warning instruction (New Jersey) · Go Syfert
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warning instruction in New Jersey

16 New Jersey opinions name it 2 courts 1983–2026 2 in the last five years

The cases below were cited by New Jersey courts in a sentence that names this issue. Sides come from how each citing opinion treated the case (Syfertize flag on that citation), so a case can appear on both: that is where the law is contested. A red or yellow chip is the case's own overall treatment.

Followed or applied (10)

CaseFollowedCited
Coffman v. Keene Corp.green
nj · 1993 · cited in 3 New Jersey opinions naming this issue, 2005–2026
2 sentences

2026In the wake of its determination that the experts’ opinions should be barred, the Appellate Division held that “[d]efendant should have been granted summary judgment due to the lack of proof of causation.” 7 Plaintiff argues that the Appellate Division should have applied a proximate cause standard to her failure to warn claim based on the heeding presumption, citing Coffman v. Keene Corp., 133 N.J. 581, 594 (1993), and other cases, and that the appellate court should have concluded there was prima facie evidence of proximate cause for the warning claim because 2.2 percent of Ozurdex units in

2018Plaintiff has the burden to prove by a preponderance of the credible evidence that Mr. Baker would have followed an adequate warning instruction if it had been provided. [(emphasis added); see id. at 8-9.] In products liability litigation, "[w]hen the alleged defect is the failure to provide warnings, a plaintiff is required to 12 A-4407-15T1 prove that the absence of a warning was a proximate cause of his harm." Coffman, 133 N.J. at 594 .

33
Rowe v. Hoffman-La Roche, Inc.green
nj · 2007 · cited in 2 New Jersey opinions naming this issue, 2018–2020
2 sentences

2020The "plaintiff must plead specific facts alleging 'deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects,' or 'manipulation of the post-market regulatory process.'" Ibid. (first quoting Rowe v. Hoffman-La Roche, Inc., 189 N.J. 615, 626 (2007); then quoting McDarby, 2 N.J.S.A. 2A:58C-4 states: "If the warning or instruction given in connection with a . . . device . . . has been approved . . . by the [FDA] under the [FDCA ,] a rebuttable presumption shall arise that the warning or instruction is adequate." A-0680-18T4 20 401 N.J. Super. at 63 ).

2018N.J.S.A. 2A:58C-4 provides that [i]f the warning or instruction given in connection with a drug or device or food or food additive has been approved or *525 prescribed by the federal Food and Drug Administration under [federal laws], a rebuttable presumption shall arise that the warning or instruction is adequate. [ (emphasis added).] The Legislature, by attaching a presumption of adequacy to FDA-approved warnings, "recognized the preeminent role of federal regulation of drugs and medical devices." Cornett v. Johnson & Johnson , 211 N.J. 362 , 387, 48 A.3d 1041 (2012) ; accord Rowe , 189 N.J.

22
Torsiello v. Whitehall Laboratoriesgreen
njsuperctappdiv · 1979 · cited in 2 New Jersey opinions naming this issue, 1983–1986
2 sentences

1986Corp., 91 N.J. 386 (1982); Beshada v. Johns-Manville Products Corp., 90 N.J. 191 (1982); Freund v. Cellofilm Properties, Inc., 87 N.J. 229 (1981); Martinez v. Atlas Bolt & Screw Co., 636 P. 2d 1287 (Colo. App. 1981); see also Torsiello v. Whitehall Laboratories, 165 N.J.

1983All of them recognize liability of the manufacturer or distributor of a product for failure to provide a warning only if the warning would have enabled the user of the product to make it reasonably safe in ordinary use or otherwise to protect himself, Michalko v. Cooke Color & Chem Corp., 91 N.J. 386 (1982); Beshada v. Johns-Manville Products Corp., 90 N.J. 191 (1982); Freund v. Cellofilm Properties, Inc., 87 N.J. 229 (1981); Martinez v. Atlas Bolt & Screw Co., 636 P. 2d 1287 (Colo. App. 1981); see also Torsiello v. Whitehall Laboratories, 165 N.J.

22
Perez v. Wyeth Laboratories Inc.green
nj · 1999 · cited in 3 New Jersey opinions naming this issue, 2006–2026
2 sentences

2026Ibid.

2017Significantly, the PLA also provides that: 68 A-4760-14T1 If the warning or instruction given in connection with a drug or device or food or food additive has been approved or prescribed by the federal Food and Drug Administration under the "Federal Food, Drug, and Cosmetic Act," . . . a rebuttable presumption shall arise that the warning or instruction is adequate. . . . [N.J.S.A. 2A:58C-4.] In Perez, supra, 161 N.J. at 25 , the Court held that "[f]or all practical purposes, absent deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects, compliance with FDA stan

13
Kendall v. Hoffman-La Roche, Inc.green
nj · 2012 · cited in 1 New Jersey opinions naming this issue, 2017–2017
1 sentence

2017Significantly, the PLA also provides that: 68 A-4760-14T1 If the warning or instruction given in connection with a drug or device or food or food additive has been approved or prescribed by the federal Food and Drug Administration under the "Federal Food, Drug, and Cosmetic Act," . . . a rebuttable presumption shall arise that the warning or instruction is adequate. . . . [N.J.S.A. 2A:58C-4.] In Perez, supra, 161 N.J. at 25 , the Court held that "[f]or all practical purposes, absent deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects, compliance with FDA stan

11
Wyeth v. Levinegreen
scotus · 2009 · cited in 1 New Jersey opinions naming this issue, 2016–2016
1 sentence

2016See ibid.

11
Zammit v. Shire US, Inc.green
mied · 2006 · cited in 1 New Jersey opinions naming this issue, 2007–2007
2 sentences

2007Compare Zammit v. Shire US, Inc., 415 F.Supp.2d 760, 764-65 (E.D.Mich.2006) (holding that defendant drug manufacturer was not liable to plaintiff for failure to warn under section 600.2946(5) because drug was approved by the FDA), with Feldman v. Lederle Labs., 125 N.J. 117, 156-57 , 592 A.2d 1176 (1991) (recognizing that fee presumption is only rebut-table, and not conclusive).

2007Compare Zammit v. Shire US, Inc., 415 F.Supp. 2d 760, 764-65 (E.D.Mich.2006) (holding that defendant drug manufacturer was not liable to plaintiff for failure to warn under section 600.2946(5) because drug was approved by the FDA), with Feldman v. Lederle Labs., 125 N.J. 117, 156-57 , 592 A. 2d 1176 (1991) (recognizing that the presumption is only rebuttable, and not conclusive).

11
Feldman v. Lederle Laboratoriesgreen
nj · 1991 · cited in 1 New Jersey opinions naming this issue, 2007–2007
2 sentences

2007Compare Zammit v. Shire US, Inc., 415 F.Supp.2d 760, 764-65 (E.D.Mich.2006) (holding that defendant drug manufacturer was not liable to plaintiff for failure to warn under section 600.2946(5) because drug was approved by the FDA), with Feldman v. Lederle Labs., 125 N.J. 117, 156-57 , 592 A.2d 1176 (1991) (recognizing that fee presumption is only rebut-table, and not conclusive).

2007Compare Zammit v. Shire US, Inc., 415 F.Supp.2d 760, 764-65 (E.D.Mich.2006) (holding that defendant drug manufacturer was not liable to plaintiff for failure to warn under section 600.2946(5) because drug was approved by the FDA), with Feldman v. Lederle Labs., 125 N.J. 117, 156-57 , 592 A.2d 1176 (1991) (recognizing that fee presumption is only rebut-table, and not conclusive).

11
Worm v. American Cyanamid Co.green
ca4 · 1992 · cited in 1 New Jersey opinions naming this issue, 1996–1996
1 sentence

1996The manufacturer in that case cannot comply with both. [Worm v. American Cyanamid Co., 970 F.2d 1301, 1307 (4th Cir.1992).] As another Federal Court observed: [a] jury verdict or Court decision ruling that compliance with the labeling requirements of the FHSA does not provide sufficient warning under state law would frustrate the congressional purpose of providing nationally uniform requirements. [Lee, supra, 792 F.Supp. at 1008 .] In Cipollone, supra, the United States Supreme Court considered the preemption of state law tort actions under a provision of the Federal Cigarette Labeling and Adv

11
Shackil v. Lederle Laboratoriesgreen
nj · 1989 · cited in 1 New Jersey opinions naming this issue, 1991–1991
2 sentences

1991N.J.S.A. 2A:58C-1 (section 8, not codified, provides for immediate effect); see Shackil v. Lederle Laboratories, 116 N.J. 155, 214 , 561 A. 2d 511 (1989) (O'Hern, J., dissenting).

1991N.J.S.A. 2A:58C-1 (section 8, not codified, provides for immediate effect); see Shackil v. Lederle Laboratories, 116 N.J. 155, 214 , 561 A. 2d 511 (1989) (O'Hern, J., dissenting).

11

Distinguished, questioned or overruled (0)

CaseNegativeCited
No negative-treatment citations attached to this issue in New Jersey. Read the followed side critically anyway.

Also cited on this issue (14)

CaseCitedYears
Martinez v. Atlas Bolt & Screw Co. green
coloctapp · 1981
2 sentences

1986Corp., 91 N.J. 386 (1982); Beshada v. Johns-Manville Products Corp., 90 N.J. 191 (1982); Freund v. Cellofilm Properties, Inc., 87 N.J. 229 (1981); Martinez v. Atlas Bolt & Screw Co., 636 P. 2d 1287 (Colo. App. 1981); see also Torsiello v. Whitehall Laboratories, 165 N.J.

1983All of them recognize liability of the manufacturer or distributor of a product for failure to provide a warning only if the warning would have enabled the user of the product to make it reasonably safe in ordinary use or otherwise to protect himself, Michalko v. Cooke Color & Chem Corp., 91 N.J. 386 (1982); Beshada v. Johns-Manville Products Corp., 90 N.J. 191 (1982); Freund v. Cellofilm Properties, Inc., 87 N.J. 229 (1981); Martinez v. Atlas Bolt & Screw Co., 636 P. 2d 1287 (Colo. App. 1981); see also Torsiello v. Whitehall Laboratories, 165 N.J.

21983–1986
Beshada v. Johns-Manville Products Corp. green
nj · 1982
2 sentences

1986Corp., 91 N.J. 386 (1982); Beshada v. Johns-Manville Products Corp., 90 N.J. 191 (1982); Freund v. Cellofilm Properties, Inc., 87 N.J. 229 (1981); Martinez v. Atlas Bolt & Screw Co., 636 P. 2d 1287 (Colo. App. 1981); see also Torsiello v. Whitehall Laboratories, 165 N.J.

1983All of them recognize liability of the manufacturer or distributor of a product for failure to provide a warning only if the warning would have enabled the user of the product to make it reasonably safe in ordinary use or otherwise to protect himself, Michalko v. Cooke Color & Chem Corp., 91 N.J. 386 (1982); Beshada v. Johns-Manville Products Corp., 90 N.J. 191 (1982); Freund v. Cellofilm Properties, Inc., 87 N.J. 229 (1981); Martinez v. Atlas Bolt & Screw Co., 636 P. 2d 1287 (Colo. App. 1981); see also Torsiello v. Whitehall Laboratories, 165 N.J.

21983–1986
Freund v. Cellofilm Properties, Inc. green
nj · 1981
2 sentences

1986Corp., 91 N.J. 386 (1982); Beshada v. Johns-Manville Products Corp., 90 N.J. 191 (1982); Freund v. Cellofilm Properties, Inc., 87 N.J. 229 (1981); Martinez v. Atlas Bolt & Screw Co., 636 P. 2d 1287 (Colo. App. 1981); see also Torsiello v. Whitehall Laboratories, 165 N.J.

1983All of them recognize liability of the manufacturer or distributor of a product for failure to provide a warning only if the warning would have enabled the user of the product to make it reasonably safe in ordinary use or otherwise to protect himself, Michalko v. Cooke Color & Chem Corp., 91 N.J. 386 (1982); Beshada v. Johns-Manville Products Corp., 90 N.J. 191 (1982); Freund v. Cellofilm Properties, Inc., 87 N.J. 229 (1981); Martinez v. Atlas Bolt & Screw Co., 636 P. 2d 1287 (Colo. App. 1981); see also Torsiello v. Whitehall Laboratories, 165 N.J.

21983–1986
Michalko v. Cooke Color & Chemical Corp. green
nj · 1982
2 sentences

1986Corp., 91 N.J. 386 (1982); Beshada v. Johns-Manville Products Corp., 90 N.J. 191 (1982); Freund v. Cellofilm Properties, Inc., 87 N.J. 229 (1981); Martinez v. Atlas Bolt & Screw Co., 636 P. 2d 1287 (Colo. App. 1981); see also Torsiello v. Whitehall Laboratories, 165 N.J.

1983All of them recognize liability of the manufacturer or distributor of a product for failure to provide a warning only if the warning would have enabled the user of the product to make it reasonably safe in ordinary use or otherwise to protect himself, Michalko v. Cooke Color & Chem Corp., 91 N.J. 386 (1982); Beshada v. Johns-Manville Products Corp., 90 N.J. 191 (1982); Freund v. Cellofilm Properties, Inc., 87 N.J. 229 (1981); Martinez v. Atlas Bolt & Screw Co., 636 P. 2d 1287 (Colo. App. 1981); see also Torsiello v. Whitehall Laboratories, 165 N.J.

21983–1986
Brown v. United States Stove Co. green
nj · 1984
1 sentence

2022Ibid.

12022–2022
McDarby v. Merck & Co., Inc. green
njsuperctappdiv · 2008
2 sentences

2020The heightened pleading requirement "serves to permit a determination whether a failure to warn claim is preempted by the MDA or is a permissible parallel state claim." Ibid.

2020The "plaintiff must plead specific facts alleging 'deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects,' or 'manipulation of the post-market regulatory process.'" Ibid. (first quoting Rowe v. Hoffman-La Roche, Inc., 189 N.J. 615, 626 (2007); then quoting McDarby, 2 N.J.S.A. 2A:58C-4 states: "If the warning or instruction given in connection with a . . . device . . . has been approved . . . by the [FDA] under the [FDCA ,] a rebuttable presumption shall arise that the warning or instruction is adequate." A-0680-18T4 20 401 N.J. Super. at 63 ).

12020–2020
Cornett v. Johnson & Johnson red
nj · 2012
2 sentences

2018N.J.S.A. 2A:58C-4 provides that [i]f the warning or instruction given in connection with a drug or device or food or food additive has been approved or *525 prescribed by the federal Food and Drug Administration under [federal laws], a rebuttable presumption shall arise that the warning or instruction is adequate. [ (emphasis added).] The Legislature, by attaching a presumption of adequacy to FDA-approved warnings, "recognized the preeminent role of federal regulation of drugs and medical devices." Cornett v. Johnson & Johnson , 211 N.J. 362 , 387, 48 A.3d 1041 (2012) ; accord Rowe , 189 N.J.

2018N.J.S.A. 2A:58C-4 provides that [i]f the warning or instruction given in connection with a drug or device or food or food additive has been approved or *525 prescribed by the federal Food and Drug Administration under [federal laws], a rebuttable presumption shall arise that the warning or instruction is adequate. [ (emphasis added).] The Legislature, by attaching a presumption of adequacy to FDA-approved warnings, "recognized the preeminent role of federal regulation of drugs and medical devices." Cornett v. Johnson & Johnson , 211 N.J. 362 , 387, 48 A.3d 1041 (2012) ; accord Rowe , 189 N.J.

12018–2018
Boes v. HOFFMANN-LA ROCHE, INC. neutral
nj · 2007
1 sentence

2008Banner v. Hoffmann-La Roche Inc., 383 N.J.Super. 364, 378 , 891 A. 2d 1229 (App.Div.2006), certif. denied, 190 N.J. 393 , 921 A. 2d 447 (2007).

12008–2008
BANNER EX REL. BANNER v. Hoffmann-La Roche Inc. green
njsuperctappdiv · 2006
2 sentences

2008Banner v. Hoffmann-La Roche Inc., 383 N.J.Super. 364, 378 , 891 A. 2d 1229 (App.Div.2006), certif. denied, 190 N.J. 393 , 921 A. 2d 447 (2007).

2008Banner v. Hoffmann-La Roche Inc., 383 N.J.Super. 364, 378 , 891 A. 2d 1229 (App.Div.2006), certif. denied, 190 N.J. 393 , 921 A. 2d 447 (2007).

12008–2008
Batson v. Lederle Laboratories green
nj · 1997
1 sentence

1997Additionally, there is a rebuttable presumption that the warning or instruction is adequate if the warning or instruction was "given in connection with a drug or device... has been approved or prescribed by the federal Food and Drug Administration under the `Federal Food, Drug, and Cosmetic Act.'..." Id.

11997–1997
Lee v. Boyle-Midway Household Products, Inc. green
pawd · 1992
1 sentence

1996The manufacturer in that case cannot comply with both. [Worm v. American Cyanamid Co., 970 F.2d 1301, 1307 (4th Cir.1992).] As another Federal Court observed: [a] jury verdict or Court decision ruling that compliance with the labeling requirements of the FHSA does not provide sufficient warning under state law would frustrate the congressional purpose of providing nationally uniform requirements. [Lee, supra, 792 F.Supp. at 1008 .] In Cipollone, supra, the United States Supreme Court considered the preemption of state law tort actions under a provision of the Federal Cigarette Labeling and Adv

11996–1996
Melvin Moss v. Parks Corporation, (Two Cases) green
ca4 · 1993
2 sentences

1996In considering the extent of FHSA preemption in Moss, supra, 985 F. 2d at 736 , the Fourth Circuit noted a previous decision where it had stated that: [if] federal law mandates a specific label and pennits nothing additional or different, it can hardly be urged that a state tort duty based on a warning requirement that is more elaborate and different does not conflict.

1996In considering the extent of FHSA preemption in Moss, supra, 985 F. 2d at 736 , the Fourth Circuit noted a previous decision where it had stated that: [if] federal law mandates a specific label and pennits nothing additional or different, it can hardly be urged that a state tort duty based on a warning requirement that is more elaborate and different does not conflict.

11996–1996
Forster v. R.J. Reynolds Tobacco Co. green
minnctapp · 1988
1 sentence

1991Section four of the Products Liability Law, N.J.S.A. 2A:58C-4, creates a rebuttable presumption that a warning or instruction is adequate "if the warning or instruction given in connection with a drug * * * has been approved or prescribed by the federal Food and Drug Administration." The section also defines adequate warning as follows: An adequate product warning or instruction is one that a reasonably prudent person in the same or similar circumstances would have provided with respect to the danger and that communicates adequate information on the dangers and safe use of the product, * * * i

11991–1991
Torsiello v. Whitehall Laboratories green
nj · 1979
1 sentence

1983Super. 311 (App.Div. 1979), certif. den. 81 N.J. 50 (1979).

11983–1983

Statutes the citing opinions construe

NJ § N.J. Stat. § 2A:58C-1 (5) NJ § N.J. Stat. § 2A:58C-4 (5) NJ § N.J. Stat. § 2A:58C-2 (3) USC § 21u.s.c.301 (3)

Counted by distinct opinions that both name this issue and are annotated to the section; sections every opinion cites regardless of issue are not filtered here, so read the counts against the total above.

Where else courts name it

CA 20 (1958–2022) NJ 16 (1983–2026) LA 13 (1957–2025) PA 13 (1974–2026) OH 7 (1990–2016) TX 7 (1983–2020) NY 6 (2003–2026) AZ 5 (1985–2023) FL 5 (1988–2017) MA 5 (1970–2024) MI 5 (1958–2016) OK 5 (1960–2021) IL 5 (1980–2023) MD 4 (1975–2001) IN 4 (2000–2017) AL 4 (1973–1995) MO 3 (1947–2015) GA 3 (1978–1998) AR 3 (1987–2025) UT 3 (2006–2025) IA 3 (1968–2012) OR 3 (1913–2011) KS 3 (1990–2020) MN 2 (2015–2019) CT 2 (1992–2009) KY 2 (2013–2021) CO 2 (1994–2021) WI 2 (2004–2004)

Opinions by the citing court's state. A doctrine retained in one state and abandoned in another shows up here as a year span that stalls.

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