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Ever since our Bone Screw days, when we used the strategy to great effect, we’ve rooted for defendants undertaking to beat post-MDL remand plaintiffs in guerrilla litigation in numerous courts across the country.  The way to do it is twofold:  On the one hand the defendant creates litigation uncertainty by hemming the other side in with pro-defense precedent that will hamstring their future litigation (think Buckman).  On the other, the defendant seeks out opponents unprepared to actually litigate all the MDL cases they’ve brought, leading to dismissals or very favorable settlements.

Here are a couple more recent examples – one for each prong.

Heath v. C.R. Bard, 2021 WL 3172315 (M.D. Tenn. July 27, 2021), is an example of the option-limiting function of stare decisis.  The defendant did not get the entire case thrown out – at least not at that stage, but the case-specific losses (learned intermediary causation on the implanter’s testimony and Restatement (Second) of Torts §402A, comment k (1965)) and an inadequate warning claim) are overshadowed by the claims that got dismissed as a matter of law.

The first of those is FDCA-based negligence per se.  As is often the case, plaintiffs rather indiscriminately alleged FDCA violations and claimed that all of them constituted negligence per se.  Id. at *9.  Heath disagreed.  First, most of the allegations were “‘administrative requirements’ insufficient for supporting a negligence per se claim.”  Id. at *10.

Where a statutory provision does not define a standard of care but merely imposes an administrative requirement, such as the requirement to obtain a license or to file a report to support a regulatory scheme, violation of such requirement will not support a negligence per se claim, even if the regulatory scheme as a whole is designed to protect the public or to promote safety.

Id.  This aspect of Heath is a particularly apt application of the pro-defense precedent creating effect of post-MDL litigation strategy, since the decision relies on three cases to reach its conclusion:  Bish v. Smith & Nephew Richards, Inc., 2000 WL 1294324 (Tenn. App. Aug. 23, 2000), King v. Danek Medical, Inc., 37 S.W.3d 429 (Tenn. App. 2000), and Talley v. Danek Medical, Inc., 179 F.3d 154 (4th Cir. 1999).  All three of those cases are from the Bone Screw litigation – and are still capable of getting plaintiffs’ claims dismissed almost 20 years after that litigation ended.

The plaintiff in Heath did allege one non-administrative FDCA violation, “mislabeling.”  Heath, 2021 WL 3172315, at *10.  However, that claim was impliedly preempted.  “[A] number of courts,” including the MDL judge and another Tennessee district court, have held that the FDCA “impliedly preempts state-law negligence per se claims based on FDCA violations.”  Id. (citations omitted).

This court agrees.  It is one thing for the State of Tennessee to impose liability related to medical devices that functions alongside federal statutes and regulations.  It would be another for Tennessee to appoint itself an independent enforcer of federal laws that Congress has expressly precluded it from enforcing.  The court, accordingly, will dismiss [negligence per se] on the ground that a claim based solely on a federal statutory or regulatory violation would be preempted.


The defense also prevailed in Heath over the plaintiff’s punitive damages claim – also in a way that will help future defendants in similar litigation.  Most importantly, “approval or license,” as used in Tennessee’s punitive damages compliance defense statute includes §510(k) clearance:

Neither “approval” nor “license” has a statutory definition for the purposes of Tennessee’s statutes limiting noneconomic damages.  If one limits those terms to their use in ordinary speech, however, it seems clear that authorization to market a product pursuant to the §510(k) process is, in fact, a form of “approval.”  Indeed, as [defendant] points out, the U.S. Supreme Court itself has referred to “§510(k) approval” in its opinions.

Id. at *11 (citing, inter alia, that pesky Buckman Bone Screw decision).  Plaintiff, of course raised the bogus argument, weaponized in pelvic mesh litigation, that Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), requires an all or nothing approach – either medical device approval is preemptive or it has nothing at all to do with safety and should be entirely ignored.  Heath disagreed:

[T]hat the relevant statutes are ones of broad, general applicability makes it less likely that the General Assembly would have intended to use “approval” in a specialized sense.  The only way that the General Assembly could have intended to use “approval” narrowly here would have been if that legislative body had specifically had the distinction between PMA and lesser forms of FDA review in mind.  But if the General Assembly was that deep into the details of federal pharmaceutical law, why did it not more clearly indicate that it was drawing such a distinction? . . .  [plaintiff’s] argument requires the court to assume that the General Assembly was cognizant of, and intended to invoke, a counterintuitive, formal distinction used only in federal medical device law, while, at the same time, being unusually casual and imprecise about the way it referred to that distinction.  That reading strikes this court as implausible.

2021 WL 3172315, at *12.  Heath also rejected the argument that Lohr held that safety was irrelevant to substantial equivalence FDA clearance.  “Clearance pursuant to §510(k), therefore, does, in fact, entail FDA review of facts intended to resolve issues of safety − simply through a different and less arduous process than PMA.”  Id. at *13.

Finally, plaintiffs could not seek punitive damages based on the statute’s fraud on the FDA exception.

The U.S. Supreme Court and the Sixth Circuit have both held that a state’s laws will be preempted if they veer too far into the realm of policing a party’s actions during the FDA review process, which those courts recognize as particularly within the domain of the FDA itself and, more generally, the federal government and federal law.  There is little doubt that Tennessee’s statute, as written, at least risks running afoul of that rule.

Id. (citations omitted).  That pesky Buckman case again.  And thanks to Heath, future defendants now have excellent precedent to rely upon in future litigation under Tennessee law.

The second case, Reynolds v. C.R. Bard, 2021 WL 4193199 (W.D. Wis. Sept. 15, 2021), dealt with a common plaintiff post-MDL tactic, belated submission of improper “supplemental” expert opinions that should have been produced during the MDL itself.  This modus operandi is inherent in the MDL plaintiff-side business model that:  (1) numbers matter more than anything else, and (2) the less real work an attorney does in cases that are going to settle, the greater the profit.  But when cases don’t settle, that often means the plaintiff is not prepared for remand.  Reynolds is an example of the second prong of a successful post-MDL remand defense strategy – picking off plaintiffs unprepared to try their cases.

We’ve discussed this phenomenon mostly in the mesh litigation context, but it’s hardly unique to those products.  In Reynolds, the plaintiff was non-compliant.  The device was removable, he was supposed to have a “follow up” discussion about removal two months after surgery, but he “did not make” such an appointment for 3½ years.  2021 WL 4193199, at *3.  Unfortunately, in the interim, “his filter had by then fractured and perforated” plaintiff’s vein.  Id.  Thereafter, removal was successful, except for the one part of the fractured strut.  Id.  Plaintiff never had physical symptoms (perhaps why he didn’t have any follow-up), so he could claim only emotional distress from possible future complications.  Id.

Not surprisingly, after remand, plaintiff in Reynolds submitted a new expert who:  (1) did not reveal the basis of his opinions, (2) offered “general” (non-plaintiff-specific) opinions that should have been produced in the MDL.  Id. at *4.  Plaintiff’s fallback position was that his expert discovery failures were harmless.  Id.

Ignoring point one (where plaintiff’s excuses were criticized, but no issue decided), Reynolds agreed that the plaintiff had blatantly violated both MDL and remand court orders.

Having reviewed [the expert’s] report, the court agrees that the opinions expressed go only to the risks of [the implant] generally.  Indeed, the vast majority of [the] report analyzes the relative risks of adverse events related to [plaintiff’s device] compared to other [products] on the market.  Although he then purports to opine as to the probability that [plaintiff] could have avoided an adverse health event due to [device] failure, it is apparent from the report that [the expert] arrived at this estimate based only on his general analysis, not from any individualized assessment.

2021 WL 4193199, at *5 (emphasis original).  New expert report stricken.  Id. at *6.  Plaintiff’s attempt to introduce a new general expert after remand was violated the “key purpose” for having MDLs in the first place, “to consolidate and complete as efficiently as reasonable all shared pretrial matters, including especially general discovery.”  Id.  “To permit plaintiff to inject a new general expert opinion into this case would undermine this very purpose.”  Id.

There’s more.  “For reasons unknown to the court, however, plaintiff chose not to disclose” an MDL expert who gave essentially the same testimony.”  Id. at *6.  The only MDL experts plaintiff designated had been excluded during the MDL for using unreliable methodology.  Id. at *6-7.  Thus, the plaintiff in Reynolds was without any relative risk testimony, and had summary judgment entered against his design defect claim under Wisconsin’s product liability statuteId. at *8-9.

The Reynolds plaintiff hadn’t done the necessary spadework for his warning claim either.  Thanks mostly to pro-defense precedent created in a prior MDL, the learned intermediary rule applied to Wisconsin law, and that was fatal.  Under the learned intermediary rule:  “the relevant question is whether [plaintiff’s] implanting doctor . . . would have changed his treatment decisions,” and “plaintiff has offered no evidence from [the implanter] by affidavit or deposition testimony regarding his treatment decisions.”  Id. at *9 (emphasis original).

Oops.  That’s another thing that the plaintiff in Reynolds should have done, but didn’t.

Nor – with no admissible expert testimony about there actually being any comparative difference in complication rates – could the plaintiff argue that the warning was inadequate for not mentioning that which could not now be proven.  Id.

Thus, summary judgment granted and the case was dismissed with prejudice:

[S]ummary judgment is not a dress rehearsal or practice run; it is the put up or shut up moment in a lawsuit. . . .  Given the long-past expert disclosure deadlines and impending trial date, the court sees no fair way to correct plaintiff’s glaring omissions.  Accordingly, the court will grant defendant’s summary judgment motion.

Reynolds, 2021 WL 4193199, at *10 (citation and quotation marks omitted).

So, let these two cases be a reminder that post-MDL remand success for defendants is achieved both by making plaintiffs pay a price by making future litigation harder, and by catching them right now with their pants down.