NC General Statutes

N.C. Gen. Stat. § 99B-5 (2026)

Claims based on inadequate warning or instruction

✓ current as of July 2026
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(a) No manufacturer or seller of a product shall be held liable in any product liability action for a claim based upon inadequate warning or instruction unless the claimant proves that the manufacturer or seller acted unreasonably in failing to provide such warning or instruction, that the failure to provide adequate warning or instruction was a proximate cause of the harm for which damages are sought, and also proves one of the following:

(1) At the time the product left the control of the manufacturer or seller, the product, without an adequate warning or instruction, created an unreasonably dangerous condition that the manufacturer or seller knew, or in the exercise of ordinary care should have known, posed a substantial risk of harm to a reasonably foreseeable claimant.

(2) After the product left the control of the manufacturer or seller, the manufacturer or seller became aware of or in the exercise of ordinary care should have known that the product posed a substantial risk of harm to a reasonably foreseeable user or consumer and failed to take reasonable steps to give adequate warning or instruction or to take other reasonable action under the circumstances.

(b) Notwithstanding subsection (a) of this section, no manufacturer or seller of a product shall be held liable in any product liability action for failing to warn about an open and obvious risk or a risk that is a matter of common knowledge.

(c) Notwithstanding subsection (a) of this section, no manufacturer or seller of a prescription drug shall be liable in a products liability action for failing to provide a warning or instruction directly to a consumer if an adequate warning or instruction has been provided to the physician or other legally authorized person who prescribes or dispenses that prescription drug for the claimant unless the United States Food and Drug Administration requires such direct consumer warning or instruction to accompany the product. (1995, c. 522, s. 1.)

 

Notes of Decisions
Cited in 49 cases (25 in the last 5 years), 2000–2026 · leading case: Evans v. Evans, 569 S.E.2d 303 (N.C. Ct. App. 2002).
Evans v. Evans, 569 S.E.2d 303 (N.C. Ct. App. 2002). · cites it 45× “N.C. Gen.Stat. § 99B-5(a) (2001). Plaintiff argues that the testimony of Dr.”
Sparks v. Oxy-Health, LLC, 134 F. Supp. 3d 961 (E.D.N.C. 2015). · cites it 18× “§ 99B-6; inadequate warning, in violation of N.C. Gen.Stat. § 99B-5; breach of the implied warranty of merchantability, in violation of North Carolina’s Uniform Commercial Code (the “UCC”), N.”
Dewitt v. Eveready Battery Co., Inc., 550 S.E.2d 511 (N.C. Ct. App. 2001). · cites it 10× “[6] In contrast to Plaintiff's warranty claim based on inadequate warnings, Plaintiff's negligence claim for inadequate warnings is governed by N.C. Gen.Stat. § 99B-5. N.C.G.S. §§ 99B-1.”
Martha Carlson v. Boston Sci. Corp., 856 F.3d 320 (4th Cir. 2017). “N.C. Gen. Stat. Ann. § 99B-5(a). Thus, even assuming the warnings in connection with the DFU were inadequate, Appellee is only liable if such inadequate warnings proximately caused Appellant’s injuries.”
In Re Zyprexa Prods. Liab. Litig., 489 F. Supp. 2d 230 (E.D.N.Y 2007). · cites it 2× “" N.C. Gen.Stat. § 99B-5(a); see also Part III.”
Kristiana Burrell v. Bayer Corp., 918 F.3d 372 (4th Cir. 2019). “One example will suffice: In North Carolina, a claim for inadequate warning is made out if "the manufacturer or seller acted unreasonably in failing to provide such warning;" the "failure to provide adequate warning or instruction was a proximate cause of the harm for which…”
Finch v. Covil Corp., 388 F. Supp. 3d 593 (M.D.N.C. 2019). · cites it 2× “See N.C. Gen. Stat. § 99B-5(a), (c). North Carolina does not appear to have adopted the "sophisticated user" defense, whereby a manufacturer is absolved of any duty to warn employees directly when a product is sold to an employer who is aware of its dangers.”
State Ex Rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899 (W. Va. 2007). · cites it 2× “See N.C. Gen.Stat. § 99B-5(c) (1995). [7] Thus, the total number of jurisdictions recognizing the learned intermediary doctrine, either by decision of the highest court or by statute, is only twenty-two.”
Smith v. Wyeth-Ayerst Labs. Co., 278 F. Supp. 2d 684 (W.D.N.C. 2003). · cites it 2× “N.C. Gen. Stat. § 99B-5. Defendant’s knowledge, or lack thereof, regarding the potential dangers of its product are indeed relevant to the issues of duty and causation.”
Block v. Woo Young Med. Co., 937 F. Supp. 2d 1028 (D. Minnesota 2013). · cites it 5× “provide a warning or instruction was the proximate cause of her harm; and (3) that when the pain pump left Woo Young’s control without an adequate warning or instruction, it created an unreasonably dangerous condition that Woo Young knew, or in the exercise of ordinary care…”
Larkin v. Pfizer, Inc., 153 S.W.3d 758 (Ky. 2004). “§ 2A:58C-4 (1987); N.C. Gen.Stat. § 99B-5(c) (1996); Ohio Rev.”
McNeil-Williams v. DePuy Orthopaedics, Inc., 384 F. Supp. 3d 570 (E.D.N.C. 2019). · cites it 4× “2017), for the proposition that failure to warn claims under N.C. Gen. Stat. § 99B-5(a) are not preempted.”
— N.C. Gen. Stat. § 99B-5(a) — 28 cases
Evans v. Evans, 569 S.E.2d 303 (N.C. Ct. App. 2002). “N.C. Gen.Stat. § 99B-5(a) (2001). Plaintiff argues that the testimony of Dr.”
Dewitt v. Eveready Battery Co., Inc., 550 S.E.2d 511 (N.C. Ct. App. 2001). “[6] In contrast to Plaintiff's warranty claim based on inadequate warnings, Plaintiff's negligence claim for inadequate warnings is governed by N.C. Gen.Stat. § 99B-5. N.C.G.S. §§ 99B-1.”
Martha Carlson v. Boston Sci. Corp., 856 F.3d 320 (4th Cir. 2017). “N.C. Gen. Stat. Ann. § 99B-5(a). Thus, even assuming the warnings in connection with the DFU were inadequate, Appellee is only liable if such inadequate warnings proximately caused Appellant’s injuries.”
Kristiana Burrell v. Bayer Corp., 918 F.3d 372 (4th Cir. 2019). “One example will suffice: In North Carolina, a claim for inadequate warning is made out if "the manufacturer or seller acted unreasonably in failing to provide such warning;" the "failure to provide adequate warning or instruction was a proximate cause of the harm for which…”
Finch v. Covil Corp., 388 F. Supp. 3d 593 (M.D.N.C. 2019). “See N.C. Gen. Stat. § 99B-5(a), (c). North Carolina does not appear to have adopted the "sophisticated user" defense, whereby a manufacturer is absolved of any duty to warn employees directly when a product is sold to an employer who is aware of its dangers.”
— N.C. Gen. Stat. § 99B-5(a)(1) — 6 cases
Evans v. Evans, 569 S.E.2d 303 (N.C. Ct. App. 2002). “N.C. Gen.Stat. § 99B-5(a) (2001). Plaintiff argues that the testimony of Dr.”
Walls v. Ford Motor Co. (M.D.N.C. 2022).
Walls v. Ford Motor Co. (M.D.N.C. 2022).
— N.C. Gen. Stat. § 99B-5(a)(2) — 5 cases
Evans v. Evans, 569 S.E.2d 303 (N.C. Ct. App. 2002). “N.C. Gen.Stat. § 99B-5(a) (2001). Plaintiff argues that the testimony of Dr.”
Cora Mitchell v. City of Warren, MI, 803 F.3d 223 (6th Cir. 2015).
McNeil-Williams v. DePuy Orthopaedics, Inc., 384 F. Supp. 3d 570 (E.D.N.C. 2019). “2017), for the proposition that failure to warn claims under N.C. Gen. Stat. § 99B-5(a) are not preempted.”
Block v. Woo Young Med. Co., 937 F. Supp. 2d 1028 (D. Minnesota 2013). “provide a warning or instruction was the proximate cause of her harm; and (3) that when the pain pump left Woo Young’s control without an adequate warning or instruction, it created an unreasonably dangerous condition that Woo Young knew, or in the exercise of ordinary care…”
Weaver v. AMV Holdings, LLC (N.C. Ct. App. 2026).
— N.C. Gen. Stat. § 99B-5(a)(l) — 1 case
Evans v. Evans, 569 S.E.2d 303 (N.C. Ct. App. 2002). “N.C. Gen.Stat. § 99B-5(a) (2001). Plaintiff argues that the testimony of Dr.”
— N.C. Gen. Stat. § 99B-5(b) — 4 cases
Sparks v. Oxy-Health, LLC, 134 F. Supp. 3d 961 (E.D.N.C. 2015). “§ 99B-6; inadequate warning, in violation of N.C. Gen.Stat. § 99B-5; breach of the implied warranty of merchantability, in violation of North Carolina’s Uniform Commercial Code (the “UCC”), N.”
Delaney v. Deere & Co., 999 P.2d 930 (Kan. 2000).
Eason v. Cleveland Draft House, LLC, 673 S.E.2d 883 (N.C. Ct. App. 2009).
Sisk v. Abbott Labs., 298 F.R.D. 314 (W.D.N.C. 2014).
— N.C. Gen. Stat. § 99B-5(c) — 9 cases
State Ex Rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899 (W. Va. 2007). “See N.C. Gen.Stat. § 99B-5(c) (1995). [7] Thus, the total number of jurisdictions recognizing the learned intermediary doctrine, either by decision of the highest court or by statute, is only twenty-two.”
In Re Zyprexa Prods. Liab. Litig., 489 F. Supp. 2d 230 (E.D.N.Y 2007). “" N.C. Gen.Stat. § 99B-5(a); see also Part III.”
Larkin v. Pfizer, Inc., 153 S.W.3d 758 (Ky. 2004). “§ 2A:58C-4 (1987); N.C. Gen.Stat. § 99B-5(c) (1996); Ohio Rev.”
Souther v. Eli Lilly & Co., 489 F. Supp. 2d 230 (E.D.N.Y 2007).
Smith v. Ethicon, Inc. (M.D.N.C. 2020).
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