The Evolving Law of Informed Consent
Trial attorneys must be aware of the often overlapping claims of informed consent and breach of standards of care in order to make strategic decisions regarding which issues will be tried.
July 26, 2019 at 10:30 AM
9 minute read
It is well settled that a patient in a medical negligence action has three avenues of relief against a physician: (1) deviation from the standard of care; (2) lack of informed consent; and (3) battery. Newmark-Shortino v. Buna, 427 N.J. Super. 285, 302 (App. Div. 2012), certif. denied, 213 N.J. 45 (2013); citing Howard v. Univ. of Med. & Dentistry of N.J., 172 N.J. 537, 545 (2002). “Although each cause of action is based on different theoretical underpinnings, it is now clear that deviation from the standard of care and failure to obtain informed consent are simply sub-groups of a broad claim of medical negligence.'” Ibid. (quoting Teilhaber v. Greene, 320 N.J. Super. 453, 463 (App. Div. 1999).
Informed consent differs from breach of standard of care, as the key to an informed consent claim is the doctor's duty to provide material information to the patient in order to permit the patient to make informed decisions regarding their care and treatment. Informed consent is a negligence concept “predicated upon the duty to disclose to a patient such information as will enable the patient to make an evaluation of the nature of the treatment and any attendant substantial risks as well as of available options” in treatment or otherwise. Largey v Rothman, 110 N.J. 204, 208 (1988). Informed consent is defined by the “prudent patient” standard, which is what a reasonable patient would expect to hear from the doctor, not what the doctor believes he should inform the patient. Id. It is predicated on “the patient's right to self-determination.” Canesi v. Wilson, 158 N.J. 490, 503-4. “Informed consent obligates a doctor to disclose material risks inherent in a procedure or course of treatment so that the patient can make an informed decision.” Matthies v. Mastromonaco, 160 N.J. 26, 36 (1999). A patient must be provided “sufficient information to enable them to 'evaluate knowingly' the available options in their course of treatment.” Perna v. Pirozzi, 92 N.J. 446, 459 (1983).
The standard governing the required disclosure of information is defined as “what a reasonably prudent patient would deem material to make an informed decision about undergoing the recommended treatment.” Largey v. Rothman, 110 N.J. at 211-212; Blazoski v. Cook, 346 N.J. Super. 256, 267 (App. Div.) certif. denied, 172 N.J. 181 (2002). It is an objective standard, “relating to the patient's needs and not the physician's judgment.” Blazoski, at 267. The test is what the reasonably prudent patient would find significant, given the risks, to make an informed decision regarding the course of treatment. Id.; citing Acuna v. Turkish, 192 N.J. 399, 415 (2007); Howard v. Univ. of Med. & Dentistry of N.J., 172 N.J. at 547; Matthies, 160 N.J. at 36 (emphasis added).
Since the reasonable patient standard focuses on what information a reasonably prudent patient would expect to hear in making medical decisions, expert testimony is not needed in order to establish the standard of disclosure. Febus v. Barot, 260 N.J. Super. 322 (App. Div. 1992). Under the prudent patient standard, an expert may not opine that the doctor complied with his duty of informed consent in what was disclosed to the patient. Whether the doctor provided sufficient information to the patient is a fact-sensitive jury question and no expert testimony may be adduced on the adequacy of the disclosures. Id.
Caputa v. Antiles, 296 N.J. Super. 123 (App. Div. 1996), is highly instructive on this issue. In that case, plaintiff asserted both a breach of standards claim and an informed consent claim arising out of the care and treatment for a kidney stone. The defense expert opined that the doctor conformed to the standard of care in recommending surgical removal of the stone and that he was not obligated to explain to the patient the available treatment options. The trial court refused to permit the informed consent claim to go to the jury, reasoning that the plaintiff had asserted a breach of standards case and the defense expert had opined that under the standard of care the doctor was not obligated to inform the patient of treatment options. The trial court concluded that, in view of the defense expert opinions, the sole claim was breach of standards.
The Appellate Division reversed and remanded for a new trial on the informed consent claim, reasoning that the informational duty was separate and apart from the breach of standards of care claim. It also held that the defense expert could not opine regarding whether the doctor met his duty to disclose, since the informed consent claim is governed by the “prudent patient” standard, and no expert testimony is permitted on whether the patient received full and complete information. The Caputa court found that the decisive factor in any informed consent analysis is whether the physician adequately presents the material information to the patient. In that analysis, the “test of materiality is simply whether a reasonably prudent patient in which the physician knows or should know to be in the plaintiff's position, would likely attach significance to the risk or cluster of risks ….” Caputa, 296 N.J. Super at 134; quoting Largey v. Rothman, 110 N.J. at 211.
In line with Caputa, the Appellate Division has reconfirmed that there can be both an informed consent claim and a breach of standards claim arising out of the same facts. Newmark-Shortino v. Buna, 427 N.J. Super. 285, involved the treatment of an ectopic pregnancy resulting in the termination of a viable pregnancy as a result of negligent care. We argued in Newmark-Shortino that the care of plaintiff gave rise to both an informed consent claim and a breach of standards claim. Over our objection, the trial court allowed the defense expert to testify that the doctor did not breach his informational duty (informed consent), and the trial court only submitted the breach of standards claim to the jury. The Appellate Division reversed and remanded on the informed consent claim and again reiterated that there can be both an informed consent and a breach of standards claim in the same case, and that under the “prudent patient” standard, expert testimony was not permitted on the issue of whether the doctor provided full and complete medical information to the patient.
In addition to holding that both informed consent and breach of standard of care can be pursued in the same case, courts have also made clear that there are many variations on the informed consent claim. The old notion that informed consent claims are limited to only decisions to undergo treatment or surgery was long ago supplanted by a more modern and expansive view. While the early cases involved informed consent primarily relating to the choice of surgical procedures, present day informed consent is not limited to this factual setting.
Indeed, in Howard v. Univ. of Med. & Dentistry of N.J., 172 N.J. 537, the New Jersey Supreme Court addressed a doctor's misrepresentation of his credentials and experience in performing complex neurosurgery, and the court held that a claim based upon misrepresentation of background and experience is a type of informed consent claim premised on a patient's “right to know” material information that might impact the patient's decision-making. The modern view of informed consent is a “patient centered view” which “stresses the patient's right to self-determination, and the fiduciary relationship between a doctor and his or her patients.” Id. at 547, quoting Canterbury v. Spence, 464 F.2d 772, 786-88 (D.C.Cir. 1972) cert. denied, 409 U.S. 1064 (1972). It requires a doctor to disclose “material information” to the patient “even if the patient does not ask questions.” Id.
More recently, in Ringstaff v. Eakin, 2014 WL 656855 (App. Div. Feb. 21, 2014), the Appellate Division in an unpublished decision held that failure to provide information regarding the signs and symptoms of blood clots in the discharge instructions following knee surgery is an informed consent claim. In rejecting the defense argument that the adequacy of the discharge instructions was subsumed in the breach of standards claim (same as this case), the Appellate Division affirmed the no cause on the breach of standards, and reversed and remanded on the informed consent claims which were not submitted to the jury.
Plaintiff alleged that the orthopedic physicians failed to communicate to the patient the warning signs of blood clots, more particularly that “calf pain could be a symptom of a life threatening blood clot” and failed to educate her on the “significance of calf pain.” Id. at 6. The trial court refused to submit the informed consent claim to the jury, reasoning that the failure to warn regarding potential blood clots and pulmonary embolism were all part of the standard of care claim.
The Appellate Division reversed and held that the jury should have been charged on informed consent. The court further noted that the defense should not have been permitted to argue that the patient had acted “unreasonably” after the surgery as she had not advised her doctors that she had become pale and stopped eating. Id. at 7. Instead, the court reasoned, the doctrine of informed consent is “predicated on the patient's right to self-determination” and, without having been informed about the significance of signs or symptoms, the patient was deprived of her right to exercise that right to self-determination and understand the risks of seeking or not seeking treatment. Id. at 8; quoting Canesi v. Wilson, 158 N.J. 490, 503-04 (1999).
The Ringstaff holding, relying upon well settled Supreme Court precedent, leaves no doubt that the informational duty of the doctor to explain in the discharge instructions the potential complications that may occur after discharge is another variation of informed consent.
Trial attorneys must be aware of the often overlapping claims of informed consent and breach of standards of care in order to make strategic decisions regarding which issues will be tried and the consequences of trying one, or both, causes of actions together.
Bruce H. Nagel is a partner with Nagel Rice in Roseland. He is a trial attorney specializing in complex litigation including serious personal injury, tort, class actions, medical malpractice and business disputes.
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