Court Opinion

ID: 4289965
Source: CourtListenerOpinion
Date Created: 2018-06-29 16:00:33.0567+00
Date Added: 2024-06-11T14:38:01.181341
License: Public Domain

RECOMMENDED FOR FULL-TEXT PUBLICATION
                               Pursuant to Sixth Circuit I.O.P. 32.1(b)
                                       File Name: 18a0128p.06

                    UNITED STATES COURT OF APPEALS
                                   FOR THE SIXTH CIRCUIT

 RITA MCDANIEL, Individually and as Personal              ┐
 Representative of the Estate of Johnny F. McDaniel,      │
 Deceased,                                                │
                                   Plaintiff-Appellant,   │      No. 17-5741
                                                           >
                                                          │
        v.                                                │
                                                          │
                                                          │
 UPSHER-SMITH LABORATORIES, INC.,                         │
                              Defendant-Appellee.         │
                                                          ┘

                          Appeal from the United States District Court
                       for the Western District of Tennessee at Memphis.
                    No. 2:16-cv-02604—Jon Phipps McCalla, District Judge.

                                     Argued: April 10, 2018

                                Decided and Filed: June 29, 2018

                Before: COLE, Chief Judge; SILER and COOK, Circuit Judges.
                                   _________________

                                           COUNSEL

ARGUED: Samuel C. Cole, COLE, EASLEY, SCIBA & WILLIAMS, Victoria, Texas, for
Appellant. Mark C. Hegarty, SHOOK, HARDY & BACON LLP, Kansas City, Missouri, for
Appellee. ON BRIEF: E. Kirk Wood, Jr., WOOD LAW FIRM, LLC, Birmingham, Alabama,
for Appellant. Eric E. Hudson, Kyle R. Cummins, BUTLER SNOW LLP, Memphis, Tennessee,
for Appellee.

        COOK, J., delivered the opinion of the court in which SILER, J., joined, and COLE, C.J.,
joined in part. COLE, C.J. (pp. 10–13), delivered a separate opinion concurring in part and
dissenting from Part II.B. of the majority opinion.
 No. 17-5741              McDaniel v. Upsher-Smith Laboratories, Inc.                    Page 2

                                        _________________

                                             OPINION
                                        _________________

       COOK, Circuit Judge.         Rita McDaniel’s husband died after taking a course of a
prescription drug manufactured by Upsher-Smith Laboratories, Inc. She sued, alleging that
Upsher-Smith’s failure to ensure that a Medication Guide accompanied the prescription led to
her husband ingesting—and dying because of—a drug that wasn’t meant for him. We are tasked
with deciding whether the Federal Food, Drug, and Cosmetic Act (“FDCA”) impliedly preempts
McDaniel’s Tennessee failure-to-warn claims premised solely on Upsher-Smith’s failure to
provide the Medication Guide as required by FDA regulations. It does. We AFFIRM.

                                                  I.

                                                  A.

       We take as true the well-pleaded allegations in McDaniel’s complaint and summarize
them as follows. See Stein v. HHGREGG, Inc., 873 F.3d 523, 528 (6th Cir. 2017).

       Upsher-Smith manufactures a generic form of the prescription drug amiodarone
hydrochloride (“amiodarone”). The FDA approved amiodarone in its brand-name formulation as
a drug of last resort for patients suffering from ventricular fibrillation and ventricular
tachycardia, both life-threatening heartbeat irregularities.

       As a generic manufacturer of amiodarone, Upsher-Smith has an ongoing duty to ensure
that it includes the same labeling approved for its brand-name counterpart. See 21 U.S.C.
§ 355(j)(2)(A)(v). One of those labeling requirements is to make “Medication Guides” available
for distribution to each patient with each prescription, by providing them—or the means to
produce them—to distributors, packers, or authorized dispensers of the drug.          21 C.F.R.
§ 208.24(b). Medication Guides explain the approved uses of a drug and its side effects to a
patient “in nontechnical, understandable language” that is clearly presented in at least 10-point
font. See id. § 208.20.
 No. 17-5741            McDaniel v. Upsher-Smith Laboratories, Inc.                       Page 3

       The Medication Guide for amiodarone warns patients that the drug “should only be used
in adults with life-threatening heartbeat problems called ventricular arrhythmias.” Lung damage
is listed as a “serious side effect” of taking the drug, along with related symptoms such as
shortness of breath and wheezing. Because “the medicine stays in your body for months after
treatment is stopped,” these adverse effects may continue even after ceasing treatment.

                                               B.

       Rita McDaniel, Johnny’s widow, sued Upsher-Smith on behalf of her late husband’s
estate. In general, she alleges that her husband died in July 2015 because he had been taking
amiodarone. More specifically, Johnny’s doctor prescribed him a course of amiodarone to treat
his non-life threatening atrial fibrillation. Johnny apparently did not receive the corresponding
Medication Guide when he filled his prescriptions in May and June 2015 because Upsher-Smith
neglected to ensure its availability. Thus, he was unaware that only adults with life-threatening
heartbeat problems who had unsuccessfully sought alternative treatments should take the drug.

       McDaniel sued on multiple theories, but only her Tennessee strict-liability failure-to-
warn, negligent failure-to-warn, and negligence-per-se claims are before us. The failure-to-warn
claims are premised solely on Upsher-Smith’s failure to provide a Medication Guide. Upsher-
Smith moved to dismiss for failure to state a claim under Federal Rule of Civil Procedure
12(b)(6). The district court granted Upsher-Smith’s motion and dismissed the failure-to-warn
claims with prejudice, holding that they were impliedly preempted under the FDCA. The court
explained that McDaniel failed to cite any Tennessee duty paralleling the federal duty to provide
a Medication Guide. Said differently, the claims would not exist in the absence of the FDCA.

                                               II.

                                               A.

       We review de novo the district court’s dismissal on federal preemption grounds.
Fulgenzi v. PLIVA, Inc., 711 F.3d 578, 583 (6th Cir. 2013).

       When state and federal laws clash, federal law reigns supreme and state law is preempted.
U.S. Const., art. VI, cl. 2. “State-law claims can be preempted expressly in a federal statute or
 No. 17-5741             McDaniel v. Upsher-Smith Laboratories, Inc.                       Page 4

regulation, or impliedly, where congressional intent to preempt state law is inferred.” Yates v.
Ortho-McNeil-Janssen Pharm., Inc., 808 F.3d 281, 293 (6th Cir. 2015). In the absence of an
express preemption statute, as here, federal law may impliedly preempt state law to the extent the
two laws conflict. Fid. Fed. Sav. & Loan Ass’n v. de la Cuesta, 458 U.S. 141, 153 (1982). This
type of implied preemption, known as conflict preemption, comes in two forms—impossibility
and obstacle preemption. State Farm Bank v. Reardon, 539 F.3d 336, 342 (6th Cir. 2008).
Impossibility preemption exists when compliance with both federal and state law is impossible.
Gade v. Nat’l Solid Wastes Mgmt. Ass’n, 505 U.S. 88, 98 (1992); Florida Lime & Avocado
Growers, Inc. v. Paul, 373 U.S. 132, 142–43 (1963). Obstacle preemption exists when state law
serves as an obstacle to the purposes and objectives embodied in a federal law. Gade, 505 U.S.
at 98; Hines v. Davidowitz, 312 U.S. 52, 67 (1941).

                                                B.

       McDaniel’s failure-to-warn claims based on Upsher-Smith’s alleged failure to provide a
Medication Guide are impliedly preempted. Except in circumstances not relevant here, “all such
proceedings for the enforcement, or to restrain violations, of [the FDCA] shall be by and in the
name of the United States.” 21 U.S.C. § 337(a). “The FDCA leaves no doubt that it is the
Federal Government rather than private litigants who are authorized to file suit for
noncompliance . . . .” Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 349 n.4 (2001).

       In alleging a failure to warn, McDaniel does not “rely[] on traditional state tort law which
had predated the federal enactments in question[]. On the contrary, the existence of these federal
enactments is a critical element in [her] case.” Id. at 353. McDaniel seeks to enforce the federal
regulation requiring drug manufacturers to ensure the availability of Medication Guides for
distribution to patients. See 21 C.F.R. § 208.24. Her complaint makes this eminently clear. For
instance, she asserts:

       The failure to provide each patient a “Medication Guide” by failing to provide the
       Medication Guides to the distributor for ultimate distribution to the patient with
       the drug is a direct violation of the FDA’s mandate to the manufacturers of the
       drug intended to warn patients directly outside the communication with the
       prescribing physician, of the very dangers of amiodarone toxicity that injured
       Johnny McDaniel.
 No. 17-5741             McDaniel v. Upsher-Smith Laboratories, Inc.                       Page 5

Other parts of the complaint similarly demonstrate that the existence of the Medication Guide
regulation is a “critical element” in McDaniel’s suit. Here are just a few:

       •   The Defendant manufacturer, Upsher-Smith, was responsible by federal
           regulation for ensuring that the appropriate warning labels and Medication
           Guides were provided to McDaniel. Had the Medication Guide been provided
           by Upsher-Smith to the distributor or his pharmacists for distribution to him as
           required by FDA regulations, McDaniel . . . would not have taken
           amiodarone[.]
       •   Because his distributors and pharmacists were not provided a Medication
           Guide to give directly to him outside of his doctor’s office and interaction as
           required by FDA regulations by the Defendant manufacturer, McDaniel did
           not know “the medicine stays in your body for months after treatment is
           stopped.”
       •   McDaniel did not receive a Medication Guide because the Defendant Upsher-
           Smith did not provide the Medication Guide to the distributors for distribution
           to him by his pharmacists as required by the FDA and did not ensure that the
           Medication Guide was distributed to McDaniel.

       McDaniel’s opposition to Upsher-Smith’s motion to dismiss further underscores that this
litigation is strictly about Upsher-Smith’s compliance with federal regulations that are
enforceable only by the Federal Government. She insisted that her “failure-to-warn claims [are]
based on Upsher-Smith’s failure to provide the FDA required Medication Guide to Johnny” and
that “[t]he Medication Guide that Johnny did not receive was required by federal law to be
provided to” him. What’s more, McDaniel explicitly disclaimed the argument that her failure-to-
warn claims stem from inadequate content. She described her complaint as alleging that Upsher-
Smith “failed to actually and physically provide for the appropriate distribution of federally
mandated warnings in the form of the Medication Guide.” Then she doubled down on her
reliance on the FDA’s regulations: “The allegation is not one of adequacy or ‘content’ failure to
warn, (i.e., the verbiage or even the format fails), but an actual and physical negligent failure of
Upsher-Smith to fulfill its federally mandated responsibility to ensure Medication Guides are
available for distribution directly to patients with each prescription.”

       McDaniel cannot salvage her appeal by hanging her hat on a generic duty to warn under
Tennessee law. Cf. Loreto v. Procter & Gamble Co., 515 F. App’x 576, 579 (6th Cir. 2013)
(“The [FDCA’s] public enforcement mechanism is thwarted if savvy plaintiffs can label as
 No. 17-5741                 McDaniel v. Upsher-Smith Laboratories, Inc.                                   Page 6

arising under a state law for which there exists a private enforcement mechanism a claim that in
substance seeks to enforce the FDCA.”). McDaniel’s failure-to-warn claims are governed by the
Tennessee Products Liability Act of 1978 (“TPLA”). Tenn. Code Ann. § 29-28-102(6) (defining
all actions based upon theories of strict liability or negligence as a “[p]roduct liability action”
subject to the TPLA). Under the TPLA (which McDaniel neither references in her complaint nor
discusses in her briefing before us or the district court), “[a] manufacturer or seller of a product
in Tennessee ‘shall not be liable for any injury to a person or property caused by the product
unless the product is determined to be in a defective condition or unreasonably dangerous at the
time it left the control of the manufacturer or seller.’” Strayhorn v. Wyeth Pharm., Inc., 737 F.3d
378, 392 (6th Cir. 2013) (quoting Tenn. Code Ann. § 29-28-105(a)). True, Cansler v. Grove
Manufacturing Co. explained that, under Tennessee law, “[a] product may also be considered
defective or unreasonably dangerous if the manufacturer failed to provide adequate warnings
informing users of dangers involved in using the product.” 826 F.2d 1507, 1510 (6th Cir. 1987).
The Cansler plaintiff sought to show that a crane “was defective or unreasonably dangerous
because the warnings concerning the dangers . . . were inadequate to apprise” him of “the nature
and extent of the danger.” Id. at 1509. But this is of no help to McDaniel, who has pleaded that
the “adequacy” of warnings to her husband is not the issue; the issue is Upsher-Smith’s alleged
failure to ensure the Medication Guide’s availability for distribution. The TPLA does not create
a parallel duty to provide a Medication Guide.

         McDaniel finds little support in other failure-to-warn-via-Medication-Guide caselaw.
That’s because the majority of the district courts to consider this very issue have found identical
claims preempted. See Moore v. Zydus Pharm. (USA), Inc., 277 F. Supp. 3d 873, 881 (E.D. Ky.
2017) (“Since Ms. Moore’s claim concerning receipt of the medication guide exists exclusively
due to the federal regulatory scheme, her claim must fail as the cause of action is merely based
upon alleged violation of the FDCA . . . .”);1 Bean v. Upsher-Smith Pharm., Inc., No. 4:16-cv-
01696-RBH, 2017 WL 4348330, at *6–7 (D.S.C. Sept. 29, 2017) (“Because the requirement to

         1The   Moore plaintiff made the same unavailing argument in opposition to that motion to dismiss as
McDaniel—that “the allegation is not one of an adequacy or ‘content’ failure to warn . . . but an actual and physical
negligent failure of Zydus to fulfill its federally-mandated responsibility to ensure that Medication Guides are
available for distribution.” 277 F. Supp. 3d at 880.
 No. 17-5741                 McDaniel v. Upsher-Smith Laboratories, Inc.                                    Page 7

provide a Medication Guide to distributors is based solely in the requirements of the FDCA and
related regulations, and there is no parallel duty to provide a Medication Guide under South
Carolina law, Plaintiff’s claims based upon failure to provide a Medication Guide are preempted
under Buckman.”), appeal docketed, No. 17-2263 (4th Cir. Oct. 27, 2017); Elliott v. Sandoz, Inc.,
No. 2:16-cv-00861-RDP, 2016 WL 4398407, at *5–6 (N.D. Ala. Aug. 18, 2016) (holding
“Plaintiff’s claim that Defendant was negligent for failing to provide Medication Guides to
Decedent is preempted by [FDCA §] 337(a)”); Allain v. Wyeth Pharm., Inc., No. 2:14-cv-00280-
KOB, 2015 WL 3948961, at *8–9 (N.D. Ala. June 29, 2015) (finding preempted the plaintiff’s
claim that defendants failed to provide Medication Guides to plaintiff’s pharmacy); see also
Caughron v. Upsher-Smith Labs., Inc., No. 3:17-cv-21-DPM, 2017 WL 3015606, at *1 (E.D.
Ark. July 5, 2017) (“Any claim based on failure to provide the medication guide to Mr.
Caughron is preempted. 21 C.F.R. § 208.24(b) & (c).”).2

         The best support McDaniel marshals is Fulgenzi v. PLIVA, Inc.                         Unfortunately for
McDaniel, that case does not compel us to reverse. In Fulgenzi, the generic-drug manufacturer
PLIVA never updated its metoclopramide labeling to include the warning newly added to
Schwarz Pharma’s branded equivalent Reglan. 711 F.3d at 580. Fulgenzi’s plaintiff alleged that
PLIVA’s failure to update its labeling violated the federal duty of sameness required of branded-
and generic-drug labeling and “rendered its warnings inadequate under Ohio law.” Id. at 581–
82. The court held that her Ohio tort claim was not preempted because “[h]er suit instead
relie[d] upon the adequacy of the warnings and the causation of her injuries” instead of the
“[f]ailure to update from one adequate warning to another.” Id. at 587. Plus, “[o]n the merits,
whether PLIVA ha[d] violated its federal duties [was] irrelevant to the adequacy of its
warnings.” Id.

         But here, as explained above, adequacy of the warnings is not the issue. Rather, it is
Upsher-Smith’s alleged failure to ensure the amiodarone Medication Guide’s availability for
distribution—the failure to comply with a federal regulation that only the Federal Government

         2Although    the overwhelming weight of authority on this question tips the scales toward preemption, we
recognize that it is not unanimous. See, e.g., Marvin v. Zydus Pharm. (USA) Inc., 203 F. Supp. 3d 985, 989 (W.D.
Wisc. 2016) (“Plaintiffs’ claim is a tort law claim based on defendant’s alleged failure to warn, rather than fraud on
a federal agency. Accordingly, the claim is not subject to implied preemption under Buckman.”).
 No. 17-5741             McDaniel v. Upsher-Smith Laboratories, Inc.                          Page 8

may enforce—that is the ballast steadying McDaniel’s claim. In other words, whereas “[t]he
federal duty of sameness [was] not ‘a critical element’ in Fulgenzi’s case,” id. (quoting
Buckman, 531 U.S. at 353), the federal duty of ensuring that Medication Guides are available for
distribution to a patient is the only element of McDaniel’s failure-to-warn claims.

       McDaniel insists that she, like the Fulgenzi plaintiff, alleged a federal-law violation
strictly to avoid impossibility preemption under PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011).
See Fulgenzi, 711 F.3d at 587. We are not persuaded. In Mensing, patients who had taken
generic metoclopramide and developed tardive dyskinesia sued the generic manufacturers for
failing to update the warning labels to adequately advise of the medication’s risks. 564 U.S. at
610. They claimed that state tort law obligated these manufacturers to use a stronger label. Id. at
617. But FDA regulations require sameness between the warning labels of a brand-name drug
and its generic counterpart. Id. at 613; 21 C.F.R. §§ 314.94(a)(8), 314.127(a)(7). The generic
manufacturers were in a bind. If they strengthened the label to satisfy state law, they’d run afoul
of their federal duty of sameness; if they retained the label to satisfy federal law, they’d fall short
of their state-law duty to provide adequate labeling. 564 U.S. at 618. Finding it impossible for
the generic manufacturers to comply with state and federal law, the Supreme Court held that
state law must give way and the tort claims were preempted. Id. at 618, 624.

       This case is not like Mensing. There, the plaintiffs alleged that the warning labels were
inadequate because they did not disclose the mounting evidence of elevated tardive dyskinesia
risks associated with long-term metoclopramide use. Here, McDaniel claims that her husband
did not receive the Medication Guide with his amiodarone prescription. The adequacy of
warnings is not the issue—McDaniel has told us so.

       And McDaniel’s contention that she alleged a violation of FDA regulations only to guard
against dismissal on impossibility preemption grounds is a red herring. Whereas the Fulgenzi
plaintiff’s claim of inadequate labeling did not depend on PLIVA violating its federal duties,
711 F.3d at 587, McDaniel is suing Upsher-Smith because its alleged conduct violates the
federal Medication Guide regulations. Cf. id. at 588 (acknowledging that Buckman applies
where an “element of the claim is premised on a federal-law violation”). How do we know that
these FDA regulations are essential to her claims?          Again, we need look no further than
 No. 17-5741              McDaniel v. Upsher-Smith Laboratories, Inc.                             Page 9

McDaniel’s own words: she alleges “an actual and physical negligent failure of Upsher-Smith to
fulfill its federally mandated responsibility to ensure Medication Guides are available for
distribution directly to patients with each prescription.” We won’t ignore the language of
McDaniel’s allegations simply so that we may shoehorn her claims into Fulgenzi’s realm.

        So, in our words, the existence of the FDA regulations requiring a manufacturer to ensure
the availability of Medication Guides for distribution to patients is critical to McDaniel’s case.
See Buckman, 531 U.S. at 353. Because McDaniel’s failure-to-warn claims “would exert an
extraneous pull on the scheme established by Congress,” id., they are therefore impliedly
preempted by the FDCA, see 21 U.S.C. § 337(a).3

                                                    C.

        We do not, however, address whether the FDCA impliedly preempts a claim under the
doctrine of negligence per se. Under this doctrine, McDaniel seeks to rely on Upsher-Smith’s
violation of the Medication Guide regulations and a state misbranding statute to establish a duty
of care and a breach of that duty. We conclude that McDaniel waived the right to do so under
Tennessee law.

        Although the negligence per se doctrine does not create a new cause of action, a plaintiff
must nonetheless plead a separate claim for negligence per se under Tennessee law. See Messer
Griesheim Indus., Inc. v. Eastman Chem. Co., 194 S.W.3d 466, 482–83 (Tenn. Ct. App. 2005).
In her complaint, McDaniel pleads a separate claim for negligence per se, but only in support of
an off-label promotion claim. The district court viewed it as such in dismissing the claim, and
McDaniel does not challenge the dismissal of her off-label promotion claim on appeal. Nor did
McDaniel argue sufficiently in support of the doctrine in her briefing below. As we have often
repeated, “an argument not raised before the district court is waived on appeal to this Court.”
Scottsdale Ins. Co. v. Flowers, 513 F.3d 546, 552 (6th Cir. 2008).

                                                   III.

        We AFFIRM.
        3Because    our ruling rests on preemption, we decline to address the effect of Tennessee’s learned
intermediary doctrine on the issues presented.
 No. 17-5741             McDaniel v. Upsher-Smith Laboratories, Inc.                    Page 10

               ________________________________________________________

                   CONCURRING IN PART AND DISSENTING IN PART
               ________________________________________________________

         COLE, Chief Judge, concurring in part and dissenting in part. We are obligated to
consider the words in a complaint. At this stage, they are all that we may consider. In re
Omnicare, Inc. Sec. Litig., 769 F.3d 455, 466 (6th Cir. 2014). McDaniel states in her complaint
that Upsher-Smith failed to provide “sufficient instructions or warnings” of the “potential risks
and side effects of amiodarone” by “failing to ensure [her late husband] was timely provided the
Medication Guide.” Compl., R.1, ¶¶ 91, 94. In my view, these words mean what they say—that
the failure to provide a medication guide rendered the warnings that were provided inadequate.
The majority contends otherwise, concluding that the “adequacy of the warnings is not the
issue.” Maj. Op. 7. By doing so, it distinguishes Fulgenzi v. PLIVA, Inc., 711 F.3d 578 (6th Cir.
2013).

         I respectfully dissent from Part II.B of the majority’s opinion and conclude that we are
bound by Fulgenzi to hold that the Food, Drug and Cosmetic Act (“FDCA”) does not impliedly
preempt McDaniel’s Tennessee failure-to-warn claims under theories of strict liability and
negligence. However, I agree with the majority that McDaniel has waived the right to rely on
the doctrine of negligence per se under Tennessee law.

                                                I.

         The crux of McDaniel’s Tennessee claims is straightforward: Upsher-Smith failed to
provide a medication guide to her late husband, and that failure rendered inadequate the
warnings of amiodarone’s potential risks and side effects it did provide and caused her late
husband’s death.

         Implied preemption leaves open a narrow gap for state failure-to-warn claims against
generic drug manufacturers that resides between its two forms—impossibility and obstacle
preemption.     The claim must be premised on conduct that violates the FDCA to avoid
impossibility preemption. PLIVA, Inc. v. Mensing, 564 U.S. 604, 618–19 (2011). This is so
because the FDCA requires a generic drug to have the same warnings as its brand-name
 No. 17-5741             McDaniel v. Upsher-Smith Laboratories, Inc.                      Page 11

counterpart (under the federal duty of sameness), so that simultaneous compliance with any state
duty to supply different warnings would be impossible. Id. At the same time, to avoid obstacle
preemption, the violation of the FDCA cannot be “a critical element” of the claim. Buckman Co.
v. Plaintiffs' Legal Comm., 531 U.S. 341, 353 (2001).

       That narrow gap was successfully threaded in Fulgenzi. There, as here, the plaintiff
brought a state claim against a generic drug manufacturer for its alleged failure to adequately
warn of a drug’s risks. Id. at 579–80. The claim differed only insofar as the plaintiff alleged that
the failure to update the contents of the drug’s labeling—and not the failure to supply a separate
medication guide—rendered the warnings inadequate. Id. As with all failure-to-warn claims
against generic drug manufacturers, the plaintiff could argue that the warnings were inadequate
only to the extent that they failed to conform to the warnings provided by the brand-name
manufacturer in violation of the federal duty of sameness. Id. at 584–85. We held that the
plaintiff’s claim was not preempted because the generic drug manufacturer’s violation of the
federal duty of sameness, although alleged in the complaint, was not a necessary (and thus not a
critical) element of her claim under Ohio law. Id. at 581–82, 587 & n.5.

       McDaniel’s Tennessee failure-to-warn claims are no different. In her complaint, she
alleges that Upsher-Smith violated the federal duty of sameness by failing to provide warnings in
the form of a medication guide. But she cannot be faulted for doing so. The plaintiff in Fulgenzi
made the same allegation—the only difference being the means of violating the duty. Id. at 581–
82. And that same allegation in McDaniel’s complaint is “essential to her case—but only to
avoid [impossibility] preemption under Mensing.” Id. at 587. That is because McDaniel must
discuss federal law to show why her claims are not barred by impossibility preemption. See
Mensing 564 U.S. at 618–19.         It does not mean that she “seeks to enforce . . . federal
regulation[s].” Maj. Op. 4.

       McDaniel’s claims are premised on a violation of an independent Tennessee duty to
warn, not federal law. “The alleged breach arises from the same act”—namely, the failure to
provide a medication guide. Fulgenzi, 711 F.3d at 587. Indeed, it must arise from the same act
to avoid impossibility preemption. See Mensing, 564 U.S. at 618–19. “[B]ut the legal basis is
different.” Fulgenzi, 711 F.3d at 587. McDaniel’s claims depend on whether the warnings
 No. 17-5741             McDaniel v. Upsher-Smith Laboratories, Inc.                       Page 12

provided were inadequate and proximately caused her late husband’s death. See id. at 587;
Barnes v. Kerr Corp., 418 F.3d 583, 590 (6th Cir. 2005) (listing elements of Tennessee failure-
to-warn claims). Because the fact of a federal-law violation is not a necessary element of those
claims, they are not subject to obstacle preemption under Buckman. Fulgenzi, 711 F.3d at 587 &
n.5.

       When faced with an apparent conflict between the words in a complaint and a brief
responding to a motion to dismiss, we are obligated to choose the former. It is, after all, the
sufficiency of the allegations in the complaint that we are evaluating. See Fed. R. Civ. P.
12(b)(6). The majority focuses on a singular remark in McDaniel’s briefing that “[t]he allegation
is not one of adequacy or ‘content’ failure to warn, (i.e., the verbiage or even the format fails),
but an actual and physical negligent failure of Upsher-Smith to fulfill its federally mandated
responsibility to ensure Medications Guides [sic] are available for distribution directly to patients
with each prescription.” R. 23, PageID 111. The majority interprets that statement to mean that,
unlike in Fulgenzi, McDaniel “pleaded that the ‘adequacy’ of warnings . . . is not the issue.”
Maj. Op. 6.

       The complaint tells us that McDaniel pleaded precisely the opposite: “The warnings and
directions provided with amiodarone by [Upsher-Smith] failed adequately to warn of the
potential risks and side effects of amiodarone.” Compl., R. 1, ¶¶ 91, 98. And context tells us
that the purported concession in the brief was meant to explain why the claim is not barred by
impossibility preemption—clarifying in the same section that what she meant is that she “does
not allege that the contents of the labeling should have been changed” in violation of the federal
duty of sameness, only that a separate “Medication Guide and its warnings were not provided to
him in accordance” with that duty. R. 23, PageID 113. Indeed, it necessarily follows that
McDaniel’s claims challenge the adequacy of the warnings that were provided, alleging as they
do that a death would not have occurred but for the failure to provide additional warnings in the
form of a medication guide.
 No. 17-5741             McDaniel v. Upsher-Smith Laboratories, Inc.                     Page 13

                                                II.

       Tennessee’s learned intermediary doctrine does not bar McDaniel’s claims. Under this
doctrine, Upsher-Smith argues that its duty to warn under Tennessee law extended only to her
husband’s prescribing physician. And this would mean that McDaniel’s claims are barred, either
because (1) there is no Tennessee duty paralleling the federal duty to provide a medication guide,
or (2) she fails to allege that the prescribing physician was inadequately warned.

       Upsher-Smith cannot dispense with its duty to warn McDaniel’s late husband of
amiodarone’s risks. Under Tennessee law, the learned intermediary doctrine “constitutes a
defense,” rather than a common-law rule delineating to whom a manufacturer owes the duty to
warn. See Nye v. Bayer Cropscience, Inc., 347 S.W.3d 686, 701 (Tenn. 2011). When the
defense is invoked, “a pharmaceutical manufacturer can discharge its duty to warn by providing
the physician with adequate warnings of the drug’s risks.” Id. This defense, however, does not
eliminate Upsher-Smith’s “continuing duty to warn the users” of its prescription drugs. See
Payne v. Novartis Pharm. Corp., 767 F.3d 526, 530 (6th Cir. 2014) (interpreting Tennessee law).
Adequately warning a physician is simply one means of discharging that duty.

       Dismissal under this defense would be premature at this juncture. A plaintiff is not
required to plead around all potential defenses. Xechem, Inc. v. Bristol-Myers Squibb Co.,
372 F.3d 899, 901 (7th Cir. 2004). Only when a plaintiff “admits all the ingredients of an
impenetrable defense” may a complaint that otherwise states a claim be dismissed. Id. As
Upsher-Smith points out, McDaniel does not allege that her husband’s physician was unaware of
the risk of lung damage associated with amiodarone. But she also does not allege that his
physician was aware of that risk. Discovery is the proper vehicle to explore those factual issues.

       At this stage, it is enough that McDaniel has pleaded a plausible claim to relief that is
neither precluded by the learned intermediary doctrine nor preempted by the FDCA.