Allain v. Wyeth-Ayerst Laboratories, Inc et al
MEMORANDUM OPINION Signed by Chief Judge Karon O Bowdre on 6/29/15. (SAC )
2015 Jun-29 AM 11:37
U.S. DISTRICT COURT
N.D. OF ALABAMA
IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF ALABAMA
MICHAEL W. ALLAIN, as Executor of the )
Estate of ROBERT EARL DREHER, SR., )
) Case No. 2:14-cv-00280-KOB
WYETH PHARMACEUTICALS, INC., et )
On February 14, 2014, Plaintiff Michael Allain, as executor of the estate of Robert Earl
Dreher Sr., brought suit against Defendants Wyeth Pharmaceuticals, Inc., Sandoz
Pharmaceuticals Corp., Novartis Pharmaceuticals Corp., and Upsher-Smith Laboratories, Inc.,1
asserting a claim for wrongful death. (Doc. 1). On January 14, 2015, this court dismissed
without prejudice Mr. Allain’s Complaint as insufficiently pled and for failing to state a claim
against the Defendants. (Doc. 32). Mr. Allain subsequently filed his First Amended Complaint,
again asserting a wrongful death claim against Upsher-Smith, Sandoz, and Wyeth.2 (Doc. 34).
This matter is now before the court on Upsher-Smith and Sandoz’s (“Generic Defendants”)
motions to dismiss. (Docs. 38 & 45). Also before the court is brand-name manufacturer
Wyeth’s motion to dismiss. (Doc. 36).
Defendant Upsher-Smith Laboratories, Inc. is incorrectly identified in the First Amended
Complaint as “Upsher-Pharmaceuticals, Inc.”
In his First Amended Complaint, Mr. Allain did not assert a claim against Novartis, and the
court subsequently dismissed Novartis from the case. (See Doc. 35).
In their current motions, the Defendants contend that Mr. Allain’s First Amended
Complaint fails to cure the deficiencies in his initial Complaint and that it still fails to state a
claim. For the reasons discussed below, the court will GRANT the Generic Defendants’ motions
and GRANT IN PART and DENY IN PART Wyeth’s motion.
I. Standard of Review
A Rule 12(b)(6) motion to dismiss attacks the legal sufficiency of the complaint.
Generally, the Federal Rules of Civil Procedure require only that the complaint provide “‘a short
and plain statement of the claim’ that will give the defendant fair notice of what the plaintiff’s
claim is and the grounds upon which it rests.” Conley v. Gibson, 355 U.S. 41, 47 (1957) (quoting
Fed. R. Civ. P. 8(a)). A plaintiff must provide the grounds for his entitlement, but Rule 8
generally does not require “detailed factual allegations.” Bell Atl. Corp. v. Twombly, 550 U.S.
544, 555 (2007) (quoting Conley, 355 U.S. at 47). It does, however, “demand more than an
unadorned, the-defendant-unlawfully-harmed-me accusation.” Ashcroft v. Iqbal, 566 U.S. 662,
The Supreme Court explained that “[t]o survive a motion to dismiss, a complaint must
contain sufficient factual matter, accepted as true, to ‘state a claim that is plausible on its face.’”
Iqbal, 556 U.S. at 678 (quoting Twombly, 550 U.S. at 570). To be plausible on its face, the claim
must contain enough facts that “allow the court to draw the reasonable inference that the
defendant is liable for the misconduct alleged.” Iqbal, 556 U.S. at 678. 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. (internal quotation
omitted). “Where a complaint pleads facts that are merely consistent with a defendant’s liability,
it stops short of the line between possibility and plausibility of entitlement to relief.” Id. (internal
FDA Regulatory Framework
Pursuant to the Federal Food, Drug, and Cosmetic Act (“FDCA”), the Food and Drug
Administration regulates the approval of both brand-name and generic drugs. See 21 C.F.R. §
314.50(c)(2)(1) (brand-name drugs); 21 C.F.R. § 314.94(a)(8) (generic drugs). Under the FDCA,
the requirements for obtaining FDA approval vary greatly depending on whether the
manufacturer is seeking approval for a new drug or is applying to manufacture a generic version
of an already approved drug. A manufacturer seeking approval of a new drug must demonstrate
that the drug is safe and effective, and that the proposed labeling of the drug is accurate and
adequate. See 21 U.S.C. § 355(b); 21 U.S.C. § 352(f)(2). In contrast, a generic manufacturer
seeking FDA approval must only demonstrate that the generic drug is chemically and practically
the bioequivalent of the brand-name drug and that the labeling is the same as that approved for
the brand-name drug. See 21 U.S.C. 355(j)(4)(G).
Statement of Facts
The following facts are taken from Mr. Allain’s First Amended Complaint and are
accepted as true for the purposes of the motions to dismiss.
FDA Approval of Cordarone
In 1985, Wyeth Pharmaceuticals received FDA approval to begin manufacturing and
selling Cordarone in the United States. Cordarone is a prescription drug approved as a “drug of
last resort” for patients suffering from life-threatening ventricular fibrillation or ventricular
tachycardia and is only to be used in situations where the patient’s condition would not respond
to other available drugs and therapies. Wyeth was the sole manufacturer of Cordarone from 1985
until Upsher-Smith and Sandoz received FDA approval to begin manufacturing and selling
generic versions of Cordarone in 1998. Upsher-Smith produced a generic version of Cordarone
known as Pacerone, and Sandoz produced a generic version known by the drug’s chemical name,
amiodarone hydrochloride. Both of the generic versions were the bioequivalent of Cordarone
and mirrored the warning labels of Cordarone.
Although the FDA approved the sale of Cordarone and its generic equivalents, Cordarone
was known to cause numerous side effects, the most serious of which is pulmonary lung disease.
Cordarone can cause two different types of lung disease. First, it can produce a pneumonia like
condition, which can cause shortness of breath and coughing. This condition usually improves
once the patient stops ingesting the drug. Second, it can cause stiffening of the lungs that
restricts a patient’s breathing. This condition can occur years after a patient finishes taking
Cordarone and can be fatal. Because of the serious side effects of Cordarone, the FDA required
that manufacturers of Cordarone and its generic counterparts either (1) provide 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,” or
(2) provide “the means to produce Medication Guides in sufficient numbers” for the distributor
of the drug to provide the guides to the consumers. See 21 C.F.R. § 208.24(b).
Mr. Dreher’s use of Generic Amiodarone
In February of 2011, Robert Dreher’s physician, Dr. Macy Smith, prescribed him a
ninety-day course of generic amiodarone tablets manufactured by Sandoz to treat Mr. Dreher’s
atrial fibrillation. Because Mr. Dreher suffered from atrial fibrillation, not ventricular
fibrillation, and because his condition was not life threatening, his use of the drug was considered
“off-label.” At the time Mr. Dreher filled his prescription, the pharmacy should have provided
Mr. Dreher with a medication guide. However, the pharmacy allegedly failed to do so because
Sandoz had not provided the medication guide to the pharmacy, as required by the FDA.
Because he did not receive a medication guide, Mr. Dreher was not informed of the risks of
amiodarone or that his use of the drug was considered “off-label.”
In August of 2011, Mr Dreher received a second prescription for a ninety-day course of
amiodarone from a physician at the Veterans Affairs office. That doctor prescribed Mr. Dreher a
ninety-day course of Pacerone manufactured by Upsher-Smith. Mr. Dreher’s use of Pacerone
was also “off-label.” When Mr. Dreher filled his prescription for Pacerone at his pharmacy, the
pharmacy again failed to provide a medication guide to Mr. Dreher warning of the risks of
Pacerone. This time, the pharmacy allegedly failed to do so because Upsher-Smith had failed to
fulfill its FDA mandated duty to provide the medication guides to the pharmacy.
From February 2011 to January 2012, Mr. Dreher experienced many of the symptoms
associated with amiodarone use, including shortness of breath, wheezing, trouble breathing,
coughing, and tiredness. Mr. Dreher’s condition continued to deteriorate, and, on February 15,
2012, Mr. Dreher passed away at the age of eighty four. Mr. Allain alleges that Mr. Dreher died
as a result of taking amiodarone.
Wyeth’s Off-Label Promotion of Cordarone
In 1985, the same year that the FDA approved Cordarone, Wyeth began aggressively
marketing the drug. Although Wyeth was aware of the serious side effects of Cordarone and that
Cordarone was approved only as a “drug of last resort,” it nevertheless promoted Cordarone for
“off-label” use —i.e. for a purpose other than that approved by the FDA. According to Mr.
Allain, “an entire generation of physicians” were misled by Wyeth’s marketing campaign and
Wyeth’s promotional activities “would have greatly affected” Mr. Dreher’s physicians’ decisions
to prescribed generic versions of Cordarone to Mr. Dreher. In addition to his allegations against
Wyeth, Mr. Allain also alleges that “Sandoz and Upsher Defendants’ and/or its agents’
pharmaceutical sales representatives actively promoted their generic amiodarone in the stream of
commerce for the ‘off-label’ uses openly promoted by Defendant Wyeth.” (Doc. 34, at 27). Mr.
Allain, however, fails to identify any specific methods by which the Generic Defendants
promoted the off-label use of amiodarone.
Following Mr. Dreher’s death, Mr. Allain, the executor of Mr. Dreher’s estate, brought
suit against the Defendants, asserting a single count of wrongful death. In that count, Mr. Allain
asserts that Mr. Dreher’s death was caused by “the negligent actions of Defendant Wyeth in the
long term promotional and marketing activities associated with the sale of amiodarone and the
failure to adequately inform physicians of the potential dangers associated with the drug” as well
as “the negligent actions of Defendants Sandoz and Upsher for their failure to provide up to date
labeling and to provide Medication Guides to distributors for the ultimate distribution of the
Medication Guides to patients as required by FDA rules and regulations.” (Doc. 34, at 37).
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 decedents death. Ala. Code § 6-5-410.
In the present case, Mr. Allain’s wrongful-death claim is premised on three alleged instances of
misconduct. First, Mr. Allain alleges that the Defendants failed to warn Mr. Dreher of the
dangers of amiodarone. Second, Mr. Allain alleges that the Defendants promoted amiodarone
for off-label use. Finally, Mr. Allain alleges that the Defendants are liable for Mr. Dreher’s death
because they failed to provide the Medication Guides to the pharmacy as required by FDA
regulations. This court will address each of Mr. Allain’s allegations in turn.
Adequacy of Amiodarone’s Warning Labels
Throughout his First Amended Complaint, Mr. Allain challenges the adequacy of the
warnings labels on the generic versions of amiodarone, he states:
[T]he Cordarone®/amiodarone/Pacerone®, manufactured and/or supplied by
Defendants was and is unaccompanied by proper warnings regarding all possible
adverse side effects . . . . (Doc. 34, at 28) (emphasis added)
Defendants failed to warn of material facts regarding the safety and efficacy of
Cordarone®/amiodarone/Pacerone®, such that this drug would likely have never
been approved, and no physician would have been able to prescribe this drug for use
in the United States. (Doc. 34, at 28) (emphasis added)
[T]he warnings for Cordarone®/amiodarone/Pacerone®, in effect during the relevant
time period were vague, incomplete, and/or otherwise wholly inadequate . . . . (Doc.
34, at 30) (emphasis added).
Based on that language, Mr. Allain appears to assert a claim for wrongful death based on
failure to warn and predicated on the alleged inadequacy of the Defendants’ warning labels.
However, in his response to the Defendants’ motions, Mr. Allain states he “does not allege that
the contents of the label should have been changed, but that the warnings in the form of the
Medication Guide were not provided in accordance with the FDA mandate.” (Doc. 42, at 13).
Thus, although the language in his First Amended Complaint indicates that he is asserting a
claim for failure to warn, Mr. Allain’s response establishes that he has disavowed any claim
against the Defendants premised on the adequacy or content of the warnings. As such, to the
extent that the First Amended Complaint could be read as asserting a failure-to-warn claim, it is
due to be dismissed with prejudice.
Additionally, even if Mr. Allain had not withdrawn such a claim against the Generic
Defendants, the claim would be preempted under PLIVA, Inc. v. Mensing, 131 S. Ct. 2567
(2011). In Mensing, the Supreme Court addressed impossibility preemption in the context of
failure-to-warn claims asserted against a generic-drug manufacturer. See id at 2573. The
plaintiff in Mensing argued that state law required the generic manufacturer to provide a stronger
warning on its drug label than the warning provided on the brand-name drug label. In addressing
the plaintiff's argument, the Court noted that under the FDCA, generic-drug manufacturers "have
an ongoing federal duty of ‘sameness,'" requiring generic-drug manufacturers to match the
equivalent brand-name manufacturer's labeling. Id. at 2575. Because the FDCA limits a generic
manufacturer’s ability to provide additional warnings on its drug, the Court held that failure-towarn claims against a generic manufacturer are preempted by federal law. See id. at 2577–78.
Thus, Mensing squarely precludes any suit against the Generic Defendants based on the alleged
inadequacy of amiodarone’s warnings, and Mr. Allain’s failure-to-warn claim against the Generic
Defendants would be due to be dismissed even if he had not withdrawn it.
Off-label Promotion of Amiodarone
Next, Mr. Allain asserts that the “Defendants” collectively “engaged in a massive and
fraudulent marketing and promotional scheme in which they aggressively and fraudulently
promoted Cordarone®/amiodarone for [off-label use].” (Doc. 34, at 29). Although Mr. Allain
alleges that both Wyeth and the Generic Defendants are liable for their participation in the
alleged off-label promotion of amiodarone, the specific factual allegations Mr. Allain asserts
against the Generic Defendants vary greatly from the allegations against Wyeth. As such, this
court will address Mr. Allain’s claim against the Generic Defendants separately from his claim
The Generic Defendants’ Off-Label Promotion of Amiodarone
The Generic Defendants contend that Mr. Allain’s claims against them for the off-label
promotion of amiodarone are preempted by Mensing. According to the Generic Defendants, Mr.
Allain’s claims are, at their core, failure-to-warn claims, and, as such, are barred by Mensing. In
response, Mr. Allain argues that Mensing only dealt with “label warnings and the inability of a
generic manufacturer to change the federally dictated labeling of the brand manufacturer.” (Doc.
48, at 11) (emphasis added). Because his allegation of “off-label” promotion does not relate to
the labeling of amiodarone, Mr. Allain contends that his claims are not barred by Mensing.
Though both Mr. Allain and the Generic Defendants present argument in support of their
positions, none of the parties point to any binding precedent addressing the impact of Mensing on
claims premised on a generic manufacturer’s promotion of its generic drug for off-label use.
This court, however, need not address the issue because, assuming arguendo that such claims are
not preempted by Mensing, Mr. Allain has still failed to plead sufficient factual allegations to
survive a motion to dismiss.
Mr. Allain’s First Amended Complaint suffers from the same deficiencies that led this
court to dismiss his initial complaint. Once again, Mr. Allain frequently lumps the Defendants
together and makes conclusory allegations that provide no basis for differentiating the alleged
misconduct of one Defendant from the other. For example, Mr. Allain makes the following allegations:
At all material times, Defendants marketed Cordarone/amiodarone/Pacerone, as
having approval, characteristics, uses, and benefits that the drug did not have.
At all material times, Defendants respectively, jointly and severally, did design,
create, test, develop, label, sterilize, package, manufacture, market, promote,
advertise, distribute, sell, warn, and/or otherwise caused the product to be placed into
the stream of commerce, and ultimately to be ingested by Robert Dreher, Sr.
At all material times, Defendants willfully failed and refused to actively and
affirmatively monitor Cordarone/amiodarone/Pacerone’s “off-label,” unapproved
uses insofar that such uses causes catastrophic injuries and death. Defendants,
however, continued to sell Cordarone/amiodarone/Pacerone for unapproved uses.
(Doc. 34, at 31–32). As this court informed Mr. Allain in its order dismissing his initial
complaint, such allegations are insufficient to satisfy Rule 8 because they fail to allege specific
instances of misconduct against specific defendants. (See doc. 31, at 6–7).
Even setting aside Mr. Allain’s propensity to lump the Defendants together, Mr. Allain
fails to assert any factual allegations in support of his claims against the Generic Defendants for
the off-label promotion of amiodarone. In the First Amended Complaint, Mr. Allain states that
“Sandoz and Upsher Defendants’ and/or its agents’ pharmaceutical sales representatives actively
promoted their generic amiodarone in the stream of commerce for the ‘off-label’ uses openly
promoted by Defendant Wyeth.” (Doc. 34, at 27). Mr. Allain also alleges that Upsher-Smith and
Sandoz “took advantage of the pervasive promotional activities of Defendant Wyeth and
[Upsher-Smith and Sandoz]’s generic version[s] of the drug directly benefitted from the decades
of marketing of the drug for ‘off-label’ uses by Defendant Wyeth.” (Doc. 34, at 10–11). He
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. Iqbal, 556 U.S. at 678 (internal
quotation omitted) (alteration in original).
In addition to being deficient under Rule 8, Mr. Allain’s claim for fraudulent
misrepresentation is also deficient under the heightened pleading requirements of Rule 9(b) of
the Federal Rules of Civil Procedure. See Ziemba v. Cascade Intern., Inc., 256 F.3d 1194, 1202
(11th Cir. 2001); Inman v. Am. Paramount Fin. 517 Fed. Appx. 744, 748 (11th Cir. 2013).
When pleading a fraud claim, “a plaintiff must allege: (1) the precise statements, documents, or
misrepresentations made; (2) the time, place, and person responsible for the statement; (3) the
content and manner in which these statements misled the [p]laintiff; and (4) what the defendants
gained by the alleged fraud.” Am. Dental Ass’n v. Cigna Corp., 605 F.3d 1283, 1291 (11th Cir.
2010) (internal citation omitted).
The allegations in Mr. Allain’s First Amended Complaint fall well short of that standard.
In his First Amended Complaint, Mr. Allain made the following allegations against the Generic
At all material time, [Defendants] simultaneously engaged in a massive and
fraudulent marketing and promotional scheme in which they aggressively and
fraudulently promoted Cordarone/amiodarone for uses never authorized by the FDA.
In fact, Defendants Marketed, promoted, and “pushed”
Cordarone/amiodarone/Pacerone, not as a drug of last resort, but as a drug suitable
as an initial therapy and to treat non-life threatening heart conditions. (Doc. 34, at
At all material times, Defendants respectively, jointly and severally, also promoted
Cordarone/amiodarone/Paceron for heart conditions less severe than life-threatening
ventricular arrhythmia (the only purpose for which the drug originally received FDA
approval). (Doc. 34, at 29).
[U]pon information and belief, Sandoz and Upsher Defendants’ and/or its agents’
pharmaceutical sales representatives actively promoted their generic amiodarone in
the stream of commerce for the “off-label” uses openly promoted by Defendant
Wyeth. (Doc. 34, at 27).
The Defendants . . . promoted and conspired together and with others to promote the
use of amiodarone as an initial, first-line therapy for arrhythmia and other heart
ailments. (Doc. 34, at 4).
These allegations satisfy neither the “precise statements” nor the “time, place, and
person” requirements of Rule 9(b). Mr. Allain fails to point to any statements made by either of
the Generic Defendants that misled Mr. Dreher, Mr. Dreher’s physicians, or any physician for
that matter. Without factual support, Mr. Allain’s general allegations that the Generic
Defendants engaged in a “massive and fraudulent marketing and promotional scheme” cannot
survive a motion to dismiss.
In sum, the allegations in the First Amended Complaint related to the Generic
Defendants’ involvement in the off-label promotion of amiodarone are woefully deficient and
satisfy neither Rule 8 or Rule 9. As such, Mr. Allain’s claims against the Generic Defendants for
their alleged off-label promotion of amiodarone are due to be dismissed. However, the court will
dismiss the claims without prejudice because it is not clear that Mr. Allain cannot state such a
claim against the Generic Defendants.
Wyeth’s Off-Label Promotion of Amiodarone
Mr. Allain’s allegations of off-label promotion against Wyeth in the First Amended
Complaint are similarly vague. In the section entitled “Cordarone, Concealment, and the OffLabel Promotional Scheme by Defendant Wyeth,” Mr. Allain sets forth an extensive list of
alleged wrongdoings in support of his allegation that Wyeth promoted Cordarone for off-label
use. (Doc. 34, at 17). Upon closer examination, however, the vast majority of these allegations
are unrelated to the promotion of Cordarone. For instance, Mr. Allain begins that section by
reciting more than twenty instance in which the FDA required Wyeth to revise its Cordarone
warning labels. Those label revisions, however, are irrelevant in the pending suit because, as
stated in his response, Mr. Allain “does not allege that the contents of the label should have been
changed.” (Doc. 42, at 13). Mr. Allain also discusses the Australian government’s decision to
issue a warning regarding possible adverse effects caused by Cordarone as well as Wyeth’s
decision to stop distributing Cordarone in Canada in 1996. Again, Mr. Allain fails to shed any
light on how those allegations relate to his claim against Wyeth his claim of off-label promotion
Although much of Mr. Allain’s allegations against Wyeth are unrelated to the off-label
promotion of Cordarone, Mr. Allain does allege a few specific instances that are relevant to his
claim against Wyeth. Specifically, Mr. Allain alleges that in 1989, 1992, and 1998, the FDA sent
“violation communications” to Wyeth regarding Wyeth’s dissemination of false and misleading
materials to physicians. (Doc. 34, at 19). Additionally, Mr. Allain alleges that Wyeth sponsored
a Continuing Medical Education conference in 1998 during which it distributed a “68-page
official looking, peer review-appearing magazine” that downplayed the side effects of Cordarone
and promoted the drug for off-label use. (Doc. 34, at 21). Thus, in contrast to his allegations
against the Generic Defendants, Mr. Allain has articulated a specific method of how Wyeth
promoted Cordarone to physicians for off-label use. These sufficient allegations survive a
motion to dismiss. See Ashcroft v. Iqbal, 566 U.S. 662, 678 (2009).
Mr. Allain’s First Amended Complaint also sufficiently alleges that Wyeth’s off-label
promotion of amiodarone caused Mr. Dreher’s physicians to prescribe him amiodarone for offlabel use. In his First Amended Complaint, Mr. Allain alleges that Mr. Dreher’s physician was
“a victim of Defendant Wyeth’s long term and successful promotional efforts” and that those
efforts “would have greatly affected her decision to prescribe amiodarone to Robert Dreher Sr.”
(Doc. 34, at 11–12). Admittedly, these allegations are somewhat vague and dubious.
Nevertheless, the court’s role at this stage is simply to determine whether Mr. Allain’s claim is
plausible, not probable. See Iqbal, 566 U.S. at 678 (“[t]o survive a motion to dismiss, a
complaint must contain sufficient factual matter, accepted as true, to ‘state a claim that is
plausible on its face.’”) (internal quotation omitted). Because his claim against Wyeth for the
off-label promotion of amiodarone is plausible, Wyeth’s motion to dismiss this claim is due to be
The Defendants’ Failure to Provide Medication Guides
Mr. Allain’s final allegation of misconduct against the Defendants is that they failed to
provide medication guides to Mr. Dreher’s pharmacy. This claim, however, is barred by either
21 U.S.C. § 337(a) or Alabama’s learned intermediary doctrine.
The duty of the Defendants to provide medication guides to Mr. Dreher’s pharmacy arises
solely under federal law. See 21 C.F.R. § 208.24(b). Indeed, Mr. Allain states in his First
Amended Complaint that the Defendants’ failure to provide the medication guides to the
pharmacy was “a direct violation of the FDA’s mandate to manufacturers of the drug . . . .”
(Doc. 34, at 36). However, Mr. Allain may not bring suit against the Defendants for their alleged
violation of the FDCA because 21 U.S.C. § 337(a) specifically prohibits enforcement of the
FDCA’s provisions by private litigants. See 21 U.S.C. § 337(a) (“[A]ll such proceedings for the
enforcement, or to restrain violations, of [the FDCA] shall be by and in the name of the United
States.”); Buckman Co. v. Plaintiff’s Legal Comm., 531 U.S. 341, 349 n.4 (2001) (“The FDCA
leaves no doubt that it is the Federal Government rather than private litigants who [is] authorized
to file suit for noncompliance with [its] provisions.”).
Additionally, to the extent that Mr. Allain asserts that the Defendants violated Alabama
law by failing to provide medication guides to Mr. Allain’s pharmacy, the claim is barred by 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. See Stone v. Smith, Kline & French Labs., 447 So. 2d. 1301, 1304
(Ala. 1984) (internal citation omitted); Wyeth, Inc. v. Weeks, 159 So. 3d 649, 673–74 (Ala. 2014)
(holding that once a prescription manufacturer warns the prescribing physician, “the
manufacturer has no further duty to warn the patient directly”). Thus, the Defendants had no
duty under Alabama law to directly warn Mr. Dreher of the dangers of amiodarone by providing
a medication guide to him or to provide medication guides to Mr. Dreher’s pharmacy. Instead,
the Defendants’ only duty under Alabama law is to provide adequate warnings to Mr. Dreher’s
prescribing physician. As such, Mr. Allain cannot assert a claim under Alabama law against the
Defendants for failing to provide Mr. Dreher’s pharmacy or Mr. Dreher himself with a
Because Mr. Allain’s claims against the Defendants for their alleged failure to provide
medication guides to Mr. Dreher’s pharmacy is barred by either section 21 U.S.C. § 337(a) or the
learned intermediary doctrine, the claim is due to be dismissed with prejudice.3
Even if this claim were not barred by the learned intermediary doctrine and 21 U.S.C. §
337(a), the claim would still be due to be dismissed against Wyeth as Mr. Dreher never ingested
Cordarone, the version of amiodarone Wyeth manufactured, and therefore, Wyeth could not have owed a
duty to provide a medication guide to Mr. Dreher when he ingested a different manufacturer’s drug.
For the reasons discussed above, the court GRANTS Upsher and Sandoz’s Motions to
Dismiss. The court DISMISSES WITH PREJUDICE Mr. Allain’s claims against UpsherSmith and Sandoz for failure to warn and failure to provide medication guides to Mr. Dreher’s
pharmacy. The court DISMISSES WITHOUT PREJUDICE Mr. Allain’s claims against
Upsher-Smith and Sandoz for their alleged promotion of amiodarone for off-label use.
Additionally, the court GRANTS IN PART and DENIES IN PART Wyeth’s motion to
dismiss. The court GRANTS Wyeth’s motion as to Mr. Allain’s claims against Wyeth for
failure to warn and for failing to provide medication guides to Mr. Dreher’s pharmacy, and
DISMISSES those claims WITH PREJUDICE. The court DENIES Wyeth’s motion only as
to Mr. Allain’s claim against Wyeth for the off-label promotion of Cordarone. This sole claim
Within Mr. Allain’s responses to the motions to dismiss, he requests leave to amend his
First Amended Complaint to remedy any pleading deficiencies. Out of an abundance of patience,
the court GRANTS Mr. Allain’s motion to amend and allows Mr. Allain one more chance to
amend his complaint to address the issues cited in this opinion regarding the claims dismissed
without prejudice. Because Mr. Allain abandoned his failure-to-warn claim and because he
cannot state a claim against the Defendants for their alleged failure to ensure Mr. Dreher received
a medication guide, this court GRANTS Mr. Allain’s motion to amend only as to his claim
against the Generic Defendants for their alleged off-label promotion of amiodarone.
Done and Ordered this 29th day of June, 2015.
KARON OWEN BOWDRE
CHIEF UNITED STATES DISTRICT JUDGE
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