FDA-approved warning (New Jersey) · Go Syfert
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FDA-approved warning in New Jersey

8 New Jersey opinions name it 2 courts 1989–2018 0 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 (7)

CaseFollowedCited
Cornett v. Johnson & Johnsongreen
nj · 2012 · cited in 2 New Jersey opinions naming this issue, 2017–2018
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.

12
Rowe v. Hoffman-La Roche, Inc.green
nj · 2007 · cited in 1 New Jersey opinions naming this issue, 2018–2018
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.

11
PV Ex Rel. TV v. Camp Jayceegreen
nj · 2008 · cited in 1 New Jersey opinions naming this issue, 2017–2017
1 sentence

2017See Camp Jaycee, 75 A-4760-14T1 supra, 197 N.J. at 153 .

11
Lopez v. Swyergreen
nj · 1973 · cited in 1 New Jersey opinions naming this issue, 2012–2012
2 sentences

2012See Lopez v. Swyer, 62 N.J. 267 , 300 A.2d 563 (1973).

2012See Lopez v. Swyer, 62 N.J. 267 , 300 A.2d 563 (1973).

11
prod.liab.rep.(cch)p 10,997 Katie Laurel Wells v. Ortho Pharmaceutical Corporationgreen
ca11 · 1986 · cited in 1 New Jersey opinions naming this issue, 2006–2006
1 sentence

2006Corp., 788 F. 2d 741, 746 (11th Cir.) (applying Georgia law), cert. denied, 479 U.S. 950 , 107 S.Ct. 437 , 93 L.

11
Erny v. Estate of Merolagreen
nj · 2002 · cited in 1 New Jersey opinions naming this issue, 2006–2006
2 sentences

2006See Erny v. Russo, 333 N.J.Super. 88, 96 , 754 A. 2d 606 (App.Div.2000), rev'd on other grounds, 171 N.J. 86 , 792 A. 2d 1208 (2002) (where the trial judge allowed the plaintiff to seek application of New York law after the liability trial, we said, "[i]n view of the broad discretion enjoyed by the trial court in such matters, we refrain from disturbing that determination.") As a preliminary determination, the motion judge correctly found an actual conflict between Michigan law and New Jersey law on the viability of a failure-to-warn claim with respect to FDA-approved warnings.

2006See Erny v. Russo, 333 N.J.Super. 88, 96 , 754 A. 2d 606 (App.Div.2000), rev'd on other grounds, 171 N.J. 86 , 792 A. 2d 1208 (2002) (where the trial judge allowed the plaintiff to seek application of New York law after the liability trial, we said, "[i]n view of the broad discretion enjoyed by the trial court in such matters, we refrain from disturbing that determination.") As a preliminary determination, the motion judge correctly found an actual conflict between Michigan law and New Jersey law on the viability of a failure-to-warn claim with respect to FDA-approved warnings.

11
Erny v. Russogreen
njsuperctappdiv · 2000 · cited in 1 New Jersey opinions naming this issue, 2006–2006
2 sentences

2006See Erny v. Russo, 333 N.J.Super. 88, 96 , 754 A. 2d 606 (App.Div.2000), rev'd on other grounds, 171 N.J. 86 , 792 A. 2d 1208 (2002) (where the trial judge allowed the plaintiff to seek application of New York law after the liability trial, we said, "[i]n view of the broad discretion enjoyed by the trial court in such matters, we refrain from disturbing that determination.") As a preliminary determination, the motion judge correctly found an actual conflict between Michigan law and New Jersey law on the viability of a failure-to-warn claim with respect to FDA-approved warnings.

2006See Erny v. Russo, 333 N.J.Super. 88, 96 , 754 A. 2d 606 (App.Div.2000), rev'd on other grounds, 171 N.J. 86 , 792 A. 2d 1208 (2002) (where the trial judge allowed the plaintiff to seek application of New York law after the liability trial, we said, "[i]n view of the broad discretion enjoyed by the trial court in such matters, we refrain from disturbing that determination.") As a preliminary determination, the motion judge correctly found an actual conflict between Michigan law and New Jersey law on the viability of a failure-to-warn claim with respect to FDA-approved warnings.

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 (16)

CaseCitedYears
Perez v. Wyeth Laboratories Inc. green
nj · 1999
2 sentences

2018The presumption of adequacy necessarily "helps to ensure that manufacturers are not made guarantors against remotely possible, but not scientifically-verifiable, side-effects of prescription drugs," Perez , 161 N.J. at 25 , 734 A.2d 1245 , and "reduc[es] the burden placed on [manufacturers of medications with FDA-approved warnings] by product liability litigation," Rowe , 189 N.J. at 626 , 917 A.2d 767 .

2018The presumption of adequacy necessarily "helps to ensure that manufacturers are not made guarantors against remotely possible, but not scientifically-verifiable, side-effects of prescription drugs," Perez , 161 N.J. at 25 , 734 A.2d 1245 , and "reduc[es] the burden placed on [manufacturers of medications with FDA-approved warnings] by product liability litigation," Rowe , 189 N.J. at 626 , 917 A.2d 767 .

32012–2018
Feldman v. Lederle Laboratories green
nj · 1991
2 sentences

2018In Feldman v. Lederle Laboratories , the Court acknowledged that the PLA's "plain language defies the conclusion that the presumption cannot be overborne." 125 N.J. 117 , 157, 592 A.2d 1176 (1991).

2018In Feldman v. Lederle Laboratories , the Court acknowledged that the PLA's "plain language defies the conclusion that the presumption cannot be overborne." 125 N.J. 117 , 157, 592 A.2d 1176 (1991).

22008–2018
Wyeth v. Levine green
scotus · 2009
1 sentence

2018Id. at 578 , 129 S.Ct. 1187 . **275 Thus, an FDA-approved warning for a drug on the market for many years may grow stale in light of "newly acquired information" about "a clinically significant hazard" in the use of the drug by certain consumers. 21 C.F.R. § 201.57 (c) ; 21 C.F.R. § 314.70 (c).

12018–2018
Cont'l Ins. Co. v. Honeywell Int'l, Inc. green
nj · 2018
2 sentences

2018Co. v. Honeywell Int'l, Inc. , 234 N.J. 23 , 46, 188 A.3d 297 (2018) (quoting DeMarco v. Stoddard , 223 N.J. 363 , 383, 125 A.3d 367 (2015) ). **255 Here, we must compare New Jersey's PLA with the product-liability laws or analogues of forty-four other jurisdictions. 9 *518 New Jersey's rebuttable presumption of adequacy, which specifically attaches to FDA-approved warnings, sets our law apart from most other states' laws.

2018Co. v. Honeywell Int'l, Inc. , 234 N.J. 23 , 46, 188 A.3d 297 (2018) (quoting DeMarco v. Stoddard , 223 N.J. 363 , 383, 125 A.3d 367 (2015) ). **255 Here, we must compare New Jersey's PLA with the product-liability laws or analogues of forty-four other jurisdictions. 9 *518 New Jersey's rebuttable presumption of adequacy, which specifically attaches to FDA-approved warnings, sets our law apart from most other states' laws.

12018–2018
Thomas Demarco v. Sean Robert Stoddard, D.P.m(073949) green
nj · 2015
2 sentences

2018Co. v. Honeywell Int'l, Inc. , 234 N.J. 23 , 46, 188 A.3d 297 (2018) (quoting DeMarco v. Stoddard , 223 N.J. 363 , 383, 125 A.3d 367 (2015) ). **255 Here, we must compare New Jersey's PLA with the product-liability laws or analogues of forty-four other jurisdictions. 9 *518 New Jersey's rebuttable presumption of adequacy, which specifically attaches to FDA-approved warnings, sets our law apart from most other states' laws.

2018Co. v. Honeywell Int'l, Inc. , 234 N.J. 23 , 46, 188 A.3d 297 (2018) (quoting DeMarco v. Stoddard , 223 N.J. 363 , 383, 125 A.3d 367 (2015) ). **255 Here, we must compare New Jersey's PLA with the product-liability laws or analogues of forty-four other jurisdictions. 9 *518 New Jersey's rebuttable presumption of adequacy, which specifically attaches to FDA-approved warnings, sets our law apart from most other states' laws.

12018–2018
McDarby v. Merck & Co., Inc. green
njsuperctappdiv · 2008
2 sentences

2017That is, in New Jersey it has been recognized that the PLA's statutory presumption may be overcome by a showing of deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects, Perez, supra, 161 N.J. at 25 , or substantial evidence of economically driven manipulation of the post-market regulatory process, McDarby, supra, 401 N.J.

2017That is, in New Jersey it has been recognized that the PLA's statutory presumption may be overcome by a showing of deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects, Perez, supra, 161 N.J. at 25 , or substantial evidence of economically driven manipulation of the post-market regulatory process, McDarby, supra, 401 N.J.

12017–2017
Prince v. Garruto, Galex & Cantor neutral
njsuperctappdiv · 2001
2 sentences

2008Although plaintiffs may present expert testimony in an attempt to rebut the statutory presumption, Prince v. Garruto, Galex & Cantor, 346 N.J.Super. 180, 188-89 , 787 A. 2d 245 (App.Div.2001), the presumption in favor of the adequacy of FDA-approved warnings will not be deemed rebutted unless plaintiffs produce the type of evidence identified in Perez, Rowe, or McDarby .

2008Although plaintiffs may present expert testimony in an attempt to rebut the statutory presumption, Prince v. Garruto, Galex & Cantor, 346 N.J.Super. 180, 188-89 , 787 A. 2d 245 (App.Div.2001), the presumption in favor of the adequacy of FDA-approved warnings will not be deemed rebutted unless plaintiffs produce the type of evidence identified in Perez, Rowe, or McDarby .

12008–2008
Langley v. Young green
scotus · 1986
1 sentence

2006Corp., 788 F. 2d 741, 746 (11th Cir.) (applying Georgia law), cert. denied, 479 U.S. 950 , 107 S.Ct. 437 , 93 L.

12006–2006
Bergh v. Department of Transportation green
scotus · 1986
1 sentence

2006Corp., 788 F. 2d 741, 746 (11th Cir.) (applying Georgia law), cert. denied, 479 U.S. 950 , 107 S.Ct. 437 , 93 L.

12006–2006
Quillen v. Bowen green
scotus · 1986
1 sentence

2006Corp., 788 F. 2d 741, 746 (11th Cir.) (applying Georgia law), cert. denied, 479 U.S. 950 , 107 S.Ct. 437 , 93 L.

12006–2006
Abbott v. American Cyanamid Co. green
ca4 · 1988
2 sentences

1991In Abbot v. American Cyanamid Co., 844 F. 2d 1108 , cert. denied, 488 U.S. 908 , 109 S.Ct. 260 , 102 L.Ed. 2d 248 (1988), the Fourth Circuit was faced with the same issue presented in Hurley, namely, preemption of defective-design and failure-to-warn claims by FDA regulations governing vaccines.

1991In Abbot v. American Cyanamid Co., 844 F.2d 1108 , cert. denied, 488 U.S. 908 , 109 S.Ct. 260 , 102 L.Ed.2d 248 (1988), the Fourth Circuit was faced with the same issue presented in Hurley , namely, preemption of defective-design and failure-to-warn claims by FDA regulations governing vaccines.

11991–1991
James L. Hurley, Jr., Etc. v. Lederle Laboratories Division of American Cyanamid Co., Defendants green
ca5 · 1988
2 sentences

1991Thus, assuming that the FDA has processed all the relevant and available information in arriving at the prescribed warning, its decision as to the proper wording must preempt by implication that of a state. [ Ibid. ] The court limited the inquiry on remand to whether Lederle had withheld information from the FDA; "[o]therwise, the FDA-approved warning is sufficient." Id. at 1543 .

1991Thus, assuming that the FDA has processed all the relevant and available information in arriving at the prescribed warning, its decision as to the proper wording must preempt by implication that of a state. [ Ibid. ] The court limited the inquiry on remand to whether Lederle had withheld information from the FDA; "[o]therwise, the FDA-approved warning is sufficient." Id. at 1543 .

11991–1991
American Cyanamid Co. v. Abbot ex rel. Abbot green
scotus · 1988
2 sentences

1991In Abbot v. American Cyanamid Co., 844 F. 2d 1108 , cert. denied, 488 U.S. 908 , 109 S.Ct. 260 , 102 L.Ed. 2d 248 (1988), the Fourth Circuit was faced with the same issue presented in Hurley, namely, preemption of defective-design and failure-to-warn claims by FDA regulations governing vaccines.

1991In Abbot v. American Cyanamid Co., 844 F.2d 1108 , cert. denied, 488 U.S. 908 , 109 S.Ct. 260 , 102 L.Ed.2d 248 (1988), the Fourth Circuit was faced with the same issue presented in Hurley , namely, preemption of defective-design and failure-to-warn claims by FDA regulations governing vaccines.

11991–1991
Garrett v. General Motors Corp. green
scotus · 1988
2 sentences

1991In Abbot v. American Cyanamid Co., 844 F. 2d 1108 , cert. denied, 488 U.S. 908 , 109 S.Ct. 260 , 102 L.Ed. 2d 248 (1988), the Fourth Circuit was faced with the same issue presented in Hurley, namely, preemption of defective-design and failure-to-warn claims by FDA regulations governing vaccines.

1991In Abbot v. American Cyanamid Co., 844 F.2d 1108 , cert. denied, 488 U.S. 908 , 109 S.Ct. 260 , 102 L.Ed.2d 248 (1988), the Fourth Circuit was faced with the same issue presented in Hurley , namely, preemption of defective-design and failure-to-warn claims by FDA regulations governing vaccines.

11991–1991
Morison v. United States green
scotus · 1988
2 sentences

1991In Abbot v. American Cyanamid Co., 844 F. 2d 1108 , cert. denied, 488 U.S. 908 , 109 S.Ct. 260 , 102 L.Ed. 2d 248 (1988), the Fourth Circuit was faced with the same issue presented in Hurley, namely, preemption of defective-design and failure-to-warn claims by FDA regulations governing vaccines.

1991In Abbot v. American Cyanamid Co., 844 F.2d 1108 , cert. denied, 488 U.S. 908 , 109 S.Ct. 260 , 102 L.Ed.2d 248 (1988), the Fourth Circuit was faced with the same issue presented in Hurley , namely, preemption of defective-design and failure-to-warn claims by FDA regulations governing vaccines.

11991–1991
James L. Hurley, Jr., Etc. v. Lederle Laboratories Division of American Cyanamid Co., Defendants green
ca5 · 1989
1 sentence

1989Id.

11989–1989

Where else courts name it

NJ 8 (1989–2018) CA 6 (1996–2014) PA 3 (2013–2019) TX 3 (2009–2015) IL 3 (2015–2015) MD 2 (2005–2014)

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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