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Florida Statute 768.1256 - Full Text and Legal Analysis
Florida Statute 768.1256 | Lawyer Caselaw & Research
Link to State of Florida Official Statute
F.S. 768.1256 Case Law from Google Scholar Google Search for Amendments to 768.1256

The 2025 Florida Statutes

Title XLV
TORTS
Chapter 768
NEGLIGENCE
View Entire Chapter
768.1256 Government rules defense.
(1) In a product liability action brought against a manufacturer or seller for harm allegedly caused by a product, there is a rebuttable presumption that the product is not defective or unreasonably dangerous and the manufacturer or seller is not liable if, at the time the specific unit of the product was sold or delivered to the initial purchaser or user, the aspect of the product that allegedly caused the harm:
(a) Complied with federal or state codes, statutes, rules, regulations, or standards relevant to the event causing the death or injury;
(b) The codes, statutes, rules, regulations, or standards are designed to prevent the type of harm that allegedly occurred; and
(c) Compliance with the codes, statutes, rules, regulations, or standards is required as a condition for selling or distributing the product.
(2) In a product liability action as described in subsection (1), there is a rebuttable presumption that the product is defective or unreasonably dangerous and the manufacturer or seller is liable if the manufacturer or seller did not comply with the federal or state codes, statutes, rules, regulations, or standards which:
(a) Were relevant to the event causing the death or injury;
(b) Are designed to prevent the type of harm that allegedly occurred; and
(c) Require compliance as a condition for selling or distributing the product.
(3) This section does not apply to an action brought for harm allegedly caused by a drug that is ordered off the market or seized by the Federal Food and Drug Administration.
History.s. 15, ch. 99-225.

F.S. 768.1256 on Google Scholar

F.S. 768.1256 on CourtListener

Amendments to 768.1256


Annotations, Discussions, Cases:

Cases Citing Statute 768.1256

Total Results: 7  |  Sort by: Relevance  |  Newest First

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Tillman v. C.R. Bard, Inc., 96 F. Supp. 3d 1307 (M.D. Fla. 2015).

Cited 14 times | Published | District Court, M.D. Florida | 2015 U.S. Dist. LEXIS 40338, 2015 WL 1456657

...Bard also contends, as a "preliminary point,” that it is "entitled to a rebuttable presumption of no liability under Florida law because the G2 filter complied with federal safety regulations.” See Bard Motion at 16. This presumption, known as the Government Rules Defense, is set forth in section 768.1256(1) of the Florida Statutes, which provides: In a product liability action brought against a manufacturer or seller for harm allegedly caused by a product, there is a rebuttable presumption that the product is not defective or unreaso...
..., regulations, or standards are designed to prevent the type of harm that allegedly occurred; and (c)Compliance with the codes, statutes, rules, regulations, or standards is required as a condition for selling or distributing the product. Fla. Stat. § 768.1256 (1)....
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In Re Trasylol Prods. Liab. Litig.-MDL-1928, 763 F. Supp. 2d 1312 (S.D. Fla. 2010).

Cited 3 times | Published | District Court, S.D. Florida | 2010 U.S. Dist. LEXIS 140358, 2010 WL 5579867

...d gross negligence, the plaintiffs also claimed that proof of a violation of the FDCA would give rise to negligence per se and shift the burden to defendant to prove that Bendectin did not cause their injuries. Id. at 293, 312. [17] Under FLA. STAT. § 768.1256, (1) In a product liability action brought against a manufacturer or seller for harm allegedly caused by a product, there is a rebuttable presumption that the product is not defective or unreasonably dangerous and the manufacturer or sell...
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In re Stand. Jury Instructions in Civil Cases—Report No. 09-10, 91 So. 3d 785 (Fla. 2012).

Cited 2 times | Published | Supreme Court of Florida | 2012 WL 1722576

NOTE ON USE FOR 403.18c Florida Statutes section 768.1256 provides for a rebuttable presumption in the
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In Re Stand. Jury Instructions in Civil Cases—report No. 13-01 (Prods. Liab.), 160 So. 3d 869 (Fla. 2015).

Cited 1 times | Published | Supreme Court of Florida | 2015 WL 1400770

...to be illustrative and may be modified to fit the facts of each case. 403.11 INFERENCE OF PRODUCT DEFECT OR NEGLIGENCE (Reserved) NOTES ON USE FOR 403.11 - 14 - 1. F.S. 768.1256 provides for a rebuttable presumption in the event of compliance or noncompliance with government rules....
...The court should not, however, instruct on risk/benefit as both a test of defectiveness under 403.7 and as an affirmative defense under 403.18. c. Government Rules Defense: No instruction provided. NOTE ON USE FOR 403.18c Florida Statutes section F.S. 768.1256 provides for a rebuttable presumption in the event of compliance or noncompliance with government rules....
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Monsanto Co. v. Lawrence J. Behar (Fla. 3d DCA 2025).

Published | Florida 3rd District Court of Appeal

...Stat. Monsanto reasonably relied on decades of scientific evidence. The EPA has continuously reevaluated glyphosate and approved it for use. The EPA further dictates the label of the product and found that a cancer warning label would be false and misleading. See § 768.1256(1), Fla....
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In Re: Stand. Jury Instructions in Civil Cases - Report No. 19-03 (Fla. 2020).

Published | Supreme Court of Florida

...The court should not, however, instruct on risk/benefit as both a test of defectiveness under 403.7 and as an affirmative defense under 403.18. c. Government Rules Defense: No instruction provided. NOTE ON USE FOR 403.18c F.S. 768.1256 provides for a rebuttable presumption in the event of compliance or noncompliance with government rules....
...Learned intermediary defense. See Aubin v. Union Carbide Corp., 117 So. 3d 489, 515–16 (Fla. 2015). The list of factors set forth in this instruction is not exclusive and may be modified to fit the facts of the case. 5. Government Rules Defense. F.S. 768.1256 provides for a rebuttable presumption in the event of compliance or noncompliance with government rules. The statute does not state whether the presumption is a burden-shifting or a vanishing presumption....
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Bennett ex rel. Bennett v. Forest Labs., 99 F. Supp. 3d 1360 (M.D. Fla. 2015).

Published | District Court, M.D. Florida | 2015 U.S. Dist. LEXIS 48895, 2015 WL 1648240

...3 Forest Laboratories was heavily involved with the warnings associated with Lexapro, the drug ingested by Terri René. As a result, the Court cannot rely on Guarino as a proper basis to grant summary judgment. Hi. Whether the claims are barred by Florida Statute § 768.1256? Forest Laboratories argues all claims are barred pursuant to Florida Statute § 768.1256 because it complied with all federal regulations governing the manufacture and sale of Lexapro....
...Litig., No. 3:06-md-1760, 2009 WL 2497229 (M.D.Tenn. Aug. 13, 2009), aff’d Emerson v. Novartis Pharms. Corp., 446 Fed.Appx. 733 (6th Cir.2011). In response, Bennett argues the Florida Statute also provides him with a rebuttable presumption. See Fla. Stat. § 768.1256 (2)....
...mpliance as a condition for selling or distributing the product. (3)This section does not apply to an action brought for harm allegedly caused by a drug that is ordered off the market or seized by the Federal Food and Drug Administration. Fla. Stat. § 768.1256 ....