Must a Doctor Warn of Unknown Risks?

The Supreme Court described its decision in Largey as “discard[ing]” this old rule and “ adopt[ing] instead the . . . ‘reasonable patient’ rule.” This clearly represented a significant change in the law of this state. See, e.g., Frost v. Brenner, 300 N.J. Super. 394, 404 (App. Div. 1997) (Largey “reformulated the elements of a malpractice action based on the lack of informed consent.”) Unstated in the Supreme Court’s decision was whether the effect of its ruling was to be prospective or retrospective.

There have been a number of circumstances in which a physician has faced potential liability for a medical decision regarding the use of a drug or product that was made before the change embodied in Largey and where there was a latent risk of injury that later became manifest and led to litigation. Among others, this was seen in connection with the drug tetracycline and the silicone gel breast implant device.

In the unpublished decision of Prince v. Eisenstein, Docket No. A-4587-94 (App. Div. 1997), the Appellate Division considered a medical malpractice case involving the use of the antibiotic tetracycline. The plaintiff, while an infant, had frequent upper respiratory infections as well as middle ear infections. He received Declomycin on numerous occasions during the first five years of his life between 1965 and 1970. His treating physicians testified that as of 1970 they stopped using tetracyclines on a routine basis because they had become aware of increasing reports of tooth-staining attributed to the medication. Such reports had begun to appear by the late 1950s, indicating that the use of tetracycline in young children had caused irreversible staining and discoloration of the permanent teeth and even, in extreme cases, malformation of the teeth. This had also been reported in the fetuses of pregnant women treated with the medication before giving birth. By the end of 1963, the FDA required all tetracycline manufacturers to issue a precaution to physicians respecting the tooth-staining risk of that medication. But it was not until 1970 that the FDA required a warning that tetracycline drugs should not be used in the age group of patients under 8 years unless other drugs were not likely to be effective or were contraindicated.

The jury returned a verdict in favor of the defendant physicians as to both malpractice and informed consent claims. While the Appellate Division affirmed, it recognized the unsettled state of the law in regard to the question of informed consent. It assumed that the prudent patient standard applied to this case arising out of the 1965-1970 time period but did so “without passing on the merits of the issue.” Slip opinion at 6 n. 1.

A Pennsylvania trial court reached a somewhat contrary conclusion in connection with silicone gel breast implant claims. Neither the manufacturer’s information nor the medical literature reported any possible connection between the breast implant device and autoimmune disorders or connective tissue disease until the 1980s. The mass tort litigation that followed the 1992 FDA moratorium was largely focused on the autoimmune disorders and connective tissue disease claims.

Unlike New Jersey’s view of informed consent claims as a form of negligence, Pennsylvania had developed an approach grounded in the tort of battery. That is to say, where there was a lack of informed consent, the resulting touching of a patient by the physician was not authorized and hence constituted a battery. See, e.g., Gray v. Grunnagle, 223 A.2d 663 (Pa. 1966). Pennsylvania uses the reasonable patient standard for disclosure. See, e.g., Cooper v. Roberts, 286 A.2d 647 (Pa. Super. Ct. 1971). In Pennsylvania, informed consent claims are largely limited to surgical procedures and do not encompass such treatments as the use of medication. See, e.g., Morgan v. MacPhail, 704 A.2d 617 (Pa. 1997). In 1996, the Pennsylvania legislature enacted a statute regarding the law of informed consent. 40 P.S.A. � 1301.811-A. The statute enacted a hybrid tort moving away from the battery theory of liability. This legislation was repealed with an amended recodification in 2000. 40 P.S.A. � 1303-504. The standard of disclosure is a description of “risks and alternatives that a reasonably prudent patient would require to make an informed decision as to that procedure.”

In In re Silicone Breast Implant Litigation, 2003 WL 23278213 (Pa. Com. Pl. 2003), the court considered the scope of risks to be disclosed by the defendant physician and the scope of recovery for resulting injuries if liability were found. The plaintiff asserted that such risks included pain, infection, breakage of the implant, excessive firmness of the breast in reaction to the implant device, and the possibility of the implant causing autoimmune disease. The court had granted a defense motion to preclude the autoimmune disease claims because of the lack of generally acceptable scientific evidence to support the claim.

The dates on which the surgical procedures had been performed are not set forth in the opinion. But since the FDA issued a moratorium on the availability and sale of the silicone gel implant in May 1992, it is evident that the operations predated the Pennsylvania informed consent legislation. Without citation of authority or analysis, the court explicitly stated that it would not apply the new standard because “these laws became effective after these breast implant surgeries.” 2003 WL 23278213 n. 2.

Changes in legislation are generally given prospective effect while the overruling of precedents is traditionally viewed as retrospective in effect. Compare Williamson v. Treasurer, 357 N.J. Super. 253, 270-72 (App. Div.), certif. denied, 177 N.J. 493 (2003), with Darrow v. Hanover Tp., 58 N.J. 410, 413 (1971). But changes in case law are not always given retrospective application. The issue requires a consideration of the principles for determining whether a new rule of decisional law is to be applied prospectively or retroactively.

In Fischer v. Canario, 143 N.J. 235 (1996), the Supreme Court summarized the factors to be assessed:

(1) the purpose of the new rule and whether it would be advanced by retroactive application; (2) the reliance placed on the old rule by the parties and the community; and (3) the effect that retroactive application would have on the administration of justice. [Id. at 244.]

The question before the Court in Fischer was whether the rule developed to apportion a damages assessment between a pre-existing condition and subsequent negligent medical care as promulgated in Scafidi v. Seiler, 119 N.J. 93 (1990), was to be applied retroactively. It considered the stated factors and concluded that the concept of limiting plaintiff’s damages to the value of the lost chance involved important policy matters that were implicit in the “increased risk” causation rule announced in an even earlier case. It found an issue of “fundamental fairness” in defining the contours of a physician’s liability for medical malpractice to the losses actually attributable to the physician’s negligence. The Court concluded that a purely prospective application of Scafidi would frustrate these objectives. Moreover, while Scafidi represented a significant change, the rule had been foreshadowed in earlier decisions of the Court if not in fact anticipated. The damages apportionment rule did not recognize a new cause of action or eliminate a cause of action. The Court specifically stated that the damages apportionment rule “does not cause persons to modify their behavior in any significant manner.” Id. at 249-50. It also determined that applying the new damages rule would not impact on cases that had already been tried. Thus, it concluded under all the circumstances that retroactive application of the Scafidi damages apportionment rule was fair and appropriate.

Silicone gel breast implants became available in 1963. The patients in the New Jersey silicone gel breast implant litigation had had operations that spanned a time period from the early 1970s into the mid-1990s leading up to the FDA moratorium. Thus there were cases that both predate and postdate the issuance of the Largey opinion.

Although an obligation on the part of physicians to inform patients as to medical treatment matters has been long-standing, there is a risk of unfairness in judging a physician based on standard of disclosure that is recognized as a reformulation of the rules and the elements of the cause of action. Simply put, there was no chance to modify conduct so as to comply with the new rules. Of course, it may be true that the reasonable physician has always disclosed the material information that a prudent patient would want to know regarding risks and alternatives of medical treatment.

Nonetheless as we move along the continuum in time since the announcement of the new Largey prudent patient standard in 1988, fewer and fewer matters will be predate the decision. But to the extent the Largey standard is applied retroactively, its analysis needs to be restated and assessed in connection with latent risks of product-related injury. The test for informed consent is an objective and not subjective disclosure of information that a “reasonably prudent patient” would need in reaching a decision concerning a given procedure and the extent of the information is defined in terms of its “materiality.” The Largey Court had cited with approval the decision in Calabrese v. Trenton State College, 162 N.J. Super. 145 (App. Div. 1978), aff’d, 82 N.J. 321 (1980), in which the court stated that “the doctor’s duty of disclosure is imposed by law and not by medical consensus.” 162 N.J. Super. at 156. The Largey standard was re-examined by the court in Febus v. Barot, 260 N.J. Super. 322 (App. Div. 1992). The Febus court recognized that the sufficiency of disclosure under the “prudent patient” standard requires that the disclosure be viewed through the mind of the patient, not the physician. The court noted that with this shift of emphasis came “the recognition that expert testimony is not required in order to establish the medical community’s standard for disclosure and whether a physician failed to meet that standard.” Id. at 327. But medical testimony is still needed to establish the fact of a risk being associated with a procedure and that it was recognized as such by the medical community. Id. This is separate from the patient-based standard for disclosure.

While the focus in an informed consent case may have shifted from what “reasonable physicians” in the field believe is necessary information to impart to the patient to what a “reasonable patient” would want to know in making decisions relative to treatment, the scope of the physician or surgeon’s duty to disclose is not open-ended. In Largey the Supreme Court rejected the notion that adoption of the prudent patient standard “would compel disclosure of every risk (not just material risks) to any patient (rather than the reasonable patient).” 110 N.J. at 213 (emphasis in original). The Supreme Court did not define the contours of “material risks” in its decision. Nor has any subsequent case drawn anything approaching a bright line in what continues to be an incredibly imprecise area of exposure for physicians. But case law has provided some pertinent guidance.

In Febus v. Barot, supra, plaintiff had plastic surgery to correct stretch marks on her abdomen. She claimed to have been told that the only visible consequence would be a “bikini scar” over the pubic area. Instead, the surgery resulted in extensive scarring and numbness over her abdomen. Plaintiff provided no expert report in support of her claims and opposed a motion for summary judgment on the ground that under Largey, no expert was required. The Appellate Division stated:

Although, under this doctrine, no medical expert is required to prove that an undisclosed risk would have been material to the patient’s consent, it must first be shown that the risk was one of which the physician should have been aware, and that it was recognized within the medical community. [260 N.J. Super. at 327 (emphasis added).]