Cordis Corporation v. O’Shea
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DISTRICT COURT OF APPEAL OF THE STATE OF FLORIDA
FOURTH DISTRICT
July Term 2009
CORDIS CORPORATION and JOHNSON & JOHNSON OF NEW
JERSEY, INC., d/b/a JOHNSON & JOHNSON,
Petitioners,
v.
SEAN O’SHEA,
Respondent.
No. 4D09-1597
[September 9, 2009]
PER CURIAM.
Petitioners Cordis Corporation a n d Johnson & Johnson of New
Jersey, Inc. seek prohibition barring the circuit court from continuing to
entertain a complaint against them alleging various claims involving the
use of a Cypher brand cardiac drug-eluting stent. The petition follows a
March 2, 2009 order which granted in part and denied in part their
motion to dismiss the third amended complaint with prejudice.
Part of petitioners’ defense is that federal law preempts state causes of
action. Th e Cypher stent is considered a Class III medical device
regulated by the Food and Drug Administration (FDA) pursuant to the
1976 Medical Device Amendments (MDA) to the Food, Drug, and
Cosmetic Act, 21 U.S.C. §§ 301-399a. Class III devices are used for
“supporting or sustaining human life or for a use which is of substantial
importance in preventing impairment of human health.” 21 U.S.C. §
360c(a)(1)(C)(ii)(I). Before a manufacturer can market a Class III device,
it must submit a Pre-Market Approval (PMA) application providing the
FDA with “reasonable assurance” that the device is both safe and
effective. See 21 U.S.C. § 360e(d)(2). The FDA may deny the application,
request additional information from the manufacturer, or grant approval.
The manufacturer must comply with all design, manufacturing and
labeling specifications set forth in a PMA approval order. 21 C.F.R. §
814.80. Petitioners advise that the FDA continues its oversight of the
safety and effectiveness of PMA-approved devices after approval.
Petitioners contend that the Cypher brand stent was the first drug-
eluting stent of its kind. It was approved by the FDA through a PMA in
April, 2003 for use b y physicians in patients with atherosclerotic
obstructive coronary disease.
Th e conditions of approval call for
continuing supervision by the FDA. Petitioners’ argument is that the
FDA’s extensive oversight of the Cypher brand stent’s safety and
effectiveness leads to federal preemption of a n y state claim that
challenges the FDA’s determination that the stent is safe.
In a thoughtful series of orders, the circuit court dismissed some
claims, allowed others to proceed, and considered the application of
Riegel v. Medtronic, Inc., 552 U.S.
, 128 S. Ct. 999 (2008), where the
Supreme Court wrote:
State requirements are pre-empted under the MDA only to
the extent that they are “different from, or in addition to” the
requirements imposed by federal law. Section 360k(a)(1).
Thus, Section 360K does not prevent a State from providing
a damages remedy for claims premised on a violation of FDA
regulations; the state duties in such a case “parallel,” rather
than add to, federal requirements.
Id. at 1011 (citations omitted).
We reject petitioners’ assertion that this case is controlled by
American Maritime Officers Union v. Merriken, 981 So. 2d 544 (Fla. 4th
DCA 2008). In American Maritime, we held that a petition for prohibition
would lie where a complaint against a benefits plan alleging
whistleblower claims was completely preempted by federal ERISA law.
However, that holding was based up o n ERISA’s grant of exclusive
jurisdiction to federal district courts for violations under its laws. See 29
U.S.C. § 1132(e). No similar statute grants exclusive jurisdiction over the
subject matter of this case.
We agree with respondent that this is a case of defensive, and not
complete, preemption. Further, the issues presented are more properly
characterized as a “choice of law” issue rather than “choice of forum”
preemption, which would provide exclusive jurisdiction in the federal
courts. See Bertoni v. Stock Bldg. Supply, 989 So. 2d 670, 674 (Fla. 4th
DCA 2008) (in which the court contrasted defensive preemption with
complete preemption); Days Inn Acquisition Corp. v. Hutchinson, 707 So.
2d 747, 749 n.1 (Fla. 4th DCA 1997) (where court recognized that a
question of whether federal law governed the substance of a dispute was
not a question of subject matter jurisdiction); Cent. Nat’l Bank of Miami v.
Cent. Bancorp, Inc., 411 So. 2d 358 (Fla. 3d DCA 1982). We agree with
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the analysis of Gonzales v. Surgidev Corp., 899 P.2d 576, 582 (N.M.
1995):
In considering whether federal preemption affects subject
matter jurisdiction, the issue is not whether Congress
intended to replace state law with a federal regulatory
scheme but “whether jurisdiction provided by state law is
itself pre-empted by federal law vesting exclusive jurisdiction
over that controversy in another body.” International
Longshoremen’s Ass’n v. Davis, 476 U.S. 380, 387-88 (1986).
The Davis Court labeled this distinction choice-of-forum
preemption, which deprives the state court of subject matter
jurisdiction, as opposed to choice-of-law preemption, which
limits the court’s ability to grant relief on a state law claim.
Id. at 391. Under choice-of-law preemption, a state court
has jurisdiction to entertain the claim, but it must apply
federal law in deciding the claim on the merits. In contrast,
under choice-of-forum preemption, the state court lacks
jurisdiction even to entertain the claim, which can then only
be raised in federal court. The Davis Court noted that choice
of forum preemption “does not apply to preemption claims
generally but only to those preemption claims that go to the
State's actual adjudicatory or regulatory power as opposed to
the State's substantive laws.” Id. at 391 n.9.
(Some internal citations omitted).
We dismiss the petition for writ of prohibition without prejudice to
petitioners’ right to raise their challenges on final appeal.
GROSS, C.J., DAMOORGIAN and GERBER, JJ., concur.
*
*
*
Petition for writ of prohibition to the Circuit Court for the Fifteenth
Judicial Circuit, Palm Beach County; Glenn D. Kelley, Judge; L.T. Case
No. 502006CA013019XXXXMB.
Jeffrey B. Shapiro and Andrea Cox of Arnstein & Lehr LLP, Miami, for
petitioners.
Jane Kreusler-Walsh and Rebecca Mercier Vargas of Kreusler-Walsh,
Compiani & Vargas, P.A., West Palm Beach, and Theodore Babbitt of
Babbitt, Johnson, Osborne & LeClainche, P.A., West Palm Beach, for
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respondent.
Not final until disposition of timely filed motion for rehearing.
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