Opinion ID: 2228331
Heading Depth: 2
Heading Rank: 2

Heading: Breach of Duty to Warn

Text: Plaintiff below raises three distinct but closely related claims of malpractice. The first is that defendant failed to explain adequately the risks associated with the implants and the implant surgery and that this deprived her of the opportunity to give informed consent to the surgery. Indiana jurisprudence recognizes such claims as a variety of negligence or medical malpractice. [9] The second claim is that defendant negligently inserted the implants. This is the more typical form of medical malpractice claim. The third claim is that the defendant failed to warn her of safety concerns which are associated with the implants and which the manufacturer and the FDA raised after her surgery. It is this third claim which we address here. Defendant does not appear to seriously dispute that there is a duty to warn a patient of an FDA safety alert, as plaintiff alleges, or that he failed to notify plaintiff here of the FDA safety alert. Although defendant points out that there is currently no statute or common law establishing this duty, he did not move to dismiss the claim and rather assumes that he had at least some duty to act. We agree that defendant did have a duty to warn plaintiff regarding the safety of her implants. In malpractice cases which sound in negligence, as in other negligence cases, a plaintiff must establish three elements: (1) a duty on the part of the defendant to conform his conduct to a standard of care arising from his relationship with the plaintiff; (2) a failure on the part of defendant to conform his conduct to the requisite standard of care required by the relationship; and (3) an injury to the plaintiff proximately caused by the breach. See Walker v. Rinck, 604 N.E.2d 591, 594, 596 (Ind.1992); Webb v. Jarvis, 575 N.E.2d 992, 995 (Ind.1991); Cowe v. Forum Group, Inc., 575 N.E.2d 630, 636 (Ind.1991); Burke v. Capello, 520 N.E.2d 439, 441 (Ind. 1988), overruled on other grounds, Vergara By Vergara v. Doan, 593 N.E.2d 185, 186-87 (Ind.1992). The question of whether a duty exists on the part of a particular defendant to conform his conduct to a certain standard for the benefit of the plaintiff is generally a question of law. See Cowe, 575 N.E.2d at 636. A court considers and weighs three factors in making this determination: (1) the relationship between the parties; (2) the reasonable foreseeability of harm to the person injured; and (3) public policy concerns. See Walker, 604 N.E.2d at 594; Stump v. Commercial Union, 601 N.E.2d 327, 332 (Ind. 1992); Webb, 575 N.E.2d at 995. See also Perdue Farms, Inc. v. Pryor, 683 N.E.2d 239, 241 (Ind.1997); Hooks SuperX, Inc. v. McLaughlin, 642 N.E.2d 514, 517 (Ind.1994). In general, though, courts will find that a duty of care exists if reasonable persons would recognize it and agree that it exists. See Stump, 601 N.E.2d at 332. See generally W. Page Keeton et al., Prosser & Keeton on Torts § 53, at 359 (5th ed.1984) [hereinafter Prosser ]. The question of what standard of care applies in a specific context, and the related question of whether the defendant has breached his duty to adhere to that particular standard, are often questions of fact. See Hooks SuperX, Inc., 642 N.E.2d at 519. In medical malpractice cases, for example, we have held that the general standard of care that a health care provider must exercise is that degree of care, skill, and proficiency exercised by reasonably careful, skillful, and prudent practitioners in the same class to which he belongs, acting under the same or similar circumstances. Oelling v. Rao, 593 N.E.2d 189, 191 (Ind.1992). To establish the particular standard of care in a malpractice case and the breach of the duty to adhere to that particular standard, however, a plaintiff must often present expert testimony to the trier of fact about what other reasonable doctors similarly situated would have done under the circumstances. See id. This is so because of the often highly technical and complicated nature of medical treatment. See Burke, 520 N.E.2d at 441. Nevertheless, not all medical malpractice cases are so technical that they require expert testimony, and when no reasonable jury could reach any conclusion other than that a specific standard of care is applicable and was breached, the questions of what specific standard is applicable and whether that standard was breached are questions of law for the court. See Culbertson v. Mernitz, 602 N.E.2d 98, 104 (Ind.1992) (stating that expert testimony is necessary except in those cases where deviation from the standard of care is a matter commonly known by lay persons); Burke, 520 N.E.2d at 441. See generally Prosser § 37, at 237-38. The specific questions presented here are as follows: (1) whether there is a specific duty to warn a patient that a medical device previously placed in the patient by that physician or oral surgeon may be unsafe and to urge them to get follow-up care when the manufacturer and/or the FDA have issued safety alerts regarding the medical device; (2) whether the physician or oral surgeon owes any such duty not only to his current patients but also to former patients; and (3) whether the duty to warn, assuming it exists, has been breached here. We conclude that, as a matter of law, defendant had a duty to warn both current and former patients, including plaintiff, of safety issues highlighted by the manufacturer and/or the FDA, and that, based on the undisputed facts, defendant has breached that duty here. In analyzing the first two questions, we consider and weigh the three factors set forth in Walker. As to the relationship between the parties, there can be no question that a health care provider such as a physician or an oral surgeon owes a general duty to his patient. See Oelling, 593 N.E.2d at 191. The duty of an oral surgeon to his patient arises from the contractual relationship entered into between the two of them. See Walker, 604 N.E.2d at 594. Moreover, the relationship between a health care provider, such as a physician or oral surgeon, and a patient is special and particularly important in that the patient relies heavily on the expertise of that health care provider in making decisions that may greatly impact the patient's health and well-being. Because of the nature of this relationship, it is essential that the health care provider disclose material facts to the patient at appropriate times during the course of the patient's treatment so that the patient may make informed decisions about health care issues. See supra note 9. There is nothing about the nature of the relationship that would warrant any conclusion other than that the physician or oral surgeon has a duty to warn his patients about manufacturer and FDA safety alerts that pertain to medical devices the physician or oral surgeon previously inserted or implanted in his patients. The question of foreseeability is equally clear. Once a doctor or oral surgeon receives a safety alert about a project, it can hardly be argued that any harm to a patient arising from this product is not foreseeable. A manufacturer or the FDA issues a special safety alert or recalls a medical device precisely because the product puts the patient at risk of harm. See Walker, 604 N.E.2d at 594-95. As to the public policy factor, there are compelling reasons to require that health care providers who insert or implant medical devices in their patients stay abreast of safety issues pertaining to those medical devices and promptly pass along important information regarding the safety or risks associated with those devices to their patients. This is particularly true when, as in cases such as this one, the manufacturer or the FDA issues safety alerts or when the FDA recalls the device. The physician or oral surgeon who inserted or implanted the device needs to stay informed about such pronouncements to perform effectively and responsibly as a professional. The physician or oral surgeon who inserted the medical device is also in a good position to maintain records of patients who have such devices so that they may be notified if significant new information pertaining to the safety of the medical devices becomes available. Any countervailing interest in guarding against imposing potentially burdensome requirements for finding patients who may have relocated can be addressed by qualifying the duty so that the physician or oral surgeon need only take reasonable steps to update patient information and to locate patients whose address of record changes. Our conclusion that there is a duty to warn a patient of safety issues raised by the manufacturer and/or the FDA finds support in decisions of other jurisdictions that either expressly or implicitly have recognized a duty to warn in similar circumstances. See Allen v. Belinfante, 217 Ga.App. 754, 458 S.E.2d 867, 869-70 (1995) (dental implants); Welch v. McCarthy, 677 A.2d 1066, 1069 (Me. 1996) (dental implants); Tanuz v. Carlberg, 122 N.M. 113, 921 P.2d 309, 313 (1996) (dental implants); Reyes v. Anka Research, Ltd., 111 Misc.2d 152, 443 N.Y.S.2d 595, 597 (Sup. Ct.1981) (intrauterine device); Bruske v. Hille, 567 N.W.2d 872, 876 (S.D.1997) (dental implants). Having concluded that a physician or oral surgeon who implants medical devices in a patient has a duty to warn the patient of safety issues raised by the manufacturer and/or the FDA, we also conclude that this duty extends to both current and former patients. The analysis of the three factors is essentially the same for both classes of patients. It makes no sense to differentiate between the two classes of patients in this context given the strong public policy reasons for imposing a duty as outlined above, and given that, as the facts in this case demonstrate, there is no bright line test for distinguishing between a current patient who perhaps has not seen the provider for quite some time and a former patient who has intentionally severed all ties with the provider. This conclusion finds support in cases from other jurisdictions. See, e.g., Tanuz, 921 P.2d at 310-11, 313 (citing Kern By and Through Kern v. St. Joseph Hospital, 102 N.M. 452, 697 P.2d 135, 139 (1985)). While we need not decide today the precise limits of the duty to warn, at the very least, a safety alert issued by the manufacturer or the FDA triggers the need to make reasonable efforts to contact all current and former patients with the implants. Defendant does not dispute that the FDA issued a safety alert in 1990, that defendant had access to plaintiff's new Arizona address and in fact forwarded her dental record to her at her request, and that he nonetheless failed to notify her of the safety issues relating to the dental implant he had previously inserted in 1988. Whether this constitutes a breach of the duty to warn can, on remand, be the subject of further motions for summary judgment or a trial on the merits.