Having started my career in mass torts, one of the first things I learned about was the U.S. Food and Drug Administration (FDA) 510(k) clearance process regarding a medical device. It wasn’t until very recently (late November 2017 to be exact) that I realized how little the general public knows about this process. I was watching one of my favorite TV shows, “Chicago Med,” which focuses on the emergency department at a fictional hospital, Gaffney Chicago Medical Center, and its doctors and nurses, when the following scene took place (I am no screenwriter so I’ll do my best to set the stage):
Dr. Connor Rhodes, a cardio-thoracic surgeon, arrives to the hospital late due to some stress at home. He’s immediately presented with a former patient who is complaining of coughing and wheezing. Dr. Rhodes is perplexed as he had just replaced this patient’s aortic valve two weeks ago without complication. A colleague and trauma surgeon, Dr. Ava Bekker, instantaneously makes a presumption that Dr. Rhodes must have done something wrong, like misorient the valve, especially because of all the personal drama he is dealing with at home. But Dr. Rhodes assures her this is not possible as the surgery went off without a hitch.
As the patient continues to deteriorate, it becomes clear that the patient is suffering from a leak in his valve, which is causing fluid to back up into his lungs. Dr. Rhodes is instructed by his attending surgeon, Dr. Isidore Latham, to review his notes and learn from his error. Dr. Rhodes suggests a re-do, but Dr. Latham insists it is too risky to re-open the patient and that he can be managed with medications, although his quality of life will suffer.
Cut to a new scene in which Dr. Rhodes is seen agonizing over his notes trying to figure out what went wrong. He, again, insists on re-doing the surgery but is denied. Finally, Dr. Latham agrees to re-do the surgery because the patient has now made the request.
During surgery, Dr. Latham notes there is no cause of the leak—that the ventricles were opening freely and were oriented correctly. Dr. Rhodes is watching the surgery from the observation deck and has a revelation—it’s the valve itself that’s causing the issue—the leaflets are asymmetrical which would cause enough of an opening for the blood to leak. Further observation shows the valve’s leaflets are in fact not closing properly and the valve is bad. In observing the patient in the recovery room, Drs. Rhodes and Latham have the following exchange regarding the defective valve:
Dr. Latham: Seems the hospital changed valve manufacturers several weeks ago. This particular manufacturer didn’t bother to conduct any human testing.
Dr. Rhodes: They can do that?
Dr. Latham: All they have to do is prove that it performs the same function as a previous device.
Dr. Rhodes: Unbelievable.
Chicago Med season 3, episode 2, air date 11/28/17.
I couldn’t believe my ears. As someone intimately familiar with the 510(k) process, I knew exactly what Dr. Latham was referencing, and was surprised that the “Chicago Med” writers had painted Dr. Rhodes, their star cardio-thoracic surgeon, in such ignorance. Dr. Rhodes was absolutely correct, the 510(k) clearance process allows a medical device manufacturer to market and sell their device, so long as the FDA determines that the device is substantially equivalent to an already legally marketed device (referred to as the “predicate device”). The FDA notes on their website “a claim of substantial equivalence does not mean the new and predicate devices must be identical. Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics, as applicable.”
What does this all actually mean? Unfortunately, it means that a medical device manufacturer is not required to do any pre-market human testing on a device so long as they prove to the FDA that their device is substantially similar to another device already on the market. You read that right: no pre-market testing on a human is required if the device meets the definition of substantially similar (as described above) to another device already on the market. So that hip replacement your family member just had—it’s very possible the device that was implanted was never actually tested in a human by the manufacturer. And here’s the kicker: if the predicate device is voluntarily or involuntarily recalled for whatever reason, this has no effect on the substantially similar device. That device is not recalled and there is no requirement that its recipients be alerted that the predicate device has been recalled.
So at this point you may be asking yourself is there an alternative for medical device manufacturers for getting their products cleared by the FDA other than via 510k. The answer is yes and that clearance process is called pre-market approval (PMA). Pursuant to the FDA’s own website, “PMA is the most stringent type of device marketing application required by FDA … PMA approval is based on a determination by the FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s).” Thus, due to the cost and time required to perform the necessary testing for a PMA application, manufacturers obviously prefer to utilize the 510(k) process over the PMA process as much as possible.
Aside from the above differences in the 510(k) and PMA approval processes, there is another striking difference between the two: a medical device that has been approved by the FDA using the PMA process is, in certain instances, pre-empted (meaning exempt from common law claims that impose different requirements from the FDA’s requirements) and device manufacturers are often immune from personal injury actions involving those products. The same does not apply to devices approved through the 510(k) process, and so devices manufactured under the 510(k) process subject their manufacturers to litigation.
While I do have a reputation for getting too emotionally invested in television shows, I do realize “Chicago Med” is fictional. Even so, I can’t help but be disturbed that a cardio-thoracic surgeon like Dr. Rhodes was portrayed as being unfamiliar with the FDA medical device clearance process. While I have faith that real, licensed and practicing doctors are familiar with the FDA processes, I do think it’s important for the general public to be more aware so that individuals and their family members can make an informed decision when faced with surgery involving medical devices. Be sure to ask questions of the surgeon and you can even do your own research which is readily available on the FDA’s website.
Emily B. Ashe is an associate in Anapol Weiss’ mass tort department. She concentrates her practice on defective medical devices and pharmaceutical drug cases.