This post is from the non-Reed Smith side of the blog.

This blog has repeatedly lamented the tendency of MDL courts to flout federal pleading standards when assessing the sufficiency of master complaints. All too often MDL courts disregard Rule 8(a), which—as authoritatively interpreted by the Supreme Court in Twombly and Iqbal—requires plaintiffs to plead facts plausibly suggesting an entitlement to relief, and Rule 9(b), which requires that fraud be alleged with particularity. Today we report on another example of this unfortunate tendency, In re: Allergan Biocell Textured Breast Implant Product Liability Litigation, 2021 WL 1050910 (D.N.J. Mar. 19, 2021). Although the court got a number of things right and dismissed a few claims from the master complaint, it allowed all too many of the claims to proceed on frustratingly familiar grounds that effectively insulate MDL master complaints from many motions to dismiss.

As its full name indicates, In re: Allergan involves the manufacturer’s Class III textured breast implants and Class II textured tissue expanders, which were voluntarily recalled after evidence suggested that they cause a certain form of cancer at a higher rate than other textured breast implants. The plaintiffs allege that the process by which the implants were manufactured resulted in “overly aggressive and inconsistent texturing” that in turn allegedly increased the implants’ surface area and led particles to form on their surface. The plaintiffs claim that these purported conditions caused them to suffer cancer or be at a higher risk of suffering cancer. Based on those allegations, the plaintiffs assert failure-to-warn, manufacturing-defect, negligence-per-se, breach-of-warranty, misrepresentation, and consumer-fraud claims under the state laws of various states.

The manufacturer moved to dismiss the plaintiffs’ master complaint, moving to dismiss all claims on state-law grounds and moving to dismiss the claims implicating Class III devices on preemption grounds as well. The motion to dismiss on preemption grounds targeted claims involving devices that had received premarket approval (PMA) from the FDA and devices that that had been cleared by the agency under the Investigational Device Exemption. Applying unduly lenient pleading standards, the court granted the motion in small part and denied it in large part. The court justified its application of a lax pleading standard on two grounds.

First, the court refused to consider whether the master complaint adequately pleaded certain elements of the plaintiffs’ claims, precisely because those claims were asserted in an MDL master complaint. For example, the court declared that it “need not review the factual sufficiency of Plaintiffs’ negligent misrepresentation allegations,” explaining that assessing their “factual sufficiency under the potentially varying state laws of negligent misrepresentation would be both cumbersome and unrealistic at this stage, especially when individual Plaintiffs may allege separately in their Short Form Complaints [the] misrepresentations to which they each [supposedly] have been exposed.” 2021 WL 1050910, at *32. Indeed, time and again the court “decline[d] to scrutinize … at this stage” of the proceedings whether the master complaint alleged facts sufficient to establish elements of the plaintiffs’ claims. Id. at *42. This is true with respect to claims subject to Rule 8(a) as well as claims subject to Rule 9(b). Simply put, the court would not apply the otherwise applicable pleading requirements because the complaint at issue was a master complaint in an MDL. When one compares the result in the In re: Allergan MDL to the opposite result in D’Addario v. Johnson & Johnson, 2021 WL 1214896 (D.N.J. 2021), a one-off case raising similar allegations against another manufacturer’s textured breast implants, the MDL effect is cast in sharp relief.

The court’s second justification for ignoring basic federal pleading standards is in some sense even more disturbing because it would by its logic apply to all cases, not just MDLs. According to the court, “fairness compels that some leniency be afforded plaintiff[s] from the stringent Twombly/Iqbal pleading standards to allow [their manufacturing-defect] claim to proceed” because the plaintiffs “do[] not have access to” the relevant PMAs, which are confidential, and are thus supposedly unable to plead a specific federal violation, as is necessary to avoid express preemption under 21 U.S.C. § 360k(a). 2021 WL 1050910, at *13 (internal quotation marks omitted). That of course echoes the Seventh Circuit’s abominable decision in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), which we have pilloried many times, including here and here. And, as in Bausch, the court’s analysis fails to appreciate that both Twombly and Iqbal involved situations in which the plaintiffs did not have access to information within the defendant’s control. In Twombly, the plaintiffs asserted an antitrust claim that required them to prove, and thus to allege, a conspiracy among the defendants. Despite the defendants controlling the information that would be necessary to establish a conspiracy, the Supreme Court held that the plaintiffs were required to plead facts sufficient to plausibly suggest an entitlement to relief. Iqbal confirmed that requirement, holding that a plaintiff who brought a Bivens action had to plead facts sufficient to plausibly suggest that the defendant acted with “discriminatory intent,” even though the defendant’s mental state was known only to the defendant. In short, Twombly and Iqbal hold that a plaintiff must plead facts sufficient to state a claim even where the plaintiff is at an informational disadvantage. Like Bausch before it, In re: Allergan cannot be reconciled with this Supreme Court precedent.

You know that things are not going to go well from a defense perspective when a court ignores Twombly and Iqbal. And, sure enough, there is much to dislike in In re: Allergan.

That said, the court did get some things right.

Rejecting the plaintiffs’ contrary contention, the court held that claims implicating devices used pursuant to the Investigational Device Exemption (IDE) are subject to express preemption under 21 U.S.C. § 360k(a). 2021 WL 1050910, at *8.

Another bright spot in an otherwise dreary decision is the court’s recognition that the Changes Being Effected (CBE) regulation, which allows device manufacturers to change a device label under certain circumstances without receiving prior FDA approval, “is permissive, not mandatory”—and that a state-law failure-to-warn claim that would require a manufacturer to have used the CBE process to change its label is therefore preempted under § 360k(a) because it would impose “a state-law duty that differs from or adds to the federal requirements.” 2021 WL 1050910, at *9–10 (internal quotation marks omitted). On this basis, the court dismissed the plaintiffs’ failure-to-warn claims insofar as they rested on the allegation that the manufacturer failed to revise its labeling to warn of the purportedly enhanced risk of cancer.

Satisfying too is the court’s recognition that § 360k(a) preempts claims implicating a device that had originally been classified as a Class II device but was subsequently reclassified as a Class III device and given premarket approval. As the court put it, “claims against … reclassified devices, which had the PMA approval when used by Plaintiffs, are treated no differently from the claims against the” devices that were PMA-approved from the outset. 2021 WL 1050910, at *14.

Finally, the court correctly concluded that the plaintiffs’ failure-to-warn claims were expressly preempted insofar as they rested on the manufacturer’s alleged failure “to conduct post-PMA clinical studies,” because “there is no state law duty that requires [a manufacturer] to undertake [such] studies.” 2021 WL 1050910, at *15.

Apart from that and the dismissal of a various claims under the laws of various states, the decision isn’t great, but it does provide ample fodder for this blogpost.

Different models of breast implants are at issue in the In re: Allergan MDL. They were distributed through different legal pathways. The great majority received PMA; a few others were IDE devices; yet others (empty implants used as “tissue expanders”) were cleared through the 510(k) process. As noted above, the court recognized that claims implicating IDE devices, like those implicating PMA devices, are subject to preemption under § 360k(a). Although the manufacturer did not seek dismissal of claims implicating the tissue expanders on preemption grounds, the court nevertheless addressed preemption in the context of 510(k) devices. Without any analysis beyond an indirect citation to the ill-conceived and outdated decision in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), the court said in dicta that claims implicating 510(k) devices are not subject to preemption.  As the blog has noted before, that conclusion is dubious not only because the 510(k) today is significantly different from the process by which the Lohr device was cleared, but also given PLIVA v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), which suggest that some claims implicating 510(k) devices are at least impliedly preempted even if not expressly preempted.

While the court recognized that claims implicating PMA and IDE devices are in principle subject to preemption under § 360k(a), it took an exceedingly narrow view of when claims are preempted.

Citing a series of unpublished Ninth Circuit decisions that mechanically follow that court’s misguided decision in Stengel v. Medtronic, Inc., 704 F.3d 1224 (2013), while at the same time ignoring Mink v. Smith & Nephew, Inc., 860 F.3d 1319 (11th Cir. 2017), and other precedential appellate decisions that have rejected such claims, the court held that failure-to-warn claims predicated on a manufacturer’s alleged failure to file adverse-event reports with FDA are neither expressly nor impliedly preempted

In so concluding, the court disregarded the nature of adverse-event reports, misconstrued Restatement (Second) of Torts § 388 cmt. n, and adopted an unduly restrictive view of Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001). The court failed to recognize that, as explained in Aaron v. Medtronic, Inc., 209 F. Supp. 3d 994, 1005 (S.D. Ohio 2016), adverse-event reports are not warnings. The court compounded that error by misreading the Restatement as imposing a state-law duty to submit adverse-event reports to the FDA. Comment n to § 388 says that a manufacturer can satisfy its duty to warn a product’s end-user by warning a third-party “through whom the [product] is supplied” when the manufacturer can reasonably rely on the third-party to convey the warning to the end-user, such as when the third-party has a duty to do so. In treating the FDA as a third-party intermediary for purposes of § 388, the court ignored the obvious fact that medical products such as breast implants are not supplied by the FDA, the fact that the FDA is not obligated to make adverse-event reports public, and the fact that adverse-event reports are not actively distributed to doctors even when made public. Finally, declaring itself “bound by the Third Circuit’s interpretation of the holdings in Buckman,” the court—citing no Third Circuit decision, when the only Third Circuit precedent, Sikkelee v. Precision Airmotive Corp., 907 F.3d 701, 716–17 (3d Cir. 2018), supports preemption—suggests that failure-to-warn claims predicated on a manufacturer’s alleged failure to file adverse-event reports with FDA are not preempted under Buckman because Buckman’s holding is, supposedly, limited to fraud-on-the-FDA claims. 2021 WL 1050910, at *11. That suggestion ignores the various cases that have characterized such failure-to-warn claims as fraud-on-the agency claims and cannot be reconciled with the Supreme Court’s own understanding of Buckman, which, the Court has explained, held that the FDCA preempts any “state tort-law claim based on failure to properly communicate with the FDA.” PLIVA, Inc. v. Mensing, 564 U.S. 604, 619 (2011).

The In re: Allergan court also missed the mark when analyzing whether plaintiffs’ manufacturing-defect claims are preempted. As noted at the outset, the court—ignoring Twombly and Iqbal in the name of “fairness”—excused the plaintiffs’ failure to identify a specific PMA requirement that the manufacturer allegedly violated. Moreover, it held that the plaintiffs could base their manufacturing-defect claims on the manufacturer’s alleged violation of an FDA Current Good Manufacturing Practice (CGMP). 2021 WL 1050910, at *13. There is conflicting law on that point, and the court’s conclusion is arguably contrary to Irizarry v. Abbott Laboratories, 833 F. App’x 947, 949–50 (3d Cir. 2020), in which the Third Circuit affirmed the dismissal of a manufacturing-defect claim, finding that a complaint that “d[id] not set forth the premarket approval requirements” that were allegedly violated “d[id] not plausibly allege” a parallel claim that survived preemption.” This blog has repeatedly argued that because the CGMPs are intentionally vague and designed to give manufacturers complete discretion in how they are to be implemented, a state-law claim based on an alleged CGMP violation necessarily imposes a state-law duty that is “different from, or in addition to” the federal requirements and is thus expressly preempted under 21 U.S.C. § 360k(a).

But even if a CGMP violation could in theory support a manufacturing-defect claim, it is hard to see how 21 C.F.R. § 820.30(g), the CGMP cited by the In re: Allergan court, could sustain a non-preempted claim. To start, § 820.30(g) addresses “design validation,” not manufacturing processes. Furthermore, its requirement that a manufacture conduct “testing of production units under actual or simulated use conditions” is—to the knowledge of this blogger—not found in the law of any state. If it is not, and the court cited no state’s laws to suggest otherwise, then a claim based on an alleged violation of § 820.30(g) would be both expressly preempted, because the state and federal requirements would not be “identical” (Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996)), and impliedly preempted, because the “existence of the[] federal enactment is a critical element in [the plaintiffs’] case.” Buckman, 531 U.S. at 353.

As if these problems weren’t enough, the court’s conclusion that the plaintiffs’ manufacturing-defect claims avoid preemption disregards the essence of their master complaint. To state a manufacturing-defect claim, one must allege and ultimately prove that the particular unit received by the plaintiff differed from its intended design or from other ostensibly identical units. The In re: Allergan plaintiffs, however, do not allege that their textured breast implants differed from their intended design or from other ostensibly identical units. On the contrary, the plaintiffs contend that every Biocell breast implant was defective because the manufacturing process supposedly resulted in the formation of particles and excessive surface areas—and even assert a class action on behalf of all recipients. Thus, plaintiffs’ real complaint is with the manufacturing process as designed and as approved by the FDA. That is to say, the plaintiffs’ manufacturing defect claims “are a frontal assault on the FDA’s decision to approve” the device’s PMA “after weighing the product’s benefits against its inherent risks.” In re Medtronic, Inc., Sprint Fidelis Leads Prod. Liab. Litig., 623 F.3d 1200, 1207 (8th Cir. 2010).

By this point it should not surprise the reader that the In re: Allergan court denied the manufacturer’s motion to dismiss the plaintiffs’ negligence-per-se claims on preemption grounds. What is particularly depressing about the court’s ruling in this regard is that it relied on In re Orthopedic Bone Screw Product Liability Litigation, 193 F.3d 781 (3d Cir. 1999), to support its conclusion. But that decision is part of the same litigation that ended in Buckman, which squarely held that 21 U.S.C. § 337(a) impliedly preempts any state-law claim for which the existence of the FDCA “is a critical element.” 531 U.S. at 353. Given that the plaintiffs’ negligence-per-se claims rest on the defendants’ alleged violation of the FDCA and its implementing regulations, Buckman plainly precludes such claims (as many but not all courts have held). The In re: Allergan court went astray when it concluded that the plaintiffs’ negligence-per-se claims were not preempted under Buckman because they “invoke the statutory violations to prove defendants’ liability for a separate underlying tort, instead of contending the violations themselves form a cause of action.” 2021 WL 1050910, at *14 (quotation marks omitted). But the mere fact that states recognize negligence actions does not save negligence-per-se claims from preemption. Rather, to avoid preemption under Buckman, “the conduct on which the claim is premised must be the type of conduct that would traditionally give rise to liability under state law—and that would give rise to liability under state law even if the FDCA had never been enacted.” Riley v. Cordis Corp., 625 F. Supp. 2d 769, 777 (D. Minn. 2009). A negligence-per-se claim predicated on a violation of the FDCA and its implementing regulations does not satisfy that test.

Despite getting most of the preemption analysis wrong, the In re: Allergan court did ultimately dismiss some of the plaintiffs’ failure-to-warn, negligence-per-se, negligent-misrepresentation, warranty, and medical-monitoring claims on state-law grounds, concluding (after providing useful multi-state surveys) that some states do not recognize the plaintiffs’ theories of liability. That is a good reminder that dismissal on state-law grounds is possible even when a court gets the preemption analysis wrong and that counsel should not rely exclusively on preemption when seeking dismissal of arguably preempted claims.

But the In re: Allergan court let most of the claims (and class allegations) through after declaring once again that it would review the sufficiency of plaintiffs’ allegations “with leniency.” 2021 WL 1050910, at *18. That’s an MDL for you.

Approximately 18 months ago we reported on C.D. California cases that silicone breast implant defendants managed to keep in federal court and then get dismissed with prejudice. We expressed delight with the opinions because the court’s discussions of fraudulent joinder and preemption were particularly insightful. No doubt another source of our delight was that the author of the opinion was Judge Andre Birotte, a former colleague in the U.S. Attorney’s Office, and a person for whom our admiration is boundless.

Our blog accepts comments. Believe it or not, those comments do not always consist of unalloyed praise. We occasionally get portrayed as hard-hearted villains who gleefully trample on widows and orphans. That happened with our post on Judge Birotte’s decisions. How dare we extol a decision that slammed the courthouse door shut on grievously hurt plaintiffs? The comment included doubts about our fitness for polite company. Well, believe it or not, we are capable of human sympathy. We do recognize that some people are injured by bad conduct and deserve compensation. Still, we dwell in a world in which sometimes bad things happen to people through no one’s fault. We also dwell in a world in which every valid legal claim arrives accompanied by ten or one hundred others that possess more opportunism than merit. Clearly, though, the commenter would have none of that. She concluded by thanking the stars above that we were not the last word; there was always the Ninth Circuit.

The Ninth Circuit has now reviewed the cases. It would be churlish of us to say that the Ninth Circuit ruled that we were right. It would be accurate to say that the Ninth Circuit ruled that Judge Birotte was right. More specifically, the Ninth Circuit issued four memorandum dispositions affirming the district court’s rulings that disposed of 21 plaintiffs’ claims.

The four decisions are: (1) Nunn v. Mentor Worldwide, LLC, 2021 WL 406304 (9th Cir. Feb. 5, 2021), (2) Billetts v. Mentor Worldwide, LLC, 2021 WL 406313 (9th Cir. Feb. 5, 2021), (3) Sewell v. Mentor Worldwide, LLC, 2021 WL 406623 (9th Cir. Feb. 5, 2021), and (4) Vieira v. Mentor Worldwide, LLC, 2021 WL 406628 (9th Cir. Feb. 5, 2021). The four decisions are virtually identical.

The appellate court saw no error in the district court’s denial of the plaintiffs’ motions to remand because (a) the co-defendant’s deposition was “other paper” that provided sufficiently new information to trigger removal; and (b) there was clear and convincing evidence that the non-diverse defendant had been fraudulently joined. That defendant was not involved in manufacturing or supplying the silicone used in the implants. Recovery against that defendant was impossible.

The Ninth Circuit also upheld the district court’s ruling on the merits. The plaintiffs had attempted to evade preemption of their failure to warn claims by relying on the parallel claim exception. The plaintiffs’ failure to warn claims were premised on an alleged failure to report adverse event claims. Such a claim, sadly, has legs under California law (not too many other places), but here it was entirely too conclusory and speculative under Twombly. The plaintiffs postulated that if the defendant had conducted post-approval studies with more participants, it would have seen more adverse events, and then would have been required to report them to the FDA. Huh? Such counterfactual clairvoyance did not impress the court. In any event, there is no parallel state law duty (not even in California) supporting a claim regarding the conduct of post-approval studies. Further, there is no federal requirement to warn patients or doctors directly of adverse events.

The plaintiffs continued their tour circumnavigating preemption by relying on their manufacturing defect claim. For that claim to survive, the plaintiffs must allege that the defendants “deviated from a particular pre-market approval or other FDA requirement applicable to the Class III medical device.” They cannot “simply demonstrate a defect or a malfunction and rely on res ipsa loquitur to suggest only … that the things speaks for itself.” The plaintiffs contended that the breast implants contained some unspecified materials that differed from those approved by the FDA. Nice try. The Ninth Circuit held that such vague allegations were insufficient because the plaintiffs did not allege which particular FDA requirement was violated.

The Ninth Circuit ended the opinions by acknowledging that it was “sympathetic to Plaintiffs’ health problems,” but still ruling that the complaint was bereft of legal support, and that Judge Birotte had not abused his discretion in denying the plaintiffs’ requests for leave to amend as futile.

If our critic remains unpersuaded by the Ninth Circuit’s reasoning, we hope she at least is open to the possibility that sympathy and dismissal can coexist. After all, the Ninth Circuit said so.

We offer a tip of the cyber cap to Dustin Rawlin and the Tucker Ellis team for achieving these results. They have done a splendid job of defending their client. If we continue to be the target of slings and arrows from our critics, we may turn to them for help.

We praised Brooks v. Mentor Worldwide, LLC, 2019 WL 4628264 (D. Kan. Sept. 23, 2019), when it was first decided, as “checking all the boxes.”  Last week the Tenth Circuit affirmed, and believe us, it rechecked all those boxes.

In Brooks v. Mentor Worldwide LLC, ___ F.3d ___, 2021 WL 245246 (10th Cir. Jan. 26, 2021), plaintiffs appealed dismissal of claims against an FDA pre-market approved (“PMA”) breast implant manufacturer “for failure to warn and manufacturing defect, sounding in ordinary negligence, negligence per se, and strict liability.”  Id. at *2.  They were shut out.  Dismissal of all claims affirmed.

Brooks viewed the FDCA as containing “two preemption provisions.”  Id.  Section 360k(a), provided for “express preemption,” and §337(a) is an “implied preemption provision” demonstrating that “Congress intended that the MDA be enforced exclusively by the Federal Government.”  Id. at *3 (quoting Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 352 (2001)).  The express preemption provision “preempts a tort claim unless the federal requirements impose duties that are at least as broad as those” imposed by the state law,” whereas the other “preempts any state tort claim that exists solely by virtue of an FDCA violation.”  Id. (citations and quotation marks omitted).  Together, they:

Leave[] only a narrow gap of possible state tort claims.  Any such claim must be predicated on conduct that violates the FDCA but may not be brought solely because that conduct violates the FDCA − the conduct must also violate a parallel state-law requirement.

Id. (emphasis original).  Thus, to survive preemption:

a plaintiff must plead conduct that (1) violates the FDCA (because state law may not impose additional or different duties) and (2) would be actionable under state law independently of the FDCA (because a plaintiff may not seek to enforce the FDCA).

Id. at *4 (citations omitted).

“Negligence per se” failed these tests miserably.  There simply wasn’t any independent state-law claim.  “When we ask whether liability under negligence per se exists independently under state law, regardless of the FDCA or MDA, we must answer ‘no.’”  Id.  This is simply the inherent nature of what negligence per se is.

[N]egligence per se . . . relies on a federal requirement to supply the duty of care and looks to a violation of the requirement as the breach of that duty.  Any negligence per se action premised on an MDA violation necessarily seeks to enforce the MDA rather than a parallel state-law duty.  And only the United States may enforce the MDA.

Id. (Buckman citations omitted).

Not only that, but state-law negligence per se does not support FDCA-based allegations.  Congress expressly precluded private FDCA enforcement through §337(a).  A negligence per se claim predicated on this type of statute “lacks viability under the laws of either Kansas or Missouri,” the two relevant states.  Kansas “limits negligence per se to violations of a statute for which the legislature intended to create a private cause of action.”  Missouri “limits negligence per se to violations of a statute where the legislature intended to replace the ordinary negligence standard of care.”  Id. (state law citations omitted).  The FDCA, with its express prohibition of private enforcement, met neither state’s negligence per se criteria.  Id.

This aspect of Brooks is particularly gratifying to us, because the decision recognizes the importance of legislative intent – one of the state-law limits to negligence per se we’ve advocated on the Blog since day one.  Thus negligence per se was impliedly preempted because “[t]he MDA’s text tells us that Congress created no private cause of action in the MDA, and Buckman tells us that Congress did not intend the MDA to supplant state-law duties of care.”  2021 WL 245246, at *4 (citations omitted).

Next up was “ordinary negligence and strict liability for failure to warn.”  Id.  In scattershot fashion, plaintiffs in Brooks argued “that Defendant breached a duty to warn (1) patients, (2) physicians, and (3) the FDA about the implants’ health risks.”  Id.

One, two, three strikes yer out.

The purported duty to warn patients directly was a gimme.  “Plaintiffs identify no federal requirement that a Class III-device manufacturer provide a warning directly to a patient.”  Id.  Therefore, any such claim was “in addition to” federal requirements.  Id. (“any state-law duty to do so adds to the federal scheme as it is before us”).  Express preemption.

As for standard duty to warn physicians under the learned intermediary rule, there was no mandatory duty to “update” FDA approved labels.

Defendant could have changed its labeling without FDA approval by a permissive mechanism, but that mechanism is not mandatory.  21 C.F.R. §814.39.  It allows, but does not require, a change.  And absent a federal requirement that they do so, federal law expressly preempts any state-law duty requiring a manufacturer to update its labeling.

Brooks, 2021 WL 245246, at *5 (case citations omitted).  Express preemption.

The purported “duty to warn the FDA” involved allegations about both “post-approval, FDA-mandated testing” and failure to “report negative results.”  Id.  Implied preemption wiped out these purported duties, under either Kansas or Missouri law:

Plaintiffs have not identified a state-law duty to comply with FDA-imposed post-approval requirements such as testing and reporting.  Buckman made clear that only the federal government may enforce reporting requirements and investigate and respond to suspected fraud.  Similarly, the government retains the exclusive right to enforce post-approval requirements. . . .  Federal law thus impliedly preempts Plaintiffs’ claims based on alleged failures to properly conduct post-approval testing and reporting as attempts to enforce the MDA.

Id. (citations omitted).

Plaintiffs in Brooks made their final stand around their manufacturing defect claim.  In the abstract, at least, such a claim could plausibly exist – but plaintiffs didn’t come close to pleading one.  Once again, we love TwIqbal:

Labels, conclusions, formulaic recitations of elements, and naked assertions will not suffice. An allegation is conclusory where it states an inference without stating underlying facts or is devoid of any factual enhancement.

Brooks, 2021 WL 245246, at *5 (citations omitted).  “Conclusory allegations are “not entitled to the assumption of truth.”  Id. (citation and quotation marks omitted).

Plaintiffs “sp[un] a wide-reaching story of noncompliance with FDA regulations and requirements.”  Id.  But like most plaintiffs, their allegations were long on innuendo and short on facts.  There were plenty of “[b]ald accusations such as ‘defendant violated the law,’” and “largely historical facts” about “indiscretions in conducting studies and reporting results.”  Id.  They didn’t matter, since those allegations did “not touch on any specific flaw in the manufacturing process relevant to Plaintiffs’ own implants.”  Id.  But that’s precisely what a manufacturing defect is – some kind of “specific flaw” in a plaintiff’s “own” device.  Other allegations of noncompliance do not matter.

The manufacturing-related allegations failed because they were entirely boilerplate:

Plaintiffs conclude that the implants “differed from the specifications agreed to by the FDA” and “used materials and components which differed from those approved by the FDA,” without alleging any supporting facts.

Id.  They also alleged vaguely:

that Defendant (1) “fail[ed] to follow good manufacturing practices,” (2) had “not complied with applicable federal regulations” and “fail[ed] to adhere to manufacturing protocols approved by the FDA,” (3) “carelessly and negligently s[old] and distribut[ed]” the implants “in violation of” federal law, (4) “negligently incorporate[ed] components and/or materials” that were not “commercially reasonable” and “could not stand up to normal usage,” and (5) “fail[ed] to exercise reasonable care in inspecting and testing … manufacturing, quality control and quality assurance processes.”

Id.  Those aren’t facts; they’re legal conclusions.  And since “[p]laintiffs did not plead factual allegations to support these or any of their other conclusions, . . . they cannot sustain a claim for relief.”  Id.

The district court thus properly ruled the entire complaint preempted.

Plaintiffs’ final argument was procedural – that they should have had another shot at amending their complaint.  Their supposed “motion” to amend wasn’t worthy of the name.  “Because we do not recognize Plaintiffs’ single sentence as a cognizable motion, the district court did not abuse its discretion in denying that request.”  Id. at *7 (citations omitted).  Since “[p]laintiffs made a strategic choice” and “took none of the available avenues to amend their Complaint,” the court saw no reason to “protect them from their own inaction.”  Id.

Thus Brooks adds to the growing weight of precedent that none of the following can defeat preemption where a PMA medical device is at issue:

  • Negligence per se based on purported FDCA violations.
  • A mandatory state-law duty to update warnings where the FDA’s CBE regulation is merely voluntary.
  • Violation of alleged duties to conduct FDA-mandated post-manufacturing testing.
  • Violation of alleged duties to report adverse events to the FDA.
  • Vague manufacturing defect allegations of failure to comply with “specifications” and/or using noncompliant materials or components.
  • Vague manufacturing defect allegations about “good manufacturing practices,” regulatory violations, “reasonable care,” and lack of inspection or testing.

From what we’ve seen, plaintiffs in breast implant litigation don’t have anything else.

We slipped our summer vacation in just before summer slipped away. Last week, we walked the rocky shores of Cape Cod, ate lobstah rolls the size of trolley cars, and navigated our way through the traffic catastrophes charmingly known in New England as “rotaries.” On our last day in the Bay State, the temperature plunged. Many fellow strollers on the sand donned down jackets. Summer in Massachusetts has a way of vanishing suddenly.

On our six and half hour drive back home, we dreamed up an outline for a short story entitled “Thoreau in the Passenger Seat.” Odds are we’ll never follow through, so here’s a sketch.

While we ogled the beautiful red-and-white Nauset Lighthouse in Eastham, a scruffy, bearded guy sidled up close to us (not much social distancing) and described the lighthouse’s history. Then he held forth about the power and majesty of the surf below. Many waves were 20 feet high. They crashed with fury. His words climbed above the din, and were poetic and precise. This shore saw scores of shipwrecks. Sharks had been spotted throughout the season. According to this strangely intense guy, who told us his name was Henry, the only comparable beach in the northeastern quadrant of the country was said to be the vast expanse on Long Beach Island in New Jersey, which he had never actually laid eyes on, but fervently hoped to someday.

It so happened that we would be driving down in that direction the next morning, and we said we’d be happy to give our new friend a lift. Deal. So at 10 am sharp on Saturday, we picked Henry up at the Dunkin’ Donuts in Mashpee, drove across the Bourne Bridge, and proceeded southwest. Through New Bedford and Fall River, Henry’s conversation was interesting enough, though his pro-whaling and pro-Lizzy Borden positions struck us as a bit off-key. We also noticed a hygiene deficiency; he gave off a slight whiff of pond scum. Then he started fiddling with the radio stations. Our usual rule is that the driver calls the tune. If Casey Kasem’s America Top 40 keeps us calm and steady in the middle lane, that should suffice. Yes, the time period of this particular Top 40 show, September 1978, was a particularly putrid moment for popular music. The Grease soundtrack dominated the charts. The number one song was “Boogie Oogie Oogie.” But Henry wanted to play the Hair Nation station. We demurred. A dose of Great White, Ratt, and Poison would prompt us to drive into a pylon. After we slapped Henry’s hand away from the dial, he stewed sullenly for a half hour.

The silence was tense, but was preferable to the way it ended – Henry started jibbering about the local flora and fauna, and none of what he said seemed remotely plausible. We’re pretty sure that the trees outside Providence, Rhode Island do not leak jello, and we doubt that salmon sing in the streets of Stamford, Connecticut. By the time we crossed the George Washington Bridge, we had grown quietly desperate to get away from this guy. If there was an ejection seat button, we’d have pushed it. The gas gauge was nearing the E, so we pulled into the first service station in New Jersey. Filling the tank cost almost $50. We eyed Henry expectantly. He never once reached for his wallet. Instead, he acidly observed that the namesake for the Turnpike Plaza, Vince Lombardi, couldn’t hold a Yankee candle to Bill Belichick’s record with the New England Patriots. We seethed. Then Henry said he needed to visit the men’s room and the Popeye’s chicken stand. Why couldn’t he have done that while we gassed up, especially since he wasn’t going to chip in at all? We sighed, pulled around, dropped him off, and waited. We waited about sixty seconds. That was just enough time to wrestle with our conscience, accelerate onto the ramp, and get back into the highway.

In his book on Cape Cod, Thoreau wrote that a man could stand on the great beach on Eastham and “put all America behind him.” At the Vince Lombardi rest stop on the New Jersey Turnpike, we decided to put Henry behind us. All the way down to the Philly suburbs, we didn’t look at our rearview mirror once.

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Today we will look at our rearview mirror. It is worthwhile to reflect upon Webb v. Mentor Worldwide LLC et al., 2020 WL 1685323 (N.D.N.Y. April 7. 2020), because it adds to the consensus that breast implant litigation is severely circumscribed by express preemption. Breast implants are class III medical devices. They go through the Premarket Approval (PMA) process and are subject to the Medical Device Amendments (MDA) of 1976 provision, 21 USC section 360k, which preempts any safety-related state rule regarding medical devices that is different from or in addition to federal requirements.

In Webb, the plaintiff claimed that her breast implants caused her to suffer many serious physical ailments. Her lawsuit included the usual panoply of causes of action for manufacturing defect, design defect, failure to warn, and breach of warranty. The court held that all were preempted.

The failure to warn, design defect, and warranty claims were clearly preempted. Any additional warning or different design would necessarily be different from or in addition to the federal scheme. Why do plaintiff lawyers even bother to include these claims anymore?

As usual, the real action resided in the manufacturing defect claim. As usual, the plaintiff argued for the narrow parallel claim exception, meaning that the claims were premised on violations that implicated both federal and state law. Also as usual, all the plaintiff could cite in the way of federal law were generic Quality System Regulations and Current Good Manufacturing Practices (CGMP). The plaintiff never specified how the defendant violated those regulations. The Webb court correctly held that any action premised on vague, overboard violations of general regulations would necessarily subject a defendant to standards different from or in addition to the MDA provisions.

There are some courts out there that permitted manufacturing defect claims based on vague CGMP violations to elude preemption. Those decisions are in the minority and are poorly reasoned. With the Webb decision in the books, that minority rule is even more in the minority, and the poor reasoning behind it is now even more obviously poor.

There are two other aspects of the Webb decision that the defense bar might find an opportunity to employ. First, the court rejected the plaintiff’s effort to include the manufacturer’s parent company as a defendant. The conclusory allegations of alter ego status could not survive a motion to dismiss. Second, the court denied the plaintiff’s request to amend her complaint. The plaintiff had not offered to amend her complaint after being served with the defendant’s pre-motion letter, and did not include a proposed amendment when she ultimately did seek permission to amend.

Thoreau ended Walden by announcing that “There is more day to dawn.” Not for the Webb complaint. Not for breast implant claims.

Back in the Pleistocene era when we toiled in law school, it seemed as if modern tort law developed as the result of a cross-continental game of ping pong played between the California and New Jersey courts. That still seems to be the case. Sure, there is the occasional, horrific verdict in flyover country that makes us stand up and take notice. But such cases seldom offer any doctrinal breakthrough; rather, they are barbaric yawps by courts determined to aid local plaintiff lawyers and wave every bit of prejudicial detritus along to the jury box. For legal rulings of consequence, whether admirable or execrable, count on California or New Jersey courts to say something interesting. (The trial bench in New Jersey has improved considerably. Fifteen years ago we wouldn’t have so readily embraced these Springsteen lyrics, but today we do: “Put your makeup on/fix your hair up pretty/And meet me tonight in Atlantic City.”)

Consider the new wave of breast implant litigation. There is a recent California decision that is so awful as to force us to avert our eyes. Someone else can (and will) blog about that one. Today’s favorable (from the perspective of sound policy, the Enlightenment, and the defense bar) premarket approval (“PMA”) breast implant preemption decision, D’Addario v. Johnson & Johnson et al., 2020 WL 3546750 (D.N.J. June 30, 2020), is Jersey justice at its finest – even when applying Connecticut law. The plaintiffs alleged that breast implants caused the patient to suffer from breast implant-associated anaplastic large cell lymphoma (“BIA-ALCL”). Look here for background on BIA-ALCL. The plaintiffs in D’Addario, the patient and her husband, filed claims for strict liability-manufacturing defect and failure to warn in violation of the Connecticut Product Liability Act (“CPLA”), negligent misrepresentation, breach of express and implied warranty, violation of the Connecticut Unfair Trade Practices Act (“CUTPA”), and loss of consortium.

The first issue was whether the misrepresentation, warranty, and CUTPA claims were subsumed by the CPLA. The issue was crystal clear regarding the misrepresentation and warranty claims. Even the plaintiffs agreed that the claims were subsumed by the CPLA. And let’s take a moment to praise states that have passed Product Liability Acts. New Jersey is one of them. Louisiana is another. So is Connecticut. These acts impose some degree of order on the chaos that product liability common law all too often is. We would do virtually anything – trade Joel Embiid to the Knicks, watch a season of 90 Day Fiance, or forego anesthetic for our next dental extraction – to see Pennsylvania replace its incoherent common law with a Product Liability Act.

The plaintiffs tried to save their CUTPA claim. A CUTPA claim seeks to redress a financial injury. That sort of thing is typically not regarded as a part of the traditional tort remedy for harm caused by a defective product. The plaintiffs in D’Addario tried to characterize their injuries as “financial” in nature, but the court did not buy it. The plaintiffs alleged that the defendants’ deceptive trade practices caused the patient to suffer from permanent and continuing injuries that require “ medical treatment and hospital expenses.” Sure, there is a financial component to all that, but, in the end, the plaintiffs’ injuries alleged were “ hose typically asserted in garden-variety products liability suits.” Goodbye CUTPA, hello CLPA.

The second issue was juicier: are the plaintiffs’ product liability claims preempted? By now it should be clear that product liability claims against these class III PMA breast implants are pretty much always going to be preempted. As usual, the plaintiffs claimed that they were alleging a “parallel” claim involving a violation of both federal and state law. And, as usual, the plaintiffs did not allege any such parallel claim. The manufacturing defect claim was preempted because the plaintiffs did not tie what they claimed was wrong with the device to any particular FDA PMA requirement. “It is not enough to state that a state law parallels federal law generally.” Vague, general claims of numerous regulatory violations do not cut it, nor do vague, general incantations of causation. The plaintiffs complained that the implants contained an endotoxin, but there was no allegation “that the FDA required the exclusion of this endotoxin.” Better luck next time. (And, sadly, the court dismissed without prejudice, so maybe there will be a next time.)

The D’Addario court also held that the failure to warn claim was preempted. The warning claim was either challenging FDA-approved warnings or alleging some form of fraud on the FDA (possibly failure to report claim), and either way was preempted. To the extent plaintiffs took issue with the original warning provided to consumers, healthcare providers, and the public, the court deemed the claim preempted because the company could not provide warnings or instructions different from those initially approved by the FDA. To the extent plaintiffs challenge the information provided to the FDA in its premarket approval application, the court concluded: (1) the plaintiffs “identified no separate state law duty to warn the FDA,” and (2) such a claim alleges fraud on the FDA and would be impliedly preempted under Buckman. Thus, the D’Addario court dismissed the plaintiffs’ failure-to-warn claim.

The misrepresentation and warranty claims are preempted for the same reasons. In addition, the breach of warranty claim “based on device safety and effectiveness fails because Plaintiffs fail to allege a violation of a federal regulation.” At bottom, the plaintiffs’ claims challenged the safety and effectiveness of the breast implants, and “to find for Plaintiffs, the Court would necessarily contradict the FDA’s determination of safety and effectiveness during premarket approval.”

Our cup runneth over. But wait, there’s more. The D’Addario court smacked down the all-too-common plaintiff sin of lumping together allegations against multiple defendants. The court held that all counts must be dismissed because “Plaintiffs’ Complaint broadly alleges Defendants’ misconduct but fails to allege the conduct for which each defendant is culpable.” The plaintiffs tossed in the usual allegations of “agents” or “alter egos,” without a shadow of a factual basis for such allegations. The D’Addario court put the issue elegantly: “It is not enough to say that ‘each of the defendants is responsible for everything.’” Look, pleadings that lump together multiple defendants contravene Federal Rule of Civil Procedure 8. They also fail to supply adequate notice. They are also just plain lazy. The Jersey court did not stand for it. Fuhggedaboutit.

The D’Addario court also dismissed the loss of consortium claim as a matter of law because it is a derivative claim and plaintiffs failed to assert any product liability claim.

We’ve lived in both Jersey and California. We love both places. But for sensible legal opinions (and better pizza), the Garden State comes out on top. And, as Ella sang, “If you don’t feel so hot / Go out to some Jersey spot / Whether you’re hep or not / The Jersey bounce’ll make you swing.”

By the way, if this case sounds familiar, maybe it us because it is similar to the Cashen v. Mentor case we covered here. In that case, a New Jersey court held that the Ohio Product Liability Act subsumed breast implant claims, and that claims were preempted. Maybe we should let New Jersey courts handle the law from all 50 jurisdictions.

Congrats to the defense team of Dustin Rawlin, Monee Hanna (Tucker Ellis), and Michael Zogby and Jessica Brennan (Faegre Drinker Biddle & Reath).

This week we are pleased to report on yet another breast implant case in which a plaintiff’s effort to circumvent preemption failed. In Diodato v. Mentor Workdwide LLC, 2020 WL 3402296 (D. Md. June 19, 2020), the plaintiff brought manufacturing defect, breach of warranty, and failure to warn claims that were typically skimpy in terms of laying out what federal law/regulation/specification the defendant allegedly violated.

The plaintiff had breast implants placed in 2014, experienced some symptoms (including a lump in her breast) in 2019, and had the implants removed at which time the left implant was found to have ruptured. Based on that concatenation of facts, the plaintiff alleged that the “hole” in the implant must have been due to a manufacturing defect and must have existed at the time the implant left the possession of the manufacturer and was simply undetected by the implanting physician because the manufacturer failed to warn the doctor to inspect the implant before surgery.

It turns out that there was a great big hole in the plaintiff’s legal theories.

In a blessedly concise opinion (we’re noticing a lot of that during this pandemic lockdown – it almost makes up for the horrible Covid dreams and Covid digestion problems) the Diodato court summarized the preemption analysis nicely: for claims against a class III medical device to survive, they must rest on conduct that both violates the federal scheme and also would give rise to recovery under state law even absent the federal violation. The court also wasted a minimum of time and ink in rejecting the plaintiff’s conclusory allegations, observing that “The Complaint does not disclose the foundation for Plaintiff’s belief that the rupture existed at the time the implant left Mentor’s possession. Likewise, the Complaint includes no discussion of Mentor’s manufacturing process or of any warnings Mentor provides.”

In concluding that the plaintiff’s manufacturing defect claim was preempted, the Diodato court held that “The Complaint alleges that a hole existed at the time the implant left Mentor’s possession, and reasons that the alleged existence of such a hole necessarily implies a manufacturing defect. However, in a case involving a Class III medical device, it is not enough that the plaintiff allege the existence of a deficiency. In addition, the plaintiff must allege ‘how the manufacturing process failed, or how it deviated from the FDA approved manufacturing process.’” So much for the manufacturing defect claim.

The failure to warn and warranty claims also flunked. Again, there was no alleged divergence between the defendant’s conduct and FDA requirements. Moreover, the Diodato court emphasized that the plaintiff entirely failed to address the product’s FDA-approved warnings, which specifically warn of rupture and notifies physicians that they should carefully inspect the MemoryGel implant before implantation for rupture or holes.

The Diodato court’s conclusion that these claims were preempted seems straightforward and inevitable, but is nonetheless important because so many breast implant claims seem to follow this same playbook. You might even call the Diodato case a gift from God. (That is what Diodato literally means.). It is hard for breast implant plaintiffs to get around preemption. Check that; it is almost always impossible.

All that being said, the dismissal in Diodato was without prejudice: “Though Plaintiff has failed to state a claim, the Court is not convinced that any amendment is certain to be futile.” Perhaps we will see an amended complaint. Perhaps (Probably?Certainly?) it will meet with an identical, preempted fate.

Congrats to the victorious defense team, which includes Dustin Rawlin, Monee Hanna, and Rachel Byrnes (all of Tucker Ellis) and Craig Thompson (Venable).

It’s a short work week, and we’ve got a short case for today’s discussion. Ebrahimi v. Mentor Worldwide LLC, 2020 WL 2510760 (9th Cir. May 12, 2020), eats up only one page when we set our printer to double-sided (which we always do now, since the pandemic work-at-home routine gobbles up paper and ink cartridges). As with Cuban coffee, a Hemingway story, or an episode of Children’s Hospital, short here means good. Very good. (We’ve written about the Ebrahimi litigation before, including here and here and here. Ebrahimi is clearly a gift that keeps on giving.)

The plaintiff in Ebrahimi alleged injuries from a silicone breast implant. Such implants are class III medical devices, which means that they went through the premarket approval process of the Medical Device Amendments to the Food, Drug, and Cosmetic Act. And that means that any state law tort claim that tries to impose requirements that are different from or in addition to FDA requirements would be preempted.

That preemption is pretty iron clad for design defect claims. Lately, we’ve seen more and more plaintiffs attempt to circumvent that preemption by styling their claim as manufacturing defect rather than design defect. That’s a bit of a change from what had been standard practice. More often, manufacturing defect claims were mere makeweight – the plaintiffs just about never really sniffed any evidence that the product at issue wandered from specs, and they would ultimately not even oppose the inevitable summary judgment motion. But the times they are a changing.

And yet, a rose by any other name would still be preempted. In Ebrahimi, the plaintiff claimed that the breast implant failed because the manufacturer violated the FDA’s Current Good Manufacturing Practices (“CGMP”). That’s the usual maneuver to try to state a parallel claim, which would elude preemption by alleging that the defendant deviated from a particular Pre-market approval or other FDA requirement applicable to the class III medical device. Anybody can claim a CGMP violation. But is more than an incantation of those four letters required? Bad courts say no, while good courts say yes. The district court was a good court, and granted the defendant’s Rule 12(b)(6) motion to dismiss.

Would the Ebrahimi appellate court also be a good court? Yes, and it is the court where we clerked, the Ninth Circuit. That circuit has long been unfairly maligned. Sure, it can let loose the occasional stinker (E.g., Stengel), but its overall output is as sound as any other court. Sometimes we get used to thinking negatively about something long past the point when it stopped being true. Adam Sandler, it turns out, is capable of fine acting. American cars are well-made. Philly sports fans are actually … okay, so some things don’t change. But the Ninth Circuit has smart judges who get things right.

The Ebrahimi court got it right: “Ebrahimi essentially contends that the court can plausibly infer that Mentor must have violated at least one of the FDA’s CGMPs by not catching her allegedly defective implants. However, even if more general FDA’s requirements are sufficient for a parallel claim, mere allegations suggesting that [Ebrahimi’s] particular breast implant[s] w[ere] defective do not show that [Mentor] failed to comply with the FDA’s Current Good Manufacturing Practices.”

Let’s count the things the Ninth Circuit got right in Ebrahimi:

1. It rejected the parallel claim.
2. It rejected the attempt to recast the claim as manufacturing defect.
3. It rejected the vague reliance on violations of CGMP.
4. It rejected the plaintiff’s reliance on a quasi res ipsa loquitur theory (that the defendant must have done something wrong because the device injured the plaintiff).

That’s a nice litany of correctness for such a short opinion.

Last week we discussed the Jacob v. Mentor Worldwide, LLC case, in which a pro se plaintiff alleged injuries from breast implants and complained that the manufacturer had inadequately warned of the risks. The claim boiled down to an attack on the FDA-approved labeling of a class III medical device, and that meant it was preempted. The court dismissed the case in its entirety, but gave leave to amend. We said we awaited the outcome of further proceedings.

Well, that was dim-witted of us. The opinion we blogged about was from last July. Any decent associate would have Shepardized the case and learned that the plaintiff had, in fact, amended the complaint, and the court did, in fact, dismiss it yet again. (That happened on December 10, 2019.) But in our self-quarantined, self-pitying, terrified news-watching, ice cream-eating state, we dropped the ball. Luckily, the attentive, diligent, victorious, omnicompetent defense counsel folks at Tucker Ellis filled us in on what the medical experts would call the sequelae.

The plaintiff, still acting pro se (you can see where this is going, right?), amended the complaint to allege claims of violation of premarket approval, breach of implied warranty, and lack of informed consent (failure to warn) against the manufacturer. But the pro se doctor plaintiff did not stop there. She also alleged a medical malpractice claim against her doctor, as well as claims against the American Society of Plastic and Reconstructive Surgeons (ASPRS) and the FDA.

Let’s start with the new defendants. The medical malpractice claim was barred by Florida’s medical-negligence four year statute of repose. That four year period precludes lawsuits against medical providers no matter when the plaintiff discovered the alleged negligence. Moreover, the plaintiff had not complied with the pre-lawsuit screening process that Florida requires (as do many other jurisdictions) plaintiffs to go through prior to filing a lawsuit. All of that is just another example of doctors getting much more favorable legal treatment than the smart and kind people who invent the products that allow doctors to do what they do. One would have thought that the pro se plaintiff, who was a doctor herself, might have been aware of these procedural hurdles. But we digress. The cause of action against the ASPRS failed because there was no privity between the plaintiff and that organization, nor was there any causal nexus in sight between the ASPRS and the plaintiff’s injuries. As for the claim against the FDA, there are two words that slam the door shut: sovereign immunity.

The amended claims against the manufacturer weren’t really so amended. The court held that the amendments did “not satisfy the Court’s July 17, 2019 order,” “failed to cure the deficiencies,” and were merely an attempt “to repackage the previously preempted claims.” The ‘new’ claims, at bottom, were still gripes about a failure to warn. That sorry sameness again banged against Riegel and Buckman preemption. This time the court dismissed the case with prejudice.

So at least when we likened the plaintiff to Sisyphus, we weren’t wrong. She pushed the rock, the amended complaint, up a hill, and it rolled right back down. Now we have learned that the plaintiff has filed an appeal with the Eleventh Circuit. It looks to us like yet another push of the rock up the hill.

No writer made as strong an impression on us in high school as Albert Camus. The opening of The Stranger is arresting: “Mother died today. Or maybe it was yesterday, I don’t know.” Our teacher pronounced The Plague to be an even better book, and he often quoted the bit about how we had “to be content to live only for the day, alone under the vast indifference of the sky.” [One of our time entries for yesterday is very similar.] Now, in the days of the coronavirus, it is hard not to bump into borrowed lines from The Plague, especially this one: “There are more things to admire in men than despise.” Perhaps Camus would rethink that after wandering down supermarket aisles denuded of toilet paper.

Camus has put us in the mood for absurdity, so let’s take a look at a pro se product liability lawsuit attempting to squeeze into the overused, incoherent, narrow-gap, Riegel “parallel claim” exception. In Jacob v. Mentor Worldwide, LLC, 2019 WL 3229010 (M.D. Fla. July 17, 2019), the plaintiff alleged that a breast implant ruptured and caused her to suffer from a “lupus-like syndrome.” The plaintiff had an M.D. after her name, but we don’t know what sort of doctor she was. What we do know is that she wasn’t much of a lawyer and, as the saying goes, had a fool for a client. The complaint included causes of action for negligence, failure to warn (of the foreign country origin and of the risk of failure), and manufacturing defect. The defendant, represented by actual lawyers, moved to dismiss on the grounds of express and implied preemption.

In responding to the motion, the plaintiff argued that she was adversely affected by the implants, that, as a doctor, she could attest to the harm she suffered, that the implants were unduly porous, and that the defendant’s failure to disclose the risk of syndromes mimicking connective tissues disease led to a misdiagnosis of her condition. What does any of that have to do with preemption? Not a thing. That made life easy for the court: “Defendant is correct that Plaintiff’s claims are the extent that Plaintiff is seeking to recover for Defendant’s alleged labeling or manufacturing requirements that are different from, or in addition to, those imposed by the FDA. Similarly, Defendant is correct that Plaintiff’s claims are preempted to the extent that Plaintiff is seeking to enforce federal requirements that are not grounded in traditional state tort law.”

The problem for the plaintiff is that all her claims fell into those preempted categories. Her claims talk about failures to warn the public, doctors, and the FDA (can you say Buckman?) and, most obviously preempted of all, failures to “revise the product labeling” and communicate the “true rate” of adverse events.

Moreover, the court was irked by the plaintiff’s wholesale failure to comply with the Federal Rules of Civil Procedure. Rule 8 insists on “short and plain” statements of jurisdictional bases and substantive claims. Each allegation must be “simple, concise, and direct.” Apparently, the plaintiff’s prose flunked these requirements. (She should have read Camus – talk about simple, concise, and direct!). Rule 10 requires numbered paragraphs, and the plaintiff did not even get that right.

The court gave the plaintiff 28 days to amend her complaint, but ordered that any claim that “seeks to recover for Defendant’s alleged labeling or manufacturing requirements that are different from, or in addition to, those imposed by the FDA, or seeks to enforce federal requirements that are not grounded in traditional state-tort law,” is dismissed with prejudice.

So the plaintiff was free to try again. That possibility puts us in mind of another work by Camus, The Rebel. The central image of that work (a philosophical investigation, not a novel) is the myth of Sisyphus.

In the meantime, we’ll leave you with another quote from The Plague: “What’s true of all the evils in the world is true of plague as well. It helps men to rise above themselves.”

From our days as a prosecutor, we built up a healthy respect for the power of conspiracy claims. They can be a splendid tool for dragging in more defendants, beating the rule against hearsay (coconspirator statement exception), beating the statute of limitations (a continuing conspiracy can bring even old statements up to date), and telling a story. But that story has to make sense, and conspiracy claims have knowledge requirements. That is also true for claims of aiding and abetting.

Some of those dynamics came into play in Angell v. Allergan Sales, LLC, 2019 U.S. Dist. LEXIS 142768 (M.D. Fla. Aug. 26, 2019). Angell is a civil, not criminal, case. The plaintiffs’ main beef was with a couple of plastic surgeons who allegedly performed unnecessary breast implant revision surgeries. Maybe it is because suing doctors is hard and seldom remunerative that the plaintiffs also tried to rope in the deep-pocket manufacturer via aiding/abetting and conspiracy theories. Those theories did not make a whole lot of sense, and that lack of sense likely made it easier for the court to throw out the claims against the manufacturer for failure to plead adequate knowledge.

The plaintiffs claimed that the plastic surgeons drummed up extra business for themselves by falsely telling patients that breast implants had failed and needed replacing. The surgeons exploited the manufacturer’s warranty program, whereby the manufacturer not only paid for the replacement product, but also paid part of the costs of the surgery. Thus, the surgeons could offer what looked like a good deal to the patients. It was not a good deal, because it put the patients through unnecessary surgeries, where bad things could, and occasionally did, happen. It was a good deal for the surgeons, because the scheme put more money in their pockets.

But was it a good deal for the manufacturer? It would seem not. You might even call the claim implausible. The scheme cost the manufacturer money. It also necessarily impugned the reputation of the products. But according to the plaintiffs, the manufacturer played along with the scheme, treating the free product and surgery subsidies as essentially kickbacks to the surgeons, who were high-volume customers.

The manufacturer filed a motion to dismiss the claims against it for aiding and abetting the surgeons’ scheme and for conspiring with them to commit fraud. The crux of the argument for dismissing the claims was that the plaintiffs had not alleged sufficient knowledge on the part of the manufacturer that the surgeons were perpetrating a fraud. The court agreed with the manufacturer and dismissed the claims, because the complaint merely alleged facts showing, at most, that the manufacturer should have known something was hinky. But “should have known” is not the same thing as actual knowledge.

Part of the conditions for FDA approval of the breast implants was that the manufacturer was required to inspect explanted breast implants to look for defects. The breast implants explanted by the defendant surgeons were, by and large, not defective. And yet the manufacturer continued to pay the warranty claims to the unscrupulous surgeons. But all that means is that the manufacturer might have been lax or dumb. Perhaps it should have investigated further. But it was under no duty to do so, and the plaintiffs admitted as much. Saying that the company had everything in its possession to conclude that 2+2=4 is not the same as saying that anyone in the company actually had done the math.

It really does come down to plausibility and our old friends Twombly and Iqbal. The Angell court could not infer that the manufacturer’s approval of the surgeons’ warranty claims “was atypical and indicative of its knowing assistance with the [surgeons’] fraudulent scheme, or merely reflective of a business decision not to scrutinize warranty claims in order to foster goodwill with doctors and patients.”

Thus, the court dismissed the claims against the manufacturer, rejecting the plaintiffs’ effort to drag it in via causes of action for aiding and abetting and conspiracy.