This case involves a hip replacement device MDL. It was alleged that the device manufacturer did not provide proper adverse event reports to the FDA as the data was coming in. An expert in FDA regulations was sought to discuss how the labeling and warnings on the device would have changed had the FDA received proper information from the device manufacturer.
Question(s) For Expert Witness
- 1. Were you involved in adverse event reporting at the FDA?
- 2. Are you knowledgeable about how these reports effect how medical devices are labeled?
Expert Witness Response E-004882
I am a former FDA reviewer and manager at FDA/CDRH. I am also a biomedical scientist, a licensed professional engineer, a board-certified human factors (CPE) engineer, and I hold two doctorate degrees. I am an expert in medical device labeling. Adverse event reporting is part of post-market risk management. I am an expert in this subject matter area, with multiple publications on risk management and a recent 3-lecture international webinar series on risk management for medical devices sponsored by QMED. I am currently working on an adverse reporting case for a medical device on behalf of a plaintiff.