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Desperate to get around preemption, in PM medical device and generic drug cases, plaintiffs have been pushing disguised fraud on the FDA claims under the rubric of “negligent failure to report.”  Even though such claims facially challenge the adequacy of information that a regulated party submits to the FDA (a Buckman no-no), some courts have cut plaintiffs a break where just about every other claim they might make would be preempted.  E.g., Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013); Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011); Stoddard
v. PLIVA USA, Inc.
, 2014 WL 4416085 (E.D.N.C. Sept. 8, 2014).

Even putting preemption aside, failure to report claims are lousy cases.  Causation, in particular, is a problem, as a concurring opinion in Stengel pointed out:

 Because they predicate their claim on [defendant’s] reporting duty to the FDA, as they must to avoid express preemption, [plaintiffs] face a causation hurdle that would not otherwise exist.  To prevail, they will ultimately have to prove that if [defendant] had properly reported the adverse events to the FDA as required under federal law, that information would have reached [plaintiff’s] doctors in time to prevent his injuries.

704 F.3d at 1234.
Nor can plaintiffs alleging failure to report assert that the FDA would have acted differently, since that was what Buckman preemption was all about – common law claims predicated on the FDA itself doing something different inherently conflict with what the FDA actually did.  Causation in such a claim must focus, as Stengel observed, on a prescriber’s receipt of additional information.

As we’ve discussed at length – even with a cheat sheet on the subject – the FDA’s voluntary reporting databases have lots of problems, so much so that the FDA itself warns against using them to evaluate cause and effect.  One of these problems is that, for products unfortunate enough to become mass tort targets, lawyer-generated reporting (anybody can file a report) swamps legitimate adverse event reports filed by manufacturers or health care providers.

[T]he distortion in pharmacovigilance signals as a
result of excess reporting by attorneys is a cause for concern in a pharmacovigilance database with known underreporting of adverse events across all drugs.  This may result in an overestimation of the strength of association.

Stobaugh, et al., “Alleged Isotretinoin-Associated Inflammatory Bowel Disease:  Disproportionate Reporting by Attorneys to the Food and Drug Administration Adverse Event Reporting System,” 69 J. Am. Acad. Dermatology, 393, 397 (Sept. 2013).

Because of these problems, the FDA’s voluntary reporting system is in the process of being replaced by the “Sentinel” system, which allows the FDA to analyze “big data” – electronic patient records maintained by many of the largest health insurers in the country.  Together, Sentinel participants insure, and thus give the FDA access to records for, over 170 million people.  Here’s a description of Sentinel from a recent article:

The Sentinel network consists primarily of eighteen organizations that include some of the nation’s largest health insurers . . . and various disease registries.  In addition, other institutions have collaborated in establishing the network, and the FDA says that it has access to selected data from eighty-eight hospitals and other inpatient facilities.


Overall, the FDA and [the entity managing Sentinel] say that they have access to prescription medication data on approximately 178 million people, with the routine accrual of medication data on 48 million currently enrolled or treated at the eighteen core partner organizations.  Sentinel, they say, has 358 million person-years of data that include 4.0 billion prescriptions, 4.1 billion doctor or lab visits and hospital stays, and 42.0 million acute inpatient stays.

Health Policy Brief, “The FDA’s Sentinel Initiative,” at 3 (Wood Fdn. Jun. 4, 2015).  While the other side may have figured out how to game the FDA’s voluntary reporting systems to create phony “signals,” we don’t think they can easily game – or even access – Sentinel.

What that means for failure to report claims is that the FDA no longer relies chiefly on reporting systems (voluntary or mandatory) for seeking out pharmacovigilence “signals,” and probably won’t be relying on such reporting at all in the future. There goes causation out the window, since the reports in question will no longer (to the extent they ever were) be of much significance.

The widespread transition to electronic medical records has enabled a new era of FDA “big data” analysis of medical events that isn’t hamstrung by underreporting, biased reporting, or even purported “failure” to report.  With AERS, MAUDE and other FDA reporting systems in the process of being superseded by 21st Century technology, it will become impossible, if it isn’t already, for plaintiffs to establish that any defendant’s alleged “failure to report” adverse events had any impact at all on information relied upon by prescribing physicians.