The Food and Drug Administration (FDA) has a federal mandate to keep the public safe from dangerous and defective products, including faulty medical devices. The FDA carries out this important work by “helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.”
While “speed[ing] innovations” seems like a good thing in today’s technology-driven world, as with anything else, it runs the risk of sacrificing thorough review. Some products may get by on the fast track, but the consequences of a faulty medical device can be catastrophic.
Issues with the FDA approval process: the “fast track”
Not all medical devices make it to market the same way. The FDA can place a product or device on a “fast-track” approval process called the Premarket Notification 510(k). Under this process,
“a premarketing submission [is] made to FDA to demonstrate that the [new] device to be marketed is safe and effective by proving substantial equivalence (SE) to a legally marketed device (predicate device) that is not subject to Premarket Approval (PMA). Submitters must compare their 510(k) device to a similar legally marketed U.S. device(s). A device recently cleared under 510(k) is usually used as a predicate device. However, any legally U.S. marketed device may be used as a predicate.”
For example, if a company manufactures a new type of pacemaker that is “substantially equivalent” to an older, predicate model, it can bypass much of the mandated testing and bring its device to market much sooner. Ideally, this process is designed to keep the FDA from getting bogged down in reviewing products with minor updates or slight modification.
While putting a medical device on the “fast track” for approval sounds desirable, the truth is that untested, unsafe products have made it to market faster, causing an increase in user injury. In some cases, the predicate models themselves were recalled, but manufacturers were still able to use them when creating their own models.
As a result, the FDA has announced plans to “make ‘transformative’ changes in the way more than 80 percent of medical devices are cleared for sale in the United States. Some 32 million Americans walk around with such products in their bodies,” per the Washington Post. However, as the Washington Post also reports, this proposed transformation may leave much to be desired. The problem involves two important “loopholes” that remain, enabling certain products to avoid human clinical trials before they make it to market.
According to the FDA, the most consequential change it’s considering for product approval process is recommending that companies be limited to using predicate devices that are no more than 10 years old. However, this is only a recommendation and not a mandate. As a result, medical device manufacturers would still have the option to use predicate devices that date back much farther.
The second loophole is the supplement pathway, which the Washington Post reports, “applies to new versions of the highest-risk devices, such as artificial hips, deep brain stimulators and spine implants. This process allows manufacturers to inform the FDA that they want to market an updated version of a device with minor changes — once again, allowing them to circumvent clinical trials.” The supplement pathway poses a particular risk for people with cardiac implants. According to Harvard researchers, “many of the pacemaker, ICD, and CRT models currently used by clinicians have come via the PMA supplement process. Most device models approved as PMA supplements are deemed safe and effective without requiring new clinical data, reinforcing the importance of postapproval surveillance of these devices.”
The patient suffers the consequences of an unsafe medical device
While there are certainly benefits to the FDA employing alternative methods of approval, the consequences of an unsafe product lie with the user. This is particularly personal when it comes to a product that will live inside a patient. Having a defective medical device implanted in one’s body can lead to life-changing – and even fatal – complications. In some cases, follow-up surgeries are required to address the damage caused by the device. In addition, the patient may require the implantation of a new, replacement medical device, additional medications, and repeated doctor visits.
If you have suffered any of these consequences, an experienced medical product liability attorney from our team can help you recover the compensation you need for your quantifiable financial losses as well as your pain and suffering.
At Harris Lowry Manton LLP, our team of experienced medical product liability attorneys take on the most complex defective medical device claims. If you or a loved one has suffered injuries or complications due to a faulty medical device implant or other product, we can fight hard to help you secure the monetary damages you are owed. To schedule a free case evaluation, complete our contact form or call us at 404.998.8847 in Atlanta or 912.417.3774 in Savannah.