Our last post talked about carbohydrate-rich Thanksgiving food. Today, we are talking about a putative class action on the labeling of certain diet foods, particularly in regard to “net carbs” and sugar alcohols. This was not planned. Colella v. Atkins Nutritionals, Inc., No. 17-cv-5867 (KAM), 2018 WL 6437082 (E.D.N.Y. Dec. 7, 2018), on the other hand, has all the hallmarks of a case brought for no reason other than to reward the lawyer. The same lawyer brought multiple cases in multiple courts raising the same allegations. The purported class representative in this one claimed to have bought only three of the thirty-one products he sued over and it is hard to imagine how he sustained any harm, let alone a harm that continues. Two of the other cases produced decisions on similar issues, which the Colella court cited frequently, so this was not really new ground. We will just cite those now and cut back on internal cites later: Fernandez v. Atkins Nutritionals, Inc., No. 3:17-CV-1628, 2018 WL 280028 (S.D. Cal. Jan. 3, 2018); Johnson v. Atkins Nutritionals, Inc., No. 2:16-CV-4213, 2017 WL 6420199 (W.D. Mo. Mar. 29, 2017). That will also be the last of our references to dieting, a subject with which we stubbornly deny knowledge.

Plaintiff centered his consumer fraud and warranty claims on the allegations that sugar alcohols in a number of the defendant’s products should count toward any tally of net carbohydrates and their consumption does affect blood sugar levels. Sugar alcohols are used as sweeteners in a number of foods and, as it turns out, FDA has a fairly developed history of addressing them in connection with labeling. Predictably, especially if you have read other posts on lawsuits over food labeling, the defendant’s motion to dismiss the amended complaint teed up express preemption under the FDCA and primary jurisdiction, along with TwIqbal and substantive state law. The end result was that plaintiff lost most of his claims, but will get a third chance to plead a consumer fraud claim as to a portion of his apparent issues with the labeling for defendant’s products. As we have noted before, we do think it is better to assess whether viable state law claims have been supported by factual pleading (with or without the heightened standard applicable for fraud-based claims like the plaintiff here was asserting) before turning to whether express preemption or primary jurisdiction would apply. The Colella court flipped the order of analysis, so something is left at least for now.

We will follow the court’s order of analysis in our discussion after a little more on the claims. The products’ labeling, and the company’s website, made clear that all counts of “net carbs” excluded sugar alcohol (like they excluded fiber). They further touted the low number of net carbs and explained that sugar alcohols could be ignored because they do not impact blood sugar like other carbohydrates that count toward the net carbs total. Plaintiff claimed this was a misrepresentation of the available science and that sugar alcohol consumption did have an impact on blood sugar. He also claimed FDA agreed that sugar alcohol should be counted toward total carbohydrates (but not net carbs). Lastly, he claimed he had relied on the labeling’s statements about net carbs and sugar alcohol in buying three products (once, apparently). Based on this, he wanted a range of damages for a purported class of purchasers of a bunch of products.

The express preemption analysis was fairly thorough and technical, because non-identical state law claims as to nutrient content labeling and health-related claims are expressly preempted but the regulations are complicated on those issues. What was not complicated was the rejection of plaintiff’s call to a presumption against preemption. Bexis should be happy with the quotation of Puerto Rico v. Franklin California Tax-Free Tr., 136 S. Ct. 1938, 1946 (2016), for the proposition that where a statute includes an express pre-emption clause, “[the court] do[es] not invoke any presumption against pre-emption but instead ‘focus[es] on the plain wording of the clause, which necessarily contains the best evidence of Congress’ pre-emptive intent.’” It was also acknowledged that there is express preemption of “state law requirements regarding nutrient content claims” under the FDCA and POM Wonderful. Statutes and regulations require labeling of nutrients in food, including “[t]otal fat, saturated fat, cholesterol, sodium, total carbohydrates, complex carbohydrates, sugars, dietary fiber, and total protein contained in each serving size or other unit of measure.” The regs also spell out how sugar alcohols should be handled and we will just repeat what the Colella court wrote:

Relevant to the instant case, “§ 101.9(c)(6) …. requires that food labels include … a statement of the number of grams of total carbohydrate in a serving, and a statement of the number of grams of total dietary fiber in a serving.” Fernandez, 2018 WL 2128450, at *4. Dietary fibers and sugar alcohols are considered carbohydrates for the purpose of calculating “total carbohydrates,” and the FDA provides extensive guidance regarding the treatment of sugar alcohols. 21 C.F.R. § 101.9(c)(6)(i)-(iv). Disclosure of sugar alcohols and their weights in the nutrition facts panel of a label is voluntary, however, if a claim is made about the grams of sugar alcohol on the label, disclosure must be made in accordance with 21 C.F.R. § 101.9(c)(6). Section 101.9(c)(6)(iv) states: “[a] statement of the number of grams of sugar alcohols in a serving may be declared voluntarily on the label, except that when a claim is made on the label or in labeling about sugar alcohol or total sugars, or added sugars when sugar alcohols are present in the food, sugar alcohol content shall be declared.” 21 C.F.R. § 101.9(c)(6)(iv); see also Fernandez, 2018 WL 2128450, at *4.

Statements about nutrients, however, do not necessarily have express preemption.

Under § 101.13(i)(3), “the label or labeling of a product may contain a statement about the amount or percentage of a nutrient if … [t]he statement does not in any way implicitly characterize the level of the nutrient in the food and it is not false or misleading in any respect.” Thus, “A nutrient content claim governed by § 343(r)(2) is …any claim outside of the nutrition-facts box that the manufacturer has chosen to make about the same kind of nutrients discussed inside the … nutrition information box.” Id.

With that backdrop, the court came to different conclusions about express preemption as to claims based on simply listing the number of net carbs or explaining how calculated them, on the one hand, and claims based on characterizing the number of net carbs as “Only Xg Net Carbs” and discussing the impact of sugar alcohols on blood sugar, on the other. Much of the analysis related to plaintiff’s argument that statements about net carbs cannot be preempted because they are not explicitly mentioned in the regulations. “Plaintiff’s argument that Section 343(q) of the NLEA and its implementing regulations, do not specifically list Net Carbs as a nutrient nor require the inclusion of Net Carbs in the Nutrition Facts panel is unavailing. The broad language in Section 343(r)(1) includes claims regarding nutrients, and relationships of nutrients, ‘of the type’ required by paragraph (q)(1) or (q)(2), obviating the need for specific categorical references to nutrients and nutrient relationships . . . ” The court also did not require that the FDA had to have expressly permitted the challenged labeling language. Here, there was ample evidence that FDA considered the language without prohibiting them. Among that evidence was the rejection of a citizen petition on the net carbs description in one of the products, noting “The agency has not generally objected to the use of ‘net carbohydrate” type information on food labels if the label adequately explains how the terms are used. If [the] FDA determines that such statements or their explanations are false or misleading, we will take appropriate action.” Thus, the court concluded that, “while the FDA may not have considered the exact language addressed …, it had clearly addressed the substance of the claims at issue.”

Statements about the products having “only” a certain number of grams of net carbs and explaining whether sugar alcohols have an effect on blood sugar levels did not have the same record and were not preempted. Implied nutrient claims—the implication of “only” is the net cabs in these products was low—are subject to misbranding unless FDA has set a criteria and it has been met. That has not happened with net carbs yet. As to explaining blood sugar impact, the court did not consider that to be a claim about nutrient content or a health related claim. We get the former, but the explanation of the latter was lacking. At least in the lay sense, saying nutrients in the food do not impact blood sugar does seem like a claim about health.

Getting past preemption did not mean plaintiff was done. Primary jurisdiction was looming. As would be expected, every claim that was preempted was also subject to primary jurisdiction. The net was cast a little broader, though.

Upon consideration of plaintiff’s claims and application of the four factors, primary jurisdiction applies with regard to plaintiff’s Net Carbs figures and calculations, and the “Only Xg Net Carbs” statements, as “[i]t is clear that it is the FDA’s role to decide what calculation methods manufacturers may use, not the courts.” Johnson, 2017 WL 6420199, at *9. Primary jurisdiction does not apply to plaintiff’s claims as to whether the labeling statements on the impact of sugar alcohols on blood sugar are false or misleading, as that is a factual issue within the traditional real of judicial competency.

Boiling it down, the distinction seemed to be that it is for FDA to determine the criteria for low net carbohydrate food, which is closely related to a number of issues it already decides. While there was not much analysis as to the discussion of blood sugar impact, the court clearly felt that was the sort of thing that it could decide as misleading or not without treading on regulatory toes.

Only after addressing preemption and primary jurisdiction did the court turn to whether New York state law claims for consumer fraud and warranty had been stated on the face of the complaint. Consumer fraud was not and it was not very close. Facts were not asserted that the challenged labeling was deceptive in a material way, which should require extra facts under Fed. R. Civ. P. 9(b). Nor did asserted facts establish any injury. Even with a reduced bar for economic injury from an allegedly over-priced product, “plaintiff only conclusorily asserts that Atkins Nutritionals charges a premium for its products and provides no facts regarding what the premium was, what price he paid for the products, or the price of non-premium products.” So, plaintiff did not assert any consumer fraud claim, regardless of what defense might apply.

He also did not have a warranty claim, because New York requires timely notice and that was not alleged. The court declined to adopt an exception to this rule for consumer products. This defect could not be cured with re-pleading. The plaintiff would get a third shot at pleading facts for some consumer fraud claim not subject to express preemption or primary jurisdiction. We have a hard time seeing a claim based solely on sugar alcohols and whether the amounts in these products affect blood sugar levels. Plaintiff can claim this information was material to his decision to buy this manufacturer’s Chocolate Chip Cookie Dough Bar, Sweet & Salty Trail Mix, and Chocolate Peanut Candies over other items at his local Wal-Mart, but it is hard to imagine facts supporting that convenient assertion.

 

Contrary to rumor, we are not on the verge of changing our name to the Filter Device Litigation blog. True, we are now on a several consecutive weeks run of sharing very good IVC opinions. In fact, we will likely have two this week. The recent outbreak of good sense largely emanates from Indiana, but today’s case, Broge v. ALN Int’l, Inc., 2018 U.S. Dist. LEXIS 204486 (N.D. Cal. Dec. 3, 2018), shows that logic can prevail even in (gasp) the Bay Area. Hold your nasty comments – we were born in the Bay Area and admire it endlessly. Our native-son regard for the place does not prevent us from acknowledging that defense-friendly product liability wins there are as rare as football wins this season on either side of the Bay. But the Raiders and 49ers both won last Sunday, and now we have a case from ND Cal. that insists that plaintiffs lob in the occasional fact in their complaints. Sometimes man bites dog. Sometimes Adam Sandler puts out a good movie. Sometimes a politician commits candor. Sometimes our kids answer our texts.

In Broge, the plaintiff’s IVC filter had become embedded in her vena cava wall. It took two surgeries to remove the filter. She sued in Santa Clara County Superior Court, alleging strict liability failure to warn and manufacturing defect, breach of warranty, negligent and fraudulent misrepresentation, and the inevitable violations of California Business & Professions Code sections 17200 and 17500. The only defendant was ALN International, though the complaint devoted a lot of space to the conduct and knowledge of other entities, including ALN Implants Chirurgicaux and ALN Implants. The case was removed to federal court on the basis of diversity of citizenship, and then the defendant filed a motion to dismiss. The court granted the motion in part, and its opinion noted that it was odd of the complaint to sue one entity based on alleged sins of another. That opinion can be found at Broge v. ALN Int’l, Inc., 2018 WL 2197524 (N.D. Cal. May 14, 2018). The plaintiff was given leave to amend and did so, but did not do so very well. The defendant filed another motion to dismiss. In scrutinizing the amended complaint, the Broge court did not merely cite the Twombly and Iqbal cases, it actually applied them. That spelled doom for the amended complaint, which did not contain much beyond bare conclusions.

Take the failure to warn claim, for example. The plaintiff alleged that another entity, ALN Implants, should have known and discovered the defects. That would not affix liability to the actual defendant in the case. Further, as is all too typical, the amended complaint contained mere conclusions that better warnings would have altered the physician’s decision to prescribe the IVC filter. The plaintiff’s curative amendment cured nothing.

The manufacturing defect claim fared no better. In an earlier complaint, the plaintiff simply said the product “contained manufacturing defects.” That is obviously not good enough. On the next go-round, the plaintiff said that the IVC filter at issue did not conform to a hook design that should have permitted easy removal. Well, that at least seems a bit better. But the amended complaint still failed to allege how the product deviated from the design – all it talked about was the result. Even worse, the amended complaint still, almost perversely, hung the alleged hook malfunction on an entity that was not in the lawsuit, ALN Implants.

The negligent misrepresentation claim offered no facts suggesting that the defendant lacked reasonable grounds to believe its safety and efficacy representations were not true, the warranty claim rested in part upon a representation by a third party, and the fraud claim lacked specificity on the who, what, when, where, and how. The Cal. Bus. Code claims were merely fraud claims in another guise, so they also did not make the grade. There was also a claim for punitive damages. Because that claim was derivative of the fraud claim, it, too, was a goner.

The Broge court dismissed the claims, but because California is a land of not just second, but third, chances, the plaintiff was given, again, leave to amend. Perhaps the court will eventually grow weary of reading threadbare complaints that contain more ambition than facts. As long as the court keeps coming out with precise, demanding opinion that respect pleading standards, we won’t grow weary of reading such opinions.

As we roll out of bed on the day after Thanksgiving, we are often confronted with contradictory thoughts. For instance, “why did I have that third plate at dinner?” might be followed by “How can I eat some leftovers for breakfast?”  Leftovers are as much of an American tradition on this day as watching videos of altercations during frenzied early holiday shopping. Both celebrate wretched excess in their own way. Some leftovers, however, can be combined to create something tasty and worthwhile. Other leftover uses should not be attempted. We would put sandwiches of turkey, stuffing (dressing down South), and cranberry goop in the former category and Brussels sprouts omelets in the latter.

A while back, for a few years, we chronicled a real turkey of a case called Howard. The saga is recounted here, where the plaintiff’s expert was finally kicked for the unreliability of his defect opinion about the PMA device at issue in the case. Along the way, the case generated two notably foul (fowl?) opinions. Deciding on preemption in the context of a theoretical claim, the Sixth Circuit held that a negligence per se claim could be a parallel claim and avoid express preemption.  Years later, on a referred question, the Oklahoma Supreme Court okayed a negligence per se claim under Oklahoma law based on violations of the FDCA.  That gobbler took home the ribbon for third worst of 2013.  Our well-documented view that there can be no negligence per se claims based on violations of the FDCA notwithstanding, Oklahoma now has a claim that came from a case that was soon to be plucked and exposed as lacking merit.

A few years later, the plaintiffs in Cantwell v. De La Garza, No. CIV-18-272-D, 2018 WL 5929638 (W.D. Okla. Nov. 13, 2018), sued an implanting orthopedic surgeon, non-profit health care system, and medical device manufacturer for alleged injuries from the alleged off-label use of a PMA medical device in a spinal surgery. The manufacturer moved to dismiss. We do not have many details of the underlying facts or allegations, but we are focusing on the negligence per se claim—the leftover from the Howard turkey, in case you missed our less-than-subtle theme. A few weeks before the Oklahoma Supreme Court’s decision in Howard, the Western District of Oklahoma rejected the purported parallel claims in Caplinger. After a motion to reconsider was denied, the Tenth Circuit affirmed in Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015), one of our favorite preemption decisions and a 2015 winner.  In part because that decision was authored by future Justice Gorsuch, we have drilled down on Caplinger a few times and tracked its impact.

The Cantwell plaintiffs claimed that the manufacturer had promoted the device to be used off-label—it was approved for use in the thoracolumbar spine, but was used in the cervical spine—and that violated apparently unspecified provisions of the FDCA and its regulations. Under the Oklahoma Supreme Court’s decision in Howard, “To establish negligence per se, the plaintiff must demonstrate the claimed injury was caused by the violation [of a statute], and was of the type intended to be prevented by the statute . . . [and] the injured party [was] one of the class intended to be protected by the statute.” Pretty much the hornbook definition, along with the requirement that the plaintiff prove breach, causation, and damage. In the context of pleadings and the Howard decision, the court went back to basics. Plaintiffs did not plead a particular statute or regulation that had been allegedly violated, let alone that could be tied to the injuries attributed to the device at issue. Howard did not lower the pleadings bar: “The court said nothing to suggest, however, that a plaintiff wishing to bring such a claim could proceed without identifying the statute or regulation allegedly violated, and thus the duty allegedly breached by the defendant’s conduct.” Looking to Caplinger and the unaddressed but obvious issue of preemption, the court noted that “such identification is particularly important in the area of medical devices, where a state-law negligence claim must survive the FDCA’s provision of a federal preemption device.” So, no identified allegedly violated federal statute or regulation meant no properly pleaded claim for negligence per se. Citing to the FDCA in general or invoking the loaded term “off-label” was not enough to get past a motion to dismiss. Predictably, though, the dismissal was without prejudice, so we expect plaintiffs will try again. If they do, then we would not be surprised if Justice Gorsuch’s former colleagues on the Tenth Circuit get another chance to weigh in on express preemption with a re-heated version of Howard.

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.

We recently commented on Sumpter v. Allergan, Inc., 2018 WL 4335519 (E.D. Mo. Sept. 11, 2018), for several reasons – all bad – but one stands out, the ruling that used what’s essentially res ipsa loquitur to wave plaintiff through PMA preemption with a manufacturing defect.  According to Sumpter:

Plaintiffs allege that, due to manufacturing defect, the products . . . [user plaintiff] received were not the products approved by the FDA.  Even though “the precise contours of their theory of recovery have not yet been defined,” the Court holds Plaintiffs’ allegations sufficiently allege that Defendants did not adhere to FDA manufacturing requirements.

Id. at *2.  For this remarkable inference, Sumpter cites only Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), which had nothing to do with manufacturing defects as a form of parallel claim.

What Sumpter held is not the law.  Not even close.  While we recognize that manufacturing defect claims in some circumstances can thread the “narrow gap” between express and implied preemption, such allegations cannot do so by mere inference.  “Plaintiffs cannot simply incant the magic words ‘[defendant] violated FDA regulations’ in order to avoid preemption.”  Wolicki-Gables v. Arrow International, Inc., 634 F.3d 1296, 1301 (11th Cir. 2011) (citation and quotation marks omitted).

This complaint is impermissibly conclusory and vague; it does not specify the manufacturing defect; nor does it specify a causal connection between the failure of the specific manufacturing process and the specific defect in the process that caused the personal injury. Nor does the complaint tell us how the manufacturing process failed, or how it deviated from the FDA approved manufacturing process.

Funk v. Stryker Corp., 631 F.3d 777, 782 (5th Cir. 2011).

To infer an FDCA violation, and therefore an unpreempted manufacturing defect, from the mere fact of a device malfunction demands an “actual guarantee” of safety.  But “the FDA recognizes the device will not always function in accordance with specifications,” so such “additional requirement[s]” are “precluded.”  Walker v. Medtronic, Inc., 670 F.3d 569, 580 (4th Cir. 2012).  The “FDA approves the process by which a Class III device is manufactured, but it does not guarantee that every device manufactured in that process will work.”  Banner v. Cyberonics, 2010 WL 455286, at *4 (D.N.J. Feb. 4, 2010).  Therefore, “if the FDA approves a manufacturing process and the defendant-manufacturer conforms with it, a device thereby produced that nevertheless does not function as intended does not give rise to liability.”  Id.

For similar reasons, numerous courts have rejected res ipsa loquitur as a basis for inferring FDCA violations in PMA preemption cases.

[Plaintiff] relies, instead, on the doctrine of res ipsa loquitur for the proposition that full compliance would have resulted in a problem-free device.  Res ipsa loquitur does not suffice.  Res ipsa loquitur permits an inference of negligence when there can be no other explanation. . . . If negligence were the only cause of a Class III device’s failure, there would be no need for the MDA’s ongoing reporting requirements. See 21 C.F.R. § 814.84(b)(2). Plaintiff is ultimately wrong when he assumes that premarket approval guarantees the device is completely safe.

Clark v. Medtronic, Inc., 572 F. Supp.2d 1090, 1094 (D. Minn. 2008).  “Because of the general nature of the doctrine of res ipsa loquitur, a fact finder could rule in favor of [plaintiff] without finding that [defendant] violated any federal regulation.  Such a finding would impose requirements ‘different from, or in addition to,’ those in the [device’s] PMA and would thus be expressly preempted.”  Williams v. Bayer Corp., 541 S.W.3d 594, 612-13 (Mo. App. 2017).  Accord McAfee v. Medtronic, Inc., 2015 WL 3617755, at *6 (N.D. Ind. June 4, 2015) (“[t]o the extent [plaintiff] alleges that [defendant] is liable under a theory of res ipsa loquitur . . ., his claims are preempted”); Kallal v. Ciba Vision Corp., 2013 WL 328985, at *3 (N.D. Ill. Jan. 28, 2013) (preempting “argument hints at reliance on the doctrine of res ipsa loquitur”), aff’d, 779 F.3d 443 (7th Cir. 2015); Knoppel v. St. Jude Medical, Inc., 2013 WL 12116393, at *7 (C.D. Cal. Sept. 24, 2013) (“the res ipsa loquitur doctrine is barred by [preemption] because the PMA process does not demand that a product be risk free, but only that its benefits, if manufactured according to specifications, outweighs its risks”); Gross v. Stryker Corp., 858 F. Supp.2d 466, 483 (W.D. Pa. 2012) (“references to federal regulations in his negligence and res ipsa loquitur claims are too vague and general”); Desabio v. Howmedica Osteonics Corp., 817 F. Supp.2d 197, 202 (W.D.N.Y. 2011) (res ipsa claims “are based squarely on Defendants’ purported breach of state tort duties of care,” which “are precisely the type of claims Riegel held are preempted”); Cafferty v. Cayuga Medical Center, 2011 WL 541809, at *5 (N.D.N.Y. Feb. 8, 2011) (“one may not infer a manufacturing defect without creating a duty that adds to, rather than parallels, federal requirements”); Funk v. Stryker Corp., 673 F. Supp.2d 522, 531 (S.D. Tex. 2009), (because “the PMA process does not demand that an innovation be risk free . . . [i]t would follow that one may not infer a defect in the product simply because a patient encountered negative side effects in using it”), aff’d, 631 F.3d 777 (5th Cir. 2011); LeMay v. Eli Lily [sic] & Co., 960 F.Supp. 183, 186 (E.D. Wis. 1997) (parallel claims “proceed only for violations of the FDA regulations” but “res ipsa loquitur could allow recovery for negligence that Congress has preempted,” so plaintiffs “may not rely on the doctrine”).

Therefore, “[t]he fact that the [defendant’s device] allegedly failed does not itself establish a deviation from the FDA-approved standards.”  Smith v. St. Jude Medical Cardiac Rhythm Management Div., 2013 WL 1104427, at *4 (D. Md. Mar. 13, 2013).  In Burgos v. Satiety, Inc., 2013 WL 801729 (E.D.N.Y. March 5, 2013), no inference that an investigational device violated FDA regulations could be inferred from its malfunction, even though plaintiff had been offered a settlement and there were allegations of spoliation (neither of which were present in Sumpter).

Plaintiff has failed to provide any circumstantial evidence, other than the fact that Plaintiff was injured and that she was offered some money, to argue that the . . . device was actually manufactured in a way that violated the IDE.  Plaintiff has not presented any evidence that the . . . device was adulterated, or that it was unreasonably dangerous and unfit for [its] intended purpose to show that the IDE was violated.  Failure to provide any evidence in support of Plaintiff’s claim is fatal and it must be dismissed.

Id. at *7 (citations and quotation marks omitted).  See also Herrnandez v. Stryker Corp., 2015 WL 11714363, at *3 (W.D. Wash. March 13, 2015) (plaintiff could not escape preemption on “conclusory allegations” that explanted device violated FDA regulations); Ali v. Allergan USA, Inc., 2012 WL 3692396, at *11 (E.D. Va. Aug. 23, 2012) (facts that support causation from a malfunction “are not sufficient to link the [malfunction] or [plaintiff’s] injuries to any federal violation . . . in the manufacture of the device”); Anthony v. Stryker Corp., 2010 WL 1387790, at *4 (N.D. Ohio Mar. 31, 2010) (an “attempt to recast generalized deviations from ‘manufacturing performance standards’ as specific violations of federal regulations is insufficient to state a claim”); Rankin v. Boston Scientific Corp., 2010 WL 672135, at *4 (E.D. Ky. Feb. 19, 2010) (“that the [device] allegedly failed during normal use does not override the clear language of §360(a) or the Supreme Court’s ruling in Riegel that the plaintiffs’ claims are preempted by federal law”); Cenac v. Hubbell, 2009 WL 10678961, at *4 (E.D. La. July 31, 2009) (“mere fact that a device malfunctions or produces an adverse result does not plead a violation of federal law”); Delfino v Medtronic, Inc., 2018 WL 2688420, at *8 (Minn. Dist. May 18, 2018) (“the mere fact that a device malfunctioned is not evidence that the device violated any federal requirement”).

Sumpter cited nothing to support its letting the plaintiff slide under TwIqbal on the theory that a device malfunction, without more, is enough to establish not only a product defect, but an FDCA violation.  That’s two bridges too far.  One can only hope that defense counsel will be able to show the trial court the error of its ways soon, without the need for an appellate court to do it for them.

One of our primary goals is to bring you the latest and greatest news in the drug and device litigation world. But sometimes we don’t learn of a case at the time it’s decided. So, then we need to move on to another of our guiding principles – if it’s good for the defense, we talk about it. So, while today we happen to have come upon a case that was decided in 2017, it dovetails with our recent post Taking Out the Laundry With TwIqbal where we talked about plaintiffs’ attempts to bluff their way to a valid parallel violation claim. And that’s exactly what the plaintiff in Rand v. Smith & Nephew, Inc., 2017 WL 8229320 (C.D. Cal. Apr. 5, 2017) tried to do. Plaintiff put together a “laundry list” of allegations that the defendant’s device violated with no hint of what exactly the defendant did that was in violation. In our prior post we commented that “most courts are willing to use TwIqbal to call bull$%@&! on these types of allegations.” Fortunately, Rand can be added to that list.

The device at issue in Rand is a hip resurfacing prosthesis that underwent pre-market approval from the FDA. That’s why we are talking about parallel violation claims. Following a nice Riegel analysis, the court looked at plaintiff’s allegations for each cause of action.

Strict liability: Under California law, this is a claim for a design, manufacturing and warning defect. Because the FDA reviews “device design, manufacturing processes, and device labeling” as part of the PMA, “the MDA preempts state-law claims against these three aspects of PMA-compliant devices.” Id. at *4. So, plaintiff made 2 laundry lists – one of “various federal regulations” and another of defendant’s alleged misconducts. Double the nonsense.

First, plaintiff included regulations that go to the adequacy of defendant’s PMA application. “But FDA’s approval demonstrates the agency’s reasonable assurance of [the device’s] safety and effectiveness based on the application.” Id. So any claim premised on those regulations is preempted. Second, the court moved on to TwIqbal finding some allegations so poorly pleaded that it is “impossible to determine whether they add to federal requirements and hare hence preempted.” Id. Finally, some allegations were completely conclusory.

Plaintiff’s second list wasn’t much better. Not only did it include conclusory allegations – basically just speculation – but plaintiff also included alleged misconduct that was irrelevant. For example, plaintiff alleged wrongdoing regarding device components used in off-label combinations but plaintiff was implanted with such a combination. In other words, plaintiff was tossing pasta at the wall and just hoping something stuck. That’s not good enough under TwIqbal.

The only allegation that made the cut was failure to report adverse events. Id. This is California, so it’s to be expected.

Negligence: This largely mirrors plaintiff’s strict liability claim and suffers the same fate. The only new “misconduct” included in the negligence count was about defendant’s withdrawal of the device for “demographics groups” to which plaintiff didn’t belong. Irrelevant. Id. at *5. And, plaintiff surmised that defendant’s breach proximately caused his injury but provided no support for that allegation. Id. The entire negligence claim was dismissed.

Breach of express warranty: Again, most of plaintiff’s allegations are insufficient:

Without more details, the statements that [defendant’s] devices are of merchantable quality, safe, effective, and fit and proper for its intended use are no more than an affirmation merely of the value of the goods or a statement purporting to be merely the seller’s opinion or commendation of the goods. Such unspecific statements do not create a warranty.

Id. (citation and quotation marks omitted). The court did find that a press release cited by plaintiff created an express warranty but plaintiff failed to allege how the press release violated any PMA requirement. Without that, the claim was dismissed without prejudice.

Breach of implied warranty: This claim was preempted:

Both types of implied warranties involve an assertion that the goods are fit for then intended purpose. Implied warranty of merchantability further imposes labeling requirement and requires that the goods conform to the statements on the label. But these conditions are precisely what a PMA entails. Thus, unless the defendant violates these conditions under the PMA, § 360k(a) expressly preempts this claim.

Id. at *6 (citation omitted). Since plaintiff used the device for the purpose the FDA approved – no breach of implied warranty claim.

Fraudulent concealment: Here again plaintiff attempts to rely on a failure to report adverse events to state his claim. But essential to a fraud claim is that defendant had a duty to disclose the concealed fact to plaintiff. Id. We think this negates failure to report as a basis for strict liability as well and we’ve made our views on that clear many times. Here, plaintiff didn’t allege that federal regulations require defendant to report adverse events to plaintiff – nor can he because that’s not the law. That means that this would be an “additional requirement” which is preempted. Id..

The claim also failed for no allegation of intentional concealment by defendant and for not satisfying Rule 9(b)’s heightened pleading requirement for fraud. Id.

It may not be the latest and greatest, but it adds to the wealth of decisions tossing plaintiffs’ multi-paragraph list of violations which are a lot more bark than bite.

In medical device product liability cases to which preemption by reason of FDA pre-market approval (“PMA”) applies, courts have consistently misinterpreted the Supreme Court’s dictum in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) − finding the plaintiff’s “parallel” violation claims waived by failure to assert in the court of appeals – as somehow endorsing such claims.  Of course, only those PMA plaintiffs able to take advantage of prior FDA enforcement actions (usually, but not exclusively, warning letters or recalls) really have any basis to raise so-called “parallel” claims, but that certainly won’t stop other plaintiffs desperate to avoid preemption.

Lacking factual basis to make a valid parallel claim, such plaintiffs frequently try to bluff their way through by burying their opponents in garbage.  Typically, this ploy takes the form of a “laundry list” of allegations that the defendant’s device violated just about every FDA good manufacturing practice (“GMP” or “CGMP” in the cases) in the title 21 of Code of Federal Regulations, and for good measure, sometimes other regulations as well.  These allegations often go on for several pages in a complaint, with no hint of what exactly the defendant did that was in violation, and even less about how any of these purported violations caused any injury to this particular plaintiff.

Fortunately, most courts are willing to use TwIqbal to call bull$%@&! on these types of allegations.  “To plead a parallel claim successfully, a plaintiff’s allegations must meet the plausibility standard articulated by the Supreme Court in Iqbal and Twombly.”  Shuker v. Smith & Nephew PLC, 2015 WL 1475368, at *13 (E.D. Pa. March 31, 2015), aff’d, 885 F.3d 760 (3d Cir. 2018).  “[M]ore is required to make out a parallel claim than conclusory statements that a defendant violated multiple regulations.”  Swisher. v. Stryker Corp., 2014 WL 1153716, at *2 (W.D. Okla. March 14, 2014).  “Plaintiff must do more than simply allege the existence of the regulation, and then state that Defendants violated it.” Grant v. Corin Grp. PLC, 2016 WL 4447523, at *6 (S.D. Cal. Jan. 15, 2016).

One of the first cases to encounter, and to dispatch, this kind of abusive pleading was Ilarraza v. Medtronic, Inc., 677 F. Supp.2d 582 (E.D.N.Y. 2009).  Since the complaint in Ilarraza “goes on to list eleven federal regulations alleged to have been violated,” id. at 583, the opinion needed over two  pages just to explain the regulations that plaintiff claimed that the defendant violated.  Id. at 586-88.  However, “no regulation relied upon refers specifically to the medical device at issue here.”  Id. at 588.  TwIqbal therefore barred the claims:

[W]here, as here, a plaintiff relies on nothing more that CGMP’s in support of a parallel cause of action, preemption bars the claim. . . .  Plaintiff’s claim cannot withstand the pleading requirements [that] . . . require dismissal of complaints that do nothing more than engage ion a “formulaic recitation of the elements of a cause of action.  Where, as here, the plaintiff has done nothing more that recite unsupported violations of general regulations, and fails to tie such allegations to the injuries alleged, the complaint is properly dismissed.

*          *          *          *

Here, Plaintiff fails to set forth any specific problem, or failure to comply with any FDA regulation that can be linked to the injury alleged.

Id. at 588, 589 (Twombly citations omitted).

Another early pleading case is In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147 (D. Minn. 2009), in which MDL plaintiffs, after Riegel was decided, loaded up their master complaint with lots of alleged regulatory violations.  Id. at 1153-54.  Dismissing the complaint, the court held:

Plaintiffs’ failure to allege in detail the federal requirement(s) purportedly violated by Medtronic also raises the specter of Twombly. . . .  Hence, their assertion that the [device] did not comply with the CGMPs/QSR is insufficient, without more, to save their claims. Under Twombly, Plaintiffs were required to provide enough factual detail in the Complaint to alert [defendant] of the “grounds” upon which their manufacturing-defect claim rests. Merely alleging that [defendant] failed to comply with the CGMPs/QSR . . . is insufficient without some factual detail about why that violates federal standards.

Id. at 1158 (citations and quotation marks omitted).  The Eighth Circuit affirmed, holding, in pertinent part, that “Plaintiffs simply failed to adequately plead that [defendant] violated a federal requirement specific to the FDA’s PMA approval of this Class III device.”  In re Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation, 623 F.3d 1200, 1207 (8th Cir. 2010).

But TwIqbal has defeated “laundry list” pleadings much more recently.  In Canary v. Medtronic, Inc., 2017 WL 1382298 (E.D. Mich. April 18, 2017), plaintiffs’ complaint recited “over the course of nine pages and nearly thirty paragraphs . . . a plethora of CGMPs and other regulatory provisions to which Defendant allegedly was subject.”  Id. at *8.  Nonetheless, the court TwIqballed the complaint.

A number of courts have rejected this “laundry list” approach to pleading a parallel claim arising from a manufacturer’s alleged violation of FDA regulations or CGMPs. . . .  [T]he allegations that follow Plaintiff’s lengthy recitation of purportedly relevant CGMPs and regulatory duties are too vague and conclusory to satisfy the Twombly/Iqbal standard of plausibility. . . .  [T]he allegations put forward by Plaintiff here in support of her product liability claims lack the factual content necessary to permit the plausible inferences (i) that Defendant violated one or more FDA regulations . . . and (ii) that Plaintiff was injured as a result of these violations.

Id. (citations omitted).

A similar result was reached in McLaughlin v. Bayer Corp., 172 F. Supp.3d 804 (E.D. Pa. 2016).  Five unrelated plaintiffs tried to gin up a parallel claim with a long list of purported regulatory violations, filing a single complaint that “simply include[d] a laundry list of over twenty-five federal ‘requirements,’” to which were appended “over twenty alleged breaches” – all “without giving any indication as to what federal requirement was violated by each alleged breach.”  Id. at 820-21.  TwIqbal barred that hot mess:

Most importantly . . . Plaintiffs have failed to allege any identifiable causal connection between the alleged [violations] and Plaintiffs’ resulting injuries. . . . The Complaint then baldly alleges that all identified . . . breaches caused Plaintiffs’ damages. . ., [but] [g]iven the lack of allegations that in any way link [defendant’s] failure to follow procedures . . . with . . . any of Plaintiffs’’ [] devices . . ., we can only conclude that Plaintiffs’ claims are based entirely on speculation.  Indeed, we are unable to discern any plausible and non-speculative causal connection between any of [defendant’s] alleged . . . failings and . . . Plaintiffs’ [] devices.  Accordingly, we conclude that the negligent risk management claim, as currently pled, does not set forth a plausible claim for relief.

172 F. Supp.3d at 821 (citations and quotation marks omitted).  A similar string of regulatory violation allegations got the bum’s rush in Gelber v. Stryker Corp., 788 F. Supp.2d 145 (S.D.N.Y. 2011), because, “[t]o the extent these vague and conclusory allegations are not impliedly preempted . . ., plaintiffs have failed to set forth facts to plausibly allege how defendants violated these provisions or how [injured plaintiff’s] injury is linked to any such violation.”  Id. at 164-65.

Likewise, in Raab v. Smith & Nephew, Inc., 150 F. Supp.3d 671 (S.D.W. Va. 2015), plaintiffs’ allegations of “wholesale noncompliance with the requirements of . . . a series of statutory provisions” failed TwIqbal.  Id. at 698.

[P]laintiffs do not allege how any of the defendant’s promotional activities violated federal law because they neither identify any specific conduct on the part of the defendant . . . nor any substantive federal regulation, restriction, or standard . . . actually made applicable to any of the defendant’s devices.  On such allegations, the defendant (and this Court) are left to guess as to the manner in which the defendant was negligent under state law.  More is required of a valid parallel claim.

Id. (citations omitted).  A similar “list[] without any supporting factual allegations eight provisions of the FDCA and corresponding federal regulations which Plaintiff’s allegedly violated” was TwIqballed in Gavin v. Medtronic, Inc., 2013 WL 3791612, at *16 (E.D. La. July 19, 2013), since “Plaintiff has failed to identify violations of federal regulations and provide allegations connecting those violations to Plaintiff’s specific injury.”  Id. at *17.

Parallel violation claims fail where “plaintiff cites generally applicable CGMPs and contends the [PMA device] violated them, without alleging specific facts to support his assertions.”  Gale v. Smith & Nephew, Inc., 2013 WL 9874422, at *3 (S.D.N.Y. Sept. 13, 2013).  In Shuker, the court denied plaintiff’s attempt to amend the complaint, due to woefully insufficient pleading:

In Count II of their Second Amended Complaint, Plaintiffs allege Defendants were negligent in that they breached their duty “to comply with the [FDCA] and the regulations promulgated pursuant to the Act” by violating a host of statutory and regulatory provisions.  Although defendants devote twenty pages − approximately one-third of the Second Amended Complaint − to cataloging these alleged violations, they offer no legal support for, or explanation of, most of the theories they seek to advance. . . .  As a result, the Court is left to parse a lengthy laundry list of FDCA provisions and FDA regulations.

2015 WL 1475368, at *13 (factual citations omitted).  The allegations failed because “Plaintiffs have not pleaded facts supporting a plausible inference that Defendants engaged in” the claimed violations, pleaded “conclusory allegation[s]” that were “entirely speculative,” and “provide[d] no explanation of any such deviation[s].”  Id. at *14, 16.

The same result occurred in Paturzo v. Boston Scientific Corp., 2017 WL 8220600 (C.D. Cal. April 21, 2017), where bald allegations of multiple regulatory violations could not save a supposed “parallel” claim from dismissal:

Although Plaintiffs list several federal regulations that Defendants purportedly violated, they fail to allege any facts relating the [device failure] to Defendants’ manufacturing processes and, specifically, the FDA’s requirements for manufacturing. Plaintiffs’ allegations of Defendants’ failure to establish or maintain certain quality control procedures are simply regurgitations of the text of the federal regulations.  Alone, they amount to no more than an allegation that Defendants violated federal standards.

Id. at *5.  The court could “draw no reasonable inference that the [device failure] was the result of a manufacturing defect, let alone that the manufacturing defect arises from Defendants’ failure to comply with FDA requirements. Id. Accord Chester v. Boston Scientific Corp., 2017 WL 751424, at *9 (D.N.J. Feb. 27, 2017) (complaint “provides a laundry list of FDA regulations with which Defendants were obligated to comply” but “is missing . . . any plausible pleading of if, how, or when Defendants violated any of the listed regulations”).

See also Skinner v. St. Jude Medical, Inc., 2016 WL 4054931, at *3 (W.D. La. July 27, 2016) (“it is difficult to discern whether any of [plaintiffs’] claims are parallel claims because the amended complaint contains little more than a laundry list of bare, conclusory allegations”); Nevolas v. Boston Scientific Corp., 2016 WL 1532259, at *3-4 (W.D. Okla. April 15, 2016) (5 paragraphs of violation allegations insufficient; “more is required to make out a parallel claim than conclusory statements that a defendant violated multiple regulations) (quoting Swisher, supra); Ward v. St. Jude Medical, Inc., 2016 WL 1208789, at *2 (S.D. Fla. March 28, 2016) (“Although the amended complaint alleges that the defendants violated various federal statues, it does not present device-specific premarket violations linked to the plaintiffs’ alleged harm.”); Ellis v. Smith & Nephew, Inc., 2016 WL 7319397, at *4-5 (D.S.C. Feb. 16, 2016) (list of 12 alleged violations “failed to allege how the violations of these federal requirements would give rise to liability under state law for [plaintiff’s] injuries”); Grant, 2016 WL 4447523, at *6 (complaint “is utterly devoid of factual allegations concerning what manufacturing procedures Defendants allegedly violated”); Nevolas v. Boston Scientific Corp., 2016 WL 347721, at *3 (W.D. Okla. Jan. 28, 2016) (complaint “simply makes numerous conclusory allegations, devoid of any factual support, that defendant violated in unspecified ways various federal regulations and federal manufacturing requirements”); Thibodeau v. Cochlear Ltd., 2014 WL 3700868, at *4 (D. Ariz. July 25, 2014) (“negligence claims cannot simply put forth a laundry list of PMA or federal law provisions Defendants failed to follow without some factual allegations in support”); Williamston v. Medtronic, Inc., 2014 WL 2042004, at *7 (W.D. La. May 15, 2014) (footnote omitted) (“[t]he simple listing of various federal regulations is insufficient to successfully plead a state law claim predicated on the violation of federal requirements”); McPhee v. DePuy Orthopedics, Inc., 2013 WL 5462762, at *5 (W.D. Pa. Sept. 30, 2013) (“Plaintiffs merely list the CFR provisions and assert that Defendant was negligent in violating the listed provisions”); Desai v. Sorin CRM USA, Inc., 2013 WL 163298, at *6-7 (D.N.J. Jan. 15, 2013) (list of regulations “fail[s] to assert the facts necessary, or indeed, any facts at all, to establish a claim that would parallel a violation of federal law” and “fail[s] to allege any ‘cognizable link’ between [the] alleged federal violations and [plaintiff’s] injury”); Cohen v. Guidant Corp., 2011 WL 637472, at *2 (C.D. Cal. Feb. 15, 2011) (complaint was “flawed . . . because it lists boilerplate FDA regulations without linking any of those regulations to a defect in [plaintiff’s] specific pacemaker that was caused by Defendants violating FDA regulations”); Cenac v. Hubbell, 2010 WL 11537934, at *2-3 (E.D. La. April 16, 2010) (list of four regulatory violations in complaint TwIqballed “because it provides no facts with respect to how [defendant] violated federal regulations”).

In Weaver v. Ethicon, Inc., 2016 WL 7098781 (S.D. Cal. Dec. 6, 2016), plaintiffs tried to cobble together a failure-to-report claim from an allegation that defendant violated no less than fourteen FDA regulations. Id. at *5 (listing regulations).  This “laundry list” failed because “[a] general allegation that Defendant failed to report adverse events to the FDA is not sufficient to demonstrate causation.”  Id. at *6 (citations omitted).  Plaintiffs’ “acts present only conclusory allegations that Defendant failed to report adverse events without specific instances of actual adverse events.”  Id.  For a comprehensive rundown (as of September, 2016) of causation issues in failure-to-report cases, see this prior post.

A fortiori, the minimalist approach the pleading FDCA violations also fails.  Plaintiffs “cannot simply incant the magic words ‘[defendant] violated FDA regulations’ in order to avoid preemption.”  Wolicki-Gables v. Arrow International, Inc., 634 F.3d 1296, 1301 (11th Cir. 2011).  “[B]road references to federal regulations in pleadings are insufficient.”  Gross, 858 F. Supp.2d 466, 494 (W.D. Pa. 2012).

Although Plaintiff acknowledges that [defendant] must comply with the specific regulations that apply to the . . . PMA device, he does not outline what these regulations are or how [defendant] allegedly violated same.  Because Plaintiff pled his negligence claim in a very general manner, he has failed to state a claim for negligence that survives preemption.

Id. at 497 (citation omitted).  In Olmstead v. Bayer Corp., 2017 WL 3498696 (N.D.N.Y. Aug. 15, 2017), the plaintiff alleged generally that the defendant violated the FDA’s CGMPs, citing generally, “21 C.F.R. §820.1 et. seq.”  But “[p]laintiff fail[ed] to explain how Defendants violated the CGMPs.”  Id. at *4.  That attempt resulted in dismissal because:

Plaintiff has failed to identify a single parallel federal statute or regulation related to any of her claims.  Therefore, the Court concludes that, as a matter of law, the MDA expressly preempts Plaintiff’s claims.

Id. (footnote omitted). See also Ali v. Allergan USA, Inc., 2012 WL 3692396, at *7 (E.D. Va. Aug. 23, 2012) (plaintiff’s “Complaint offers a series of conclusory allegations that that [defendant] violated federal law in the manufacture and marketing of the [device].  However, without factual enhancement, these statements are insufficient to plead plausible federal violations”); Parker v. Stryker Corp., 584 F. Supp. 2d 1298, 1302 (D. Colo. 2008) (“nowhere does plaintiff’s complaint provide any factual detail to substantiate that crucial allegation”).

Thus, although on first glance a complaint’s multi-paragraph list of FDA regulations that the defendant allegedly violated may look imposing, chances are that the plaintiff has failed either to plead facts sufficient to establish any violation as to the particular device or to allege how the purported violations caused a product defect that actually caused the injuries being alleged.  In either instance, the plaintiff’s “parallel” claim preemption dodge should properly be TwIqballed.

For at least forty years we’ve been hearing that soccer is going to supplant baseball, basketball, or football among America’s top three sports.  It hasn’t happened.  Maybe we heirs of Washington, Jefferson, Ruth, Rice, and Chamberlain have limited enthusiasm for one-nil scores and players diving and mimicking death throes in a cheap effort to extract a penalty kick.


Meanwhile, we have seen boxing subside in the country’s consciousness, bullied out of the way by mixed martial arts (MMA). It’s hard to believe one of those M’s does not stand for mayhem.  Forget about the Marquis of Queensbury’s niceties.  In MMA, the contestants are free to kick, choke, and elbow each other.  Hit a man when he’s down?  That’s not forbidden in MMA. Nope, that’s when the action is just getting started.  Pretty much anything goes in MMA.  
But you cannot use anabolic steroids.  If you test positive, you get suspended.  Rules are rules.  

The plaintiff in In re Lyman Good Dietary Supplements Litigation, 2018 U.S. Dist. LEXIS 131668 (SDNY Aug. 6, 2018), was an MMA fighter who was suspended because he tested positive for a banned substance.  The court employs the short-hand reference “andro” for the banned substance, and so shall we.  The plaintiff claimed that he had unknowingly ingested andro that was present in two dietary supplements that had been labeled to be free of any banned substances. The plaintiff alleged that the manufacturers and sellers of the dietary supplements promised that the products were “safe,” “without the use of banned substances,” “banned substance free,” and in compliance with “strict quality assurance procedures.”  The presence of andro broke such promises, and the plaintiff’s career had suffered a serious bruise. The plaintiff sued the manufacturers, high ranking executives at the manufacturers, and the retailer. The causes of action were interesting, including some you’d expect (breach of warranties, fraud, deceptive practices, false advertising, negligence, and strict liability) and some you wouldn’t (intentional infliction of emotional distress, assault and battery).  The defendants moved to dismiss and ended up winning more than they lost.

The court dismissed the claims for fraud, assault and battery, and intentional infliction of emotional distress.  Fraud claims are subject to heightened pleading requirements, which the complaint didn’t come within a puncher’s chance of satisfying. All we get are general allegations of fraudulent intent, along with generalized motive to earn profits.  That isn’t nearly enough.  The court applied a rear naked choke to the fraud claim and counted it out.  The assault and battery claim was a wild swing and miss.  The plaintiff’s theory was that putting a substance in someone’s body without consent is battery, but there was no case support for that, plus the plaintiff never alleged the requisite intention to inflict injury.  Here comes a reverse guillotine, and watch the court slice off the assault and battery claims.  Lack of intent is also what doomed the claim for intentional (or reckless) infliction of emotional distress.  The court also could identify no alleged outrageous conduct that went “beyond all possible bounds of decency.”  (To be sure, when one is dealing with MMA, it might seem difficult to meet that standard.) 

The court dismissed the claims against the executives, both on the merits and for want of personal jurisdiction.  Suing executives is fairly rare, and there are reasons for that.  Piercing the corporate veil requires a showing that the executives exercised compete domination and disregarded corporate formalities, including use of corporate funds for personal purposes.  At most, the complaint alleged that the individual defendants were high-level officers with wide-ranging authority, but an officer or director is not personally liable for the torts of a corporation merely by reason of occupying an important office.  The complaint utterly failed to allege that the executives used corporate domination to perpetrate a fraud.  In any event, there was no personal jurisdiction over the individuals.  They all had general authority over their corporations, but were not the primary drivers of the particular transactions in New York that gave rise to the litigation.  Hello sleeper hold, and good-bye claims against the individual defendants.  

The retailer prevailed on most of its motions to dismiss.  The claims for implied warranty of fitness for particular purpose, express warranty, and false advertising were carried out of the ring, but the claim of implied warranty of merchantability emerged unscathed.   The only express warranty by the retailer listed in the complaint was a statement in its 10-K annual report that the company used quality control procedures and that it refused to sell products that did not comply with law or were unsafe.  Those representations are pretty general, and the plaintiff did not even claim to have read them or relied upon them prior to purchase.  Nor did the annual report constitute a form of advertisement.  The court granted the plaintiff leave to amend the claim for implied warranty of fitness for particular purpose because, even though the complaint was bereft of any assertions that the plaintiff and the store had any conversations about how the plaintiff would use the supplements to prepare for MMA combat, the plaintiff wanted to add six paragraphs alleging precisely such conversations.  If such conversations did take place, it would not be “outside the realm of reasonable knowledge” that professional competitions require drug testing.   Thus, the particular purpose warranty claim might live to fight again.

The opinion in Lyman Good is solid and clear.  It goes through the different causes of action and defendants one-by one, jab by jab.  It reminds us that MMA is not the only place where rules are rules.

Every now and then, the Reed Smith powers that be make seats in the firm’s skybox at the Phillies’ (first place – who woulda thunk?) stadium available to folks like us.  As a result we attended back-to-back concerts by the Eagles and Billy Joel last weekend.  Yes, we know that dates us – that was obvious from crowd demographics – but we don’t mind.  Joel (who according to Wikipedia, caught his first big break in Philly back in 1972) played until nearly midnight after the show’s opening was delayed by a cloudburst.  He made sure to perform “Allentown” with its Pennsylvania themes, but Joel being Joel, he also played “New York State of Mind.”

Our immediate Philadelphian chip-on-our-shoulder reaction was, “Don’t bring that New York %@#&*! down here.  If you have to sing about New York City, at least play “Miami 2017” (he didn’t).”  But then we got back to work, and we ended up thinking, actually there is at least one good recent reason for us to look to New York.

TwIqbal.

Over the last few weeks, New York courts have produced two of the best TwIqbal decisions that we’ve ever seen: Quintana v. B. Braun Medical, Inc., 2018 WL 3559091 (S.D.N.Y. July 24, 2018), and Oden v. Boston Scientific Corp., ___ F. Supp.3d ___, 2018 WL 3102534 (E.D.N.Y. June 4, 2018).  If more courts applied TwIqbal as faithfully as this duo, you know what?  Lawyers on the other side might actually have to comply with Rule 11 and actually investigate their cases before filing them.

Both cases involve Class II medical devices (IVC filters), so their TwIqbal application is not related to federal preemption and so-called “parallel” violation claims.  They’re just straight-out TwIqbal fundamentalism.  So, for those of you who file TwIqbal motions in order to force plaintiffs to plead what the heck their cases are about (most of us D-siders these days), and who use our TwIqbal Cheat Sheet to find good cases in your jurisdiction to cite, here’s a rundown of the relevant rulings.

Warning Defect

Given the nature of a warning-based product defect claim, “a claim premised upon a failure to warn theory should be dismissed in the event a plaintiff fails to plead facts establishing how or why the warning provided was inadequate.”  Oden, 2018 WL 3102534, at *6.  “[C]onclusory” warning allegations that failed TwIqbal are:

  • “Defendant failed to provide sufficient warnings and instructions”
  • “Defendant knew or should have known, and adequately warned that its product created a risk of serious and dangerous side effects, including but not limited to. . . .”
  • “The warnings given did not accurately reflect the risk, incidence, symptoms, scope or severity of such injuries to the consumer”
  • Defendant “only provides limited information [concerning] possible complications”
  • “Defendant’s warnings page on their website . . . fails to address the full extent of complications [and] magnitude of risks involved”

Id. None of this boilerplate, individually or collectively, survived TwIqbal.  “[T]he Complaint fails to provide facts identifying how or why the included warnings were inadequate.”  Id. at *7.  Given the warnings referenced in the complaint (labeling, product brochure, instructions for use, website), the complaint came nowhere near meeting TwIqbal requirements:

[T]he Complaint fails to provide facts identifying how or why the included warnings were inadequate.  Although Plaintiff claims that Defendant failed to warn or otherwise provided inadequate warnings of all of the aforementioned risks, the Complaint is silent as to how the warnings that were indisputably provided . . . were inadequate.  Moreover, Plaintiff has failed to provide the necessary factual nexus showing how the warnings that were provided were insufficient since merely asserting that warnings were not “adequate” or “sufficient” are nothing more than legal conclusions.  Without facts setting forth what the warnings stated and how and/or why the warnings were inadequate, Plaintiff’s failure to warn claim is insufficiently pleaded.

Id. at *7 (citations and quotation marks omitted).

Another pleading deficiency was the complaint’s failure to distinguish between “actual injuries Plaintiff experienced versus those complications which potentially could result from implantation of the [device].”  Id. (emphasis original).  “Nor does the Complaint contain any nonconclusory allegations that Plaintiff’s treating physician was not adequately informed or apprised of the potential risks.”  Id.  In a learned intermediary case, “to the extent Plaintiff’s failure to warn claim is premised upon Defendant’s alleged failure to warn ‘consumers’ . . . such a claim is not viable in the first instance.”  Id.  Thus a plaintiff must plead “facts to suggest that [the] physician did not possess independent knowledge about the risks associated with” the device.  Id.

Likewise, in Quintana, “Plaintiff’s allegations of inadequate warnings” were “for the most part, conclusory.”  2018 WL 3559091, at *6.  Plaintiff “fails to identify how those warnings were inadequate.”  Id.  Further, plaintiff failed to plead warning causation under the learned intermediary rule:

To this point, Plaintiff alleges, “as a direct and proximate cause of the wrongful acts and omissions of Defendants, Plaintiff suffered economic damages, severe injuries, and emotional distress.”  This conclusion, however, is not sufficient to plausibly show that the failure to warn Plaintiff’s physician caused Plaintiff’s injuries because we know nothing about what caused her [injury] – i.e., what about the device failed or what was Plaintiff’s diagnosis – nor anything about whether Plaintiff would have heeded an appropriate warning.

Id.

Design Defect

Oden held that a design defect claim is properly TwIqballed where it “fails to identify a particular problem in the design of [the device] and . . . merely plead[s] that the [device]  is ‘defective.’”  2018 WL 3102534, at *4.  A mere “list of allegedly unreasonable risks” “does not identify a specific component or particularized issue with the design itself.”  Id.  Similarly, describing a product as “unreasonably dangerous” when it “left the hands of the Defendant” does not adequately allege a defect.  Such descriptions “lack[] any facts indicating the particular component that was defective or otherwise identifying a specific problem.”  Id.  “Without such facts, Plaintiff’s design defect claim fails.”  Id.  Moreover, a design defect claim must allege an alternative design:

Plaintiff’s design defect claim also fails on the independent ground that the Complaint does not plead the existence of a feasible alternative design. . . .  [A] plaintiff must plead facts alleging the existence of a feasible alternative design.  The only paragraph in the Complaint specifically referring to this element merely states that “safer, reasonable alternative designs existed and could have been utilized,” but fails to identify what feasible alternative designs are available.

Id. at (citations and quotation marks omitted).  Pleading the availability of a “different” product (“retrievable,” as opposed to “permanent[]”) doesn’t hack it, “since the design and purpose of these two products is different.”  Id.

In pleading design defect, Quintana required plaintiffs to allege “a specific defect” as well as “facts about the “circumstances of the purported failure of the [device] that would give rise to the inference of proximate cause.”  2018 WL 3559091, at *4.  “A boilerplate reference to a design defect” that the product was “unable to withstand . . . normal” conditions failed TwIqbal.  Id.  As to product “risks,” a complaint must “state [] facts to indicate how those risks resulted from a specific design defect” and “how that defect was a substantial factor in causing [plaintiff’s] injuries.”  Id.  “[T]he assumption that [a] device must have failed because of reports of failures or complications by other consumers is plainly inadequate” to plead a design defect.  Id.  As in Oden, alleging a product to be “unreasonably dangerous” doesn’t adequately allege a defect.  Id.  A plaintiff must plead “how [a] problem rendered the product defective, whether it affected his [device], [and] how it caused [the] alleged injuries.”  Id. (citation and quotation marks omitted).  Further, “res ipsa loquitur is an evidentiary principle and does not apply to pleading requirements.”  Id. at *5.  Even if res ipsa were appropriate, it is insufficient when “Plaintiff fails to provide sufficient factual exposition to account for the possibility that other factors caused [the] injury.”  Id.  Finally, “[i]t also appears that Plaintiff’s design defect claim fails for failure to allege a feasible design alternative.”  Id. at 5 n.5.

Manufacturing Defect

The plaintiff’s “conclusory” allegations in Oden failed to plead a manufacturing defect “since they fail to allege a specific manufacturing defect affecting the [device] implanted in Plaintiff as compared to other [devices] that were produced by Defendant.”  2018 WL 3102534, at *5 (emphasis original).  “[A] claim devoid of allegations that a particular unit differed when compared to others in the same product line will be dismissed.”  Id.  “[A]lleg[ing] that some ‘condition or conditions’ existed that ultimately caused Plaintiff’s injuries” is a “vague assertion” that “fails to place Defendant on notice as to what the particular error in the manufacturing process was.”  Id.

Quintana did not involve a manufacturing defect claim.

Express Warranty

Oden reiterated that, to pursue a claim for breach of express warranty, “plaintiff must allege that there was an affirmation of fact or promise by the seller, the natural tendency of which was to induce the buyer to purchase and that the warranty was relied upon to [Plaintiff’s] detriment.”  2018 WL 3102534, at *8 (citation and quotation marks omitted).  An allegation that, somewhere in the defendant’s “literature, advertisements, promotions and . . . representations by their marketing team and sales agents,” a promise was made that the device was “safe, effective and fit for implantation” in various ways didn’t cut the mustard.  Id.  Even assuming these were “material statements amounting to a warranty,” no reliance was pleaded:

[T]he Complaint merely alleges Plaintiff’s purported “reliance” without providing any underlying factual details concerning when, where and how such reliance arose. Even assuming that Plaintiff was provided with a brochure . . ., the Complaint is devoid of any facts that would permit the inference that Plaintiff actually read these statements and directly relied upon them when making the decision to utilize Defendant’s product.  In addition, there are no facts illustrating that Plaintiff’s physicians ever reviewed the statements contained on Defendant’s website or those set forth in the product brochure prior to making the decision to recommend use of the [device].  Without such allegations, any purported claim that such reliance existed is implausible.

Id. at *9 (citations and quotation marks omitted).

In Quintana express warranty claims failed equally miserably.  “Plaintiff has failed to adequately plead reliance because her amended complaint lacks details regarding whether and how Plaintiff or her physicians reviewed and relied upon these warranties.”  2018 WL 3559091, at *7 (citations omitted).

Implied Warranty

Quintana did not involve implied warranty claims, but Oden did – two claims, for both merchantability and fitness for a particular purpose.  2018 WL 3102534, at *9-10.  Merchantability claims were TwIqballed, for lack of a proper defect claim, as already detailed.  Id. at *9.  Fitness claims failed because they were “altogether conclusory.”  Id. at *10.  “Where a plaintiff fails to plead that a defendant knew of the particular purpose for which that plaintiff was buying a product, a complaint will be dismissed.”  Id. at *9 (citation and quotation marks omitted).  This complaint didn’t so plead.  Id. at *10.  “[A] product’s intended or ordinary purpose is not necessarily equivalent with a particular purpose for which Plaintiff seeks to purchase a product.”  Id.  “Moreover, the Complaint does not contain any factual allegations leading to the inference that Defendant was aware that Plaintiff and/or his physicians were directly relying upon Defendant’s skill and judgment when the determination was made to purchase the” device.  Id.

Other

Both the Oden and Quintana complaints also contained the usual litany of fraud, fraudulent concealment, negligent misrepresentation, and consumer fraud claims.  These were all dismissed as well.  Oden, 2018 WL 3102534, at *10-15; Quintana, 2018 WL 3559091, at *7-10.  The fate of these claims was mostly decided under the particularity standards of Fed. R. Civ. P. 9(b) rather than TwIqbal.  Oden was of the view that the consumer fraud claims were subject only to TwIqbal standards, 2018 WL 3102534, at *14, and dismissed them on that basis:

[T]his cause of action fails because Plaintiff has not sufficiently pleaded causation.  Although Plaintiff sets forth certain statements contained on Defendant’s website and in its product brochure, these allegations neither explicitly state nor permit the plausible inference that Plaintiff actually saw these statements prior to making the determination (in conjunction with his physicians) to purchase the [device]. . . .  [T]he relevant factual background to support the above [allegations] is simply lacking.  As a result, Plaintiff has failed to sufficiently plead the third element of this claim.

Id. (citations omitted).

Quintana dismissed consumer fraud claims on the same basis, 2018 WL 3559091, at *10, although it is unclear whether the dismissal was under Rule 8 or Rule 9(b).  Unlike Oden, Quintana also applied TwIqbal to the plaintiff’s negligent misrepresentation claim, out of an abundance of caution, id. at *9 and held the claim inadequately pleaded under the learned intermediary rule.

[E]ven under the more lenient standards of Rule 8(a), Plaintiff’s negligent misrepresentation fails because she has not plausibly alleged reliance. . . .  [Plaintiff’s] allegation indicates only that Plaintiff relied on her physician’s advice and leaves open the question whether the physician relied on Defendants’ representations when giving Plaintiff that advice.  Because Plaintiff fails to plausibly allege what misrepresentation her physician relied on, her negligent misrepresentation claim is dismissed.

Id.

Finally, remember that we’re very picky on our TwIqbal Cheat Sheet.  We only include cases where a motion to dismiss was granted in its entirety.  In none of our 200+ drug/device TwIqbal cases did a single claim survive dismissal (sometimes on grounds other than TwIqbal).  New York has always been a productive source for TwIqbal Cheat Sheet cases:

Black v. Covidien, PLC, 2018 WL 573569 (W.D.N.Y. Jan. 26, 2018); Rincon v. Covidien, 2017 WL 2242969 (S.D.N.Y. May 22, 2017); Teixeria v. St. Jude Medical S.C., Inc., 193 F. Supp.3d 218 (W.D.N.Y. 2016); Morrison v. Hoffmann-La Roche, Inc., 2016 WL 5678546 (E.D.N.Y. Sept. 29, 2016); Adams v. Stryker Orthopaedics, 2016 WL 2993213 (S.D.N.Y. May 23, 2016); Ortiz v. Allergan, Inc., 2015 WL 5178402 (S.D.N.Y. Sept. 4, 2015); Rodman v. Stryker Sales Corp., 2014 WL 5002095 (S.D.N.Y. Oct. 7, 2014), aff’d, 604 F. Appx. 81 (2d Cir. 2015); Cordova v. Smith & Nephew, Inc., 2014 WL 3749421 (E.D.N.Y. July 30, 2014); Burkett v. Smith & Nephew GMBH, 2014 WL 1315315 (E.D.N.Y. March 31, 2014); Simon v. Smith & Nephew, Inc., 990 F. Supp.2d 395 (S.D.N.Y. 2013); Bertini v. Smith & Nephew, Inc., 2013 WL 6332684 (E.D.N.Y. July 15, 2013); Goldin v. Smith & Nephew, Inc., 2013 WL 1759575 (S.D.N.Y. April 24, 2013); In re Pamidronate Products Liability Litigation, 842 F. Supp.2d 479 (E.D.N.Y. 2012); Reed v. Pfizer Inc., 839 F. Supp.2d 571 (E.D.N.Y. 2012); Bowdrie v. Sun Pharmaceutical Industries Ltd., 2012 WL 5465994, (E.D.N.Y. Nov. 9, 2012); Desabio v. Howmedica Osteonics Corp., 817 F. Supp.2d 197 (W.D.N.Y. 2011); Gelber v. Stryker Corp., 752 F. Supp.2d 328 (S.D.N.Y. Sept. 14, 2010); In re Fosamax Products Liability Litigation, 2010 WL 1654156 (S.D.N.Y. April 9, 2010); Ilarraza v. Medtronic, Inc., 677 F. Supp.2d 582 (E.D.N.Y. 2009); Horowitz v. Stryker Corp., 613 F. Supp.2d 271 (E.D.N.Y. 2009); Lewis v. Abbott Laboratories, 2009 WL 2231701 (S.D.N.Y. July 24, 2009).

But you will find a couple of citations in Quintana and Oden to TwIqbal cases that we don’t include because they only dismissed complaints in part.  See Parillo v. Stryker Corp., 2015 WL 12748006 (N.D.N.Y. Sept. 29, 2015); DiBartolo v. Abbott Laboratories, 914 F. Supp.2d 601 (S.D.N.Y. 2012).  That’s OK – it’s a matter of legal judgment what to cite for any particular proposition.  Our philosophy is that we want to be picky, so we don’t give anyone a bum steer with a case citation that may be harmful on some other TwIqbal point.  As Billy Joel would say, “It’s no big sin to stick your two cents in if you know when to leave it alone.”

When we first looked at the decision for today’s post, we thought about comparing it to fan fiction. If you aren’t familiar with the term it is fiction stories written about characters from an original work of fiction created by fans of the original work as opposed to its creator. Pretty straightforward in concept. But while fan fiction has become more mainstream in recent years (one of the most popular fan fiction websites has almost 600,000 entries under the Harry Potter category alone), it still has a fairly bad reputation as the dark side of geek fandom. And let’s face it, the bulk of the people writing fan fiction aren’t going to be the next J.K. Rowling. And, fan fiction is at its core a product of fandom. So, you have to be fairly well-versed in the original to even think about understanding its offspring. That said, fan fiction having found a home on the internet has led to the development of communities that rally around the original work and discuss and debate everything from literary theory to pop culture.

But upon further reflection, we think the court’s decision in Proffitt v. Bristol Myers Squibb Co., 2018 U.S. Dist. LEXIS 111895 (S.D.W.Va. Jul. 5, 2018), is more like a reimagining of an old classic. There are many lists of books based on other books. Some authors create sequels or prequels to old classics. Possibly delving into storylines that were only marginally touched in the original. Those might be classified as published fan fiction – and some of it quite good. Wicked, for instance, long before it was a hit Broadway musical, was a Wizard of Oz spinoff about the life of the Wicked Witch of the West written by Gregory Maguire. But there are books that are re-tellings of original masterpieces designed to give the reader a more modern or updated take. For example, if you’ve read A Thousand Acres by Jane Smiley and you haven’t read Shakespeare’s King Lear, you should. Shakespeare’s king has to divide his kingdom among his three daughters and only realizes too late which one is the worthiest. Smiley updated the story to a farm in Iowa and overall paints a kinder picture of the sisters but the parallel cannot be denied.   Or, what about Bridget Jones’ Diary and Pride and Prejudice. Bridget and Elizabeth Bennett certainly have plenty in common, but Helen Fielding really stayed close to Jane Austen’s classic when she wrote Mark Darcy who is unquestionably Fitzwilliam Darcy in the 20th century.

So what’s the upshot of all of this, other than perhaps to inspire a summer reading list? Sometimes a story is so good it’s worth telling again, just updated. That’s essentially what the court did in Proffitt. The slip opinion is 12 pages long and almost 5 full pages are block quotes. We don’t mean that to be a negative thing. The court found it needed to say little new because the important stuff was already written.

Plaintiff sued the manufacturer of an antipsychotic drug he took alleging it caused him to develop tardive dyskinesia (limb twitching, facial tics, jaw clenching, etc.). Id. at *1. Plaintiff brought claims for negligent and strict liability failure to warn and breach of implied warranty of merchantability based on a failure to provide a reasonable warning. Id. at *2. Defendant moved to dismiss the complaint on the ground that plaintiff’s claims were insufficiently pleaded. That’s chapter 1 – the background.

In Chapter 2 – the standard of review – the court recounts what has fondly become known on this blog as TwIqbal. Here, the court didn’t need to reinvent the wheel. The Fourth Circuit had already summed it up quite nicely in Nemet Chevrolet, LTD v. Consumeraffairs.com, Inc., 591 F.3d 250 (4th Cir. 2009). The complaint needs enough facts to state a claim that is plausible on its face. Proffitt, at *3-4.

Moving into Chapter 3 – the analysis – the court found two more significant texts on which to rely. Remember, all of plaintiff’s claims are based on alleged failure to warn about tardive dyskinesia. But the drug’s label always contained a warning about that very condition. While plaintiff failed to even allude to the warning in his complaint, the court quoted all 5 paragraphs about tardive dyskinesia. Id. at *6-8. Which led the court to observe that plaintiff’s complaint neither alleges how that warning was inadequate or what an appropriate warning would look like. Id. at *8.

And here is where Proffitt really becomes a re-telling of Reed v. Pfizer, Inc., 839 F. Supp.2d 571, 575-77 (E.D.N.Y 2012). Because Reed had already done all the work. It explains exactly why given facts like Proffitt, a failure to warn claim can’t survive a TwIqbal challenge. The Reeds, like the Proffitts¸ failed to identify how the warning given by the defendant about the very risk at issue was inadequate. In both Reed and the more recent version, Proffitt, plaintiffs failed to allege any facts to suggest that the warnings in both cases were insufficient, erroneous, or contained misrepresentations. See generally Proffitt, at *8-12. Sometimes there is simply no improving on the original:

To cut to the chase, the fact (taken here as true) that [Reed/Proffitt] suffered from certain conditions that were also identified risks of ingesting [the drug] is tragic, but cannot alone make plausible a claim that defendants misrepresented or hid those risks in some way. Plaintiffs have alleged factual content sufficient only to make plausible that [Reed/Proffitt] ingested [the drug] and thereafter suffered serious harm. If such allegations were sufficient to state a failure to warn claim, then anyone experiencing harm after using a product where the harm is a warned-of risk could successfully plead a claim. Perversely, the pleaded fact that a warning was given would be the only pleaded fact supporting the claim that a lawfully adequate warning was not given. To allow such a naked claim to go forward would merely green light for plaintiffs an expedition designed to fish for an in terrorem increment of the settlement value, rather than a reasonably founded hope that the discovery process will reveal relevant evidence.

Id. at *11-12 (quoting Reed, other citations omitted).

Reed had also already done a good job of collecting many supporting cases but the Proffitt court updated the citations as well. Id. at *12-14.

And so the decision concludes by acknowledging the great work of the prior courts to have dealt with the issue and dismissing plaintiff’s claims as inadequately pleaded. Once again TwIqbal triumphs over a factually barren complaint.