Shirley J. BELL, Plaintiff-Appellant v. PFIZER, INC.; Wyeth, LLC; Schwarz Pharma, Inc.; Pliva USA; Alaven Pharmaceutical, LLC, Defendants-Appellees.
No. 12-1674
United States Court of Appeals, Eighth Circuit
Submitted: Nov. 15, 2012. Filed: June 14, 2013.
Rehearing and Rehearing En Banc Denied July 23, 2013.
716 F.3d 1087
Here, by contrast, Ridout‘s evidence is not inconsistent with a reasonable inference of age discrimination; in fact it is entirely consistent with such an inference. See Maschka, 122 F.3d at 571. On such a record the ultimate question as to whether Ridout‘s termination was a result of unlawful discrimination is not one for summary judgment.
III.
For all these reasons, we reverse the grant of summary judgment and remand to the district court for further proceedings consistent with this opinion.
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, see
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. See
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),
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 609, 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 618, 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 625-26, 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
II. DISCUSSION
A. 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.”
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.”
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
We deny Bell‘s motion. Bell‘s district court brief is already part of the record we have reviewed. See
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. See
As noted by the district court, to prove her product liability claims under Arkansas law, Bell must show that a product manufactured or distributed by the brand defendants caused her injuries. See Chavers v. Gen. Motors Corp., 349 Ark. 550, 79 S.W.3d 361, 369-70 (2002); Jackson v. Anchor Packing Co., 994 F.2d 1295, 1303 (8th Cir. 1993) (observing “plaintiffs in Arkansas must introduce sufficient evi-
Bell acknowledges “it is necessary to establish proximate cause by way of product identification” with respect to her strict liability and breach of warranty claims, but maintains her “negligence, misrepresentation, suppression of evidence and fraud claims do not require product identification.” Bell provides no support under Arkansas law for the distinction she draws—a distinction that runs counter to the APLA‘s approach of treating all product liability actions consistently, regardless of the theory of recovery.
In fact, one of the cases on which Bell relies to attempt to show a negligence exception, Rogers v. Armstrong World Indus., Inc., 744 F.Supp. 901, 904 (E.D.Ark.1990), noted product identification was an element of strict products liability, breach of warranty, and negligence claims under Arkansas law. See id. at 904 (“[A]lthough the plaintiff relies on several theories of recovery, it is uncontroverted that under Arkansas law an essential element of each cause of action is that plaintiff‘s injuries were proximately caused by his exposure to the defendant‘s product.“). Bell‘s recitation of the elements of misrepresentation and fraud under Arkansas law fails to persuade us the Arkansas Supreme Court would create an exception to the Arkansas product identification requirement to allow Bell to hold the brand defendants liable for injuries caused by their competitor‘s generic products.
Even if we were to ignore Arkansas‘s product identification requirement, Bell has also failed to establish the brand defendants “owed her a duty of care necessary to trigger liability” under Arkansas law. Wyeth, 588 F.3d at 614 (applying Minnesota law). “As a general rule, a manufacturer has a duty to warn the ultimate user of the risks of its product.” West v. Searle & Co., 305 Ark. 33, 806 S.W.2d 608, 613 (1991). Bell, like the plaintiff in Wyeth, points to nothing in Arkansas law that supports extending such a duty of care to the customer of a competitor using a competing product. See Wyeth, 588 F.3d at 613-14 & n. 9.
Bell argues her injuries were foreseeable and the brand defendants should be liable for misrepresentations to Bell and her physician about the safety of metoclopramide. We rejected those arguments in Wyeth as insufficient to show a duty under Minnesota law. See id. (reasoning “[t]he manufacturers of Reglan intended to communicate with their customers, not the customers of their competitors” and concluding “holding name brand manufacturers liable for harm caused by generic manufacturers ‘stretch[es] the concept of foreseeability too far‘” (quoting Foster, 29 F.3d at 171)). Anticipating Arkansas law, we reach the same conclusion here. The dis-
D. Pliva
1. Hatch-Waxman Amendments and FDA Regulations
The labeling of prescription drugs is governed by the Federal Food, Drug, and Cosmetic Act (FDCA),
To obtain approval for a generic drug, the manufacturer generally must show the generic drug is “bioequivalent” to the brand name drug and has the same active ingredients, route of administration, dosage, and strength.
The federal labeling regulations also apply to letters providing “additional warnings to prescribing physicians and other healthcare professionals” (Dear Doctor letters), which must be “consistent with and not contrary to [the drug‘s] approved ... labeling.” Id. at 615, 131 S.Ct. at 2576 (quoting
2. Preemption
The Supremacy Clause of the United States Constitution establishes federal law as “the supreme Law of the Land.”
In Mensing, the Supreme Court found it impossible for Pliva and other generic manufacturers of metoclopramide “to com-
In light of the decision in Mensing, the district court permitted Bell to amend her complaint against Pliva. Bell‘s amended complaint again asserted claims for negligence; strict liability; breach of warranties; misrepresentation, suppression of evidence, and fraud; and gross negligence. 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,” the district court dismissed Bell‘s claims with prejudice.
Bell contends the district court erred in dismissing all of her claims based on impossibility preemption. According to Bell, “[i]t is clear from the [Mensing] Court‘s decision that the preemption found to exist applies only to allegations that a generic manufacturer should have unilaterally changed the content of its metoclopramide label“—leaving many of Bell‘s state law claims viable, including many of her failure to warn claims. In support, Bell relies on Bartlett v. Mut. Pharm. Co., 678 F.3d 30, 37-38 (1st Cir. 2012), cert. granted sub nom., Mut. Pharm. Co. v. Bartlett, 568 U.S. 1045, 133 S.Ct. 694, 184 L.Ed.2d 496 (2012), in which the First Circuit determined the FDCA did not preempt the plaintiff‘s design defect claim against the manufacturer of a generic drug. The First Circuit acknowledged some “tension not with the holding but with part of [Mensing‘s] rationale,” but determined Mensing was “a limited departure from a general no-preemption rule” as stated in Wyeth v. Levine, 555 U.S. 555, 129 S.Ct. 1187, 173 L.Ed.2d 51 (2009). Id. at 38 (acknowledging “the developing split in the lower courts” regarding Mensing‘s reach and stating “it is up to the Supreme Court to decide whether [Mensing‘s] exception is to be enlarged to include design defect claims“).2
In contrast to Bell‘s unduly narrow view of Mensing, Pliva broadly contends “[t]he only authority the district court needed to reach its conclusion ... was the Supreme Court‘s decision in Mensing.” Pliva contends the district court correctly determined Bell‘s claims are all “premised on a failure to warn” and thus barred by the preemption analysis in Mensing.
In challenging Bell‘s critique of the “ample authority” upon which the district court relied in dismissing Bell‘s claims, Pliva asserts the courts in the cited cases, like those in “the overwhelming decisions issued by courts around the country in [Mensing‘s] wake,” found claims similar to Bell‘s (1) preempted by Mensing, (2) failed to state a claim upon which relief could be granted, or (3) barred under applicable state law. See, e.g., Demahy v. Schwarz Pharma, Inc., 702 F.3d 177, 186 (5th Cir. 2012) (observing “[p]ost-Mensing ... a seeming majority of federal district courts to consider other state-law tort claims have found them to be preempted ... failure-to-warn claims under different names” and “other courts have specifically held ... design defect claims against generic metoclopramide manufacturers to be preempted based on Mensing“). Pliva contends the courts in those cases rejected the same arguments Bell makes here.
Yet that is precisely the analysis that is missing in this case. Because the district court construed Bell‘s claims as failure to warn claims, we do not have the benefit of the district court‘s analysis of whether Bell‘s non-warning design defect and breach of implied warranty claims adequately state viable claims under Arkansas law. Those questions are best addressed first in the district court. See Beckon, Inc. v. AMCO Ins. Co., 616 F.3d 812, 820 (8th Cir. 2010) (declining to affirm on alternative ground not considered by the trial court without expressing any opinion on the merits). We also leave for the district court to consider in the first instance whether Pliva has met its burden of establishing impossibility preemption or any other defense with respect to those claims. See Levine, 555 U.S. at 573, 129 S.Ct. 1187 (“Impossibility pre-emption is a demanding defense.“). We reverse the district court‘s dismissal of Bell‘s non-warning design defect and breach of implied warranty claims and remand for further consideration.
3. 2004 Label Change
In 2004, the FDA approved the brand name Reglan manufacturer‘s request to add 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. Bell alleges her claims that Pliva‘s failure caused her injuries “survive an impossibil-
The district court determined Bell did “not have a federal private cause of action” based on Pliva‘s failure to incorporate the 2004 brand name label change into its label in light of Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 353, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001) (holding state law “fraud-on-the-agency” claims are impliedly preempted by the FDCA). The district court further determined Pliva‘s failure to incorporate the label change did not vitiate Pliva‘s preemption defense because Arkansas adhered to the learned intermediary doctrine.
As adopted in Arkansas, the learned intermediary doctrine “provides an exception to the general rule that a manufacturer has a duty to warn the ultimate user of the risks of its products.” Kowalski v. Rose Drugs of Dardanelle, Inc., 2011 Ark. 44, 378 S.W.3d 109, 120 (2011). “[A] drug manufacturer may rely on the prescribing physician to warn the ultimate consumer of the risks of a prescription drug. The physician acts as the ‘learned intermediary’ between the manufacturer and the ultimate consumer.” Id. (quoting West, 806 S.W.2d at 613). In applying the doctrine to prescription drugs, the Arkansas Supreme Court explained (1) the patient relies on her physician‘s independent medical judgment that the drug is appropriate not on the manufacturer, (2) “it is virtually impossible in many cases for a manufacturer to directly warn each patient,” and (3) imposing “a duty to warn the user directly would interfere with the relationship between the doctor and the patient.” Id.
With respect to the relationship between the patient, the physician, and the pharmaceutical manufacturer,
the patient must look to the physician, for it is only the physician who can relate the propensities of the drug to the physical idiosyncracies of the patient. “It is the physician who is in the best position to decide when to use and how and when to inform his patient regarding risks and benefits pertaining to drug therapy.” W. Keeton, R. Keeton, & D. Owen, Prosser and Keeton on Torts § 96, at 688 (5th ed. 1984).
Id. (quoting McKee v. Am. Home Prods., Corp., 113 Wash.2d 701, 782 P.2d 1045, 1050-51 (1989) (en banc)).
In light of the circumstances in this case, the district court did not err in concluding Bell could not state a viable claim based upon Pliva‘s failure to incorporate the 2004 change into its label. “Under the learned intermediary doctrine, the manufacturer‘s failure to provide the physician with adequate warnings of the risks associated with a particular 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 warning should have communicated.‘” Ehlis v. Shire Richwood, Inc., 367 F.3d 1013, 1016 (8th Cir. 2004) (quoting Christopher v. Cutter Labs., 53 F.3d 1184, 1192 (11th Cir. 1995)).
Bell‘s physician prescribed Reglan—not generic metoclopramide manufactured by Pliva. Bell admits that in prescribing Reglan, her physician relied on information published in the brand defendants’ “package inserts and/or the Physicians’ Desk Reference ... or otherwise disseminated by” the brand defendants. “Thus, the causal link between [Bell‘s] injury” and Pliva‘s admitted failure to incorporate the
Because Bell‘s physician prescribed Reglan and relied on its labeling, there is nothing to indicate Pliva‘s failure to update its warning affected Bell‘s physician‘s prescribing decision or Bell‘s injury in any way. Because there is no causal link between Pliva‘s failure to incorporate the 2004 labeling change and Bell‘s injury, the district court‘s dismissal of that claim was not error, regardless of whether Mensing preempted that claim.
III. CONCLUSION
We affirm the district court‘s summary judgment in favor of the brand defendants and dismissal of Bell‘s claims based upon Pliva‘s alleged failure to warn and failure to incorporate the 2004 label change. We reverse the district court‘s prejudicial dismissal of Bell‘s non-warning design defect and breach of implied warranty claims and remand for further proceedings consistent with this opinion.
Bradley L. WINTERS, Petitioner-Appellant v. UNITED STATES of America, Respondent-Appellee.
No. 12-1992
United States Court of Appeals, Eighth Circuit.
Submitted: Jan. 17, 2013. Filed: June 17, 2013.
Rehearing and Rehearing En Banc Denied July 24, 2013. Rehearing Denied Aug. 12, 2013.
* Judge Colloton and Judge Kelly did not participate in the consideration or decision of this matter.