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1. Manufacturer or seller places a defective product on the market;
2. The defective product is sold in an unreasonably dangerous condition;
3. The product reaches the plaintiff without substantial change in the condition in which the product is sold; and
4. The defect is the proximate cause of the plaintiff’s injury.

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1. Manufacturer or seller places a defective product on the market;
2. The defective product is sold in an unreasonably dangerous condition;
3. The product reaches the plaintiff without substantial change in the condition in which the product is sold; and
4. The defect is the proximate cause of the plaintiff’s injury.

To prevail on a failure to warn claim, a plaintiff must prove: (1) that the warnings were inadequate; (2) that the inadequacy of the warnings proximately caused the injury; and (3) that the plaintiff suffered an injury by using the product. Colville v. Pharmacia & Upjohn Co., 565 F. Supp. 2d 1314, 1320 (N.D. Fla. 2008); see also Wright v. Howmedica Osteonics Corp., 741 F. App’x 624, 626 (11th Cir. 2018).

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FLORIDA STATE COURTS

Supreme Court:  Aubin v. Union Carbide Corp., 177 So. 3d 489, 502 (Fla. 2015).

First District: R.J. Reynolds Tobacco Co. v. Nelson, 353 So. 3d 87, 89 (Fla. 1st DCA 2022); Lawrence v. Brandell Prods., 619 So. 2d 427, 428 (Fla. 1st DCA 1993).

Second District: Fish Tale Sales & Serv. v. Nice, 106 So. 3d 57, 59 (Fla. 2d DCA 2013).

Third District: LaBarre v. Bristol-Myers Squibb Co., 544 F. App’x 120, 125 (3d Cir. 2013); Siemens Energy & Automation v. Medina, 719 So. 2d 312, 315 (Fla. 3d DCA 1998).

Fourth District: Harrell v. BMS Partners, LLC, 350 So. 3d 361, 366 (Fla. 4th DCA 2022).

Fifth District: Cintron v. Osmose Wood Preserving, 681 So. 2d 859, 861 (Fla. 5th DCA 1996); Giddens v. Denman Rubber Mfg. Co., 440 So. 2d 1320, 1322 (Fla. 5th DCA 1983).

FLORIDA FEDERAL COURTS

Eleventh Circuit:  Nbis Constr. v. Liebherr-Am., Inc., 93 F.4th 1304, 1310 (11th Cir. 2024).

Northern District: Colville v. Pharmacia & Upjohn Co. LLC, 565 F. Supp. 2d 1314, 1320 (N.D. Fla. 2008); McAllister v. Savage Arms, Inc., 5:21CV123-TKW-MJF, 2023 WL 8231503, at *4 (N.D. Fla. Nov. 27, 2023).

Southern District: Zamora v. AAP Implants, Inc., No. 24-CV-21625, 2024 WL 4851352, at *3 (S.D. Fla. Nov. 21, 2024), report and recommendation adopted, No. 24-CV-21625, 2024 WL 5040719 (S.D. Fla. Dec. 9, 2024); Patt v. Volkswagen Group of Am., Inc., 22-CV-21585, 2024 WL 1675301, at *5 (S.D. Fla. Apr. 18, 2024); In re Aesculap Implant Sys. LLC, 2:19-CV-14421, 2019 WL 7343255, at *1 (S.D. Fla. Dec. 31, 2019).

Middle District: Disarro v. EzriCare, LLC, 2:23-CV-230-JES-KCD, 2023 WL 4737010, at *6 (M.D. Fla. July 25, 2023); Brosius v. Home Depot Inc., 6:20-CV-1136-ACC-DCI, 2022 WL 1272087, at *4 (M.D. Fla. Feb. 8, 2022).

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2 Defenses to Claim for Strict Liability – Failure to Warn

(1) Fla. R. Civ. P. 1.110(d) (pleading affirmative defenses), and other standard defenses. See § 1.

(2) Statute of Limitations: § 95.11(3), Fla. Stat. (four years).

(3) Statute of Repose: § 95.031(2)(b), Fla. Stat. (twelve years).

(4) A distributor of an inherently dangerous commodity must provide fair and adequate warning of its dangerous potentialities to its users, and is strictly liable for injuries caused by the failure to do so. Tampa Drug Co v. Wait, 103 So. 2d 603, 607 (Fla. 1958); see also Goodyear Tire & Rubber Co. v. Hughes Supply, Inc., 358 So. 2d 1339 (Fla. 1978).

(5) Manufacturers are strictly liable for failing to warn of dangerous contents in their products “which could damage or injure even when the product is not used for its intended purpose.” High v. Westinghouse Elec. Corp., 610 So. 2d 1259, 1262 (Fla. 1992).

(6) An adequate warning should contain wording directed to the “significant dangers arising from failure to use the product in the prescribed manner, such as the risk of serious injury or death.” Grieco v. Daiho Sangyo, Inc., 344 So. 3d 11, 20 (Fla. 4th DCA 2022).

(7) There is no duty to warn of obvious or known dangers. Scheman-Gonzalez v. Saber Mfg. Co., 816 So. 2d 1133, 1139 (Fla. 4th DCA 2002).

(8) “[I]n pleading the elements of a failure-to-warn claim in the context of a medical device, a plaintiff must allege that the manufacturer failed to warn the patient’s physician of the risks associated with a medical product’s prescribed use, not its alleged defects… Further, because Florida has adopted the learned intermediary doctrine, the manufacturer’s duty to warn runs to the physician, not to the patient…” Zamora v. AAP Implants, Inc., No. 24-CV-21625, 2024 WL 4851352, at *3 (S.D. Fla. Nov. 21, 2024), report and recommendation adopted, No. 24-CV-21625, 2024 WL 5040719 (S.D. Fla. Dec. 9, 2024); see also Beale v. Biomet, Inc., 492 F. Supp. 2d 1360, 1368 (S.D. Fla. 2007).

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