Photo of Bexis

Jacob v. Mentor Worldwide, LLC, 40 F.4th 1329 (11th Cir. 2022), is a very peculiar case and will probably leave some plaintiffs wondering if, maybe, they would be better off without their lawyers.

The plaintiff in Jacob sued the manufacturer of a Class III, FDA premarket-approved medical device.  As almost all our blog’s readers know, that means federal preemption of many, and often all, claims against the manufacturer.

And sure enough, that’s what happened in Jacob.  The first time around, in Jacob v. Mentor Worldwide, LLC, 389 F. Supp.3d 1024 (M.D. Fla. July 17, 2019), the defendant’s motion to dismiss was granted against all the plaintiff’s claims.  First, the plaintiff’s non-parallel claims were “preempted to the extent” that they would have imposed “alleged labeling or manufacturing requirements that are different from, or in addition to, those imposed by the FDA.”  Id. at 1028.  The warning claim was absolutely out, and the manufacturing defect claim, although it “may theoretically be sustainable,” wasn’t pleaded properly.  Id. at 1029.  In addition, the plaintiff asserted a failure-to-report claim that was “preempted to the extent that Plaintiff is seeking to enforce federal requirements that are not grounded in traditional state-tort law.”  Id. at 1028.  Plaintiff was granted leave to replead unpreempted claims.  Id. at 1030.

So plaintiff tried again – and failed – in Jacob v. Mentor Worldwide, LLC, 2019 WL 6766574 (M.D. Fla. Dec. 10, 2019).  This time, plaintiff pleaded “1) violation of [defendant’s] premarket approval; 2) breach of implied warranty; and 3) lack of informed consent (failure to warn).”  Id. at *1.  She also tried to sue three new defendants – a doctor, a medical society and the FDA itself.  Id.  The medical claims were time-barred, and the FDA won on sovereign immunity.  Id. at *2-3.  Since the “sole basis” of the PMA claim was “to enforce federal requirements that are not grounded in traditional state-tort law, that claim was preempted under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  2019 WL 6766574, at *3.  The other two new claims were not only preempted, but failed on independent state-law grounds – warranty for lack of privity and informed consent because it was inconsistent with the learned intermediary rule.  Id. at 3-4.

Thus, plaintiff lost.  But in that regard she didn’t do any worse than a lot of other plaintiffs suing over the same PMA medical device.  See Brooks v. Mentor Worldwide, LLC, 985 F.3d 1272 (10th Cir. 2021); Weber v. Allergan, Inc., 940 F.3d 1106 (9th Cir. 2019); Kline v. Mentor Worldwide, LLC, 2021 WL 1173279 (E.D. Cal. March 29, 2021); Webb v. Mentor Worldwide LLC, 453 F. Supp.3d 550 (N.D.N.Y. 2020); Dietz v. Allergan, Inc., 2020 WL 6220125 (Ill. Cir. Oct. 8, 2020); D’Addario v. Johnson & Johnson, 2020 WL 3546750 (D.N.J. June 30, 2020), amended complaint dismissed, 2021 WL 1214896 (D.N.J. March 31, 2021); Diodato v. Mentor Worldwide LLC, 2020 WL 3402296 (D. Md. June 19, 2020); Jacob v. Mentor Worldwide, LLC, 393 F. Supp.3d 912 (C.D. Cal. 2019); Vieira v. Mentor Worldwide, LLC, 392 F. Supp.3d 1117 (C.D. Cal. 2019), affd, 845 F. Appx. 503 (9th Cir. 2021); Tinkler v. Mentor Worldwide, LLC, 2019 WL 7291239 (S.D. Fla. Dec. 30, 2019); Williams v. Mentor Worldwide LLC, 2019 WL 4750843 (N.D. Ohio Sept. 30, 2019); Sewell v. Mentor Worldwide, LLC, 2019 WL 4038219 (C.D. Cal. Aug. 27, 2019), affd, 847 F. Appx. 380 (9th Cir. 2021); Billetts v. Mentor Worldwide, LLC, 2019 WL 4038218 (C.D. Cal. Aug. 27, 2019), affd, 847 F. Appx. 377 (9th Cir. 2021); Stampley v. Allergan USA, Inc., 2019 WL 1604201 (Mag. W.D. La. March 15, 2019), adopted, 2019 WL 1601613 (W.D. La. April 15, 2019); Cashen v. Johnson & Johnson, 2018 WL 6809093 (New Jersey Super. Law Div. Dec. 24, 2018); Shelp v. Allergan, Inc., 2018 WL 5734664 (W.D. Wash. Nov. 2, 2018), amended complaint dismissed, 2018 WL 6694287 (W.D. Wash. Dec. 20, 2018); Laux v. Mentor Worldwide, LLC, 2017 WL 5186329 (C.D. Cal. Nov. 8, 2017), affd, 786 F. Appx. 84 (9th Cir. 2019); Ebrahimi v. Mentor Worldwide LLC, 2017 WL 4128976 (C.D. Cal. Sept. 15, 2017), amended complaint dismissed, 2018 WL 2448095 (C.D. Cal. May 25, 2018), second amended complaint dismissed, 2018 WL 6829122 (C.D. Cal. Dec. 27, 2018), aff’d, 804 F. Appx. 871 (9th Cir. 2020); Ortiz v. Allergan, Inc., 2015 WL 5178402 (S.D.N.Y. Sept. 4, 2015); Lindler v. Mentor Worldwide LLC, 2014 WL 6390307 (D.S.C. Oct. 23, 2014); Malonzo v. Mentor Worldwide, LLC, 2014 WL 2212235 (N.D. Cal. May 28, 2014); Couvillier v. Allergan, Inc., 2011 WL 8879258 (Mag. W.D. La. Jan. 20, 2011), adopted, 2011 WL 8879259 (W.D. La. Feb. 9, 2011); Williams v. Allergan USA, Inc., 2009 WL 3294873 (D. Ariz. Oct. 14, 2009) (all plaintiffs having all claims dismissed as a matter of law).

But did we mention that this particular plaintiff, Ms. Jacob, was pro se?  For any non-lawyer readers, that means the plaintiff was representing herself, without a lawyer.

At least before she got a lawyer on appeal, she was.

And to the court of appeals in Jacob, 40 F.4th 1329, that made all the difference.  “Because [plaintiff] is a pro se litigant, we liberally construe her pleadings, holding them to a less stringent standard than pleadings drafted by attorneys.”  Id. at 1334 (citation and quotation marks omitted).  Apparently, such “less stringent” review even applies once the plaintiff obtains appellate counsel.

And, boy, was the review “less stringent.”

Her belatedly retained counsel, on appeal, at least had the good sense to abandon everything except the manufacturing defect claim – so no more failure to report, no more warning, no more supposed “informed consent,” and no more warranty.  That, at least, had the appellate court considering only the claim that the district court had allowed could “theoretically be sustainable.”  Id. at 1334.  But plaintiff still had a problem.  Her amended complaint, filed after the district court’s first dismissal, omitted the original manufacturing-based claim.  That’s a problem because “[o]rdinarily, an amended pleading supersedes the former pleading.”  Id.

No problem, held the Eleventh Circuit, she was pro se.

But we have also held that a plaintiff does not waive his right to appeal the dismissal of a claim . . . by amending the complaint and omitting the dismissed claim, provided that repleading the dismissed claim would have been futile. . . .  [T]he district court rejected as insufficient [plaintiff’s] claims alleging that [defendant] committed parallel violations of state and federal law.  To be sure, the district court said that some of [plaintiff’s] claims “may theoretically be sustainable” and granted her leave to amend.  But the district court did not identify which claims, if any, it thought could “theoretically” survive a motion to dismiss or how. . . .  [Plaintiff] reasonably concluded that repleading her claims in the same way would have been futile.

Id. at 1334-35. Thus, unless the district court affirmatively tells a pro se plaintiff exactly which claims were “theoretically” viable and “how” to amend them, the claims will be treated as “futile” – even though the district court had written in the opinion that they weren’t.

It gets worse.

Having first resurrected plaintiff’s manufacturing defect claims from what would have been waiver for a represented party, Jacob next found that this claim escaped preemption.  Manufacturing defect claims can be pleaded as parallel claims, even though this plaintiff didn’t plead any or argue any of the “parallel claim” attributes necessary to fit through the “narrow gap.”  Id. at 1336.

No problem, held the Eleventh Circuit, she was pro se.

“[Plaintiff] replies that she plausibly alleged that [defendant] violated parallel state and federal duties − which is enough for her pro se pleading to survive a Rule 12(b)(6) motion − and developed those arguments in later filings.  We agree with [plaintiff].”  Id.  Nobody else would be allowed to sandbag the district court by not making the necessary arguments until on appeal, but under Jacob, a pro se plaintiff can.  Plaintiff’s “preservation” – if it can be called that, was rather indirect.  First, she had argued “that [defendant’s] product “failed” to “meet very basic standards of safety” in certain ways.  Id. at 1337. Okay, but nowhere did she allege, or argue, that those ways violated the FDCA.  Second, she “opposed [defendant’s] preemption argument, contending that she was ‘personally aware of a case similar to mine that has passed preemption in another state’ and that ‘[t]he factors surrounding my case are equally strong, if not more.’”  Id. But apparently the plaintiff never identified what this case was, what its reasoning was, or how her own facts compared.  Again, no represented party could get away with anything close to that.

No problem, held the Eleventh Circuit, she was pro se.

“Because the district court adopted [defendant’s] preemption argument in dismissing [plaintiff’s] complaint, [she] may challenge the district court’s ruling accepting those arguments on appeal.”  Id.  Wow!  As long as a defendant makes an argument that the court adopts, apparently pro se plaintiffs don’t have to preserve any particular arguments themselves.

Then Jacob effectively abolished TwIqbal for pro se plaintiffs:

[Plaintiff] alleges that [defendant] manufactured the [device] using “improper and non-conforming component parts and materials, in violation of Florida law” and that the design was also “inconsistent with [the] specifications and conditions of the FDA’s Quality System Regulations and design control requirements.”

Id.  That’s it for the supposed “parallel” claims.  What the offending “component” or “material” was isn’t stated, nor how anything was “inconsistent” with some unidentified “regulation” or “requirement.”  Nor was there any allegation that the device, as sold, deviated from the manufacturer’s intended design, which is a requirement of Florida law, just as it is everywhere else.  E.g., In re Standard Jury Instructions in Civ. Cases − Rep. No. 09-10 (Products Liability), 91 So.3d 785, 788 (Fla. 2012) (“A product is unreasonably dangerous because of a manufacturing defect if it was not built according to its intended design. . . .”).

No problem, held the Eleventh Circuit, she was pro se.

[Defendant] argues that [plaintiff’s] claims fail because they are not pleaded with sufficient detail, relying heavily on our decision in Wolicki-Gables [v. Arrow International, Inc., 634 F.3d 1296 (11th Cir. 2011). . . .  [U]nlike the plaintiff in Wolicki-Gables [plaintiff] is a pro se litigant whose pleadings are held to a less stringent standard than pleadings drafted by attorneys and will, therefore, be liberally construed.

Jacob, 40 F.4th at 1338.  Furthermore, “the federal requirements at issue need not be device specific..”  Id.

But what about the other side of the “narrow gap,” implied preemption?

No problem, held the Eleventh Circuit, she was pro se.

“[C]onstruing her pro se pleadings liberally, [plaintiff’s] manufacturing defect claims are sufficiently pleaded.”

[Plaintiff’s] state-law claims also avoid implied preemption.  We have held that a . . . state-law negligence claim based on a manufacturing defect theory “falls into the category of traditional state tort law that is not impliedly preempted”. . . .   Similarly, a Florida state-law strict liability claim based on a manufacturing defect theory enforces “the traditional state tort duty of a manufacturer to use care in manufacturing the medical device.  No duty is owed to the FDA.”

Id. at 1339 (quoting Mink v. Smith & Nephew, Inc., 860 F.3d 1319, 1330-31 (11th Cir. 2017)).

Thus, the plaintiff in Jacob avoids the fate of preemption-based dismissal that has properly and correctly befallen so many other plaintiffs – all represented by counsel – who brought similar lawsuits involving the same class of PMA medical devices.  We can imagine all of these other plaintiffs shaking their heads, wondering why they even bothered signing away 33% or more of their potential recoveries in order to retain counsel to file claims that were ultimately held preempted.  If every court was as content to indulge the foibles of (at least formerly) pro se plaintiffs as Jacob was, would plaintiffs do better without any lawyers at all?