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.

Permit us to recount a recent travel misadventure, though whatever eventual connection we draw to today’s case will be specious at best. Last Friday, we traveled from Philadelphia to Hartford, Connecticut for a deposition.  We were fresh off of a long flight home from Europe and were hesitant to take on a couple hundred miles of driving at each end of the day, so we investigated our options.  In the morning, direct flights from PHL to BDL abound.  But after 6 p.m., when our deposition was scheduled to end, there are no direct flights home. Nor are there Amtrak trains leaving Hartford after that hour.  So we threw up our hands and reserved a connecting flight home, reasoning that sleeping, reading, and eating Biscoff cookies would be more relaxing than driving.  This even though, to get from Hartford to Philadelphia, we had a totally illogical connection at Dulles, many miles out of the way.

Our originating flight landed at Dulles early.  And our 9:30 pm connection was showing “on time” on the board.  At 9:15 pm, the following announcement came over the loudspeaker: “We are very sorry, but your first officer is coming in on a flight that is delayed, so we need to delay your 9:30 pm flight until 11:30 pm.”  We were not pleased, but the new schedule would still get us home, crucial because we were leaving at noon on Saturday for an overnight trip.  At 11:20, the gate agent announced, “Your first officer’s flight has landed.  Give us a few minutes and we’ll get you boarded.”  At 11:30, we heard the following, dripping with contrition: “We are SO SORRY, but we are unable to put together a crew for your flight tonight, so we are delaying this flight until NOON TOMORROW.” [Emphasis added.]  Turns out that the long-awaited first officer had now exceeded his maximum hours for the day.

We did not react politely to this. We asked, “You mean to tell us that nothing in your computer could have told you this before we sat here for two hours and lost all other options??”  We did not receive a satisfactory response.  Ultimately, we took a 45-minute cab ride to Union Station (cavernous, pitch-black, and empty) and caught a 3:10 a.m. (!!) Amtrak train to Philadelphia.  When all was said and done, that was all that was left.

“Not much left” also describes (we warned you) today’s case, an excellent PMA and Buckman preemption decision out of the Northern District of Illinois.  In Gravitt v. Mentor Worldwide, 2018 WL 2933609 (N.D. Ill. June 12, 2008), the plaintiff alleged that she was injured by the defendant’s silicone breast implant.  Her complaint asserted claims under Illinois law, alleging design and manufacturing defects, failure to warn, and the defendant’s alleged failure to comply with the FDA’s pre-market approval (“PMA”) process for Class III medical devices, including numerous allegations of deficiencies in the defendant’s design and execution of post-PMA studies ordered by the FDA.

In earlier motion practice, the court dismissed most of the plaintiff’s claims without prejudice.  (We published a guest post on the first dismissals here.)  The plaintiff filed an amended complaint, which the court commented “strongly resemble[d] the original complaint.” Gravitt, 2018 WL 2933609 at *1.  The defendant again moved to dismiss, arguing that the plaintiff’s claims were expressly preempted under the Medical Device Amendments (“MDA”) to the FDCA or impliedly preempted under Buckman.

Express Preemption

The defendant argued that the plaintiff’s claims were expressly preempted to the extent that they were based on alleged methodological defects in the defendant’s post-PMA studies. The Court explained that under SCOTUS’s Lohr decision, as construed by the Seventh Circuit in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), as well as SCOTUS’s Riegel decision, state law tort claims related to Class III medical devices granted PMA are allowed to proceed if they: 1) allege violations of common-law duties that parallel federal requirements; or 2) claim violations of federal law.  Conversely, state law claims that “would impose on [the defendant] a requirement that is in addition to federal requirements” – in other words, claims that the defendant “violated state tort law notwithstanding compliance with the relevant federal requirements” – are preempted. Gravitt, 2018 WL 2933609 at *4 (internal punctuation and citations omitted).

The court held that, while the complaint alleged numerous deficiencies in the defendant’s post-PMA studies and alleged that each deficiency amounted to an “independent failure to comply with the FDA’s post-approval requirements” and thus a ground for withdrawal of PMA, the plaintiffs “simply assume[d], without legal or other support, that those deficiencies amount[ed] to violations of the FDA’s conditions for PMA.” Id. at *6 (citations omitted).   The court concluded that “such an assumption may not ground a viable claim,” id., and held that certain categories of the plaintiff’s allegations were expressly preempted.

Implied Preemption

But the court held that other categories of the plaintiff’s allegations were not expressly preempted. Specifically, the court held that “the complaint plausibly alleged that [the defendant] violated federal law” by failing to satisfy several categories of requirements related to, inter alia, follow-up of study participants, collecting and reporting of data at required intervals and related updates to labeling, warning of newly-discovered risks of the device, and failing to comply with requirements for manufacturing facilities.  Because the plaintiff “plausibly alleged” that these “shortcomings in [the defendant]’s post-PMA testing and manufacturing processes violated federal law,” section 360(a) of the MDA did not preempt those claims. Id. But the court emphasized, “Plaintiffs may proceed with those claims, however, only if they pass through a second legal filter” – the “filter” of implied Buckman preemption of “fraud on the FDA claims.” Id. at *7.

The court explained that, under Buckman, “federal law preempts claims to the extent they seek to deploy state law in the service of policing fraud against federal agencies based on statements that federal  law required the defendant to make to the agency, id. (internal punctuation and citation omitted), but doesn’t preempt traditional tort law claims involving breach of a duty to the plaintiff.  The court held:

Here, several of the claims that survive express preemption – for example, claims that the defendant reported results of the core study for fewer than the required number of years and recruited fewer than the required number of patients for a large post-approval study – are impliedly preempted under Buckman because those shortcomings breached no . . .  [tort duty to the plaintiff].  Rather, as in Buckman, those claims are unconnected to any traditional state tort duty, meaning that the existence of the relevant federal enactments is a critical element of those claims.

Id. (internal punctuation and citation omitted).  The court noted that the plaintiff attempted to tie the defendant’s alleged misconduct to her state tort claims, alleging that, if the defendant had more fully complied with the PMA process, its “disclosures would have led to much wider knowledge of the risks associated with its product.” Id. (internal punctuation and citations omitted).  But, it emphasized, “the Buckman analysis centers on the nature of the asserted claim and the source of the violation, not on the violation’s effects . . . . A claim arising entirely out of a violation of [the defendant’s] compliance with the FDA’s requirements in granting PMA is . . . . preempted under Buckman. Id.

Two categories of claims remained. The court dismissed the plaintiff’s claims alleging that the defendant’s manufacturing facilities failed to comply with applicable law and regulations, holding that the complaint had not adequately alleged a true manufacturing defect claim.  In addition, the plaintiff had failed to respond to the defendant’s arguments against these claims.  The last claim alleged that the defendant learned, but did not disclose, that its device had a higher likelihood of rupture than had been reported.  The court acknowledged that these claims were not fully developed in the complaint, but held that Rule 9(b)’s particularity requirement did not apply to the claims.  Holding that the plaintiff’s pleading “cross[ed] the line from conceivable to plausible,” satisfying Twiqbal, the court allowed the claims to proceed.

But that was all that was left.  The claims that were preempted – expressly and impliedly – were dismissed with prejudice, in an infrequent and laudable turn of events.   We would wax on at greater length, but today’s flight is boarding in a few minutes.  At least that’s what the board says.  We’ll keep you posted.

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

You’re likely all familiar with the phrase, “don’t look a gift horse in the mouth.” Checking out a gift horse’s teeth is like looking for the price tag of the gift to see how much it’s worth. The expression is meant to convey that upon receiving a gift you should accept it gratefully. But what happens when you don’t accept the gift at all. In many instances, politely declining a gift is completely acceptable. When the gift actually comes in the form of help, passing it up may well be to your own detriment. Sure, it looks good to stand on your own two feet. To accomplish something on your own. But sometimes offers of help are extended because they are needed. A parent offers to help a child tie his shoe. A teacher offers to guide a student through a math lesson. A young man offers to cut the grass for an elderly neighbor. Or perhaps a judge offers plaintiff an opportunity to take discovery to save her case. And that plaintiff says: No thanks. I’ll stand “on the allegations contained in [my] original complaint.” That plaintiff shouldn’t be surprised that what wasn’t good enough the first time around, isn’t good enough the second.

The case is Benyak v. Medtronic, Inc., 2018 Ill. App. Unpub. LEXIS 998 (Ill. App. Jun. 14, 2018) and involves an implanted intrathecal pump that plaintiff alleges became inverted in her body causing her pain. Id. at *2. Plaintiff alleged only negligent design and manufacturing defect and negligent education of medical providers. Id. at *2-3. The medical device underwent pre-market approval by the FDA and so defendant moved to dismiss the claims as preempted. That motion was granted but the court granted plaintiff leave to serve written discovery on the manufacturer and then to file an amended complaint. Plaintiff opted to do neither and so the court dismissed her claims with prejudice. Id. at *2. Plaintiff then appealed that dismissal arguing that her original allegations should have survived defendant’s motion to dismiss.

The Illinois Appellate Court authored a nice accounting of PMA preemption, see id. at *5-15, which we won’t completely recount here because if you are even an infrequent reader of this blog, you’re likely well-versed in PMA preemption. And if not, check out this scorecard to start your PMA preemption education. We will point out the court’s proper conclusion that because of the MDA’s express preemption provision, there is no presumption against preemption. Id. at *10. Also that the court landed where most court’s do, finding that there is only “a small window in which a state-law claim may escape express or implied preemption.” Id. at *13. Finally, before turning to the case-specific details, the court notes that “the manner in which allegations are pled guides the analysis of whether a state-law claim involves requirements different from, or in addition to, the federal requirements.” Id. at *15.

Since it was undisputed that the device at issue was a PMA device, there was also no dispute that the FDA had established requirements applicable to it. Id. So the court moved on to the next part of the PMA-preemption analysis – did plaintiff’s state law claims involve requirements related to safety and effectiveness different from or in addition to federal requirements. Because safety was at the heart of plaintiff’s claims, the only real issue was the “different or in addition to” standard. In other words, did plaintiff’s claim parallel the federal requirements established by the FDA for this device.

As for design and manufacturing defect – plaintiff’s complaint was completely silent as to whether the device was designed or manufactured differently or out of compliance with the FDA’s approval and protocols. Id. at *16-17.

Absent such factual allegations, plaintiff, in essence, posits that the [device] should have been designed and manufactured differently than what the FDA approved during the premarket approval process, which necessarily would impose a requirement for the [device] that is different from, or in addition to, the requirements already imposed by the FDA.

Id. at *17.

On appeal, plaintiff argued that “the ability of the [device] to remain upright” was a premarket requirement that defendant failed to meet. However, the complaint “never specifically identified any specific requirement resulting from the premarket approval process.” Id. at *19. And this brings us back to that gift horse:

Understandably, at the time plaintiff filed her complaint, she might not have had enough facts to support her allegations, which is why the circuit court allowed her leave to serve written discovery on defendants and file an amended complaint. Had she taken the opportunity to conduct the discovery, she could have bolstered the allegations of her complaint and perhaps, her state-law claim would not have been expressly preempted by the MDA. But she chose not to conduct the discovery nor file an amended complaint, resulting in her design and manufacturing defect claim, as pled in her complaint, being expressly preempted.

Id. at *19-20. It jumped right up and bit her.

As for plaintiff’s other claim, negligent instruction, it is not a recognized claim under Illinois law. Id. Even if it were, plaintiff didn’t allege that the instructions defendant provided deviated from those approved by the FDA during the PMA process. Id. at *21. So, that’s two grounds to affirm the dismissal. Plaintiff attempted to turn the claim into a learned intermediary claim arguing it was really a failure to warn the doctor claim. But, that’s not what plaintiff alleged in the complaint. The complaint never mentions learned intermediary and the court was unwilling to construe it as such.

Finally, plaintiff asked for the case to be remanded with leave to amend her complaint. Wow. Once you refuse a gift it’s much less likely you’ll get offered it again. The appellate court found that because plaintiff had “intentionally” chose not to take discovery and amend her complaint when that opportunity was afforded to her, “she has waived any right to a remand with leave to amend.” Id. at *22.

We often talk about giving plaintiffs second bites at trying to plead their claims. But if you’re going to toss the apple away without so much as a nibble, don’t be surprised when the gift horse you decided to ignore gobbles it up and spits it out with nothing left for you to chomp on.

 

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

Today is a follow-up post on Bell v. Boehringer Ingelheim Pharms, No. 17-1153, 2018 U.S. Dist. LEXIS 90337 (W.D. PA. May 31, 2018). When we last blogged about this case back in February, the court had tossed out everything except negligence and fraud/misrepresentation claims on well-settled Pennsylvania law that prescription drug cases sound only in negligence. The court then dismissed the remaining claims for failure to satisfy TwIqbal pleading standards. Plaintiffs were afforded an opportunity to amend and re-plead the claims recognized under state law. They did. And once again, they don’t get by TwIqbal.

So, what’s missing this time around? The court starts out by noting that despite being dismissed for factual insufficiency, plaintiff made few factual revisions in the amended complaint. Id. at *4. So few that the court was able to essentially adopt its factual recitation from the first decision. Id. That’s an underwhelming start and things don’t improve for the plaintiff as the court examines each claim in turn.

Starting with plaintiff’s catch-all negligence claim, the court found “[t]he amended complaint contains a boilerplate laundry-list of alleged negligence that is virtually identical to the negligence claim in the original complaint.” Id. at *12. Since plaintiff just re-packaged his conclusory allegations from the original complaint, the amended complaint once again fails to state “any facts about how defendants breached their duty or how defendants’ conduct caused [plaintiff’s] injury.” Id. at *13. At the heart of plaintiff’s negligence claim was his allegation that defendants should have changed their label to warn about the risk of kidney injury following FDA approval. But for that claim to survive, plaintiff would have had to have pleaded what new information became available to warrant a change, what the changed warning should have said, and how any alleged breach was the cause of plaintiff’s injury. Id. at *13-14. Absent all those pieces, plaintiff’s negligence claim was dismissed.

Negligent misrepresentation was even easier to dismiss because it was an exact duplicate of the original complaint. Id. at *14. We’ve all heard the expression that the definition of insanity is doing the same thing over and over and expecting a different result. Well, same allegations equal same result. Dismissal.

Next up was plaintiff’s negligent design claim. This claim was previously dismissed for failure to plead the availability of a safer, alternative design as required by Pennsylvania law. So, plaintiff argued he satisfied that requirement in the amended complaint by pointing to other available products. But different products are just that different products – not alternative ways to design the product at issue. Saying plaintiff could have taken a different product doesn’t do anything to establish how the design of defendant’s product was defective or how it could have been designed differently. Id. at *15. Another dismissal.

Last, plaintiff based his fraud claims on allegations that defendants concealed information about the risks of the drug from the FDA, the public, plaintiff, and plaintiff’s physicians. But fraud claims don’t just have to satisfy TwIqbal, they are held to the more rigorous Rule 9(b) standard. Generality won’t suffice. Id. at *16. And plaintiff’s claim was just that, too general. The amended complaint contained no allegations about what information was concealed. It was missing the “who, what, when, where and how” of defendants’ alleged fraud, i.e., the “first paragraph of any newspaper story.” Id. at *17. So, fraud was dismissed as well.

Despite the complete lack of factual support for any of plaintiff’s claims, he once again asked for a chance to re-plead. The court, somewhat reluctantly, granted the request but made it clear that any final attempt by plaintiff to fix these pleading deficiencies would have to be a significant improvement. Specifically, plaintiff has

to clearly articulate the legal theory he is pursuing and to allege sufficient facts to make each element of the claim plausible. He must also eliminate his overbroad, conclusory “shotgun” allegations so that defendants are given adequate notice of what [plaintiff] claims they did wrong.

Id. at *18-19. Given plaintiff’s track record, this seems like a fairly high hurdle to clear. Stay tuned to see if plaintiff tees it up for strike three.

 

Is fear of injury the same thing as injury?  The question answers itself.  At least it should.  They are not the same, and there are strong jurisprudential reasons for courts to throw out cases alleging mere fear of injury.  We have a No Injury scorecard documenting a pretty clear court consensus that fear of injury should not be enough to get a case to the jury.  Think of diet drug cases where the claim was an increased risk of heart valve injury.  Most courts concluded that such fear did not amount to actionable injury.  Considerations of Article III case or controversy or standing or ripeness usually persuaded courts that fear of physical injury simply did not cut it.  But not always.  So it is good that today’s case, Perez v. B. Braun Medical, Inc., 2018 WL 2316334 (S.D.N.Y. May 9, 2018), gets added to the defense side of the ledger.  In 2010, the plaintiff had been implanted with an IVC filter to treat her pulmonary embolism (PE) and deep vein thrombosis (DVT).  The implant was intended to be permanent.  In subsequent years there were reports of IVC filters causing problems via misalignment and migration.  In 2014, the FDA urged doctors to remove IVC filters within one to two months after the danger of PE subsides.  The plaintiffs alleged that the defendants in this case continued to market their IVC filter for long-term use — according to the court, the complaint alleged that the defendants were “defying the FDA’s general recommendations.”  Meanwhile, no doctor recommended that the plaintiff remove the IVC filter, even though in 2016 a CT scan showed that the tip of the IVC filter possibly had tilted.  That tipping point was apparently not enough to remove the filter, but was enough to file a lawsuit.  The complaint alleged that the IVC filter was defective and increased the risk that the plaintiff would suffer a serious injury. The plaintiff also referenced unspecified economic and psychological damages. The defendants moved to dismiss the complaint for failure to state a claim upon which relief can be granted, arguing that the complaint did not adequately allege that the plaintiff had suffered any cognizable injury.  The court granted the motion to dismiss.  It analyzed the personal injury, warranty, fraud, and New York Business law claims separately, so we will do likewise.

1. Personal Injury Claims

The plaintiff alleged that her physical injuries were the post-implant likely tilting of the IVC filter, psychological trauma of living with a defective product implanted in her body, and the increased risk of future injuries due to the IVC filter.  The problem for the plaintiff was that New York law is reasonably clear that a mere threat of future harm is insufficient to impose liability against a defendant in a tort context.  To be sure, the complaint also alleged that the plaintiff “sustained serious personal injuries,” “serious physical injuries,” and “severe injuries,” that she suffered “loss of enjoyment of life, disability, and other losses,” and that she “incurred substantial medical costs and expenses to treat and care for Plaintiff’s injuries described herein.”  But those are more rote formulas than factual allegations.  The complaint certainly never described the nature of the injuries.  New York law does recognize claims for emotional distress, but such claims must be premised on truly outrageous conduct, and nothing like that resided in the complaint.  Perhaps the best thing that the plaintiff had was an allegation that the defendants marketed permanent filters even after the “FDA warnings that caution generally against long-term implantation of IVC filters.” But because those warnings, whether or not they said what the plaintiff alleged, did not happen until after the plaintiff’s implant, they could not preserve the plaintiff’s claims.

2. Breach of Warranty Claims

The defendants had a strong statute of imitations argument, because the clock on warranty claims usually starts at the time delivery, which was in 2010, more than seven years before the complaint was filed.  New York’s statute of limitations for warranty claims is four years.  The plaintiff trued to dodge the statute of limitations by arguing that the warranty explicitly extended to future performance, and that existed here because the defendants had stated that the IVC filters were safe and effective for permanent implantation.  But the complaint did not explain how the plaintiff’s particular IVC filter had fallen short.  Again, the mere tilting of the IVC filter, even with a risk of future harm, did not equate to a cognizable injury,  New York courts (like most courts on planet Earth) have acknowledged a policy of protecting court dockets from “being clogged with frivolous and unfounded claims.”  Warranty claims often seem like add-ons in product liability cases, and here they were frail add-ons to already frail claims.

3. Fraud Based Claims

Fed. R. Civ. P. 9(b) requires that fraud claims be pleaded with specificity, and the Perez complaint did not come close to meeting this standard.  Again, the plaintiff leaned on the defendants’ representations that the IVC filters were safe and effective for their intended and reasonably foreseeable use.  But the plaintiff never explained why those statements are fraudulent. After all, the the complaint admitted that IVC filters can be used to reduce the risk of PE and DVT, and it nowhere alleges that the plaintiff’s filter performed in a manner different from how the defendants describe.  Whatever the complications and injuries that the defendants failed to warn the plaintiff about, the complaint did not specifically describe them, and could not allege that the plaintiff had sustained any such complications and injuries.  Moreover, the complaint lacked any facts showing that the alleged omissions were made with an intent to deceive.  The plaintiff simply had not made out a case for fraud.

4. New York General Business Law Claim

The complaint’s final count alleged that the defendants engaged in consumer fraud in violation of New York General Business Law Sections 349 and 350<http://www.westlaw.com/Link/Document/FullText?findType=L&pubNum=1000081&cite=NYGBS350&originatingDoc=Ib48241005e2b11e89868e3d0ed3e7ebe&refType=LQ&originationContext=document&vr=3.0&rs=cblt1.0&transitionType=DocumentItem&contextData=(sc.FindAndPrintPortal)>. Section 349 prohibits “[d]eceptive acts or practices in the conduct of any business, trade or commerce or in the furnishing of any service in this state.” Section 350 prohibits “[f]alse advertising.”  As with the plaintiff’s breach of warranty and fraud based claims, the New York Business Law claims failed to show what materially misleading representations the defendants made. That there are side effects associated with IVC filters that are implanted long-term, does not mean that the plaintiff’s IVC filter “had not been effective for implantation into the IVC to prevent PE and DVT for which it was designed or that it is not safer than the alternative.”

What is interesting about the Perez case is how the lack of a real injury did not just undermine the personal injury claims (seems obvious enough), but also undermined the representational claims.  What is doubly interesting about the Perez case is that the no-injury defense worked with respect to an implanted device.  Most of the good cases on our no injury scorecard involved drugs.  Arguably, a plaintiff has a little more to work with when there is a device implanted in the body.  There is a continuing exposure.  Nevertheless, mere fear of injury could not overcome the court’s fear of frivolous claims.

Today’s post is another guest post from friend of the Blog Kevin Hara, of Reed Smith, who channels our resident movie critic in this wide-ranging discussion of pleading and procedural weirdness.  As always with our guest posts, the author deserves 100% of the credit, and any blame, for what follows.

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If ever one wanted to feature a case where the plaintiffs and their attorneys fumbled and stumbled around like Keystone cops, it would be Paulsen v. Abbott Laboratories, 2018 U.S. Dist. LEXIS 50256 (N.D. Ill. March 27, 2018), involving the prescription drug Lupron, used to treat endometriosis.  The case really reminded me of the madcap, masterful ensemble movie, “It’s A Mad, Mad, Mad, Mad World” (hereinafter, “Mad World”) (yes, it’s a bit dated in some ways, but it still merits watching if you haven’t) with a veritable Who’s Who of 1950s-1960s Hollywood comedy royalty, including Edie Adams, Sid Caesar, Milton Berle, Ethel Merman, Jonathan Winters, Terry Thomas, Mickey Rooney, Phil Silvers, and Buddy Hackett.  Not to mention two time Oscar Winner Spencer Tracy and Jimmy Durante, who literally kicks the bucket as his character passes away and starts the mayhem.  Even if one does not consider the film a classic, its cultural relevance is beyond debate, as in addition to the headliners, the supporting cast included Peter Falk, Eddie “Rochester” Anderson, the 3 Stooges, and the great Arnold Stang.  Moreover, it bears mention that the renowned director of Mad World, was Stanley Kramer, more recognized for his social dramas, including Guess Who’s Coming to Dinner, The Defiant Ones, and Judgment at Nuremberg.  With such an accumulation of talent, it comes as no surprise that Mad World received six Academy Award and two Golden Globe nominations, and is categorized by many as an all-time classic in American movie history.  The plot is full of twists and turns, but beautifully elevated, with stellar writing and acting to match: 5 strangers witness an accident, and simultaneously learn about a large sum of money hidden in a park, buried beneath a large “W,” with Durante’s last gasp.  At first, they agreed to equal shares of the $350,000, but soon each plots to recover the loot on his own, and everyone begins a mad dash with assorted partners in crime (spouses, friends, relatives, etc.) to be the first to reach the cash.  In so doing, each of five groups tries to undermine the others, and they all encounter setbacks from being locked in the basement of a hardware store, stranded on a highway with a child’s bicycle, sinking in a river, a drunken airplane pilot, and more.  (For those of you from younger generations who are Googling the names or the movie above, you might be more familiar with a newer iteration of a similar story in the movie Rat Race, starring Whoopi Goldberg, Dean Cain, John Cleese, Cuba Gooding, Jr., Cathy and Kathy Bates, among others.)

If you have not seen the movie, you certainly should, but one iconic scene essentially captures the film, a sequence in which Winters demolishes an entire gas station, mostly by hand, in several hilarious, frenetic minutes. The movie ends with all of the misguided, money hungry adventurers in the hospital with multiple injuries, but none of the treasure.  In a last, desperate (and shameless) grab for the bounty, the hapless male contingent is catapulted, one by one, from the ladder of a fire engine attempting to rescue them, as the terrified crowd below watches and the entire haul slowly floats to the now delighted onlookers.  In short, grasping for money, at the expense of ethics, morality, and intelligent planning gets you nowhere.

Procedural History

Much like the film, Paulsen has misdeeds galore, with seeming chaos at every turn, thanks to its beginning as a multi-plaintiff, misjoined complaint with a California resident, and a Georgia resident (Ms. Paulsen) bringing an action in the Eastern District of New York in April 2010. See Cardenas v. Abbott Labs., 2011 U.S. Dist. LEXIS 116879 (N.D. Ill. March 7, 2011).  Plaintiffs alleged injuries as a result of injections of the drug, and asserted negligence, strict liability, failure to warn, breach of warranty and fraud causes of action against various defendants.  In homage to the movie, it is fitting to provide aliases for the defendants using the names of the actors in the movie – because it is the plaintiff’s shenanigans that are the focus here – not the defendants’ titles and actions. Therefore, in that regard, the defendants are now dubbed Abbott Laboratories (hereinafter “Sid”), Takeda Pharmaceuticals of North America, Inc., (“Ethel”),Takeda Chemical Industries, Inc., (“Milton”) and TAP Pharmaceutical Products, Inc. (“Jonathan”) (collectively, “Defendants”). Id. at *3.  The Defendants filed a motion to dismiss, objecting to venue, so plaintiffs amended their complaint, adding New York and New Jersey plaintiffs.  Didn’t matter.  The case was transferred to the Southern District of New York. Id. Defendants again filed a motion to dismiss, and the Southern District of New York transferred the action to the Northern District of Illinois in 2011, addressing issues of venue and personal jurisdiction, and dismissing defendant “Milton” because it was not served with the complaint. Id. (but more on that later). Id. Finally, the Illinois federal court considered a substantive (Rule 12 (b)(6)) motion to dismiss, and found that plaintiffs provided “nothing but the fact that [they] received Lupron injections ‘on several occasions.’” Id. at *12-13.  For example, the complaint failed to indicate “whether Plaintiffs [were] women, nor [did] it establish whether Lupron was prescribed to Plaintiffs” for on- or for off-label use.  All these omitted facts were, obviously, “particularly within Plaintiffs’ control.” Id. Therefore, the court dismissed the complaint, with leave to amend to allow plaintiffs to put “some minimal amount of flesh” on their bare-bones allegations. Id. at *13-14.

Plaintiffs filed an amended complaint in October 2011, and discovery commenced, but with Paulsen the only remaining plaintiff, in August 2013 her counsel moved to withdraw. See Paulsen, 2018 U.S. Dist. LEXIS 50256, at *8.  The judge granted the motion, allowing plaintiff 30 days to file an appearance.  That didn’t happen either.  The action was dismissed for lack of prosecution in October 2013 after plaintiff failed to appear. Id.

Plaintiff’s Second Action

Undeterred, plaintiff filed a new complaint on May 11, 2015, alleging claims for negligence, strict product liability, failure to warn, breach of warranty, and fraud against “Sid”, “Ethel”, “Milton” and “Jonathan”. Id. at *9.  Plaintiff alleged that she had been injected with Lupron twice for on-label treatments, and had suffered various injuries, all of which occurred in Georgia. Id. at * 3-4.  Defendants moved to dismiss, claiming that the lawsuit was untimely and seeking application of the six-month limitation in Georgia’s savings statute [Ga. Code Ann. § 9-2-61(a)], while plaintiff maintained that Illinois’s one-year period governed the issue, 735 ILCS 5/13-217.6. Id. at *10.  After determining that the only Illinois citizen, Sid, was a real party in interest (a dispositive issue, because if not, Georgia’s statute controlled time-barring the case), the judge denied the motions to dismiss without prejudice. Id. at *10-11.

Dismissal of Milton and Jonathan

Defendants resubmitted their motions to dismiss in April 2017, arguing that Milton and Jonathan were not properly served, an interesting issue that itself could be the subject of its own post. Id. at *17-18.  Suffice it to say that the court ruled that service on Jonathan’s surviving corporation (because Jonathan no longer existed at the time the case was originally filed in 2010) was improper because in essence, “[p]laintiff cannot effectively serve one corporation by serving a completely different corporation.” Id. at *19, 25.

As to Milton, the court did not reach the service issue because plaintiff voluntarily dismissed Milton on July 9, 2011, − but refiled the action, again, on May 11, 2015, well outside the one-year limitation of Illinois’s savings statute. Id. at *26-27.  Thus, the court dismissed the claims against Milton with prejudice. Id. at *27.

Rule 12(b)(6) Motion

At long last, the court turned to the Rule 12(b)(6) motion to dismiss for failure to state any cognizable claims, pursuant to TwIqbal.  By now, it should hardly surprise anyone (even plaintiff herself, one would think) that the claims were almost all poorly pled, and most were dismissed.  For example there was “nothing in the complaint that connect[ed] Ethel to Jonathan and its alleged responsibility for Lupron-related activities beyond their shared parent company.” Id. at *30.  The familiar catchall of “Defendants” failed to state a plausible claim against Ethel and was “therefore insufficient to satisfy Rule 8’s pleading the claims,” resulting in the court’s dismissal of all claims without prejudice. Id.

Merits of Plaintiff’s Causes of Action

Turning to the merits, court next conducted a choice of law analysis, using Illinois’s “most significant relationship test” to determine whether Illinois or Georgia law applied. The court ultimately decided that Georgia law would apply, largely because plaintiff resided in, and suffered her alleged injuries in that state, which had the strongest interest in the litigation. Id. at *35-37.

After determining that plaintiff sufficiently alleged that Sid played a role in manufacturing Lupron beyond its ownership of Jonathan, the court declined to dismiss strict products liability and failure to warn claims against Sid. Id. at *40.  However, it ruled that plaintiff’s allegations that Sid failed to adequately test the product before approval, did not advise “Plaintiffs and their physicians,” and misrepresented “the dangers associated with the use of Lupron,” failed to allege either that Sid owed or breached a duty to plaintiff. Id. at *45.  The allegations could not support plaintiff’s negligence claims against that defendant. Id. Nor could plaintiff state a claim for express warranty through statements that Defendants “expressly represented” that Lupron was “safe and efficacious,” “safe and fit for its intended use,” or “of merchantable quality.” Id. at *46-47.  In dismissing plaintiff’s claim, the court observed that “Plaintiff [did] not identify any specific warranty that Sid made to her … “nor [did] she identify the content of any statement by Abbot.” Id. at *47.  Similarly, plaintiff’s breach of implied warranty claim failed because she could not establish privity – as the complaint stated only that she used Lupron, and was devoid of allegations “that she purchased it.” Id. at * 49.

Further – and utterly unsurprisingly by this point − plaintiff’s fraudulent misrepresentation claim was not pled with the heightened particularity required by Rule 9(b), “[t]he who, what, when, where, and how: the first paragraph of any newspaper story.” Id. at *50 (citation omitted).  Rather, the complaint merely claimed that Defendants generally misrepresented the product’s safety in its labeling, marketing, and advertising over several decades. Id. However, plaintiff failed to articulate “who made these statements (other than Defendants, without specifying which Defendant made which statement), where and when these statements were made (other than to say sometime in the 1990s-2000 in Georgia and elsewhere), or how exactly Lupron’s safety was misrepresented.” Id. at *51.  Finally, her negligent misrepresentation claim was also doomed absent “allegations pointing to [defendant’s] statements on which Plaintiff relied” prior to her Lupron injection. Id.  Therefore, the court concluded that plaintiff’s negligent misrepresentation claim could not proceed “under Rule 8’s pleading standard,” and it too, was dismissed. Id. at *52-53.

In a nutshell, plaintiff ran afoul of every tenet of basic pleading 101 by repeatedly offering only threadbare allegations without specific facts; generalized and conclusory allegations leveled only at “Defendants;” and rote recitations of the elements of a claim without the facts to support it. However, to our chagrin, and much more to that of the Defendants, the court dismissed all of plaintiff’s claims, except for strict product liability and failure to warn, with leave to amend, despite seven years of failed pleadings. Id. at *54.  At least, the court issued plaintiff a none too subtle warning, stating it was “cognizant of the long procedural history,” and conditioning its leave for plaintiff to file an “amended complaint consistent with this opinion, if Plaintiff believes that she can overcome the deficiencies identified above for the dismissed claims.” Id. at *55 (emphasis added).

Given Plaintiff’s history of inartful pleading, repeated procedural errors, and other tactical blunders, one can expect, and hope, that like the buffoons in “Mad World,” when this case finally does end, plaintiff and her attorneys will wind up empty-handed.