Better late than never. We missed last month the decision in Costa v. Johnson & Johnson, No. CV 17-452 WES, 2023 WL 2662903, at *3 (D.R.I. Mar. 28, 2023), a product liability asserting a pelvic mesh medical device was defective. Plaintiff alleged, inter alia. a failure to warn claim under Rhode Island law.
Under that state’s failure-to-warn theory of strict product liability, a plaintiff must prove that the failure to warn of the product’s dangers “that are reasonably foreseeable and knowable at the time of marketing” “render[ed] the product unreasonably dangerous in spite of all reasonable care exercised by the manufacturer.” Castrignano, 546 A.2d at 779, 782. “The plaintiff has the burden of proving a defect in the product and that his or her injury was proximately caused by this defect.” Austin v. Lincoln Equip. Assocs., Inc., 888 F.2d 934, 936 (1st Cir. 1989). The Rhode Island Supreme Court has described the standard as “equivalent to the standard for negligence.” Castrignano, 546 A.2d at 782; accord DiPalma v. Westinghouse Elec. Corp., 938 F.2d 1463, 1466 (1st Cir. 1991) (“It is clear under Rhode Island law that the duty to warn … is measured, in all respects material to this case, by the same standard as the duty to warn that is enforceable in a negligence cause of action.”). Plaintiffs must establish the standard of care with expert testimony. See Mills v. State Sales, Inc., 824 A.2d 461, 468 (R.I. 2003); Raimbeault v. Takeuchi Mfg. (U.S.), Ltd., 772 A.2d 1056, 1063 (R.I. 2001).
Defendants argued that the learned intermediary doctrine applied here. Under the doctrine, a manufacturer of a prescription 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 any warning to the patient directly. The rationale supporting this learned intermediary rule is that health-care professionals are in a position to understand the significance of the risks involved and to assess the relative advantages and disadvantages for the patient. The duty then devolves on the health-care provider to supply to the patient such information as is deemed appropriate under the circumstances so that the patient can make an informed choice. Accordingly, if the specific risk was known to the physician, a manufacturer’s alleged failure to warn of that risk cannot be considered a defect. See In re Zyprexa Products Liab. Litig., 277 F.R.D. 243, 250 (E.D.N.Y. 2011) aff’d sub nom Greaves v. Eli Lilly & Co., 503 F. App’x 70, 71 (2d Cir. 2012).
The Rhode Island Supreme Court has not expressly adopted the learned intermediary doctrine, and Plaintiffs here urged the court to certify the question to the Rhode Island Supreme Court. The federal court declined this invitation. “Even in the absence of controlling precedent, certification would be inappropriate where state law is sufficiently clear to allow us to predict its course.” In re Engage, Inc., 544 F.3d 50, 53 (1st Cir. 2008); see Hugel v. Milberg, Weiss, Bershad, Hynes & Lerach, LLP, 175 F.3d 14, 18 (1st Cir. 1999) (“[W]hen state law is sufficiently clear to allow [a federal court] to predict its course, certification is both inappropriate and an unwarranted burden on the state court.”).
Here, a number of factors counseled in favor of predicting that the Rhode Island Supreme Court would adopt the learned intermediary doctrine. First, the Rhode Island Supreme Court has implicitly referenced the doctrine when describing the proximate cause element of a failure to warn claim. See Hodges v. Brannon, 707 A.2d 1225, 1227-28 (R.I. 1998). In addition, the Rhode Island Supreme Court frequently relies on the Second and Third Restatements of Torts as a basis for the state’s product liability law. Specifically, the learned intermediary doctrine is defined in § 388 of the Second Restatement, which the Rhode Island Supreme Court has cited with approval in other contexts. See Maggi v. De Fusco, 267 A.2d 424, 427 (R.I. 1970) (citing § 388(b)). The doctrine is also defined in § 6 of the Third Restatement of Torts: Products Liability, other provisions of which the Rhode Island Supreme Court has cited with approval. See, e.g., Calise v. Hidden Valley Condo Ass’n, 773 A.2d 834, 846 n.13 (R.I. 2001) (citing Restatement (Third) Torts). Thus, the Rhode Island Supreme Court’s treatment of the Second and Third Restatements left the federal court with “no reason to expect Rhode Island, if it were to adopt the learned intermediary doctrine, to offer an unusual interpretation of it, thereby rejecting the current edition of the Restatement.” Hogan v. Novartis Pharms. Corp., No. 06 Civ. 0260(BMC)(RER), 2011 WL 1533467, at *10 (E.D.N.Y. Apr. 24, 2011).