Bell and Fullington, she “alleged that her prescribing physician was not aware of the 2004 warning against long-term use of metoclopramide

and, thus, that Pliva's failure to warn was the proximate cause of her injuries.” Brinkley's allegations take her claim out of the frying pan, into the fire.

Even if we assume Brinkley's allegations, liberally construed in her favor, fairly allege her prescribing physician was unaware of the risk of long-term metoclopramide use, Brinkley still has not pled a submissible case. See Winter v. Novartis Pharm. Corp., 739 F.3d 405, 408 (8th Cir.2014) (explaining under Missouri law, “[a] submissible case requires substantial evidence that the injury is a natural and probable consequence of the defendant's behavior”); Williams v. Daus, 114 S.W.3d 351, 358–59 (Mo.Ct.App.2003) (en banc) (same).

To recover for a failure to warn under [the learned intermediary] doctrine, a plaintiff

...