It would seem to go without saying that for a defendant to be liable for the purported “common-law” claim of failure to report adverse events to the FDA, there must actually be some adverse events that needed to be reported.  One would think so, but certain California breast implant plaintiffs (yes, some still exist) would beg to differ – at least they did before the recent decision in Mize v. Mentor Worldwide LLC, No. BC649083, slip op. (Cal. Super. Oct. 1, 2018).

One problem that that current breast implant litigants face that their more numerous predecessors did not is preemption.  All that earlier litigation caused the FDA to upclassify breast implants to Class III, pre-market approved devices, and PMA means preemption.

In California, that also means the filing of half-baked, failure-to-report claims that no self-respecting plaintiff would otherwise bring, as a way to allege something that gets around preemption.  Trouble is, these breast implant plaintiffs can’t even allege that the defendant didn’t report any adverse incidents.  Even what plaintiff did allege was notably speculative:

Plaintiff now has alleged, however, that if [defendant] had reported additional adverse incidents subsequent to 2000, and if the FDA had made such incidents public, and if Plaintiff’s doctors had been aware of such reports, Plaintiff’s doctors might have provided an earlier diagnosis leading to earlier surgery to remove the implants and Plaintiff’s damages . . . might have been lessened.

Slip op. at 5. That’s a lot of “what ifs” piled on top of “what ifs,” but this plaintiff couldn’t even get to that.

There weren’t any unreported adverse events.

So the plaintiff tried to make them up.

The entire questionable “causal chain” wasn’t based on any known, but unreported, events at all, but rather on allegations about how studies were conducted:

[I]t is premised on [defendant’s] failure to report adverse incidents that were not detected because of how [defendant] conducted the studies rather than on a failure to report adverse incidents that actually occurred.

Id.  Even for a liberal jurisdiction, that was just too much.  There must be something that actually wasn’t reported.

Because Plaintiff has failed to allege facts showing that [defendant] failed to report actual adverse events that in fact occurred, the failure to warn (failure to report adverse events) claim is preempted because plaintiff has failed to allege how [defendant’s] actions in conducting these studies violated federal law.

Id.

While the Mize court “adopted the reasoning” of Ebrahimi v. Mentor Worldwide LLC, 2017 WL 4128976 (C.D. Cal. Sept. 15, 2017) – a case we discussed hereMize was really a step into fantasy beyond even Ebrahimi.  As pleaded, Ebrahimi at least involved allegations that (vaguely) alleged that events weren’t reported.  Mize didn’t.  She seems to have been alleging that the defendant was obligated to conduct studies in a way that maximized the number of reportable adverse events.  That “duty” is, of course, contrary to tort policy and medical ethics, both of which seek to reduce, not increase, product injuries.

The plaintiff in Mize also tried to allege a “manufacturing defect,” but that didn’t fare any better.  Lacking any direct evidence, plaintiff tried to rely on “allegations that supported . . . [a] 1998 Consent Decree.” Slip op. at 3.  But plaintiff’s implant wasn’t manufactured until at least two years after that decree, and the decree itself was “evidence of a promised change in practices,” so the decree could not be evidence of any defect in the device implanted in the plaintiff.  Id.  Again, simple logic seems beyond the plaintiff in Mize.

Finally, the Blog wishes to express its appreciation to Dustin Rawlin, of Tucker Ellis, and his team of, Peter Choate, Monee Hanna and Allison Burke, who not only won the case, but were thoughtful enough to send it along to us.  Keep up the good work.

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JAMES M. BECK is Counsel resident in the Philadelphia office of ReedSmith. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). He wrote the seminal law review article on off-label use cited by the Supreme Court in Buckman v. Plaintiffs Legal Committee. He has written more amicus briefs for the Product Liability Advisory Council than anyone else in the history of the organization, and in 2011 won PLAC’s highest honor, the John P. Raleigh award. He has been a member of the American Law Institute (ALI) since 2005. He is the long-time editor of the newsletter of the ABA’s Mass Torts Committee.  He is vice chair of the Class Actions and Multi-Plaintiff Litigation SLG of DRI’s Drug and Device Committee.  He can be reached at jmbeck@reedsmith.com.  His LiinkedIn page is here.