N.J. Stat. » Title 2A — ADMINISTRATION OF CIVIL AND CRIMINAL JUSTICE
New Jersey Statutes

N.J. Stat. § 2A:58C-5 (2026)

Punitive damages under food and drug product liability, limitation

✓ current as of May 2026
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5. a. (Deleted by amendment, P.L.1995, c.142.)

b. (Deleted by amendment, P.L.1995, c.142.)

c. Punitive damages shall not be awarded if a drug or device or food or food additive which caused the claimant's harm was subject to premarket approval or licensure by the federal Food and Drug Administration under the "Federal Food, Drug, and Cosmetic Act," 52 Stat.1040, 21 U.S.C. s.301 et seq. or the "Public Health Service Act," 58 Stat.682, 42 U.S.C. s.201 et seq. and was approved or licensed; or is generally recognized as safe and effective pursuant to conditions established by the federal Food and Drug Administration and applicable regulations, including packaging and labeling regulations. However, where the product manufacturer knowingly withheld or misrepresented information required to be submitted under the agency's regulations, which information was material and relevant to the harm in question, punitive damages may be awarded. For purposes of this subsection, the terms "drug," "device," "food," and "food additive" have the meanings defined in the "Federal Food, Drug, and Cosmetic Act."

d. (Deleted by amendment, P.L.1995, c.142.)

Notes of Decisions
Cited in 35 cases (11 in the last 5 years), 1990–2024 · leading case: Forman v. Novartis Pharm. Corp., 793 F. Supp. 2d 598 (E.D.N.Y 2011).
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Forman v. Novartis Pharm. Corp., 793 F. Supp. 2d 598 (E.D.N.Y 2011). · cites it 26× “” N.J.S.A. § 2A:58C-5(c). However, under the statute, this immunity is unavailable and punitive damages are permitted “where the product manufacturer knowingly withheld or misrepresented information required to be submitted under the agency’s regulations, which information was…”
Sullivan v. Novartis Pharm. Corp., 575 F. Supp. 2d 640 (D.N.J. 2008). · cites it 4× “9 to -17, and the punitive damages provision of the NJPLA (N.J.S.A. § 2A:58C-5(c)). After Plaintiffs filed the complaint, but before service could be effected, Novartis filed the Notice.”
Sullivan v. Novartis Pharm. Corp., 602 F. Supp. 2d 527 (D.N.J. 2009). · cites it 11× “Plaintiffs NJPLA punitive damages claim relies on N.J.S.A. § 2A:58C-5(c), which provides in relevant part: Punitive damages shall not be awarded if a drug .”
Wal-Mart Stores, Inc. v. Alexander, 868 S.W.2d 322 (Tex. 1994). · cites it 2× “§ 549.20(4) (West Supp.1993); Mo. Ann.Stat.”
Stromenger v. Novartis Pharm. Corp., 941 F. Supp. 2d 1288 (D. Or. 2013). · cites it 9× “and was approved or licensed,” N.J. Stat. Ann. § 2A:58C-5, subd. (c). Id.”
In re Accutane Litig., 194 A.3d 503 (N.J. 2018). “N.J.S.A. 2A:58C-5(c) states in part that punitive damages are not available "if a drug .”
Stange, T. v. Janssen Pharm., 179 A.3d 45 (Pa. Super. Ct. 2018). “) 5 NJPLA, N.J. Stat.Ann. § 2A:58C-5(c). 6 The conflict of law issue arises from three cases decided prior to the global order entered in the In Re Risperdal® Litigation .”
Zimmerman v. Novartis Pharm. Corp., 889 F. Supp. 2d 757 (D. Md. 2012). · cites it 3× “Although this Court agrees that the presumption against preemption applies to state tort claims implicating health and safety generally, the Court concludes that such a presumption does not apply to that part of Plaintiffs claim, which by virtue of New Jersey law, conditions any…”
Walus v. Pfizer, Inc., 812 F. Supp. 41 (D.N.J. 1993). · cites it 4× “This section, however, simply addresses the type of damages that may be recovered if a valid basis for liability is established. Where a valid basis for liability does not exist, as in the instant case, reliance on section 2A:58C-5 is misplaced.”
Germanio v. Goodyear Tire & Rubber Co., 732 F. Supp. 1297 (D.N.J. 1990). · cites it 5× “” N.J.S.A. 2A:58C-5; see also Fischer v. Johns-Manville Corp.”
Farmers Ins. Exch. v. Shirley, 958 P.2d 1040 (Wyo. 1998). · cites it 2× “• New Jersey N.J. Stat. Ann. §§ 2A:58C-5(b) and (d) (West 1987) (mandates separate proceedings for determination of compensatory and punitive damages).”
Huskey v. Ethicon, Inc., 29 F. Supp. 3d 736 (S.D.W. Va 2014). “” *746 N.J. Stat. Ann. § 2A:58C-5 (emphasis added).”
Show all 35 citing cases →
N.J. Stat. § 2A:58C-5(a): 1 case
Germanio v. Goodyear Tire & Rubber Co., 732 F. Supp. 1297 (D.N.J. 1990). “” N.J.S.A. 2A:58C-5; see also Fischer v. Johns-Manville Corp.”
N.J. Stat. § 2A:58C-5(b): 4 cases
Wal-Mart Stores, Inc. v. Alexander, 868 S.W.2d 322 (Tex. 1994). “§ 549.20(4) (West Supp.1993); Mo. Ann.Stat.”
Farmers Ins. Exch. v. Shirley, 958 P.2d 1040 (Wyo. 1998). “• New Jersey N.J. Stat. Ann. §§ 2A:58C-5(b) and (d) (West 1987) (mandates separate proceedings for determination of compensatory and punitive damages).”
Germanio v. Goodyear Tire & Rubber Co., 732 F. Supp. 1297 (D.N.J. 1990). “” N.J.S.A. 2A:58C-5; see also Fischer v. Johns-Manville Corp.”
Transp. Ins. Co. v. Moriel, 879 S.W.2d 10 (Tex. 1994).
N.J. Stat. § 2A:58C-5(c): 21 cases
Forman v. Novartis Pharm. Corp., 793 F. Supp. 2d 598 (E.D.N.Y 2011). “” N.J.S.A. § 2A:58C-5(c). However, under the statute, this immunity is unavailable and punitive damages are permitted “where the product manufacturer knowingly withheld or misrepresented information required to be submitted under the agency’s regulations, which information was…”
Sullivan v. Novartis Pharm. Corp., 602 F. Supp. 2d 527 (D.N.J. 2009). “Plaintiffs NJPLA punitive damages claim relies on N.J.S.A. § 2A:58C-5(c), which provides in relevant part: Punitive damages shall not be awarded if a drug .”
Sullivan v. Novartis Pharm. Corp., 575 F. Supp. 2d 640 (D.N.J. 2008). “9 to -17, and the punitive damages provision of the NJPLA (N.J.S.A. § 2A:58C-5(c)). After Plaintiffs filed the complaint, but before service could be effected, Novartis filed the Notice.”
In re Accutane Litig., 194 A.3d 503 (N.J. 2018). “N.J.S.A. 2A:58C-5(c) states in part that punitive damages are not available "if a drug .”
Stromenger v. Novartis Pharm. Corp., 941 F. Supp. 2d 1288 (D. Or. 2013). “and was approved or licensed,” N.J. Stat. Ann. § 2A:58C-5, subd. (c). Id.”
N.J. Stat. § 2A:58C-5(d): 1 case
Tarr v. Bob Ciasulli's MacK Auto Mall, Inc., 943 A.2d 866 (N.J. 2008).
N.J. Stat. § 2A:58C-5(e): 3 cases
Sullivan v. Novartis Pharm. Corp., 575 F. Supp. 2d 640 (D.N.J. 2008). “9 to -17, and the punitive damages provision of the NJPLA (N.J.S.A. § 2A:58C-5(c)). After Plaintiffs filed the complaint, but before service could be effected, Novartis filed the Notice.”
Forman v. Novartis Pharm. Corp., 793 F. Supp. 2d 598 (E.D.N.Y 2011). “” N.J.S.A. § 2A:58C-5(c). However, under the statute, this immunity is unavailable and punitive damages are permitted “where the product manufacturer knowingly withheld or misrepresented information required to be submitted under the agency’s regulations, which information was…”
Stromenger v. Novartis Pharm. Corp., 941 F. Supp. 2d 1288 (D. Or. 2013). “and was approved or licensed,” N.J. Stat. Ann. § 2A:58C-5, subd. (c). Id.”
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