II. STANDARD OF REVIEW: REMOVAL
The question presented is whether Plaintiffs' state law claims
for misrepresentation and fraud by Defendants regarding the drug
Ritalin should be restated as a claim "arising under" federal
law, due to the regulation of Ritalin under the FDCA.
Congress has provided for removal of cases from state court to
federal court only if the federal court would have had original
jurisdiction over the action. 28 U.S.C. § 1441(a). Congress gave
the federal courts general federal question jurisdiction in the
Judiciary Act of 1875, providing "[t]he districts courts shall
have original jurisdiction of all civil actions arising under
the Constitution, laws or treaties of the United States."
28 U.S.C. § 1331 (emphasis added). Federal removal statutes are to
be strictly construed, and all doubts regarding removal are to be
resolved in favor of remand. Boyer v. Snap-on Tools Corp.,
913 F.2d 108, 111 (3d Cir. 1990), cert. denied, 498 U.S. 1085, 111
S.Ct. 959, 112 L.Ed.2d 1046 (1991) (citations omitted).
The presence of federal question jurisdiction is governed by
reference to the "well-pleaded complaint" doctrine. Merrell Dow
Pharmaceuticals, Inc. v. Thompson, 478 U.S. 804, 808, 106 S.Ct.
3229, 92 L.Ed.2d 650 (1986) (citing Franchise Tax Board v.
Construction Laborers Vacation Trust, 463 U.S. 1, 9-10, 103
S.Ct. 2841, 77 L.Ed.2d 420 (1983)). Pursuant to this doctrine, a
case "arises under" federal law and is therefore removable only
if a federal claim exists on the face of Plaintiffs' complaint.
Id. The fact that Plaintiff's state law claims may be pre-empted
by federal law is insufficient to confer federal question
jurisdiction. Dukes v. U.S. Healthcare, Inc., 57 F.3d 350, 353
(3d Cir. 1995). Thus, removal is not proper if based on a defense
or an anticipated defense which is federal in nature, even if
both parties admit that the federal defense is the only real
question in the case. See Caterpillar Inc. v. Williams,
482 U.S. 386, 393, 107 S.Ct. 2425, 96 L.Ed.2d 318 (1987) ("The fact
that a defendant might ultimately prove that a plaintiff's claims
are preempted under [a federal statute] does not establish that
they are removable to federal court."); see also Gully v. First
Nat'l Bank 299 U.S. 109, 116, 57 S.Ct. 96, 81 L.Ed. 70 (1936)
("By unimpeachable authority, a suit brought upon a state statute
does not arise under an Act of Congress or the Constitution of
the United States because prohibited thereby") (emphasis
One corollary to the well-pleaded complaint rule is the
doctrine of "complete preemption."*fn5 Caterpillar, 482 U.S.
at 393, 107 S.Ct. 2425. Although normally federal preemption only
provides a federal defense and does not permit removal, in
certain circumstances the preemptive force of federal law is so
powerful that it completely displaces any state law cause of
action, and leaves room only for federal law for purposes of the
"well-pleaded complaint" rule. Metropolitan Life Ins. Co. v.
Taylor, 481 U.S. 58, 63-65, 107 S.Ct. 1542, 95 L.Ed.2d 55
(1987); see also Dukes, 57 F.3d at 354;*fn6 15 James Wm. Moore
Moore's Federal Practice, ¶ 103.45 (3d ed. 1999). This is
known as the jurisdictional doctrine of "complete preemption" or
"displacing preemption." Complete preemption only exists if: (1)
"the statute relied upon by the defendant as preemptive contains
civil enforcement provisions within the scope of which the
plaintiff's state claim falls," Railway Labor Executives Ass'n
v. Pittsburgh & Lake Erie R.R. Co., 858 F.2d 936, 942 (3d Cir.
1988) (citing Franchise Tax Board, 463 U.S. at 24, 26, 103
S.Ct. 2841); and (2) there is "a clear indication of a
Congressional intention to permit removal despite the plaintiff's
exclusive reliance on state law." Railway Labor, 858 F.2d at
942 (citing Metropolitan Life Ins. Co., 481 U.S. at 64-66, 107
S.Ct. 1542). The Third Circuit explained the logic of these
In order to determine whether it possesses this
authority to recharacterize, the federal court must
first ask whether the statute relied upon by the
defendant as preemptive contains civil enforcement
provisions within the scope of which the plaintiff's
state claim falls . . . If the federal statute
creates no federal cause of action vindicating the
same interest the plaintiff's state cause of action
seeks to vindicate, recharacterization as a federal
claim is not possible and there is no claim arising
under federal law to be removed and litigated in the
Railway Labor, 858 F.2d at 942 (citing Franchise Tax Board,
463 U.S. at 24, 26, 103 S.Ct. 2841). This two part test for
complete preemption is "the only basis for recharacterizing a
state law claim as a federal claim removable to a district
court." Goepel v. National Postal Mail Handlers Union,
In the instant case, Plaintiffs' Complaint does not rely on
federal law; all of the claims expressly stated by Plaintiffs are
traditional state law tort and fraud claims. Nonetheless,
Defendants contend that removal is proper, and make several
separate but related arguments in opposition to Plaintiffs'
motion to remand. Defendants first claim that because Plaintiffs'
Complaint seeks injunctive relief in a form which requires
further approval from the FDA under the FDCA, 21 U.S.C. § 321 et
seq., federal question jurisdiction exists. Specifically,
Defendants contend that any change to the literature, labeling
or other information they disseminate requires further approval
of the FDA. Defendants argue that because Congress expressly
entrusted the FDA to approve and handle all federally-regulated
drug labeling, the state court lacks the power to provide this
Even assuming, arguendo, that a state court could not order
the injunctive relief sought by Plaintiffs without the approval
of the FDA, removal does not necessarily follow.*fn8 If it is
presumed that, in enacting the FDCA, Congress determined that
only the FDA may approve changes to labels or other literature
regarding FDA-approved drugs, Defendants would have only
established that the FDCA may provide a defense to Plaintiffs'
state law claims or remedies. However, removal is not proper if
based on a defense or an anticipated defense which is federal in
nature, even if both parties admit that the federal defense is
the only real question in the case. See Caterpillar, 482 U.S.
at 393, 107 S.Ct. 2425.*fn9
The existence of a federal defense (also known as "defensive
preemption") does not provide a sufficient federal question for
removal. Metropolitan Life Ins. Co., 481 U.S. at 67, 107 S.Ct.
1542. "The fact that [Defendants] might ultimately prove that
[Plaintiffs'] claims [for injunctive relief] are pre-empted under
[the FDCA] does not establish that they are removable to federal
court." Caterpillar, 482 U.S. at 393, 107 S.Ct. 2425. Even
assuming that the FDCA preempts the injunctive relief sought by
Plaintiffs, this Court lacks jurisdiction unless (1) "the statute
relied upon by the defendant as preemptive contains civil
enforcement provisions within the scope of which the plaintiff's
state claim falls," Railway Labor, 858 F.2d at 942 (citing
Franchise Tax Board, 463 U.S. at 24, 26, 103 S.Ct. 2841); and
(2) there is "a clear indication of a Congressional intention to
permit removal despite the plaintiff's exclusive reliance on
state law." Railway Labor, 858 F.2d at 942 (citing
Metropolitan Life, 481 U.S. at 64-66, 107 S.Ct. 1542).
The FDCA contains no private civil enforcement provisions which
would encompass Plaintiffs' claims. See Thompson v. Merrell Dow
Pharmaceuticals, 766 F.2d 1005 (6th Cir. 1985); aff'd Merrell
Dow Pharmaceuticals, Inc. v. Thompson, 478 U.S. 804, 106 S.Ct.
3229, 92 L.Ed.2d 650 (1986). See also In re Orthopedic Bone
Screw Products Liability Litigation, 193 F.3d 781, 788 (3d Cir.
1999) ("It is well
settled . . . that the FDCA creates no private right of action");
PDK Labs., Inc. v. Friedlander, 103 F.3d 1105, 1113 (2d Cir.
1997); Mylan Labs., Inc. v. Matkari, 7 F.3d 1130, 1139 (4th
As the Supreme Court found in Merrell, because no federal
right of action existed under the FDCA, removal was not proper:
The significance of the necessary assumption that
there is no federal private cause of action thus
cannot be overstated. For the ultimate import of such
a conclusion, as we have repeatedly emphasized, is
that it would flout congressional intent to provide a
private federal remedy for the violation of the
federal statute. We think it would similarly flout,
or at least undermine, congressional intent to
conclude that the federal courts might nevertheless
exercise federal-question jurisdiction and provide
remedies for violations of that federal statute . . .
Merrell, 478 U.S. at 812, 106 S.Ct. 3229.