A case study in unethical conduct of a medical device manufacturer
This conduct my have been legal. It should not be. We will suggest regulatory changes that will prevent a recurrence.
Learning Areas:Ethics, professional and legal requirements
Public health or related laws, regulations, standards, or guidelines
Describe the company's response to known failures of medical device Identify where executives postponed meaningful action despite knowledge of device malfunction Evaluate the motives behind withholding failure rates and postponing recall Discuss the responsibility of the company to provide properly functioning product to customers Evaluate FDA Medical Device approval process and it's recent changes
Keyword(s): Ethics, Medical Devices
Qualified on the content I am responsible for because: I have published several pioneering papers on corruption of science by corporations in pharmaceutical and medical device production. i teach on this subject matter at Brown University Medical School.
I have testified before several FDA drug review panels. I released Zyprexa documents which indicated that Lilly was marketing this drug to a target population who would experienced a 3 fold increase in mortality. I served as a consultant to the US Attorney in that case.
Any relevant financial relationships? No
I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.