Joyce Walsh, et al., Appellants,

This opinion is nonprecedential except as provided by
Minn. R. Civ. App. P. 136.01, subd. 1(c).

STATE OF MINNESOTA
IN COURT OF APPEALS
A23-0060

Joyce Walsh, et al.,
Appellants,

vs.

Upsher-Smith Laboratories, Inc.,
Respondent,

John Does 1-50,
Defendants.

Filed October 2, 2023
Affirmed
Bratvold, Judge

Hennepin County District Court
File No. 27-CV-20-6531

Brendan J. Flaherty, Oft Law, PLLC, Minneapolis, Minnesota; and

Samuel Cole (pro hac vice), Sam Cole Legal Services, PLLC, Richardson, Texas (for
appellants)

Kay Nord Hunt, Lommen Abdo, P.A., Minneapolis, Minnesota; and

Richard G. Morgan, Cameron R. Woods, Lewis Brisbois Bisgaard & Smith LLP,
Minneapolis, Minnesota (for respondent)

Considered and decided by Reyes, Presiding Judge; Smith, Tracy M., Judge; and
Bratvold, Judge.
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NONPRECEDENTIAL OPINION
BRATVOLD, Judge
Appellants are a group of 101 individuals alleging damages for personal injury or
wrongful death caused by taking a prescribed generic drug for a heart condition not
indicated on the manufacturer’s medication guide. A prescription of this type is commonly
called “off-label” use. Appellants sued the drug manufacturer, alleging that, among other
theories, it failed to warn patients and their physicians of the risks associated with the
drug’s off-label use. The district court granted summary judgment in favor of the drug
manufacturer after determining it was undisputed that the manufacturer discharged its duty
to warn patients by complying with federal requirements for medication guides that are
provided to pharmacies. The district court concluded that the drug manufacturer was not
required to show “that it satisfied its duty to warn patients through another method, such
as warning their doctors.”
Appellants challenge the district court’s summary-judgment decision, arguing that
their claims for failure to warn physicians survive the dismissal of their claims for failure
to warn patients via compliance with medication-guide regulations . Appellants contend
that the district court erred because compliance with federal regulations on medication
guides is not sufficient to establish that the drug manufacturer adequately warned
physicians. Appellants add that the record evidence presents a genuine issue of material
fact as to whether the manufacturer adequately warned physicians about the dangers of
prescribing this generic drug for off-label use.
3
Appellant’s principal brief does not dispute that the drug manufacturer’s medication
guide complied with federal regulations and adequately warned patients. Although
appellant’s reply brief attempts to revive a challenge to patient warnings, we reject that
attempt. Based on existing Minnesota law, a drug manufacturer’s duty to warn runs to the
patient. Therefore, a drug manufacturer discharges its duty to warn patients by complying
with federal regulations for medication guides—in part because state law does not impose
a duty to warn patients by another method, i.e., separately warning the patient’s physician.
For these reasons, the district court correctly determined that the drug manufacturer was
entitled to summary judgment as a matter of law. Thus, we affirm without considering
additional issues raised by the parties.
FACTS
This appeal concerns patients who were prescribed a generic drug as an off-label
treatment for a stable cardiac condition even though the drug’s approved use was to treat
life-threatening cardiac arrhythmias. The following summarizes the district court record as
relevant to the issue on appeal.
General Background
The United States Food and Drug Administration (FDA) oversees the labeling of
prescription drugs. Federal regulations require that “human prescription drug products”
have an FDA -approved label if “it is necessary to the patients’ safe and effective use of
drug products,” primarily when the prescription drugs are “used on an outpatient basis
without direct supervision by a health professional.” 21 C.F.R. § 208.1(a), (b) (2022).
Generic drug manufacturers have a duty to ensure that the generic warning label is the same
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as the brand-name warning label, known as the “duty of sameness.” PLIVA, Inc. v.
Mensing, 564 U.S. 604, 613 (2011).1
FDA regulations also require drug manufacturers to provide “medication guides,”
defined in 21 C.F.R. § 208.3(h) (2022) and governed by 21 C.F.R. § 208.20-.26 (2022).
Federal regulations detail what type of information a drug manufacturer must include in a
medication guide and describe a manufacturer’s obligation to provide medication guides
to distributors, such as pharmacies. 21 C.F.R. § 208.20, .24.
The FDA approved the use of amiodarone hydrochloride (amiodarone) in 1985
under the trade name Cordarone®, which is manufactured by a pharmaceutical company
not party to this appeal . Respondent Upsher-Smith Laboratories Inc. (Upsher-Smith) is a
pharmaceutical manufacturer that makes a generic version of amiodarone. 2 The FDA
approved Upsher- Smith’s application to manufacture and sell this generic version of
amiodarone in 1998.

1 The supreme court in PLIVA stated:
The FDA . . . tells us that it interprets its regulations to require
that the warning labels of a brand-name drug and its generic
copy must always be the same—thus, generic drug
manufacturers have an ongoing federal duty of ‘sameness.’
The FDA’s views are controlling unless plainly erroneous or
inconsistent with the regulation[s] or there is any other reason
to doubt that they reflect the FDA’s fair and considered
judgment.
564 U.S. at 613 (quotation and citation omitted).

2 Upsher-Smith’s version of amiodarone is called Pacerone®. This opinion will refer to the
drug manufactured by Upsher-Smith as amiodarone.
5
The FDA-approved label for Upsher-Smith’s amiodarone states that it is “indicated
for the treatment of documented, life -threatening recurrent ventricular fibrillation and
life-threatening recurrent hemodynamically unstable tachycardia in adults who have not
responded to adequate doses of other available antiarrhythmics or when alternative agents
cannot be tolerated.” The prescribing information for amiodarone also warns that
amiodarone can cause “pulmonary toxicity” at rates reported “as high as 17% and is fatal
in about 10% of cases.” The medication guide for amiodarone warns patients that
amiodarone “should only be used to treat people who have been diagnosed with
life-threatening heartbeat problems called ventricular arrhythmias” and lists “lung
problems” as a serious side effect.
Complaint and Motion to Dismiss
Appellants are a group of 101 plaintiffs. Some are patients who were prescribed
amiodarone by their physicians, and others are wrongful-death trustees and family
members of patients who died after being prescribed amiodarone. Appellants allege that
doctors prescribed amiodarone off-labe l to treat atrial fibrillation, a stable cardiac
arrythmia commonly referred to as “a-fib,” and that use of amiodarone led to injury to the
plaintiff or death of the decedent. As mentioned above, amiodarone’s indicated use is for
ventricular fibrillation, or “v-fib.”
In April 2020, appellants sued for damages, alleging that Upsher- Smith failed to
warn the patients and their physicians of the harmful and deadly side effects of
amiodarone’s off-label use for a-fib. Appellants’ complaint alleged seven causes of action:
(1) strict products liability for a failure to warn, (2) negligence for a failure to warn,
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(3) negligence in marketing and sales, (4) negligence per se, (5) strict liability for a
manufacturing defect, (6) fraud and deceit, and (7) wrongful death. In September 2020,
appellants filed a first amended complaint that generally included the same factual
allegations and legal claims and added more plaintiffs.
In July 2020, Upsher- Smith moved to dismiss under Minn. R. Civ. P. 12.02(e),
arguing that appellants’ claims were preempted by federal law, failed as a matter of law,
or were inadequately pleaded. In January 2021, the district court granted Upsher-Smith’s
motion to dismiss in part. The district court agreed that many of appellants’ claims were
preempted by federal law or inadequately pleaded and, on that basis, dismissed appellants’
claims that alleged a failure to report adverse events to the FDA, manufacturing defects,
fraud and deceit, and negligent misrepresentation.
The district court then turned to appellants’ failure-to-warn claims, discussed Wyeth
v. Levine, 555 U.S. 555 (2009), and concluded that preemption did not bar appellants’
failure-to-warn claims under state law. The district court rejected Upsher- Smith’s
argument that “the existence of a federal duty [to warn] negates the existence of a parallel
state duty” to warn. The district court emphasized that appellants “are not asking for
warnings additional to or different from those already required by the FDA,” relying on
our analysis in Angeles v. Medtronic, Inc., 863 N.W.2d 404, 409 (Minn. App. 2015).
The district court determined that appellants’ failure-to-warn claims alleged that
Upsher-Smith failed to warn (1) patients by violating federal medication-guide regulations
and (2) physicians by failing to provide FDA-approved medication information. The
district court reasoned that appellants’ theories addressed ways a drug manufacturer could
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discharge its duty to warn and rejected Upsher-Smith’s argument that appellants were
“attempting to require more warnings than the FDA did.” The district court pointed out
that appellants’ position was “not asking for warnings additional to or different from those
required by the FDA.” The district court concluded that appellants adequately pleaded their
failure-to-warn-via-medication-guide and failure-to-warn -physicians claims. Therefore,
appellants’ failure- to-warn claims based on strict liability and negligence survived
Upsher-Smith’s motion to dismiss.
Summary-Judgment Motions
In May 2021, Upsher-Smith moved for summary judgment under Minn. R. Civ. P.
56.01, seeking to dismiss appellants’ remaining failure-to-warn claims. Upsher-Smith
argued that it was entitled to judgment as a matter of law because it provided adequate
prescribing information to physicians and it complied with all federal regulations about
providing medication guides to distributors, such as pharmacies.
In October 2021, the district court denied Upsher-Smith’s summary-judgment
motion.3 The district court first determined that appellants raised a genuine issue of
material fact as to whether Upsher-Smith used effective “methods of warning physicians
about the dangers of [off-label] prescriptions.” The district court concluded that, “[o]n the
present record, the Court cannot find, as a matter of law, that Upsher-Smith satisfied its
duty to warn [appellants’] physicians.” Second, the district court determined that

3 Upsher-Smith petitioned this court for discretionary review of the district court’s October
2021 denial of the summary-judgment motion, which we denied in December 2021. Walsh
v. Upsher-Smith Lab’ys, Inc., No. A21-1455 (Minn. App. Dec. 14, 2021) (order).
8
appellants’ medication-guide claims were not “ripe for summary judgment” because
appellants had “not yet had an opportunity to depose” an Upsher-Smith employee and thus
had made a sufficient showing of their need for “specific additional discovery.”
In June 2022, Upsher -Smith filed a renewed motion for summary judgment.
Upsher-Smith first argued that, under Minnesota law, Upsher-Smith’s duty to warn runs to
the patient and may be satisfied by providing adequate warnings to either the patient or the
patient’s physician. Upsher-Smith reasoned that its compliance with the federal
medication-guide regulations was undisputed and that it therefore satisfied its duty to warn
patients under state law. Upsher-Smith emphasized that “compliance with the federal
Medication Guide regulations is the sole issue presented in this [summary-judgment]
motion.” And Upsher-Smith urged that “once Upsher-Smith shows it has complied with its
duty to warn patients by complying with medication guide regulations, it need not also
prove that it complied with that duty by warning the patient’s doctors.”
In November 2022, the district court granted Upsher-Smith’s summary-judgment
motion and dismissed appellants’ failure-to-warn claims. The district court examined the
record evidence and legal arguments in detail and determined that there was no genuine
issue of material fact regarding whether Upsher-Smith complied with federal regulations
on providing medication guides as stated in 21 C.F.R. § 208.24(b).
The district court next considered whether summary judgment on appellants’
“medication guide claims disposed of this case.” The district court first reasoned that
appellants’ failure-to-warn claims were based on Upsher-Smith’s failure to warn patients
via compliance with medication-guide regulations, failure “to provide FDA warnings to
9
doctors,” or failure “to do both.” The district court also noted that, in its January 2021
order, it determined that appellants’ failure-to-warn claims corresponded to the alternative
ways a drug manufacturer could discharge its duty to warn. The district court decided it
would “not reconsider” that determination on summary judgment.
The district court stated that appellants, in response to Upsher-Smith’s motion to
dismiss, “acknowledge[d] that if Upsher-Smith complied with the Medication Guide
regulations, it would have no liability on their state-tort claims.” Because record evidence
established that Upsher-Smith had complied with the medication-guide regulations and
“Upsher-Smith is not also required to show that it satisfied its duty to warn patients through
another method, such as warning their doctors,” the district court determined that no
genuine issue of material fact remained for trial. The district court concluded that
Upsher-Smith had satisfied its duty to warn patients and granted summary judgment in
Upsher-Smith’s favor.
This appeal follows.
DECISION
Appellants argue that the district court erred when it granted summary judgment in
favor of Upsher-Smith on appellants’ failure -to-warn-physicians claims. Upsher-Smith
argues that the district court properly granted summary judgment because Upsher-Smith
discharged its duty to warn patients by complying with federal medication-guide
regulations, and thus, it did not also need to warn physicians. Alternatively, Upsher-Smith
argues that summary judgment may be affirmed because appellants failed to produce any
10
evidence that federally approved warnings were unknown to or unavailable to their
physicians.
An appellate court “review[s] the grant of summary judgment de novo to determine
‘whether there are genuine issues of material fact and whether the district court erred in its
application of the law.’” Montemayor v. Sebright Prods., Inc., 898 N.W.2d 623, 628 (Minn.
2017) (quoting Stringer v. Minn. Vikings Football Club, LLC, 705 N.W.2d 746, 754 (Minn.
2005)); see also Minn. R. Civ. P. 56.01. “In doing so, [an appellate court] must not weigh
facts or determine the credibility of affidavits and other evidence.” Montemayor,
898 N.W.2d at 628 (quotation omitted). Summary judgment is “inappropriate when
reasonable persons might draw different conclusions from the evidence presented.” Id.
(quoting Osborne v. Twin Town Bowl, Inc., 749 N.W.2d 367, 371 (Minn. 2008)). An
appellate court “need not adopt the reasoning of the district court” and “may affirm a grant
of summary judgment if it can be sustained on any grounds.” Doe v. Archdiocese of St.
Paul, 817 N.W.2d 150, 163 (Minn. 2012).
In their principal brief, appellants do not challenge the district court’s determination
that Upsher-Smith complied with federal medication-guide regulations or that, in doing so,
Upsher-Smith discharged its duty to warn patients. To the extent appellants attempt to
resurrect their failure-to-warn-patients claims in their reply brief, we reject that attempt, as
is discussed in more detail below. In short, the issue presented is whether appellants’
failure-to-warn-physicians claims survive summary judgment given that appellants no
longer dispute that Upsher-Smith complied with federal medication-guide regulations.
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We begin with a brief summary of relevant law. Minnesota recognizes a
manufacturer’s common-law duty to warn of foreseeable dangers posed by prescription
drugs. See Mulder v. Parke Davis & Co., 181 N.W.2d 882, 885 (Minn. 1970); see also
Lovejoy v. Minneapolis-Moline Power Implement Co., 79 N.W.2d 688, 693 (Minn. 1956)
(stating that a “manufacturer of a chattel” may be liable if it “knows or should know that
the chattel is apt to cause bodily harm if not used in a specific manner if [it] fails to furnish
adequate warning as to the dangers inherent in its use”).
Minnesota also recognizes that the manufacturer’s duty to warn runs to the patient.
Gray v. Badger Mining Corp., 676 N.W.2d 268, 279 n.7 (Minn. 2004) (stating that a drug
manufacturer has “a duty to warn the patient”). This duty to the patient is similar to the
common-law duty to warn users of a product. See Frey v. Montgomery Ward & Co.,
258 N.W.2d 782, 788 (Minn. 1977) (“[W]here the manufacturer or the seller of a product
has actual or constructive knowledge of danger to users, the seller or manufacturer has a
duty to give warning of such dangers.”); see also Mulder , 181 N.W.2d at 885 & n.1
(discussing that “[t]he [drug] manufacturer has no duty to warn the lay public regarding
prescription drugs” and noting that “the manufacturer is not liable” if the plaintiff’s doctor
was “fully aware” of the relevant hazard).
The district court relied on these principles i n resolving Upsher-Smith’s renewed
motion for summary judgment. The district court first determined it was undisputed that
Upsher-Smith complied with federal regulations to “ensur[e] that Medication Guides are
available for distribution to patients” pursuant to 21 C.F.R. § 208.24(b)(2). Federal
regulations require manufacturers to “ensur[e] that Medication Guides are available for
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distribution to patients” by either “[p]roviding Medication Guides in sufficient numbers to
distributors,” such as pharmacies, or “[p]roviding the means to produce Medication Guides
in sufficient numbers to distributors.” 21 C.F.R. § 208.24(b).
After reviewing the parties’ arguments and evidence in detail, the district court
concluded that “no genuine issue of material fact remains for [appellants] to pursue on their
Medication Guide claim.” The district court reasoned that “Upsher-Smith presented
evidence that it provided a website and a toll-free number to meet [the federal] regulation,
and [appellants] produced no evidence that these means prevented any of their pharmacies
from producing Medication Guides for amiodarone.” The district court concluded that
Upsher-Smith’s compliance with the medication-guide regulations discharged its duty to
warn patients. The district court next examined appellants’ failure-to-warn-physicians
claims, determining that “Upsher-Smith has shown that it complied with its duty to warn
by complying with the Medication Guide regulation” and “is not also required to show that
it satisfied its duty to warn patients through another method, such as warning their doctors.”
In their principal brief to this court, appellants contend that “state common law
negligence-based claims survive regardless of whether [Upsher-Smith] complied with the
FDA’s Medication Guide regulations” because “compliance with a federal regulation does
not delimit the scope of liability under Minnesota law.” Appellants cite two cases to support
the proposition that a drug manufacturer’s compliance with a federal regulation does not
automatically satisfy a manufacturer’s duty to warn. Blasing v. P. R. L. Hardenbergh Co.,
226 N.W.2d 110, 115 (Minn. 1975) (concluding evidence that a defendant “has complied
with a statute or ordinance regulating conduct under the circumstances is not conclusive
13
that [they were] in the exercise of due care”); Wendinger v. Forst Farms, Inc., 662 N.W.2d
546, 554 (Minn. App. 2003) (“A statutory standard is no more than a minimum, and it does
not necessarily preclude a finding that the actor was negligent in failing to take additional
precautions.” (quotation omitted)), rev. denied (Minn. Aug. 5, 2003).
Appellants correctly state the rule of law applied in Blasing and Wendinger. But
appellants’ argument that Upsher-Smith’s compliance with medication-guide regulations
“does not mean that [Upsher-Smith] satisfied its duty to warn [appellants’ physicians]” is
unavailing for three reasons.
First, appellants’ principal brief does not challenge the district court’s determination
that Upsher-Smith’s medication guide complied with federal regulations and adequately
warned patients.
Second, appellants’ theory on appeal assumes that a drug manufacturer has a duty
to warn physicians in addition to its duty to warn patients. On appeal, appellants argue that
Upsher-Smith’s “duty to warn [appellants’ physicians] . . . is a core obligation in a
prescription drug case.” This is a different theory than the theory appellants advanced in
district court. And a party may not “obtain review by raising the same general issue litigated
below but under a different theory.” Thiele v. Stich, 425 N.W.2d 580, 582 (Minn. 1988);
see also Pomush v. McGroarty, 285 N.W.2d 91, 93 (Minn. 1979) (holding that plaintiffs
could not raise a new negligence theory of recovery on appeal).
Throughout the proceedings before it, the district court described appellants’
failure-to-warn arguments as alternative ways a drug manufacturer could discharge its duty
to warn. For example, in the January 2021 order, the district court referred to one of the
14
failure-to-warn theories as appellants’ “fall back claim.” In the November 2022 order, the
district court described the medication-guide claim as an “alternative method by which
Upsher-Smith may satisfy its state-law duty to warn.” Because appellants argue for the first
time on appeal that drug manufacturers have a separate duty to warn physicians in addition
to their duty to warn patients, we need not consider appellants’ new theory. See Thiele,
425 N.W.2d at 582 (stating that we generally consider “ only those issues that the record
shows were presented and considered by the trial court” (quotation omitted)).
Third, even if we consider the merits of appellants ’
separate-duty-to-warn-physicians theory, we are not persuaded. Existing Minnesota law
does not recognize that a drug manufacturer has a separate duty to warn physicians. Rather,
Minnesota law recognizes that a drug manufacturer’s duty to warn runs to the patient.4
Appellants do not cite binding authority that holds a drug manufacturer has a separate duty
to also warn physicians about prescription drugs, and we are not aware of any. 5 Here,
Upsher-Smith discharged its duty to warn patients by complying wit h federal regulations

4 Minnesota has recognized the “learned-intermediary defense,” Gray, 676 N.W.2d at 275,
whereby a drug manufacturer “is not liable if the [prescribing physician] was fully aware
of the facts which were the subject of the warning,” Mulder, 181 N.W.2d at 885.

5 Some foreign caselaw has explicitly recognized a drug manufacturer’s exclusive duty to
warn physicians as opposed to patients. See, e.g., Carlin v. Super. Ct., 920 P.2d 1347, 1354
(Cal. 1996) (“[I]n the case of prescription drugs, the duty to warn runs to the physician, not
to the patient.”); Presto v. Sandoz Pharm. Corp., 487 S.E.2d 70, 7 3 (Ga. Ct. App. 1997)
(acknowledging the “settled ‘learned intermediary rule’ of Georgia law that the
manufacturer of a prescription drug is not normally required to directly warn the patient of
dangers in its use” and that “[o]rdinarily, in the case of prescription drugs, a warning as to
possible danger in its use to the prescribing physician is sufficient” (emphasis omitted)
(quotation omitted)).
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to distribute medication guides, and appellants do not challenge this determination on
appeal. In their principal brief to this court, appellants concede that Upsher-Smith
“complied with the letter of the Medication Guide regulations.” Additionally, appellants’
attorney confirmed at oral argument that they “are only appealing [their physicians] claim.”
Still, in their reply brief, appellants appear to shift positions and argue that, even if
Upsher-Smith complied with the federal regulations for medication guides, it “did not
exercise reasonable care in warning patients, and this issue was not even before the district
court” in Upsher-Smith’s renewed motion for summary judgment. Appellants’ reply brief
also asserts that their failure-to-warn-physicians claims “would be inapplicable only if
[Upsher-Smith] discharged its duty to warn patients, but it did not.”
Appellants’ reply-brief arguments differ from those in their district court pleadings
and memoranda. In district court, appellants consistently equated their
failure-to-warn-patients claims to Upsher-Smith’s failure “to ensure the Medication Guide
[for amiodarone] was provided.”
6 In appellants’ response to Upsher-Smith’s renewed
motion for summary judgment, appellants argued that Upsher-Smith’s “methods of

6 Appellants’ focus on the medication-guide regulation as the heart of their
failure-to-warn-patients claims is seen in the first amended complaint, which alleged that
Upsher-Smith violated its state-law duty to warn patients because Upsher-Smith was
“responsible for ensuring that the appropriate warning labels and Medication Guide were
provided.” In their response to Upsher-Smith’s motion to dismiss, appellants quoted Jones
v. Medtronic, Inc., No. A17-1124, 2018 WL 1462169, at *4 (Minn. App. Mar. 26, 2018),
to argue that “only when a manufacturer complies with the Medication Guide regulation,
has the manufacturer exercised ‘reasonable care in giving adequate and accurate
instructions as to the use of the product and a warning as to any dangers reasonably
foreseeable in its intended use.’” Appellants further argued that federal regulations “require
providing a Medication Guide to a distributor to ensure that the warning ultimately reaches
the consumer.”
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distributing Medication Guides are inadequate to ensure consumers actually receive
Medication Guides.” Appellants also argued: “In failing to ensure that plaintiffs (or
physicians) received Medication Guides in proper form, [Upsher-Smith] not only violated
its duties under FDA regulations but also fell short of its duty to adequately warn under
Minnesota state law.”
The record shows that appellants’ failure-to-warn-patients claims were synonymous
with the allegation that Upsher-Smith failed to comply with federal medication-guide
regulations. Indeed, appellants asserted that had they received the m edication guides, “all
the [appellants] would have declined to take [a]miodarone.” Therefore, when the district
court determined that Upsher-Smith complied with the federal medication-guide
regulations as a matter of law, it necessarily concluded that Upsher-Smith discharged its
duty to warn patients by meeting its obligation to “ensur[e] that Medication Guides are
available for distribution to patients.”
We need not, therefore, consider arguments in appellants’ reply brief about whether
compliance with federal medication-guide regulations satisfied Upsher-Smith’s duty to
warn patients. Appellants’ principal brief does not challenge the district court’s
summary-judgment determination dismissing appellants’ failure-to-warn-patients claims.
And generally, we do not consider issues raised for the first time in a reply brief. Moorhead
Econ. Dev. Auth. v. Anda, 789 N.W.2d 860, 887 (Minn. 2010).
Even if we were to consider appellants’ new arguments in their reply brief, we
would have an additional reason to reject them. Appellants cannot raise a new theory on
appeal. Thiele, 425 N.W.2d at 582. Here, appellants’ theory in district court was that “only
17
when a manufacturer complies with the Medication Guide regulation, has the manufacturer
exercised ‘reasonable care in giving adequate and accurate instructions as to the use of the
product and a warning as to any dangers reasonably foreseeable in its intended use.’”
In sum, the district court’s summary-judgment dismissal of appellants’
failure-to-warn-patients claims is not before us; therefore, we accept the district court’s
determination that Upsher-Smith discharged its duty to warn patients by complying with
the federal medication-guide regulations. State law does not impose a separate or additional
duty on drug manufacturers to warn physicians once a manufacturer has discharged its duty
by warning the patient. Thus, the district court did not err when it granted Upsher-Smith’s
summary-judgment motion on appellants’ state-law failure-to-warn-physicians claims.
While appellants also contend that the record raises genuine issues of fact regarding
whether Upsher-Smith adequately warned physicians and Upsher-Smith presents
alternative grounds for affirmance, we need not consider either of these additional
arguments.
Affirmed.