United States District Court, S.D. Mississippi, Southern Division
MICHAEL H. MARCELLE SR. PLAINTIFF
PICAYUNE URGENT CARE, WALGREENS DRUG STORE, and TEVA PHARMACEUTICALS DEFENDANT
MEMORANDUM OPINION AND ORDER GRANTING MOTION FOR
JUDGMENT ON THE PLEADINGS AND DISMISSING TEVA
GUIROLA, JR. CHIEF U.S. DISTRICT JUDGE.
THE COURT is the  Motion for Judgment on the Pleadings
filed by Defendant Teva Pharmaceuticals. Teva, which states
that it was incorrectly identified in the pleadings and that
its correct name is “Teva Pharmaceuticals USA, Inc.,
” asks the Court to dismiss Plaintiff Michael H.
Marcelle Sr.'s claims against it. Plaintiff Marcelle, who
is proceeding pro se, did not respond to the Motion,
and the time for doing so has now expired. See,
e.g., Fox v. United States, No.
3:10cv126-DPJ-FKB, 2013 WL 1310558, at *3 (S.D.Miss. Mar. 28,
2013) (“[A]lthough pro se litigants are
afforded substantial leeway, they too must comply with court
orders and deadlines.”) (citing Fujita v. United
States, 416 F. App'x 400, 402-03 (5th Cir. 2011)).
Having considered the Motion and the applicable law, the
Court finds that the Motion should be granted because
Marcelle is not entitled to sue Teva pursuant to the Federal
Food, Drug and Cosmetics Act (FDCA), 21 U.S.C. §§
301, et seq. Accordingly, the Court lacks
subject-matter jurisdiction over Marcelle's claim against
Marcelle states that he was prescribed Pravastatin by
Picayune Urgent Care in November 2014 but was “not told
of side effects.” (Am. Compl. 4, ECF No. 18). He
further states that “[o]n November 17, 2014 [he]
started taking Pravastatin [he] received from Walgreens Drugs
and not told of side effects.” (Id.). He
“stopped taking Pravastatin after hearing of the side
effects on February 16, 2015[, ] 61 pills later.”
(Id.). He now alleges that he has “been very
ill for the last 2 years due to Pravastatin side effects
which I was not told of[, ]” and requests an award of
$250, 000 in damages for his pain and suffering. (See
has not made any specific allegations against Teva, the
manufacturer of Pravastatin, but states in pertinent part
that the basis for this Court's jurisdiction is
“Food and Drug Administration . . . Does not follow FDA
regulations on labeling of side effects.” (Id.
at 3). Liberally construing Marcelle's Amended Complaint,
as it must, the Court has determined that Marcelle is
attempting to state a claim against Teva under the FDCA.
See Bell v. Pfizer, Inc., 716 F.3d 1087, 1094 (8th
Cir. 2013) (“The labeling of prescription drugs is
governed by the” FDCA.).
has moved to dismiss Marcelle's claims against it based
on preemption and because Marcelle is not entitled to sue
under the FDCA. The Court need not consider Teva's
preemption arguments because, as discussed in further detail
below, the Court agrees that Marcelle is not entitled to sue
under the FDCA, and, thus, the Court lacks subject-matter
jurisdiction over Marcelle's claim against
Teva. See Fed. R. Civ. P. 12(h)(3)
(“If the court determines at any time that it lacks
subject-matter jurisdiction, the court must dismiss the
action.”); see also Filer v. Donley, 690 F.3d
643, 646 (5th Cir. 2012) (“it is the duty of a federal
court first to decide, sua sponte if necessary, whether it
has jurisdiction before the merits of the case can be
“The FDA's responsibility to regulate prescription
drugs . . . and to enforce laws with respect to such drugs,
including the precise content of format and prescription drug
labeling[, ] is plenary and exclusive.” In re
Zyprexa Prods. Liab. Litig., No. 04-MD-1596, 2008 WL
398378, at *5 (E.D.N.Y. Feb. 12, 2008) (citing to the FDCA).
Only the federal government and in some instances a state may
sue under the FDCA. See 21 U.S.C. § 337.
“Every federal court that has addressed the issue has
held that the FDCA does not create a private right of action
to enforce or restrain violations of its provisions and
accompanying regulations.” Eli Lilly & Co. v.
Roussel Corp., 23 F.Supp.2d 460, 476 (D.N.J. 1998).
Because Marcelle, as an individual, cannot sue under the
FDCA, the Court lacks subject-matter jurisdiction over his
purported FDCA claim against Teva. See, e.g.,
Murungi v. Touro Infirmary, No. 11-1823, 2012 WL
1014811, at *3 (E.D. La. Mar. 21, 2012); Logan v. Burger
King Rest., No. 610-141-HFF-WMC, 2010 WL 610741, at *1
(D.S.C. Feb. 18, 2010).
THEREFORE ORDERED AND ADJUDGED that the  Motion for
Judgment on the Pleadings filed by Defendant Teva
Pharmaceuticals is GRANTED. Teva is terminated as a
ORDERED AND ADJUDGED
 After the Court ordered Marcelle to
amend his Complaint to assert a basis for federal
jurisdiction, it appears that Marcelle is now relying solely
on federal law, and, thus, federal preemption of any state
law claim(s) is not at issue. If Marcelle is trying to allege
a state law claim, he has still ...