In an embarrassment of riches, we have two guest posts in one day. This one is by Luther Munford and Erin Lane of Butler Snow. They wish to point out that they represent Ethicon in surgical mesh litigation, which is the context that their post concerns. We have mesh involvements of our own, so our normal disclaimer goes double for this one: The views expressed by our guest bloggers are their own. They get all the credit, and any blame, for what appears in this post, the subject matter of which is the admissibility of FDA 510k clearance in mesh litigation. That’s related to a post we did a couple of years ago on this same general topic.
Without further ado, we give you Luther and Erin.
Congress said in the Medical Device Act of 1976 that the purpose was to provide “reasonable assurance” that devices were safe and effective. 21 U.S.C. §360c(a)(1). Yet, here we are in 2014 and a skillfully-written plaintiff’s brief says, with a straight face, that the administration of the Act allows devices on the market “without any safety review.” Opening Brief of Appellees/Cross Appellants Donna Cisson and Dan Cisson, United States Court of Appeals for the Fourth Circuit No. 15-1102(L), June 1, 2015, p.33.
How could this be?
It is a slight-of hand worthy of a shell game, but it is a game to which many observers have fallen victim, even those who have looked very carefully.
The shell under which the bean appears to be hidden is, of course, Medtronic v. Lohr, 518 U.S. 470, 493 (1996). In that 1996 decision, the Supreme Court in dictum declared that the “focus” of most of the FDA’s medical device regulation process was “not safety.” The Court said this because Congress had allowed the FDA to clear for sale new devices “equivalent” to others that had “never been formally reviewed … for safety or efficacy” because they were sold before the medical device law went into effect in 1976. In other words, Congress had grandfathered them.
Even those critical of Lohr have assumed that it is where the bean lies. They have just argued that the shell has morphed into something different. They have assumed that grandfathering remains important and have just contended that statutory amendments have strengthened the requirements for clearance. See Ralph F. Hall and Michelle Mercer, Rethinking Lohr: does “SE” Mean Safe and Effective, Substantially Equivalent, or Both?, 13 Minn. J.L. Sci. & Tech. 737 (2012); James M. Flaherty Jr., Defending Substantial Equivalence: An Argument for the Continuing Validity of the 510(k) Premarket Notification Process, 63 Food & Drug L.J. 901, 907-916 (2008) (survey of statutory and regulatory changes). See also FDA, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]/Guidance for Industry and Food and Drug Administration Staff (2014) at p. 6 (“principles of safety and effectiveness underlie the substantial equivalence determination in every 510(k) review”).
But in fact, for most of the medical devices that enter the market today, grandfathering is irrelevant. It is irrelevant because the 1976 Act established an alternative to grandfathering, i.e. clearance based on post-1976 predicate devices classified after what can be called a very “formal review” of their risks and benefits. To stretch the metaphor beyond the breaking point, the shell under which the bean truly lies today is not grandfathering, but classification.
In the Act, Congress instructed the FDA to convene medical panels to classify devices. And where after 1976 the FDA classified a device or group of devices as presenting a low or moderate risk, the statute authorized clearance based on
equivalence to the classified device. As stated in 21 U.S.C.§ 360c(f)(1)(A), clearance can be based on a predicate device marketed after 1976 which “has been classified in class I or II.”
So where a device group has been classified, the answer to the question, “equivalent to what?” is quite different from the answer given by Lohr, which dealt with a Class III device for which this alternative was not available. It is not “equivalent to
my grandfather” as was the case in Lohr. It is “equivalent to a device classified by the FDA as being reasonably safe and effective” after 1976.
In order to look at how the classification process has worked, it is helpful to examine the governing law as it has been
applied to the product group at issue in Cisson, surgical mesh.
Continue Reading Guest Post – Classification: When “Equivalence” Means “Safety”