In an earlier post, we discussed how the FDA, for over twenty years, from mid-1997 through mid-2019, created and operated an “alternative summary reporting (“ASR”) system for many (but not all) medical device-related adverse events.  In June 2019 the FDA “formally ended” the ASR program, “revoked all . . . exemptions,” and opened “all” ASR reporting data to the public through “legacy files.”

One quirk of ASR reports is that they could not be included on the FDA’s public “MAUDE” (Manufacturer and User Facility Device Experience) database of medical device adverse events, because the FDA required an incompatible format for ASR submissions.  Predictably, plaintiffs in any litigation where the defendant’s participation in the FDA ASR program was relevant started screaming about “coverups” despite the FDA itself receiving all the adverse report data that it wanted, in a form that made it easier for the Agency to use.  Plaintiffs doubled down on already suspect “failure to report” claims.  They’ve been claiming that, under state tort law, device manufacturers had a “duty” not only to comply with FDA reporting requirements, but to do so in the most public manner possible, even when the FDA preferred streamlined ASR reporting.

But that’s all plaintiff-side blather.  When push comes to shove, these claims have not resulted in anything worthy of jury consideration.  See Hunt v. Covidien LP, 2024 WL 2724144, at *6-77 (D. Mass. May 28, 2024) (expert testimony on defendant’s ASR excluded as “unhelpful”); Gravitt v. Mentor Worldwide, LLC, 646 F. Supp3d 962, 966-70 (N.D. Ill. 2022) (preemption and lack of causation); In re Allergan PLC Securities Litigation, 2019 WL 4686445, at *25 (S.D.N.Y. Sept. 20, 2019) (“FDA encouraged manufacturers to file ASRs in order to reduce redundant paperwork and allow the FDA to more efficiently review adverse events”) (citation and quotation marks omitted).

To these cases, we can now add Corrigan v. Covidien LP, ___ F. Supp.3d ___, 2024 WL 4190064 (D. Mass. Sept. 13, 2024), which throws plenty of shade at those plaintiffs’ questionable, and ultimately non-causal, ASR-based duty to report claims under Massachusetts law.  Corrigan first dealt with what it called plaintiffs’ “traditional” (that is, not FDA-based) inadequate warning claim.  Summary judgment was appropriate because the implanting surgeon was a doctor, not a regulator.  The surgeon knew what he was doing and didn’t spend his time chasing down adverse event reports – on MAUDE or anywhere else.  That surgeon:

• “never reviewed the product warnings or instructions prior to the surgery”;
• “was already aware of the risks [his patient allegedly suffered] and warned [him]” about them;
• “knew that a [device] malfunction could cause” such risks;
• “never reviewed any [of defendant’s] marketing materials”;
• “never looked up adverse event reports either generally or on the FDA MAUDE or ASR Program website”; and
• testified that “the risks [at issue] were well known within the medical community.”

2024 WL 4190064, at *6.  That’s the kind of testimony that makes a plaintiff say, “ouch.”  And it makes courts say, “motion granted.”  Thus, “[b]ased on [the surgeon’s] testimony, there is no genuine issue of material fact as to this requisite element of Plaintiffs’ failure to warn claim.”  Id.  Any heeding presumption (Massachusetts misguidedly allows one) was resoundingly rebutted:

[T]he record is that [the surgeon] did not read, or . . . rel[y] upon adverse events reports, which he did not research beforehand, to influence his decision to use the [defendant’s device].  The Court concludes that [defendant] has rebutted the presumption that [the surgeon] would have heeded any warning and that Plaintiffs have not shown a triable issue of material fact as to causation, specifically as to [defendant’s] instructions or by submitting adverse event reports through the ASR program.

Id. (citations omitted).  The same abject failure to establish causation likewise required summary judgment against plaintiffs’ negligent misrepresentation and consumer protection claims.  Id. at *7-8.

As for plaintiffs’ “novel” reporting-based warning theory – first, compliance with the FDA’s ASR program was not “deceptive as a matter of law.”  “[A]lthough Plaintiffs allege that [defendant] undermined the level of risk posed . . . by choosing to report adverse events to the ASR Program instead of MAUDE, Plaintiffs do not persuasively explain how same rises to deceptive conduct.”  Id. at 5.  The medical article plaintiffs cited as understating the risk was just that – medical, not regulatory.  That article “does not cite to or state that it relies on any FDA ASR or MAUDE reporting data for its incidence.”  Id.  Nor did Massachusetts law (which both parties considered applicable) recognize any FDA-based duty to report, even to MAUDE:

According to Plaintiffs, [defendant] purposely kept information from the public, and significantly medical providers, by reporting to the ASR Program which was not publicly available until 2019.  To succeed on this claim, Plaintiffs would need to prove that [defendant] had a duty to report this information publicly.  Plaintiffs, here, have pointed to no such duty.  Other sessions of this Court have recognized that there is no Massachusetts law that imposes such a duty.

Id. at *7 (citations to two of the favorable cases we have collected in the Massachusetts section of our 50-state survey omitted).

Having found that no state-law duty to report existed, Corrigan did not reach the defendant’s implied preemption argument.  Id. at *7 n.7.  That’s not surprising, since courts properly avoid constitutional issues when cases can be decided on non-constitutional grounds, but unfortunate nonetheless – because, as everyone knows, the Blog loves federal preemption in prescription medical product liability litigation context.

In our prior post on ASR reporting, we offered both express and implied preemption arguments against what we guess should be called “failure to report publicly” claims.  Realistically, as long as Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), remains on the books, the implied preemption argument is stronger, since the FDA’s stated reason for instituting the ASR program in the first place – to “reduce the burden on . . . FDA that results from preparation, receipt, processing and evaluation of individual event reports” – is squarely in the Buckman wheelhouse.  Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 351 (2001) (preemption prevents “a deluge of information that the Administration neither wants nor needs”).  That is in addition to the usual preemption problems with failure to report claims generally:  that they are solely based on FDCA requirements that only the government can enforce (21 U.S.C. §337(a)) and amount to fraud on the FDA claims because they attack the completeness of materials addressed to the FDA rather than the general public.

Plaintiffs have been attracted to the ASR tempest in a teapot because it lets them scream about large numbers of adverse events being “concealed” from the public, even though the events were all reported to the FDA in the precisely the format that the FDA wanted at the time, and have been in the public domain since 2019.  Corrigan demonstrates that, as a practical matter, such claims are simply bogus.  The doctors that prescribe and use medical devices don’t go rooting through adverse event reports (either in MAUDE or in the legacy ASR Data Files that the FDA released).  Nor do most medical journal articles, as also was the case in Corrigan.  Statistical analysis of adverse event reports is fraught with problems:

[T]his passive surveillance system has limitations.  The incidence, prevalence, or cause of an event cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use.

FDA, “Medical Device Reporting (MDR)” at “Overview of Medical Device Reporting.”  Thus, use of such reports to determine “incidence, prevalence, or cause” is primarily undertaken by bottom-feeding plaintiffs’ experts doing precisely what the FDA says shouldn’t be done.  Such reports are not reviewed by doctors, such as the surgeon in Corrigan, actually providing therapeutic medical care to real patients.