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We had to shake our heads at the recent 360 story entitled, “Allergan Breast Implant Risk MDL Heading to New Jersey” – the link is here for those of you with a subscription.

The idea of a “risk” MDL seems bizarre.  The story involves a particular type of cancer, and states that “four proposed class actions” are being coordinated.  If it’s one thing that our federal and state class action cheat sheets teach, it is that class actions are inappropriate for cases involving personal injury.  Hence, it appears that the description of a “risk” MDL is shorthand for class actions alleging a “risk” of that type of cancer in persons who have never (and probably will never) be diagnosed.

But according to the story, at least some of these would-be class representatives have actually “fallen victim” to the cancer.  That’s another blatant class action no-no – actually injured persons cannot represent classes of purportedly “at risk” persons with no present injury.  E.g., Amchem Products, Inc. v. Windsor, 521 U.S. 591, 624 (1997) (“exposure-only plaintiffs especially share little in common, either with each other or with the presently injured class members”) (citation and quotation marks omitted).  Further, if (as the 360 article states) the plaintiffs are demanding that the defendant “cover the costs of removing and replacing” the products, there are no state-law claims for medical monitoring either, because (putting aside the many other individualized issues) medical monitoring is just that:  an action solely for costs of “monitoring,” not prophylactic treatment.  This kind of claim was tried, and roundly rejected, in the cases involving Shiley heart valves we list in our compensatory injury cheat sheet.

But it gets worse.

This isn’t your mother’s breast implant litigation.

Breast implants are now Class III pre-market approved (“PMA”) medical devices.

That means express preemption under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  Even one of the worst post-Riegel preemption decisions recognized that 21 U.S.C. “Section 360k provides immunity for manufacturers of new Class III medical devices to the extent that they comply with federal law.”  Bausch v. Stryker Corp., 630 F.3d 546, 553 (7th Cir. 2010).  That’s a statement of the “parallel claim” exception to PMA preemption that courts have read into Riegel.

Back to the 360 article.  “The suits allege that [defendant] used a loophole in the U.S. Food and Drug Administration’s reporting requirements” and “it wasn’t until the agency tightened the requirements in 2017 that more adverse event reports came to light.”  Translation:  the complained-of reporting complied with the FDA’s requirements at the time, and when the FDA changed its requirements, the defendant changed its reporting to remain in compliance.  The complaints claim that, while “[m]anufacturers are supposed to report possible safety concerns about their products to the FDA through its public, searchable database” called “MAUDE,” the defendant instead “report[ed] them in so-called alternative summary reports, which are not required to be reported to MAUDE.”  Translation:  the defendant used an available, if “overlooked,” FDA reporting procedure to satisfy its legal obligation to report adverse events.  Or, as the FDA itself puts it on its website:

In 2017, the FDA began to sunset the ASR [alternative summary report] Program and requiring manufacturers with ASR exemptions to submit, in addition to the spreadsheet, a companion report that includes the total number of events being summarized.

We were also able to find the FDA’s – now withdrawn – guidance on alternative summary reports on its website, here.

Thus, it is readily apparent that the complaints don’t state any actual FDCA violation – only that the defendant, until 2017, had a choice as to how to report adverse events to the FDA, and chose the most streamlined route (allowing “submi[ssion] in a line-item format,” according to the then-applicable FDA guidance) available for meeting its FDA reporting obligations.  When the FDA “rolled out more rigorous reporting requirements in 2017,” the defendant also complied, which resulted in more public reports.

Thus, the plaintiffs in this “risk MDL” are claiming that, even though the FDCA did not obligate the defendant to use MAUDE reporting prior to 2017, some state common-law duty to use MAUDE existed and gave rise to tort liability.  What part of “different from or in addition to” (the preemptive language of §360k(a)) don’t these plaintiffs understand?  The claims described by 360 facially assert state-law reporting duties both “different from” FDA requirements (which at the time allowed “alternative summary reports”) and “in addition to” those same requirements.  What the 360 article reports isn’t even a “failure to report” claim – because at minimum that kind of claim asserts an actual violation of an FDCA reporting duty.  Again, this much is established even in cases we love to hate.  A failure-to-report claim:

alleges that, under federal law, [a defendant] had a “continuing duty to monitor the product after pre-market approval and to discover and report to the FDA any complaints about the product’s performance and any adverse health consequences of which it became aware and that are or may be attributable to the product.”  It further alleges that [defendant] failed to perform its duty under federal law to warn the FDA.

Stengel v. Medtronic Inc., 704 F.3d 1224, 1232 (9th Cir. 2013) (applying Arizona law) (emphasis added), overruled on state law grounds, Conklin v. Medtronic, Inc., 431 P.3d 571, 578-79 (Ariz. 2018).  Here, assuming the 360 article is accurate, no actual federal reporting violation is alleged.  At all times, the defendant’s reporting complied with what FDA regulations then allowed.  Sure, these plaintiffs don’t like what FDA regulations permitted – but that’s precisely why Congress imposes preemption in this type of case.

So our reaction to the “risk MDL” described in the 360 article is that:  (1) it can’t be a class action; (2) state law doesn’t provide the relief being requested; but in any event (3) the only common issue should be that the whole thing is preempted under Riegel.