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.

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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.

As readers of this blog well know, the scheme Congress enacted in 1976 and revised in 1990 requires the FDA to place devices in classes according to the amount of regulation needed to provide “reasonable assurance of safety and effectiveness.”   Those that need the least are in Class I.  Those that may additionally need only what are called “special controls” are placed in Class II.  And those whose risks are sufficiently great or unknown are placed in Class III and subjected to special scrutiny and regulation. See 21 U.S.C. § 360c(a)(1).  But the purpose in all cases is to provide that reasonable assurance.

Congress in 1976 instructed the FDA to create medical panels to classify devices.  The panel members, paid for their work, were to be persons who “possess skill in the use of, or experience in the development, manufacture, or utilization” of the devices. 21 U.S.C. § 360c(b)(2).  They were to be organized “according to the various fields of clinical medicine and fundamental science in which devices intended for human use are used.” 21 U.S.C. § 360c(c)(1).  Panels had to explain why Class III treatment was not necessary to provide reasonable assurance of safety and efficacy if they were evaluating devices to be implanted in the human body. 21 U.S.C. § 360c(c)(2).  Before the FDA adopted a recommendation, it was to publish the panel recommendations in the Federal Register and invite public comment.  Again, if the FDA decided not to place an implantable device in Class III, it was to provide “a full statement of the reasons.” 21 U.S.C. § 360c(d)(2)(B).

So it was with surgical mesh.

In 1978, the FDA assigned three classification panels the job of evaluating surgical mesh: General and Plastic Surgery, Orthopedic Device, and Gastroenterology and Urology.  They were to classify devices based on “[p]anel members’ personal knowledge of, and clinical experience with, the devices under review.” 47 Fed. Reg. 2810, 2812 (Jan. 19, 1982).  In their deliberations, they considered risks such as infection, foreign body reaction, and discomfort.  Id.

In 1982, the panels recommended that surgical mesh (21 CFR § 878.3300) be placed in Class II.  Their report said that surgical meshes have “an established history of safe and effective use.”  47 Fed. Reg. 2810, 2817 (Jan. 19, 1982).  It said they “meet a generally accepted satisfactory level of tissue compatibility.”  Id.  The panels cited medical literature to support their conclusions.  See id. at 2817-2818.

The FDA tentatively agreed with the classification “because of the extensive clinical usage of surgical mesh over a long period of time and because there is sufficient information available to establish a performance standard that would provide reasonable assurance of the safety and effectiveness of the device.”  Id. at 2817.  The FDA noted that surgical meshes had then been in use for 20 years.  See id.  It cited three studies on the use of polypropylene mesh, and noted that one of them:

reported on 53 patients for the repair of incisional hernias with polypropylene mesh. During 8 years (1970-1978), there was no operative mortality and the mesh had been uniformly well tolerated. The recurrence rate was found to be 11 percent, a distinct improvement over the era before the mesh was used.

Id. at 2817 (citing Gerald M. Larson and Harold W. Harrower, Plastic Mesh Repair of Incisional Hernias, 135 American Journal of Surgery 559 (April 1978)).  That study declared that complications from use of mesh were “rarely serious,” that mesh did not increase the frequency of wound infection,” and that polypropylene mesh “does not appear to degrade or lose strength in patients.”  Larson et al., 135 American Journal of Surgery at 562.  The FDA also cited an earlier one-year dog
study which found that found a “minimal foreign body reaction” to the mesh.  Francis C. Usher, Hernia Repair with Knitted Polypropylene Mesh, 117 Surgery Gynecology and Obstetrics 239 (1963).  See also B.T. Casebolt, Use of Fabric Mesh in Abdominal Wall Defects, 72 Missouri Medicine 71 (1975) (evaluating 35 cases over periods of up to nine years).  The FDA published the classification along with others and invited public comment.

In 1988, after reviewing the comments and holding public hearings, the FDA published the final classification of surgical mesh as Class II.  53 Fed. Reg. 23856 (June 24, 1988).  It rejected a claim that Class II devices were not safe and effective until a performance standard was adopted.  Id. at 23860.  It reiterated that the “biocompatibility of [surgical mesh and certain other devices] “has been established through their successful use for a number of years” and “the probable benefit to health from proper use of these devices outweighs an[y] likelihood of illness or injury resulting from their use.” Id. at 23861.   With respect to surgical mesh, it said Class II performance standards might be needed, however, because “long-term biocompatibility” was still an issue.  Id. at 23862.

So where the predicate is a post-1976 product classified as surgical mesh, 21 CFR § 878.3300, there has been, contrary to Lohr, a formal expert panel and FDA review of safety and effectiveness which led to classification of the predicate device. The determination by the FDA that the new product was equivalent in safety and effectiveness is thus an affirmative finding that the new device is, in fact, reasonably safe and effective.

Given the prominent role that classification plays in the statute and in the history, it is worth asking why its role has been overlooked in the debate over Lohr.  The closest any of the commentators on Lohr have come is to say that the FDA system “uses data” in the 510(k) notice to determine classification.

For one thing, some Class III products may still be cleared based on equivalence to pre-1976 devices.  Like the device at issue in Lohr, they have not been found safe enough to be placed in Class II and yet the FDA has still not required that they go through the approval process.

Another potential problem is that the FDA, when it adopted a regulation identifying devices that qualified for predicate status, did not follow the simple statutory language, which says any post-1976 device “which has been classified  in class I or II” can be a predicate.  21 U.S.C. 360c(f)(1(A)(i).  Instead it said devices which “have been reclassified from class III to class II or I” which is narrower and confusing.  21 CFR § 807.92(a)(3).  This is not a problem for surgical mesh, an implantable device, because Congress classified all implantable devices as Class III until a medical panel decided otherwise.  21 U.S.C. § § 513(c)(2)(C), (d)(2)(B).  But it suggests a narrower group than the statutory language would permit.

Whatever the reason, when any court confronts the Lohr dictum, it needs to ask the question “equivalent to what?”  If the answer is a device in a group that the FDA and its medical panels have classified as being safe and effective, then the dictum should be reversed, for in that circumstance “equivalence is safety.”

And there is a broader point. Where Congress has told the FDA how to provide “reasonable assurance” of safety and
effectiveness, and the FDA has done what Congress has instructed, it is not within the proper province of a court to disregard what the FDA has done simply because it disagrees with the methods Congress chose.  Lohr was a peculiar case in which the FDA had not yet done what Congress had told it to do with a Class III product.  But where the FDA has acted, its action should be respected.  That should be true even when it has classified a device as being so safe as to be entirely exempt from the 510(k) or any other premarket review process.