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Breast implant litigation seems like ancient history.  We are by no means young.  Just trust us on this one.  We remember when the Watergate hearings riveted America, when the space shuttle first flew, and when Milli Vanilli said they were better than the Beatles, but were later exposed as lip-syncing phonies.  But for some reason all those events seem like yesterday compared to In re Breast Implant, or whatever it was called.  Maybe it’s because attorneys we know and admire reminisce about their breast implant cases.

Or maybe it is because breast implant litigation, as retold by our colleagues, is a paradigm for all that is wrong with medical device, mass tort litigation.  Protracted court proceedings.  Expensive discovery.  Armies of lawyers.  Bankrupt manufacturers.  Medically useful products driven from the market (remember, not all breast implant patients were vain; many had genuine needs for prosthetic treatment).  And all of this occurred without any reliable scientific evidence linking the product to the alleged injuries.

What a difference a couple of decades make.  In Malonzo v. Mentor Worldwide, LLC, 2014 U.S. Dist. LEXIS 73353 (N.D. Cal. May 28, 2014), the plaintiff’s breast implant case did not make it past the pleadings.  She alleged that her saline breast implant leaked and caused a mycobacterial infection, but alas, these breast implants were Class III medical devices approved through the FDA’s rigorous premarket approval process.  Id. at *2, *5.

This brings express preemption into play, resulting in an eminently justified motion to dismiss. Id. at *3.  As the district court correctly observed, the Medical Device Amendments provide that “[N]o state . . . may establish or continue in effect with respect to a device intended for human use any requirement (1) which is different from, or in addition to, any requirement applicable under this chapter to the device; and (2) which relates to the safety of effectiveness of the device . . . .” Id. at *6 (quoting 28 U.S.C. § 360k(a)).  The PMA process clearly established federal “requirements” applicable to the breast implants at issue, so the issue was whether the plaintiff’s multiple state-law claims threatened state-law requirements that were “different from, or in addition to” the federal requirements and related to safety and efficacy.  Id. at **6-7.

The answer was yes, and the district court dismissed the complaint on the basis that federal law preempted all of the plaintiff’s state-law claims.  The court, however, did not stop there, resulting in both good news and bad news.  The bad news is that the plaintiff sought leave to amend “based on her contentions that the reporting requirements for Class III medical devices were not met,” and the district court indulged that request by granting leave.  Id. at **7-8.  This is a direct outgrowth of Stengel v. Medtronic Inc., 704 F.3d 1224, 1226 (9th Cir. 2013), the wrongly decided Ninth Circuit opinion with a cert petition pending before the U.S. Supreme Court. In Stengel, the plaintiff purported to allege state law failure-to-warn claims based on the purported failure to report adverse events to the FDA, which the Ninth Circuit held were neither different from nor in additional to federal regulations requiring adverse event reporting.  That is to say, they were “parallel” claims.  We don’t agree with Stengel, and we think that a so-called “parallel” claim is nothing more than a private party trying to enforce federal drug and medical device regulations, which the FDCA prohibits.  Nonetheless, thanks to Stengel, the plaintiff in Malonzo got her second chance.

The good news is that the district court understood what the plaintiff had to plead to state a claim and seemed to express some skepticism on whether the plaintiff could do it.  The district court, for example, saw that the plaintiff was trying to enforcement federal requirements directly, and admonished her to allege state law requirements.  Id. at *8.  The district court also noted the need to allege that the purported failure to report adverse events actually caused the plaintiff’s injury.  Id.  We like this remark:

Although she conjectures that Defendant failed to report similar injuries with other patients, she has no facts to support this assumption.  At this point, the only failure to report she argues about is with respect to the saline breast implants implanted in her.  Any failure to report her injuries or any defects with her implants could not have caused her injury.

Id. at *8.  We agree.  Conjecture and assumptions cannot carry the day, and unless the plaintiff has a time machine, a failure to report an injury (even if true) cannot have contributed to that same injury.  (But apparently, this plaintiff is not the only one who had this idea, see Heisnerv. Genzymze (N.D. Ill. Apr. 30, 2009)).

Finally, “to the extent [the plaintiff] seeks to bring any claim for misrepresentation or warranty must allege the content and location of such representation or warranty.” Id. at *9.

Some might see this as the district court providing a roadmap, but we prefer to view it as a throw down.  This case should not go forward, and our hope is that state-law tort claims arising from the use of PMA medical devices will go the way of the Dodo.  Ancient history.