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(April 11, 2018)
SAN DIEGO, April 11, 2018 /PRNewswire/ -- Do you know if your surgeon is experimenting on you? Using devices that were not cleared or approved by the FDA for the use intended? Getting paid hundreds of thousands of dollars by the device manufacturer to promote, market, and research these devices? Robert Vaage, a personal injury attorney in San Diego, recently settled a case for more than $1 million involving an alleged conspiracy between a cosmetic surgeon and medical device company to promote and experimentally use its devices in breast reconstruction surgery.
Plaintiff Wendy Knecht of Los Angeles, California, filed a lawsuit against Plastic Surgeon Max Lehfeldt and Allergan, Inc., a New Jersey based medical device manufacturer of the SERI Surgical Scaffold and Natrelle breast expanders, alleging that Dr. Lehfeldt conspired with Allergan to promote and use the SERI and Natrelle expander devices in an experimental manner without her knowledge. The FDA did not clear SERI for use in breast reconstruction surgery or with breast tissue expanders, yet Dr. Lehfeldt used both products in Ms. Knecht in her breast reconstruction surgery.
"A patient has the right to know if his or her surgeon intends to implant devices that were the subject of a clinical study," explained Vaage. "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."
During the case, Vaage discovered that Dr. Lehfeldt was paid hundreds of thousands of dollars by Allergan to market/promote and research SERI. He was Allergan's #1 SERI consultant and held stock in Allergan. Virtually all of the work that Dr. Lehfeldt performed for Allergan was related to SERI, including a clinical study to test the use of SERI and Natrelle in breast reconstruction surgery.
Mrs. Knecht alleged that the SERI and Natrelle expanders failed and caused her injuries and disfigurement that required three additional surgeries to remove these Allergan products and repair the damage. She ultimately settled her case with Dr. Lehfeldt for his insurance policy limit of $1,000,000. Allergan settled all claims for a confidential amount.
This most recent settlement with a surgeon and device manufacturer is Vaage's fourth verdict or settlement for a client stemming from allegations that the medical device manufacturer fraudulently conspired with a physician to gain patient consent to undergo experimental surgical procedures.
Robert F. Vaage is a trial attorney in San Diego, California. He has represented patients in fraud and conspiracy cases involving physicians and medical device manufacturers.
Case Information: Wendy Knecht v. Max R. Lehfeldt, M.D.; Teleos Plastic Surgery, A Medical Corporation; Allergan, Inc., a corporation; and DOES 1 through 25, inclusive, Case No. BC641979, filed 11/28/16 in the Los Angeles Superior Court, Central District.
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SOURCE Law Offices of Robert Vaage
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