McLeod et al v. Sandoz Inc

Filing 21

ORDER: Defendant Sandoz, Inc.'s [ECF No. 6 motion to dismiss is GRANTED in part and DENIED in part. Specifically, Plaintiffs' first, second, third, fourth, and sixth causes of action are DISMISSED with prejudice. T he Court DENIES without prejudice Sandoz's motion to dismiss Plaintiffs' fifth cause of action (fraudulent "off-label" promotion) and seventh cause of action (loss of consortium based on fraudulent "off-label" promotion). Plaintiff shall file an amended complaint regarding Plaintiff's fifth and seventh causes of action within fifteen (15) days of the entry of this Order. IT IS SO ORDERED. Signed by Honorable R Bryan Harwell on 3/31/2017. (mcot, )

UNITED STATES DISTRICT COURT
DISTRICT OF SOUTH CAROLINA
FLORENCE DIVISION
James E. McLeod and
Glenda McLeod,

)
)
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Plaintiffs,
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v.
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Sandoz, Inc.,
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)
Defendant.
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______________________________)

Civil Action No.: 4:16-cv-01640-RBH

ORDER

This matter is before the Court on Defendant Sandoz, Inc.’s [ECF No. 6] motion to dismiss.
For the reasons stated below, the Court grants in part and denies in part Defendant Sandoz, Inc.’s
motion to dismiss.1
Factual2 and Procedural Background
Plaintiffs, James E. and Glenda McLeod, filed their Complaint on May 23, 2016, alleging
claims against Defendant Sandoz, Inc. for: 1) strict products liability - failure to warn; 2) negligence
- failure to warn; 3) negligence - “off label” marketing and sale; 4) negligence per se - “off label”
marketing/sale and failure to provide Medication Guide; 5) fraud and deceit; and 6) loss of
consortium. The claims arise from Plaintiff James E. McLeod’s use of the pharmaceutical drug
amiodarone for treatment of his non-life threatening atrial fibrillation. Plaintiffs allege that after

1

Under Local Civil Rule 7.08 (D.S.C.), “hearings on motions may be ordered by the Court in its
discretion. Unless so ordered, motions may be determined without a hearing.” Upon review of the briefs,
the Court finds that a hearing is not necessary.

2

W hen reviewing a motion made under Federal Rule of Civil Procedure 12(b)(6), the court must
“accept all well-pleaded allegations in the plaintiff’s complaint as true and draw all reasonable factual
inferences from those facts in the plaintiff’s favor.” Edwards v. City of Goldsboro, 178 F.3d 231, 244 (4th
Cir. 1999). Accordingly, the Court will assume the facts alleged in the Complaint are true for purposes of
resolving the pending motion to dismiss.

ingesting amiodarone, which was manufactured by Defendant Sandoz, Inc. (“Sandoz”), McLeod
developed and was diagnosed with shortness of breath and chronic obstructive and progressive
pulmonary disease. [Complaint, ECF No. 1, at ¶ 18]. The amiodarone tablets were manufactured
and sold by Sandoz as a generic version of Wyeth’s Cordarone®.
In 1985, brand manufacturer Wyeth (who is not a party to this litigation) received FDA
approval to market and sell the anti-arrhythmic heart medication Cordarone® (amiodarone
hydrochloride) under a special “needs” approval without the usual FDA approved, double-blind,
randomized clinical trials. Id. at ¶ 29. The customary and rigorous randomized clinical trials now
required by the FDA for all new drug applications have never been conducted for Cordarone® or its
generic equivalent, amiodarone. Id.
The FDA approved Cordarone® (amiodarone hydrochloride) only as a drug of “last resort”
for patients suffering from documented recurrent life-threatening ventricular fibrillation and
ventricular tachycardia when these conditions would not respond to other available anti-arrhythmic
drugs and therapies. Id. at ¶ 30. Plaintiffs allege Wyeth, however, aggressively and successfully
marketed Cordarone® for inappropriate “off label” uses as a “first line anti-arrhythmic therapy.” Id.
Generally, Plaintiff alleges he was not in a situation of last resort as to the management of his atrial
fibrillation.
Plaintiffs contend Wyeth also instituted and maintained an active promotional campaign
touting the anti-arrhythmic benefits of amiodarone, from which generic manufacturers such as
Sandoz still benefit. Id. at ¶ 31. As a result of Wyeth’s off-label promotion, amiodarone became a
first line therapy for atrial fibrillation because physicians were not warned of many of the potential
dangers of the drug. Id. Wyeth’s alleged fraudulent and misleading marketing campaigns resulted in
2

warning letters from the FDA to stop the false and misleading promotion of the drug that
downplayed the risks and promoted the drug as a first line anti-arrhythmic therapy. Id. The FDA
letters noted it is unlawful for a manufacturer to promote any drug for a use not described in the
approved labeling of the drug. Id. Unapproved uses are deemed “off-label” because they have not
been approved by the FDA. Id.
In 1998, Wyeth received approval for the manufacture, marketing, sale and distribution of
the generic formulation of Cordarone®, amiodarone hydrochloride. Id. at 32. Plaintiffs assert
Defendant Sandoz took advantage of the pervasive promotional activities of Wyeth and allege that
Sandoz’s version of the drug directly benefited from Wyeth’s marketing of the drug for “off-label”
uses. Id.
Sandoz was required to provide patients prescribed amiodarone with all FDA approved
labels, warnings and Medication Guides with information exactly as required of the brand
formulation manufacturer, Wyeth. Id. at ¶ 33. The Medication Guide for amiodarone outlined
serious side effects, such as lung damage, shortness of breath, wheezing, trouble breathing,
coughing, tiredness, weakness, nervousness, irritability, restlessness, decreased concentration, and
depression. Id. at ¶ 39.
Before being prescribed amiodarone, Plaintiff James McLeod was diagnosed with atrial
fibrillation that was not deemed life threatening. Id. at ¶ 34. The management of McLeod’s atrial
fibrillation was not considered a medical situation of “last resort.” Id.
Beginning in June of 2014 and continuing through November 2015, McLeod was prescribed
a course of 200 mg amiodarone tablets for treatment of his non-life threatening atrial fibrillation. Id.
at ¶ 35. McLeod was not aware that his use of amiodarone was for an “off-label” use and he did not
3

receive the required Medication Guide from Sandoz. Id. Correction of atrial fibrillation and any use
except in situations of last resort were never FDA approved uses of Cordarone® or its generic
equivalents. Id. McLeod’s prescription was for an “off-label” use and without the benefit of the
FDA mandated Medication Guide. Id.
The prescription for the amiodarone tablets was marked with the numbers 00185-0144-60
and was manufactured by Sandoz. Id. at ¶ 36. Plaintiffs allege the “off-label” prescription and
distribution of the drug to control a non-life threatening atrial fibrillation, also a direct result of the
long term promotional efforts of Sandoz and without the required Medication Guide, was a
producing and proximate cause of James McLeod’s physical condition and injuries from
amiodarone toxicity. Id. Plaintiffs allege that if McLeod had received the Medication Guide, he
would have been aware of the serious lung related side effects and would not have taken
amiodarone. Id. at ¶¶ 38-39.
In the fall of 2014-2015, McLeod began to experience many of the symptoms outlined in the
Medication Guide including shortness of breath, wheezing, trouble breathing, coughing, tiredness,
weakness, nervousness, irritability, restlessness, decreased concentration, and depression. Id. at ¶ 44.
McLeod’s condition continued to deteriorate and in March of 2015, he was admitted to McLeod
Regional Medical Center with severe shortness of breath. In October 2015, McLeod was diagnosed
with COPD. Id. at ¶ 46.
Plaintiffs allege Sandoz received direct notice of adverse events resulting from the use of
amiodarone including pulmonary toxicity, pulmonary fibrosis, lung damage, hepatic damage and
failure, neurotoxicity, peripheral neuropathy, neonatal hypothyroidism, optic neuritis, toxic optic
neuropathy, blindness, serious exacerbation of arrhythmias, and congestive heart failure such as that
4

experienced by McLeod. Id. at ¶ 49. Plaintiffs assert Sandoz failed to disclose to the FDA,
healthcare professionals, consumers, or McLeod information concerning the incidents and actual
adverse events, injuries, and deaths suffered by amiodarone users. Id. at ¶ 53.
Plaintiffs also allege Sandoz took advantage of the promotional efforts of Wyeth for “offlabel” uses, in addition to its own efforts, including the following:
a)

Direct-to-physician and direct-to-pharmacist promotion through sales
representatives;

b)

Promotion through funding and manipulation of so-called “educators” who
organize and arrange continuing medical education (CME) courses for
physicians and pharmacists;

c)

Formulation of unlawful conspiracies with certain medical marketing and
medical “education” entities to promote – without appearing to promote –
“off-label” uses;

d)

Sponsorship and funding of the production of CME materials;

e)

Cultivation and development of so-called “opinion leaders” in local medical
communities and support for the careers and research of those physicians,
pharmacists, and researchers who advocate off-label uses;

f)

Sponsorship of journal supplements and symposia on “off-label” uses;

g)

Placing (through sponsorship of limited trials, studies, and surveys) of
medical literature databases showing positive effects (already established) on
risk factors with the twin purposes of overwhelming any independent study
showing negative effects on different risk factors, and causing earnest but
5

time-crunched physicians to be impressed with the sheer quantity of favorable
(but redundant) studies on MedLine, or medical library, search;
h)

Media advertisements and brochures, some of which were disguised as
“educational materials”;

i)

Coordination of physician-to-physician interactions that are biased toward
“off-label” usages;

j)

Internet listings that omit important warnings and information; and

k)

Various other forms of marketing and promotion.

Id. at ¶ 53. Despite FDA warnings and thousands of adverse patient experiences, Sandoz continued
their alleged fraudulent marketing, promotional, and sales practices. Id. at ¶ 56.
Plaintiffs allege the amiodarone manufactured and/or supplied by Sandoz was not
accompanied by proper warnings regarding all possible adverse side effects and comparative
severity and duration of such side effects. Id. at ¶ 58. Plaintiffs further allege the amiodarone
manufactured, distributed, and/or supplied by Sandoz was defective due to inadequate postmarketing warning and instruction because, after Sandoz knew or should have known of the risk of
injury from amiodarone, especially in “off-label” use, Sandoz failed to provide adequate warnings to
physicians and consumers, including Plaintiff McLeod, and continued to aggressively sell
amiodarone for “off-label” use. Id. at ¶ 61. Plaintiffs contend the warnings for amiodarone were
vague, incomplete, and/or otherwise wholly inadequate. Id. at ¶ 67.
Plaintiffs allege Sandoz owed a duty to engage in honest and non-deceptive practices;
exercise due care under the circumstances; exercise due care in the design, manufacture, marketing,
promotion, sale, and distribution of amiodarone; to provide a reasonably safe and non-defective
6

drug; to provide adequate and appropriate warnings; to comply with federal guidelines; and/or to
sell and distribute the drug in accordance with FDA restrictions. Id. at ¶ 69.
Plaintiffs filed their Complaint on May 23, 2016, alleging claims for: 1) strict products
liability - failure to warn; 2) negligence - failure to warn; 3) negligence - “off label” marketing and
sale; 4) negligence per se - “off label” marketing/sale and failure to provide Medication Guide; 5)
fraud and deceit; and 6) loss of consortium. Plaintiffs seek compensatory and exemplary damages,
applicable interest, costs, attorney’s fees and all such other relief the Court deems proper.
Sandoz responded with the pending motion to dismiss under Rule 12(b)(6) of the Federal
Rules of Civil Procedure arguing that each of Plaintiffs’ claims are preempted by federal law and
should be dismissed. Sandoz also argues Plaintiffs’ fraud claim fails to meet the heightened
pleading requirements of Fed. R. Civ. P. 9(b) and their off-label promotion claims fail in light of the
learned intermediary doctrine that applies to prescription drug manufacturers. Sandoz further argues
that Plaintiffs’ Medication Guide claim fails under the learned intermediary doctrine and also
because there is no private right of action for failure to provide a Medication Guide. Sandoz further
maintains that the duty to provide the Medication Guide to Plaintiff McLeod fell upon the CVS or
Walgreens pharmacies that dispensed the drug, not Sandoz. Finally, Sandoz argues that because all
of Plaintiff James McLeod’s claims are either preempted or insufficiently pled, Plaintiff Glenda
McLeod’s loss of consortium claim also fails.
Rule 12(b)(6) Standard
When deciding a motion to dismiss made under Federal Rule of Civil Procedure 12(b)(6),
the Court must accept all well-pled facts alleged in the complaint as true and draw all reasonable
inferences in the plaintiff's favor. Nemet Chevrolet, Ltd. v. Consumeraffairs.com, Inc., 591 F.3d 250,
7

253 (4th Cir. 2009). A complaint must state a “plausible claim for relief” to survive a 12(b)(6)
motion to dismiss. Walters v. McMahen, 684 F.3d 435, 439 (4th Cir. 2012) (quoting Ashcroft v.
Iqbal, 556 U.S. 662, 679 (2009)). The Court will not dismiss the plaintiff's complaint so long as he
provides adequate detail about his claims to show he has a “more-than-conceivable chance of
success on the merits.” Owens v. Baltimore City State's Attorneys Office, 767 F.3d 379, 396 (4th
Cir. 2014) (citing Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007)). “Once a claim has been
stated adequately, it may be supported by showing any set of facts consistent with the allegations in
the complaint.” Twombly, 550 U.S. at 563. A complaint will survive a motion to dismiss if it
contains “enough facts to state a claim to relief that is plausible on its face.” Id. at 570. However,
when a plaintiff's assertions “amount to nothing more than a ‘formulaic recitation of the elements’ ”
of a cause of action, the Court may deem such allegations conclusory and not entitled to an
assumption of veracity. Iqbal, 556 U.S. at 681 (quoting Twombly, 550 U.S. at 555).
Discussion
I.

Federal Preemption
A.

Mensing and Bartlett Preemption

Sandoz argues that because each of Plaintiffs’ claims is essentially a failure to warn or
design defect claim, each claim is preempted pursuant to the Supreme Court cases PLIVA Inc. v.
Mensing, 564 U.S. 604 (2011) and Mutual Pharm. Co. v. Bartlett, 133 S.Ct. 2466, 2470, 186
L.Ed.2d 607 (2013). Mensing and Bartlett address the preemptive effect of the Food, Drug, and
Cosmetic Act (“FDCA”) on state tort laws as they apply to generic drug manufacturers.
Under the Hatch–Waxman amendments, codified at 21 U.S.C. § 355(j), the FDCA imposes
substantially different requirements on producers of name brand drugs and producers of
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non-branded, or generic, counterparts. Manufacturers of generic medications gain authorization to
market their products by demonstrating that those products are equivalent to the previously
authorized name brand versions in a number of ways, including formulation and labeling. Generic
drug manufacturers must maintain this equivalence to maintain authorization. See 21 U.S.C. §
355(j). In other words, the FDCA and its related regulations limit a generic drug manufacturer’s
ability to attach additional warnings to their drug. While brand companies are free to unilaterally
disseminate additional information about their drugs-including updated warnings and instructions
for use – through direct correspondence to healthcare providers, generic drug companies may not.
“Federal law ... demand[s] that generic drug labels be the same at all times as the corresponding
brand-name drug labels.” Mensing, 564 U.S. at 618. In fact, “changes unilaterally made to
strengthen a generic drug’s warning label would violate the [federal law].” Id. at 614.
In Mensing, the Supreme Court made clear that under § 355(j) generic drug manufacturers
are not entitled to unilaterally change their labeling and therefore any state law tort premised on the
failure of a generic to alter its labeling is preempted. Id. at 618. In Bartlett, the Supreme Court
emphasized that generics are also not permitted to change the formulation of their products. 133
S.Ct. at 2471, 2475. Further, the Court rejected the argument that a generic drug manufacturer is
required to leave the marketplace in order to avoid state law liability resulting from its inability to
change either its labeling or formulation. Id. at 2477. Stated another way, courts may not avoid
preempting a state law by imposing liability on a generic manufacturer for choosing to continue
selling its product. Together, these cases establish that under the FDCA a generic may not
unilaterally change its labeling or change its design or formulation, and cannot be required to exit
the market or accept state tort liability for its failure to change its labeling, design, or formulation.
9

Plaintiffs respond that Mensing and Bartlett do not apply because their claims do not
challenge the adequacy or “content” of the warning label, but rather challenge Sandoz’s alleged
“off-label” marketing and alleged failure to provide a Medication Guide to McLeod. Plaintiffs’
claims appear to be premised on the notion that the warnings contained within the Medication Guide
were adequate.3 Yet, Plaintiffs’ complaint also alleges “the warnings for amiodarone, in effect
during the relevant time period were vague, incomplete, and/or otherwise wholly inadequate, both
substantively and graphically, to alert prescribing physicians, pharmacists, consumer patients and
McLeod of the actual risks associated with this drug.” [ECF No. 1, Complaint at ¶ 67]. Plaintiff
further alleges:
At all material times, the amiodarone, manufactured and/or
supplied by Defendant was and is unaccompanied by proper
warnings regarding all possible adverse side effects and
comparative severity and duration of such adverse effects; the
warnings given did not and do not accurately reflect the severity or
duration of the adverse side effects or the true potential and/or
likelihood or rate of the side effects. This is particularly so with
regard to “off-label” use. . . .
At all material times, the amiodarone manufactured, distributed,
and/or supplied by Defendant was defective due to inadequate
post-marketing warning and instruction because after Defendant
knew or should have know of the risk of injury from amiodarone,
especially in “off-label” use, Defendant failed to provide adequate
and required warnings to physicians, users or consumers of
amiodarone. . .
The warnings and directions provided with amiodarone by
Defendant failed to adequately warn of the potential risks and side

3

Plaintiffs’ Complaint alleges: “Had the Medication Guide been provided by Sandoz to the
distributor or his pharmacist for distribution to him as required by FDA regulations, McLeod would have
been aware of the serious lung related side effects that would lead to his physical condition and injuries . . .
McLeod would not have taken amiodarone and would not have incurred the serious and life threatening
injuries had he received the required Medication Guide.” [ECF No. 1, Complaint at ¶ 38].

10

effects of amiodarone and the dangerous propensities of said
medication, which risks were known or were reasonably
scientifically knowable to Defendant when, among other things,
they failed to ensure the Medication Guide was provided to all
consumers, including Plaintiff.
Id. at ¶¶ 58, 61 & 92. Plaintiffs do not address this apparent inconsistency in their briefs and appear
to have abandoned any claims regarding the adequacy or content of the warnings for amiodarone.
However, to the extent those claims are not abandoned, they are due to be dismissed as preempted
under Mensing and Bartlett because Sandoz could not have changed the content of the warning
labels or Medication Guide and could not have disseminated additional warnings regarding “offlabel” use without violating federal law.
Separate and apart from the Medication Guide claims, the Court questions whether
Plaintiffs’ “off-label” promotion claims can survive the preemption analysis under Mensing and
Bartlett. Plaintiffs argue that their “off-label” promotion claims are not preempted under Mensing
and Bartlett because the claims do not challenge the adequacy or content of the manufacturer’s
warning for amiodarone. In the Court’s view, Plaintiffs’ claims have a tendency to do exactly that.
The basis for Plaintiffs’ “off-label” marketing claims is that Sandoz, by virtue of its marketing of
amiodarone for first line non-life threatening atrial fibrillation treatment instead of “last resort”
treatment, rendered the manufacturer’s warning inadequate. If Plaintiffs’ “off-label” claims are
successful, in order to avoid future liability Sandoz could arguably be required to either: 1) change
the warning label or disseminate additional warnings to reflect the alleged additional dangers
associated with the “off-label” use of amiodarone for atrial fibrillation; or 2) exit the market place.
Such a result requires preemption under Mensing and Bartlett. However, as noted in Whitener v.
PLIVA, Inc., 2012 WL 1995795, at *4 (E.D. La. June 4, 2012), “there is something troubling about
11

permitting a generic defendant to violate federal law by actively and aggressively promoting a drug
for a purpose not contemplated by the label approved by the FDA while also hiding behind an
inability to provide warnings connected to that off-label use because it cannot change the approved
label.” The Court also notes that no circuit court of appeals to date has held that “off-label”
promotion claims are preempted under Mensing and Bartlett. At this early stage of the case, the
Court declines to hold that Plaintiffs’ “off-label” promotion claims are nothing more than preempted
failure to warn claims.
B.

Buckman Preemption

With regard to Plaintiffs’ claims related to “off-label” promotion and the failure to provide a
Medication Guide - claims that, according to Plaintiffs, do not challenge the adequacy or content of
the warning label for amiodarone, Sandoz argues that because those claims are premised solely upon
federal duties, and there is no private right of action to enforce those federal duties, Plaintiffs’
claims for “off-label” promotion and failure to provide a Medication Guide are impliedly preempted
under Buckman v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) and 21 U.S.C. § 337(a).
1.

“Off-label” Promotion

At the outset, it should be noted that Plaintiffs advance “off-label” promotion claims based
on both fraud and negligence theories. Because the claims are based on different theories of
recovery, they require different treatment. As explained more fully below, Plaintiffs’ negligent “offlabel” promotion claim is preempted under Buckman and 21 U.S.C. § 337(a) because it is premised
solely upon duties set forth in the FDCA and applicable regulations and there are no parallel South
Carolina state tort remedies for the negligent “off-label” promotion of generic drugs. Plaintiffs’
fraudulent “off-label” promotion claim, premised on Sandoz’s obligations under state fraud law to
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refrain from falsely promoting their drugs for unapproved uses, is not preempted.
The FDCA does not provide a private right of action for a defendant's violation of its
provisions. See Merrell Dow Pharm. Inc. v. Thompson, 478 U.S. 804, 810 (1986). Instead, “all such
proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name
of the United States.” 21 U.S.C. § 337(a). Accordingly, where “the existence of these federal
enactments is a critical element in [plaintiff's] case,” and where a plaintiff's claims “exist solely by
virtue of the FDCA ... requirements,” state law claims are impliedly preempted by the FDCA.
Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 352 (2001). Where, by contrast, a plaintiff's
claims rest on “traditional state tort law principles of the duty of care,” the establishment of which
“predated the federal enactments in question,” a plaintiff may bring a state law claim for conduct
also in violation of the FDCA. Id. Buckman does not extend so far as to restrict “certain state-law
causes of actions that parallel federal safety requirements.” Id.; see Caplinger v. Medtronic, Inc.,
784 F.3d 1335, 1339 (10th Cir. 2015) (“Buckman left undisturbed ... state lawsuits based on
‘traditional state tort law’ that ‘predate[s]’ the FDCA but happens to ‘parallel’ it.”).
Under Buckman, “[f]or a state-law claim to survive, ... the claim must be premised on
conduct that both (1) violates the FDCA and (2) would give rise to a recovery under state law even
in the absence of the FDCA.” Williams v. Smith & Nephew, Inc., 123 F.Supp.3d 733, 746 (D. Md.
2015) (quotations omitted); see Evans v. Rich, No. 5:13–CV–868–BO, 2014 WL 2535221, at *2
(E.D.N.C. June 5, 2014) (“The test for determining whether a state law claim is impliedly
preempted is whether or not the claim would exist in the absence of the FDCA.”); Loreto v. Procter
& Gamble Co., 515 Fed.Appx. 576, 579 (6th Cir.2013) (“If the claim would not exist in the absence
of the FDCA, it is impliedly preempted.”); see also In re Medtronic, Inc., Sprint Fidelis Leads
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Products Liab. Litig., 623 F.3d 1200, 1204 (8th Cir.2010) (recognizing “a narrow gap through
which a plaintiff's state-law claim must fit if it is to escape express or implied preemption[:] ... the
plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly
preempted under Buckman).”) (quotations omitted).
In this case, Plaintiffs’ claims of negligence and negligence per se based on the alleged “offlabel” promotion of amiodarone are impliedly preempted under Buckman because the duties
Plaintiffs allege Sandoz breached regarding “off-label” promotion exist solely under the FDCA. For
instance, Plaintiffs allege:
Defendant owed a duty to Plaintiff to market and sell amiodarone
for uses approved by the FDA and for uses for which it has been
established as efficacious and safe.
Defendant, as the manufacturer, designer and marketer of
amiodarone, owed a duty of care to Plaintiff and other consumers
of amiodarone to ensure it marketed and sold it only for approved
uses. Instead, Defendant engaged in a campaign to market the drug
for “off-label” uses, in particular for the treatment of atrial
fibrillation.
Defendant owed a duty to Plaintiff to market and sale [sic]
amiodarone only for uses approved by the FDA and for uses for
which it has been established as efficacious and safe.
Defendant violated this duty by marketing, promoting and selling
amiodarone for uses not approved by the FDA.
[Complaint at ¶¶ 105, 106, 112, and 113, ECF No. 1]. Plaintiff has not directed the Court to any
S.C. state law causes of action that parallel the federal safety requirements limiting the “off-label”
promotion of drugs. Plaintiffs’ claim for the negligent “off-label” promotion of amiodarone would
not exist in the absence of the FDCA. Accordingly, Plaintiffs’ claim for negligence and negligence
per se based on Sandoz’s alleged “off-label” promotion of amiodarone for atrial fibrillation is
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impliedly preempted under Buckman and due to be dismissed. See, e.g. Perdue v. Wyeth Pharms.,
Inc., __ F. Supp. 3d __, 2016 WL 3951091, at *5 (E.D.N.C. 2016) (dismissing plaintiff’s claim for
negligent “off-label” promotion of amiodarone because the claim was not premised on conduct that
would give rise to a recovery under state law in the absence of the FDCA).
By contrast, Plaintiffs’ fraud claim related to the promotion and marketing of amiodarone is
not preempted under Buckman. Plaintiffs’ fraud claim is premised on state common law fraud that
predates the FDCA. See, e.g., Tallevast v. Herzog, 83 S.E.2d 204, 206-07 (S.C. 1954); Jones v.
Cooper, 109 S.E.2d 5, 7 (S.C. 1959). State laws traditionally prohibit fraud and deceit in
advertising and marketing. Plaintiffs essentially allege that Sandoz misrepresented the safety and
efficacy of amiodarone and falsely promoted the drug for unapproved uses. [Complaint at ¶¶ 116129]. Plaintiffs further allege:
Defendant misled Plaintiff, Plaintiff’s physician, and the public
into believing that amiodarone was safe and effective for use in the
treatment of atrial fibrillation, and engaged in deceptive,
misleading and unconscionable promotional or sales methods to
convince health care professionals and patients to use amiodarone .
. ., even though Defendants knew or should have known that
amiodarone was unreasonably unsafe.
Defendant’s advertising program and promotional items, by
containing affirmative misrepresentations and omitting material
facts, falsely and deceptively sought to create the image and
impression that amiodarone was safe for human use, had no
unacceptable side effects, and would not interfere with daily life.
Defendant’s advertising program and promotional items, by
containing affirmative misrepresentations and omitting material
facts, falsely and deceptively sought to create the image and
impression that amiodarone was safe for human use, had no
unacceptable side effects, and would not interfere with daily life.
Defendant actively concealed, failed to disclose, misstated,
15

downplayed and understated the health hazards and risks
associated with the use of amiodarone. Defendant, through their
promotional practices, deceived potential treating physicians,
Plaintiff, other patients, and the public. Defendants falsely and
deceptively kept relevant information from potential treating
physicians, the FDA and the general public, including Plaintiff,
regarding the safety of amiodarone in terms of its “off-label” use.
Defendant expressly denied that amiodarone created an increased
risk of injury and took affirmative steps to prevent the discovery
and dissemination of any evidence on the increased likelihood of
injury from amiodarone in terms of its “off-label” use.
Defendant did not accurately report the results of adverse events by
withholding from the FDA, physicians, Plaintiff, and the public,
the truth regarding amiodarone failures for years, all the while
undertaking a major advertising campaign to sell amiodarone.
Defendant received reports of amiodarone’s side effects
attributable to “off-label” use from various sources, and withheld
this information and maintained it in their possession, while
continuing to sell amiodarone to individuals such as Plaintiff.
Defendant effectively deceived and misled the scientific and
medical communities regarding the risks and benefits of
amiodarone. Defendant failed to fully inform physicians, patients,
including Plaintiff, and the public of the true defects in
amiodarone, which were known to Defendant, and continued to
assure physicians and patients that amiodarone was adequate and
reliable for the purpose intended and continued to continue to sell
amiodarone.
Through the materials they disseminated, Defendant falsely and
deceptively misrepresented or omitted a number of material facts
regarding amiodarone as set forth in detail above.
Defendant possessed evidence demonstrating amiodarone caused
serious adverse side effects. Nevertheless, Defendant continued to
market amiodarone by providing false and misleading information
with regard to its safety to Plaintiff and Plaintiff’s treating
physician.
Among Defendant’s numerous misrepresentations and misleading
omissions to Plaintiff, Plaintiff’s physician and the general public
16

are Defendant’s assurances that amiodarone was a safe and
effective drug for the treatment of atrial fibrillation. Defendant
made such statements even after they became aware of numerous
and serious complications with amiodarone. Defendant did not
reveal (and instead actively concealed) their knowledge of
numerous and serious complications with amiodarone. Despite
their knowledge of serious problems with amiodarone, Defendant
continued and continue to market amiodarone.
Defendant also concealed from Plaintiff and Plaintiff’s physician
the material facts they were obligated to disclose, including that
amiodarone was not FDA approved for the treatment of atrial
fibrillation, was not an appropriate “first line of treatment” for
atrial fibrillation, is required to be accompanied by a Medication
Guide intended to warn the consumer of the serious,
life-threatening complications from the use of amiodarone and was
approved by the FDA for limited use without any associated
clinical trials establishing the safety and efficacy of the drug.
Id. at ¶¶ 117-126. Sandoz’s alleged fraudulent conduct, as set forth in Plaintiffs’ Complaint, would
give rise to recovery even in the absence of the FDCA. Therefore, Plaintiffs’ fraud claim based on
the promotion and marketing of amiodarone is not preempted under Buckman.
2.

Medication Guide

Plaintiffs also assert failure to warn and negligence claims based on Sandoz’s alleged failure
to provide a Medication Guide with Plaintiffs’ prescription of amiodarone. The duty to provide a
Medication Guide exists solely under the FDCA and its applicable regulations. See 21 U.S.C. §
355(j)(2)(A)(v) & 355(j)(4)(G))) and 21 C.F.R. § 208.24. Specifically, 21 C.F.R. § 208.24 provides
that “[e]ach manufacturer who ships a container of drug product for which a Medication Guide is
required under this part is responsible for ensuring that Medication Guides are available for
distribution to patients.” Because the requirement to provide a Medication Guide to distributors is
based solely in the requirements of the FDCA and related regulations, and there is no parallel duty

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to provide a Medication Guide under South Carolina law, Plaintiffs’ claims based upon failure to
provide a Medication Guide are preempted under Buckman. See Perdue, 2016 WL 3951091, at *5.
Stated another way, Plaintiffs’ claims against Sandoz for failure to provide a Medication Guide are
preempted and due to be dismissed because the claims would not exist in the absence of the FDCA.4
II.

Learned Intermediary Doctrine
Sandoz argues that Plaintiffs’ claims related to “off-label” promotion fail under the learned

intermediary doctrine because Plaintiffs have not alleged that the prescribing physicians would have
changed their prescribing decisions had different or additional warnings accompanied amiodarone,
and have not alleged that McLeod’s prescribing physicians relied upon any representations or
statements by Sandoz. Plaintiffs did not respond to Sandoz’s learned intermediary doctrine
argument and, importantly, do not argue that the learned intermediary doctrine does not apply.5
Although there is no South Carolina Supreme Court case specifically adopting the learned
intermediary doctrine in the context of pharmaceutical drug or device litigation, the Fourth Circuit
Court of Appeals has predicted that the South Carolina Supreme Court would adopt the doctrine if
presented with the issue. Brooks v. Medtronic, Inc., 750 F.2d 1227, 1231 (4th Cir. 1984); Odom v.
G.D. Searle & Co., 979 F.2d 1001, 1003 (4th Cir.1992). Under the learned intermediary doctrine,

4

Plaintiffs’ Medication Guide claims are also due to be dismissed because, pursuant to the learned
intermediary doctrine, the manufacturer’s duty to warn only extends to the prescribing physicians, not the
patient. Odom v. G.D. Searle & Co., 979 F.2d 1001, 1003 (4th Cir.1992); Sauls v. Wyeth Pharms., Inc., 846
F. Supp. 2d 499, 504 (D.S.C. 2012); Dreher v. Wyeth Pharms, Inc., No. 2:14-cv-00280-KOB, 2015 W L
3948961, at *8 (N.D. Ala. June 29, 2015).

5

Plaintiffs' failure to respond to the learned intermediary argument is striking because Plaintiffs'
counsel has been involved in several other amiodarone cases that were dismissed in part pursuant to the
learned intermediary doctrine. See, e.g. Stephens v. Teva Pharms., U.S.A., Inc., 70 F. Supp. 3d 1246, 1254
(N.D. Ala. 2014); Allain v. Wyeth Pharms., Inc., No. 2:14-cv-00280-KOB, 2015 W L 178038, at *6 (N.D.
Ala. Jan. 14, 2015); Connolly v. Sandoz Pharms. Corp., No. 2:14-cv-152-W CO, 2014 W L 12480025, at *5
(N.D. Ga. Dec. 23, 2014).

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“the manufacturer's duty to warn extends only to the prescribing physician, who then assumes
responsibility for advising the individual patient of risks associated with the drug or device.” Odom,
979 F.2d at 1003. The manufacturer of a drug has a duty to warn the patient’s doctor who acts as a
“learned intermediary” between the patient and the manufacturer. The rationale behind this doctrine
is the doctor is in a better position to warn the patient than the manufacturer. In a prescription drug
case, a plaintiff must not only show that the drug manufacturer's warning was inadequate, but “also
establish that the inadequacy of the warning was the proximate cause of the plaintiff's injury.” Sauls,
846 F. Supp. 2d at 502 (citing Stanback v. Parke, Davis, & Co., 657 F.2d 642, 645 (4th Cir.1981)).
In light of the learned intermediary doctrine, “the burden remains on the plaintiff to demonstrate that
the additional non-disclosed risk was sufficiently high that it would have changed the treating
physician's decision to prescribe the product for the plaintiff.” Odom, 979 F.2d at 1003.
Plaintiffs alleged:
Defendant actively concealed, failed to disclose, misstated,
downplayed and understated the health hazards and risks
associated with the use of amiodarone. Defendant, through their
promotional practices, deceived potential treating physicians,
Plaintiff, other patients, and the public. Defendants falsely and
deceptively kept relevant information from potential treating
physicians, the FDA and the general public, including Plaintiff,
regarding the safety of amiodarone in terms of its “off-label” use.
Defendant expressly denied that amiodarone created an increased
risk of injury and took affirmative steps to prevent the discovery
and dissemination of any evidence on the increased likelihood of
injury from amiodarone in terms of its “off-label” use.
Defendant did not accurately report the results of adverse events by
withholding from the FDA, physicians, Plaintiff, and the public,
the truth regarding amiodarone failures for years, all the while
undertaking a major advertising campaign to sell amiodarone.
Defendant received reports of amiodarone’s side effects
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attributable to “off-label” use from various sources, and withheld
this information and maintained it in their possession, while
continuing to sell amiodarone to individuals such as Plaintiff.
[Complaint at ¶¶ 119-121, ECF No. 1]. Plaintiffs further allege Defendant “misled Plaintiff,
Plaintiffs’ physician, and the public into believing that amiodarone was safe and effective for use in
the treatment of atrial fibrillation, and engaged in deceptive, misleading and unconscionable
promotional or sales methods to convince health care professionals and patients to use amiodarone.”
Id. at ¶ 117.
Although Plaintiffs have alleged that Sandoz misled McLeod’s prescribing physicians into
believing that amiodarone was safe and effective for use in the treatment of atrial fibrillation,
Plaintiffs have not alleged that McLeod’s prescribing physicians would have changed their
prescribing decision had different or additional warnings accompanied amiodarone. Of course, to
the extent Plaintiffs claim that different or additional warnings should have accompanied
amiodarone with regard to its “off-label” use, those claims against a generic drug manufacturer
would be clearly preempted under Mensing and Bartlett because Sandoz could not change the FDA
approved warnings for amiodarone.
The application of the learned intermediary doctrine to Plaintiffs’ “off-label” promotion
claims exposes a conceptual flaw in Plaintiffs’ case. To avoid preemption under Mensing and
Bartlett, Plaintiffs state they do not challenge the adequacy or content of the FDA approved
warnings for amiodarone. To support their Medication Guide claim, Plaintiffs also contend the
Medication Guide adequately set forth the risks associated with amiodarone and if Plaintiff McLeod
had received the Medication Guide, he would not have taken amiodarone. [Complaint at ¶ 38, ECF
No. 1]. Yet, in order to overcome the learned intermediary doctrine in this case, Plaintiff McLeod’s
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prescribing physicians would essentially have to testify that they were unaware of a risk that
Plaintiffs allege was adequately disclosed in the Medication Guide for amiodarone. Critically,
Plaintiffs have not alleged that the prescribing physicians did not receive the Medication Guide or
were otherwise unaware of its contents.
Plaintiffs have not alleged that McLeod’s prescribing physicians were unaware of the
contents of the Medication Guide or the risk of pulmonary toxicity or lung problems possibly
resulting in death. Further, Plaintiffs have not alleged that the prescribing physicians would have
changed their decision to prescribe amiodarone had they been aware of the risk of pulmonary
toxicity or lung problems possibly resulting in death. Plaintiffs have failed to state a claim to relief
that is plausible on its face as Plaintiffs have not pled facts sufficient to establish causation in light
of the learned intermediary doctrine. See, e.g. Luberda ex rel. Luberda v. Purdue Frederick Corp.,
No. 4:13-cv-00897-RBH, 2014 WL 1315558, at *6 (D.S.C. March 28, 2014).
The Court considered dismissing Plaintiffs’ fraudulent “off-label” promotion claim without
prejudice on the basis of the learned intermediary doctrine; however, Plaintiffs have asked to amend
their complaint and it is not clear to the Court whether dismissal without prejudice would create
issues for Plaintiffs regarding the statute of limitations. To be clear, Plaintiffs’ “off-label”
promotion claim premised on negligence and negligence per se is dismissed with prejudice because
that claim is preempted under Buckman. Plaintiffs’ “off-label” promotion claim based on fraud may
proceed if Plaintiffs can amend their fraudulent “off-label” promotion claim to state facts sufficient
to establish causation in light of the learned intermediary doctrine. See Luberda, 2014 WL 1315558,
at *6 (allowing amendment of complaint to plead facts in accordance with the learned intermediary
doctrine). If Plaintiffs elect to amend their fraudulent “off-label” promotion claim, they should be
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mindful of the specificity requirements for fraud claims under Rule 9(b) of the Federal Rules of
Civil Procedure.
Conclusion
For the reasons stated above, Defendant Sandoz, Inc.’s [ECF No. 6] motion to dismiss is
GRANTED in part and DENIED in part. Specifically, Plaintiffs’ first, second, third, fourth, and
sixth causes of action are DISMISSED with prejudice. The Court DENIES without prejudice
Sandoz’s motion to dismiss Plaintiffs’ fifth cause of action (fraudulent “off-label” promotion) and
seventh cause of action (loss of consortium based on fraudulent “off-label” promotion). Plaintiff
shall file an amended complaint regarding Plaintiffs’ fifth and seventh causes of action within
fifteen (15) days of the entry of this Order.
IT IS SO ORDERED.
March 31, 2017
Florence, South Carolina

s/ R. Bryan Harwell
R. Bryan Harwell
United States District Judge

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