United States District Court, N.D. Alabama, Southern Division
SUBSTITUTED MEMORANDUM OPINION
[1]
MADELINE HUGHES HAIKALA UNITED STATES DISTRICT JUDGE
This
matter is before the Court on defendant Allergan USA's
motion to dismiss. (Doc. 23). Allergan argues that federal
law preempts plaintiff Rosalie Rice's state law claims
and that Ms. Rice has not stated a plausible claim for relief
pursuant to Federal Rule of Civil Procedure 12(b)(6). (Doc.
24). Ms. Rice concedes that she has not adequately pleaded
some of her claims, and she has indicated that she is willing
to dismiss those claims without prejudice. This opinion
addresses Allergan's preemption defense with respect to
the balance of Ms. Rice's claims.
STANDARD
OF REVIEW
Rule
12(b)(6) enables a defendant to move to dismiss a complaint
for “failure to state a claim upon which relief can be
granted.” Fed.R.Civ.P. 12(b)(6). Pursuant to Rule
8(a)(2), a complaint must contain, “a short and plain
statement of the claim showing that the pleader is entitled
to relief.” Fed.R.Civ.P. 8(a)(2). “Generally, to
survive a [Rule 12(b)(6)] motion to dismiss and meet the
requirement of Fed. R. Civ. P. 8(a)(2), a complaint
need not contain ‘detailed factual allegations, '
but rather ‘only enough facts to state a claim to
relief that is plausible on its face.'” Maledy
v. City of Enterprise, 2012 WL 1028176, at *1 (M.D. Ala.
Mar. 26, 2012) (quoting Bell Atl. Corp. v. Twombly, 550
U.S. 544, 555, 570 (2007)). “Specific facts are
not necessary; the statement need only ‘give the
defendant fair notice of what the . . . claim is and the
grounds upon which it rests.'” Erickson v.
Pardus, 551 U.S. 89, 93 (2007) (quoting
Twombly, 550 U.S. At 555).
A
plaintiff does not have to “negate an affirmative
defense in [her] complaint.” La Grasta v. First
Union Securities, Inc., 358 F.3d 840, 845 (11th Cir.
2004) (internal quotation marks and citation omitted). A
court may dismiss a claim on the basis of an affirmative
defense when the plaintiff's “allegations, on their
face, show that an affirmative defense bars recovery on the
claim.” Cottone v. Jones, 326 F.3d 1352, 1357
(11th Cir. 2003). The Court must “accept[] the
allegations in the complaint as true and constru[e] them in
the light most favorable to the plaintiff.”
Miljkovic v. Shafritz & Dinkin, P.A., 791 F.3d
1291, 1297 (11th Cir. 2015) (quoting Hill v. White,
321 F.3d 1334, 1335 (11th Cir. 2003)) (per curiam) (internal
marks omitted). The Court presents Ms. Rice's allegations
accordingly.
BACKGROUND
Allergan
manufactures and distributes the LAP-BAND, a surgically
implanted medical device designed to help patients lose
weight. (Doc. 18, ¶¶ 19- 25, 45). The LAP-BAND is
placed around the outside of the stomach to “create a
small ‘pouch' in the upper part of the stomach to
control the speed by which food passes to the lower part of
the stomach . . .” (Doc. 18, ¶ 19). Allergan's
initial efforts to obtain FDA approval for the product were
not successful. (Doc. 18, ¶ 21). The FDA gave premarket
approval or PMA for the LAP-BAND in 2001. (Doc. 18, ¶
22). Premarket approval reflects a great deal of
investigation by the FDA and indicates that the FDA has found
that there is “reasonable assurance” that the
medical device is safe and effective when used under the
conditions included in the device's label. The PMA also
indicates that the FDA has concluded that the
manufacturer's proposed labelling for the device
“is neither false nor misleading.” (Doc. 18,
¶ 9).
When
the FDA granted PMA for the LAP-BAND, Allergan's label
for the product indicated a 1% risk of erosion. (Doc. 18,
¶ 31). Erosion appears to occur when the LAP-BAND slips
and erodes into the stomach. (Doc. 18, ¶¶ 32,
36).[2]Erosion can require reoperation and removal
of the LAP-BAND. (Doc. 18, ¶ 32).
After
manufacturers like Allergan receive premarket approval, they
must meet various reporting requirements. For example, they
must report to the FDA adverse events associated with their
product. (Doc. 18, ¶ 14). As a condition of PMA,
Allergan agreed to conduct a post-approval clinical study to
collect data on the long-term safety and effectiveness of the
LAP-BAND. The clinical study had to include patient follow-up
for five years post-implantation. (Doc. 18, ¶ 24). PMA
also was conditioned on Allergan's compliance with
general and device-specific requirements. (Doc. 18, ¶
25). “Failure to comply with the conditions of approval
invalidates [the PMA]. Commercial distribution of a device
that is not in compliance with these conditions is a
violation of the act.” (Doc. 18, ¶ 25).
Based
on the results of its own studies, Allergan has maintained
its disclosure of a 1% erosion rate for the LAP-BAND;
however, outside medical studies “indicate a much
higher complication rate.” (Doc. 18, ¶¶
26-31). Outside studies reveal that the possibility of
erosion increases over time. (Doc. 18, ¶¶ 33- 36)
(listing a 2006 study indicating failure rates of 13.2% after
18 months, 23.8% after 3 years, 31.5% after 5 years, and
36.9% after 7 years, and finding a 9.5% erosion rate after 5
years; a 2008 study indicating failure rates of 15% after 1
to 3 years increasing to 40% after 8 to 9 years; a 2011 study
indicating a 28% erosion rate after 12 years; and a 2012
study indicating a 19.2% removal rate after 6 years with band
erosion as the second most common cause of removal). Although
the FDA generally must approve changes to product labels, a
manufacturer may add to its label, without prior FDA
approval, information that strengthens a warning or
precaution about an adverse reaction when the additional
information “enhance[s] the safe use of the
product” or “delete[s] misleading, false, or
unsupported indications.” (Doc. 18, ¶ 13). Ms.
Rice alleges that despite the erosion rate data from outside
studies, Allergan “continues to represent in labelling
and to the public erosion rates of approximately 1%.”
(Doc. 18, ¶ 31).
In
early 2007, Ms. Rice's surgeon implanted the LAP-BAND to
treat Ms. Rice for morbid obesity. (Doc. 18, ¶ 38).
Toward the end of 2014, Ms. Rice began having difficulty
swallowing, and she was vomiting frequently. (Doc. 18, ¶
39). On November 26, 2014, Ms. Rice's surgeon discovered
that the LAP-BAND “had eroded into [Ms. Rice's]
stomach such that only the buckle itself was external to the
stomach.” (Doc. 18, ¶ 40) (internal marks
omitted). Ms. Rice's surgeon removed the LAP-BAND and
“repaired the gastric perforation caused by the eroded
LAP-BAND.” (Doc. 18, ¶ 40).
Ms.
Rice filed this lawsuit on August 22, 2016. (Doc. 1). She
alleged seven state law causes of action against Allergan:
negligence, strict liability failure to warn, design defect,
manufacturing defect, breach of warranty, fraudulent
misrepresentation, and violation of the Alabama Deceptive
Trade Practices Act (ADTPA). (Doc. 18, ¶¶ 44-105).
Pursuant to Rule 12(b)(6), Allergan has asked the Court to
dismiss these claims based on express preemption, implied
preemption, and failure to state a claim with sufficient
factual specificity. (Doc. 24, pp. 9-10).
ANALYSIS
A.
Sufficiency of Factual Allegations
Before
the Court may address Allergan's preemption arguments, it
first must consider Allergan's argument that Ms. Rice has
failed to allege sufficient facts to support her claims.
Mink v. Smith & Nephew, Inc., 860 F.3d 1319,
1328 (11th Cir. 2017) (quoting Slack v. McDaniel,
529 U.S. 473, 485 (2000) for the proposition that
“courts should ‘not pass upon a constitutional
question although properly presented by the record, if there
is also present some other ground upon which the case may be
disposed of.'”). Under Rule 12(b)(6), a district
court must determine whether a complaint contains
“enough facts to state a claim to relief that is
plausible on its face.” Twombly, 550 U.S. at
570. “Determining whether a complaint states a
plausible claim for relief will [ultimately] . . . be a
context-specific task that requires [a district court] to
draw on its judicial experience and common sense.”
Ashcroft v. Iqbal, 556 U.S. 662, 679 (2009).
Ms.
Rice “concedes a lack of factual support at this time
to plead parallel [state] claims” as to her third,
fourth, fifth, and seventh causes of action and
“concedes to dismissal of those specific claims without
prejudice.” (Doc. 26, p. 1). Accordingly, the Court
dismisses Ms. Rice's claims for design defect,
manufacturing defect, breach of warranty, and violation of
ADTPA without prejudice. This leaves Ms. Rice's claims
for negligence, failure to warn, and negligent or fraudulent
misrepresentation. (Doc. 18).
1.
Negligence
Under
Alabama law, to establish a claim for negligence, “the
plaintiff must prove: (1) a duty to a foreseeable plaintiff;
(2) a breach of that duty; (3) proximate causation; and (4)
damage or injury.” Lemley v. Wilson, 178 So.3d
834, 841-42 (Ala. 2015), reh'g denied (Apr. 17,
2015) (quoting Martin v. Arnold, 643 So.2d 564, 567
(Ala. 1994)). In support of her negligence claim, Ms. Rice
alleges, among other things, that Allergan “breached
federal device requirements and parallel Alabama law duties
to exercise reasonable and prudent care in development,
testing, design, manufacture, inspection, marketing,
labeling, promotion, distribution, sale, post-market
surveillance and adverse events reporting of the
LAP-BAND” by (1) manufacturing a device that presented
“an unreasonable risk of failure, particularly over
time, as it relates to band erosion and perforation, ”
(2) designing and manufacturing a device “with
insufficient strength or structural integrity to withstand
long term placement within the human body, a manner for which
the device was indicated, ” (3) “marketing and
recommending to Plaintiff and her physician the use of the
LAP-BAND in such a manner as to misrepresent the safety and
efficacy of the device, including the heightened risk of
device-associated complications over time”; (4)
“failing to provide adequate labeling for the LAP-BAND
device when it knew or should have known the safety and
efficacy of the device was being misrepresented in its
labeling”; (5) “failing to place into effect
‘labeling changes that add or strengthen a
contraindication, warning, precaution, or information about
an adverse reaction, ' or that ‘add or strengthen
an instruction that is intended to enhance the safe use of
the device, ' or ‘that delete misleading, false or
unsupported indications'”; (6) “failing to
report required adverse events associated with the LAP-BAND
to the FDA, thereby preventing the dissemination of key
safety information to Plaintiff and her physician prior to
and after ...