Opinion ID: 902503
Heading Depth: 2
Heading Rank: 4

Heading: Pliva

Text: The labeling of prescription drugs is governed by the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq. “[A] manufacturer seeking federal approval to market a new drug must prove that it is safe and effective and that the proposed label is accurate and adequate.” Mensing, 564 U.S. at ___, 131 S. Ct. at 2574. In 1984, Congress amended the FDCA to allow manufacturers of generic drugs to obtain “FDA approval simply by showing equivalence to a reference listed drug that has already been approved by the FDA.” Id. at ___, 131 S. Ct. at 2574 (citing 21 U.S.C. § 355(j)(2)(A)). The amendments, commonly referred to as the HatchWaxman Amendments, permitted generic “manufacturers to develop generic drugs inexpensively, without duplicating the clinical trials already performed on the equivalent brand-name drug.” Id. at ___, 131 S. Ct. at 2574. -8- 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. 21 U.S.C. § 355(j)(2)(A). The generic manufacturer must also “‘show that the [safety and efficacy] labeling proposed . . . is the same as the labeling approved for the [brand-name] drug.’” Mensing, 564 U.S. at ___, 131 S. Ct. at 2574 (quoting 21 U.S.C. § 355(j)(2)(A)(v)) (alterations in Mensing). This federal duty of “sameness” regarding the warning label is “ongoing.” Id. at ___, 131 S. Ct. at 2575. FDA regulations permit “changes to generic drug labels only when a generic drug manufacturer changes its label to match an updated brand-name label or to follow the FDA’s instructions.” Id. at ___, 131 S. Ct. at 2575-76 (deferring to the FDA’s interpretation of its change process and regulations). 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 ___, 131 S. Ct. at 2576 (quoting 21 C.F.R. § 201.100(d)(1)) (alterations in Mensing). Letters containing “substantial new warning information would not be consistent with the drug’s approved labeling” and, if sent by the generic manufacturer but not the brand name manufacturer, “would inaccurately imply a therapeutic difference between the brand and generic drugs and thus could be impermissibly ‘misleading.’” Id. at ___, 131 S. Ct. at 2576 (quoting 21 C.F.R. § 314.150(b)(3)).
The Supremacy Clause of the United States Constitution establishes federal law as “the supreme Law of the Land.” U.S. Const., art. VI, cl. 2. State law that directly conflicts with federal law “must give way.” Mensing, 564 U.S. at ___, 131 S. Ct. at 2577. “[S]tate and federal law conflict where it is ‘impossible for a private party to -9- comply with both state and federal requirements.’” Id. at ___, 131 S. Ct. at 2577 (quoting Freightliner Corp. v. Myrick, 514 U.S. 280, 287 (1995)). In Mensing, the Supreme Court found it impossible for Pliva and other generic manufacturers of 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. As such, 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. In so holding, the Supreme Court rejected this court’s conclusions that the generic manufacturers could have satisfied their state law duties without violating federal law by (1) proposing a label change to the FDA that it could impose, (2) suggesting the FDA send a warning letter, or (3) by suspending sales of the product, Wyeth, 588 F.3d at 608-11. See Mensing, 564 U.S. at ___, 131 S. Ct. at 2576-77; Wyeth II, 658 F.3d at 867 (vacating the sections of our opinion in Wyeth addressing those issues); but see Mensing, 564 U.S. at ___, 131 S. Ct. at 2587 n.8 (Sotomayor, J., dissenting) (finding it unnecessary to consider whether generic manufacturers “could not show impossibility because federal law merely permitted them to sell generic drugs [but] did not require them to do so”). 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-towarn 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 -10- 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. ___, 133 S. Ct. 694 (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 (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. While we agree with the district court that the vast majority of Bell’s allegations in her amended complaint set forth preempted failure to warn claims, we are unable to conclude, at this point, that Bell’s design defect and breach of implied warranty claims, other than those based on an inadequate warning or labeling, are “in essence, 2 The First Circuit may have its wish. On November 30, 2012, the Supreme Court granted certiorari to determine whether federal law preempts “state law designdefect claims targeting generic pharmaceutical products.” See Mut. Pharm. Co., 568 U.S. at ___, 133 S. Ct. at 694. The answer to that question may affect Bell’s nonwarning claims against Pliva, but need not delay our disposition of this appeal under the circumstances. -11- failure-to-warn claims that are barred by Mensing.” Pliva asserts “the Mensing complaint raised the very same claims Ms. Bell asserts here—and more” and suggests the Supreme Court in Mensing categorically rejected all of Bell’s claims.3 But a key distinction exists between Mensing’s claims and Bell’s. Mensing did not contest the trial court’s characterization of her claims as asserting failure to warn claims “at the core.” Wyeth, 588 F.3d at 605. Bell does. At this stage, we must accept Bell’s allegations as true and construe them in her favor. See Murphy, 699 F.3d at 1033. 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. 3 Noting Mensing pled fourteen causes of action, including strict liability, negligent failure to warn, breach of warranty, misrepresentation, fraud, unfair trade practices, false advertising, and consumer fraud, Pliva points out the Supreme Court in Mensing stated “federal law preempts these lawsuits,” not just Mensing’s failure to warn claims. Mensing, 564 U.S. at ___, 131 S. Ct. at 2581. -12- 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 (“Impossibility pre-emption is a demanding defense.”). We reverse the district court’s dismissal of Bell’s nonwarning design defect and breach of implied warranty claims and remand for further consideration.
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 impossibility preemption analysis.” In support, Bell directs our attention to Fulgenzi v. PLIVA, Inc., 711 F.3d 578, 584 (6th Cir. 2013), in which the Sixth Circuit concluded Mensing did not preempt the plaintiff’s argument, under Ohio law, “that PLIVA’s warning was inadequate to the extent that it did not include the language contained in the updated Reglan label from 2004.” 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 (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. -13- 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., 378 S.W.3d 109, 120 (Ark. 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., 782 P.2d 1045, 1050-51 (Wash. 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 -14- 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 2004 label change, if any, was broken because Bell’s “‘prescribing physician had “substantially the same” knowledge as an adequate warning from the manufacturer should have communicated to him.’” Id. 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.