Elliot v. Sandoz Inc

Filing 15

MEMORANDUM OPINION. Signed by Judge R David Proctor on 8/18/2016. (KAM, )

FILED
2016 Aug-18 AM 11:53
U.S. DISTRICT COURT
N.D. OF ALABAMA

UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF ALABAMA
SOUTHERN DIVISION

FRANCES ELLIOTT, as Executor of the
}
Estate of CHARLES EDWARD ELLIOTT, }
Deceased,
}
}
Plaintiff,
}
}
v.
}
}
SANDOZ, INC.,
}
}
Defendant.
}

Case No.: 2:16-cv-00861-RDP

MEMORANDUM OPINION
I.

Introduction
This case is before the court on Defendant’s Motion to Dismiss Plaintiff’s Complaint

(Doc. # 5), filed July 5, 2016. The Motion is fully briefed. (Docs. # 6, 12, 14). After careful
review, and for the reasons stated below, the court concludes that the Motion is due to be
granted.
II.

Background Facts and Procedural History 1
Plaintiff filed her complaint on behalf of her deceased husband’s estate on May 25, 2016,

alleging a wrongful death claim against Defendant based on Defendant’s failure to warn, offlabel promotion, 2 negligence, and failure to provide Medication Guides to the decedent. (Doc. #
1). Defendant is a New Jersey corporation with its principal place of business in New Jersey.

1

“A Rule 12(b)(6) motion questions the legal sufficiency of a complaint; therefore, in assessing the merit
of a Rule 12(b)(6) motion, the court must assume that all the factual allegations set forth in the complaint are true.”
Mays v. United States Postal Service, 928 F. Supp. 1552, 1557-58 (M.D. Ala. 1996). Thus, for the purpose of
resolving Defendant’s Motion, the court treats the facts alleged in the Complaint as true.
2

“Off-label” refers to the use of a drug for a purpose other than its FDA approved use. (Doc. # 1 at ¶ 30).

(Doc. # 1 at ¶ 19). It is involved in the manufacture, distribution, marketing, sale, labeling, and
design of amiodarone both in the State of Alabama and throughout the United States. (Id.).
Charles E. Elliott (“Decedent”), resided in Vincent, Alabama before his death on June 8,
2015. (Doc. # 1 at ¶ 17). Plaintiff, Decedent’s widow and Executor of his Estate, resides in
Vincent, Alabama.

(Id. at ¶ 18).

Decedent was diagnosed with atrial fibrillation but the

condition was not considered to be life threatening. (Id. at ¶ 33). Beginning in March 2015, and
continuing through May 2015, Dr. Christopher King (a non-party to this case) prescribed him a
course of 200 mg amiodarone hydrochloride (“amiodarone”) tablets for treatment of his non-life
threatening atrial fibrillation. (Id. at ¶ 34). Amiodarone is the generic for Cordarone®, a
medication initially produced by the brand manufacturer (and non-party) Wyeth. (Id. at ¶ 28).
Decedent filled the prescription at (non-party) The Medicine Chest Pharmacy and ingested the
drug according to his physician’s instructions. (Id.). He did not receive a Medication Guide
from his pharmacist because, Plaintiff avers, Defendant did not provide them to The Medicine
Chest Pharmacy. (Id.). Decedent was unaware that his use of the amiodarone was for an offlabel use. (Id. at ¶¶ 36, 39).
Decedent’s prescription for the amiodarone tablets were marked with the numbers 001850144-60 which identified the tablets as manufactured, marketed, and distributed by Defendant.
(Doc. # 1 at ¶ 35). After taking the amiodarone tablets, Decedent began experiencing the
following side-effects (which are the side-effects listed in the Medication Guide): lung damage,
shortness of breath, wheezing, trouble breathing, coughing, tiredness, weakness, nervousness,
irritability, restlessness, decreased concentration, and depression. (Id. at ¶¶ 38, 43). The effects
of amiodarone are extremely long lasting, and can continue to affect patients long after they
cease to use the drug, and cause serious pulmonary injuries. (Id. at ¶ 40). Decedent was

2

admitted to St. Vincent’s East in May 2015, with severe pulmonary issues. (Id. at ¶ 45). He
subsequently died from complications arising from the amiodarone tablets in June 2015. (Id. at ¶
1).
Wyeth received FDA approval to market and sell Cordarone® only as a drug of last
resort for patients suffering from documented recurrent life-threatening ventricular fibrillation
and ventricular tachycardia. (Id. at ¶¶ 9, 29). Wyeth’s FDA approval did not require the usual
mandated, rigorous trials; rather, the FDA approved double-blind, randomized clinical trials. (Id.
at ¶¶ 28, 73). Wyeth has never conducted such trials. (Id.). The FDA approval for Cordarone®
is a “special needs” approval. (Id. at ¶ 28)
Wyeth aggressively and successfully marketed Cordarone® for off-label uses as a “first
line anti-arrhythmic therapy.” (Id. at ¶ 29). The campaign for making Cordarone® a “first-line”
anti-arrhythmic drug was so successful that it prompted the FDA to warn Wyeth that promoting
an off-label use of the drug is unlawful. (Id. at ¶ 30). In 1998, Wyeth received approval for the
manufacturing, marketing, sale, and distribution of the generic formulation of Cordarone®,
amiodarone hydrochloride. (Id. at ¶ 31).
Defendant began producing the generic amiodarone in 1988. (Doc. # 1 at ¶¶ 3, 31).
Defendant’s generic drug is subject to the same advertising, marketing, and promotional
requirements and restrictions set forth by the FDA for Wyeth in their advertising, marketing, and
promotion of Cordarone®. (Id. at ¶ 31, citing 21 U.S.C. § 355(j)). One of these requirements is
Defendant’s production of a Medication Guide, which contains the appropriate and up-to-date
warning labels, to ultimately be given directly to patients in order to ensure that patients have
access to important side-effect information. (Doc. # 1 at ¶ 41 (citing 21 C.F.R. § 208.24)).

3

Pursuant to 21 C.F.R.. § 208.24 a manufacturer of a drug (such as Defendant) is required to
ensure that Medication Guides are available for distribution to patients by either:
(1) Providing Medication Guides in sufficient numbers to distributors, packers, or
authorized dispensers to permit the authorized dispenser to provide a
Medication Guide to each patient receiving a prescription for the drug
product; or
(2) Providing the means to produce Medication Guides in sufficient numbers to
distributors, packers, or authorized dispensers to permit the authorized
dispenser to provide a Medication Guide to each patient receiving a
prescription for the drug product.
Decedent did not receive a Medication Guide from Defendant. (Doc. # 1 at ¶ 37). Because
neither Defendant nor Decedent’s pharmacist provided a Medication Guide, Decedent was not
aware that amiodarone “should only be used in adults with life-threatening heartbeat problems
called ventricular arrhythmias,” and even then only when “other treatments did not work or were
not tolerated.” (Id. at ¶ 39, quoting the Medication Guide for amiodarone HCI3).
Plaintiff alleges Defendant has benefitted from Wyeth’s marketing campaign. (Doc. # 1
at ¶¶ 31, 32). Defendant and its agents also “actively promoted” the amiodarone it manufactured
for off-label use. (Id. at ¶¶ 3, 53-55, 61, 69). Its “pervasive” promotional scheme allegedly
“involved and continues to involve a calculated and deceitful sales and promotional campaign”
that was fraudulent in nature. (Id. at ¶¶ 5, 63-65, 67). There are strict FDA regulations about the
form and contents of such promotions, and it is unlawful for a manufacturer to promote any drug
for a use not described in the approved labeling of the drug. (Id. at ¶ 6). See also 21 U.S.C. §§
331, 352. Plaintiff contends Defendant saw a significant profit potential in off-label promotion
of amiodarone with the knowledge of its dangers when used off-label. (Doc. # 1 at ¶¶ 11-12).
Plaintiff asserts that Defendant was aware at the time of Decedent’s death that
amiodarone was being prescribed for off-label purposes. (Doc. # 1 at ¶ 13). She also alleges that
3

The Medication Guide is available at http://www.fda.gov/downloads/Drugs/DrugSafety/UCM152841.pdf.

4

Defendant was and is aware, or should have been aware, of the risks and dangers of using
amiodarone for its off-label purpose. (Id. at ¶¶ 47-49, 51, 60). Further, Plaintiff asserts that at
all times, Defendant designed, created, tested, developed, labeled, sterilized, packaged,
manufactured, marketed, promoted, advertised, distributed, sold, warned, and otherwise caused
amiodarone to be placed into the stream of commerce. (Id. at ¶70). And, Plaintiff avers, but for
Defendant’s “negligent actions,” Decedent would not have ingested amiodarone. (Id. at ¶ 88).
Plaintiff filed this lawsuit, seeking compensatory damages, applicable interest, costs of
suit, attorneys’ fees, and all other relief the court deems proper under a wrongful death claim.
(Doc. # 1). Defendant responded by filing its Motion to Dismiss pursuant to Federal Rule of
Civil Procedure 12(b)(6). (Doc. # 5). In the Motion, Defendant argues that the claims against it
should be dismissed because they are preempted by federal law and, in the alternative, are
insufficiently pled. (Doc. # 6).
III.

Standard of Review
The Federal Rules of Civil Procedure require only that the complaint provide “a short and

plain statement of the claim showing that the pleaser is entitled to relief.” Fed. R. Civ. P. 8(a)(2).
However, the complaint must include enough facts “to raise a right to relief above the
speculative level.” Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555 (2007). Pleadings that
contain nothing more than “a formulaic recitation of the elements of a cause of action” do not
meet Rule 8 standards, nor do pleadings suffice that are based merely upon “labels and
conclusions” or “naked assertion[s]” without supporting factual allegations. Twombly, 550 U.S.
at 555, 557. In deciding a Rule 12(b)(6) motion to dismiss, courts view the allegations in the
complaint in the light most favorable to the non-moving party. Watts v. Fla. Intl. Univ., 495 F.3d
1289, 1295 (11th Cir. 2007).

5

To survive a motion to dismiss, a complaint must “state a claim to relief that is plausible
on its face.” Twombly, 550 U.S. at 570. “A claim has facial plausibility when the plaintiff
pleads factual content that allows the court to draw the reasonable inference that the defendant is
liable for the misconduct alleged.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). Although “[t]he
plausibility standard is not akin to a ‘probability requirement,’” the complaint must demonstrate
“more than a sheer possibility that a defendant has acted unlawfully.” Id. A plausible claim for
relief requires “enough fact[s] to raise a reasonable expectation that discovery will reveal
evidence” to support the claim. Twombly, 550 U.S. at 556.
In considering a motion to dismiss, a court should “1) eliminate any allegations in the
complaint that are merely legal conclusions; and 2) where there are well-pleaded factual
allegations, ‘assume their veracity and then determine whether they plausibly give rise to an
entitlement to relief.’” Kivisto v. Miller, Candield, Paddock & Stone, PLC, 413 Fed. Appx. 136,
138 (11th Cir. 2011) (quoting Am. Dental Assn. v. Cigna Corp., 605 F.3d 1283, 1290 (11th Cir.
2010)). That task is context specific and, to survive the motion, the allegations must permit the
court based on its “judicial experience and common sense . . . to infer more than the mere
possibility of misconduct.” Twombly, 550 U.S. at 556. Further, “courts may infer from the
factual allegations in the complaint ‘obvious alternative explanation[s],’ which suggest lawful
conduct rather than the unlawful conduct the plaintiff would ask the court to infer.” Am. Dental ,
605 F.3d at 1290 (quoting Iqbal, 556 U.S. at 682). If the court determines that well-pleaded
facts, accepted as true, do not state a claim that is plausible, the claims are due to be dismissed.
Twombly, 550 U.S. at 556.
IV.

Analysis
Plaintiff brings a wrongful death cause of action, claiming (1) a failure to warn by

6

Defendant (based upon Decedent not receiving a Medication Guide), and (2) negligently
fraudulent marketing.

(Doc. # 1).

Under Alabama's wrongful death statute, the personal

representative of a deceased individual can bring suit to recover damages for "the wrongful act,
omission, or negligence of any person, persons, or corporation" that resulted in the Decedent’s
death. Ala. Code § 6-5-410. Fraud in Alabama is committed when “[m]isrepresentations of a
material fact made willfully to deceive, or recklessly without knowledge, and acted on by the
opposite party, or if made by mistake and innocently and acted on by the opposite party.” Code
of Ala. § 6-5-101.
Defendant makes two arguments in its Motion to Dismiss.

First, it contends that

Plaintiff’s claims are preempted by federal law under the precedent set forth in PLIVA, Inc. v.
Mensing, 131 S. Ct. 2567 (2011), Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013),
Guarino v. Wyeth, LLC, 719 F.3d 1245 (11th Cir. 2013), and Metz v. Wyeth LLC, 525 Fed. Appx.
893 (11th Cir. 2013) (per curiam). Second, and alternatively, Defendant contends that Plaintiff’s
claims are insufficiently pled.
A. Plaintiff’s Failure To Warn Claims Are Preempted
A court may dismiss a complaint when the claim hinges on a dispositive issue of law and
a defendant shows it is entitled to judgment as a matter of law based on a plaintiff’s pleadings.
Marshall County Bd. Of Educ. v. Marshall County Gas Dist., 992 F.2d 1171, 1174 (11th Cir.
1993).

Defendant argues that Mensing and its progeny preempt Plaintiff’s claims because

Plaintiff’s “allegations necessarily contend Defendant’s labeling should have contained different
or additional warnings.” (Doc. # 6, pp. 8-9).
The Supreme Court held in Mensing that when state laws require stricter warning labels
on generic drugs than federal regulations permit, the Supremacy Clause causes the federal

7

regulations to preempt the state law. Mensing, 131 S. Ct. at 2577. Subsequently, in Bartlett, the
Court reaffirmed the holding of Mensing, ruling that New Hampshire’s de facto additional
warning requirements were preempted by federal regulations. 4 Bartlett, 133 S. Ct. at 2470.
The Eleventh Circuit expanded the scope of Mensing in its Guarino decision. In Guarino
, our circuit rejected an argument that would have required generic drug manufacturers to notify
pharmacists and doctors of required label changes. Guarino, 719 F.3d at 1249 (“Were we to
accept the failure-to-communicate theory, generic manufacturers such as Teva would need to
take affirmative action to notify consumers, doctors, or pharmacists of FDA-approved changes to
the drug label in order to avoid liability. Yet ‘[b]ecause the duty of sameness prohibits the
generic manufacturers from taking such action unilaterally, they are dependent on brand-names
taking the lead.’”), quoting Morris v. Pliva, Inc., 713 F.3d 774, 777 (5th Cir. 2013). In Metz, a
panel, citing Guarino, recognized Mensing as the law of the land. See Metz, 525 Fed. Appx. at
893.
In order to determine if Mensing preempts Plaintiff’s claims here, the court must examine
Plaintiff’s stated cause of action. Plaintiff explains her cause of action as follows:
The death of Charles Elliott was directly and proximately caused by the negligent
actions of [Defendant] in the off-label and other negligent promotional and
marketing activities associated with the sale of amiodarone and the negligent
actions of Defendant . . . for their failure to warn by providing up to date and
required labeling and to provide Medication Guides to distributors for the ultimate
4

Specifically, the Court wrote:

New Hampshire law imposes a duty on manufacturers to ensure that the drugs they market are not
unreasonably unsafe, and a drug’s safety is evaluated by reference to both its chemical properties
and the adequacy of its warnings. Because Mutual was unable to change sulindac’s composition
as a matter of both federal law and basic chemistry, New Hampshire’s design-defect cause of
action effectively required Mutual to change sulindac’s labeling to provide stronger warnings. But,
as this Court recognized just two Terms ago in [Mensing], federal law prohibits generic drug
manufacturers from independently changing their drugs’ labels. Accordingly, state law imposed a
duty on Mutual not to comply with federal law. Under the Supremacy Clause, state laws that
require a private party to violate federal law are pre-empted and, thus, are without effect.
Bartlett, 133 S. Ct. at 2470 (internal citations and quotations omitted).

8

distribution of the Medication Guides to patients as required by FDA rules and
regulations and as generally related to the manufacture, marketing, distribution
and sale of Cordarone®/amiodarone as described herein.
(Doc. # 1, p. 26). She argues that, correctly interpreted, her cause of action asserts a wrongful
death claim based upon of Defendant’s negligent failure to follow FDA regulations.
Accordingly, she contends, Mensing and its progeny do not apply because Defendant is alleged
to have violated both state and federal law. (Doc. # 12, p. 10). And, as the argument goes,
because the suit arises from Defendant’s failure to follow federal law, there is nothing to
preempt. (Id., citing Whitener v. PLIVA, Inc., No. 10-cv-1552, 2012 WL 3948797 (E.D. La.
Sept. 10, 2012)). The court disagrees.
Even if the court accepts arguendo that Plaintiff is correct and an exception to Mensing
exists when a defendant violates FDA regulations, her argument runs into a different hurdle in
the form of 21 U.S.C. § 337(a). Section 337(a) provides that “[e]xcept as provided in subsection
(b), all such proceedings for the enforcement, or to restrain violations, of [the Federal Food,
Drug, and Cosmetic Act] shall be by and in the name of the United States.” 21 U.S.C. § 337(a).
Subsection (b) allows a state to bring suit “in its own name and within in its jurisdiction
proceedings” of concerning enforcement or violation of specified sections of Title 21 of the
United States Code, in certain situations. See id. at § 337(b).
The Supreme Court has held that “that it is the Federal Government rather than private
litigants who are authorized to file suit for noncompliance with the medical device provisions.”
Byckman v. Plaintiffs’ Legal Comm., 531 U.S. 341, 349 n.4 (2001). However, there has been
discord in circuit and district courts as to whether Byckman and section 337(a) preclude a claim
that is based on a defendant not following FDA regulations. See Allain v. Wyeth Pharms., Inc.,
No. 14-cv-280, 2015 WL 3948961, at *8 (N.D. Ala. June 29, 2015) (“Mr. Allain may not bring

9

suit against the Defendants for their alleged violation of the FDCA [to [provide Medication
Guides] because 21 U.S.C. § 337(a) specifically prohibits enforcement of the FDCA's provisions
by private litigants.”); Hafer v. Medtronic, Inc., 99 F. Supp. 3d 844, 862 (W.D. Tenn. 2015) (“If
Plaintiffs claim negligence based solely on Defendants' failure to comply with federal law or
solely on illegal off-label promotion (i.e. negligence per se), Plaintiffs' claims are impliedly
preempted under Byckman.”); Blankenship v. Medtronic, Inc., 6 F. Supp. 3d 979, 990 (E.D. Mo.
2014) (“Although Missouri products liability law supports recovery under a negligence theory,
the conduct plaintiff complains of relates to Medtronic's promotion of the Infuse device for the
off-label uses, which is a negligence “claim [that] would not exist if the FDCA did not exist.”)
(quoting Linegar v. Armour of America, 909 F.2d 1150, 1152-53 (8th Cir. 1990)). But see Bass v.
Stryker Corp., 669 F.3d 501, 514 (5th Cir. 2012) (“Purcel also indicated that 21 U.S.C. § 337(a)
did not preempt negligence and products liability causes of action under Texas law.”).
The court finds the argument in favor of preemption is persuasive. Plaintiff seeks to sue
Defendant for an alleged violation of federal law and regulations—that is, Defendant’s failure to
provide the Medication Guide. (See Doc. # 12, p. 1 (“[Plaintiff]’s complaint alleges commonlaw negligent failure-to-warn claims based on [Defendant]’s failure to provide the FDA required
Medication Guide” to decedent.”)). The duty of Defendant to provide Medication Guides to
pharmacies (i.e., “distributors, packers, or authorized dispensers”) arises solely under federal
law. See 21 C.F.R. § 208.24(b). (Defendant has no duty to provide Medication Guides to
patients). Even if Mensing and its progeny do not apply in this case (which is doubtful because
Plaintiff is ultimately arguing a “failure to communicate” theory reminiscent of that asserted in
Guarino, 719 F.3d 1245), Plaintiff’s claim that Defendant was negligent for failing to provide
Medication Guides to Decedent is preempted by section 337(a).

10

Ultimately, Plaintiff seeks recovery because she alleges Defendant violated FDA
regulations. Although Plaintiff couches that claim under a negligence standard, granting relief
would essentially hold Defendant liable for not following federal law and regulations. This
amounts to an attempt to end run around section 337(a). Plaintiff’s failure to warn claims fail as
a matter of law.
B. The Learned-Intermediary Doctrine Bars Plaintiff’s Failure To Warn Claims
Plaintiff asserts in her opposition brief that Defendant also failed to adequately warn the
medical community, including Dr. King, of the dangers of the generic amiodarone. (Doc. # 12).
That claim is derived from a mixture of Plaintiff’s fraudulent marketing and failure to warn
claim (analyzed above). Accordingly, the court concludes for the reasons stated above that any
such failure to warn the medical community claim is preempted.
But even if Plaintiff’s failure to warn claim were not preempted, it is barred as a matter of
law for another reason: the learned-intermediary doctrine. “Alabama’s learned intermediary
doctrine imposes on a prescription drug company a duty to provide warnings solely to the
prescribing physician rather than to the patient directly.” Allain, 2015 WL3948961, at *8 (citing
Stone v. Smith, Kline & French Labs., 447 So. 2d 1301, 1304 (Ala. 1984)) (additional citations
omitted). The Alabama Supreme Court has stated that:
[t]he principle behind the learned-intermediary doctrine is that prescribing
physicians act as learned intermediaries between a manufacturer of a drug and the
consumer/patient and that, therefore, the physician stands in the best position to
evaluate a patient’s needs and to assess the risks and benefits of a particular
course of treatment for the patient.
Wyeth, Inc. v. Weeks, 159 So. 3d 649, 672-73 (Ala. 2014).

This doctrine exists because

consumers can obtain prescription drugs only though a physician or other qualified healthcare
provider, and physicians are trained to understand the highly technical warnings required by the

11

FDA in drug labeling. Id. at 673 (citing 21 U.S.C. § 353(b)(1); 21 C.F.R. § 201.56). The
doctrine “recognizes the role of the physician as a learned intermediary between a drug
manufacturer and a patient.” Id.
“Under the learned intermediary doctrine the adequacy of [Defendant’s] warning is
measured by its effect on the physician, to whom it owe[s] a duty to warn, and not by its effect
on the consumer.” Weeks, 159 So. 3d at 673 (quoting Toole v. Baxter Healthcare Corp., 235
F.3d 1307, 1313-14 (11th Cir. 2000)) (citations, quotations and changes omitted).

“A

prescription-drug manufacturer fulfills its duty to warn the ultimate users of the risks of its
product by providing adequate warnings to the learned intermediaries who prescribe the drug.
Once that duty is fulfilled, the manufacturer has no further duty to warn the patient directly.” Id.
(emphasis added).

To be sure, “[h]owever, if the warning to the learned intermediary is

inadequate or misrepresents the risk, the manufacturer remains liable for the injuries sustained by
the patient.” Id. But for this to be the case, a patient must make a specific showing:
that the manufacturer failed to warn the physician of a risk not otherwise known
to the physician and that the failure to warn was the actual and proximate cause of
the patient’s injury. In short, the patient must show that, but for the false
representation made in the warning, the prescribing physician would not have
prescribed the medication to his patient.
Id. at 673-74.
Here, the learned intermediary doctrine bars Plaintiff’s failure to warn claim for two
reasons. First, Plaintiff has not pleaded any plausible facts that show Defendant failed to
adequately warn Dr. King of the dangers of amiodarone. Instead, she has made a conclusory
statement that “Defendant failed to provide adequate and required warnings to physicians” (Doc.
# 1 at ¶ 60), which the court disregards. Further, she has alleged general, conclusory statements
concerning promotions, marketing, and education given to medical providers, but has not set

12

forth any facts suggesting Dr. King was the target of or influenced by any of these actions. (See
Doc. # 1). Again, the court must disregard those conclusory allegations.
Second, Plaintiff has not shown that Defendant was the amiodarone manufacturer that
allegedly failed to adequately warn Dr. King about the dangers of amiodarone. Again, the legal
principle applicable here is that:
FDA regulations require that a generic manufacturer’s labeling for a prescription
drug be exactly the same as the brand-name manufacturer’s labeling. The
Supreme Court in [Mensing] held that it would have been impossible for the
generic manufacturers to change their warning labels without violating the federal
requirement that the warning on a generic drug must match the warning on the
brand-name version, preempting failure-to-warn claims against generic
manufacturers.
Weeks, 159 So.3d at 677. Defendant owed a duty under FDA mandates to provide the same
warning as that provided by Wyeth. 5 The court has determined that Plaintiff’s claims that it
failed to do so are preempted by Mensing.
Finally, as already noted, Defendant is not the only manufacturer of amiodarone. Wyeth
is, of course, one such manufacturer.

The court takes judicial notice that other generic

manufacturers of amiodarone include Upsher-Smith Laboratories, Inc., Teva Pharmaceuticals
USA, Inc., and Barr Laboratories, Inc. See Allain, 2015 WL 3948961, at *1; Stephens v. Teva
Pharms., U.S.A., 70 F. Supp. 3d 1246, 1247 (N.D. Ala. 2014). Although Decedent’s prescription
was filled with amiodarone pills bearing a number indicating Defendant manufactured them, any
of the foregoing amiodarone manufacturers may (or may not) have influenced or warned Dr.
King (adequately or inadequately) concerning off-label use of amiodarone. The Complaint does
5

To be sure, Defendant may have been able to provide additional information outside of drug labels to
physicians to those required by the FDA, but the court is not convinced that it had any legal duty to do so, and is
doubtful that it is even authorized to do so. See Morris v. PLIVA, Inc., 713 F.3d 774, 777 (5th Cir. 2013) (quoting
Mensing, 131 S. Ct. at 2576) (“[I]f generic manufacturers, but not the brand-name manufacturer, sent [additional
warnings such as a ‘Dear Doctor’ letters], that would inaccurately imply a therapeutic difference between the brand
and generic drugs and thus could be impermissibly ‘misleading.’”). Cf. also Morris, 713 at 777 (observing that “it is
logically incoherent to contend that PLIVA had a duty to apply the 2004 warning label when Appellants also assert
repeatedly that no labels predating 2009 were adequate”).

13

not provide any allegations that it was Defendant’s failure to adequately warn Dr. King that
proximately caused Plaintiff’s death. Accordingly, the learned-intermediary doctrine also bars
Plaintiff’s failure to warn claim. 6
C. Plaintiff’s Off-Label Marketing Claim Is Due To Be Dismissed
Plaintiff has also alleged that Defendant engaged in a pervasive scheme of promotion and
marketing amiodarone for off-label use, despite being aware of its dangers when so used.
Although she characterizes her claim as one for negligent marking and negligent
misrepresentations, the claim is pleaded in the nature of one for purposeful, knowing, or reckless
fraud.
Under Alabama law, “[m]isrepresentations of a material fact made willfully to deceive, or
recklessly without knowledge, and acted on by the opposite party, or if made by mistake and
innocently and acted on by the opposite party, constitute legal fraud.” Ala. Code § 6-5-101. “A
claim of fraudulent misrepresentation comprises the following elements: ‘(1) a false
representation (2) concerning a material fact (3) relied upon by the plaintiff (4) who was
damaged as a proximate result.” Weeks, 159 So. 3d at 656 (quoting Fisher v. Comer Plantation,
772 So, 2d 455, 463 (Ala. 2000)) (additional citation omitted).
In federal court, a fraud claim must comply with Federal Rule of Civil Procedure 9(b).
Pursuant to Rule 9(b), when a party alleges fraud or mistake, she “must state with particularity
the circumstances constituting fraud or mistake. Malice, intent, knowledge, or other conditions
of a person’s mind may be alleged generally.” Fed. R. Civ. P. 9(b). Accordingly, a plaintiff
pursuing a fraudulent misrepresentation complaint must allege: “(1) the precise statements,
documents, or misrepresentations made; (2) the time, place, and person responsible for the
6

Although Plaintiff requests leave to amend her Complaint in the instance the court determines it fails to
state a claim, such an amendment would be futile for her failure to warn claims. Therefore, concerning these claims,
Plaintiff’s request is denied.

14

statement; (3) the content and manner in which these statements misled the Plaintiffs; and (4)
what the defendants gained by the alleged fraud.” Am. Dental Assn. v. Cigna Corp., 605 F.3d
1283, 1291 (11th Cir. 2010) (quoting Brooks v. Blue Cross & Blue Shield of Fla., Inc., 116 F.3d
1364, 1380-81 (11th Cir. 1997)). Of course, the heightened pleading requirements of Rule 9(b)
must also satisfy the plausibility mandate set forth in Twombly and Iqbal.

Unfortunately,

Plaintiff has failed to satisfy either requirement.
First, Plaintiff has provided only conclusory allegations concerning Defendant’s
marketing and promotional activities. For example, Plaintiff simply claims that Defendant “took
advantage of” and benefitted from Wyeth’s promotions (Doc. # 1 at ¶¶ 31, 32, 53). Plaintiff also
alleges, upon information and belief, that Defendant “and/or their agents’ pharmaceutical sales
representatives and materials and sources actively promoted their generic amiodarone in the
stream of commerce for the ‘off-label’ uses openly promoted by Wyeth.” (Id. at ¶ 54). She has
“offered no facts to support these allegations, and, thus, these allegations are quintessential
examples of the ‘naked assertion[s] devoid of further factual enhancement’ that the Supreme
Court declared to be insufficient to survive a motion to dismiss.” Allain, 2015 WL 3948961, at
*6 (quoting Iqbal, 556 U.S. at 678) (alteration in original).
Further, Plaintiff’s claim for fraudulent misrepresentation is also deficient under Rule
9(b). For example, in addition to the allegations discussed above, Plaintiff avers that “[a]t all
material times, Defendant respectively, also promoted amiodarone for heart conditions less
severe than life-threatening ventricular arrhythmia (the only purpose for which the drug
originally received FDA approval).” (Doc. # 1 at ¶ 62).

These allegations do not satisfy the

“precise statements” or the “time, place, and person” requirements of Rule 9(b). Plaintiff fails to
point to any statements made by Defendant (or its agents) that misled Decedent, Decedent’s

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physicians, or any physician. “[A] fraud claim fully accrues once any legally cognizable damage
has proximately resulted, i.e., once the plaintiff has ‘detrimentally’ relied on the fraud.” Weeks,
159 So. 3d at 672 (quoting Ex parte Haynes Downard Andra & Jones, LLP, 924 So. 2d 687, 694
(Ala. 2005)) (alteration in original).

Her Complaint does not set forth precisely when

Defendant’s alleged promotional and marketing scheme occurred and when Decedent,
Decedent’s physicians, or any other physicians may have heard or been influenced by that
scheme (other than a start date in the 1980s when Wyeth began its marketing campaign).
In sum, the allegations in the Complaint related to Defendant’s off-label promotion of
amiodarone are “woefully deficient and satisfy neither Rule 8 or Rule 9.” Allain, 2015 WL
3948961, at *7. Thus, Plaintiff’s claims against Defendant for its alleged off-label promotion of
amiodarone are due to be dismissed.
V.

Conclusion
For these reasons, the court concludes that Defendant’s Motion to Dismiss (Doc. # 5) is

due to be granted. Plaintiff’s failure to warn claims are due to be dismissed with prejudice, and
her off-label promotion of amiodarone claims are due to be dismissed without prejudice.
Plaintiff’s request to amend her Complaint is due to be granted (in part) insofar as it related to an
off-label promotion claim. At this point, it is not clear that Plaintiff cannot state such a claim
against Defendant.
A separate order shall be entered.
DONE and ORDERED this August 18, 2016.

_________________________________
R. DAVID PROCTOR
UNITED STATES DISTRICT JUDGE

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