Product liability litigation over Class III medical devices is an interesting creature.  Absent something unusual, cases and litigations should not get past motions to dismiss.  That is pretty clearly what Congress intended when an express preemption provision was added to the Medical Device Amendments of 1976.  We understand that each plaintiff may think her case is exceptional in that it should meet the exception to the rule of preemption.  (We do not really think the plaintiff lawyers think that, although they sure argue it enough.)  But the usual is more common than the unusual by definition.  When you hear hoof beats, you should look for a horse not a zebra, unless you happen to be in a part of the world where zebras are endemic or end up in a zebra enclosure in a zoo.  When you hear Class III medical device product liability case, you should look for all claims to be dismissed unless there is something as unusual as a basis to claiming the plaintiff’s particular device deviated from its FDA-approved specifications.

In 2001, the Supreme Court made getting past motions to dismiss harder when it held in Buckman that plaintiffs could not recover claims predicated on violations of FDA regulations.  An unfortunate fiction developed post-Buckman—particularly after Riegel v. Medtronic, Inc. 552 U.S. 312 (2008)—that plaintiffs could assert “parallel claims” that were neither expressly preempted by the provisions of the MDA nor impliedly preempted under Buckman.  We, and others, have described the purported path of a parallel claim as being like navigating between Scylla and Charybdis, a monster and whirlpool on opposite sides of a narrow strait per ancient Greek mythology.  Without claiming that mythology is the same as fiction—we are not touching that with a twenty foot sarissa—we can say that a true parallel claim is as rare as a striped unicorn or perhaps a flying horse.  The unfortunate fiction of which we spoke above has taken shape with particularly egregious appellate decisions like Bausch such that some trial courts are advised, when they hear the hoof beat of a Class III medical device product liability case, to expect Pegasus or his stripy, horned pal to gallop around the corner.

Viewed over the course of more than five years and many decisions, three of which have featured in prior posts (here, here, and here, which drew honorable mention honors in 2018), we think Bausch delayed the inevitable in Gravitt v. Mentor Worldwide, LLC, __ F.Supp.3d __, 2022 WL 17668486 (N.D. Ill. Dec. 14, 2022), by insisting that parallel claims for failure to report adverse events to FDA exist.  After an unnecessary odyssey, the manufacturer of a Class III breast implant won summary judgment on the last of plaintiffs’ claims, alleged failure to report adverse events to FDA.  (We say “plaintiffs,” but the decision referred to the plaintiff with the implant—who we will call the “plaintiff”—by her first name and the consortium plaintiff by his first name.  In terms of whether the last claim was supported, the court referred the female plaintiff only and somehow omitted any reference to “burden.”  These are usually signs that at least one claim will survive summary judgment.)  A shout out to Dustin Rawlin and his colleagues for sticking it out on this case and sending us this decision.

The core facts of the case were simple, but the shifting allegations on reporting were not.  The implant was approved via PMA in November 2006; plaintiff had her bilateral implant surgery in December 2009, at which time the physician labeling described the risk of rupture and gel bleed, along with the existence of literature describing a possible link to connective tissue disease and a range of neurological and other symptoms; plaintiff was specifically warned of rupture before electing to have the implant procedure; after some uncertain period of describing a diverse array of new or worsening symptoms, plaintiff had a rupture of one implant diagnosed and both implants removed in October 2016.  She sued in 2017 with a bunch of the typical claims for medical device cases.

Our prior posts linked above detail some of the history of the case.  The overview is that Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), required the Gravitt court to let one claim survive the motion to dismiss, based on the idea that the purported claim for failure to report to FDA “implicates the state law duty of a manufacturer to inform regulators and the public when it has a reason to know that a product is riskier than initially believed.”  2022 WL 17668486, *2.  Given the amount of ink we have spilled on this (like this survey with a healthy discussion on the contrast between Illinois state court and federal court decisions), we will just say here that a state law duty to inform federal regulators is nonsense and a duty of a Class III device manufacturer to “inform … the public when it has a reason to know that [the device] is riskier than initially believed” would be different from and in addition to the federal requirement.  After five years of briefing and discovery, summary judgment on that dubious claim remained unless plaintiff could “offer evidence that Mentor violated a federal requirement by underreporting to the FDA Memory Gel’s risk of rupture or gel bleed and that the violation caused her injuries.”  Id.  We will limit our commentary to saying this was a generous standard, both in terms of the substantive law and the burdens under Rule 56, and then focus on why plaintiff failed it anyway.

Plaintiff did not contend that the manufacturer actually materially underreported the rate of rupture or gel bleeds or that the nonexistent underreporting caused her injuries.  End of story, right?  Not quite.  Plaintiff maintained that the alleged underreporting of alleged consequences of ruptures and bleeds to FDA somehow caused her injuries.  This approach failed on several grounds.  First, the claim that survived the motion to dismiss was on alleged underreporting of ruptures and bleeds, which defined the scope of discovery.  Changing tack after the fact did not work.  Second, with a 2009 implant and 2016 explant, the (post-suit) 2019 release by FDA of reports on the device that had been submitted previously meant that “any underreporting by Mentor of adverse health consequences associated with gel bleed could not have affected her healthcare decisions as to the implants”  Id. at *3.  (This is also overly generous, because Illinois does not have a post-sale duty to warn so there would have needed to have been some connection between reporting in the three years prior to plaintiff’s implant and her physician’s decisions in connection with her implant surgery.)  Third, plaintiff offered a technical argument that the manufacturer really did not have the reporting exemption from FDA that it used, but this was factually inaccurate.  Fourth, the court also entertained the possibility that FDA might have decided to disclose additional reports earlier than it did had the manufacturer reported differently, but plaintiff forfeited that argument.  In any event, plaintiff had no evidence that the manufacturer underreported anything in violation of FDA regulations; pointing to changes in internal policies on reporting “autoimmune symptom events” did not support a violation.  Id. at *4.  There is another obvious flaw here not noted by the court:  FDA decides when to grant exemptions and when to release data from alternate reporting systems, so implied preemption should apply.

The other giant hole, which should have ended all of this inquiry without further ado, was that plaintiff never offered any evidence from her implanting physician as to the impact of the additional reports.  Id. at *5.  That is pretty basic stuff to be missing after all this time and effort by the parties and the court.  There was also “no basis to conclude that the FDA would have more quickly made public the ASR and PSR reports” had the manufacturer done something differently.  Id.  And—again, this is pretty clearly dispositive—the implanter was informed by the label of “some literature supporting the possibility that silicone implants could cause autoimmune symptoms like those [plaintiff] suffered.”  Id.  Under these circumstances, that a change in reporting would have avoided plaintiff’s injuries “would require an unrealistically speculative causal chain.”  Id.  We think that is going to be the case for virtually every “claim” of failure to report to FDA about a Class III medical device, especially where the reporting concerned a labeled event based on published literature.  Courts should be willing to ditch such implausible claims up front.