In light of the a new FDA rule that says that some Class III medical devices approved during the 1970’s must now prove their safety, here at HensonFuerst we believe that these and many other outdated yet approved devices are receiving not only an unjust loophole, but also an unsafe one under the Riegel v. Medtronic decision that determined that because of preemption, it is difficult to sue a medical device maker for a device that has been approved by the FDA. It is especially unsettling that the process by which these products have been approved has been grossly negligent for such a long time. Furthermore, FDA has no subpoena power—making manufacturers even unaccountable to the government.
Please navigate to the Fierce Pharma website for an article on Bart Stupak’s push for FDA to have subpoena power.
Also, click to read an article from ZDNet Healthcare which talks further about the FDA’s re-approval of devices that have been preempted by federal law considered free from litigation.