WHITE v. BREG INC

Filing 82

ORDER that the Dft shall file a memo addressing MDA preemption as it relates to the facts & allegations of this case not later than 5/13/2011. Pla shall file a response not later than 5/23/2011. Signed by JUDGE RICHARD SMOAK on 5/4/2011. (sea)

IN THE UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF FLORIDA
PENSACOLA DIVISION
ALISON SAPP WHITE,
Plaintiff,
vs.

CASE NO. 3:10-cv-102/RS-EMT

BREG, INC., a Delaware Corporation,

Defendant.
_________________________________________/
ORDER
Plaintiff’s First Amended Complaint (Doc. 3) alleges that jurisdiction is supported
by 28 U.S.C. § 1332, diversity of citizenship between the parties. Proper jurisdiction is a
prerequisite to the judicial resolution of claims. Ex parte McCardle, 74 U.S. 506, 514
(1869).
The Medical Devise Amendments of 1976 (“MDA”), 21 U.S.C. § 360(c), et. seq.,
to the Food, Drug and Cosmetic Act, 21 U.S.C. § 301, et. seq., preempt certain state law
claims. 21 U.S.C.S. § 360k(a) reads as follows:
[N]o State or political subdivision of a State may establish or
continue in effect with respect to a device intended for human
use any requirement-(1) which is different from, or in addition to, any
requirement applicable under this Act to the device, and
(2) which relates to the safety or effectiveness of the device
or to any other matter included in a requirement applicable to
the device under this Act.

A recent case in the Eleventh Circuit, Wolicki-Gables v. Arrow Int'l, Inc., 634 F.3d
1296 (11th Cir. 2011), found that the MDA preempted certain state law claims against a
pain pump manufacturer. Specifically, claims under Florida law for “strict liability for
manufacturing and design defect and failure to warn, and . . . negligent design,
manufacture, and assembly” were preempted. Id. Here, the Amended Complaint alleges
two causes of action related to the pain pump in question -- strict products liability and
negligence (Doc. 3, p. 7-8).
Neither party has addressed this critical issue of federal preemption. Because
federal preemption, if applicable, would eliminate this court’s jurisdiction to hear these
state law claims, this issue must be resolved before a ruling on the Motion for Summary
Judgment (Doc. 53).
IT IS ORDERED that the Defendant shall file a memorandum addressing MDA
preemption as it relates to the facts and allegations of this case not later than May 13,
2011. Plaintiff shall file a response not later than May 23, 2011.

ORDERED on May 4, 2011.
/S/ Richard Smoak
RICHARD SMOAK

UNITED STATES DISTRICT JUDGE