Garza et al v. WYETH LLC et al
Filing
99
ORDER denying 78 Generic Defendants' Second Motion to Dismiss.(Signed by Judge Nelva Gonzales Ramos) Parties notified.(amireles, )
IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF TEXAS
CORPUS CHRISTI DIVISION
MARIA LUISA GARZA and
OSCAR GARZA, SR.,
Plaintiffs,
v.
WYETH LLC, et al.,
Defendants.
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CIVIL ACTION NO. 2:12-CV-00198
ORDER DENYING GENERIC DEFENDANTS’ SECOND MOTION TO DISMISS
Before the Court is Defendants Teva Pharmaceuticals USA, Inc.; Pliva, Inc.; Barr
Pharmaceuticals, LLC; Barr Laboratories, Inc.; Watson Laboratories, Inc.; and Watson Pharma,
Inc.’s Motion to Dismiss Plaintiffs’ Fourth Amended Complaint. (D.E. 78.) The above-named
Defendants manufactured the generic form of the drug Reglan/metoclopramide HCl (hereinafter
referred to as “metoclopramide”), and these Defendant are collectively referred to herein as the
“Generic Defendants.” In a prior Order granting in part and denying in part Generic Defendants’
first motion to dismiss, the Court dismissed Plaintiffs’ failure-to-warn claims against Pliva, Inc.,
Barr Pharmaceuticals, LLC, and Barr Laboratories, Inc. (D.E. 84.) Teva Pharmaceuticals USA,
Inc., Watson Laboratories, Inc., and Watson Pharma, Inc. remain in the suit. For the reasons set
forth below, the present motion, Generic Defendants’ second motion to dismiss, is DENIED.
FACTUAL ALLEGATIONS
The Court’s analysis is based on the factual allegations set forth in Plaintiffs’ Fourth
Amended Complaint. (D.E. 72.) The relevant facts from the Fourth Amended Complaint, which
for purposes of this motion must be accepted as true and viewed in the light most favorable to
Plaintiffs, are as follows.
This action is brought by Plaintiff Maria Luisa Garza and her husband, Plaintiff Oscar
Garza, Sr. Mr. Garza seeks compensatory and exemplary damages for loss of consortium and
household services as Ms. Garza’s spouse. Ms. Garza seeks compensatory damages for mental
anguish, physical disfigurement, physical impairment, loss of earnings, and reasonable and
necessary medical expenses, in addition to exemplary damages.
Ms. Garza alleges her injuries resulted from being prescribed and ingesting the
prescription drug metoclopramide over an extended period of time.
Her physician first
prescribed metoclopramide at a dosage of 10mg in June 2007 to treat gastroesophageal reflux
disease. In July 2009, she began exhibiting abnormal muscle movements, which have since been
linked to her overexposure to the drug. Prolonged exposure to metoclopramide is known to
cause injuries to the central nervous system and the extrapyramidal motor system. Some patients
develop tardive dyskinesia, a severe and often permanent neurological movement disorder.
Labeling approved by the United States Food and Drug Administration (FDA) for
metoclopramide last appeared in the Physician’s Desk Reference in 2002. In 2003, the FDA
approved the addition of new warnings to be added to the drug’s label. In July 2004, the FDA
approved the addition of a bolded warning to the label stating that therapy with the drug “should
not exceed 12 weeks in duration.” And in February 2009, the FDA ordered a black box warning,
its strongest, stating that “Treatment with metoclopramide can cause tardive dyskinesia, a serious
movement disorder that is often irreversible . . . . Treatment with metoclopramide for longer
than 12 weeks should be avoided in all but rare cases.”
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During the time that Ms. Garza was prescribed and ingested metoclopramide, Generic
Defendants were engaged in the business of testing, manufacturing, labeling, marketing,
distributing, promoting, and/or selling either directly or indirectly, through third parties or related
entities, metoclopramide in the State of Texas and in interstate commerce. Generic Defendants
TEVA Pharmaceuticals USA, Inc. (TEVA), Watson Laboratories, Inc. (Watson Labs), and
Watson Pharma, Inc. (Watson Pharma) failed to update their labels to match the 2003, 2004, and
2009 label changes approved by the FDA. As a result, Ms. Garza and her physicians were
unaware of the risks and warnings about metoclopramide therapy exceeding twelve weeks. Had
Ms. Garza and her physicians understood the nature and extent of the risk posed, her physicians
would not have prescribed the medication past twelve weeks, and Ms. Garza would not have
taken the drug past twelve weeks.
LEGAL STANDARD
On a Rule 12(b)(6) or 12(c) motion to dismiss, the Court must examine the complaint in
the light most favorable to Plaintiffs, accepting all allegations as true and drawing all reasonable
inferences in favor of Plaintiffs. Kaiser Aluminum & Chem. Sales, Inc. v. Avondale Shipyards,
Inc., 677 F.2d 1045, 1050 (5th Cir. 1982); Piotrowski v. City of Houston, 51 F.3d 512, 514
(5th Cir. 1995). The Court need not, however, accept as true legal conclusions masquerading as
factual allegations, and “[t]hreadbare 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).
Plaintiffs must allege sufficient facts that give rise to a reasonable inference that Defendants are
liable. Id.; Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 556 (2007). The factual allegations
must raise Plaintiffs’ claim for relief above the level of mere speculation. Twombly, 550 U.S.
at 555. As long as the complaint, taken as a whole, gives rise to a plausible inference of
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actionable conduct, Plaintiffs’ claims should not be dismissed. Id. at 555–56. This test of the
pleadings is devised to balance Plaintiffs’ right to redress against the interests of the parties and
the Court in minimizing expenditures of time, money, and resources. Id. at 557–58.
ANALYSIS
A.
Texas Law
Generic Defendants argue that Plaintiffs’ failure-to-update theory is not viable under
Texas law. (D.E. 78 at 7.) As addressed in the Court’s Order granting in part and denying in part
Generic Defendants’ first motion to dismiss, under Texas law, generic drug manufacturers have a
duty to warn prescribing physicians of the dangers to patients associated with the use of their
products of which the manufacturers had actual or constructive knowledge at the time the
product was sold. (D.E. 84 at 5.)
One way to satisfy this duty is for the generic drug
manufacturers to provide warning labels with their drugs that are consistent with those approved
by the FDA for the brand-name drug and utilized by the brand-name drug manufacturers.
Furthermore, as discussed in this Court’s previous Order, this duty to provide up-to-date labels
warning about the known dangers of their drugs is not preempted under PLIVA, Inc. v. Mensing,
131 S.Ct. 2567 (2011) where the state law duty is consistent with the requirements set forth
under federal drug laws. (See analysis set forth in D.E. 84 at 4–7.)
Generic Defendants now argue that Plaintiffs’ failure-to-update theory of liability fails
under Texas law because Plaintiffs claim that all labels were inadequate, at least through 2009,
including labels containing the 2003 and 2004 FDA-approved updates to the brand-name labels.
(D.E. 78 at 9–10.) The Fourth Amended Complaint, however, does not allege that the 2004
FDA-approved label was inadequate. Plaintiffs’ assertion of liability is premised on allegations
that long-term treatment beyond twelve weeks with metoclopramide increases a patient’s risk of
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developing certain central nervous system disorders such as tardive dyskenia, that Generic
Defendants were aware of this risk, that changes were made to the brand-name drug labels in
2004 and 2009 that advised consumers and physicians of this risk, and that Generic Defendants
failed to update their labels to warn consumers and their physicians of this risk.
The Court rejects Generic Defendants’ argument that Plaintiffs’ failure-to-update theory
is not viable under Texas law. The Fourth Amended Complaint states a viable products liability
claim under Texas law, which is not preempted by federal drug labeling laws under Mensing.
Plaintiffs allege that Generic Defendants failed to update their labels about the danger of
metoclopramide use exceeding twelve weeks, despite their actual or constructive knowledge of
this risk, and despite FDA-approved labeling changes to the brand-name drug in 2004 and 2009
specifically warning of this risk. Viewing the allegations in the light most favorable to Plaintiffs,
the Court concludes that Plaintiffs have alleged sufficient facts to give rise to a reasonable
inference that Defendants are liable under Texas law.
B.
Standing and Subject Matter Jurisdiction
Next, Generic Defendants argue that Plaintiffs lack standing and the Court lacks subject
matter jurisdiction to consider Plaintiffs’ failure-to-update theory of liability because there is no
private right of action under the Food, Drug, and Cosmetic Act (FDCA). (D.E. 78 at 10–15.)
Plaintiffs respond that the lack of a private cause of action under the FDCA is irrelevant because
Plaintiffs’ asserted cause of action arises under Texas’ product liability laws, not federal law.
(D.E. 85.)
Texas recognizes a cause of action for failure to provide an adequate product safety
warning that results in an injury to a consumer. See, e.g., Centocor, Inc., v. Hamilton, 372
S.W.3d 140 (Tex. 2012). Nowhere does the Fourth Amended Complaint assert a violation of the
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FDCA. Moreover, the Court determined above that Plaintiffs have alleged sufficient facts to
give rise to a reasonable inference that Defendants are liable under Texas’ product liability laws.
Accordingly, the Court concludes that Plaintiffs have standing to bring this cause of action and
that the Court has subject matter jurisdiction to hear this case pursuant to 28 U.S.C. 1332.
C.
Texas Civil Practice & Remedies Code § 82.007
Finally, Generic Defendants argue that Plaintiffs’ claims are barred by TEX. CIV. PRAC. &
REM. CODE § 82.007. (D.E. 78 at 19.) The Court considered this issue in its Order granting in
part and denying in part Generic Defendants’ first motion to dismiss. (D.E. 84 at 7–8.) Therein,
the Court concluded that before a drug manufacturer may assert a presumption of no liability
under Section 82.007, it must demonstrate that it distributed its product with the proper FDAapproved warnings and information. Plaintiffs theory of liability is that Generic Defendants
failed to provide FDA-approved warnings and information. Therefore, viewing the allegations
of the Fourth Amended Complaint in the light most favorable to Plaintiffs, Generic Defendants
are not entitled to a presumption of no liability.
CONCLUSION
For the reasons set forth above, Generic Defendants’ second motion to dismiss (D.E. 78)
is DENIED. The Court retains Plaintiffs’ failure-to-warn claims against Teva Pharmaceuticals
USA, Inc., Watson Laboratories, Inc., and Watson Pharma, Inc.
ORDERED this 28th day of June 2013.
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NELVA GONZALES RAMOS
UNITED STATES DISTRICT JUDGE
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