Schrock et al v. Wyeth Inc et al

Filing 328

ORDER granting 315 Qualitest's Motion to Dismiss and dismissing plaintiffs' claim against Qualitest (as more fully set out in the order). Signed by Honorable Vicki Miles-LaGrange on 12/8/2011. (ks)

IN THE UNITED STATES DISTRICT COURT FOR THE
WESTERN DISTRICT OF OKLAHOMA
SUSAN SCHROCK, and
STEVE SCHROCK,
Plaintiffs,
v.
PLIVA USA, INC., and
QUALITEST PHARMACEUTICAL,
INC.,
Defendants.

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Case No. CIV-08-453-M

ORDER
Before the Court is defendant Qualitiest Pharmaceuticals, Inc.’s (“Qualitiest”) Motion to
Dismiss, or in the Alternative, Motion for Continuance, filed October 27, 2011. On November 17,
2011, plaintiffs filed their response, and on November 22, 2011, Qualitiest filed its reply. Based
upon the parties’ submissions, the Court makes its determination.
I.

Introduction
Qualitest was engaged in the business of testing, developing, manufacturing, labeling,

marketing, distributing, promoting, and selling of Reglan/metoclopramide (“metoclopramide”).
Qualitest submitted an Abbreviated New Drug Application to the Food and Drug Administration
(“FDA”), requesting permission to manufacture, market, and distribute the generic metoclopramide.
Plaintiff alleges that Qualitest failed to investigate the accuracy of its metoclopramide drug
labels and relied upon the name brand manufacture and listed drug companies to review the medical
literature for its metoclopramide.

Plaintiff further alleges that the package insert for the

metoclopramide understated the risk of acute and long-term side effects of ingesting the drug.
Qualitest and other manufactures advertised metoclopramide as a safe and effective treatment of

diabetic gastroparesis, gastrophageal reflux disease, and other gastrointestinal disorders.
In March 2000, plaintiff Susan Schrock’s (“Susan”) physician prescribed Susan
metoclopramide to treat her reflux.

According to plaintiffs, Susan’s physician relied upon

information published in the metoclopramide’s package insert and/or the Physicians’ Desk Reference
or information otherwise disseminated by the Reference Listed Drug company and/or New Drug
Application Holder. Plaintiffs allege that Susan ingested the metoclopramide as prescribed and that
Susan’s long-term ingestion of the drug caused her to suffer from tardive dystonia.1
On April 30, 2008, plaintiffs filed their Complaint. On February 8, 2011, the Court stayed
the case at bar pending review by the United Stated Supreme Court in the matters of Demahy v.
Actavis, Inc., 593 F.3d 428 (5th Cir. 2010) certiorari granted no. 09-1501, and Mensing v. Wyeth,
Inc., 588 F.3d 603 (8th Cir. 2009), certiorari granted Nos. 09-993 and 09-1039. After granting
certiorari, the Supreme Court consolidated the matters and issued its opinion styled as PLIVA, Inc.
v. Mensing, 131 S. Ct. 2567 (2011) (hereafter, “Mensing”). Accordingly, on August 22, 2011, the
Court lifted the stay in this matter.
In the Court’s July 20, 2010 Order, the Court found that the statute of limitations barred
plaintiffs’ recovery for negligence, strict liability, gross negligence, misrepresentation, fraud, and
punitive damages. Plaintiffs’ sole remaining claim against Qualitest is for breach of warranties.
II.

Standard
Regarding the standard for determining whether to dismiss a claim pursuant to Rule 12(b)(6),

the United States Supreme Court has held:
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Tardive dystonia is a debilitating neurological disorder characterized by involuntary and
uncontrollable movements of the head, neck, face, arms, legs and trunk. There is no cure for
tardive dystonia.
2

To 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. A claim has facial plausibility when the plaintiff
pleads factual content that allows the court to draw the reasonable
inference that the defendant is liable for the misconduct alleged. The
plausibility standard is not akin to a “probability requirement,” but it
asks for more than a sheer possibility that a defendant has acted
unlawfully. 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.
Ashcroft v. Iqbal, 129 S. Ct. 1937, 1949 (2009) (internal quotations and citations omitted). Further,
“where the well-pleaded facts do not permit the court to infer more than the mere possibility of
misconduct, the complaint has alleged - but it has not shown - that the pleader is entitled to relief.”
Id. (internal quotations and citations omitted). Additionally, “[a] pleading that offers labels and
conclusions or a formulaic recitation of the elements of a cause of action will not do. Nor does a
complaint suffice if it tenders naked assertion[s] devoid of further factual enhancement.” Id. at 1949
(internal quotations and citations omitted).
III.

Discussion
In Mensing, the Supreme Court concluded that federal drug regulations prevented generic

manufacturers from independently changing their safety and efficacy labels. Mensing, at 2577.
Further, the Supreme Court specifically held that federal drug regulations preempted a state law
imposed duty to provide an adequate and safe warning label. Id. at 2581. The Supreme Court
further opined:
[W]hen a party cannot satisfy its state duties without the Federal
Government’s special permission and assistance, which is dependent
on the exercise of judgment by a federal agency, that party cannot
independently satisfy those state duties for pre-emption purposes.
Here, state law imposed a duty on the Manufacturers to take a certain
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action, and federal law barred them from taking that action. The only
action the Manufacturers could independently take—asking for the
FDA’s help—is not a matter of state-law concern.

Id. In light of the Supreme Court’s decision in Mensing, plaintiffs’ breach of warranties claim is
preempted by federal drug regulations. The gravamen of plaintiffs’ breach of warranties claim
alleges that “[d]efendants marketed and promoted their [metoclopramide] as safe and efficacious for
its intended uses . . . . Defendants expressly and impliedly warranted that the [metoclopramide] were
not unreasonably dangerous and instead were merchantable and fit for its intended use . . . .”
Plaintiff’s First Amended Complaint [docket 228], at ¶ 4.08. Based upon the Mensing decision,
plaintiffs’ breach of warranties claim is preempted because federal regulations bar Qualitest from
independently changing its safety and efficacy labels; Qualitest’s only independent action was asking
for the FDA’s help. Therefore, Qualitest could not satisfy its state law imposed duty for preemption
purposes.
Accordingly, the Court should dismiss this matter as plaintiffs’ breach of warranties claim
is preempted.
IV.

Conclusion
For the reasons set forth above, the Court GRANTS Qualitest’s Motion to Dismiss, or in the

Alternative, Motion for Continuance [docket no. 315] and DISMISSES plaintiffs’ claim against
Qualitest.
IT IS SO ORDERED this 8th day of December, 2011.

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