Under the learned intermediary rule, a manufacturer of a medical device can discharge its liability by providing an adequate warning of the risks of the device to “prescribing and other health-care providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings,” even if the manufacturer did not provide the warning to the patient directly. Restatement (Third) of Torts: Products Liability § 6(d)(1) (Am. L. Inst. 1988).
The rationale supporting this “learned intermediary” rule is that only health-care professionals are in a position to understand the significance of the risks involved and to assess the relative advantages and disadvantages. . . . The duty then devolves on the physician to supply to the patient such information as is deemed appropriate under the circumstances so that the patient can make an informed choice.
Id. cmt. B.
The learned intermediary rule is a proposition of state law. While it has been widely accepted around the United States, and precedent supports the rule in all 50 states and two other American jurisdictions, there are still 10 states where there is no state appellate court precedent adopting the learned intermediary rule. One of the 10 states where an appellate court has not adopted the learned intermediary rule is Rhode Island. While state court decisions, of course, take precedence regarding application of the rule, federal precedent can be instructive and serves as a good prediction of future state appellate court adoption. Fortunately, on March 28, 2023, a Rhode Island federal court provided such federal precedent and predicted that the Rhode Island Supreme Court would join the rest of the states and adopt the learned intermediary rule, thereby moving the United States closer to unanimous application of the rule.
Costa v. Johnson & Johnson: Rhode Island and the Learned Intermediary rule
In Costa v. Johnson & Johnson, a pelvic mesh case on remand from a multidistrict litigation (MDL) in the U.S. District Court for the Southern District of West Virginia, the prescribing/implanting physician testified that he was aware of all the relevant risks listed in the Instructions for Use (IFU) from his own training and research. C.A. No. 17-452 WES, 2023 U.S. Dist. LEXIS 54734, at *3 (D.R.I. Mar. 28, 2023). The defendant manufacturer moved for summary judgment on all counts, including the plaintiff’s failure to warn claim.
Despite Rhode Island’s lack of a definitive learned intermediary precedent, the defendant argued that the learned intermediary rule should apply. Rather than claiming that the Rhode Island Supreme Court would decline to adopt the learned intermediary rule, the plaintiff argued that the question should be certified to the Rhode Island Supreme Court. The standards for certifying a question require conducting a substantive analysis of the issue. So, the Costa court performed a substantive analysis and found that prevailing Rhode Island state law was “sufficiently clear” to predict that the Rhode Island Supreme Court would adopt the learned intermediary doctrine based on the following considerations. Id. at *9.
Costa first pointed to the Rhode Island Supreme Court’s discussion of “the proximate cause element of a failure to warn claim” in Hodges v. Brannon—a prescription drug case where the jury instruction on the failure to warn claim described the proximate cause standard as “whether or not [the plaintiff’s physician] would have prescribed the drug [to the plaintiff] in 1986 if he had been provided with an adequate warning,” Hodges, 707 A.2d 1225, 1227–28 (R.I. 1998)—finding that the Rhode Island Supreme Court “implicitly referenced the [rule].” Costa, 2023 U.S. Dist. LEXIS 54734, at *9. Also consistent was the reasoning in Hogan v. Novartis Pharmaceuticals Corp., where a New York federal court applying Rhode Island law found no causation where the prescribing physician “testified that, despite the risks of [the drug], he believed that his decision to prescribe the medication to plaintiff was the correct one.” No. 06–CV–260, 2011 WL 1533467, at *9–10 (E.D.N.Y. Apr. 23, 2011). Costa also relied on the Rhode Island Supreme Court’s history of approving sections of the Second and Third Restatements of Torts as indicative that it would follow the current restatement. Costa, 2023 U.S. Dist. LEXIS 54734, at *10. Relying on Greaves v. Eli Lilly & Co. and Hogan, Costa “followed the lead of other federal courts” in predicting that the Rhode Island Supreme Court would adopt the learned intermediary rule. Id. (citing Greaves, 503 F. App’x 70 (2d Cir. 2012)).
Given the court’s prediction, the plaintiff in Costa could not carry her burden. The implanting physician was aware of the risks that the plaintiff contended were inadequately described in the device’s IFU—poor wound healing, mesh erosion, acute and chronic pain, dyspareunia, etc. Id. at *11–12. And the court pointed to the fact that the implanter testified that the plaintiff was an appropriate candidate for the procedure. Id. at *12–13. Such being the case, the defendant won summary judgment on the plaintiff’s failure to warn claim.
Learned Intermediary Rule: Argument for Universal Adoption
Pivoting to a more global view of the landscape of failure to warn claims in product liability cases concerning medical devices and prescription drugs: Costa is significant because of its prediction that the Rhode Island Supreme Court will adopt the learned intermediary doctrine. When the Rhode Island Supreme Court and other appellate courts in the remaining undecided states do get a chance to weigh in on the learned intermediary doctrine, there are several reasons why they may want to side with the reasoning in Costa and the controlling law in the great majority of states.
Fundamentally, the learned intermediary rule is “based on the principle that prescribing physicians act as ‘learned intermediaries’ between a manufacturer and consumer and, therefore, stand in the best position to evaluate a patient’s needs and assess the risks and benefits of a particular course of treatment.” Vitanza v. Upjohn Co., 778 A.2d 829, 836–37 (Conn. 2001). “When the purchase of the product is recommended or prescribed by an intermediary who is a professional, the adequacy of the instructions must be judged in relationship to that professional.” Mampe v. Ayerst Lab’ys, 548 A.2d 798, 802 n.6 (D.C. 1988). The rule is legal recognition that prescription medical products are not available to the public at large because the Food and Drug Administration (FDA) has determined that such products have inherent risks of sufficient danger that require a physician’s review before use.
An accurate description of the risks and benefits of prescription medical products requires precise medical terminology, which is not easily understood by most patients undergoing surgery, and those patients typically lack any formal medical training. Such warnings are “designed for the physician and not the patient.” Oksenholt v. Lederle Lab’ys, 656 P.2d 293, 297 (Or. 1982). The rule ensures scientific precision—and, more importantly, safety—by allowing prescription medical product manufacturers to draft their warnings to be read by doctors rather than patients:
Warnings for prescription drugs are intended for the physician, whose duty it is to balance the risks against the benefits of various drugs and treatments and to prescribe them and supervise their effects. The physician acts as an “informed intermediary” between the manufacturer and the patient; and, thus, the manufacturer’s duty to caution against a device’s risks is fulfilled by giving adequate warning through the prescribing physician, not directly to the patient.
Martin v. Hacker, 628 N.E.2d 1308, 1311 (N.Y. 1993). Put simply, cutting doctors out of the medical device distribution system in favor of direct patient warnings could end up endangering the medical patients who need the advice of medically trained, board-certified doctors the most.
For the law to make medical device manufacturers responsible for ensuring delivery of technical medical product information about prescription medical devices directly to the average patient is also overly burdensome and inconsistent with the preexisting regulatory framework promulgated by the FDA and followed for nearly 100 years. It is frequently impractical, or even impossible, for manufacturers to provide direct warnings to unknown patients, particularly in a medical emergency. West v. Searle & Co., 806 S.W.2d 608, 613 (Ark. 1991); Cunningham v. Charles Pfizer & Co., 532 P.2d 1377, 1381 (Okla. 1974); Talley v. Danek Med., Inc., 179 F.3d 154, 163 (4th Cir. 1999) (applying Virginia law).
It would also be dangerous and carry other adverse ramifications. To illustrate, a patient’s inability to properly weigh the risks against the attendant benefits, resulting from a lack of professional training and experience in the area of medicine and implantation of medical devices, could result in his or her decision to forgo lifesaving treatment. The learned intermediary rule reflects reality by recognizing that doctors make most prescribing decisions for their patients—in the context of a physician-patient relationship in which patients rely upon their doctors to explain treatment decisions, and not upon their own reading and comprehension of product labeling. See, e.g., West, 806 S.W.2d at 613; Humes v. Clinton, 792 P.2d 1032, 1039 (Kan. 1990); Williams v. Am. Med. Sys., 548 S.E.2d 371, 375 (Ga. Ct. App. 2001); Reaves v. Ortho Pharm. Corp., 765 F. Supp. 1287, 1289 (E.D. Mich. 1991). Thus, “[i]t is . . . the duty of the physician to advise the patient of any dangers or side effects associated with the use of the drug as well as how and when to take the drug.” Coyle v. Richardson-Merrell, Inc., 584 A.2d 1383, 1385 (Pa. 1991). “Education of the physician, on the one hand, and communication to the patient, on the other, are distinct processes, and the manufacturer’s duty involves only the former.” Harwell v. Am. Med. Sys., Inc., 803 F. Supp. 1287, 1299 (M.D. Tenn. 1992).
Ironically, most plaintiffs argue against the learned intermediary rule, but a tort system that requires manufacturers to bypass doctors and warn patients directly would disrupt the physician-patient relationship, thereby having a detrimental effect on global patient treatment. Doctors are highly trained, with their own professional and legal obligations to their patients. They ensure that patients do not overreact to the many warnings (often directed to limited situations or patient populations) that the FDA requires product labeling to include. Morgan v. Wal-Mart Stores, Inc., 30 S.W.3d 455, 467 (Tex. Ct. App. 2000) (“[I]mposition of a generalized duty to warn would unnecessarily interfere with the relationship between physician and patient.”); see also Swayze v. McNeil Lab’ys, Inc., 807 F.2d 464, 471 (5th Cir. 1987) (applying Mississippi law) (“When the physician-patient relationship does exist . . . we hesitate to encourage, much less require, a drug manufacturer to intervene in it.”).
Because the typical manufacturer’s warning provides a litany of possible complications, no matter how unlikely the possibility of occurrence, the average patient might overreact or misunderstand such warnings and forgo beneficial, or even vital, medical treatment. Larkin v. Pfizer, Inc., 153 S.W.3d 758, 764 (Ky. 2004). Further, patients do follow their physicians’ advice and rarely even read device labeling, thereby defeating causation. Accordingly, the learned intermediary rule keeps doctors as the primary source of patient information about medical treatment and accords with real-world practices. The rule ensures that trained professional physicians with years of training and experience advise patients on the risks and benefits of surgery. The rule also ensures that once a manufacturer has warned a doctor, it “may reasonably assume that the physician will exercise his informed judgment in the patient’s best interests.” Tracy v. Merrell Dow Pharms., Inc., 569 N.E.2d 875, 876 (Ohio 1991). That makes sense, that is fair for all, and that should be the law of the land.
The rule is especially important for those patients faced with emergent medical situations:
One in a serious medical condition . . . as a general matter faces unsettling and potentially harmful risks if advice from non-physicians, contrary to what the doctor of his choice has decided should be done, must be supplied to him during the already stressful period shortly before his trip to the operating room.
Brooks v. Medtronic, Inc., 750 F.2d 1227, 1232 (4th Cir. 1984) (applying South Carolina law). Thus, medical device manufacturers are not “advisers” to physicians during the informed consent process, Polley v. Ciba-Geigy Corp., 658 F. Supp. 420, 421 (D. Alaska 1987), nor are they responsible for how physicians conduct their business. Ellis v. C.R. Bard, 311 F.3d 1272, 1283 (11th Cir. 2002) (applying Georgia law); Prohaska v. Sofamor, S.N.C., 138 F. Supp. 2d 422, 444 (W.D.N.Y. 2001). In other words, “the treating physician is in a better position to warn the patient than the manufacturer.” McCombs v. Synthes, 587 S.E.2d 594, 595 (Ga. 2003).
These points are only some of the reasons why appellate courts in the remaining states without definitive precedent, like Rhode Island, should think carefully not only about the logic and reasoning advanced by the overwhelming majority of states that have adopted the learned intermediary rule but also about the safety of patients undergoing emergent surgical procedures.
