SAN DIEGO, Nov. 29, 2016 /PRNewswire/ -- Los Angeles resident Wendy Knecht filed a lawsuit yesterday[11/28/16] in Los Angeles Superior Court alleging that her plastic surgeon, Max R. Lehfeldt, M.D., of Teleos Plastic Surgery, conspired with medical device manufacturer Allergan, Inc., to promote and use SERI surgical scaffold and Natrelle breast tissue expanders in her in an off-label, experimental manner without her knowledge. She has sued Dr. Lehfeldt and his practice for medical negligence, breach of fiduciary duty, lack of informed consent and fraud. She sued Allergan for negligence, fraud, and failure to warn and is seeking punitive damages.
According to the complaint filed by San Diego Attorney Robert Vaage, the SERI surgical scaffold never received clearance by the FDA for use in breast reconstruction or with the Natrelle breast expanders. The complaint goes on to allege that Dr. Lehfeldt had an extensive financial/research relationship with Allergan, with financial and research interests in the SERI and Natrelle products. He has acted as a speaker and "faculty member" for Allergan, and consulted on the use and marketing of Allergan products. The complaint alleges that Dr. Lehfeldt was paid by Allergan to promote and use its products, and at the time he treated Ms. Knecht, Dr. Lehfeldt was a principal investigator for an ongoing FDA-sanctioned clinical study regarding the use of the SERI scaffold with the Natrelle breast expanders in breast reconstruction surgery. Ms. Knecht was unaware of Dr. Lehfeldt's extensive relationship with Allergan or his financial and research interests in the SERI and Natrelle products.
"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," explained Vaage. "Ms. Knecht 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/clinical evidence that this SERI surgical scaffold, which is derived from silk, is safe to use in breast reconstruction surgery. Dr. Lehfeldt knew that; Allergan knew that. Unfortunately, Ms. Knecht did not."
Ms. Knecht alleges that the SERI surgical scaffold and Natrelle breast tissue expanders failed and caused her injuries, leaving her disfigured and requiring additional reconstructive surgery to remove the Allergan devices and repair the damage done. Ms. Knecht had double mastectomies because of her high genetic risk of developing breast cancer.
For more information concerning this lawsuit, please contact The Law Offices of Robert Vaage at 619-338-0505 or e-mail [email protected]. Robert F. Vaage is a trial attorney in San Diego, California. He has represented patients in fraud cases involving physicians and medical device manufacturers.
SOURCE The Law Offices of Robert Vaage