United States District Court, E.D. Louisiana
ORDER & REASONS
the Court is Defendant Vintage Pharmaceuticals, LLC's
(“Vintage”) Motion to Dismiss, R. Doc. 15.
Plaintiff has not filed an opposition to the Motion. Having
reviewed Vintage's arguments and the applicable law, the
Court now issues this Order and Reasons.
products liability case arises from injuries allegedly
sustained by Plaintiff as a side effect of ingesting various
antipsychotic prescription drugs, including Risperdal
(risperidone), Risperdal Consta (a long-acting injectable
form of risperidone), Invega (paliperidone), and/or
Risperidone. R. Doc. 1 at 3. Plaintiff claims that Defendants
falsely advertised these drugs, illegally promoted the drugs
as safe for off-label uses, and minimized the side effects
that might result, including the injuries Plaintiff suffered,
such as gynecomastia. R. Doc. 1 at 3. Plaintiff asserts
claims based on the Louisiana Products Liability Act
(“LPLA”), as well as state law claims based in
negligence, redhibition, breach of various warranties, and
strict liability. R. Doc. 1 at 4-10. Plaintiff also alleges
Defendants violated federal regulations. R. Doc. 1 at 11-12.
Vintage Pharmaceuticals, LLC (named as Endo Pharmaceuticals
Inc in the Complaint) has filed a Motion to Dismiss
Plaintiff's claims under Federal Rule of Civil Procedure
12(b)(6). R. Doc. 15-1 at 1. Vintage does not manufacture the
“brand name” drug, Risperdal, but instead
produces a generic version of the drug. Generic drugs can
obtain FDA approval by demonstrating they are equivalent to a
drug that has already received approval from the FDA. A
generic drug manufacturer is “responsible for ensuring
that its warning label is the same as the brand
name's.” PLIVA, Inc. v. Mensing, 564 U.S.
604, 612-13 (2011). Thus, to obtain FDA approval, Vintage
need only show that it's generic version of Risperidone
is identical to the brand name version-Risperdal.
alleges that Plaintiff's non-LPLA state law claims must
be dismissed because the LPLA provides the exclusive remedy
for products liability actions against manufacturers under
Louisiana law. R. Doc. 15-1 at 2. Further, Vintage contends
that claims for failure-to-warn, design defect, and breach of
express warranty under the LPLA are preempted by federal law,
and that Plaintiff fails to plead facts sufficient to support
his claim for a manufacturing defect under the LPLA. R. Doc.
15-1 at 2. Finally, Vintage avers that there is no cause of
action for violating federal regulations. R. Doc. 15-1 at 2.
Thus, Defendant Vintage avers Plaintiff's claims against
it must be dismissed.
LAW AND ANALYSIS
Federal Rules of Civil Procedure permit a defendant to seek a
dismissal of a complaint based on the “failure to state
a claim upon which relief can be granted.” Fed.R.Civ.P.
12(b)(6). A complaint should not be dismissed for failure to
state a claim “unless it appears beyond doubt that the
plaintiff can prove no set of facts in support of his claim
which would entitle him to relief.” Conley v.
Gibson, 355 U.S. 41, 47 (1957). Generally, when
evaluating a motion to dismiss pursuant to Rule 12(b)(6), the
court should not look past the pleadings.
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.'”
Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting
Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570
(2007)). The district court must construe facts in the light
most favorable to the nonmoving party and must accept as true
all factual allegations contained in the complaint.
Ashcroft, 556 U.S. at 678. “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.”
Id. A court “do[es] not accept as true
conclusory allegations, unwarranted factual inferences, or
legal conclusions.” Plotkin v. IP Axess Inc.,
407 F.3d 690, 696 (5th Cir. 2005).
Vintage moves to dismiss all Plaintiff's state-law
negligence claims as precluded by the Louisiana Products
Liability Act. The LPLA provides the only remedies available
under Louisiana law against the manufacturer of a product.
See La. Rev. Stat. § 9:2800.54(B); Stahl v.
Novartis Pharm. Corp., 283 F.3d 254, 261 (5th Cir.
2002). Thus, Plaintiff's non-LPLA state law claims must
Defendant argues that Plaintiff's claims for failure to
warn, design defect, and breach of express warranty under the
LPLA are preempted by federal law. LPLA claims for
failure-to-warn, design defect, and breach of express
warranty claims against manufacturers of generic drugs are
preempted by federal law. Johnson v. Teva Pharm. USA,
Inc., 758 F.3d 605 (5th Cir. 2014); see also PLIVA,
Inc. v. Mensing, 131 S.Ct. 2567 (2011). Generic drug
manufacturers must use the same label and warnings and have
the same chemical composition as the FDA-approved brand-name
version of the drug. Generic drug manufacturers cannot modify
that label, add inconsistent or additional warnings, or in
any way change the chemical composition of the drug. In sum,
generic manufacturers cannot simultaneously comply with
federal law and meet additional requirements under state tort
law. Therefore, the Court agrees with Vintage and finds that
federal law preempts Plaintiff's failure to warn and
design defect claims under the LPLA.
sole remaining claim under the LPLA is a manufacturing defect
claim. To prevail on a manufacturing defect claim under the
LPLA, Plaintiff must demonstrate that at the time the drug
left the manufacturer's control, it “deviated in a
material way from the manufacturer's specifications or
performance standards for the product or from otherwise
identical products manufactured by the same
manufacturer.” La. R.S. § 9:2800.55. Plaintiff
does not provide any factual allegations to support this
claim, or refute Vintage's argument that his claim based
on a manufacturing defect should be dismissed. Thus, the
Court finds this claim cannot survive a motion to dismiss.
Plaintiff states claims for violations of federal law.
According to Plaintiff, Vintage violated 21 U.S.C. § 321
and § 352, which give the FDA the authority to regulate
drugs and explains the criteria for determining when a drug
has been misbranded. 21 U.S.C. § 321, 352. Neither of
these statutes provides a private cause of action, and the
Court will not infer that Congress intended to create one.
See Pramann v. Janssen Pharm., Inc., No. CV
16-12413, 2017 WL 58469, at *3 (E.D. La. Jan. 5, 2017);
see also Detgen ex rel. Detgen v. Janek, 752 F.3d
627, 629 (5th Cir. 2014) (“Normally a cause of action
must be found in a statute.”). Thus, Plaintiff's
claims based on the violation of federal law must be