Wednesday, September 9, 2009

FDA Preemption Claim Rejected By Fourth District - Defensive Preemption Not Complete Preemption

In Cordis Corporation v. O’Shea (4D09-1597), the Fourth District denied the petitioner's writ of prohibition without prejudice for the petitioner's to raise the challenge on final review.  The court stated:
Part of petitioners’ defense is that federal law preempts state causes of action. The Cypher stent is considered a Class III medical device regulated by the Food and Drug Administration (FDA)...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’ 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).
The court then rejected the argument that American Maritime Officers Union v. Merriken, 981 So. 2d 544 (Fla. 4th DCA 2008) controlled the preemption analysis.  The American Maritime Officers Union decision was previously discussed here.  Specifically, the court stated:
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 on 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.
Finally, the court agreed that this was defensive preemption and not complete preemption (as was found in American Maritime Officers Union).  "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...We agree with 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.'


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