Products Liability Law Reporter

A federal district court held that dismissal was not warranted in a case alleging that the manufacturer and seller of an implantable surgical scaffold device failed to adequately warn a patient’s treating physician of the dangers of using the device for breast reconstruction.

Gianna Krstic underwent bilateral breast reconstruction surgery performed by a plastic surgeon. During the procedure, the surgeon implanted the SERI Surgical Scaffold—a silk-derived, bioresorbable device designed to support and repair soft tissue after surgery—into Krstic’s breasts without her knowledge. Krstic subsequently developed chest and arm pain, swelling, and infections at the surgery site. She consulted multiple physicians and was told that her problems were related to the SERI, which had allegedly malfunctioned, hardened inside of her breasts, and caused scar tissue to develop. She underwent corrective surgery and required hospitalization for pericarditis and pleural effusion. She continues to suffer from pain, anxiety, and depression and has incurred lost income.

Krstic filed suit against Allergan, Inc., which manufactured the SERI at the time of her surgery, and Sofregen Medical Inc., Allergan’s reported successor-in-interest for the SERI. The plaintiff alleged negligence, including claims for failure to warn and defective design and manufacture, and fraudulent concealment based on the defendants’ alleged failure to warn. The plaintiff contended that the FDA had not cleared the SERI for use in breast plastic and reconstructive surgeries but that Allergan, after acquiring the SERI in 2010, began to market the device as safe for this type of use. Moreover, the plaintiff asserted, Allergan failed to warn plastic surgeons or patients of the risks associated with off-label use of the SERI, including that it could harden in soft tissue, leading to injuries and complications, particularly during breast reconstruction surgery.

The defendants each moved to dismiss, arguing lack of causation and disputing the plaintiff’s failure-to-warn claims.

Denying the motions, the district court, applying Florida law, considered the defense argument that the plaintiff had failed to allege that her treating surgeon would have acted differently had she received an adequate warning from Allergan. Citing case law, the court said that the manufacturer of a dangerous product must provide adequate warnings of the product’s known risks. In the context of medical devices, the court added, this duty is directed not toward the patient but toward the treating physician, who is the learned intermediary capable of weighing the product’s potential benefits against its dangers. To prevail on a failure-to-warn claim, a plaintiff must show an inadequate product warning; proximate cause, including a showing that a treating physician would not have used the product had the manufacturer provided adequate warnings; and injury resulting from use of the product.

Applying these principles here, the court concluded that the learned intermediary doctrine does not bar the plaintiff’s failure-to-warn claims. The plaintiff alleged that Allergan had failed to warn her plastic surgeon of the risks associated with the SERI, including that it was more likely to malfunction and harden when used in breast reconstruction surgery; the surgeon lacked independent knowledge of those risks; and significant injuries resulted from being implanted with the device. The defendants have not rebutted the plaintiff’s allegations of inadequate warning or lack of independent knowledge, the court said, adding that a reasonable inference can be made that adequate warnings would have altered the surgeon’s decision to use the SERI, thereby preventing the plaintiff’s injuries.

Accordingly, the court concluded that the plaintiff had plausibly alleged proximate cause and that denial of the defendants’ motions to dismiss was warranted.

Citation: Krstic v. Sofregen Med. Inc., 2021 WL 372452 (D. Mass. Feb. 3, 2021).

Plaintiff counsel: AAJ members Wendy R. Fleishman, New York City; and Paula S. Bliss, Plymouth, Mass.