learned intermediary doctrine in New Jersey

2018Under the learned intermediary doctrine, "a pharmaceutical manufacturer generally discharges its duty to warn the ultimate user of prescription drugs by supplying physicians with information about the drug's dangerous propensities." Id. at 10 , 734 A.2d 1245 (quoting Niemiera , 114 N.J. at 559 , 555 A.2d 1112 ).

2018Under the learned intermediary doctrine, "a pharmaceutical manufacturer generally discharges its duty to warn the ultimate user of prescription drugs by supplying physicians with information about the drug's dangerous propensities." Id. at 10 , 734 A.2d 1245 (quoting Niemiera , 114 N.J. at 559 , 555 A.2d 1112 ).

2005Prior to Largey v. Rothman, 110 N.J. 204 , 540 A.2d 504 (1988), New Jersey applied the so-called “professional” standard in determining whether a physician had obtained informed consent from his or her patient in advance of performing a medical procedure or prescribing a medication.

2005Prior to Largey v. Rothman, 110 N.J. 204 , 540 A.2d 504 (1988), New Jersey applied the so-called “professional” standard in determining whether a physician had obtained informed consent from his or her patient in advance of performing a medical procedure or prescribing a medication.

2005Once the physician has been warned, the choice of which drugs to use, and the duty to explain the risks involved, is his.” Id. at 870 .

2005Once the physician has been warned, the choice of which drugs to use, and the duty to explain the risks involved, is his." Id. at 870 .

2019Id. at 820 .

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.

2017Corp., 283 F.3d 254, 268 (5th Cir.), cert. denied, 537 U.S. 824 , 123 S. Ct. 111 , 154 L.

2017Corp., 283 F.3d 254, 268 (5th Cir.), cert. denied, 537 U.S. 824 , 123 S. Ct. 111 , 154 L.

2017Corp., 283 F.3d 254, 268 (5th Cir.), cert. denied, 537 U.S. 824 , 123 S. Ct. 111 , 154 L.

2017Ibid.; Yarrow v. Sterling Drug, Inc., 263 F. Supp. 159, 162 (D.S.D. 1967), aff'd, 408 F.2d 978 (8th Cir. 1969).

2006Ibid.

2006Physician involvement was particularly significant because Pennsylvania had adopted the learned intermediary doctrine, which limits the liability of prescription drug manufacturers and "reflects the determination by the Pennsylvania courts to preserve the primacy of the physician's role in making treatment decisions for Pennsylvania patients." Id. at 378 .

1999Mitchell L.Rev. 931, 956 (1993) (footnotes omitted).] When all of its premises are absent, as when direct warnings to consumers are mandatory, the learned intermediary doctrine, “itself an exception to the manufacturer’s traditional duty to warn consumers directly of the risk associated with any product, simply drops out of the calculus, leaving the duty of the manufacturer to be determined in accordance with general principles of tort law.” Edwards v. Basel Pharms., 116 F. 3d 1341 , 1343 (10th Cir.1997) (discussing question of adequacy of nicotine patch warning under Texas law certified in Ed

1999Mitchell L.Rev. 931, 956 (1993) (footnotes omitted).] When all of its premises are absent, as when direct warnings to consumers are mandatory, the learned intermediary doctrine, "itself an exception to the manufacturer's traditional duty to warn consumers directly of the risk associated with any product, simply drops out of the calculus, leaving the duty of the manufacturer to be determined in accordance with general principles of tort law." Edwards v. Basel Pharms., 116 F. 3d 1341 , 1343 (10th Cir. 1997) (discussing question of adequacy of nicotine patch warning under Texas law certified in E

1999Plaintiffs challenged the court’s failure to hear expert testimony on the adequacy of the warnings and the decision concerning proximate cause because “it was specifically agreed that the production of expert testimony would await the outcome of the decision on the issue of the learned intermediary doctrine.” The Appellate Division affirmed the trial court’s grant of summary judgment in favor of defendants and its determination that the learned intermediary doctrine applied. 313 N.J.Super. 511 , 713 A.2d 520 (1998).

1999Plaintiffs challenged the court’s failure to hear expert testimony on the adequacy of the warnings and the decision concerning proximate cause because “it was specifically agreed that the production of expert testimony would await the outcome of the decision on the issue of the learned intermediary doctrine.” The Appellate Division affirmed the trial court’s grant of summary judgment in favor of defendants and its determination that the learned intermediary doctrine applied. 313 N.J.Super. 511 , 713 A.2d 520 (1998).

1999Mitchell L.Rev. 931, 956 (1993) (footnotes omitted).] When all of its premises are absent, as when direct warnings to consumers are mandatory, the learned intermediary doctrine, “itself an exception to the manufacturer’s traditional duty to warn consumers directly of the risk associated with any product, simply drops out of the calculus, leaving the duty of the manufacturer to be determined in accordance with general principles of tort law.” Edwards v. Basel Pharms., 116 F. 3d 1341 , 1343 (10th Cir.1997) (discussing question of adequacy of nicotine patch warning under Texas law certified in Ed

1999Mitchell L.Rev. 931, 956 (1993) (footnotes omitted).] When all of its premises are absent, as when direct warnings to consumers are mandatory, the learned intermediary doctrine, "itself an exception to the manufacturer's traditional duty to warn consumers directly of the risk associated with any product, simply drops out of the calculus, leaving the duty of the manufacturer to be determined in accordance with general principles of tort law." Edwards v. Basel Pharms., 116 F. 3d 1341 , 1343 (10th Cir. 1997) (discussing question of adequacy of nicotine patch warning under Texas law certified in E

1999Merin v. Maglaki, 126 N.J. 430, 435 , 599 A.2d 1256 (1992).

1999Merin v. Maglaki, 126 N.J. 430, 435 , 599 A.2d 1256 (1992).

1999Defining the scope of tort liability has traditionally been accepted as the responsibility of the courts. [ 96 N.J. 538, 555-56 , 476 A.2d 1219 (1984) (footnote and internal citations omitted).] If we decline to resolve the question, we are making the substantive determination that the learned intermediary doctrine applies to the direct marketing of drugs, an issue recently debated but left unanswered by the drafters of the Restatement.

1999Defining the scope of tort liability has traditionally been accepted as the responsibility of the courts. [ 96 N.J. 538, 555-56 , 476 A.2d 1219 (1984) (footnote and internal citations omitted).] If we decline to resolve the question, we are making the substantive determination that the learned intermediary doctrine applies to the direct marketing of drugs, an issue recently debated but left unanswered by the drafters of the Restatement.