This case involves numerous plaintiffs who suffered complications related to a birth control medical device. The plaintiffs suffered perforation of the uterus and other organs, migration of the device throughout the body, as well as immune reactions to the device causing headaches, weight gain, and hair loss. It was alleged that after being granted approval for the device, the device manufacturer failed to comply with FDA requirements. An expert in medical device regulation was sought to discuss FDA requirements for medical device manufacturers, enumerate the warnings and marketing regulations laid forth by the FDA, and explain post-market surveillance practices.
Question(s) For Expert Witness
1. Please briefly describe your medical device regulation experience.
2. Can you speak to marketing and warnings concerns relevant to the FDA and device manufacturers?
Expert Witness Response E-053014
I have extensive medical device regulation experience, including marketing, warning concerns, and device post-approval processes. I have experience in RA/Clinical and RA/QA at various levels including specialist, director, client manager, project manager, third party, expert witness, and consultant. I previously served as the lead regulator on device and combination product submissions and clinical trial submissions to FDA. I have received 54 FDA approvals for medical devices in the past 9 years, and have received FDA approval for 6 clinical trials in that same period. I have submitted and managed 24 presubmission packages to FDA and held hundreds of meetings and conference calls with the FDA during that time. I have managed experts and testing labs globally to complete product testing and respond to AI requests on time. I have also managed human factor and usability studies, biocompatibility studies, sterilization and disinfection validations, packaging validations, shelf life and life of device programs, electrical and EMC safety testing, software validations, performance testing, risk assessments, conditioning and cleaning validations for reprocessed equipment, and radiation safety reporting as part of applications and AI responses. I have managed and developed promotional and advertising campaigns and evaluated the post-approval off-label marketing, including adulteration and misbranding. I have advised on corporate quality and regulatory compliance issues. To ensure compliance with regulatory requirements and QMS regarding supplier controls, manufacturing, sterilization, promotion and labeling, complaint handling, CAPA, and PMS requirements, I have implemented investigations into complaints, adverse events, recalls, and non-conforming material reviews. I have experience drafting expert reports on regulatory and quality topics for medical devices and combination products.
About the author
Wendy Ketner, M.D.
Dr. Wendy Ketner is a distinguished medical professional with a comprehensive background in surgery and medical research. Currently serving as the Senior Vice President of Medical Affairs at the Expert Institute, she plays a pivotal role in overseeing the organization's most important client relationships. Dr. Ketner's extensive surgical training was completed at Mount Sinai Beth Israel, where she gained hands-on experience in various general surgery procedures, including hernia repairs, cholecystectomies, appendectomies, mastectomies for breast cancer, breast reconstruction, surgical oncology, vascular surgery, and colorectal surgery. She also provided care in the surgical intensive care unit.
Her research interests have focused on post-mastectomy reconstruction and the surgical treatment of gastric cancer, including co-authoring a textbook chapter on the subject. Additionally, she has contributed to research on the percutaneous delivery of stem cells following myocardial infarction.
Dr. Ketner's educational background includes a Bachelor's degree from Yale University in Latin American Studies and a Doctor of Medicine (M.D.) from SUNY Downstate College of Medicine. Moreover, she is a member of the Board of Advisors for Opollo Technologies, a fintech healthcare AI company, contributing her medical expertise to enhance healthcare technology solutions. Her role at Expert Institute involves leveraging her medical knowledge to provide insights into legal cases, underscoring her unique blend of medical and legal acumen.
