141st APHA Annual Meeting and Exposition

In This section

287251
A case study in unethical conduct of a medical device manufacturer

Tuesday, November 5, 2013 : 2:50 PM - 3:10 PM

David Egilman, MD, MPH , Department of Family Medicine, Brown University, Attleboro, MA
Daniel Smith , Human Biology, Brown University, Providence, RI
J&J manufactured, designed and developed a prosthetic hip implant (DePuy) intended for use in hip replacement surgeries. The device was cleared through the FDA in and went to the market in 2004. Signs of malfunction were apparent as early as 2005 and discussions of redesign began behind closed doors at the manufacturers. In 2010 the product was recalled for a higher than average failure rate. During this time company executives and consultants were aware of the malfunctioning device yet took no meaningful action to effectively redesign the product, warn doctors or consumers or remove it from the market before undue damage had been done to hip replacement patients. In that time period between 2004 and 2010 a suspected 93,000 J&J hip implants were utilized in replacement surgeries and since, in the United States alone, there have been over 10,000 lawsuits against the manufacturer for the failure of their medical device. This medical device manufacturer advertised and marketed a product that they knew to be unsafe for use which demonstrates highly unethical business practices.

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

Learning Objectives:
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

Keywords: Ethics, Medical Devices

Presenting author's disclosure statement:

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.