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Remember the days when saying things like no cutting, no backsies, no do-overs were the laws you lived by. Or when “calling” something actually gave you priority. When invoked, these rules of the playground were difficult to challenge. And if challenged, the rule-maker always had the option of the comeback position “times infinity.” Now you could try the “times infinity plus one,” but you risked being called out for shenanigans on that. Simpler times? Perhaps. But debates over hierarchy and convention did occur. Take for example, the classic case of Harry v. Lloyd and the question of whether you are permitted to triple stamp and double stamp. While that dispute may have gone unresolved, the judge in In re Bair Hugger Forced Air Warning Devices Prods. Liab. Litig., 2018 U.S. Dist. LEXIS 133061 (D. Minn. Jul. 25, 2018) had no problem relying on the no take backs rule when it came to plaintiffs’ Lexecon waivers.

In case anyone needs a quick reminder, Lexecon refers to the decision in Lexecon v. Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26 (1998) in which the Supreme Court held that an MDL court could not hold the trial of a transferred case without the consent of the parties. Leading to the birth of the Lexecon waiver.

As we often do when reviewing a new case, we take a look back on the blog to see if we’ve dealt with the topic before. Certainly we’ve shared our thoughts on Lexecon waivers several times. See here, here, and here.  But, we think the issue of retracting a Lexecon waiver is an issue of first impression for us. In fact, the Bair Hugger opinion notes that there is not much precedent on the issue. So, we decided to look at the case law ourselves.

It appears that the first time the question of retracting a Lexecon waiver was addressed was in In re Fosamax Prods. Liab. Litig., 815 F. Supp. 2d 649 (S.D.N.Y. 2011), upholding on reconsideration 2011 WL 1584584 (S.D.N.Y. Apr. 27, 2011). In that MDL, the court ordered the parties to select 25 cases that would be worked up and create the pool from which bellwether trial cases would be selected. One of the conditions of selection was that the parties would execute Lexecon waivers. Id. at 650. After bellwether trials had started, one plaintiff sought to withdraw her waiver on the grounds that her husband was too ill to attend trial in New York (they resided in Alabama) and citing the Americans with Disabilities Act (“ADA”).

In deciding what standard to apply to a request to retract a Lexecon waiver, the court found

The Lexecon waivers at issue here, on which both parties have relied during the discovery and bellwether selection phases of the Fosamax MDL, reflect plaintiffs’ and defendant’s consent to trial before this Court, and are analogous to a stipulation of fact or a stipulation to proceed for trial before the court without a jury.

In re Fosamax, 2011 WL 1584584 at *2. Because one party cannot unilaterally dissolve a stipulation supported by sufficient consideration, the waiver could only be retracted “upon a showing of good cause such as fraud, collusion, mistake or duress” or if the waiver was unconscionable, contrary to public policy, or ambiguous. In re Fosamax, 815 F. Supp. 2d at 653. The court concluded that the waivers were valid stipulations because they were given in exchange for permission to conduct discovery before remand and they were unambiguous. Id. at 654. Plaintiff failed to demonstrate good cause because her case was filed in the Middle District of Tennessee which is where it would be remanded for trial if she was relieved of her Lexecon waiver. Plaintiff’s argument that her husband couldn’t travel for trial didn’t hold up since plaintiffs had since moved to Alabama. Both the transferee and transferor courts were not near her home.

The next court to address the issue was In re Zimmer Durom Hip Cup Prods. Liab. Litig., 2015 WL 5164772 (D.N.J. Sept. 1, 2015). Here, 8 cases were selected as bellwethers and 2 were selected as the initial trial cases. Id. at *1. Counsel for plaintiffs in the first 2 trial cases agreed to waive Lexecon. Shortly after that, a Joint Case Management Order was entered stating that “Plaintiffs and Defendants waive their respective rights under [Lexecon]” and “consent to trial of the cases in the MDL by this Court.” Id. Over 4 months later, Plaintiffs’ Liaison Counsel raised for the first time their position that the language in the order did not cover all plaintiffs in the MDL. Id. at *2. Another 4 months passed before plaintiffs sought to formally retract the waivers.

The court found the language in the joint order was unambiguous and applied to all plaintiffs in the MDL. Id. at *3. Having found a valid waiver, the court had to consider whether it could be rescinded and whether Plaintiffs’ Liaison counsel’s agreement bound all plaintiffs in the MDL. The court examined both the standard utilized in In re Fosamax and the Third Circuit standard for modifying stipulations – the avoidance of manifest injustice. Id. at *4. Plaintiffs argued that the waiver on behalf of all plaintiffs was a mistake. The court found plaintiffs’ failure to take any steps to correct the mistake for months after the order was entered undermined their argument. Moreover, carelessness is not good cause. Id. And, the parties had relied on the waiver in the bellwether selection process. While the waiver could not be retracted and extended beyond the 2 initial trial cases, the court held that it only applied to plaintiffs represented by Plaintiffs’ Liaison Counsel, not every plaintiff in the MDL. Id. at *5 (acknowledging the liaison counsel had authority to enter into stipulations for all MDL plaintiffs, but that “such action would necessitate additional documentation and discussion with” individual plaintiffs’ counsel that did not occur in this instance).

That sets the stage of Bair Hugger and application of the good cause standard to requests to retract Lexecon waivers. Like in the prior cases, the litigation was at the bellwether discovery and trial phase. Eight plaintiffs waived and became the bellwether pool. After the first bellwether trial, which resulted in a defense verdict, the remaining 7 cases moved to retract their Lexecon waivers. In re Bair Hugger, 2018 U.S. Dist. LEXIS 133061 at *9. Resorting to playground rules – shenanigans. The reasons given by plaintiffs were (i) the court’s ruling applying the law of plaintiff’s state of residence rather than Minnesota law which plaintiffs contended made a “material difference in the posture of the case,” (ii) lack of consideration, (iii) no inconvenience to the parties or the court, and (iv) defendants never waived. Id. at *11.

The court quickly dismissed each argument. As to choice of law, plaintiffs provided no grounds for reasonably expecting a contrary ruling and

[r]egardless, it is unlikely that a “material difference in the posture of the case” even amounts to “good cause” for retraction. If it did, any MDL party who disliked a court’s rulings could simply issue a Lexecon retraction and undo months of work performed in reliance on the Lexecon waiver. The prospect of these unilateral retractions would undermine the bellwether trial process.

Id. at *11-12. So much for plaintiffs’ poor loser, I’m taking my toys and going home argument.

As to plaintiffs’ remaining arguments: There was consideration for the waiver. Plaintiffs got to move “to the front of the line to try their cases.” Id. at *12. The parties and the court would be inconvenienced as “changing course now would waste the resources expended in advancing the current list of Bellwethers and would delay the more than 4,500 cases in this MDL by many months.” Id. at *12-13. And, it was unclear whether defendants even needed to waive Lexecon as they reside in Minnesota, but if they did, their agreement to try the cases in Minnesota was a waiver. Id.

So, the Lexecon waivers hold up in Bair Hugger. It is not a robust body of law, but the cases at least seem in agreement on treating Lexecon waivers as pre-trial stipulations bound by the jurisdiction’s applicable law on rescinding or modifying such agreements. Whether that be good cause or manifest injustice, it’s safe to say “I take it back” is as valid an argument as “I’m rubber and your glue. . .”

Today’s post is an update to our post from just a few weeks ago regarding McWilliams v. Novartis AG, No. 2:17-CV-14302 (S.D. Fla.). At that time, the court denied summary judgment on plaintiff’s failure to warn claims, but applying New Jersey law dismissed plaintiff’s claim for punitive damages. Since the case involves an FDA-approved prescription drug, having found that New Jersey law applied to the punitive damages claim, the decision to dismiss seems very straightforward to us because according to the New Jersey Products Liability Act (“NJPLA”):

Punitive damages shall not be awarded if a drug or device or food or food additive which caused the claimant’s harm was subject to premarket approval or licensure by the federal Food and Drug Administration.

N.J. Stat. Ann. § 2A:58C-5. But plaintiff didn’t think that was where the story should end, so she filed a motion for reconsideration. Look before you leap. Be careful what you ask for. You don’t always get what you want. Whatever adage you want to use, the bottom line is still no punitive damages.

Plaintiff’s argument was solely focused on the exception to the NJPLA’s ban on punitive damages for prescription drugs. That exception says that the prohibition on punitive damages does not apply “where the product manufacturer knowingly withheld or misrepresented information required to be submitted under the agency’s regulations, which information was material and relevant to the harm in question.” N.J. Stat. Ann. § 2A:58C-5. In its decision last month, the court held that plaintiff had not argued that the exception applies and so the court did not have to address it. McWilliams v. Novartis AG, 2018 U.S. Dist. LEXIS 113862, *22 n.3 (S.D. Fla. Jul. 9, 2018).

In her motion for reconsideration, plaintiff pointed to a footnote in her opposition to the motion for summary judgment in which she did argue that she had adduced evidence of information withheld from or misrepresented to the FDA that made whether the exception applied a triable issue of fact. McWilliams v. Novartis AG, 2018 WL 3637083, *2 (Jul. 31, 2018). That footnote also stated plaintiff’s belief that “punitive damages under New Jersey law are not preempted.” Id. (citations omitted).

The court agreed that it had not considered plaintiff’s argument regarding the punitive damages exception and so granted plaintiff’s request to consider it. Id. And upon considering it, promptly concluded that it was indeed preempted.

If we’re talking about a misrepresentation to the FDA, we’re talking about fraud-on-the-FDA, so we’re talking about Buckman. It feels like a direct line to us. An express even. No stops, twists, turns, or curves. The exception to the punitive damages ban in the NJPLA is a fraud-on-the-FDA claim and Buckman says those are not allowed.  The federal circuit courts that have considered the issue (in the context of similar provisions of Michigan and Texas law) are split with the Fifth and Sixth Circuits finding the exception preempted and the Second Circuit not. Compare Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir. 2004) and Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372 (5th Cir. 2012) with Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006), aff’d by equally divided court, 552 U.S. 440 (2008). We discuss the split in more detail here, and we’re guessing we don’t need to tell you on which side of the issue we come down.

Fortunately the court in this case was persuaded that the punitive damages exception is “substantially the same” as fraud-on-the-FDA and therefore preempted by Buckman – noting that that was in fact the position of the majority of courts to have considered the issue. McWilliams, 2018 WL 3637083, *3. Another notch on the Garcia/Lofton side of the divide.

Today’s case has a little bit of everything – choice of law, statutory compliance, alternative design, warnings causation. So, the decision is a bit of “grab bag” in addition to being a “mixed bag.”

The case is Hyde v. C.R. Bard, Inc., 2018 WL 3586404 (D. Ariz. Jul. 26, 2018). To begin with, plaintiff voluntarily withdrew several claims – manufacturing defect, breach of express warranty, failure to recall, and breach of implied warranty. Id. at *2. Defendant did not move for summary judgment on negligent design defect, negligence per se, or punitive damages – so those claims remain. That left failure to warn, misrepresentation and fraud, and strict liability design defect. Of those, only strict liability design defect survived. Id.

The court first had to decide which state’s law applied. Plaintiff was living in Wisconsin when she had the IVC filter implanted but did not experience any complications until after moving to Nevada. Plaintiff argued that Nevada law should apply as the location where the injury occurred. The court disagreed. Wisconsin, the forum state, applies a two-step analysis for choice of law questions. First, are one state’s contacts so minimal that applying that state’s law would be “officious intermeddling.” Id. The court found both states to have significant contacts with the case and so moved on to step two. This consists of the analysis of 5 factors. The court found three factors (maintenance of interstate order, simplification of the judicial task, and application of the better rule of law) to be neutral. Id. at *3-4. And the remaining two favored Wisconsin. As to predictability, the IVC filter was sold in Wisconsin, implanted in Wisconsin, and defendant’s interactions with the implanting surgeon took place in Wisconsin. So, defendant could reasonably expect Wisconsin law to apply to any products liability claims arising from the use of the filter. Id. at *4. As to the forum state’s interest, Wisconsin “has a strong interest in having its laws applied to corporations transacting business with the state. Id.

 Wisconsin’s product liability statute provides a presumption that a product is not defective if it complied with relevant standards or specifications approved by a state or federal agency – such as the FDA. Defendant therefore argued that because the IVC filter was cleared by the FDA via the 510(k) process, the presumption applied. The court however, refused to apply the statutory compliance presumption because the 510(k) process is not a safety review and therefore defendant was not entitled to the non-defectiveness presumption. Id. at *6.

Another defense to strict liability claims in Wisconsin is that the harm was caused by a known and inherent risk. Defendants argued, citing to publications, FDA documents, and plaintiff’s surgeon’s testimony, that the very complication suffered by plaintiff was well known in the medical community. Id. at *7. Plaintiff countered that while the general risk may be known, the fact that defendant’s filters had a higher adverse event rate than other filters was not known. The court decided that any challenge as to incident rates is a triable issue of fact for the jury. Id.

Turning to plaintiff’s burden of proof, to maintain a claim for strict liability design or warning defect, plaintiff has to establish that the risk of harm could have been “reduced or avoided” with a “reasonable alternative design or warning.” Id.   In this case, plaintiff’s expert pointed to anchors that were added to other of the defendant’s IVC filters as a specific and available alternative design. Defendant argued that plaintiffs in the litigation claim that those other IVC filters also are defective. Essentially plaintiff relied on an allegedly defective design as the alternative to the allegedly defective design at issue. Id. That feels like it should be a non-starter. But the court said that the alternative design only has to “reduce” the risk of harm. Id. So, if the alternative is slightly less defective that appears to be enough. Again, a bit of a head scratcher.

Moving on to failure to warn, the court found plaintiff’s claim failed for lack of evidence of causation. The court skirted the issue of learned intermediary, on which the Wisconsin Supreme Court has not ruled, finding that plaintiff identified no evidence that either plaintiff or her surgeon would have changed his/her decision regarding implanting the device. Id. at *8-9. In fact, plaintiff’s surgeon testified that he didn’t recall which filter was used or who made the decision to use that filter. He further testified that he trusted the FDA, the device was meeting the expectations of the FDA, and he wouldn’t have deferred implanting the filter where it was medically necessary. Id. at *9. Put all together, there was nothing in the record to establish that a warning about greater risks would have affected either the surgeon’s or the plaintiff’s decision to use the product.

That same rationale carried over to plaintiff’s misrepresentation and fraud claims where reliance is an essential element. Plaintiff never received any independent information from the defendant nor did she point to any information from the defendant on which her surgeon relied. Id. at *10.

So, the case remains although substantially cutback. Just two quick observations from reading between and outside the lines of the opinion as to negligence per se, on which defendant did not move for summary judgment. First, if 510(k) clearance doesn’t involve “safety,” how can negligence per se apply? It would seem that following the court’s logic, the 510(k) process does not rise to the level of a substantive standard of care that can support plaintiff’s negligence per se claim. Second, back in March we reported on another partial summary judgment win in the Bard IVC Filter MDL. In that case, this same court granted summary judgment on negligence per se finding that the claim could not be based on alleged FDCA violations because there is no private right of action to enforce the Act. See prior post here. From an outsider’s perspective, it feels like negligence per se should be out of this case as well.

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

We truly dislike decisions that find that claims of failure to report adverse events to the FDA are non-preempted, parallel violation failure to warn claims. Failure to report claims are not parallel.  Federal law does not require warnings to plaintiff or her doctors.  State law does not require warnings to the FDA. In the absence of a state-law duty to make reports to a government agency, a failure to report claim is an improper private attempt to enforce the FDCA. It is a claim that should not survive either express or implied preemption.

But, some courts do allow it, such as Bull v. St. Jude Medical, Inc., 2018 WL 3397544 (E.D. Pa. Jul. 12, 2018). Now, we think the Bull court is overstating when it says “most courts” to have considered a failure to report claim have found it to be a parallel claim. We refer you to our PMA Preemption scorecard which clearly shows this is an issue on which courts are split. Nor is the reasoning of the opinion anything new. Defendant had a duty under state law to warn physicians and a duty under federal law to comply with adverse event reporting requirements and those two requirements aren’t in conflict with each other. Id. at *8. But just because two roads don’t intersect doesn’t mean they are parallel.

And, because Pennsylvania doesn’t recognize a state law failure to report claim, any such claim exists solely as a result of the FDCA and therefore should also be impliedly preempted. Again, having concluded there are parallel duties, Bull also concludes no implied preemption. The court found that plaintiff alleged a valid state law failure to warn claim that was based on a failure to comply with its federal duty to report adverse events to the FDA. Id. at *9.

We don’t like those conclusions, but it’s also not the first time we’ve seen them. Where we usually take solace is that more often than not a finding that a failure to report claim is not preempted is followed by a finding that it is also not adequately pleaded. We refer you back again to the PMA Preemption scorecard for the many, many decisions reaching that conclusion. The primary reason the claim fails TwIqbal – failure to sufficiently plead causation.

Unfortunately, the court in Bull gave plaintiff a pass on pleading physician-specific warning causation. The complaint “does not even allege that [plaintiff’s] doctors consulted the [FDA adverse event] database, or any other source of . . . adverse event reports, when making their treatment decisions.” Id. But the court found that unnecessary. Instead, all that was required was an allegation that prior to the implantation of the device in plaintiff, defendant failed to disclose adverse events that if disclosed may have led her doctor’s not to use the device. Id.

That shouldn’t be enough. Even Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013) (en banc), which allowed a failure to report claim, acknowledged that causation is a particularly problematic hurdle for plaintiffs:

Because they predicate their claim on [defendant’s] reporting duty to the FDA, as they must to avoid express preemption, [plaintiffs] face a causation hurdle that would not otherwise exist.  To prevail, they will ultimately have to prove that if [defendant] had properly reported the adverse events to the FDA as required under federal law, that information would have reached [the prescribing] doctors in time to prevent [plaintiffs’] injuries.

Stengel, 704 F.3d at 1234-35 (concurring opinion). Therefore, the causal chain requires both that the FDA would do something differently (such as make the adverse events public), and that that hypothetical action by the FDA would have caused the prescriber, in turn, to change his/her prescribing decision in some way that would have prevented the claimed injuries. Plaintiff’s allegations in Bull, as set forth in the opinion, are much too vague to support a plausible causation claim.

And the analysis shouldn’t have stopped there. The opinion actually sets forth sufficient facts that were pleaded to support reaching just the opposite conclusion on causation.

First, would the FDA would have done something differently? Plaintiff had the device implanted in 2010 and began experiencing problems with it in 2015. Bull at *5. Per the facts alleged, in 2009 the FDA conducted an inspection of defendant’s manufacturing facility. Id. at *2. The report of that inspection included information about Medical Device Reports (MDRs) that were either untimely or not submitted to the FDA. Id. at *3. It also included an analysis of MDRs both at the company and within the FDA’s database. Id. at *2-3. So, what the facts establish is that the FDA became aware of these adverse events a year before plaintiff received the device and at no time prior to plaintiff’s surgery did the FDA require defendant to take any further action to warn physicians beyond the existing labeling and warnings. So there is no causal nexus between the alleged failure to report and plaintiff’s injury.

Moreover, to the extent plaintiff relies on a 2011 FDA Safety Officer Report and a 2012 483 Inspection, those took place after plaintiff was implanted with the device and if they involve allegedly unreported events after 2010 – they can have no bearing on causation. To establish causation plaintiff should be required to prove (and plead) that had the adverse events been properly reported to the FDA, the information would have reached plaintiff’s physician in time to prevent the alleged injuries.

Second, would plaintiff’s doctors have done something differently? Well, because the FDA didn’t take action the answer is there is nothing to trigger plaintiff’s doctors doing anything different either. But, there is also the added fact that in this case after the events were reported and the FDA did require some additional warnings and even after the FDA recalled the device – plaintiff’s doctors did not explant the device. Id. at *5. While we are only privy to what’s reported in the complaint, we think the second link in the causal chain is likely broken as well.

We have a hard time imagining this case getting beyond summary judgment on causation based on what we see as the regulatory history from the opinion. We’ve talked in greater detail about this causation hurdle in failure to report cases here. So, while defendant lost at this stage, we are optimistic about a win in the future.

It can sometimes be difficult for us here at the DDL Blog to address “mixed bag” cases. We are quite clear that we are a defense side blog. Love us or hate us – we don’t pull punches. We hoard and covet preemption and learned intermediary wins and treat each one like the gem that it is. We collect and pile up class action denials, no duty cases, and Lone Pine orders. We have scorecards, and cheat sheets and surveys all designed to celebrate defense victories and assist in creating more defense victories. So, when faced with a case that only goes half way, we are left a bit deflated. It’s sort of like seeing a movie where you say the special effects were amazing, but the story – not so much. You can’t trash the movie because there was something decent. But you also aren’t giving it two thumbs up (you know, the standard movie rating before it became based on tomatoes). If a decision is all bad, we trounce it. If a decision is all good, we praise it. If it’s somewhere in the middle, we talk about it.

That about sums up our take on McWilliams v. Novartis AG, 2018 U.S. Dist. LEXIS 113862 (S.D. Fla. Jul. 9, 2018). It is a failure to warn case concerning a drug used to treat leukemia. Id. at *2. Plaintiff suffered a stroke after using the drug to treat his chronic myeloid leukemia for a little over 2 years. Id. at *3. Defendant moved for summary judgment on the grounds of preemption, adequacy of the warning, lack of proximate causation, and no punitive damages under the law of New Jersey. The court denied the first three and granted the motion on punitive damages.

As to preemption, defendant moved that the case should be dismissed based on impossibility preemption arguing that there was clear evidence that the FDA would have rejected a warning on the risk of stroke if defendant had proposed one. In support of its argument, defendant noted multiple occasions on which the issue of arterial and vascular occlusive events was raised with the FDA before the date of plaintiff’s stroke:

  • In 2011, Defendant proposed adding peripheral artery occlusive disease to the Medication Guide and the Adverse Reaction section of the label and the FDA rejected the proposal.
  • Twice in 2013 before plaintiff’s stroke, Defendant told the FDA of labeling revisions required by Canada regarding cerebrovascular events.
  • Later in 2013, the FDA required another drug in the same class to add a boxed warning that included language that “similar rates of serious vascular events have not been observed in several other drugs of this class.”

Id. at *5-6. We view that as a pretty well-documented history of FDA regulatory rejection or inaction related directly to the risk at issue. Perhaps most compelling to us was the fact that when the FDA added a “serious vascular events” warning to another product it specifically said defendant’s product (as one of the others in the class) didn’t have the same risk profile. That feels like clear evidence that the FDA would have rejected that warning if proposed by defendant. The court reasoned that just because the FDA changed one label doesn’t mean that it would not have change another. Id. at *11-12. But that misses the language the FDA used distinguishing the drug that required the warning and the others that did not.

Unfortunately for the defendant in this case, the court compared its regulatory history to the histories set forth in the cases cited where clear evidence was found and concluded that the others had more extensive histories. But is that the correct analysis? Perhaps the evidence of rejection has been stronger in other cases, but that doesn’t make the evidence in the current case any less clear.

Moving on to the actual warning itself, defendant’s first argument was that the risk of stroke was not known or knowable during the time period that plaintiff took the drug. Defendant argued that there were no article or published reports of patients experiencing strokes while taking the drug until 2 adverse events were noted in 2013. Id. at *16. Plaintiffs on the other hand argue that Canadian regulators provided defendant of information regarding an association between the drug and atherosclerotic disease in 2012. That’s not the same thing as strokes, but it was enough for the court to find a disputed issue of fact. Id. at *16-17.

Defendant also challenged proximate cause arguing that plaintiff could not prove that his prescriber would not have prescribed or would have stopped the prescription if he received a different warning. Id. at *17. As evidence of this, defendant relied on the prescriber’s testimony that he continues to prescribe the drug today. Id. Plaintiff countered with the prescriber’s testimony that when he prescribes today he does so “with careful warning.” The court concluded that because the prescriber has now changed his warning to patients, causation remains in dispute. Id. at *19.

That leaves plaintiff’s punitive damages claim which turned on choice of law. Plaintiff is a Florida resident, was prescribed the drug in Florida, and suffered his stroke in Florida. Defendant is a New Jersey corporation. Florida allows claims for punitive damages in prescription drug cases. New Jersey does not. See N.J.S.A 2A:58C-5 (no punitive damages for drugs and devices that are approved by the FDA). There’s a clear conflict. Florida uses the significant relationship test to resolve conflicts. McWilliams, at *23. Which means the court has to decide which state has the most significant relationship to the particular issue. Id.

We are all familiar with the assumption in most personal injury cases that the law of the place of injury applies. And that used to be the beginning, middle, and end of the inquiry. Until about a decade ago, the argument that defendant’s domicile should control for punitive damages didn’t have much support.  It is in defendant’s home state that the conduct that allegedly serves as the basis for punitive damages takes place. While the drug was marketed to doctors in Florida, “the alleged sales and marketing strategies originated from [defendant’s] New Jersey headquarters, and plaintiffs have not identified any way in which those strategies were implemented differently in Florida than any other state.” Id. at *26. According to the Restatement (Second) of Conflict of Laws, when the issue under consideration is about deterrence or punishment, the place where the conduct took place may have the dominant interest. Id. at *25. Since punitive damages are “designed to deter and punish” the defendant rather than compensate the plaintiff that means New Jersey has the more significant relationship and its law applies.

In this case that means no punitive damages. But as we’ve mentioned before, one of the reasons we don’t spend much time on choice of law is the rulings are double-edged and can easily be turned to apply the law of states we don’t like. As we said at the outset, this is a mixed bag case so we’ll take from it what we can get. Good news for New Jersey drug and device companies sued in other states.

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.

Being that it was the Sixth Circuit that allowed a failure-to-update claim to proceed against a generic manufacturer, when we got the recent decision in McDaniel v. Upsher-Smith Labs, 2018 U.S. App. LEXIS 17884 (6th Cir. June 29, 2018), knowing it was about whether a claim for failure to distribute a medication guide was preempted, we flipped straight to the end looking for “affirmed” or “reversed.” We wanted to get into the proper frame of mind for reading the opinion. Were we going to be disheartened like we were by Fulgenzi v. Pliva, 711 F.3d 578 (6th Cir. 2013). Or pleased by the court’s distancing itself from its prior ruling. Fortunately, it’s the latter.

While failure to distribute medication guide claims have been previously ruled on by district courts, it was a matter of first impression on appeal. The Eleventh Circuit had the issue before it just a couple of months ago, but decided the case on learned intermediary rather than preemption grounds. See our post on that case here. And while we’re at it, here is where you can find our discussion of Fulgenzi. The Sixth Circuit took just the opposite approach deciding not to reach the learned intermediary question but instead to focus all of its attentions squarely on preemption.

At issue was plaintiff’s husband’s use of a generic form of amiodarone. Plaintiff alleged that her husband did not receive the Medication Guide for the drug when he filled his prescriptions because the manufacturer failed to make sure they were available. McDaniel, at *3. This failure to provide the Medication Guide was the sole basis for plaintiff’s strict liability and negligence failure to warn claims.

So, to be clear, nowhere in plaintiff’s complaint does she allege that the warning that was provided with the drug (in its accompanying labeling) was insufficient or inadequate. Her only allegation is that the Medication Guide, the substance of which she also does not take issue with, was not provided to her husband as required by the FDCA. Which the Sixth Circuit determined was the pleading of a federal duty without any Tennessee state court parallel duty. “Said differently, the claims would not exist in the absence of the FDCA.” Id. at *4. And, that’s Buckman implied preemption territory.

The court starts by directly citing Buckman for the ruling that there is no private cause of action for enforcing the FDCA. Id. at *5. The court then quotes quite heavily from plaintiff’s complaint to demonstrate that she has not pleaded a traditional state law failure to warn to claim – indeed neither plaintiff’s complaint nor briefing even mentions the Tennessee Products Liability Act. Id. at *8-9. Instead, her allegations talk about the defendant’s failure to provide the guide “as required by the FDA.Id. at *6-7 (emphasis added). As if that wasn’t enough, in her briefing, plaintiff explicitly disclaimed any inadequate content basis for her failure to warn claims:

The allegation is not one of adequacy or “content” failure to warn, (i.e., the verbiage or even the format fails), but an actual and physical negligent failure of [defendant] to fulfill its federally mandated responsibility to ensure Medication Guides are available for distribution directly to patients with each prescription.

Id. at *8 (quoting plaintiff’s brief). So, we think the basis for the claim is quite clear. Failure to distribute the Medication Guide as required by the FDCA. Nothing more.

The court next moves to the decisions by various district courts finding failure to distribute claims preempted. See id. at *10-11. To which plaintiff responded by relying on Fulgenzi. Like we mentioned above, Fulgenzi was a failure to update case. Plaintiff alleged that the generic manufacturer defendant failed to update its labeling to include new warnings added by the brand manufacturer thereby violating both the federal duty of sameness required of generic labeling and Ohio state law requiring adequate warnings. The Fulgenzi court found that because it was the adequacy of the warning that was at issue – a traditional state law claim – rather than the failure to update, the claim wasn’t preempted. In other words, the allegation of the violation of the federal duty of sameness was not a “critical element” of the claim in Fulgenzi. It was pleaded by plaintiff to demonstrate that her state law failure to warn claim was not preempted because it paralleled a federal requirement. Plaintiff in McDaniel, tried to argue that she too only pleaded the federal-law violation to avoid impossibility preemption. In fact, the only element of her failure to warn claim was failure to comply with a federal duty. Id. at *11-12. The court was not willing to “ignore the language of [plaintiff’s] allegations simply so that [it could] shoehorn her claims into Fulgenzi’s realm.´ Id. at *14.

While we disagree with where Fulgenzi came out, we agree that even if you found Fulgenzi’s reasoning sound, it doesn’t apply to McDaniel. In this case, the court correctly concluded that the FDA requirements regarding distribution of Medication Guides was a “critical element” – actually only element — of plaintiff’s case, and therefore the claim was impliedly preempted.

Note that there is a dissenting opinion that argues the McDaniel case does fit within the Fulgenzi framework by finding that Plaintiff McDaniel also pleaded a failure to warn claim alleging inadequacy of the warning. We certainly think the language cited by the majority demonstrates that’s not the case, but we aren’t going to spend time quibbling over it because we don’t think adequacy should be outcome determinative. As we said back when we posted on Fulgenzi, there is no question that the duty at issue (to update or to distribute) is federal. Only the federal government may enforce it. Whether the updated warning and/or Medication Guide is, or is not, also “adequate” under state law amounts to nothing more than coincidence. At least that’s how we saw it then and still see it now.

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.

What happens when a case involving a medical device that received Pre-Market Approval from the FDA survives, or at least some part of it survives, a motion to dismiss based on preemption? In recent years, as the law has developed and become increasingly favorable for defendants, most of our posts about PMA preemption are at the motion to dismiss stage. That’s because usually not much survives beyond that point. So when we happened upon Delfino v. Medtronic, Inc., 2018 WL 2688420 (Minn. Dist. May 18, 2018), we decided it warranted more than just a notch on our PMA preemption scorecard.

It looks like all the claims in this case were originally tossed back in 2012 but plaintiff was given an opportunity to amend her complaint to properly allege parallel violation claims. Now, almost 6 years since that decision – during which time we assume significant discovery was conducted – all of plaintiff’s claims are being dismissed again. Plaintiff’s negligence and strict liability claims are preempted for lack of evidence of a violation of a federal requirement and plaintiff’s warranty claims are barred by the express terms of the limited warranty of the device.

The device at issue is an implantable cardioverter defibrillator (“ICD”) and there is no dispute that it is a Class III, PMA medical device and therefore subject to preemption under Riegel v. Medtronic, 552 U.S. 312 (2008). Any state law tort claim must therefore parallel, rather than add to, federal requirements. Id. at *3. In other words plaintiff has to prove the violation of a federal requirement applicable to the device, violation of an identical state-law duty, and causation. Id. It is also not disputed that the device’s battery prematurely depleted and required replacement earlier than anticipated. Id. at *1.

We won’t walk through all the nitty-gritty, but section I.C of the opinion documents how Medtronic went about introducing manufacturing and testing records to refute plaintiff’s manufacturing defect claim. Via records, deposition testimony, and affidavits Medtronic was able to demonstrate “the manufacturing and inspection history” of the device which in turn proved that the device “passed all quality control inspections, and complied with the FDA-imposed requirements.” Id. at *4. Defendant also established that they learned that a subset of the ICD’s were suffering from premature battery depletion due to the copper used in certain of the electrodes in the device’s capacitors. It was found that copper from one supplier was at the root of the problem and defendant stopped using that copper going forward. Id.

Against that history, the question for the court was whether there was any violation of a federal requirement. Plaintiff first argued that by using copper in it capacitors, defendant was violating a federal manufacturing specification that the end terminations of the capacitors consist of plated tin over nickel. Putting aside that the copper was not used in the end terminations and that defendant’s end terminations were plated tin over nickel – there was nothing in the requirement that barred the use of copper. Id. at *5-6. As the court more fully explains, PMA silence doesn’t mean PMA forbiddance. The court points first to the language of the requirement at issue to show that when the FDA wanted to impose a prohibition it did so expressly. Id. at *6. And, if plaintiff’s theory were correct, no PMA would ever have to include prohibitory language because everything not expressly allowed would in fact be prohibited. If silence is going to be so all-encompassing, the result would be an even greater review burden on the FDA. Id. Otherwise the silence would almost assuredly be deafening.

Moreover, if plaintiff wants to rely on a “prohibited-unless-expressly-authorized” theory, she’s walking herself away from a parallel violation claim. “If the federal requirements are silent on a particular matter, than any state-law requirement as to that matter is necessarily ‘in addition to’ federal requirements.” Id.  That means plaintiff’s attempt to circumvent preemption actually ran her head first into it.

Finally, in opining that the ICD should have been made without copper, plaintiff’s expert neglects to explain how the capacitors could function without it. It’s a technical argument about electrodes (and that’s not this blogger’s area of expertise) but the more general takeaway is that you can’t argue a design that is non-functional. “State tort law that requires a manufacturer’s [device] to be safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme no less than a state regulatory law to the same effect.” Id. at *7 (citation omitted).

Plaintiff’s next argument centered on device longevity. In its PMA submission, defendant included a projection that the ICD would generally perform for 5.1 years. Plaintiff argued that that projection became a requirement when the PMA was approved. But while the FDA could have established a performance standard for the ICD, it did not. Id. “Indeed, the mere fact that a device malfunctioned is not evidence that the device violated any federal requirement. Id. at *8 (with a lengthy list of citations to demonstrate the point). PMA approval is a “reasonable assurance” of safety, not a guarantee. In fact, PMA devices are by definition those with higher risks. That’s why they go through the heightened scrutiny and a risk/benefit analysis for approval. “If premature device failure were enough to withstand preemption, then few if any medical device claims would be preempted.” Id. The MDA and Riegel would be “dead letters.” Id.

Plaintiff’s final argument to try to establish a parallel violation claim was that at the time the ICD was returned to defendant, three years after manufacture, the capacitor leakage current measured higher than allowed. Id. But that’s an irrelevant fact. “For her claim to survive preemption, Plaintiff must offer evidence that [defendant] violated a federal manufacturing requirement during the device’s manufacture.” Id. To which we point you back to the really nice way Medtronic confirmed that its manufacturing process was fully compliant.

That left only plaintiff’s warranty claims. First, they were barred by the terms of defendant’s limited warranty, which defendant honored and under which plaintiff made no claim. Id. at *10. But, they were also impliedly preempted. To prevail on a warranty claim that implicates safety or effectiveness, plaintiff must convince the jury that the device was not safe and effective – directly contrary to the FDA’s conclusions. Juries can’t be allowed to “substitute their own cost-benefit analysis in place of that applied by the experts at the FDA.” Id. at *10-11.

Would we prefer an early out on a motion to dismiss? Sure. But, sometimes a few claims squeak by and when they do, as we’ve always opined, plaintiffs still face a daunting uphill battle to survive summary judgment scrutiny.

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.