Laxton v. Teva Pharmaceuticals USA Inc
MEMORANDUM AND ORDER re: 23 MOTION to Dismiss Case and Memorandum of Law in Support filed by Defendant Teva Pharmaceuticals USA Inc. IT IS HEREBY ORDERED that defendants' motion to dismiss (#23) is GRANTED in part. Signed by District Judge Stephen N. Limbaugh, Jr on 11/28/16. (CSG)
UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF MISSOURI
TEVA PHARMACEUTICALS USA, INC., )
d/b/a GATE PHARMACEUTICALS, et al. )
No. 1:16-cv-193 SNLJ
MEMORANDUM & ORDER
Plaintiff filed this lawsuit against defendant Teva Pharmaceuticals USA, Inc.,
d/b/a Gate Pharmaceuticals in circuit court in Cape Girardeau County, Missouri.
Defendant removed the matter to this Court pursuant to this Court’s diversity jurisdiction,
28 U.S.C. § 1332(a)(1). The lawsuit alleges that defendant Teva developed,
manufactured, and marketed the prescription weight-loss drug Phentermine in its generic
form and the brand name drug Adipex P. Plaintiff claims that defendant Teva failed to
warn that Phentermine and Adipex P cause blood clots and that she was injured when she
took these products. She claims Teva is liable for Failure to Warn and Design Defect
(Count I) and in Strict Liability (Count II). After removal to this Court, plaintiff
amended her complaint to add defendants the United States Food and Drug
Administration (“FDA”), Commissioner of Food and Drugs Robert Califf in his official
capacity, and Secretary of Health and Human Services Sylvia Matthews Burwell in her
official capacity. Plaintiff added Count III against those defendants for a declaratory
judgment that FDA policies and procedures that prevent generic drug manufacturers from
warning consumers about the risks of their products are arbitrary, capricious,
unreasonable, and void as against public policy.
Defendant Teva has moved to dismiss plaintiff’s complaint. The matter has been
fully briefed and is now ready for disposition.
The purpose of a Rule 12(b)(6) motion to dismiss for failure to state a claim is to
test the legal sufficiency of a complaint so as to eliminate those actions “which are fatally
flawed in their legal premises and deigned to fail, thereby sparing litigants the burden of
unnecessary pretrial and trial activity.” Young v. City of St. Charles, 244 F.3d 623, 627
(8th Cir. 2001) (citing Neitzke v. Williams, 490 U.S. 319, 326-27 (1989)). “To survive a
motion to dismiss, a claim must be facially plausible, meaning that the ‘factual content. . .
allows the court to draw the reasonable inference that the defendant is liable for the
misconduct alleged.’” Cole v. Homier Dist. Co., Inc., 599 F.3d 856, 861 (8th Cir. 2010)
(quoting Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009)).
Plaintiff’s claims against Teva are based on two state-law theories of liability:
(Count I) Teva’s failure to warn of the purported effects of using the drugs phentermine
and Adipex-P; and (Count II) Teva’s alleged defective design of its phentermine and
Adipex-P. Plaintiff admits that the Supreme Court of the United States has held that the
makers of generic drugs may not be sued under state law for failing to warn customers
about the risks associated with their products. PLIVA, Inc. v. Mensing, 564 U.S. 604, 618
(2011); see #15 at ¶¶ 32, 36. Originally, a manufacturer seeking approval to market a
new drug had to prove the drug was safe and effective and show that the proposed label
was accurate and adequate. Id. at 612. The same rules applied to all drugs until 1984,
when Congress allowed “generic drugs” to gain FDA approval by showing equivalence
to a “brand-name” drug that had already been approved by the FDA. Id. For those
generic drugs, a manufacturer had to show that its labeling was the same as labeling
approved for the brand-name drug. Id. at 612-13.
Mensing held that because generic
drug manufacturers are required by federal law to use the same warning label as its namebrand counterpart, federal law preempted state laws that might otherwise require the
manufacturer to label its drug to warn of product dangers. Id. at 618.
Plaintiffs suggest that Adipex-P is a brand name drug not subject to the Mensing
holding. Indeed, the Supreme Court has held that state law tort claims may be made
against brand-name drug manufacturers for failure to provide an adequate warning label.
Wyeth v. Levine, 555 U.S. 555, 581 (2009). However, the Court may take judicial notice
of FDA records that demonstrate Adipex-P is a generic drug for purposes of the Mensing
holding.1 The FDA records are conclusive. “Generic” drugs for the purposes of the
Mensing holding are drugs that were approved by the FDA pursuant to an Abbreviated
New Drug Application (“ANDA”). See Mensing, 564 U.S. at 612; Caraco Pharm.
Laboratories, Ltd. v. Novo Nordisk A/S, 132 S. Ct. 1670, 1676 (2012) (explaining that a
“a generic competitor” may file an ANDA that “piggy-back[s]” on the brand-name drug’s
earlier New Drug Application (“ NDA”)). Adipex-P, according to FDA records, has two
“Generally, the Court must ignore materials that are outside of the pleadings, however, district
courts ‘may take judicial notice of public records and may thus consider them on a motion to
dismiss.’” Stahl v. United States Dept. of Agric., 327 F.3d 697, 700 (8th Cir. 2003); see
Blankenship v. Medtronic, Inc., 6 F. Supp. 3d 979, 984 (E.D. Mo. 2014) (taking judicial notice of
FDA records and reports).
FDA approval numbers: the tablet is ANDA #085128; the capsule is ANDA #088023.2
Both Adipex-P drugs, then, were approved pursuant to the Abbreviated New Drug
application --- not the New Drug Applications used for brand name drugs subject to the
Wyeth holding, 555 U.S. at 561. Adipex-P is a “generic” for purposes of the Mensing
holding, and plaintiff cannot sue its manufacturer for matters regarding its labeling.
In Count III of her amended complaint, plaintiff seeks a declaratory judgment that
the policies and procedures the FDA employs that prevent generic drug manufacturers
from warning consumers adequately are arbitrary, capricious, unreasonable, and void as
against public policy. (#15 at ¶ 35.) Because the defendant agency and related officials
named in Count III have not yet responded to the Complaint (and their time for doing so
has not expired), the Court will not address Count III at this time. Furthermore, because
the disposition of Count III has bearing on the viability of Counts I and II, the Court will
dismiss Counts I and II without prejudice.
As a result, the Court will grant defendant’s motion in part as described above.
IT IS HEREBY ORDERED that defendants’ motion to dismiss (#23) is
GRANTED in part.
Dated this 28th
day of November, 2016.
STEPHEN N. LIMBAUGH, JR.
UNITED STATES DISTRICT JUDGE
http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=088023 (last visited
Nov. 23, 2016).
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