With new grass on the field, the 2019 baseball season is underway and optimism springs eternal. Here in Philadelphia, the Phillies have actually around the top of the NL east for the first time since, umm…., last year actually. But this year, having added possibly the best player and best catcher in the league, it’s not smoke and mirrors. We won’t wonk you out with stats, but in 2019 (unlike 2018) the Phillies have a significantly positive runs/runs allowed ratio. If only the pitching holds up.
Speaking of one, two, three, yer out, consider the recent developments in Covidien mesh litigation. Specifically, consider three recent wins: Nowell v. Medtronic, Inc., ___ F. Supp.3d ___, 2019 WL 1434971 (D.N.M. March 29, 2019); Kennedy v. Covidien, LP, 2019 WL 1429979 (S.D.N.Y. March 29, 2019); and Barnes v. Medtronic, PLC, 2019 WL 1353880 (E.D. Mich. March 26, 2019). Apparently emboldened by settlements in the Vaginal Mesh litigation, the other side’s funders have turned their solicitation machine on all mesh products indiscriminately, and this sort of scattershot litigation is the result. But here, three different complaints, in three different states in three different parts of the country were all dismissed on the pleadings in less than a week.
Let’s take a look.
Starting with the oldest (a relative term), Barnes alleged grossly negligent design, grossly negligent manufacture, breach of implied warranty, and fraud. 2019 WL 1353880, at *1. Since mesh is a Class II device, under the questionable decision in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), Medtronic’s preferred preemption defense isn’t widely available. Didn’t matter. There’s more than one way to win a motion to dismiss. Probably due to some quirk in Michigan law, plaintiff didn’t just allege a design defect, but rather a “grossly” negligent design. Whatever that quirk was, the allegation didn’t help the plaintiff much. As in most places, Michigan requires more for design claims than second-guessing the defendant’s design – there must an alternative design. Id. at *2. But the plaintiff in Barnes alleged only a non-mesh surgical procedure and two completely different types of mesh. Id. We’ve said it before. An alternative design is a different way to make this product, not being forced to make something else. Or, as Barnes put it, “In jurisdictions requiring plaintiffs to prove the existence of a safer alternative design, a design for a different, albeit similar, product will not suffice, even if it serves the same purpose.” Id. at *2 (citation and quotation marks omitted).
Plaintiff’s theory alleges that all polyester hernia meshes are unacceptable. Her proposed alternatives are alternative treatment methods or alternative types of mesh, not alternative production practices or designs for polyester hernia mesh. . . . Plaintiff’s design defect claim cannot succeed by categorically challenging the safety of polyester mesh and pleading only alternative categories of products as alternative production practices.
Plaintiff in Barnes also tried to use a version of res ipsa loquitur to salvage manufacturing and implied warranty claims. That didn’t work either. “The manufacturer did not implant the mesh into Plaintiff’s abdomen. At least one surgeon had to open the sealed, sterile packaging” and that “could easily have affected the integrity of the mesh implant.” Id. at *3. In the face of an alternative cause, res ipsa loquitur evaporated. Case dismissed.
In Kennedy, similar claims failed similarly. Plaintiff claimed no alternative design need be pleaded, even though New York (like Michigan) required that element before a defendant could be liable. Lose. 2019 WL 1429979, at *3 (enforcing “the general requirement that an alternative design must be pleaded, even if it is not fully developed”). “[A]lleging that the product should not be used at all is insufficient to satisfy the feasible alternative design element.” Id. at *4. Manufacturing defect? Plaintiff didn’t come close to alleging one – directly or through circumstantial evidence. Id. Warning defect? The complaint was word salad:
Plaintiff’s claim for failure to warn cannot survive the present dismissal motion because it does not identify how the warnings were inadequate or insufficient. . . . Plaintiff has failed to provide factual support for his conclusory assertion that Defendant’s warnings did not adequately caution physicians and patients concerning the risks associated with [the product].
Id. at *5 (citation omitted). As we’ve pointed out, New York federal courts have tended to be good on TwIqbal.
Kennedy picks up speed, knocking down the plaintiff’s remaining claims like a row of dominoes. Negligence? Fails just like strict liability. Id. Implied warranty? “Plaintiff has not alleged or argued a factual basis for concluding that the product was not minimally safe for its expected purpose.” Id. at *6. Express warranty? “Plaintiff does not identify a specific warranty made by Defendant that he relied on.” Id. Fraud and misrepresentation? There wasn’t any. “[T]he advertising material incorporated into the Complaint appears to have disclosed the risks of the conditions that Plaintiff has allegedly suffered.” Id. at *7. Consumer fraud. Plaintiff made it all about him. “Plaintiff has not pleaded sufficient facts to establish that Defendant’s conduct was consumer-oriented.” Id. Unjust enrichment? Absent a defect or a misrepresentation, “there is no equitable basis for a requiring restitution.” Id. at *8.
But Nowell is the biggest and baddest of the lot (and the one that will be published). Nowell has no fewer than 89 separate headnotes, but one has to wade through 22 Westlaw pages of “D said; P said” before getting to the first one. Why is it the baddest – that is to say, the best? Well, check out our learned intermediary rule “head count” post. New Mexico is one of the states where the supreme court has never spoken, and in the past one pro-plaintiff court tried to say the rule didn’t apply. Nowell went our way. To paraphrase (badly) Carl Sagan, absence of state high court precedent is not precedent for absence of the learned intermediary rule. “[S]ilence on the part of the state means only that it has not had occasion to review the matter, not that it disagrees with the federal court’s interpretation of state law.” 2019 WL 1434971, at *44 (citation and quotation marks omitted).
Pursuant to the learned-intermediary doctrine, the prescribing physician acts as a learned intermediary between a prescription drug manufacturer and the ultimate user, and the manufacturer satisfies its duty to warn by providing adequate warnings to the prescribing physician. The learned intermediary doctrine states that once a manufacturer warns a doctor about a drug’s inherent dangers, it has fulfilled its legal duty to provide a warning. . . . [A] plaintiff cannot prevail against a prescription drug manufacturer in a failure to warn case where the manufacturer warned the “learned intermediary” of the drug’s inherent risks. The overwhelming majority of jurisdictions to address this issue apply the learned intermediary doctrine to define a pharmaceutical company’s duty to warn of risks associated with the use of a prescription drug.
Id. at 40 (citations and quotation marks omitted). That’s not all, there several more pages of learned intermediary rule discussion, going through every favorable New Mexico case known to man (or at least to Bexis). Id. at *40-47. Further supporting the learned intermediary rule is the worlds longest footnote, number 25, which includes:
[M]edical device manufacturers may use the learned-intermediary doctrine in failure-to-warn cases. Numerous courts have allowed medical device manufacturers to use the learned-intermediary doctrine to defend against failure-to-warn claims. See, e.g., . . . James M. Beck, Anthony Vale, Drug and Medical Device Product Liability Deskbook §2.03 n.51 (noting that courts within every federal circuit apply the learned-intermediary rule to medical devices). . . . The Court has not found any case that does not apply the learned-intermediary doctrine to medical devices, and the Court does not think that the Supreme Court of New Mexico would be the sole entity to refuse to apply the learned-intermediary doctrine to such products. . . .
[T]he learned-intermediary doctrine applies to [plaintiff’s] failure-to-warn claims. Accordingly, the Defendants had a duty to warn only [her] treating physicians of the [device’s] risks. Argument that the Defendants owed or breached a duty to warn [plaintiff] directly is therefore irrelevant. In reaching its conclusion that the learned-intermediary doctrine would apply to surgically-implanted medical devices in New Mexico, wide-spread national recognition of the doctrine’s value encourages the Court. See Headcount: Who’s Adopted the Learned Intermediary Rule?, Drug and Device Law, https://www.druganddevicelawblog.com/2007/07/headcount-whos-adopted-learned.html (last visited March 17, 2019) (collecting cases and statutes, and noting that “all 50 states and two other jurisdictions … have precedent supportive of the learned intermediary rule”).
That’s right, Nowell quoted both Bexis’ book and the Blog in its learned intermediary rule discussion. That’s a first, as far as we know. Yet another reason to appreciate Nowell.
Turning to plaintiff’s retinue of claims, the New Mexico statute of limitations barred plaintiff’s warranty, negligence, and strict liability claims. Id. at *49-51. Then, turning to the kind of issues we follow more closely, the complaint in Nowell gets thoroughly TwIqballed. Causation is not adequately alleged. Plaintiff does not even allege that she had any of the laundry list of “common injuries caused by hernia surgeries” contained in the complaint. Id. at *52.
The Court construes only three allegations in the Amended Complaint as representing facts germane to [plaintiff’s] negligence claim. . . . Taken together, these facts — even read liberally — fall short of adequately alleging that the Defendant’s mesh was a proximate cause of [plaintiff’s] later injuries. . . . [N]othing in the Amended Complaint endeavors to explain why the Defendants’ mesh is a likely, let alone proximate, cause of [plaintiff’s] injury.
Id. at *53 (citations omitted).
Nowell also held that product defect was inadequately pleaded. The complaint “includes a litany of conclusory allegations regarding the mesh’s failure rates and tendency to cause injury, but, again, does not present a defect that could lead to the mesh’s failure and resultant injury.” Id. at *54. To complete the triple play of failure to plead any of the elements of strict liability, she didn’t plead any alternative design either.
[Plaintiff] has not alleged that, when she underwent her surgery, an alternative mesh existed which lacked the design defect and therefore would have prevented her injuries. Although the Amended Complaint states that “[s]afer and more effective alternatives to hernia mesh exist,” it merely alleges surgical techniques alternative to the use of hernia mesh altogether . . ., but not alternative designs to the Defendants’ mesh. . . . [A] design-defect claim will not stand if the only alternative is an outright ban. . . . [Plaintiff’s] failure to allege a feasible design alternative is a further basis on which the Court will dismiss her strict liability claims.
Id. at 55 (citations and quotation marks omitted).
The warning claims also failed in Nowell. “[M]any of the risks that [plaintiff] mentions are precisely the risks that the FDA considers attendant to all hernia repairs surgeries.” Id. Warning causation also went unalleged. “[Plaintiff] does not allege that any of the above warnings would have prevented [her surgeon] from using the Defendants’ mesh to repair [her] hernia.” Id.
Just as plaintiff had failed to plead defect adequately, she also failed to plead a lack of merchantability for implied warranty purposes. “[T]hese conclusory allegations amount to naked assertions devoid of the factual enhancement necessary to bridge the gap between possible and plausible.” Id. at 57 (citations and quotation marks omitted). Finally, punitive damages were dismissed for failure to plead “scienter.” Id. at *58. Ultimately, “[i]n the end, the Amended Complaint does no more than say that [plaintiff] had a mesh implant, and, years later, had an infection.” Id. at 57 n.27.
So that’s one, two, three strikes you’re out at the old ball game. We certainly hope things stay “the old ball game.” A right to these kinds of early dismissals are precisely what defendants are deprived of in multidistrict litigation.