Batchelor v. Pfizer, Inc.
MEMORANDUM OPINION AND ORDER that Plf's complaint is STRICKEN pursuant to the court's inherent authority and its authority under Rule 12(f)(1); The court GRANTS Plf leave to replead with supporting factual allegations on or before 8/15/2013; further ORDERED that Dft's 7 Motion to Dismiss is DENIED as moot. Signed by Chief Judge William Keith Watkins on 7/25/2013. (Attachments: # 1 Civil Appeals Checklist) (wcl, )
IN THE UNITED STATES DISTRICT COURT
FOR THE MIDDLE DISTRICT OF ALABAMA
CASE NO. 2:12-CV-908-WKW
MEMORANDUM OPINION AND ORDER
Plaintiff Martha Batchelor filed this action to recover damages for injuries she
suffered after taking the prescription drug depot medroxyprogesterone acetate, better
known as Depo Provera. Defendant Pfizer, Inc., which manufactures and distributes
the drug, moved to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6). For
the reasons that follow, the court will strike Plaintiff’s complaint, with leave to
replead, and deny Defendant’s motion as moot.
I. JURISDICTION AND VENUE
The court exercises subject matter jurisdiction pursuant to 28 U.S.C. § 1332.
Personal jurisdiction and venue are uncontested.
II. FACTUAL BACKGROUND
Plaintiff’s complaint is as remarkable for what it does not allege as for what it
does. Plaintiff alleges she was prescribed and took Depo Provera. She alleges
Defendant manufactured and distributed the drug. She alleges the drug causes or
increases the risk of bone density loss and associated medical complications. She
alleges Defendant is liable to her for damages, that it breached a duty owed to her,
that it violated provisions of federal law, and that it breached an implied warranty.
Plaintiff does not allege that she suffered bone density loss, only that she
“suffered serious injuries.” (Doc. # 1 ¶ 25.) Plaintiff alleges Defendant breached a
duty it owed Plaintiff, but she does not identify what act or omission of Defendant
breached that duty. Plaintiff does not identify what provision of the Federal Food,
Drug, and Cosmetic Act (“the Act”) Defendant violated or what act or omission
constituted a violation.1 Plaintiff does not allege when she took Depo Provera –
whether before or after the Food and Drug Administration required Defendant to
place a Black Box Warning on Depo Provera’s label warning of risks of bone density
District courts have the inherent authority to strike complaints and require
plaintiffs to replead. Fikes v. City of Daphne, 79 F.3d 1079, 1083 n.6 (11th Cir.
1996); see also Byrne v. Nezhat, 261 F.3d 1075, 1129–31 (11th Cir. 2001)
(encouraging district courts to strike pleadings containing insufficient factual
The Act spans from 21 U.S.C. § 301 to § 399f.
allegations pursuant to Federal Rule of Civil Procedure 12(f)(1)), abrogated on other
grounds by Douglas Asphalt Co. v. QORE, Inc., 657 F.3d 1146 (11th Cir. 2011).
After review of Defendant’s motion and Plaintiff’s complaint, the court elects to
exercise that authority here.
Rule 8 of the Federal Rules of Civil Procedure requires that a complaint
contain a “short and plain statement of the claim showing that the pleader is entitled
to relief.” Fed. R. Civ. P. 8(a)(2). “Threadbare recitals of the elements of a cause of
action, supported by mere conclusory statements, do not suffice.” Ashcroft v. Iqbal,
556 U.S. 662, 678 (2009).
The standard “does not require ‘detailed factual
allegations,’ but it demands more than an unadorned, the-defendant-unlawfullyharmed-me accusation.” Id. (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555
Plaintiff alleges six causes of action and requests punitive damages. As
Defendant correctly observes, the complaint consists of little more than “[t]hreadbare
recitals of the elements of a cause of action” and unadorned accusations. Iqbal, 556
U.S. at 678. At least once, it fails to identify a proper cause of action.
For example, Plaintiff alleges a “strict liability” claim. (Doc. # 1 ¶¶ 18–21.)
But Alabama has not adopted a no-fault concept of products liability and has instead
retained a fault-based system known as the Alabama Extended Manufacturers’
Liability Doctrine (“AEMLD”). See generally Atkins v. Am. Motors Corp., 335 So.
2d 134 (Ala. 1976), Casrell v. Altec Indus., Inc., 335 So. 2d 128 (Ala. 1976)
(announcing the AEMLD).
The AEMLD is Alabama’s “judicially created
accommodation” avoiding the doctrine of strict liability, which is applicable in
products liability cases in other jurisdictions.2 Wyeth, Inc. v. Weeks, ___ So. 3d ____,
2013 WL 135753, at *3 (Ala. Jan. 11, 2013) (quotations omitted).
Even if the court treats Plaintiff’s so-called “strict liability” claim as one arising
under the AEMLD and alleging that Defendant violated its duty to warn – as
Plaintiff’s response suggests – that claim suffers fatal deficiencies. Under Alabama
law, a pharmaceutical manufacturer’s duty to warn does not extend beyond warning
the prescribing physician:
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. However, 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. at *19.
The practical difference between the AEMLD and strict liability is that the former
allows certain affirmative defenses not countenanced in a no-fault system. Atkins, 335 So. 2d at
137; see also Bodie v. Purdue Pharma Co., 236 F. App’x 511, 517 n.9 (11th Cir. 2007)
(comparing the AEMLD with negligence and strict liability theories).
As Defendant points out, Plaintiff has pleaded no facts supporting liability
under the learned intermediary doctrine. She has not pleaded that Defendant failed
to warn her physician(s). She has not pleaded that the warning issued to her
physicians, if any, was inadequate or misrepresented the risk. Instead, Plaintiff
continues to insist Defendant is liable because it failed to warn her. (Doc. # 15 at 6
(“Plaintiff has alleged that she was not warned properly of the bone loss and
deterioration issues associated with injections of Defendant’s product, Depo-Provera.
. . . Defendant failed to warn Plaintiff of the dangers of its product, and plaintiff
suffered damages because of it.”).) Defendant had no duty to warn Plaintiff, only to
warn her physicians adequately and honestly, and Plaintiff offers no factual
allegations to support the theory that there was an inadequate or dishonest warning.
See Bailey v. Janssen Pharmaceutica, Inc., 288 F. App’x 597, 609 n.13 (11th Cir.
2008) (affirming dismissal of strict liability claim for failure to warn under Florida’s
learned intermediary doctrine where complaint did not recite contents of warning
label available or describe how it was inadequate).
Furthermore, the court has great difficulty analyzing – and Defendant has great
difficulty responding to – Plaintiff’s claims without knowing when Plaintiff took the
drug, in light of the Black Box Warning. Plaintiff says in her response that she
started taking it as early as 1995, nine years before the warning in 2004, but that
factual allegation is one of several missing from the complaint. The court cannot
assess the adequacy of the warning to Plaintiff’s physician without knowing what –
if any – warning appeared. Id.
As for Plaintiff’s negligence, negligence per se, and breach of implied warranty
of merchantability claims, the complaint’s shotgun style makes it “virtually
impossible to know which allegations of fact are intended to support which claim(s)
for relief.” Anderson v. Dist. Bd. of Trs. of Cent. Fla. Cmty. Coll., 77 F.3d 364, 366
(11th Cir. 1996); see also Magluta v. Samples, 256 F.3d 1282, 1284 (11th Cir. 2001)
(criticizing shotgun pleadings, where each count incorporates by reference allegations
made in the earlier sections, and encouraging repleading of such claims). The
shotgun pleading alone authorizes the court to exercise its discretion to strike the
But as Defendant observes, those claims are also bereft of supporting factual
allegations. In Count II, Plaintiff’s claim of negligence asserts, “Defendant breached
its duty and is guilty of negligent acts and/or omissions,” without identifying what
Defendant’s duty was or what act or omission constituted a breach.3 (Doc. # 1 ¶ 24.)
If Plaintiff’s claim is based on a negligent failure to warn, Plaintiff’s allegation that she
took Depo Provera and then suffered a serious harm also identified as a risk of Depo Provera will
not alone support her failure to warn claim. See Reed v. Pfizer, Inc., 839 F. Supp. 2d 571,
576–77 (E.D. N.Y. 2012) (“If such allegations were sufficient to state a failure to warn claim,
then anyone experiencing harm after using a product where the harm is a warned-of risk could
successfully plead a claim.”).
Count III’s negligence per se claim states Plaintiff’s legal conclusion that Defendant
violated the Act, but does not identify the provision Defendant allegedly violated or
say what constituted a violation. (See Doc. # 1 ¶ 28 (“Defendant violated the Federal
Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq.”).) And in her claim alleging
violation of an implied warranty of merchantability, Plaintiff does not identify what
made Depo Provera unmerchantable, leaving the court to assume her theory is that the
risk of bone density loss does so. See Ala. Code § 7-2-314(1) (implying warranties
of merchantability in a sale of goods by a merchant); DaimlerChrysler Corp. v.
Morrow, 895 So. 2d 861, 864 (11th Cir. 2004) (recognizing a right of action for a
violation of an implied warranty of merchantability). A case cannot rest on the
court’s assumptions about a party’s theory of liability. Plaintiff has pleaded no facts
that make plausible the notion that Depo Provera was not fit for its intended purpose
of preventing pregnancy.
Accordingly, it is ORDERED that Plaintiff’s complaint is STRICKEN pursuant
to the court’s inherent authority and its authority under Rule 12(f)(1). The court
GRANTS Plaintiff leave to replead with supporting factual allegations on or before
August 15, 2013. Failure to file a timely and compliant amended complaint will
result in dismissal.
Because Plaintiff’s complaint is stricken, it is further ORDERED that
Defendant’s Motion to Dismiss (Doc. # 7) is DENIED as moot.
DONE this 25th day of July, 2013.
/s/ W. Keith Watkins
CHIEF UNITED STATES DISTRICT JUDGE
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