McLeod et al v. Sandoz Inc
ORDER granting 24 Motion to Dismiss for Failure to State a Claim. Signed by the Honorable R Bryan Harwell on 3/23/2018. (hcic, )
UNITED STATES DISTRICT COURT
DISTRICT OF SOUTH CAROLINA
James E. McLeod and
Civil Action No.: 4:16-CV-01640-RBH
This matter is before the Court on Defendant Sandoz, Inc.’s [ECF No. 24] motion to dismiss
the amended complaint. For the reasons stated below, the Court grants Defendant Sandoz, Inc.’s
motion to dismiss.1
This case arises 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
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. [Amended Complaint, ECF No. 23, at ¶ 18]. The amiodarone tablets were
manufactured and sold by Sandoz as a generic version of Wyeth’s Cordarone®.
Plaintiffs generally allege that Sandoz failed to adequately warn Plaintiff of the risks
associated with the off-label use of amiodarone to treat non-life threatening atrial fibrillation,
particularly the risk of pulmonary toxicity-lung disease. Plaintiffs contend Sandoz failed to
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.
adequately warn when it failed to provide a Medication Guide with Plaintiff's prescription.
Plaintiffs allege the risks of amiodarone were disclosed in the Medication Guide and had the
Plaintiff 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. Plaintiffs also generally allege that
Sandoz fraudulently marketed amiodarone for the off-label use of treating non-life threatening atrial
Plaintiffs 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.
In an Order dated March 31, 2017, the Court dismissed Plaintiffs' claims for 1) strict
products liability - failure to warn; 2) negligence - failure to warn; 3) negligence - “off label”
marketing and sale; and 4) negligence per se - “off label” marketing/sale and failure to provide
Medication Guide. See [Order, ECF No. 21]. Specifically, the Court held that Plaintiffs' failure to
warn claims based on the failure to provide a Medication Guide were impliedly preempted under
Buckman v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001) and 21 U.S.C. § 337(a) because the
requirement to provide a Medication Guide to distributors is based solely on the requirements of the
FDCA and related regulations, and there is no parallel duty to provide a Medication Guide under
South Carolina law. In a footnote, the Court noted that Plaintiff's claims relating to the failure to
provide a Medication Guide were also due to be dismissed because, pursuant to the learned
intermediary doctrine, the manufacturer's duty to warn extended only to the prescribing physicians,
not the patient. The Court also held that Plaintiffs' negligent "off-label" promotion claim was
impliedly preempted under Buckman.
The only claims that were not dismissed were Plaintiffs' fraudulent off-label marketing claim
and the loss of consortium claim. However, as to the fraudulent off-label marketing claim, the
Court found that the original Complaint failed set forth facts sufficient to establish causation in light
of the learned intermediary doctrine because: 1) Plaintiffs had not alleged that Plaintiff's prescribing
physicians were unaware of the warnings set forth in the Medication Guide or the risk of pulmonary
toxicity or lung problems possibly resulting in death; and 2) Plaintiffs had 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 resulting in death. The Court permitted
Plaintiffs to amend their fraudulent off-label marketing claim to state facts sufficient to establish
causation under the learned intermediary doctrine. The Court also advised Plaintiffs that any
amendment to their fraudulent off-label marketing claim must comply with the specificity
requirements for fraud claims under Rule 9(b) of the Federal Rules of Civil Procedure.
On April 14, 2017, Plaintiffs filed an Amended Complaint alleging claims for fraudulent offlabel marketing and loss of consortium. [Amended Complaint, ECF No. 23]. In response, Sandoz
filed a second motion to dismiss arguing that Plaintiffs disregarded the Court's directives and filed
an Amended Complaint that contained many of the same deficiencies as the first complaint. Sandoz
argues that Plaintiffs' Amended Complaint fails to establish causation under the learned
intermediary doctrine. Sandoz also argues the Amended Complaint fails to meet the particularity
requirements for fraud claims under Rule 9(b) of the Federal Rules of Civil Procedure. Sandoz
further argues that Plaintiffs' Amended Complaint contains reworded claims that the Court clearly
dismissed with prejudice.
Even though Plaintiffs' Amended Complaint attempts to resurrect claims that were already
dismissed with prejudice, the only claims properly before this Court at this time are Plaintiffs'
fraudulent off-label marketing claim and the loss of consortium claim.
In their fraudulent off-label marketing claim, Plaintiffs allege that Sandoz owed a duty to
provide honest, accurate, and complete information to Plaintiff, his physicians, and the public.
[Amended Complaint, ECF No. 23 at ¶ 89]. Plaintiffs allege that Sandoz misled and deceived
Plaintiff, his physicians, and the public into believing that amiodarone was safe and effective for use
in the treatment of atrial fibrillation. Id. at ¶ 90. Sandoz allegedly concealed and understated the
health hazards and risks associated with the "off-label" use of amiodarone to treat non-life
threatening atrial fibrillation. Id. at 92. Sandoz allegedly failed to fully inform Plaintiffs' physicians
of the true defects in amiodarone. Id. at ¶ 95.
Plaintiffs allege Sandoz concealed 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 only for limited use without any associated
clinical trials. Id. at ¶ 99. Plaintiffs allege Sandoz engaged other medical professionals to
deceptively promote the off-label use and purposely avoided detailed discussions of adverse
reactions related to lung and vision injuries. Id. at ¶ 100. Plaintiffs allege the prescribing physicians
justifiably and reasonably relied to their detriment on Sandoz's misrepresentations and omissions
and their reliance on those misrepresentations and omissions proximately caused Plaintiff's injuries.
Id. at ¶ 101.
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,
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).
Sandoz argues that Plaintiffs disregarded the Court's directives and filed an Amended
Complaint that simply contains reworded claims that the Court already dismissed with prejudice.
The first page of Plaintiffs' response brief indicates that Sandoz is correct. Inexplicably, Plaintiffs
state "James McLeod's amended complaint again alleges common-law negligent failure to warn
claims based on Sandoz's failure to provide the FDA required Medication Guide to James."
[Plaintiff's Response in Opposition to Sandoz's Motion to Dismiss the Amended Complaint, ECF
No. 25 at 1]. Plaintiffs' common law negligence claim based on Sandoz's failure to provide a
Medication Guide was dismissed as impliedly preempted under Buckman v. Plaintiffs' Legal
Comm., 531 U.S. 341 (2001) and 21 U.S.C. § 337(a) because the requirement to provide a
Medication Guide to distributors is based solely on the requirements of the FDCA and related
regulations, and there is no parallel duty to provide a Medication Guide under South Carolina law.
Additionally, under South Carolina law and the learned intermediary doctrine, the manufacturer's
duty to warn extends only to the prescribing physician, not the patient. See 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
To the extent Plaintiffs attempt to re-allege failure to warn claims based on Sandoz's failure
to provide a Medication Guide, those claims have already been dismissed with prejudice and are not
properly before this Court.
The only claims properly before the Court at this stage are Plaintiffs' fraudulent off-label
marketing claim and the loss of consortium claim based on the alleged fraudulent off-label
marketing. In the March 31, 2017 Order, the Court found that Plaintiffs' fraudulent off-label
marketing claim failed to state a plausible claim because it did not contain facts sufficient to
establish causation in light of the learned intermediary doctrine. The Court then permitted Plaintiffs
to file an Amended Complaint to cure the causation defect with Plaintiffs' fraudulent off-label
The question now is whether Plaintiffs' Amended Complaint states facts sufficient to
establish causation under the learned intermediary doctrine. Under the learned intermediary
doctrine, “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. 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 again have failed to state facts sufficient to establish causation under the learned
intermediary doctrine. Plaintiffs' response in opposition to Sandoz's motion to dismiss the Amended
Complaint does not even address the learned intermediary doctrine and appears to focus on the
already dismissed claims based on Sandoz's alleged failure to provide a Medication Guide.
Plaintiffs' Amended Complaint alleges "[t]he most serious side effect of amiodarone and the
one requiring the patient Medication Guide is pulmonary toxicity-lung disease." [Amended
Complaint, ECF No. 23 at ¶ 83]. Plaintiffs contend that the prescribing physicians were misled
regarding the safety and efficacy of amiodarone for the off-label use of treating non-life threatening
atrial fibrillation but Plaintiffs do not allege that the prescribing physicians were unaware of the
"most serious side effect."2 Like the original Complaint, the Amended Complaint does not allege
that Plaintiff's prescribing physicians were unaware that pulmonary toxicity-lung disease was a side
effect of amiodarone. The Amended Complaint does not allege that Plaintiff's prescribing
physicians would have changed their decision to prescribe amiodarone had they been aware of the
risk of pulmonary toxicity-lung disease. Accordingly, 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.3 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).
Upon further consideration, the Court also finds that Plaintiffs' fraudulent "off-label"
marketing claim would be preempted under 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) for the reasons stated
in Bean v. Upsher-Smith Pharms., Inc., No.: 4:16-cv-01696-RBH, 2017 WL 4348330, at *4-6
(D.S.C. Sept. 29, 2017).4
The Court anticipates Plaintiffs would have a problem securing testimony from the prescribing
physicians that they were unaware of the most serious side effect of a drug they were actively prescribing,
especially when that side effect was disclosed in a Medication Guide. Such a lack of awareness on the part
of the prescribing physician could arguably amount to medical malpractice.
The Fourth Circuit has applied the learned intermediary doctrine to a fraud case brought under
Virginia law. This Court predicts that South Carolina courts would also apply the doctrine in a fraud case
regarding prescription drugs involving misbranding or the failure to warn. See Talley v. Danek Medical,
Inc., 179 F.3d 154 (4th Cir. 1999).
In Mensing, the plaintiffs alleged that they were injured after consuming generic metoclopramide
and asserted an array of state law claims against the generic product's manufacturers, including strict
liability failure to warn, negligent failure to warn, breach of express and implied warranties,
misrepresentation, fraud, unfair trade practices, false advertising, and consumer fraud. The Supreme Court
held that all state law tort claims involving generic drugs that impose a duty to change a drug's label are
preempted by federal law. Mensing, 564 U.S. at 609.
Mensing and Bartlett establish that under the FDCA a generic drug manufacturer, such as Sandoz,
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. Drager v.
PLIVA USA, Inc., 741 F.3d 470, 476 (4th Cir. 2014).
Within their response to the motion to dismiss, Plaintiffs request leave to amend the
complaint a second time. Rule 15(a)(2) of the Federal Rules of Civil Procedure directs that leave to
amend "shall be freely given when justice so requires." Leave to amend a pleading should be denied
only when the amendment would be prejudicial to the opposing party, there has been bad faith on
the part of the moving party, or the amendment would have been futile. See Johnson v. Oroweat
Foods Co., 785 F.2d 503, 509 (4th Cir. 1986). In this case, Plaintiffs do not elaborate as to what
amendments they would make to the Amended Complaint but instead generally request leave to
amend. Leave to amend is properly denied where the requested leave to amend is not accompanied
by a motion to amend or a proposed amended complaint. See Cozzarelli v. Inspire Pharms., Inc.,
549 F.3d 618, 630-31 (4th Cir. 2008) (finding no abuse of discretion where plaintiffs requested
leave to amend in a response but did not file a motion to amend or a proposed amended complaint).
Accordingly, in the absence of a motion to amend accompanied by a proposed Second Amended
Complaint, Plaintiffs' request to amend is denied. Furthermore, as discussed above, Plaintiffs'
In Drager, the Fourth Circuit found plaintiff's state law claims for negligent marketing, strict
liability, breach of express and implied warranty, negligent misrepresentation, and fraudulent
concealment were preempted by the FDCA. 741 F.3d 470. Specifically, the plaintiff in Drager alleged that
PLIVA made negligent misrepresentations and fraudulently concealed information about the safety of its
product from consumers and medical professionals. Id. at 479. Finding preemption, the Fourth Circuit
stated "[a]ssuming that PLIVA's representations are false and misleading because its metoclopramide is
unreasonably unsafe as marketed, it has no authority to add or remove information from its materials or to
change the formulation of the product to make its representations complete or truthful. Id. PLIVA's only
remaining options were to leave the market or accept tort liability. Id. As a result, the Fourth Circuit found
plaintiff's misrepresentation and fraudulent concealment claims were preempted by the FDCA. Id.
In this case, the basis for Plaintiff's "off-label" marketing claim 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. Under the FDCA and FDA regulations, Sandoz
could not add or strengthen any warnings for amiodarone to address any risks associated with off-label use.
If successful, Plaintiff's "off-label" promotion claims would necessarily require Sandoz 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; 2) accept state tort liability; or 3) exit the
market place. As with the claims in Drager v. PLIVA USA, Inc., 741 F.3d 470, 476 (4th Cir. 2014), such a
result requires preemption under Mensing and Bartlett. Plaintiffs' fraudulent "off-label" promotion claim is
preempted by the FDCA.
fraudulent "off-label" marketing claim is preempted by federal law. Any proposed amendment to
the complaint would most likely be futile.
Plaintiffs' loss of consortium claim, which is derivative and premised solely on dismissed
and preempted claims, is also dismissed.
For the reasons stated above, Defendant Sandoz, Inc.’s [ECF No. 24] motion to dismiss the
Amended Complaint is GRANTED. This case is DISMISSED with prejudice.
IT IS SO ORDERED.
March 23, 2018
Florence, South Carolina
s/ R. Bryan Harwell
R. Bryan Harwell
United States District Judge
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