Florida Statutes

Fla. Stat. § 768.1256 (2025)

Government rules defense.

✓ 2025 Florida Statutes — current through the 2025 Regular Session

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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

(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.

Notes of Decisions

Cited in 13 cases (3 in the last 5 years), 2007–2025 · leading case: Tillman v. C.R. Bard, Inc., 96 F. Supp. 3d 1307 (M.D. Fla. 2015).

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Tillman v. C.R. Bard, Inc., 96 F. Supp. 3d 1307 (M.D. Fla. 2015). · cites it 3× “Fla. Stat. § 768.1256 (1). "Florida's [Government Rules Defense] 'has not yet been thoroughly interpreted, and the contours and operation of the presumption are still largely unsettled.”

In Re Fosamax Prods. Liab. Litig., 742 F. Supp. 2d 460 (S.D.N.Y. 2010). · cites it 2× “See Fla. Stat. Ann. § 768.1256 . Under the statute, if the jury found that, at the time Fosamax was sold to Plaintiff "the aspect of the product that allegedly caused the harm" complied with all relevant FDA regulations, Merck would be entitled to a "rebuttable presumption" that…”

In re Welding Fume Prods. Liab. Litig., 245 F.R.D. 279 (N.D. Ohio 2007). “Fla. Stat. Ann. § 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 seller is not…”

In Re Trasylol Prods. Liab. Litig.-MDL-1928, 763 F. Supp. 2d 1312 (S.D. Fla. 2010). · cites it 2× “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 seller is not liable if, at the time…”

Secrest v. Merck, Sharp & Dohme Corp., 509 F. App'x 69 (2d Cir. 2013). “Fla. Stat. Ann. § 768.1256 (1). Secrest argues that because she alone offered a regulatory expert at trial, Dr.”

In re Stand. Jury Instructions in Civil Cases—Report No. 09-10, 91 So. 3d 785 (Fla. 2012). “18c Florida Statutes section 768.1256 provides for a rebuttable presumption in the event of compliance or noncompliance with government rules.”

Bennett ex rel. Bennett v. Forest Labs., 99 F. Supp. 3d 1360 (M.D. Fla. 2015). · cites it 6× “Bennett also argues the manufacturing company is responsible for its labels at all times.”

Boles v. Merck & Co., 742 F. Supp. 2d 460 (S.D.N.Y. 2010). · cites it 2× “See Fla. Stat. Ann. § 768.1256 . Under the statute, if the jury found that, at the time Fosamax was sold to Plaintiff “the aspect of the product that allegedly caused the harm” complied with all relevant FDA regulations, Merck would be entitled to a “rebuttable presumption” that…”

Sims v. BMW of North Am. LLC (M.D. Fla. 2025). · cites it 4× “Government Rules Defense Defendants also allege they are entitled to the government rules defense codified in Florida Statute § 768.1256.6 (Doc. 136, pp. 21–22; Doc. 137, pp.”

Melaney v. Harbor Freight Tools USA, Inc. (M.D. Fla. 2023). · cites it 3× “§ 768.1256, “it complied with all relevant government rules, regulations and standards with regard to the design, manufacture, testing, and inspection of the subject lift ladder, and as such, is entitled to a rebuttable presumption on non- liability” (the “Government Rules…”

In Re: Stand. Jury Instructions in Civil Cases - Report No. 19-03 (Fla. 2020). · cites it 2× “18c F.S. 768.1256 provides for a rebuttable presumption in the event of compliance or noncompliance with government rules.”

Monsanto Co. v. Lawrence J. Behar (Fla. 3d DCA 2025). · cites it 2× “See § 768.1256(1), Fla. Stat. (“In a product liability action brought against a manufacturer or seller for harm 13 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…”

Show all 13 citing cases →

— 768.1256(1) — 6 cases

Tillman v. C.R. Bard, Inc., 96 F. Supp. 3d 1307 (M.D. Fla. 2015). “Fla. Stat. § 768.1256 (1). "Florida's [Government Rules Defense] 'has not yet been thoroughly interpreted, and the contours and operation of the presumption are still largely unsettled.”

In Re Fosamax Prods. Liab. Litig., 742 F. Supp. 2d 460 (S.D.N.Y. 2010). “See Fla. Stat. Ann. § 768.1256 . Under the statute, if the jury found that, at the time Fosamax was sold to Plaintiff "the aspect of the product that allegedly caused the harm" complied with all relevant FDA regulations, Merck would be entitled to a "rebuttable presumption" that…”

Melaney v. Harbor Freight Tools USA, Inc. (M.D. Fla. 2023). “§ 768.1256, “it complied with all relevant government rules, regulations and standards with regard to the design, manufacture, testing, and inspection of the subject lift ladder, and as such, is entitled to a rebuttable presumption on non- liability” (the “Government Rules…”

Sims v. BMW of North Am. LLC (M.D. Fla. 2025). “Government Rules Defense Defendants also allege they are entitled to the government rules defense codified in Florida Statute § 768.1256.6 (Doc. 136, pp. 21–22; Doc. 137, pp.”

Monsanto Co. v. Lawrence J. Behar (Fla. 3d DCA 2025). “See § 768.1256(1), Fla. Stat. (“In a product liability action brought against a manufacturer or seller for harm 13 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…”

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