Tutwiler v. Sandoz Inc
MEMORANDUM OPINION AND ORDER GRANTING 22 MOTION to Dismiss Plaintiff's Amended Complaint. Costs are taxed as paid. Signed by Judge L Scott Coogler on 8/3/2017. (JLC)
2017 Aug-03 PM 04:42
U.S. DISTRICT COURT
N.D. OF ALABAMA
IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF ALABAMA
BARBARA R. TUTWILER,
Memorandum of Opinion and Order
Plaintiff Barbara Tutwiler (“Plaintiff”) brought this products liability action
against Defendant Sandoz Inc. (“Defendant”), alleging that a drug manufactured
by Defendant caused her to suffer pulmonary injuries. This Court previously
dismissed Plaintiff’s claims but allowed her an opportunity to amend her complaint
to address the pleading deficiencies. (Doc. 20.) Before this Court is Defendant’s
motion to dismiss the amended complaint. (Doc. 22.) For the reasons stated more
fully herein, the motion is due to be granted.
The facts of this case, as derived from the initial complaint, are more fully set
out in this Court’s previous Memorandum of Opinion and Order. (Doc. 20.) The
amended complaint is substantially similar. It alleges that Plaintiff’s physician
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prescribed amiodarone to Plaintiff for the treatment of her non-life-threatening
atrial fibrillation. Defendant manufactures a generic version of amiodarone that was
supplied to Plaintiff when she filled the prescription at her local pharmacy.
Although amiodarone was not approved by the federal Food and Drug
Administration (“FDA”) for the treatment of non-life-threatening atrial
fibrillation, its brand-name manufacturer marketed it extensively for this “offlabel” use. Defendant “took advantage of” the brand-name manufacturer’s
promotional efforts and engaged in its own marketing campaign to tout the drug as
an appropriate treatment for non-life-threatening atrial fibrillation. The
combination of these promotional efforts misled physicians and caused them to
prescribe amiodarone to patients with atrial fibrillation. Plaintiff further alleges that
she was not personally informed of the risks associated with her use of amiodarone
because Defendant did not distribute the FDA-mandated Medication Guide to her
pharmacy, and as a result she did not receive the Medication Guide with her filled
Standard of Review
A pleading must, in general, present “a short and plain statement of the
claim showing that the pleader is entitled to relief.” Fed. R. Civ. P. 8(a)(2). In
order to withstand a motion to dismiss, however, the complaint “must contain
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sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible
on its face.’” Lord Abbett Mun. Income Fund, Inc. v. Tyson, 671 F.3d 1203, 1207 (11th
Cir. 2012) (quoting Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009)). The plaintiff need
not put forth “detailed factual allegations” in support of the claim, but there must
be enough to “allow the court to draw the reasonable inference that the defendant
is liable for the misconduct alleged.” Iqbal, 556 U.S. at 678 (citing Bell Atl. Corp. v.
Twombly, 550 U.S. 544, 556 (2007)).
In evaluating the complaint, this Court must first “identif[y] pleadings that,
because they are no more than conclusions, are not entitled to the assumption of
truth.” Id. at 679. Next, this Court assumes the veracity of any well-pleaded factual
allegations in order to “determine whether they plausibly give rise to an
entitlement to relief.” Id. The plaintiff is not required “to specifically plead every
element of his cause of action” against the defendant, but “a complaint must still
contain enough information regarding the material elements of a cause of action to
support recovery under some ‘viable legal theory.’” Am. Fed’n of Labor & Cong. of
Indus. Orgs. v. City of Miami, 637 F.3d 1178, 1186 (11th Cir. 2011) (quoting Roe v.
Aware Woman Ctr. for Choice, Inc., 253 F.3d 678, 683–84 (11th Cir. 2001)). Mere
“labels and conclusions” in the absence of concrete factual allegations that “raise a
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right to relief above the speculative level” are insufficient to satisfy Rule 8(a)(2).
Twombly, 550 U.S. at 555–56.
A. Failure-to-Warn Claims
This Court previously dismissed with prejudice Plaintiff’s failure-to-warn
claims based on Defendant’s failure to provide a Medication Guide to her
pharmacy, holding that such claims were either preempted under federal law or
subject to Alabama’s learned-intermediary doctrine. Plaintiff’s amended complaint
nonetheless includes failure-to-warn causes of action alleging that Defendant failed
to provide a Medication Guide to Plaintiff’s pharmacy. These causes of action
claim that Defendant’s failure to provide the Medication Guide violates the “duty
of sameness.” This duty, which is imposed by FDA regulations, requires the
labeling for generic medications to be the same as the labeling for the brand-name
product. See PLIVA, Inc. v. Mensing, 564 U.S. 604, 613 (2011). However, even if
Defendant’s failure to provide a Medication Guide to Plaintiff’s pharmacy for
distribution runs afoul of these regulations, Plaintiff’s failure-to-warn claims are
nonetheless subject to Alabama’s learned-intermediary doctrine.
In Alabama, “a prescription-drug manufacturer fulfills its duty to warn the
ultimate users of the risks of its product by providing adequate warnings to the
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[physicians] who prescribe the drug.” Wyeth, Inc. v. Weeks, 159 So. 3d 649, 673
(Ala. 2014). “[I]f the warning to the [physician] is inadequate or misrepresents the
risk, the manufacturer remains liable for the injuries sustained by the patient.” Id.
To overcome the learned-intermediary doctrine and hold the manufacturer liable,
“[t]he patient must show 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. Plaintiff
does not allege that if her physician had been aware of the risks of prescribing
amiodarone to treat non-life-threatening atrial fibrillation, he would not have
prescribed the drug to her. Instead, her failure-to-warn claims are based on
Defendant’s failure to warn her personally. But it does not follow from the Alabama
Supreme Court’s description of the learned-intermediary doctrine that if the
manufacturer inadequately warns the physician, it owes an independent duty to
warn the patient directly. This is the reason why this Court previously stated that
“it appears unlikely that Plaintiff can state a failure-to-warn claim based on
Defendant’s failure to provide a Medication Guide to her pharmacy that avoids the
application of both the learned-intermediary doctrine and Mensing” and dismissed
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the failure-to-warn claims with prejudice. (Doc. 20 at 8.) The substantially similar
claims alleged in the amended complaint are also due to be dismissed.
B. Off-Label Promotion Claims
This Court also previously dismissed Plaintiffs’ off-label marketing causes of
action without prejudice because the allegations in the initial complaint did not
satisfy the heightened pleading standard for fraud under Fed. R. Civ. P. 9(b).
Although Plaintiff’s amended complaint alleges a cause of action for “negligent
marketing and sale,” she still claims that Defendant engaged in a “concerted and
systemic effort to persuade physicians . . . that amiodarone was not only safe and
efficacious for the treatment of atrial fibrillation but also approved for that use.”
(Doc. 21 at 42–43, ¶ 118.) As this Court held in dismissing Plaintiff’s initial
complaint, this allegation sounds in fraud. Further, Alabama law defines even
(“Misrepresentations 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.” (emphasis
Plaintiff’s claim for negligent marketing and sale is therefore subject to the
pleading standard in Fed. R. Civ. P. 9(b), which requires the plaintiff “to plead the
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who, what, when, where, and how of the allegedly false statements and then allege
generally that those statements were made with the requisite intent.” Mizzaro v.
Home Depot, Inc., 544 F.3d 1230, 1237 (11th Cir. 2008). To satisfy this standard, the
complaint must include (1) precisely what statements were made in what
documents or oral representations or what omissions were made; (2) the time and
place of each such statement and the person responsible for making it; (3) the
content of such statements and the manner in which they misled the plaintiff; and
(4) what the defendant obtained as a consequence of the fraud. Id. (quoting Tello v.
Dean Witter Reynolds, Inc., 494 F.3d 956, 972 (11th Cir. 2007)). Plaintiff’s amended
complaint suffers from the same defect as her initial complaint because it similarly
“fails to identify a single statement in any promotional material to support
[Plaintiff’s] contention that Defendant unlawfully promoted amiodarone for the
treatment of atrial fibrillation.” (Doc. 20 at 12.) The alleged fraud is not described
with the requisite particularity, and Plaintiff’s claim for negligent marketing and
sale is due to be dismissed.
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For the reasons stated above, Defendant’s motion to dismiss (Doc. 22) is
hereby GRANTED and the amended complaint DISMISSED. Costs are taxed to
DONE and ORDERED on August 3, 2017.
L. Scott Coogler
United States District Judge
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