Medical Device Approval Process
A recently published study in The Journal of the American Medical Association (JAMA) highlights the potential public health dangers posed by medical devices that undergo limited testing to determine their safety and effectiveness. In 2010 and 2011 there were 28 medical devices that received Premarket Approval (PMA). PMA is considered the Food and Drug Administration’s (FDA) most rigorous approval process for medical devices before they are allowed to be sold on the market. These devices require PMA because they are considered high risk and are not substantially similar to other medical devices already on the market. Once approved, these devices are generally considered Class III medical devices, and it is very difficult for individuals injured by Class III medical devices to bring suit against the manufacturer. This is because courts, including the United States Supreme Court in Riegel v. Medtronic, have held that individual claims are largely preempted by federal law. Our firm has been unable to represent many clients who have been injury by Class III medical devices because potential claims are considered preempted.
The recent JAMA study brings into question how rigorous the PMA process really is. Of the 28 medical devices that received PMA by the Food and Drug Administration (FDA) in 2010 and 2011, most averaged two premarket clinical studies. Only one of those two studies generally focused on the long-term safety and efficacy of the medical device in question (pivotal studies). Equally disturbing is that as a condition for PMA, the FDA required that these 28 medical devices undergo a total of 33 post market studies. The JAMA study found that only 6 of these 33 post market studies had been completed. The rigorous PMA process does not appear to be nearly as rigorous as advertised. This study brings into question the preemption arguments made for Class III medical devices that undergo PMA.
As we have previously blogged, approximately 99% of medical devices that are on the market do not even undergo PMA. The other 99% of medical devices are cleared through the 510K process that require zero premarket clinical studies. All medical devices that Perdue & Kidd is currently litigating underwent the 510K clearance process, including transvaginal mesh, metal on metal hip implants, and Zimmer knee implants.
If you or a loved one has suffered a medical device failure please contact the medical device litigation attorneys at Perdue & Kidd for a free consultation.