VESTED INTEREST Dr. Max Lehfeldt was allegedly on Allergan's payroll to promote and research the company's SERI surgical scaffold system.
A plastic surgeon and Allergan have reached financial settlements with a woman who accused the doctor and company of conspiring to experiment with the off-label use of a tissue scaffold system during her breast reconstruction surgery.
Wendy Knecht of Los Angeles, Calif., who had undergone double mastectomies because of her high genetic risk of developing breast cancer, claimed in a lawsuit that Max R. Lehfeldt, MD, FACS, used Allergan's SERI surgical scaffold and Natrelle breast tissue expanders, even though the scaffold system was not FDA-approved for use during breast reconstruction procedures or with Natrelle's device. She says the devices failed, leaving her disfigured and requiring 3 addition surgeries to remove the devices and repair the physical damage.
Ms. Knecht's lawsuit alleged that Dr. Lehfeldt was a paid consultant to Allergan, owned stock in the company and had earned hundreds of thousands of dollars for serving as the SERI system's primary physician promoter. She accused Dr. Lehfeldt of medical negligence, breach of fiduciary duty, lack of informed consent and fraud. She also accused Allergan of negligence, fraud and failure to warn about the off-label use of its device. Dr. Lehfeldt reached a $1 million settlement with Ms. Knecht, according to her San Diego attorney Robert Vaage. Allergan reportedly settled the charges for an undisclosed amount.
Ms. Knecht claims she was unaware at the time of her surgery that Dr. Lehfeldt was a principal investigator in an FDA-backed study designed to assess the use of the Allergan and Natrelle devices during breast reconstruction procedures.
"When a surgeon has extensive financial ties with a device manufacturer and is involved in an ongoing clinical trial, he has a duty to divulge that information to his patient," says Mr. Vaage. "[My client] did not have any of the protections she would have had as a knowing participant in a clinical trial.
"There's just no scientific proof or clinical evidence that the SERI surgical scaffold is safe to use in breast reconstruction surgery," adds Mr. Vaage. "Dr. Lehfeldt knew that and Allergan knew that. Unfortunately, Ms. Knecht did not."
Dr. Lehfeldt and an Allergan spokesperson did not respond to requests for comment.
