Wells v. Allergan USA Inc et al

Filing 74

ORDER granting 47 Motion to Dismiss; granting 48 Motion to Dismiss for Failure to State a Claim. Case dismissed without prejudice. Signed by Honorable Timothy M Cain on 1/13/2014.(gpre, )

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF SOUTH CAROLINA
GREENVILLE DIVISION
Suzy Wells,
Plaintiff,
vs.
Allergan USA, Inc. and Medicis
Aesthetics, Inc.,
Defendants.

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Civil Action No. 6:12-3509-TMC

OPINION & ORDER

This matter is before the court on the defendants’, Allergan USA, Inc. (“Allergan”), and
Medicis Aesthetics, Inc. (“Medicis”), respective motions to dismiss (ECF Nos. 47, 48) the
plaintiff’s amended complaint (ECF No. 46). After considering the record, the court grants the
defendants’ motions to dismiss.
I.

Background

The defendants manufacture the medical aesthetic products Juvederm and Restylane,
injectable gel dermal fillers. Both products are Class III medical devices, approved by the Food
and Drug Administration (“FDA”) through the premarket approval (“PMA”) process under the
Medical Device Amendments of 1976 (“MDA”), 21 U.S.C. § 360c et seq., to the Food, Drug &
Cosmetic Act (“FDCA”). The plaintiff, Suzy Wells (“Wells”), originally filed this action in state
court, alleging that the defendants manufactured, distributed, and sold medical devices that were
defective, unreasonably dangerous, and failed to contain adequate warnings when, after using the
defendants’ products, she suffered an immune system reaction that produced lesions in her lips
and Lyme-disease-like symptoms.

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The defendants removed the action to federal court and moved to dismiss on the grounds
that Wells’s claims were preempted by federal law and that, even if not preempted, Wells failed
to state a claim. (ECF No. 8.) In response, Wells moved to amend her complaint to cure the
pleading deficiencies. (ECF No. 30.) The court granted the motion and she filed her amended
complaint, alleging causes of action for negligence, strict liability, breach of warranty, unfair
trade practices, negligent misrepresentation, and post-manufacture failure to warn. (ECF No. 46.)
The defendants responded with separate motions to dismiss raising essentially the same grounds:
preemption and failure to adequately state a claim.1
II.

Legal Standard

Under the federal rules, each pleading 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). Accordingly,
pursuant to Federal Rule of Civil Procedure 12(b)(6), a claim should be dismissed when the
complaint fails to allege facts upon which relief can be granted. Fed. R. Civ. P. 12(b)(6). When
considering a motion to dismiss, the court should “accept as true all well-pleaded allegations and
should view the complaint in a light most favorable to the plaintiff.” Mylan Labs., Inc. v.
Matkari, 7 F.3d 1130, 1134 (4th Cir. 1993). However, “the pleading standard . . . demands more
than an unadorned, the-defendant-unlawfully-harmed-me accusation.” Ashcroft v. Iqbal, 556
U.S. 662, 679 (2009). Thus, the rules require more than “labels and conclusions,” “a formulaic
recitation of the elements of a cause of action,” or “naked assertions devoid of further factual
enhancement.” Id. at 678.
1

Pursuant to the local rules, this court is not required to hear oral argument on motions. Local Rule 7.08, DSC.
However, to provide the plaintiff another opportunity to present her position, the court scheduled a hearing on the
motions for November 18, 2013. Then, on motion from plaintiff’s counsel, the court continued that hearing until
January 9, 2014, a date agreed upon by counsel for both sides. The court noticed the hearing on December 3, 2013,
providing counsel over one month’s notice. Yet, plaintiff’s counsel failed to appear for the hearing. The court has
thoroughly reviewed the record in this case and the motions are fully briefed. Accordingly, the court declines to
schedule another hearing and will, instead, decide the motions before it on the briefs.
2

In sum, “[t]o survive a motion to dismiss, a complaint must contain sufficient factual
matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’” Id. (quoting Bell
Atlantic v. Twombly, 550 U.S. 544, 570 (2007)). And, for a claim to have facial plausibility, the
plaintiff must plead “factual content that allows the court to draw the reasonable inference that
the defendant is liable for the misconduct alleged.” Id. (citing Twombly, 550 U.S. at 556).
III.

Discussion

Restylane and Juvederm are both Class III medical devices under the MDA and, as such,
are subject to a rigorous premarket approval process. Riegel v. Medtronic, Inc., 552 U.S. 312,
317 (2008). During that process, the FDA evaluates everything about the device, from labeling
to safety. See Walker v. Medtronic, Inc., 670 F.3d 569, 572-73 (4th Cir. 2012). And, once a
device receives PMA, federal law forbids the manufacturer to make “changes in design
specifications, manufacturing processes, labeling, or any other attribute that would affect safety
or effectiveness” without FDA approval. Reigel, 552 U.S. at 319. The law also requires
manufacturers to “report to the FDA when an approved device ‘may have caused or contributed
to a death or serious injury’ or malfunctioned in a way that would make it likely to do so in the
future,’” Walker, 670 F.3d at 574 (citing 21 U.S.C. § 360i(a)(1)), and “periodically inform the
FDA about data from clinical studies or scientific literature related to the device,” id. (citing 21
C.F.R. § 814.84(b)).
In addition, the FDA retains exclusive enforcement authority over the manufacturers
pursuant to the FDCA. Thus, while private individuals “may report wrongdoing and petition the
agency to take action,” Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 349 (2001)
(citing 21 C.F.R. § 10.30), Congress has made clear that there is no private right of action under

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the FDCA and that all actions to enforce the statute “shall be by and in the name of the United
States.” Id. at 349 n.4 (quoting 21 U.S.C. § 337(a)).
The FDA’s exclusive enforcement right is reinforced by the MDA’s express preemption
clause, providing that no state may impose “any requirement” relating to the safety or
effectiveness of a medical device that is “different from, or in addition to, any requirement
applicable . . . to the device” under federal law.

21 U.S.C. § 360k(a).

Courts have

overwhelmingly interpreted this clause to bar common law tort claims against Class III device
manufacturers, finding that those claims seek to impose different or additional requirements for
purposes of § 360k(a). See Riegel, 552 U.S. at 322-25; Walker, 670 F.3d at 577.
However, there is one narrow exception to this rule. Plaintiffs may bring claims directly
against device manufacturers if their state law claims parallel federal law, i.e., do not impose
requirements that are different from, or in addition to, those already imposed on the
manufacturers by federal law. District courts within the Fourth Circuit have found that a wellpleaded parallel claim must at least (1) identify the federal requirement applicable to the device
with which it allegedly failed to comply and (2) explain how that violation of a federal
requirement caused the plaintiff’s injury. See, e.g., Smith v. St. Jude Med. Cardiac Rhythm
Mgmt. Div., Civil Case No. CCB-12-1746, 2013 WL 1104427, at *4 (D. Md. March 13, 2013);
Ali v. Allergan USA, Inc., No. 1:12CV115, 2012 WL 3692396, at *8 (E.D. Va. Aug. 23, 2012);
Viserta v. St. Jude Med., Inc., C.A. No. 8:11CV505, 2012 WL 667814, at *4 (D.S.C. Feb. 29,
2012); Bishoff v. Medtronic Inc., Civil Action No. 1:09CV171, 2010 WL 4852650, at *2
(N.D.W. Va. Nov. 22, 2010); Covert v. Stryker Corp., No. 1:08CV447, 2009 WL 2424559, at
*14-15 (M.D.N.C. Aug. 5, 2009).

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In this case, Wells does not seem to dispute that preemption applies, but asserts that she is
bringing a parallel claim.

However, the court finds that the Amended Complaint fails to

adequately plead specific facts as to how either defendant violated federal requirements or how
those violations caused Wells’s injuries.

Instead, Wells offers only barebones, conclusory

allegations. For example, Counts I-IV include the following language or a slight variation: “By
containing these defects, the [sic] Juvederm and Restylane failed to comply with and operate in
terms of their Pre-Market Approval from the Food & Drug Administration, approved in FDA
Applications P050047 and P020023, as well as all other relevant supplemental applications.”
(ECF No. 46, Am. Compl. ¶¶ 12, 16, 21, 29.) However, the Amended Complaint does not
identify specific device defects or violations of any specific PMA terms. Without specific
factual support for her allegations, Wells’s Amended Complaint fails to state a plausible claim
and must be dismissed.
Wells contends that she cannot plead additional facts without access to confidential PMA
documents and urges the court to allow this case to proceed to discovery.2 In support of this
argument, Wells relies almost exclusively on Walker v. Medtronic, Inc., Civil Action No. 2:0800317, 2008 WL 4186854 (S.D.W. Va. Sept. 9, 2008). Walker, however, is fairly unique in its
timing.

While the parties were already engaged in discovery and the district court was

considering a motion for summary judgment, the Supreme Court decided Riegel. The court
found that the plaintiff had not adequately alleged the type of claim that would survive Riegel,
but allowed her to amend to correct the deficiency. After the plaintiff amended her complaint,
the court granted summary judgment for the defendants on the ground that the plaintiff’s claims

2

The court held a telephonic status conference on this issue on October 16, 2013. At that point, all briefing on the
motions to dismiss had been filed and the court decided, for the sake of efficiency and fairness, to stay all deadlines,
including discovery, until it could resolve the motions to dismiss. (ECF No. 64.) As noted, the motions were
scheduled for hearing on November 18, 2013, but thereafter continued on motion of the plaintiff.
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were preempted.

See Walker v. Medtronic, Inc., Civil Action No. 2:08-00317, 2010 WL

4822135 (S.D.W. Va. Nov. 24, 2010).
The Fourth Circuit affirmed the district court’s decision in an order that has helped
outline the requirements for pleading parallel claims after Riegel – the same requirements the
court relies on today. See Walker v. Medtronic, Inc., 670 F.3d 569, 578-81 (4th Cir. 2012).
Now, following Riegel’s guidance, courts can ascertain earlier in the litigation whether a plaintiff
has a proper parallel claim, thus saving the parties from engaging in expensive and unnecessary
discovery.3 The court declines to lower the pleading standards for this case.
IV.

Conclusion

For the foregoing reasons, Allergan’s motion to dismiss (ECF No. 47) and Medicis’s
motion to dismiss (ECF No. 48) are both GRANTED. Accordingly, this case is DISMISSED.
Dismissal is without prejudice to the plaintiff’s right to potentially pursue relief based on a
properly pled and sufficiently supported parallel claim and with prejudice as to any claim
premised on standards different from or in addition to the standards imposed by federal law.
IT IS SO ORDERED.
s/Timothy M. Cain
United States District Judge
January 13, 2014
Anderson, South Carolina

NOTICE OF RIGHT TO APPEAL
The parties are hereby notified of the right to appeal this order pursuant to Rules 3 and 4
of the Federal Rules of Appellate Procedure.

3

In addition, the court has reviewed the discovery requests that plaintiff’s counsel submitted following the
telephonic status conference (ECF No. 66-1) and finds that much of the requested information is publicly available
on the FDA’s website.
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