Patricia Fragomeli v. Novartis Pharmaceuticals Corp , 352 F. App'x 994 ( 2009 )

NOT RECOMMENDED FOR FULL-TEXT PUBLICATION
File Name: 09a0750n.06
Nos. 08-5573, 08-5574, 08-5575 FILED
Nov 24, 2009
UNITED STATES COURT OF APPEALS LEONARD GREEN, Clerk
FOR THE SIXTH CIRCUIT
In re: AREDIA AND ZOMETA PRODUCTS )
LIABILITY LITIGATION, )
)
PATRICIA FRAGOMELI, FRANK BIOCCA, AND )
JACK CUTHBERT, )
) ON APPEAL FROM THE UNITED
Plaintiffs-Appellants, ) STATES DISTRICT COURT FOR
) THE MIDDLE DISTRICT OF
v. ) TENNESSEE
)
NOVARTIS PHARMACEUTICALS )
CORPORATION, )
)
Defendant-Appellee. )
Before: MARTIN, COLE, and KETHLEDGE, Circuit Judges.
KETHLEDGE, Circuit Judge. Patricia Fragomeli, Frank Biocca, and Jack Cuthbert
(“Plaintiffs”) appeal the district court’s order granting summary judgment in favor of Novartis
Pharmaceuticals Corporation (“NPC”) and denying their motion for additional discovery. We
affirm.
I.
Plaintiffs’ suits are part of multi-district litigation, In re Aredia & Zometa Products Liability
Litigation, involving claims that the FDA-approved drugs Aredia and Zometa cause osteonecrosis
of the jaw (“ONJ”), a disease that results in bone-tissue deterioration. Biocca and Cuthbert filed
their suits in the Southern and Eastern Districts of New York in 2006, and Fragomeli filed hers in
Nos. 08-5573, 08-5574, 08-5575
Fragomeli v. Novartis
the Middle District of Tennessee. In April 2006, the Judicial Panel on Multidistrict Litigation
transferred Biocca and Cuthbert to the Middle District of Tennessee for coordinated-pretrial
proceedings with other Aredia and Zometa suits. Plaintiffs were all Michigan citizens when they
filed suit against NPC.
NPC thereafter moved for summary judgment, arguing that Plaintiffs’ claims were
preempted. Plaintiffs opposed NPC’s motion and moved for additional discovery under Federal
Rule of Civil Procedure 56(f). The district court granted NPC’s summary-judgment motion and
dismissed Plaintiffs’ Rule 56(f) motion as futile.
This appeal followed.
II.
We review a district court’s grant of summary judgment de novo. Beecham v. Henderson
County, 422 F.3d 372, 374 (6th Cir. 2005). Summary judgment is proper “if the pleadings, the
discovery and disclosure materials on file, and any affidavits show that there is no genuine issue as
to any material fact and that the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P.
56(c).
Michigan law generally immunizes a drug manufacturer from liability for FDA-approved
drugs unless the manufacturer intentionally withholds or misrepresents information that would have
led the FDA to deny approval or withdraw the drug. Mich. Comp. Laws. § 600.2946(5)(a).
Plaintiffs sued under this fraud-on-the-FDA exception, alleging that NPC withheld or misrepresented
information about ONJ after the FDA had approved Aredia and Zometa. In this circuit, the federal
Food, Drug and Cosmetic Act, 21 U.S.C. § 301, et seq., preempts such claims, unless some federal
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Fragomeli v. Novartis
agency has already found the requisite fraud on the FDA. See Garcia v. Wyeth-Ayerst Laboratories,
385 F.3d 961, 966 (6th Cir. 2004). There is no such finding here.
But Plaintiffs argue that Garcia is distinguishable for two reasons. First, they contend they
have merely brought common-law claims that rely on fraud on the FDA to defeat an
affirmative defense, rather than an affirmative claim based on such fraud. And second, they contend
that Garcia is inapplicable to claims arising from post-approval fraud. Per Garcia’s plain terms,
however, both distinctions are beside the point: “[S]tate tort remedies requiring proof of fraud
committed against the FDA are foreclosed since federal law preempts such claims.” Id. at 966
(quotation marks and citation omitted). Plaintiffs’ claims undisputedly require proof of fraud
committed against the FDA. Plaintiffs have no federal finding to that effect. Under this circuit’s
binding precedent, therefore, Plaintiffs’ claims are preempted.
Plaintiffs also argue that the district court erred in denying their Rule 56(f) motion for
additional discovery. We review the denial of that motion for an abuse of discretion. See Lewis v.
ACB Bus. Servs., Inc., 135 F.3d 389, 409 (6th Cir. 1998). A court does not abuse its discretion in
denying a Rule 56(f) motion if further discovery cannot remedy legal or factual deficiencies in the
movant’s claims or defenses. CenTra, Inc. v. Estrin, 538 F.3d 402, 420 (6th Cir. 2008).
Here, plaintiffs sought further discovery of NPC and FDA records related to Aredia and
Zometa. In light of Garcia, that discovery would be futile. The district court did not abuse its
discretion, therefore, in denying the Rule 56(f) motion.
The judgment of the district court is affirmed.
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