There was a time when we paid quite a bit of attention to the circumstances under which a participant in a clinical trial could impose liability on the sponsor of the clinical trial. We even tried a case to a defense verdict for the sponsor of a clinical trial in a case where the plaintiff claimed, as to our client and the investigator defendant, that his HIV misdiagnosis should have been reversed during the clinical trial, which involved a medication switch for patients well controlled under an existing treatment regimen. Leading up to that trial and after it, we gained a pretty good understanding of the law on liability related to clinical trials. For instance, cases have looked at whether the learned intermediary doctrine is somehow disrupted when the prescription is written by a clinical trial investigator.  (Like here and here)  Cases have also looked at whether participants in a clinical trial can compel the sponsor to continue providing them the study drug after the trial ends.  (Like here and here)  (Legislative efforts to encourage drug manufacturers to sponsor clinical trials for rare conditions have been discussed before, like here.)

For some reason, and with one recent exception, it seems like there have been fewer of these cases in the last few years. There are certainly lots of clinical trials going on and, presumably, patients in them who might claim some injury, physical or otherwise, from their participation. Could it be that the putative plaintiffs have backed off of trying to sue clinical trial sponsors? Could it be that the plaintiff lawyers have read the rulings and decided these cases are not worth bringing? Could it be that the cases still exist, but we are not seeing decisions from them caught in the net Bexis uses to find blogworthy decisions?

We may never know the real answer, but we did see an appellate decision from New York last week in Wholey v. Amgen, Inc., — N.Y.S.3d –, 2018 WL 4866993 (N.Y. App. Div. Oct. 9, 2018). Wholey involved claims of injury from the use of a well-known and often-studied FDA-approved prescription drug both during and after a clinical trial. The defendants filed motions to dismiss, which were granted in part and denied in part, and an appeal ensued. This is the part we care about:

As the sponsors of a clinical trial, defendants owed no duty to the plaintiff Lauren Wholey, as enrollee in the trial (see Sykes v. United States, 507 Fed. Appx. 455, 462 (6th Cir. 2012); Abney v. Amgen, Inc., 443 F.3d 540, 550 (6th Cir. 2006)). Thus, her claims concerning the drug Enbrel must be limited to those that allegedly arose after she stopped participating in the trial and was prescribed the drug as a patient.

Id. at *1. When we said that was the part we care about, we meant it. That is the full discussion of the issue of liability for the sponsors of a clinical trial. No duty means no liability. We appreciate the finality and brevity of the analysis. We emulate the brevity here.

 

In a classic case of overreaching, plaintiffs in the In re Abilify MDL, sought sanctions against the defendant for not preserving emails dating between 2002 and 2006 – more than a decade before the start of the litigation. We have a hard time even contemplating what a duty to preserve that covered those emails would begin to look like. Fortunately, so did the court. Not for lack of argument by plaintiffs. They tried everything from industry-wide events to FDA requirements to alleged breach of a pharmacovigilance agreement between defendants. But this everything plus the kitchen sink approach couldn’t mask the lack of merit of any of their arguments.

Before 2007, defendant had a document retention policy of 60-days for emails. In re Abilify (Aripiprazole) Prods. Liab. Litig., 2018 U.S. Dist. LEXIS 172536 at *3 (N.D. Fla. Oct. 5, 2018).  Plaintiffs argued that destruction of email before that time constituted spoliation and warranted sanctions against defendant. A question that is governed by Federal Rule of Civil Procedure 37(e). Sanctions for failure to preserve electronically stored information (“ESI”) are permissible when ESI should have been preserved “in the anticipation or conduct of the litigation,” and the ESI was lost or destroyed due to the party’s failure to take reasonable steps to preserve and the ESI cannot be restored or replaced. All four of those conditions must be met. Making the only question for the court in this case – whether defendant had to duty to preserve emails from 2002-2006. It did not.

The court cites 11th Circuit precedent that the duty to preserve doesn’t arise until “litigation is pending or reasonably foreseeable.” Id. at *5. So plaintiffs’ first argument was that defendant should have reasonably anticipated the litigation long before the first lawsuit was filed in 2016. Plaintiffs’ argument was that the duty to preserve can be triggered by “industry-wide events, regardless of the status of individual litigation.” Id. at *7. But this theory is too outward focused. The industry-wide events plaintiffs rely on are scientific literature, other lawsuits, and adverse event reports. The early literature pertains to other drugs in the same class as Abilify and the question of whether that literature was sufficient to place defendant on notice of the risk of compulsive gambling is a “hotly contested issue in the case.” Id. at *10. Making it a

quantum leap to conclude that [defendant] had a duty to preserve all of its emails . . . simply because there may have been some scientific literature published in the late 1990’s and early 2000’s that addressed [the class of] drugs and a possible link to compulsive gambling.

Id. Relying on adverse events in clinical trials was similarly insufficient to place defendant on notice of possible litigation. Id. at *12. Other litigation about different drugs was also insufficient to put defendant on notice that it too would be sued a decade later.

The Court is not aware of any case law, which requires a drug manufacturer to preserve all of its documents where the manufacturer has not received any notice of the potential threat of litigation other than simply knowledge that there was other litigation involving a different drug prescribed for different conditions that may fall within the very broad category of dopaminergic drugs. Such an overly broad view of the duty of preservation would impose on every drug manufacturer a duty to preserve all of its documents, without regard to subject matter or time frame. That is at odds with the requirement that a party must preserve documents when it reasonably anticipates litigation.

Id. at *11 (“reasonable anticipation” is more than “mere possibility”).

Plaintiffs’ last industry-wide argument was that defendant should have put a legal hold in place based on a subpoena from the DOJ in an investigation concerning off-label promotion of Abilify. The court quickly pointed out that that investigation did not involve the safety or compulsive gambling information at issue in the MDL, but more importantly a demand from the DOJ at best triggers a duty to preserve that runs to the DOJ. That duty cannot be shifted to be owed to these plaintiffs in a separate action. Id. at *13-14.

Disregarding all of these external events to focus on the case specifics, plaintiffs’ counsel didn’t start advertising for plaintiffs until 2013 and didn’t threaten litigation until 2014. Id. at *8. So, in looking at the action of these plaintiffs, the earliest defendant could have anticipated litigation was 2014. Id.

We’re not done yet. Plaintiffs tried another duty-shifting argument, this time with the FDA.  Drug manufacturers are required to preserve adverse event data, including correspondence, for 10 years. Plaintiffs latched on to the “correspondence” language to argue that there must have been AE-related emails that were deleted. But even if true, “failure to comply with a regulatory obligation does not create a duty to preserve for purposes of a spoliation motion.” Id. at *15-16. The “obligation . . . runs to the FDA and not the plaintiffs in this case.” Id. at *16. The emails at issue were gone a decade before the defendant owed an obligation to the plaintiffs as opposed to the FDA.

Plaintiffs’ last attempt to find an earlier trigger was to point to the pharmacovigilance agreement between defendant and another manufacturer. The agreement required both parties to keep and make available to each other all of their adverse event information, and the language once again included correspondence. Id. at *19. There was no allegation that any manufacturer did not properly maintain their adverse event data, only that if the agreement included correspondence then there “must have been” relevant correspondence in the deleted emails. But putting aside plaintiffs’ obvious twisting of the true meaning of the agreement:

The more fundamental problem with Plaintiff’s argument is that Plaintiffs as non-parties to the Pharmacovigilance Agreement cannot enforce the obligations in the agreement to their benefit.

Id. Plaintiffs attempt to rely on state-law to make their case, but (1) Rule 37(e) prohibits reliance on state law to create a basis for discovery sanctions and (2) even under Florida law, the plaintiff has to be a party to the contract to use its breach as a basis for spoliation. Id. at *21.

Because defendant had “no inkling” in 2004 that potential claimants like plaintiffs even existed, there is no evidence that the auto-delete document policy in effect at that time was anything other than an ordinary business policy. Simply stated, defendants were not acting in bad faith. Id. at *23-24. Even more simply stated, defendants can’t be held to the standard of Carnac the Magnificent.

 

We’re blogging today because of an annoyance – another of these nuisance motions filed by plaintiffs that should be skirting the border of Rule 11, but unfortunately isn’t.  Our particular gripe is a motion to strike a defendant’s pleaded defenses (please don’t call them “affirmative” defenses unless they really are) because they supposedly don’t meet the pleading requirements of Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), and Ashcroft v. Iqbal, 556 U.S. 662 (2009) (collectively “TwIqbal”).  These motions are meritless for the simple reason that defenses, unlike pleading of affirmative claims, are not governed by Fed. R. Civ. P. 8(a) – the rule giving rise to TwIqbal – but rather by Fed. R. Civ. P. 8(c).  Rule 8(a), governing “claim[s] for relief,” requires “a short and plain statement of the claim showing that the pleader is entitled to relief.”  Rule 8(c), governing “affirmative defenses,” requires only that the pleader “must affirmatively state any avoidance or affirmative defense,” with no requirement of any “showing.”  Thus, the proper response should be that “[c]ourt[s] do[] not hold defenses to the strictures of Twombly and Plaintiffs’ arguments based upon Twombly and its progeny are roundly rejected.” Hamblen v. Davol, Inc., 2018 WL 1493251, at *3 (M.D. Fla. March 27, 2018).

So there.

The text of the rule should end the matter, but as with removal before service, plaintiffs advance various extra-textual dodges.  Those excuses amount to little more than, “because we have to obey TwIqbal, defendants should, too,” whatever the relevant rules actually say.  That “double standard” argument deserves a barnyard expletive, but, instead it gets this blogpost – and this quote:  “There is nothing dumber than a motion to strike boilerplate affirmative defenses; it wastes the client’s money and the court’s time.”  Raymond Weil, S.A. v. Theron, 585 F. Supp.2d 473, 489-90 (S.D.N.Y. 2008).

We start with Twombly:

[A] plaintiff’s obligation to provide the grounds of his entitlement to relief requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do. Factual allegations must be enough to raise a right to relief above the speculative level.

550 U.S. at 555 (lots of citations and quotation marks omitted) (emphasis added).  Likewise in Iqbal, the Court made clear that all Rule 8(a) claims must adhere to the same pleading standard:

Under Federal Rule of Civil Procedure 8(a)(2), a pleading must contain a “short and plain statement of the claim showing that the pleader is entitled to relief. . . .” [Rule 8(a)] demands more than an unadorned, the-defendant-unlawfully-harmed-me accusation.  A pleading that offers labels and conclusions or a formulaic recitation of the elements of a cause of action will not do.  Nor does a complaint suffice if it tenders naked assertions” devoid of further factual enhancement.  To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face.  A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.

Id. at 677-78 (again with lots of citations and quotation marks omitted) (emphasis added).

None of that has ever been true for the defenses and avoidances that Rule 8(c) simply requires be “affirmatively stated.”  “The Federal Rules of Civil Procedure do not require a heightened pleading standard for a . . . defense.”  Montgomery v. Wyeth, 580 F.3d 455, 468 (6th Cir. 2009).  “When [TwIqbal] restated the requirements of Fed. R. Civ.P. 8, the Justices did not revise the allocation of burdens concerning affirmative defenses; neither [decision] mentions affirmative defenses.”  Davis v. Indiana State Police, 541 F.3d 760, 763-64 (7th Cir. 2008).  “[A]n affirmative defense ‘need not be articulated with any rigorous degree of specificity, and is sufficiently raised for purposes of [Rule 8] by its bare assertion.’”  In re Frescati Shipping Co., 886 F.3d 291, 313 (3d Cir. 2018) (quoting Moody v. Atlantic City Board of Education, 870 F.3d 206, 218 (3d Cir. 2017)).

[Plaintiff] simply argues that the affirmative defense pleadings were defective simply because they were “bare one-liners.”  Because the applicable test does not require the district court to count the lines of text that an invoked defense uses and because the defendant’s pleading gave [plaintiff] notice of the defense, the district court did not err in permitting the defendants to assert their affirmative defenses in their answer.

Lawrence v. Chabot, 182 F. Appx. 442, 457 (6th Cir. 2006). In Twombly “the Justices did not revise the allocation of burdens concerning affirmative defenses” nor did Twombly “mention[] affirmative defenses in general.” Davis v. Indiana State Police, 541 F.3d 760, 763-64 (7th Cir. 2009); accord Brownmark Films, LLC v. Comedy Partners, 682 F.3d 687, 691 (7th Cir.2012) (declining to apply TwIqbal “heightened pleading standards” to affirmative defenses).  “[T]he ‘fair notice’ required by the pleading standards only requires describing the defense in ‘general terms.’”  Kohler v. Flava Enterprises, Inc., 779 F.3d 1016, 1019 (9th Cir. 2015).  Given the express language of Rule 8, arguments that, because plaintiffs’ “claims” are subject to TwIqbal, defendants’ defenses should be, too, are paradigms of false equivalence.

Thus, case after case has held that TwIqbal does not apply to affirmative defenses.  One particularly detailed discussion of the reasons why occurred in this product liability case involving a prescription drug:

Courts offer at least three justifications for applying a less stringent standard to affirmative defenses.  First, these courts maintain that the Twombly standard is rooted in Rule 8(a)’s “showing” requirement.  As proof, they cite various parts of the Twombly opinion, including one particularly telling passage where the United States Supreme Court explains that “Rule 8(a)(2) still requires a ‘showing,’ rather than a blanket assertion, of entitlement to relief.”  Juxtaposing the “showing” language in Rule 8(a) with the “stating” language in Rules 8(b) and (c), these same courts then point out the difference between requiring the statement of something and requiring the showing of something. . . .

Second, relying on well-settled principles of statutory construction, courts applying a lower pleading standard to affirmative defenses maintain that if the drafters of Rule 8 had intended for the “showing” requirement to apply to the pleading of defenses, they knew how to say it, as demonstrated by Rule 8(a), and would have written that requirement into Rules 8(b) and (c).  The drafters of Rules 8(b) and (c) having not done so, these courts reason, the judiciary is not free to engraft the “showing” requirement onto these rules itself.  Thus, these courts conclude, where, as with Rule 8, the language of the provision being construed is clear, the analysis ends with the language, and the court may not take into account policy considerations.

Lastly . . ., a lower pleading standard is consistent with binding case law.  While the Eleventh Circuit has addressed affirmative defenses, it has not extended the pleading requirements of Rule 8(a) beyond claims.  Rather, the appeals court has stressed that notice is the main purpose of Rule 8(c). . . .

Based on these rationales, this Court joins the growing number of courts in this circuit and others in finding that a lower pleading standard applies to affirmative defenses.  Such an approach is faithful both to the letter and the spirit of Rules 8(b) and (c), as revealed through the plain language of Rule 8 and Eleventh Circuit precedent.

Tsavaris v. Pfizer, Inc., 310 F.R.D. 678, 681-82 (S.D. Fla. 2015) (once again omitting lots of quotations and citations).  Similarly, the court in Tardif v. City of New York, 302 F.R.D. 31 (S.D.N.Y. 2014), summarized the numerous reasons why TwIqbal does not apply to defenses:

(1) textual differences between Rule 8(a), which requires that a plaintiff asserting a claim show entitlement to relief, and Rule 8(c), which requires only that the defendant state any defenses;

(2) a diminished concern that plaintiffs receive notice in light of their ability to obtain more information during discovery;

(3) the absence of a concern that the defense is “unlocking the doors of discovery”;

(4) the limited discovery costs, in relation to the costs imposed on a defendant, since it is unlikely that either side will pursue discovery on frivolous defenses;

(5) the unfairness of holding the defendant to the same pleading standard as the plaintiff, when the defendant has only a limited time to respond after service of the complaint while plaintiff has until the expiration of the statute of limitations;

(6) the low likelihood that motions to strike affirmative defenses would expedite the litigation, given that leave to amend is routinely granted;

(7) the risk that a defendant will waive a defense at trial by failing to plead it at the early stage of the litigation;

(8) the lack of detail in Form 30, which demonstrates the appropriate pleading of an affirmative defense; and

(9) the fact that a heightened pleading requirement would produce more motions to strike, which are disfavored.

Id. at 33-34 (citations and quotation marks omitted).  Accord, e.g.:

First Circuit

Vazquez-Robles v. CommoLoco, Inc., 186 F. Supp.3d 138, 149 (D.P.R. 2016) (“the Court concludes that [TwIqbal] do not apply to affirmative defenses”); Hansen v. Rhode Island’s Only 24 Hour Truck & Auto Plaza, Inc., 287 F.R.D. 119, 123 (D. Mass. 2012) (“the Court declines to apply the heightened pleading standard to defendants’ affirmative defense”).

Second Circuit

Leviton Manufacturing Co. v. Pass & Seymour, Inc., 264 F. Supp.3d 421, 427 (E.D.N.Y. 2017) (“The overwhelming majority view, to which I subscribe, is that the concept of plausibility has no application to affirmative defenses.”); Sibley v. Choice Hotels International, Inc., 304 F.R.D. 125, 133 (E.D.N.Y. 2015) (“a defendant must only ‘affirmatively state’ an affirmative defense pursuant to Rule 8(c) and need not meet the [TwIqbal] plausibility standard.”); Serby v. First Alert, Inc., 934 F. Supp.2d 506, 516 (E.D.N.Y. 2013) (“There is no requirement under Rule 8(c) that a defendant plead any facts at all.”).

Third Circuit

Schmidt v. Ford Motor Co., 198 F. Supp.3d 511, 526 n.7 (E.D. Pa. 2016) (following Tyco Fire); Gross v. Weinstein, Weinburg & Fox, LLC, 123 F. Supp.3d 575, 582-83 (D. Del. 2015) (declining to apply the plausibility standard found in TwIqbal to affirmative defenses); Mifflinburg Telegraph, Inc. v. Criswell, 80 F. Supp.3d 566, 574 (M.D. Pa. 2015) (“‘stating’ an affirmative defense provides ‘fair notice’ without specific factual allegations for each element of the defense”); Newborn Brothers Co. v. Albion Engineering Co., 299 F.R.D. 90, 97 (D.N.J. 2014) (“This Court joins those courts . . . which have held that the heightened [TwIqbal] standard is not applicable to the pleading of affirmative defenses under Rule 8(c)”); Senju Pharmaceutical Co. v. Apotex, Inc., 921 F. Supp.2d 297, 303 (D. Del. 2013) (“Due to the differences between Rules 8(a) and 8(c) in text and purpose, [TwIqbal] do not apply to affirmative defenses, which need not be plausible to survive. An affirmative defense must merely provide fair notice of the issue involved.”); XpertUniverse, Inc. v. Cisco Systems, Inc., 868 F. Supp.2d 376, 383 n.3 (D. Del. 2012) (“the majority of the District Courts in the Third Circuit have rejected the application of [TwIqbal] to defensive pleadings”; “[plaintiff] has failed to convince this Court that [TwIqbal] apply to . . . defensive pleadings”); Tyco Fire Products LP v. Victaulic Co., 777 F. Supp.2d 893, 900-01 (E.D. Pa. 2011) (“An affirmative defense need not be plausible to survive; it must merely provide fair notice of the issue involved”).

Fourth Circuit

Baron v. Directv, LLC, 233 F. Supp.3d 441, 444 (D. Md. 2017) (“a defendant’s affirmative defenses need not be pleaded according to the [TwIqbal] standard”); LBCMT 2007-C3 Urbana Pike, LLC v. Sheppard, 302 F.R.D. 385, 387 (D. Md. 2014) (“A plaintiff’s complaint invokes the jurisdiction of the court and seeks affirmative relief.  An affirmative defense does neither; consequently, it is reasonable to interpret the wording of Rule 8(b) and (c), which govern defenses and affirmative defenses, differently from the interpretation given by the Supreme Court to the distinctive wording of Rule 8(a) applicable to claims for relief.”); Lockheed Martin Corp. v. United States, 973 F. Supp.2d 591, 593-95 (D. Md. 2013) (“the Court declines to hold that [TwIqbal] apply to affirmative defenses”); Guessford v. Pennsylvania National Mutual Casualty Insurance Co., 918 F. Supp.2d 453, 468 (M.D.N.C. 2013) (“the Fourth Circuit has not directly addressed the implications [TwIqbal] on the pleading of affirmative defenses.  As such, the Court will follow the language of the Federal Rules of Civil Procedure and the Fourth Circuit’s present interpretation of that language, which requires only that a party ‘affirmatively state any avoidance or affirmative defense’ in order to provide fair notice to a plaintiff of the nature of the affirmative defense.”); Odyssey Imaging, LLC v. Cardiology Assocs., LLC, 752 F. Supp.2d 721, 725-26 (W.D. Va. 2010) (“because of these [textual] differences, Rules 8(b) and 8(c) do not require a court to subject defenses pleaded by a defendant to the same stringent plausibility standards that [TwIqbal] demand of claims for relief under Rule 8(a).”).

Fifth Circuit

Blount v. Johnson Controls, Inc., ___ F.R.D. ___, 2018 WL 4224465, at *2-3 (S.D. Miss. Sept. 5, 2018) (“The text of Rules 8(a), (b), and (c) reflects clear differences with respect to the purposes of complaints and responsive pleadings and the showings they require.  Those differences distinguish Twombly.”); United States ex rel. Parikh v. Citizens Medical Center, 302 F.R.D. 416, 418-19 (S.D. Tex. 2014) (“This Court is persuaded that the traditional fair notice standard, without the [TwIqbal] gloss, applies to an affirmative defense.”); Deniece Design, LLC v. Braun, 953 F. Supp.2d 765, 776 (S.D. Tex. 2013) (“[TwIqbal] do not apply to the pleading of” various affirmative defenses); EEOC v. Rock-Tenn Services Co., 901 F. Supp.2d 810, 832 (N.D. Tex. 2012) (declining to apply the plausibility standard found in TwIqbal to affirmative defenses); SEC v. Cuban, 798 F. Supp.2d 783, 795 n.13 (N.D. Tex. 2011) (“this court has declined so far to apply the plausibility standard to affirmative defenses”).

Sixth Circuit

Martin v. Trott Law, P.C., 265 F. Supp.3d 731, 737 (E.D. Mich. 2017) (TwIqbal “generally do not apply to pleading affirmative defenses”); Pidcock v. Schwab, 569 B.R. 463, 480 (N.D. Ohio 2017) (“The majority of courts considering this issue . . . follow[] the majority approach in finding that the [TwIqbal] pleading requirements do not apply to affirmative defenses.”).

Seventh Circuit

Ayotte v. Boeing Co., 316 F. Supp.3d 1066, 1076 (N.D. Ill. 2018) (“an affirmative defense need not be plausible to survive, and must merely provide fair notice of the issue involved”); Hancock v. Illinois Central Sweeping LLC, 73 F. Supp.3d 932, 942 (N.D. Ill. 2014) (“An affirmative defense may be pleaded in general terms and will be held to be sufficient as long as it gives the plaintiff fair notice of the nature of the defense.”).

Eighth Circuit

Wilkinson v. High Plains Inc., 297 F. Supp.3d 988, 993 (D.N.D. 2018) (“an affirmative defense . . . need not be articulated with any rigorous degree of specificity, and is sufficiently raised for purposes of Rule 8 by its bare assertion”); Summers Manufacturing Co. v. Tri-Cty. AG, LLC, 300 F. Supp.3d 1025, 1044 (S.D. Iowa 2017) (“the Court agrees with the analysis of fellow district courts . . . and finds the plausibility standard inapplicable to affirmative defenses”); Infogroup, Inc. v. DatabaseLLC, 95 F. Supp.3d 1170, 1193 (D. Neb. 2015) (“while defenses must be asserted in a responsive pleading, they need not be articulated with any rigorous degree of specificity, and may be sufficiently raised for purposes of Rule 8 by their bare assertion”); FDIC v. Dosland, 298 F.R.D. 388, 393-94 (N.D. Iowa 2013) (“I decline the [plaintiff’s] invitation to require the pleading of affirmative defenses to the [TwIqbal] ‘plausibility’ pleading standard”); Strauss v. Centennial Precious Metals, Inc., 291 F.R.D. 338, 343 (D. Neb. 2013) (“[TwIqbal] pleading standard [is] inapplicable to those affirmative defenses”); Wells Fargo & Co. v. United States, 750 F. Supp.2d 1049, 1051 (D. Minn. 2010) (“[TwIqbal] do not apply to the pleading of affirmative defenses.”).

Ninth Circuit

Rosen v. Masterpiece Marketing Group, LLC, 222 F. Supp.3d 793, 802 (C.D. Cal. 2016) (“Requiring defendants to satisfy the [TwIqbal] pleading standard within twenty-one days of being served with a complaint neither accords with the language of Rules 8(c) and 12(f), nor appears just as a matter of policy.”); Gomez v. J. Jacobo Farm Labor Contractor, Inc., 188 F. Supp.3d 986, 991-92 (E.D. Cal. 2016) (“This Court will not apply [TwIqbal] to determining the sufficiency of affirmative defenses.”); ESCO Corp. v. Cashman Equipment Co., 158 F. Supp.3d 1051, 1058 (D. Nev. 2016) (“The standard for properly pleading an affirmative defense does not rise to the same level of pleading a cause of action.”); Craten v. Foster Poultry Farms, Inc., 2016 WL 3457899, at *2 (D. Ariz. June 24, 2016) (“the text of Rule 8(c)(1) and fairness considerations compel the conclusion that [TwIqbal] do not govern pleading affirmative defenses”); Rockwell Automation, Inc. v. Beckhoff Automation, LLC, 23 F. Supp.3d 1236, 1242 (D. Nev. 2014) (“because of the difference in language between Rules 8(a) and 8(c), the Court will leave it to the appellate courts to institute something like a plausibility standard for Rule 8(c)”); Weintraub v. Law Office of Patenaude & Felix, A.P.C., 299 F.R.D. 661, 665 (S.D. Cal. 2014) (“Stating an affirmative defense under Rule 8(c), however, does not require the pleader to ‘show’ entitlement to its defense.”); Polk v. Legal Recovery Law Offices, 291 F.R.D. 485, 490 (S.D. Cal. 2013) (“Applying the same standard of pleading to claims and affirmative defenses, despite this clear distinction in the rules’ language, would run counter to the Supreme Court’s warning in Twombly that legislative action, not ‘judicial interpretation,’ is necessary to ‘broaden the scope’ of specific federal pleading standards.); Kohler v. Staples the Office Superstore, LLC, 291 F.R.D. 464, 468 (S.D. Cal. 2013) (“this Court declines to extend the [TwIqbal] pleading standards to affirmative defenses”); Roe v. City of San Diego, 289 F.R.D. 604, 609 (S.D. Cal. 2013) (“the Supreme Court’s analysis in [TwIqbal] is limited to pleadings under [Rule] 8(a)(2)”); Kohler v. Islands Restaurants, LP, 280 F.R.D. 560, 566 (S.D. Cal. 2012) (“this Court declines to extend the [TwIqbal] pleading standards to affirmative defenses”).

Tenth Circuit

Fuller v. Finley Resources, Inc., 176 F. Supp.3d 1263, 1266 (D.N.M. 2016) (“other cases from this District have declined to extend the heightened pleading standard established in [TwIqbal] to affirmative defenses”); Federal National Mortgage Ass’n v. Milasinovich, 161 F. Supp.3d 981, 994-95 (D.N.M. 2016) (following Lane); Dorato v. Smith, 163 F. Supp.3d 837, 882 (D.N.M. 2015) (following Falley); Sharp v. CGG Land (U.S.) Inc., 141 F. Supp.3d 1169, 1176 (N.D. Okla. 2015) (“recitation of the specific affirmative defenses that may be applicable is sufficient to serve this [notice] purpose”), aff’d on other grounds, 840 F.3d 1211 (10th Cir. 2016); Wells v. Hi Country Auto Group, 982 F. Supp.2d 1261, 1264 (D.N.M. 2013) (“the [TwIqbal] pleading standard does not apply to affirmative defenses”); Falley v. Friends University, 787 F. Supp.2d 1255, 1259 (D. Kan. 2011) (“Applying the Twombly standard, therefore, would likely result in increased motions practice with little practical impact on the case’s forward progression.”); Lane v. Page, 272 F.R.D. 581, 591 (D.N.M. 2011) (“[n]either the text of the rules nor the Supreme Court’s decisions in [TwIqbal] require the Court to extend the pleading standard from those cases to affirmative defenses”).

Eleventh Circuit

Luxottica Group, S.p.A. v. Airport Mini Mall, LLC, 186 F. Supp.3d 1370, 1374 n.1 (N.D. Ga. 2016) (“this Court has declined to extend the pleading requirements of Twombly to affirmative defenses”); Tomason v. Stanley, 297 F.R.D. 541, 544-45 (S.D. Ga. 2014) (“This Court therefore declines to import Twombly’s heightened pleading standard into the Rule 8(c) arena.”); Weekes-Walker v. Macon County Greyhound Park, Inc., 877 F. Supp.2d 1192, 1211-12 (M.D. Ala. 2012) (“the plausibility pleading standards of [TwIqbal] do not apply to affirmative defenses”); EEOC v. Joe Ryan Enterprises, Inc., 281 F.R.D. 660, 662-64 (M.D. Ala. 2012) (“[TwIqbal] do not apply to the pleading of affirmative defenses”); Jackson v. City of Centreville, 269 F.R.D. 661, 662-63 (N.D. Ala. 2010) (“Neither Twombly nor Iqbal address Rules 8(b)(1)(A) and 8(c) which pertain to affirmative defenses.”; “this Court does not agree with the magistrate that heightened pleading standards apply to affirmative defenses”) (reversing Magistrate); Bartronics, Inc. v. Power-One, Inc., 245 F.R.D. 532, 537 n.5 (S.D. Ala. 2007) (“Nothing in [Twombly] would appear to require more detailed pleading of affirmative defenses”).

District of Columbia Circuit

Moore v. United States, 318 F. Supp.3d 188, 193 (D.D.C. 2018) (“Two judges in this district have considered the issue and found that [TwIqbal] do not apply to affirmative defenses. This Court agrees.”); Paleteria La Michoacana v. Productos Lacteos, 905 F. Supp.2d 189, 190-93 (D.D.C. 2012) (“Imposing the plausibility requirement to affirmative defenses would be a sea change for this court’s practitioners; absent any compelling need for such a change, the court will leave Rule 8(c) undisturbed.”).

As for these quotes, we note that, as with the previous quotations, a lot of our quotes in the string-cite opinions omit internal quotes and citations.

*          *          *          *

Moreover, these cases (with one exception) are only the opinions on TwIqbal and defenses that have found their way into F. Supp. and F.R.D.  There are probably ten times as many unpublished decisions – which overwhelm even our appetite for research.  The basic search we used turned up 267 published cases (not all of which, of course, were relevant), but also 2,962 unpublished cases.

To take one example (and the only time we’re researching like this), we didn’t find a single published no-TwIqbal decision from Missouri (although there is Fleishour v. Stewart Title Guaranty Co., 640 F. Supp.2d 1088, 1090 (E.D. Mo. 2009) (“the pleading requirements under the Federal Rules simply do not require a statement of the facts necessary to support the defense”), which is hard to find because it doesn’t actually cite TwIqbal).  We’re trying to change this, but in any event, there are a raft of unpublished Missouri opinions to this effect:  See Arbogast v. Healthcare Revenue Recovery Group, 2018 WL 3643416, at *3 (E.D. Mo. Aug. 1, 2018) (“the Court finds that the pleading standards articulated in [TwIqbal] do not apply to affirmative defenses”); Westmoreland v. Medtronic, Inc., 2018 WL 3617315, at *2 (E.D. Mo. May 14, 2018) (“Courts in this District have rejected, with respect to affirmative defenses, the ‘plausibility’ standard”); Swinter Group, Inc. v. Nationwide Truckers’ Insurance Agency, 2018 WL 306024, at *4-5 (E.D. Mo. Jan. 5, 2018) (“This Court is in agreement with those courts that have found that the pleading standards articulated in [TwIqbal] do not apply to affirmative defenses”); Construction Industry Laborers, Pension Fund v. Wellington Concrete, LLC, 2016 WL 1275605, at *3 (E.D. Mo. March 31, 2016) (“affirmative defenses and avoidances are not subject to the same pleading standards as claims for relief”); FTC v. BF Labs Inc., 2015 WL 12806580, at *2 (W.D. Mo. Aug. 28, 2015) (“find[ing] that [TwIqbal] do not apply to affirmative defenses”); Consumer Financial Protection Bureau v. Moseley, 2015 WL 12834015, at *1 (W.D. Mo. May 26, 2015) (“the pleading requirements set forth in [TwIqbal] do not apply to affirmative defenses”); Florilli Transportation, LLC v. Western Express, Inc., 2015 WL 12838149, at *1 (W.D. Mo. Feb. 20, 2015) (“the pleading requirements articulated in Twombly do not apply to affirmative defenses”); Herbst v. Ressler & Assocs., Inc., 2014 WL 4205294, at *8 (E.D. Mo. Aug. 22, 2014) (“Under Rule 8, the pleader of an affirmative defense need only ‘state’ the defense, but need not ‘show’ anything”) (quoting 2 Moore’s Federal Practice §8.08[1] (3d ed. 2014)); Certain Underwriters at Lloyd’s v. SSDD, LLC, 2013 WL 6801832, at *8 (E.D. Mo. Dec. 23, 2013) (“a more lenient standard applies to affirmative defenses”); CitiMortgage, Inc. v. Just Mortgages, Inc., 2013 WL 6538680, at *8 (E.D. Mo. Dec. 13, 2013) (“affirmative defenses are not required to be initially pled according to the plausibility standard”); Baustian v. Fifth Third Bank, 2013 WL 6243857, at *2 (E.D. Mo. Dec. 3, 2013) (“the plausibility standard does not apply to affirmative defenses”); Hayden v. United States, 2013 WL 5291755, at *3 (E.D. Mo. Sept. 19, 2013) (“affirmative defenses ought not be required to be initially pled according to the plausibility standard required of claims”); United States ex rel. Health Dimensions Rehabilitation, Inc. v. RehabCare Group, Inc., 2013 WL 2182343, at *1 (E.D. Mo. May 20, 2013) (TwIqbal inapplicable to defenses); Southard v. City of Oronogo, 2013 WL 352943, at *2 (W.D. Mo. Jan. 29, 2013 (“the heightened pleading requirements set forth in [TwIqbal] do not apply to affirmative defenses”); CitiMortgage, Inc. v. Draper & Kramer Mortgage Corp., 2012 WL 3984497, at *3 (E.D. Mo. Sept. 11, 2012) (same); Willis v. Quad Lakes Enterprises, L.L.C., 2011 WL 3957339, at *2 (W.D. Mo. Sept. 7, 2011) (“The more heightened pleading standard set forth in [TwIqbal], therefore, does not apply to the pleading requirements for affirmative defenses”); Fluid Control Products, Inc. v. Aeromotive, Inc., 2010 WL 427765, at *3 (E.D. Mo. Feb. 1, 2010) (TwIqbal inapplicable to defenses, but not citing TwIqbal).

As the Missouri example demonstrates, anybody opposing a TwIqbal attack on their Rule 8(c) defenses will want to flesh out our collection of reported cases with additional support from unpublished cases involving the relevant district or circuit.  Fortunately, many of the published cases in our list also cite copiously to that unpublished precedent.

Finally, also of interest is a now-somewhat-dated law review article from 2013, William M. Janssen, “The Odd State of Twiqbal Plausibility in Pleading Affirmative Defenses,” 70 Wash. & Lee L. Rev. 1573 (2013), which – unlike us – collected decisions (through that date) on both sides of the issue. The article concluded:

[T]here is indeed today a national majority on the issue of Twiqbal’s applicability to affirmative defenses, but it is decidedly in the direction of refusing to apply “plausibility” to such pleadings.  If those opinions that sidestepped the issue are removed from the study, the resulting margin is more striking still − judges are rejecting Twiqbal for testing affirmative defenses by very nearly a two-to-one margin.

Id. at 1606.  Judging from what we’ve found since then, we think the percentages from the “Odd State” article have only grown more lopsided against TwIqbal applying to defenses. See Justin Rand, “Tightening Twiqbal:  Why Plausibility Must Be Confined to the Complaint,” 9 Fed. Cts. L. Rev. 79, 88 (2016) (“Left without guidance on this consequential issue, the majority of district courts initially answered it affirmatively − Twiqbal plausibility pleading was applied to affirmative defenses.  Yet, with the benefit of additional time, a growing majority of federal district courts has now declined to extend plausibility to affirmative defenses under Rules 8(b) and 8(c)”) (footnotes omitted).

In sum, we don’t like being harassed with bogus, make-work motions.  Our readers probably don’t either.  With this post, we hope to pass out the ammunition so that defendants can beat back these plaintiff-side arguments once and for all, and do so without having constantly to re-invent the wheel.

Did you know that October is National Cybersecurity Awareness Month?  Neither did we, until we started poking around the FDA’s recent press release announcing that it intends to update its guidance on medical device cybersecurity within the next few weeks.  We also learned that National Cybersecurity Awareness Month has been observed each October since its inception in 2004.  Observed by whom?  We’re not exactly sure.  We picture our IT consultants walking office to office handing out hats and stickers with catchy slogans like “A password is like underwear. Change it!”  Or some lame pun involving the work “phishing.”  If it were up to us, we would default to the simple and classic “Ctrl-alt-delete before you leave your seat.”

All kidding aside, cybersecurity threats have moved in recent years from theoretical to very real, and while there remains no reported instance of anyone hacking into a medical device being used to treat a patient, the potential vulnerability is one to which we need to pay attention.

That includes the FDA.  The FDA has published guidance on cybersecurity with regard to both premarket submissions and post-market submissions.  (You can see our take on the postmarket guidance here)  Based on the FDA’s press release, updates are coming to the premarket guidance, specifically to “highlight the importance of providing customers and users with a ‘cybersecurity bill of materials,’ or in other words, a list of commercial and off-the-shelf software and hardware components of a device that could be vulnerable to attack.”  This jibes with the FDA’s general approach to cybersecurity, which is to undertake a risk-based analysis that identifies vulnerabilities, assesses the potential frequency and severity of the risk, identifies mitigations, and proceeds accordingly.  Such a risk-based analysis should be familiar to anyone who operates in the medical device space, where risks and benefits are weighed on a daily basis.

The other news of the press release is the publication of a Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook, which “describes the types of readiness activities that’ll enable HDOs [healthcare delivery organizations] to be better prepared for a cybersecurity incident involving their medical devices.”  This Playbook was prepared by the MITRE Corporation, a government-sponsored research and development organization.  You can get a copy of the Playbook here, and you can that it is aimed at healthcare providers and critical healthcare infrastructure in which medical devices operate.

The purpose of the Playbook is to help HDOs get ready for cybersecurity threats affecting medical devices that could impact continuity of care and patient safety.  More specifically, the playbooks objectives are to:

  • Provide baseline medical device cybersecurity information that can be incorporated into an HDO’s emergency preparedness and response framework;
  • Outline roles and responsibilities for responders to clarify lines of communication “across HDOs, medical device manufacturers (MDMs), state and local governments, and the federal government”;
  • Describe a standardized approach to response efforts;
  • Serve as a basis for enhanced coordination activities among medical device cybersecurity stakeholders;
  • Inform decision making and the need to escalate response;
  • Identify resources HDOs can leverage as a part of preparedness and response activities; and
  • “Serve as a customizable regional preparedness and response tool for medical device cyber resiliency that could be broadly implemented.”

We put that last one in quotes because we’re not exactly sure what “cyber resiliency” means, but we assume it means the ability to fend off a cybersecurity event or at least mitigate its impact.  Toward that end, the Playbook suggests a four phase approach:  (1) Preparedness; (2) Detection and Analysis; (3) Containment, Eradication, and Recovery; and (4) Post Activity.

“Preparedness” means exactly what it says, with an emphasis on mindfulness of cybersecurity when procuring medical devices and keeping an inventory such that the HDO is always aware of what connected devices it has on hand.  HDOs should engage in “hazard vulnerability analysis” (again, a focus on risk) and plan for communicating and responding during an event.  That includes medical device manufacturers, whom the Playbook places squarely within the communication loop with the HDO and the FDA.

“Detection and Analysis” focuses on identifying when an incident has occurred and assessing its priority on a numerical scare that strangely assigns “Emergency” events to “Category 0.”  Analysis and documentation are important parts of the process, too.

The core of the response falls under “Containment, Eradication, and Recovery,” which appropriately focused on patient safety.  Is the device safe to use?  Is there a reliable way to test the device and confirm it is working correctly?  Are there spare or backup devices?  How quickly can the problem be fixed, and has there been collateral damage to the broader healthcare system?  These are the questions that HDO should be asking.

Finally, the “Post Activity.”  The Playbook recommends attention to lessons learned, including possibly retaining a digital forensics expert and updating the plan.

As we have said before, medical device cybersecurity is here to stay, and the FDA has been busy.  In addition to the Playbook (which is not an FDA document, but still, you get the gist), the FDA has entered into memoranda of understanding to form information sharing analysis organizations (“ISAOs”), which are “groups of experts that gather, analyze and disseminate important information about cyber threats.”  The Agency has participated in cybersecurity exercises and summits, and has engaged discussions with other government agencies, including the Department of Homeland Security.  It has proposed a Center of Excellence for Digital Health, which “would help establish more efficient regulatory paradigms, consider the building of new capacity to evaluate and recognize third-party certifiers, and support a cybersecurity unit to complement the advances in software-based devices.”  We will keep you posted.

It would seem to go without saying that for a defendant to be liable for the purported “common-law” claim of failure to report adverse events to the FDA, there must actually be some adverse events that needed to be reported.  One would think so, but certain California breast implant plaintiffs (yes, some still exist) would beg to differ – at least they did before the recent decision in Mize v. Mentor Worldwide LLC, No. BC649083, slip op. (Cal. Super. Oct. 1, 2018).

One problem that that current breast implant litigants face that their more numerous predecessors did not is preemption.  All that earlier litigation caused the FDA to upclassify breast implants to Class III, pre-market approved devices, and PMA means preemption.

In California, that also means the filing of half-baked, failure-to-report claims that no self-respecting plaintiff would otherwise bring, as a way to allege something that gets around preemption.  Trouble is, these breast implant plaintiffs can’t even allege that the defendant didn’t report any adverse incidents.  Even what plaintiff did allege was notably speculative:

Plaintiff now has alleged, however, that if [defendant] had reported additional adverse incidents subsequent to 2000, and if the FDA had made such incidents public, and if Plaintiff’s doctors had been aware of such reports, Plaintiff’s doctors might have provided an earlier diagnosis leading to earlier surgery to remove the implants and Plaintiff’s damages . . . might have been lessened.

Slip op. at 5. That’s a lot of “what ifs” piled on top of “what ifs,” but this plaintiff couldn’t even get to that.

There weren’t any unreported adverse events.

So the plaintiff tried to make them up.

The entire questionable “causal chain” wasn’t based on any known, but unreported, events at all, but rather on allegations about how studies were conducted:

[I]t is premised on [defendant’s] failure to report adverse incidents that were not detected because of how [defendant] conducted the studies rather than on a failure to report adverse incidents that actually occurred.

Id.  Even for a liberal jurisdiction, that was just too much.  There must be something that actually wasn’t reported.

Because Plaintiff has failed to allege facts showing that [defendant] failed to report actual adverse events that in fact occurred, the failure to warn (failure to report adverse events) claim is preempted because plaintiff has failed to allege how [defendant’s] actions in conducting these studies violated federal law.

Id.

While the Mize court “adopted the reasoning” of Ebrahimi v. Mentor Worldwide LLC, 2017 WL 4128976 (C.D. Cal. Sept. 15, 2017) – a case we discussed here – Mize was really a step into fantasy beyond even Ebrahimi.  As pleaded, Ebrahimi at least involved allegations that (vaguely) alleged that events weren’t reported.  Mize didn’t.  She seems to have been alleging that the defendant was obligated to conduct studies in a way that maximized the number of reportable adverse events.  That “duty” is, of course, contrary to tort policy and medical ethics, both of which seek to reduce, not increase, product injuries.

The plaintiff in Mize also tried to allege a “manufacturing defect,” but that didn’t fare any better.  Lacking any direct evidence, plaintiff tried to rely on “allegations that supported . . . [a] 1998 Consent Decree.” Slip op. at 3.  But plaintiff’s implant wasn’t manufactured until at least two years after that decree, and the decree itself was “evidence of a promised change in practices,” so the decree could not be evidence of any defect in the device implanted in the plaintiff.  Id.  Again, simple logic seems beyond the plaintiff in Mize.

Finally, the Blog wishes to express its appreciation to Dustin Rawlin, of Tucker Ellis, and his team of, Peter Choate, Monee Hanna and Allison Burke, who not only won the case, but were thoughtful enough to send it along to us.  Keep up the good work.

If a court acknowledges that no state or federal appellate courts in the jurisdiction have addressed the question before it, we think at a minimum there also should be an acknowledgement of the Erie doctrine. Yet, in the case of Fogel v. Sorin Group USA, Inc., 2018 WL 4680022 (S.D.N.Y. Sep. 28, 2018) you get the former without the latter. Fogel is one of our least favorite types of decisions, one that claims to be a prediction of state law but instead over reaches to create new liability where it did not previously exist. That is not the job of federal courts interpreting state law.

Under the Erie doctrine, in the words of the Supreme Court:

[a] federal court in diversity is not free to engraft onto those state rules exceptions or modifications which may commend themselves to the federal court, but which have not commended themselves to the State in which the federal court sits.

Day & Zimmerman, Inc. v. Challoner, 423 U.S. 3, 4 (1975). And, not surprisingly, the Second Circuit agrees. See Runner v. New York Stock Exchange, Inc., 568 F.3d 383 (2d Cir. 2009) (“our role as a federal court sitting in diversity is not to adopt innovative theories that may distort established state law”). But Fogel disregarded Erie and then disregarded that New York has not recognized a failure to warn claim based on failure to report adverse events to the FDA.

Here are the facts. Defendant manufacturers a heart valve that underwent pre-market approval by the FDA. Fogel at *1. Plaintiff’s child underwent surgery in which her pulmonary heart valve was replaced with defendant’s valve. Two years later, the valve failed and plaintiff’s child had to undergo revision surgery during which complications occurred that caused permanent injuries. Id. at *2.

In deciding defendant’s motion to dismiss, the court found several of plaintiff’s claims were preempted. A fraud allegation that defendant concealed information from the FDA during the PMA process was preempted under Buckman as fraud-on-the-FDA. Id. at *4. Design defect was preempted under Riegel because the valve’s design was approved by the FDA and any challenge to that design would impose state law requirements that are “different from or in addition to” FDA requirements. Id. Manufacturing defect failed because plaintiff “failed to plausibly allege a manufacturing defect that violated FDA requirements.” Id. at *5. A conclusory allegation of a deviation was insufficient.

That leaves failure to warn – where the decision goes astray. As with Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir., 2013) (en banc) and Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011), the Fogel court recognizes that a traditional state law failure to warn claim must be preempted under Riegel. “To the extent Plaintiff[] claim[s] that the [device’s] warning label was inadequate . . ., like the design-defect claim, must fail because the warning was approved by the FDA.” Fogel at *5. That should be the end of the story. Because “any attempt to predicate the [] claim on an alleged state law duty to warn doctors directly would have been expressly preempted.” Stengel, 704 F.3d at 1234. So let’s call failure-to-report claims what they really are – a sidestep around preemption. Frankly, they shouldn’t even get that far because what they really are are attempts at private enforcement of FDA reporting requirements which should be impliedly preempted under Buckman and 21 U.S.C. § 337(a).

That’s certainly the case in New York where a failure-to-report claim has not been recognized under state law. In fact, had the district court engaged in an Erie analysis it would have found that in other contexts New York has actually rejected state-law tort claims predicated on failure to report something to a governmental body. See Heidt v. Rome Memorial Hospital, 724 N.Y.S.2d 139, 787 (N.Y. App. Div. 2007) (“Plaintiff has cited no authority to support the proposition that a physician has a common-law duty to report actual child abuse, let alone suspected child abuse. There are good reasons for the absence of such a duty.”); Diana G-D v. Bedford Central School Dist., 932 N.Y.S.2d 316, 329 (N.Y. Sup. 2011), aff’d, 961 N.Y.S.2d 305 (N.Y. App. Div. 2013) (“there is simply no evidence that defendants’ failure to make such a report was knowingly and willful,” which was required for civil liability under child abuse reporting statute); In re Agape Litigation, 681 F. Supp.2d 352, 360-61 (S.D.N.Y. 2010) (rejecting private cause of action premised on federal reporting requirements in Bank Secrecy Act). A more fulsome discussion of these analogous cases in other states can be found in our post here.

District courts faced with an undecided state law question are not allowed to create liability where it did not previously exist. It was not the district court’s job to expand New York’s duty to warn the medical community to include the FDA.

The federal requirements require that adverse events and other reports be made to the FDA. While New York law may require manufacturers to warn the medical profession, that is not the same as a duty to report to the FDA.

Pearsall v. Medtronics, Inc., 147 F. Supp.3d 188, 201 (E.D.N.Y. 2015)(rejecting failure-to-report claims as preempted and not valid under NY law). So, under existing New York law, failure to warn physicians imposes an obligation different from and in addition to the FDA’s requirement to report adverse events. Making the claim both preempted as non-parallel and as purely FDCA-based.

 

We would be hard pressed to think of a recent judicial decision we have blasted as hard or often as the Third Circuit’s Fosamax opinion.  We deemed it the worst case of 2017.  It was bad enough that our hometown federal appellate court held that it was up to a jury whether the FDA would have rejected a stronger drug warning.  It was worse that the court held that a defendant had to prove by clear and convincing evidence that the FDA would have rejected the warning.  And it was still worse, and kind of weird, that the Third Circuit arrived at this holding in a case where the FDA actually had rejected a stronger warning.  The result of the Fosamax decision was that summary judgement in favor of the defense on preemption became a pipe dream, and ultimate victory at trial became a lot tougher.

Right from the start, we thought Fosamax was reversal bait.  The excellent certiorari briefing made us more sure of that.  Then, when SCOTUS invited the government to lob in an amicus brief, we became still surer.  Now that we have read the government’s brief, we are even surer. Lawyers from the Solicitor General’s office and the Department of Health and Human Services are on the brief.  These lawyers are typically brilliant and the positions they stake out typically command a lot of respect from courts.

When we clerked, our Judge always paid a lot of attention to government amicus briefs.  In the last SCOTUS case we worked on, the government’s position turned out to be pretty much dispositive.  We represented a father who had been tossed in the clink because he had failed to pay child support.  It was a civil contempt proceeding that ushered him into jail.  The state (South Carolina) did not provide him counsel because it wasn’t a criminal case.  We argued that however the case was styled, if imprisonment was a possibility, the right to counsel was implicated.  The other side was represented by then Penn Law professor, now Third Circuit Judge, Stephanos Bibas, who was an amazingly effective advocate for what we thought was a weak position.  We argued that counsel had to be provided and he argued not so.  Then the SG’s office filed a brief, and its answer split the difference: sometimes.  Guess what SCOTUS decided?  Sometimes won.

What do we have here with the government’s Fosamax brief?  The headline is that the government argues for reversal of Fosamax.  It argues that the Third Circuit erred in holding that, under Wyeth v. Levine, a jury must resolve the preemption defense “As a factual matter subject to a clear-and-convincing evidence standard.”  Yay. But is there a ‘sometimes’ aspect to the government’s position that makes us a bit uneasy?  Yes, there is.

As always, the statement of the Question Presented sets the tone.  Here is how the government frames the inquiry:  “Whether a state failure-to-warn claim alleging the insufficiency of brand-name drug labeling is preempted by the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq., when the Food and Drug Administration, after the drug manufacturer provided it with the relevant scientific data, rejected the manufacturer’s application to modify its labeling to warn about the risk underlying the tort claim.”

The first thing we notice is that the government is focusing on the fact that the FDA did actually reject a proposed warning.  That rejection came in the form of a Complete Response Letter in 2009.  The central point in the government’s brief is that the meaning and effect of that Complete Response Letter presents legal questions that a judge, not jury, must resolve. It was a federal agency decision, and courts, not juries, interpret agency decisions.  Even if factual findings are necessary to interpret the federal agency decision, such factual findings are decided by the court, not the jury.

The government’s arguments on these points are compelling, and it is hard to see how reversal can be avoided.  But how useful would reversal on this ground be for the rest of us?  Whenever the FDA actually rejects an enhanced warning, there will be an agency decision, and the government’s analysis would kick in and make the issue legal, not factual.  But what if there is no rejection?  What if the defendant wants to argue that there are other circumstances, not quite reaching the level of an actual agency rejection, that demonstrate that such rejection would have been inevitable?  Are we still in fact-land, as opposed to legal-land?  The ruling in Fosamax might end up a little narrower than we’d like.

Let’s not dwell on these questions for now.  No point in being a nervous Nellie.  There are other goodies in the government’s brief.  For instance, while the Third Circuit in Fosamax speculated that possibly the FDA’s rejection was a result of dissatisfaction with the specific language proposed by the pharmaceutical company, the government smacks that position down and restores the focus to the proper place: the state of the scientific evidence. Look again at the Question Presented.  Hone in on this language:  “relevant scientific data.” The FDA looked at the data in the available literature and adverse events reports.  “No sound basis thus exists for concluding that the FDA determined in May 2009 that the data was sufficient to warrant a warning but that it rejected petitioner’s proposal because of petitioner’s proposed text.”  If SCOTUS adopts this reasoning, as it should, plaintiffs will have one less arrow in their speculative quiver to stave off summary judgment on preemption.

Even better is how the government brief eviscerates the clear-and-convincing evidence standard.  First, the brief makes the undeniable point that the Wyeth v. Levine decision simply did not address this issue.  Thus, we are thrust upon first principles.  This is a product liability case. It is a civil action for money damages, and “nothing warrants a higher standard of proof to resolve the preemption question here.”  Absent legislative specification, there is no basis to impose a higher evidentiary standard on defendants seeking to available themselves of SCOTUS preemption doctrine.  We are not entirely fond of the government’s explanation of the Wyeth “clear evidence” language, seeming to tie it into a presumption against preemption, but we are trying not to be churlish.  In any event, we are content with the government’s fundamental point that the Wyeth v. Levine  “clear evidence” formulation was not intended “as a shorthand for a formal clear-and-convincing evidentiary standard, but merely to indicate that a manufacturer asserting preemption must show that a labeling charge was not warranted under the relevant statutory and regulatory framework.”

Once the government shows that resolving the Fosamax case requires resolving a legal issue, that no factual findings are required, and that the preponderance of the evidence standard applies, the case becomes easy.  The FDA rejected the proposed warning because the data was not yet in place to justify the warning.  The Third Circuit got it wrong, the district court got it right, and the litigation should be over.

Not too long ago we read a non-drug/device decision, Hale v. State Farm Mutual Automobile Insurance Co., 2018 WL 3241971 (S.D. Ill. July 3, 2018), which left us shaking our heads.  How this suit could not be a blatant First Amendment violation is beyond us.

But that’s not really the point of this post.

The alleged “facts” are downright bizarre:  The plaintiffs were sore losers in previous litigation against the same defendant.  They had managed, through the use of now-discredited legal gamesmanship – a nationwide class action involving the extraterritorial application of the Illinois consumer protection statute – to obtain a verdict of over a billion dollars on claims involving State Farm and allegedly inferior replacement parts used in car repairs.  Thankfully, plaintiffs couldn’t hold it.  In Avery v. State Farm Mutual Automobile Insurance Co., 835 N.E.2d 801 (Ill. 2005), the court rejected extraterritoriality and nationwide consumer fraud class actions. Id. at 855 (“we conclude that the circuit court erred in certifying a nationwide class that included class members whose claims proceedings took place outside Illinois”).  The nominal vote was 4-2, with one justice not participating, but even the dissent agreed on this issue.   Id. at 864 (“I agree with the ultimate result reached by my colleagues − I, too, would find that the circuit court erred in certifying the nationwide class”) (concurring and dissenting opinion).  There were a slew of other issues in this contentious case, but with rejection of the nationwide extraterritorial class, any basis for the boxcar, billion-dollar verdict disappeared.

But plaintiffs (or their lawyers) didn’t give up.  Instead they filed a RICO action alleging that State Farm was “racketeering” when it gave large amounts of campaign contributions – Hale contains nothing to suggest that any state-law campaign finance violations were involved − to support the election of a particular “pro-business” candidate to the Illinois Supreme Court, while the Avery appeal was pending:

In essence, plaintiffs allege that defendants secretly recruited [the candidate] to run for an open seat on the Illinois Supreme Court, where the Avery . . . appeal was pending; that defendants organized and managed his campaign behind the scenes; that defendants covertly funneled millions of dollars to support his campaign through intermediary organizations over which [defendants] exerted considerable influence.

Hale, 2018 WL 3241971, at *1.  You get the drift.  Next came the predictable allegations that everything was covered up so no recusal occurred.  Id.  The new justice supposedly “broke” a “deadlock” – yeah, right, in a case where the main result was unanimous − and “voted to overturn the judgment.”  Id.  All this purportedly nefarious politicking supposedly “deprived [plaintiff plaintiffs] of their constitutionally-guaranteed right to be judged by a tribunal uncontaminated by politics.”  Id.

It’s not the point of this post to debate the intricacies of RICO causation, damages, or enterprises.  We don’t think Hale should ever have gone that far.  We’ve previously advocated the First Amendment protection of purely scientific speech, because we don’t believe that one side to a scientific debate should be allowed to sue the other into submission.  That was our primary interest when Citizens United v. Federal Election Com’n, 558 U.S. 310 (2010), was handed down.  We frankly didn’t dream that core political speech of the sort at issue in Hale could give rise to private prosecutions under RICO.

But be that as it may. If it’s open season on the opposition’s campaign contributions, can the defense side play, too?  After all, in most judicial elections, contributions from the defense are dwarfed by what our politically minded adversaries are able to raise and spend.  It’s no secret.  Here, for example, is the “Campaign Finance Online Reporting” of the Pennsylvania Secretary of State.  You can type in the name of your most (or least) favorite judge and relevant election year and see everybody from whom s/he reported receiving contributions.  Or you can click on “contributions made” and track the donations by your favorite plaintiffs’ lawyer or firm.  Our clients have just as much of a “constitutionally-guaranteed right to be judged by a tribunal uncontaminated by politics” as do plaintiffs.  Are there RICO violations here?

But maybe that’s not enough.  Perhaps it’s too diffuse to assert a RICO violation just because the other side’s contributions made up 90%+ of the total contributions to a particular judge sitting on a particular case.  Maybe there needs to be a “pending” matter to focus things more precisely.  Still, our side might be able to play.  Consider all of those “civil enforcement” actions nominally brought by cities, counties, and states against our clients – where the real vigorish goes to the contingent fee, private counsel brought in to prosecute the action for the government.  We’ve complained about those actions, as well, without much success.  If it turns out that contingent fee counsel (or those acting in concert with counsel) made large political contributions to the particular politicians who later authorized the filing of one of those suits against a client, does the client have a RICO counterclaim under the same rationale as Hale?

Our bottom line is that suits like Hale are abuses of the judicial system and attempts to sue over the other side’s First Amendment protected political activity.  We’re, frankly, shocked that Hale survived summary judgment.  But if plaintiffs insist on opening up that Pandora’s Box, our side should consider whether it wants to play, too.

When we sit around the table this Thanksgiving, we’ll have another thing to be grateful for this year: ACI’s 23rd Annual Drug and Med Device Conference will be just days away on November 28-30, 2018 in New York City. We’re looking forward to the usual interesting and informative content, networking opportunities with clients and colleagues – and maybe even the chance to catch up with some of our loyal readers.

Bexis expects to be in his usual front and center seat if you want to chat (somebody’s got to ask questions). And you can also catch him presenting on November 29 on “Predicting Risk and Examining the Intersection of Traditional Principles of Product Liability Laws with Digital Health and 3D Printing.”

Other sessions we have earmarked on our agendas include: “MDLs: Their Intended Purpose, What Attempts Have Been Made at Improving the MDL System, and Effective Ways for Wrapping Them Up,” and “Engaging the Courts in the Right Way: What Does It Mean to Be an Innovative Thinker as an Outside Counsel?” and breakout sessions on personal jurisdiction and innovator liability.

If you want to register, you can do so here. We look forward to seeing you in New York!

Next week, under pressure from the Drug and Device Law Lifelong Best Friend, we are participating in a “murder mystery dinner theatre” in the “conservatory” of a local cemetery.   (We didn’t know cemeteries had “conservatories.”) It is a Halloween-themed event, with costumes encouraged, and we may or may not wear our eerily-lifelike Standard Poodle mask/hood. In any event, the premise of the event is that actors are scattered among the paying audience “guests.” At some point during the cocktail hour, one of the actors will “die.” During the ensuing dinner hour, clues are revealed and everyone tries to solve the “murder” in time for dessert. We think this sounds like fun, and we like the idea of not knowing what to expect and not being able to predict the result.

But sometimes a predictable result (to the extent that preemption jurisprudence is ever predictable) is just fine. In In re Bard IVC Filters Prods Liab. Litig. (Hyde v. C. R. Bard, Inc.), 2018 WL 4356638 (D. Ariz. Sept. 12, 2018), the plaintiff was implanted with the defendant’s inferior vena cava (“IVC”) filter. Three years later, the plaintiff learned that the filter had perforated the IVC wall and had fractured. The filter was removed shortly thereafter. The plaintiff filed suit, asserting the usual panoply of product liability claims. After the court granted summary judgment for the defendant on several claims, the plaintiff’s claims for strict liability design defect and negligent design remained pending, along with a claim for negligence per se.

Under Wisconsin law, which governed the plaintiff’s substantive claims, a claim for negligence per se arises from violation of a statute, where the plaintiff can show that “(1) the harm inflicted was the type the statute was designed to prevent; (2) the person injured was within the class of persons sought to be protected; and (3) there is some expression of legislative intent that the statute become a basis for imposition of civil liability.” Hyde, 2018 WL 4356638 at *2. In her negligence per se claim, the plaintiff asserted that the defendants violated provisions of the Federal Food, Drug, and Cosmetic Act. As the court commented, “Far from containing an expression that FDA regulations are intended to form the basis of civil liability, . . . [t]he FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions.” Id. (citing Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 349 n.4 (2001)) (internal punctuation and additional citations omitted).   “Thus,” the court continued, a private litigant cannot bring a state-law claim [that] is in substance . . . a claim for violating the FDCA – that is, when the state claim would not exist if the FDCA did not exist,” because, under Buckman, such claims are impliedly preempted by the FDCA.  Id. (citations omitted). All correct, even if it conflates Buckman preemption with the plaintiff’s simple failure to state a negligence per se claim under the requirements of Wisconsin state law.

The court held that, as in Buckman, the plaintiff’s negligence per se claim was more accurately characterized as a “negligence claim based solely on violations of FDA regulations,” id., and was therefore impliedly preempted. As the court emphasized, “. . .where the plaintiff was not suing under state law for conduct that happen[ed] to violate the FDCA, but instead [was] suing solely because the conduct violate[d] the FDCA,” the claim was preempted by federal law. Id. (emphasis in original, internal punctuation and citation omitted). The court contrasted such claims to traditional tort claims like plaintiff’s negligent design claim, which arose from a duty owed under state law and which was not subject to Buckman preemption.

We like this correct, methodical, predictable decision.   We’ll let you know how the mystery thing goes.