Product News and Recalls

FDA Faces Congressional Investigation Over Lack of Reaction to Heart Device Recall

congress investigating failures at FDAThe FDA’s ongoing failures to protect and represent the American people have finally caught the eyes of congressional legislators and the agency now finds itself on the hot seat over the way it handled – or failed to handle – the Medtronic HeartWare Ventricular Assist Device recall.

14 patients died and 13 cardiac pumps had to be removed from patients’ chests before the agency tasked with protecting the American public from dangerous products finally issued a recall for the device. Those numbers, however, quickly grew to be significantly higher.

As noted by Representative Raja Krishnamoorthi, the recall came “too late for many.” In fact, Rep. Krishnamoorthi stated in a letter to FDA Commissioner Robert Califf, MD that “more than 20,000 patient injuries and 3,000 deaths” were caused by the HVAD system on the FDA’s watch. “I am concerned by FDA’s slow action, over multiple administrations,” said Krishnamoorthi, “to protect patients from this product despite early warning signs.”

Not only did the FDA fail to respond to the HVAD issue in a timely manner, but it also failed to share information with other federal agencies that could have helped to save lives. Rep. Krishnamoorthi noted in his letter that the agency “must take a more proactive role in its regulation of devices that have been the subject of Warning Letters and Class I recalls, and in its communication of product defects to other agencies responsible for patient health.”

It is unfortunate that an agency with such a critical role in the lives of American citizens has grown to represent the embodiment of bureaucratic inaction and open corruption. Perhaps a congressional inquiry will move it to re-examine its priorities and take the action necessary to fulfill its duty to the people.