Court Opinion

ID: 2978575
Source: CourtListenerOpinion
Date Created: 2015-09-22 18:27:54.660173+00
Date Added: 2024-06-11T15:40:24.279697
License: Public Domain

NOT RECOMMENDED FOR FULL-TEXT PUBLICATION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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Nos. 08-5573, 08-5574, 08-5575
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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