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Bexis has been updating the preemption chapter of his treatise on drug/device product liability litigation.  He came across several preemption decisions involving defendants who employed the FDA’s “alternative summary reporting” (“ASR”) system that the agency operated for about 20 years, “from 1997 through June 2019.”  FDA, “Medical Device Reporting (MDR): How to Report Medical Device Problems,” at MDR Data Files, Alternative Summary Reports (available here).  Bexis came across preemption cases mentioning ASR reporting with respect to surgical staplers, Bell v. Covidien LP, 2023 WL 3006175, at *2 (D. Mass. April 19, 2023), breast implants, e.g., Gravitt v. Mentor Worldwide, LLC, ___ F. Supp.3d ___, 2022 WL 17668486, at *3 (N.D. Ill. Dec. 14, 2022); D’Addario v. Johnson & Johnson, 2021 WL 1214896, at *3 (D.N.J. March 31, 2021), and contraceptive devices.  McLaughlin v. Bayer Essure Inc., 2019 WL 3764658, at *1 (E.D. Pa. May 9, 2019).  It appears that plaintiffs are attempting to turn various defendants’ use of this FDA-created and authorized program into a tort (variously described as warning defect or a variant of a misrepresentation claim).

The FDA’s ASR program began in 1997, when the agency:

determined that many adverse events involving the devices listed below can be reported to the Food and Drug Administration (FDA) on a quarterly basis using a summary reporting format in lieu of individual event reports . . . without adversely affecting FDA’s ability to monitor and react to such events.

FDA “Summary Reporting Approval For Adverse Events” (July 31, 1997) (copy available here).  “[U]pon notification of acceptance, manufacturers of the listed devices will be granted . . . an exemption from the individual event reporting requirements.”  Id.  The ASR program was initially open to regulated manufacturers of twelve device categories;  Intravascular (I.V.) Administration Set, Intravascular Catheter, Implanted Subcutaneous Intravascular Catheter, Mechanical/Hydraulic Incontinence Device, Urological Catheter, Endosseous Implant, Diagnostic Intravascular Catheter, Mechanical/Hydraulic Impotence Device, Mechanical Heart Valve, Silicone Gel-filled Internal Inflatable Breast Prosthesis, Saline Internal Inflatable Breast Prosthesis, and Permanent Pacemaker Electrode.  Id.

A 1999 FDA guidance document described the ASR program as “created under the authority of 21 CFR Part 803.19.”  FDA, CDER, “Guidance for Industry − Medical Device Reporting − Alternative Summary Reporting (ASR) Program, 2000 WL 34503093, at *1 (Oct. 19, 2000).  Medical device manufacturers could “request[ FDA] approval to participate in the ASR program.”  Id.

On October 1, 1999, we (FDA) instituted new methods for the collection of summary reporting data.  Adverse events included in summary reports should be submitted in a line-item format, reporting selected data elements by individual adverse event, rather than by the previous method of grouping adverse events by device identification number.

Id.  “By law, manufacturers may request exemptions, variances or alternatives to reporting requirements under 21 C.F.R. §803.19.  Under this provision, the FDA had allowed alternative summary reports (ASRs).”  FDA, MDR Data Files, Alternative Summary Reports (Feb. 18, 2022) (available here).

Product liability plaintiffs did not like the ASR program, mostly because it did not require individualized reporting of every adverse event and because the FDA did not intend to include summary reports in its publicly available databases.  “Alternative Summary Reports,” supra (“ASR reports were not made publicly available before 2019 because they were not submitted in a format compatible with the public . . . database”).  Eventually, in 2019, the FDA discontinued ASR reporting, citing “transparency.”  FDA, “Statement on agency’s efforts to increase transparency in medical device reporting (June 21, 2019) (available here).

We were particularly intrigued by a reference in Bell to an argument that “mere utilization” of the FDA-authorized ASR program could not be a tort because it was “expressly preempted.”  2023 WL 3006175, at *7.  Unfortunately, that argument was “not elaborate[d] further” and denied without being substantively addressed.  Id.  The product in Bell was a Class II §510(k) medical device.  Since the anachronistic decision in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), is still bars almost all preemption arguments in litigation over 510(k) devices, we’ve given some thought to what such an express preemption argument would look like.  Here’s our best guess.

It would have to comply with Lohr. We start back in 1999, when coincidentally the FDA was tinkering with the ASR program, as already discussed.  Bexis made a successful preemption argument in Greenwood v. Pennsylvania Hospital, 1999 WL 1133313, at *3 (Pa. C.P. Philadelphia Co. Jun. 9, 1999), appeal quashed, 750 A.2d 381 (Pa. Super. 1999).  This was after Lohr, but before the Supreme Court revisited medical device express preemption in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).

Greenwood held only one of the plaintiff’s theories preempted, a particular design defect allegation.  Supposedly, the product was “defectively designed by the Defendant because [it was] made of stainless steel, not titanium.”  1999 WL 1133313, at *2.  However, the FDA had promulgated an “identification” regulation for this device that stated it was “made of an alloy, such as stainless steel.”  21 C.F.R. §888.3050(a).  Construing Lohr’s gloss on the medical device express preemption clause requiring “specific counterpart regulations or other specific requirements applicable to a particular device” as a preemption prerequisite, 518 U.S. at 498 (quoting 21 C.F.R. §808.1(d)), Greenwood found that claim − the device’s stainless steel composition as a design defect – preempted because of the device-specific mention of “stainless steel” in the applicable regulation.

The FDA has determined that the [product] is a class II “spinal interlaminal fixation orthosis”, and that a device matching that description may be made of an alloy such as stainless steel.  See 21 C.F.R. §888.3050(a).  The FDA had cleared the [product] and determined that it fell within §888.3050(a) at the time the Plaintiff [had it implanted].  Therefore, under federal law the use of stainless steel in the manufacturing of [the product] is not a design defect.

Greenwood, 1999 WL 1133313, at *3.

Then Riegel came along and formulated the current two-part test for express preemption in medical device litigation:  that state laws are expressly preempted if, first, the Federal Government has established “specific requirements applicable to a particular device”; and, second, the plaintiff’s claims are based on “state requirements” that are “different from, or in addition to” the federal requirements.  552 U.S. at 321-23.  Class III pre-market approved devices automatically satisfy the first prong of this test, id. at 322-23, while under Lohr’s reasoning, the §510(k) route to market usually does not, because its “requirements reflect important but entirely generic concerns about device regulation generally.”  518 U.S. at 501

But there are exceptions.  Greenwood demonstrated one of them.  Justice Breyer’s concurrence in Lohr, without which there would not have been a majority opinion as to design or warning claims, discussed another:  “a federal MDA regulation requires a 2-inch wire” would “pre-empt a state-law tort action that premises liability upon the defendant manufacturer’s failure to use a 1-inch wire.”  518 U.S. at 504.  Given such possibilities, Justice Breyer was “not convinced that future incidents of MDA pre-emption of common-law claims will be ‘few’ or ‘rare.’”  Id. at 508 (citation omitted).  If a given FDA requirement is sufficiently device specific and granular, it should satisfy Lohr’s specificity gloss regardless of the device’s classification.

We think that the same can be said about a manufacturer’s obtaining FDA permission to participate in the agency’s alternative summary reporting program.  That program was device specific, being available only to a specified list of device types – the twelve categories listed in 1997 plus any subsequent additions.  Each company’s participation required a separate application to, and approval by the FDA.  As Lohr held, there must be “a careful comparison between the allegedly pre-empting federal requirement and the allegedly pre-empted state requirement.”  518 U.S. at 500.  Thus, when it comes to the details of how to report adverse events, and the FDA’s deliberate decision to institute the ASR program as an alternative reporting system, the FDA’s approval of a defendant’s participation should be preemptive on the question of how adverse event reporting is to occur.

But what if the manufacturer allegedly failed to make its reports in compliance with the FDA’s restrictions on what types of adverse events were subject to ASR reporting?  Those are the allegations that we see in cases like Bell, 2023 WL 3006175, at *6, and Gravitt, 2022 WL 17668486, at *3.  That type of claim – challenging the sufficiency and accuracy of information submitted to the FDA according to FDA regulations – falls within the core of implied preemption under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).

So, if a plaintiff contends that a defendant abused the ASR program, that is a Buckman-preempted fraud on the FDA claim.  Narrow allegations that particular types of adverse events failed to satisfy the requirements of the ASR program arise “solely by virtue of the FDCA disclosure requirements.”  531 U.S. at 353.  No “traditional” tort obligation is anywhere in sight.  Purported “tort” claims based on the minutiae of the ASR program’s requirements “would not be relying on traditional state tort law which had predated the federal enactments in questions.  On the contrary, the existence of these federal enactments is a critical element” – likely the only element − of such ASR-based claims.  Id. at 353.  Moreover, the practical impact of ASR-based claims would be precisely what Buckman rejected:

[ASR-based claims] would also cause applicants to fear that their disclosures to the FDA, although deemed appropriate by the Administration, will later be judged insufficient in state court.  Applicants would then have an incentive to submit a deluge of information that the Administration neither wants nor needs, resulting in additional burdens on the FDA’s evaluation of an application.

Id. at 351. Indeed, the FDA created the ASR program expressly to address an information overload problem of the sort Buckman described.  See 1997 “Summary Reporting” (program created to “reduce the burden on . . . FDA that results from preparation, receipt, processing and evaluation of individual event reports”).  That the FDA later changed its mind doesn’t change the fact that, between 1997 and 2019, manufacturers approved for joining that “alternative” program were doing precisely what the FDA wanted them to do.

In short, regardless of the classification of the device − PMA or §510(k), or something else − FDA approval of a manufacturer’s decision to opt into the FDA’s ASR program subjected that manufacturer’s product to device specific reporting requirements, as a consequence of an individualized FDA decision to approve the manufacturer’s application to join that program.  We believe that this could be the basis for express preemption of the sort briefly mentioned in Bell.  Conversely, violation claims involving the ASR program are paradigmatic examples of agency fraud/private FDCA enforcement that are impliedly preempted by Buckman.