UNITED STATES DISTRICT COURT WESTERN DISTRICT OF ...

Case 6:10-cv-00886-TLM-CMH Document 99 Filed 11/15/11 Page 1 of 6 PageID #: 753
UNITED STATES DISTRICT COURT
WESTERN DISTRICT OF LOUISIANA
JANE ETTA STEVENS * CIVIL NO. 6:10-0886
VERSUS * JUDGE MELANCON
PLIVA, INC. * MAGISTRATE JUDGE HILL
REPORT AND RECOMMENDATION
ON MOTION TO DISMISS
Pending before the undersigned for report and recommendation is the Motion to Dismiss
filed by defendant, Pliva, Inc. (“Pliva”), on September 1, 2011 [rec. doc. 94]. No opposition
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has been filed, and the deadline for opposition has expired. For the following reasons, it is
recommended that the motion be GRANTED.
Background
Plaintiff, Jane Etta Steven (“Stevens”), filed suit in this Court under the Louisiana
Products Liability Act, LA. REV. STAT. § 9:2800.51 et seq., alleging that she suffers from
tardive dyskinesia and/or involuntary movement disorder caused by long-term use of
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metoclopramide, a generic form of Reglan, manufactured by Pliva. [rec. docs. 1, 17, 60, 82].
By Order dated March 21, 2011, Judge Melançon administratively terminated these proceedings
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The time for filing opposition is twenty-one days after service of the motion. LR 7.5. However,
by Order dated September 23, 2011, Judge Melancon permitted the plaintiff an additional thirty days
from the date of his Order to file her opposition to the instant Motion [rec. doc. 97].
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By Order dated May 28, 2010, the claims of plaintiffs, Suzanne Guilbeau, Roberta Phillips,
Brenda Richardson, Roy Steve, Sr., Brenda Steve, Jane Etta Stevens, and Eddie Sue Williams on behalf
of Dolly Sue Williams, were severed into separate causes of action. [rec. doc. 57].

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without prejudice to the parties’ right to file a motion to reopen the proceedings within 30 days
from the date of the United States Supreme Court’s decisions in Demahy v. Actavis, Inc., 593
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F.3d 428 (5 Cir. 2010), cert. granted No. 09-1501, and Mensing v. Wyeth, Inc., 588 F.3d 603
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(8 Cir. 2009), cert. granted No. 09-993 and 09-1039, were rendered. [rec. doc. 89]. On July
21, 2011, the parties moved to reopen/reinstate the case [rec. doc. 90], which motion was
granted on July 25, 2011 [rec. doc. 91].
On September 1, 2001, Pliva filed the instant motion to dismiss on the basis that
plaintiff’s failure-to-warn and design defect claims were preempted by federal law in light of
the Supreme Court’s decision in PLIVA, Inc. v. Mensing, 564 U.S. ___, 131 S.Ct. 2567, 180
L.Ed.2d 580 (June 23, 2011). [rec. doc. 94]. The motion is unopposed.
Law and Analysis
Standard for Motion to Dismiss
When deciding a Rule 12(b)(6) motion to dismiss, "[t]he ‘court accepts all
well-pleaded facts as true, viewing them in the light most favorable to the plaintiff.'" In re
Katrina Canal Breaches Litig., 495 F.3d 191, 205 (5th Cir. 2007) (internal quotations
omitted) (quoting Martin K. Eby Constr. Co. v. Dallas Area Rapid Transit, 369 F.3d 464,
467 (5th Cir. 2004)). "To survive a Rule 12(b)(6) motion to dismiss, the plaintiff must plead
‘enough facts to state a claim to relief that is plausible on its face.'" In re Katrina Breaches
Litig., 495 F.3d at 205 (quoting Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 127 S.Ct.
1955, 1974, 167 L.Ed.2d 929 (2007)). "Factual allegations must be enough to raise a right to
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relief above the speculative level[.]" Id. (quoting Twombly, 550 U.S. at 555, 127 S.Ct. at
1965). "While a complaint attacked by a Rule 12(b)(6) motion to dismiss does not need
detailed factual allegations, a plaintiff's obligation to provide the grounds of his entitlement
to relief requires more than labels and conclusions, and a formulaic recitation of the
elements of a cause of action will not do[.]" Twombly, 550 U.S. at 555, 127 S.Ct. at
1964-65 (citations, quotation marks, and brackets omitted) (emphasis added).
Preemption
Pliva argues that plaintiff’s claims are preempted, relying on the Supreme Court’s
decision in Mensing, supra. In Mensing, the Supreme Court consolidated the claims of
Gladys Mensing and Julie Demahy, both of whom brought suit for damages against the
generic drug manufacturers that produced metoclopramide, under Minnesota law [Mensing
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v. Wyeth, Inc., 588 F.3d 603 (8 Cir. 2009)] and Louisiana law, respectively. Demahy filed
suit in Louisiana state court, alleging that long-term metoclopramide use caused her tardive
dyskinesia and that the manufacturer was liable under the Louisiana Products Liability Act.
Following removal, the United States District Court for the Eastern District of
Louisiana (Barbier, J.) granted in part and denied in part the manufacturer’s motion to
dismiss. The Fifth Circuit affirmed that decision on appeal, finding that Demahy’s claims
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were not pre-empted. Demahy v. Actavis, Inc., 593 F.3d 428 (5 Cir. 2010).
On June 23, 2011, the Supreme Court issued its decision and reversed and remanded
each case, holding that federal law pre-empted state laws imposing the duty to change a
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drug’s label upon generic drug manufacturers. After the Supreme Court rendered its
decision, the Fifth Circuit vacated and remanded its decision for the entry of judgment in
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favor of defendant-appellant, Actavis. Demahy v. Actavis, Inc., 650 F.3d 1045 (5 Cir. Aug.
22, 2011).
Here, plaintiff alleged in her second amended complaint that defendant had failed to
warn of the risks of taking metoclopramide on its labels and package inserts. [rec. doc. 60,
6, 21-32]. This is precisely the type of claim that Mensing held was pre-empted by
federal law. Moreover, while plaintiff attempts to assert a design defect claim in her third
amended complaint without alleging any defect in Pliva’s metoclopramide [rec. doc. 82,
47] , to the extent plaintiff properly states a claim, the reasoning in Mensing compels
dismissal. Under the same federal law analyzed in Mensing [21 U.S.C. § 355(j)], a generic
pharmaceutical product must be the same as the referenced listed drug (typically a brand-
name drug) in active ingredients, safety and efficacy and hence, as was the case with
labeling, federal law pre-empts state laws imposing the duty to change a drug’s design upon
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generic drug manufacturers. See Mensing, 131 S.Ct. at 2574. As required by federal law,
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The Court reasoned as follows:
Under this law, “generic drugs” can gain FDA approval simply by showing equivalence
to a reference listed drug that has already been approved by the FDA.[Fn.2] 21 U.S.C. §
355(j)(2)(A). This allows manufacturers to develop generic drugs inexpensively, without
duplicating the clinical trials already performed on the equivalent brand-name drug. A
generic drug application must also “show that the [safety and efficacy] labeling proposed
. . . is the same as the labeling approved for the [brand-name] drug.” § 355(j)(2)(A)(v);
see also § 355(j)(4)(G); Beers §§ 3.01, 3.03[A].
In footnote 2, the Court noted:
As we use it here, “generic drug” refers to a drug designed to be a copy of a reference listed drug
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Pliva submitted the referenced listed drug’s “design” and obtained FDA approval before
marketing.
Considering the Supreme Court’s opinion, and the lack of opposition to Pliva’s
motion, the undersigned finds that plaintiff’s claims are preempted by federal law.
Accordingly, I recommend that the motion to dismiss plaintiff’s claims be GRANTED.
Conclusion
Based on the foregoing reasons, the undersigned recommends that the Motion to
Dismiss be GRANTED.
Under the provisions of 28 U.S.C. § 636(b)(1)(C) and F.R.Civ.Proc. 72(b), parties
aggrieved by this recommendation have fourteen (14) days from service of this Report and
Recommendation to file specific, written objections with the Clerk of Court. A party may
respond to another party’s objections within fourteen (14) days after being served with a
copy thereof. Counsel are directed to furnish a courtesy copy of any objections or responses
to the District Judge at the time of filing.
(typically a brand-name drug), and thus identical in active ingredients, safety, and efficacy. See, e.g.,
United States v. Generix Drug Corp., 460 U.S. 453, 454–455, 103 S.Ct. 1298, 75 L.Ed.2d 198 (1983); 21
CFR § 314.3(b) (2006) (defining “reference listed drug”).
As a result, brand-name and generic drug manufacturers have different federal drug labeling duties. A
brand-name manufacturer seeking new drug approval is responsible for the accuracy and adequacy of its
label. See, e.g., 21 U.S.C. §§ 355(b)(1), (d); Wyeth, supra, at 570–571, 129 S.Ct. 1187. A manufacturer
seeking generic drug approval, on the other hand, is responsible for ensuring that its warning label is the
same as the brand name's. See, e.g., § 355(j)(2)(A)(v); § 355(j)(4)(G); 21 CFR §§ 314.94(a)(8),
314.127(a)(7).
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FAILURE TO FILE WRITTEN OBJECTIONS TO THE PROPOSED
FACTUAL FINDINGS AND/OR THE PROPOSED LEGAL CONCLUSIONS
REFLECTED IN THIS REPORT AND RECOMMENDATION WITHIN
FOURTEEN (14) DAYS FOLLOWING THE DATE OF ITS SERVICE, OR WITHIN
THE TIME FRAME AUTHORIZED BY FED.R.CIV.P. 6(b), SHALL BAR AN
AGGRIEVED PARTY FROM ATTACKING THE FACTUAL FINDINGS OR THE
LEGAL CONCLUSIONS ACCEPTED BY THE DISTRICT COURT, EXCEPT
UPON GROUNDS OF PLAIN ERROR. DOUGLASS V. UNITED SERVICES
AUTOMOBILE ASSOCIATION, 79 F.3D 1415 (5TH CIR. 1996).
Signed November 14, 2011, Lafayette, Louisiana.
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