510(k); Pathway for Safer drugs or Recipe for Disaster
Recent medical disasters such as the DePuy ASR, DePuy Pinnacle, and transvaginal mesh cases have revealed that medical devices were approved for use without adequate clinical data based on a grandfathering type provision in the FDA called a 510(k) process, where a new device that is cleared as “substantially equivalent” as a previously approved device is allowed to bypass rigorous clinical data requirements otherwise required for approval. Recently serious questions been raised within the medical profession regarding this process.
How did this happen?
In 1976 the Medical Device Amendments created three classes of devices; Class I and II devices were already on the market, (e.g. toothbrushes, infusion pumps). Class III devices required pre market approval (PMA) which require clinical data. According to an article in the New England Journal of Medicine in January 2013,”class III devices were allowed to receive review for substantial equivalence temporarily, until the FDA down-classified these devices or promulgated regulations requiring PMA. Congress had always intended class III devices to undergo PMA, and in 1990, it directed the agency to establish a schedule to finish the transition to PMAs for all devices that were to remain in class III. As of December 19, 2012, however, the FDA still had not completed this transition to PMA for high-risk devices, although it had stated its intention to clear proposed rules for all remaining class III pre-amendment devices by December 31, 2012″
As a result of this loophole manufactures submitted devices claiming they were “substantially equivalent” to earlier “predicate devices” and were able bypass the clinical data requirements demonstrating safety and effectiveness. However, if the FDA finds the new device “substantially equivalent,” that does not mean it is also finding it is safe and effective based on any preapproval clinical trial or studies. The underlying assumption is that if the device is “substantially equivalent”, then so also must be its performance. This however has not always been the case. DePuy ASR was approved a substantially equivalent to an earlier predicate device, yet it has been a disaster resulting in 10,000 lawsuits, and 93,000 people requiring earlier intervention and revision and facing toxic poisoning from the metal ions. Similarly, defective vaginal mesh products such as Ethicon’s Gynecare, Bard’s Avulta, Boston Scientific’s Advantage, American Medical System’s Monarch, and Coloplast’s Aris, as well as many other vaginal mesh products resulted in over 12,000 lawsuits and countless women with pelvic prolapse and Stress urinary incontinence (SUI) in severe pain from eroding mesh.
In the fall of 2011 a FDA panel recommended the transvaginal mesh products be reclassified as Class III devices. At that time Colin Pollard, director of the FDA’s obstetrics and gynecology devices branch, said at the time. “We think the current 510(k) paradigm doesn’t work for these products because we don’t think we know enough about the safety and effectiveness.” On January 5, 2012 the FDA ordered mesh manufacturers to study the rates of organ damage and other complications. For more information, an article on the FDA order can be found here.
On January 21, 2011 the FDA Committee of devices forwarded seven recommendation to the Institute of Medicine of the National Academies of for review. More than 1,900 members volunteer their time, knowledge, and expertise to help the IOM in its mission to advance the nation’s health.
Dr. David Challoner, the Chair of Committee on the Public-Health Effectiveness and a committee member since 1981, responded that, after evaluating the proposals as they affected the 510(k) process,
“The IOM committee’s report concludes that the 510(k) process generally is not intended to evaluate the safety and effectiveness of medical devices and, furthermore, cannot be transformed into a premarket evaluation of safety and effectiveness.”
To view a copy of his entire response, click here: Dr. Challoner’s Letter
Dr Challoner is Vice President Emertus of Health affairs at the University of Florida. From 1988-1900, he was appointed by President Reagan to Chair the President’s Committee on the National Medal of Science. He served on the Advisory Committee to the Director of the National Institutes of Health, and the National Academies’ umbrella Committee on Science, Engineering and Public Policy (COSEPUP).
To see a recent presentation by Dr. Challoner on 510(k) and metal on metal hips, click here: Dr. Challoner Video
The New England Journal authors closely examined the history of the De Puy ASR XL acetabular component, which was approved by the FDA in 2008 without a clinical study, tracing it back five decades through 95 devices, including 15 different femoral heads and sleeves and 52 different acetabular components. According to the authors, “Clearance of the large metal-on-metal articulation was based on a much smaller group of predicates, some of which differed substantially in design from the ASR XL or had poor clinical performance. Ultimately, clearance was based on the claim that these predicate devices were substantially equivalent to three prostheses that were used before 1976: the McKee–Farrar, Ring, and Sivash metal-on-metal total hip prostheses. It is important to note that these three devices were discontinued long ago (and well before clearance of the ASR XL) because their risk of revision was so much higher than that of other hip prostheses.”
Most consumers would never know the metal on metal device implanted in their hip or their vaginal mesh was not tested or subject to rigorous clinical evaluation. Moreover, they would never suspect the process of approval of devices, cannot be “transformed into a pre market evaluation of safety and effectiveness”
At the Brandi Law Firm, we help people throughout the country who have been harmed because of a defective drug or medical device such as Actos, Fosamax, DePuy, and Vaginal Mesh. Instead of treating all victims of defective drugs and medical devices the same we take a different, more personalized approach with a team of experienced defective drug attorneys and paralegals working for every client. Our goal is to provide you with information about your legal options and to help you pursue compensation and holding these drug companies responsible for their dangerous actions. Please contact the Brandi Law Firm today (1-800-481-1615 or email us) to talk with the experienced San Francisco defective drug attorneys.