In February 2015, plaintiff Wendy Knecht, 58, an entrepreneur, inventor, writer, and former flight attendant for Pan-Am and Delta, underwent breast reconstruction surgery at Huntington Memorial Hospital, in Pasadena. The procedure was performed by Dr. Max Lehfeldt. Prior to the surgery, Knecht, who had a family history of cancer, underwent BRCA genetic testing to possibly detect the breast cancer gene. Her positive result in 2014 indicated an increased risk of breast cancer. As a result, Knecht chose to undergo a prophylactic double mastectomy with bilateral breast reconstruction surgery. She consulted multiple breast and plastic surgeons in Los Angeles, and settled on Dr. Max Lehfeldt, the president and owner of Teleos Plastic Surgery, in Pasadena. In January 2015, Knecht had her first and only preoperative consult with Lehfeldt. Knecht’s husband, a gastroenterologist, accompanied her to the appointment. During the consultation, Lehfeldt proposed a nipple-sparing, bilateral, breast reconstruction surgery with the use of Natrelle breast tissue expanders to be supported with a silk-derived mesh support device, SERI Surgical Scaffold. SERI, which was commercially launched in 2014, and Natrelle are manufactured by Allergan Inc., a New Jersey-based medical device manufacturer. SERI was 510(k) cleared by the U.S. Food and Drug Administration for use as a transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome, including reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction. However, the FDA did not clear SERI for use in breast reconstruction surgery or with breast tissue expanders. Knecht consented to the procedure based upon the information that Lehfeldt provided. Lehfeldt performed Knecht’s breast reconstruction surgery at Huntington Memorial Hospital in February 2015. During the procedure, he implanted the SERI and Natrelle devices, and no complications were noted. Over the next three months, during follow-up visits with Lehfeldt, Knecht complained of pain and heaviness at the operative site. Lehfeldt’s notes include references to the possible existence of swelling, seromas and thinning of tissues, but he allegedly told Knecht that this was normal. In May 2015, Knecht underwent surgery to exchange the Natrelle expanders for the permanent Allergan breast implants. The exchange surgery was performed by Lehfeldt, who wrote in his report that “Upon inspection of the breast pocket, we noted that there was a large section of the SeriScaffold, which was not integrated in the lower pole of the breast. This was removed. The patient had manifested some late seromas suspicious for lack of integration…” Over the next five months, Knecht continued to experience pain in her chest. She also told Lehfeldt that the implants felt too big and heavy. However, Lehfeldt allegedly assured her that her complaints were normal and would improve. Knecht eventually sought second opinions from other surgeons, and underwent her first revision reconstruction in November 2015 at Ronald Reagan UCLA Medical Center, in Los Angeles. During the surgery, SERI was again found to be non-adherent, and it was taken out. However, when Knecht was informed of the finding postoperatively, it was allegedly the first time she was made aware of any potential problem with SERI. Knecht claimed that the failed SERI and Natrelle devices caused her that left her disfigured and required three surgeries to repair the damage. Knecht sued Lehfeldt, Teleos Plastic Surgery and Allergan Inc. in Los Angeles Superior Court in November 2016. Knecht alleged that Lehfeldt’s actions constituted negligence, breach of fiduciary duty, lack of informed consent and fraud. She also alleged that Teleos Plastic Surgery was liable for Lehfeldt’s actions. Knecht further alleged that Allergan’s actions constituted negligence, fraud, and failure to warn. Pacific Communications, a subsidiary of Allergan, was also initially named as a defendant, but it was ultimately dismissed from the case. Allergan was immediately removed to federal court based primarily on the grounds that Knecht had fraudulently joined Lehfeldt and Teleos Plastic Surgery. Specifically, Allergan’s counsel asserted that the medical malpractice statute of limitations had passed and that the underlying case against those defendants could not be maintained. However, plaintiff’s counsel filed a motion to remand, which Allergan’s counsel opposed, and the federal court remanded the case back to state court on the pleadings. There were only eight depositions taken in the case: the deposition of Lehfeldt, the depositions of six current and former Allergan employees, and a person most qualified. Knecht’s deposition was never taken. Plaintiff’s counsel contended that beginning in 2011, Lehfeldt was paid hundreds of thousands of dollars by Allergan to consult on the marketing/promotion and research of SERI. Lehfeldt was allegedly Allergan’s number one SERI consultant. Lehfeldt held stock in Allergan and was the principal investigator in Allergan’s FDA-monitored clinical study, during which he investigated whether SERI was safe and effective for use in breast reconstruction surgeries or with Allergan’s Natrelle breast tissue expanders. Plaintiff’s counsel also noted that Lehfeldt taught other surgeons about his use of SERI in breast reconstruction surgery and allowed videos of him performing breast reconstruction surgery with the SERI and Natrelle devices to be used for online educational courses. As a result, Allergan referred surgeons with SERI questions to Lehfeldt, and Allergan produced emails whereby Lehfeldt shared his experience with SERI in breast reconstruction surgery with other surgeons (and copied Allergan employees on the emails). During litigation, plaintiff’s counsel obtained a warning letter sent to Allergan by the FDA in May 2015. The letter stated, “These indications fall outside of your firm’s intended use because surgical mesh has not been cleared or approved for use in breast reconstruction using a tissue expander or implant. In addition, the specific breast reconstruction surgery indication changes the intended use of a surgical mesh cleared with a general soft tissue reinforcement indication…” As a result, Allergan voluntarily ceased any marketing or promotion of SERI for use in breast reconstruction surgery. In addition, plaintiff’s counsel contended that Lehfeldt admitted that he understood that the use of SERI in breast reconstruction and/or with the Natrelle expanders was an off-label use that was not cleared or approved by the FDA. Knecht’s husband, who was present with his wife during the consultation in January 2015, claimed that Lehfeldt only proposed nipple-sparing, bilateral, breast reconstruction surgery with the use of Natrelle breast tissue expanders to be supported with SERI. Thus, he claimed that his wife consented to the procedure based upon the information that Lehfeldt provided, so Lehfeldt failed to obtain her proper informed consent. Prior to filing her legal complaint, Knecht submitted a complaint to the Medical Board of California, and Lehfeldt provided a written response. Plaintiff’s counsel contended that, in responding to the Medical Board, Lehfeldt later admitted to altering/adding information to his preoperative consultation note with respect to SERI and his consent discussion. Lehfeldt also admitted that while he knew he was required to note a late entry as such, he did not do so. He further admitted that he did not inform the Medical Board about his change to Knecht’s records. Thus, plaintiff’s counsel asserted that Knecht’s late entry was a violation of Business and Professions Code § 2262, and California Penal Code § 475.1, a misdemeanor. Knecht’s husband, who was also present with his wife when Lehfeldt discussed the outcome of the exchange surgery, claimed that Lehfeldt did not tell either of them that there were any complications related to the use of SERI or that his findings were consistent with SERI’s failure to adhere to the soft tissues and support the expanders. Thus, Knecht claimed that Lehfeldt failed to disclose the known SERI risks and complications, failed to disclose the off-label and experimental nature of the proposed surgery and device usage, failed to disclose his financial and research relationship with Allergan, and failed to offer the reasonable SERI alternatives. She claimed that as a result, Lehfeldt was negligent for failing to obtain her informed consent for the February 2015 reconstruction surgery and was negligent for the actual performance of the reconstruction surgery. Knecht also claimed that Lehfeldt committed fraud and a breach of fiduciary duty by intentionally concealing his financial and research interests in Allergan and SERI, specifically. She further claimed that Lehfeldt conspired with Allergan to promote and use the SERI and Natrelle devices in an off-label, experimental manner without her knowledge. Plaintiff’s counsel noted that Lehfeldt admitted during his deposition that he had a duty to disclose both his relationship with Allergan and his off-label use of Allergan devices to Knecht. In addition, plaintiff’s counsel asserted that the information that Lehfeldt provided on his website regarding SERI and, specifically, its safety, efficacy and uses in breast reconstruction surgery, violated the terms of Business and Professions Code § 651, which specifically prohibits healthcare providers from disseminating false or misleading information about medical treatments in their advertising, including web content. In regard to the claims against Allergan, plaintiff’s counsel asserted that Allergan was negligent for promoting SERI for use in breast reconstruction surgery and with Natrelle expanders. Counsel also asserted that Allergan fraudulently engaged in an unlawful, off-label promotional campaign to market SERI for use in breast reconstruction surgeries and with Natrelle expanders. Plaintiff’s counsel also specifically asserted that Allergan was conspiring with physicians, including Lehfeldt, to promote SERI for use in breast reconstruction surgery and with the Natrelle expanders. To support Knecht’s claims, plaintiff’s counsel found posted online in 2013, physician SERI instructional videos (copyrighted to Allergan), where Lehfeldt is performing breast reconstruction surgery with SERI and Natrelle devices. Plaintiff’s counsel also found Allergan plastic surgery order forms where healthcare providers could order SERI and Natrelle devices together. The defendants denied any wrongdoing, and claimed that Knecht gave her informed consent to undergo breast reconstruction surgery with the use of SERI and Natrelle expanders. They also claimed that Knecht consented to the use of the SERI Surgical Scaffold after being advised of the risks, complications and alternatives. Lehfeldt claimed that he disclosed his relationship with Allergan to Knecht. He also claimed that he disclosed that he had investigated SERI in a clinical study and that he was proposing to use SERI in an off-label manner in Knecht’s surgery. Allergan denied engaging in any off-label promotion of its medical devices, including promotion of SERI for use in breast reconstruction surgery or with Natrelle expanders. Specifically, Allergan claimed that the use of SERI in breast surgery was not an off-label indication. In addition, Allergan claimed the learned intermediary doctrine as a defense, and alleged that it had no direct contact with Knecht and, therefore, had no legal duty to her., Knecht claimed that she experienced pain in her chest, and felt that the implants were too big and heavy. She eventually sought second opinions from other surgeons, and underwent her first revision reconstruction in November 2015 at Ronald Reagan UCLA Medical Center. During the surgery, SERI was again found to be non-adherent, and it was taken out. Knecht claimed that the failed SERI and Natrelle devices caused her , which left her disfigured. As a result, she underwent a second revision reconstruction in June 2016 at City of Hope National Medical Center, in Duarte. During the procedure, more SERI was noted to be non-adherent, so the surgeon, Dr. James Andersen, removed as much of the SERI as he could and replaced it with the alleged gold standard in soft tissue support, Alloderm (made from human cadaver tissue). Knecht then underwent a third revision reconstruction by Andersen in December 2017, during which the implants were again exchanged. Knecht, 61 at the time of settlement, claimed that despite having three revision reconstructions, she continues to suffer from debilitating symptoms, including chest pain, discomfort, heaviness, tightness, anxiety, sleep disturbance, and physical deformities. Thus, Knecht sought recovery of medical costs and damages for her past and future pain and suffering. She also sought recovery of punitive damages against Allergan. Defense counsel denied that any of the medical devices at issue caused Knecht’s alleged , which were known complications of breast reconstruction surgery.