Harris Beach attorneys successfully moved the New York Supreme Court to dismiss a plaintiff’s medical malpractice, lack of informed consent, and negligence claims against a medical device manufacturer. Greenwood v. Tehrani, 2017 WL 4083099, 2017 NY Slip Op 31963(U) (Sup. Ct. N.Y. Cty, September 15, 2017). Plaintiff asserted injuries resulting from injections of the medical device ArteFill® (now known as Bellafill ®), a dermal filler approved by the U.S. Food and Drug Administration for the correction of facial wrinkles known as nasolabial folds, or smile lines. Plaintiff sued the plastic surgeon who treated him, the facility in which he received the injections, and the dermal filler’s manufacturer, Suneva Medical Inc. Plaintiff grouped the device manufacturer with the other defendants in his claims of negligence, medical malpractice, and lack of informed consent. The only claims directed specifically against the medical device manufacturer alleged that the manufacturer had a duty to ensure the device was used in accordance with FDA guidelines and that its sales representative, who was in the room during plaintiff’s treatment, gave advice and instruction regarding the use of the device.

Plaintiff conceded that he had not asserted any claims against the medical device manufacturer sounding in product liability such as failure to warn, design defect or manufacturing defect. Plaintiff’s negligence claim against the manufacturer was based solely on the sales representative’s advice and instruction to the treating physician. Plaintiff’s counsel argued that the gravamen of the Complaint was vicarious liability; however, the court agreed that the Complaint failed to allege vicarious liability or any underlying negligence of the sales representative. As such, in his attorney’s affirmation, plaintiff attempted to assert new claims, outside of the four corners of his Complaint, which is not permitted in opposition to a motion to dismiss. See, e.g., Cromarty v. Prentice-Hall, Inc., 72 A.D. 2d 782, 783 (2d Dep’t 1979). Plaintiff’s Complaint failed to allege what instruction or advice the sales representative gave the treating physician or how that advice led to plaintiff’s injuries and could not correct these deficiencies in his opposition.

In granting the medical device manufacturer’s motion to dismiss premised upon failure to state a cause of action, the court recognized that plaintiff could not assert medical malpractice and lack of informed consent claims against a medical device manufacturer, since a manufacturer neither practices medicine nor has a duty to inform a patient of the risks and benefits of a particular treatment. With respect to the negligence claim, the court recognized that a party injured as a result of a defective product may seek recovery based upon theories of breach of a promise (express or implied), negligence or strict liability. Under the negligence or strict liability theories, a party may bring a claim against a product manufacturer, including medical device manufacturers, because of an alleged design defect, manufacturing defect or failure to provide adequate warnings. Citing New York’s leading case on the learned intermediary doctrine, the court noted that the manufacturer’s duty is to warn the medical community, not the patient, of the product’s risks because it is 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. Martin v. Hacker, 83 N.Y.S.2d 1, 9 (1993). In the court’s decision, the judge observed that plaintiff’s Complaint did not allege that there was a manufacturing or design defect in Artefill®. Rather, the pleaded allegations stem from the sales representative’s alleged failure to ensure that the physician used the device in a safe manner, according to their own guidelines and the guidelines of the FDA. Furthermore, “while the manufacturer of a medical device has a duty to warn a patient’s physician of the risks associated with the device, the manufacturer is not responsible for how the physician uses the device and renders the medical care.” See also Prohaska v. Sofamor, S.N.C., 138 F.Supp. 2d 422, 444 (W.D.N.Y. 2001). Additionally, plaintiff’s Complaint failed to connect plaintiff’s injuries to any act or omission of the device manufacturer, thereby creating an independent basis to dismiss the negligence claim.

This case is a significant victory in New York for medical device and pharmaceutical companies as it sets a precedent to dismiss claims based on a sales representative’s statements. When faced with this type of claim, manufacturers should emphasize that the physician, not the manufacturer’s representative, makes decisions regarding a patient’s care and has the ultimate authority regarding how to use a particular device. As such, the representative is not responsible for ensuring the physician uses the device in a particular manner.

Furthermore, for a variety of reasons (e.g., statute of limitations, solvency issues, med mal caps), plaintiffs in search of a deep pocket have increasingly masked medical malpractice claims as products liability claims against drug and medical device manufacturers. Typically in these scenarios, plaintiffs allege failure to warn and/or specious “failure to train” theories, especially as here, when a sales representative was present in the room. There has been a concerted effort on the part of the plaintiffs’ bar to get creative when pleading such claims in an attempt to expand the duties traditionally held to manufacturers of drugs and devices. The Greenwood case is an example of this development but with a happy-ending—the court reinforcing well-established principles of products liability law that manufacturers of products cannot be held liable for informed consent and medical malpractice.  It upholds the proposition that manufacturers, even if they have representatives in attendance during a procedure utilizing their product, are not liable for how the physician chooses to use them.  It is important that manufacturers pay attention to these increasingly filed medical malpractice complaints masquerading as product liability cases, with particular attention to allegations that center on the sales representative or those that attempt to espouse a new theory of liability (e.g., negligent sale).  When forced with such claims, it is imperative to evaluate early dismissal under the theories put forth in this case, as well as preemption and any others that may apply.