File this under Catch 22. A study released this week found that only a fraction of the devices recalled by the FDA had been approved under the more stringent pre-market approval, or PMA process, which requires clinical tests and inspections. The PMA is usually reserved for higher risk devices, as opposed to the less stringent 510K standard for other devices.
The findings were bleak: Of 113 devices recalled between 2005 and 2009, only 21 had been approved through PMA, while 80 were cleared by the 510K process (the remaining eight were exempt from FDA review). The upshot: most devices that were recalled for life-threatening or very serious problems were originally cleared by the lower standard, suggesting a "reform" of the review process is needed.
However, the findings, which were published in the Archives of Internal Medicine (see here), bring to mind an interesting 2008 ruling by the US Supreme Court, which decided that patients can't file lawsuits against device makers when their products were approved by the FDA using the PMA process.
The court reviewed a lawsuit that pitted Medtronic against a woman whose deceased husband suffered a disabling injury when a balloon catheter burst during angioplasty. Medtronic argued that the Food, Drug, and Cosmetic Act expressly preempts, or supercedes, state law claims brought by patients who were hurt by devices that received premarket FDA approval.
The ruling gave device makers a defense in product-liability lawsuits (here is the ruling and the back story). [You may recall, however, the Supreme Court also ruled that FDA approval does not preempt state lawsuits for drugs (some background here)].
And so this suggests something of a conundrum for patients. If harm is alleged by a device that was endorsed under the more rigorous PMA process, the patient can not file a lawsuit under state law - and state courts are, generally, believed to be more sympathetic venues for product-liability litigation. Yet if a device was not reviewed under PMA, a patient can file a state lawsuit. In other words, if more devices are eventually reviewed under the PMA process, patients who allegedly suffer harm may have less recourse.
photo thx to walknboston on flickr