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Imagenetix, Inc. v. Frutarom USA, Inc.

United States District Court for the Southern District of California

December 9, 2013, Decided; December 9, 2013, Filed

CASE NO. 12CV2823-GPC(WMC)

Opinion

ORDER DENYING PLAINTIFF'S MOTION FOR SUMMARY JUDGMENT; GRANTING IN PART AND DENYING IN PART DEFENDANT'S MOTION FOR SUMMARY JUDGMENT; AND STAYING CASE

On July 26, 2013, Plaintiff Imagenetix, Inc. ("Plaintiff" or "Imagenetix") filed a motion for summary judgment on the "issue of Frutarom's liability for breach of express warranty." 1 (Dkt. No. 35.) On August 23, 2013, Frutarom USA, Inc. ("Defendant" or Frutarom") filed an opposition. (Dkt. No. 36.) Plaintiff filed a reply on September 6, 2013. (Dkt. No. 37.)

On October 23, 2013, Defendant Frutarom USA, Inc. filed a motion for summary judgment as to all causes of action in the complaint. (Dkt. No. 45.) Plaintiff filed an opposition on November 8, 2013. (Dkt. No. 49.) Defendant filed a reply on November 22, 2013. (Dkt.  [*3] No. 51.) Based on the foregoing, the Court DENIES Plaintiff's motion for summary judgment on the breach of express warranty issue; GRANTS Defendant's motion for summary judgment on the basis of primary jurisdiction; DENIES Defendant's motion for summary judgment on the issue of preemption and Plaintiff's failure to provide notice and an opportunity to cure; and STAYS the action pending a determination by the U.S. Food and Drug Administration ("FDA").

Background

Frutarom was the exclusive United States distributor of BLIS K12, a probiotic product developed and manufactured by BLIS Technologies, a New Zealand Company. (Dkt. No. 1, Compl. ¶ 7.) BLIS Technologies derived BLIS K12 from the naturally occurring bacterium Streptococcus salivarius. (Dkt. No. 36-2, D's Response to P's Separate Statement of Undisputed Material Fact ("SSUF"), No. 1.) Effective September 1, 2009, the parties entered into a Supply and Marketing Agreement ("Agreement"), where Frutarom would supply Imagenetix with BLIS K12. (Dkt. No. 49-1, Pl's Response to D's SSUF, No. 1.) In the Agreement, Imagenetix agreed to incorporate BLIS K12 into certain dietary supplements, named BioGuard, that Imagenetix would manufacture,  [*4] market, distribute, and sell in an exclusive territory. (Id., No. 2.) Frutarom also agreed that "the Raw Material [BLIS K12] shall conform to all applicable Federal, State and local laws, regulations and rules." (Id., No. 3.)

Shortly after launching the product, a consumer complained that a tablet of BioGuard had made his wife seriously ill. (Dkt. No. 36-2, D's Response to P's SSUF, No. 28.) The consumer filed an adverse event report with the FDA and notified Plaintiff that the FDA had barred import of a BLIS K12 product in 2008. (Dkt. No. 35-3, Spencer Decl. ¶ 6.) After investigating the consumer complaint, Plaintiff learned that the FDA had not approved a New Drug Application ("NDA") for BLIS K12 and that a New Dietary Ingredient ("NDI") pre-market notification also had not been filed for BLIS K12. (Id. ¶ 8.) Plaintiff stopped selling BioGuard. (Id. ¶ 7.)

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2013 U.S. Dist. LEXIS 173193 *; 2013 WL 6419674

IMAGENETIX, INC., Plaintiff, vs. FRUTAROM USA, INC., Defendant.

Prior History: Imagenetix, Inc. v. Frutarom USA, Inc., 2013 U.S. Dist. LEXIS 85624 (S.D. Cal., June 18, 2013)

CORE TERMS

primary jurisdiction, dietary supplement, summary judgment, food, dietary, preemption, ingredient, argues, notice, regulations, preempted, breached, parties, cases, summary judgment motion, express warranty, state law claim, state law, new drug, manufacturer, expertise, conflict preemption, cause of action, moving party, nonmoving, administrative ruling, regulatory authority, opportunity to cure, material fact, proceedings