Shirley Bell v. Pfizer

United States Court of Appeals
For the Eighth Circuit
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No. 12-1674
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Shirley J. Bell
lllllllllllllllllllll Plaintiff - Appellant
v.
Pfizer, Inc.; Wyeth, LLC; Schwarz Pharma, Inc.;
Pliva USA; Alaven Pharmaceutical, LLC
lllllllllllllllllllll Defendants - Appellees
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Appeal from United States District Court
for the Eastern District of Arkansas - Pine Bluff
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Submitted: November 15, 2012
Filed: June 14, 2013
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Before RILEY, Chief Judge, WOLLMAN and MELLOY, Circuit Judges.
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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 28 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. See Ark. 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.
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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 (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.
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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.” 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
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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. See Fed. 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. See Fed. 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
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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 Ark. 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.
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., 79 S.W.3d 361,
369-70 (Ark. 2002); Jackson v. Anchor Packing Co., 994 F.2d 1295, 1303 (8th Cir.
1993) (observing “plaintiffs in Arkansas must introduce sufficient evidence to allow
a jury to find that more likely than not their exposure to a particular defendant’s
product was a substantial factor in producing their injuries”); Fields v. Wyeth, Inc.,
613 F. Supp.2d 1056, 1060 (W.D. Ark. 2009) (“A basic requirement of
products-liability actions under Arkansas law is product identification, i.e. that the
actual product manufactured or distributed by the defendant caused injury to the
plaintiff.”). Because Bell never used Reglan the brand defendants manufactured, Bell
cannot hold them liable under Arkansas law.1
1
Bell argues, for the first time on appeal, that the brand defendants qualify as
“manufacturers” of the metoclopramide Bell ingested because they are the exclusive
“designer” of the product and the labeling. See Ark. Code. Ann. § 16-116-102(3)
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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 (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., 806 S.W.2d 608, 613 (Ark. 1991). Bell,
(“‘Manufacturer’ means the designer, fabricator, producer, compounder, processor,
or assembler of any product or its component parts.”). Though we are skeptical of
Bell’s new theory, “[a]bsent exceptional circumstances,” not present here, “we cannot
consider issues not raised in the district court.” Shanklin v. Fitzgerald, 397 F.3d 596,
601 (8th Cir. 2005).
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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 Reglan manufacturers 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
district court did not err in determining Bell’s claims against the brand defendants
failed as a matter of law because Bell stipulated she had not ingested a product
manufactured by the brand defendants.
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), 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 Hatch-
Waxman 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.
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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)).
2. Preemption
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
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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-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
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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 design-
defect 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 non-
warning claims against Pliva, but need not delay our disposition of this appeal under
the circumstances.
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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.
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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 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 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.
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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
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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.
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.
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