The U.S. Food & Drug Administration's (FDA) top medical device regulator, Dr. Daniel Schultz, says that he is resigning. The announcement comes after years of allegations by FDA doctors, researchers and members of Congress that Schultz favored medical device manufacturers over consumer safety.

Resignation prompts ethical questions

Schultz's resignation, which is being labeled as a “mutual agreement” between the FDA's new commissioner, Dr. Margaret Hamburg and Schultz, has prompted many to wonder whether Schultz's conduct has always been ethical. He worked at the FDA's Center for Devices and Radiological Health for 15 years and led it for the past five years.

In particular, his conduct as the top regulator was investigated by Senator Charles Grassley (R., Iowa) when Schultz approved a nerve stimulation device used to treat depression and a knee-surgery device that FDA doctors, scientists and other reviewers said shouldn't have been approved.

In fact, several FDA employees wrote to Grassley and the House Energy and Commerce Committee last fall alleging that Schultz approved these products over their objections and insinuated that he may have been favoring the medical device industry over consumer safety. Although the FDA said that it would review those approvals, no further information has been released.

Too many medical device warnings and recalls?

There have been so many warnings and recalls in the past few years that consumers are likely questioning whether the FDA has been approving too many medical devices which may have needed further testing before being released into the marketplace. Some of these include devices manufactured by Medtronic, Welch Allyn and Cardinal Health. If you've been injured due to a defective medical device, it's important to understand that every case is unique and that you may be entitled to compensation for your injuries. Contact an experienced medical device recall attorney to discuss your situation and evaluate your options.