FDA Expert Reviews Regulatory Hip Replacement Violations

Case Overview

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.

Questions to the FDA Regulations expert and their responses

Were you involved in adverse event reporting at the FDA?

I am a former FDA reviewer and manager at FDA/CDRH. Adverse event reporting is part of post-market risk management. I am currently working on an adverse reporting case for a medical device on behalf of a plaintiff.

Are you knowledgeable about how these reports effect how medical devices are labeled?

I am an expert in medical device labeling. I have multiple publications on risk management and a recent 3-lecture international webinar series on risk management for medical devices sponsored by QMED.

About the expert

This expert is a licensed professional engineer, certified quality engineer, and professional ergonomist. He earned a PhD in physiology/pharmacology & biopsychology from the University of Maryland, and his Sc.D in engineering management & I/O psychology from the George Washington University. He is a former associate professor of Biomedical Engineering and an interdisciplinary scientist for the US FDA. He is currently the CEO of a private consulting firm.