Last year’s list of the Ten Worst DDL cases was remarkable because all ten decisions came from appellate courts.  Yikes.  And it is not as if the bad appellate decisions were spread around.  Two came from our home circuit, the Third.  Two came from the reliably problematic Ninth Circuit.  But the ‘winner’ was the Eleventh Circuit, with three terrible opinions.  For defense practitioners, Eleventh Circuit precedents can create something of an obstacle course. 


It turns out that good federal district judges in SEC country also can be frustrated with what their appellate brethren hath wrought.  Last week we were sent an interesting example of this: Rowe v. Mentor Worldwide, LLC, No. 8:17-cv-2438-T-30CPT (M.D. Fla. March 2, 2018).  In that case, the plaintiff sued for negligence, strict liability, and breach of warranty arising out of injuries allegedly caused by a silicone gel breast implant. The breast implants are class 3 devices requiring premarket approval from the FDA.  The plaintiff’s implants had ruptured.  The plaintiff asserted that the defendant failed to conduct proper studies and failed to warn about known risks.  The defendant filed a motion to dismiss.  The district court wrote a thorough and well-reasoned opinion, concluding that all of the claims save one must be dismissed.  All of the claims would have been dismissed had it not been for a pesky Eleventh Circuit case that is unsound and inconsistent with other Eleventh Circuit cases.  The district judge acknowledged being stuck, but was none too happy about it.  The Rowe court’s opinion is laid out logically, and we will do our best to track it.




The court addresses “a growing plague on the justice system, which has wreaked havoc in this case and numerous others: poorly drafted pleadings.” Slip op. at 4. We get an Iqbal name-check.  The Rowe court recognizes the liberalities of notice pleading, but also recognizes that “[t]here is a point, though, where a pleading becomes deficient not because it lacks sufficient allegations to provide notice of claims, but because it buries those allegations among pages of irrelevant and impertinent material.”  Id. at 5  The complaint in this case was 60 pages, with 151 pages of exhibits.  The negligence claim includes “six separate negligence theories that are confusingly interwoven among each other.”  Id. at 5.  In short, the plaintiff “threw every allegation into the Complaint to see what would stick.”  Id. at 6.  But instead of throwing out the complaint wholesale, the court examined the particular causes of action to see which ones, in fact, would stick.


Preemption Overview


For its preemption analysis, the Rowe court largely relied on the recent Eleventh Circuit decision in Godelia.  That ends up having its ups and downs.  But the general preemption analysis is straightforward enough.  The threshold questions is whether the claims are valid under Florida state law, which governs the case.  If not, those claims are gone.  If so, the next questions is whether those claims are preempted by federal law.


Negligence failure to warn 


The plaintiff does not allege that the defendant failed to give the warning required by FDA. Therefore, the plaintiff must be seeking to impose a warning requirement that is different from or in addition to federal law.  Such a claim is expressly preempted by statute. Slip op. at 9.


Failure to report adverse events 


As any even semi-faithful reader of this blog knows, we think this claim is hogwash.  It should fail both on simple causation grounds as well as preemption.  We wrote about this issue earlier this week.  Some of you might know that the Ninth Circuit is a devilishly bad place for defendants on this issue.  But the Rowe court is not in the Ninth Circuit.  Instead, it is Eleventh Circuit law that supplies the framework, and this is one area where the Eleventh Circuit is pretty good, as it sees failure to report claims under Florida law as essentially alleging a claim of fraud on the FDA, which is preempted by Buckman. Slip op. at 10.


Failure to comply with federal laws 


The claims under this category pertain to alleged breaches of federal requirements and regulations. One example mentioned in the complaint is failure to do required studies.  But Florida law imposes no such requirement. So this claim flunks the preliminary test.  Even if the claim somehow survived that test, it would be impliedly preempted.  Id. at 11.


Negligent misrepresentation  


The plaintiff offered only the most general allegations of failures to disclose the risks of the implants. The court deemed these allegations to fall far short of Fed. R. Civ. P. 9(b), which requires specificity of fraud allegations.  The plaintiff “never identifies what the misrepresentations were, when they were made, how they were made, where they were made, or who made them.”  Id. at 12. In any event, the misrepresentations seemed to involve what was and was not told to the FDA.  Accordingly, those claims are impliedly preempted under BuckmanId. at 13.


Negligence per se 


Violation of a federal statute does not establish negligence per se if there is no federal private cause of action.  No such federal private cause of action exists here.  The complaint does not state a parallel claim, and is therefore impliedly preempted. Id. at 14.


Manufacturing defect 


Everything had been gliding along so smoothly up to this point.  Now we hit a rough patch.  The plaintiff alleged deviations from requirements in the device’s PMA, departures from good manufacturing practices, and vague failures to exercise care in the manufacturing process.  The defendant argued that the plaintiff never pointed to any device-specific requirements. It supported its argument by citing WolickiGables (11th Cir. 2011).  The Rowe court agreed that the Wolicki-Gables standard would require dismissal of the complaint.  But recent Eleventh Circuit decisions in Mink and Godelia cut the other way.  “The holdings in Mink and Godelia are directly at odds with Wolicki-Gables and appear to announce a new standard the Eleventh Circuit is directing courts to apply.”  Slip op. at 16-17.  (We listed Mink as the eighth worst DDL case of 2017.  Here is the post where we explained why we think Mink stinks.)  The Rowe court felt stuck.  Under recent rulings, the plaintiff could conceivably state a claim under parallel requirement.  At the same time, the court recognized that the “negligence count is nearly eviscerated by the Court’s ruling on the other theories.”  Id. at 17.  This, just to ensure there really is some there there, the court directed the plaintiff to replead the one surviving claim in an amended complaint. 


(This kerfuffle over what to do about competing circuit precedents reminds us of our time clerking on the Ninth Circuit, which is so huge and spread out that, believe it or not, inconsistent holdings proliferate.  What to do?  Assume there was  no en banc decision, which is what it should take to alter circuit precedent.  Does a panel need to follow the earlier or later decisions.  Your instincts might prompt you to conclude that it is always the most recent precedent that controls.  But if the recent decision’s reversal of precedent was improper, maybe even illegitimate, because it did not go the en banc route, should it really command respect?  We wrote a bit on this issue last year, as part of our extended Fosamax mourning period, and argued that the earlier precedent should control and the later deviation deserves no respect.)



Strict liability – failure to warn 


The analysis here is the same as for negligent failure to warn, and so is the result: preempted. Slip op. at 18.


Strict liability – manufacturing defect 


Remarkably, the result here is different from the negligent manufacturing defect claim.  For some unknown reason, the plaintiff did not ladle any specific federal requirements into this claim. Instead, the plaintiff simply relied on good manufacturing practices.  Not good enough.  Such allegations do not pass muster under either old or new Eleventh Circuit precedent.  Id. at 18.


Breach of implied warranty 


Plaintiffs constantly toss in warranty claims as an apparent afterthought.  Or maybe it is a no-thought.  The Rowe case is controlled by Florida law, and Florida law requires privity.  That is all perfectly obvious.  Equally obvious is that breast implants are not available for purchase directly by consumers.  The plaintiff pretty much conceded absence of privity and absence of a legal basis for proceeding with this claim, by not responding to the argument.  The court dismissed the warranty claim. 


Final scorecard


All that is left is the negligent manufacturing defect claim.  That should be a hard one for the plaintiff to win.


It occurs to us that good district judges such as Rowe’s are not the only folks who must grit their teeth and do battle with the Eleventh Circuit’s doctrinal wanderings.  Defense DDL practitioners are in the same boat.  We can relate, inasmuch as the Third Circuit (think of Fosamax) has done us few favors lately.  So we commiserate with excellent defense lawyers such as the ones who fought for and won as complete a victory as reasonably possible in the Rowe case.  Congratulations to Dustin Rawlin, Monee Hanna, and Allison Burke of Tucker Ellis, and David Walz of Carlton Fields.



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

We’ve posted on two other occasions about the Shuker v. Smith & Nephew case as the Eastern District of Pennsylvania systematically dismantled the case on the grounds of preemption and pleading deficiencies. You can find those posts here and here. Unfortunately, the recent Third Circuit opinion deciding plaintiff’s appeal isn’t the full affirmance we had been hoping for. But before you get the wrong idea, the Third Circuit got the most important issue right – when you have a multi-component medical device, PMA preemption is to be addressed on a component-by-component basis. After that, however, the appellate decision does some unraveling of the district’s dismissal of the claims that survived preemption and so the case is going back to the Eastern District.

Briefly, the facts are that plaintiff underwent a hip replacement surgery in which his surgeon opted to use a Smith & Nephew device that consisted of several component parts, one of which was the R3 metal liner. Shuker v. Smith & Nephew, PLC, 2018 U.S. App. LEXIS 5160, *11 (3d Cir. Mar. 1, 2018). Unlike the other components of the device, the liner had undergone FDA Pre-Market approval. Id. And, the parties are in agreement that the surgeon’s decision to use the R3 metal liner with this particular device was an off-label use. Id. at *12. Plaintiff suffered complications that required additional revision surgeries.

In its first decision, the district court tossed out almost all claims as preempted and any non-preempted claims for being inadequately pleaded. When plaintiff filed an amended complaint attempting to correct the pleading deficiencies for the non-preempted claims, he again missed the mark and his remaining claims were dismissed with prejudice. The district court also entered a decision finding that it lacked personal jurisdiction over Smith & Nephew, PLC – a foreign parent company. Those three rulings are what the Third Circuit addressed in last week’s decision.

The question of how to apply PMA-preemption to a multi-component device was one of first impression in the Courts of Appeal. Id. at *2. And it is an important question because surgeons engaging in off-label use do mix and match parts with different regulatory backgrounds. The Third Circuit did a precise analysis that landed at the proper conclusion. However, the analysis does start up with a bit of a hiccup. Since we are talking about PMA-preemption, we are dealing with express preemption. Yet, in a footnote the court refused to follow the Supreme Court’s recent abolition of the presumption against preemption in the express preemption context set forth in Puerto Rico v. Franklin Cal. Tax-Free Tr., 136 S.Ct. 1938 (2016), because that decision wasn’t a products liability case and therefore did not directly concern the “historic police powers of the States.” Shuker, at *16n.9. We respectfully disagree with this conclusion for all the reasons we mention in our post discussing Franklin and simply point out that other courts have reached the opposite conclusion. Accord Watson v. Air Methods Corp., 870 F.3d 812, 817 (8th Cir. 2017) (following Franklin and rejecting presumption against preemption in express preemption case); EagleMed LLC v. Cox, 868 F.3d 893, 903, (10th Cir. 2017) (same); Atay v. Cty. of Maui, 842 F.3d 688, 699 (9th Cir. 2016) (same); Conklin v. Medtronic, Inc., ___ P.3d ___, 2017 WL 4682107, at *2 (Ariz. App. Oct. 19, 2017) (under Franklin courts may not invoke a presumption against preemption in PMA preemption cases); Olmstead v. Bayer Corp., 2017 WL 3498696, at *3 n.2 (N.D.N.Y. Aug. 15, 2017) (plaintiff’s assertion of presumption against preemption in PMA preemption case held “frivolous” after Franklin).

Fortunately, that did not derail the Third Circuit from ultimately concluding that plaintiff’s negligence, strict liability, and breach of implied warranty claims were all preempted under Riegel. To do that, the court had to determine to what device it was applying the preemption analysis. Plaintiff argued that you have to look at the device that was implanted as a whole. Whereas defendant, bolstered by an amicus brief filed by the FDA at the court’s request, maintained that the proper focus is on the component of the device with which plaintiff takes issue. Shuker, at *18. Agreeing with the defense position, the court anchored its decision on three findings. First, the FDCA defines “device” to include “components, parts, and accessories.” Id. at *19. Second, the FDCA’s off-label provisions specifically acknowledge that a physician can and will use components separately from the system for which the FDA approved use. Id. at *20. And despite the use to which the component is put, the FDA’s PMA-regulations for the component follow with it. In other words, “premarket approval requirements apply equally to the components, as manufacturers generally may not deviate from the requirements imposed through premarket approval regardless of how [a component] is used.” Id. (citation and quotation marks omitted). Third, the FDA’s position is that the device is not limited to the device as a whole but includes components. Further, the FDA is charged with assuring the safety and effectiveness of components as well as finished devices. Id. at *21-22.


[t]aken together, the statutory definition of “device,” the treatment of off-label uses, and the guidance of the FDA all counsel in favor of scrutinizing hybrid systems at the component-level. . . .. And the Riegel test is properly framed at Step One as “whether the Federal Government has established requirements applicable” to a component of the hybrid system.

Id. at *22-23. Because the part of the device plaintiff attacked was the R3 metal liner which was premarket-approved, any state tort claim that seeks to impose requirements that are different from or in addition to the FDA’s requirements for that component are preempted. That includes plaintiff’s negligence, strict liability, and implied warranty claims.

The appellate court next reviewed the dismissal of plaintiff’s claims that survived preemption – negligence and fraud claims based on alleged off-label promotion in violation of federal law – and found the negligence claim was adequately pleaded but that plaintiff failed again to satisfy Rule 9’s heightened standard for pleading fraud. As to negligence, the court found TwIqbal satisfied as to duty, breach, causation where plaintiff alleged:

  • the R3 metal liner was approved only for use with a different system and therefore under federal law defendant had a duty to refrain from false or misleading advertising;
  • in a press release, defendant misleadingly marketed the R3 metal liner as an option for the system used by plaintiff’s surgeon (one other than the one it was approved for); and
  • plaintiff’s surgeon “either read” or “was aware” of the press release.

Id. at *28-29. Like the district court, the Third Circuit considered and relied upon the press release cited in plaintiff’s complaint. Unlike the district court, the Third Circuit appears to only focus on the portions of the press release upon which plaintiff relied (see prior post for more details) and concludes that’s enough to get plaintiff to the discovery stage. Id. at *29n.18. Although we wonder if the court’s calling plaintiff’s allegations enough to “nudge” the claim over the threshold is a veiled acknowledgement of just how narrowly the complaint squeaked by. See id. at *30.

Meanwhile, plaintiff’s fraud claim needed more than a nudge and it didn’t get even that. The court focused on plaintiff’s failure to plead justifiable reliance on the alleged misrepresentation. The “read” or “was aware” of allegation that sufficed for negligence lacked the requisite details regarding how the press release “induced or influenced” plaintiff’s surgeon for a fraud claim. Id. at *33-34. Plaintiff has to allege the “circumstances of the alleged [influence on Mr. Shuker’s surgeon] with sufficient particularity to place [defendant] on notice of the precise misconduct with which it is charged.” Id. at *34. Despite this having been plaintiff’s second failed attempt at meeting the pleading standard on fraud, the Third Circuit decided to give plaintiff another chance and found the claim should only be dismissed without prejudice.

Finally, there was a separate finding by the district court that it did not have personal jurisdiction over Smith & Nephew, PLC, a foreign parent company. The Third Circuit agreed with the district court that specific personal jurisdiction was not conferred on a stream-of-commerce theory. Id. at *36-37. We’ve talked about this before and more recently in light of BMS v. Superior Court, and like the Third Circuit “we have no cause to revisit” the precedent on the issue (but you should feel free to). But the court did think plaintiff alleged enough in his complaint to allow some limited jurisdictional discovery on possible alter ego based personal jurisdiction. Id. at *38-40. Emphasis on the limited part. See id. at *40n.20 (“District Court should take care to circumscribe the scope of discovery . . . to only the factual questions necessary to determine its jurisdiction;” further referencing proportionality amendment to Rule 26(b)(1)).

So, on the third pass plaintiff got a little life breathed back into this case which is unfortunate, but as the first appellate decision on component preemption – we’ll put it in the win column.

Last week we posted about the need to consider the level of detail and specificity you include in any filing. We happened to stumble across another case that prompted a word to the wise – proofread, proofread, proofread. Today’s case is a defense victory in the battle between state and federal forums, but perhaps more importantly it is a reminder that in the age of “cut and paste,” proofreading is more important than ever.

Grant v. Johnson & Johnson, 2017 U.S. Dist. LEXIS 214078 (S.D.N.Y. Dec. 19, 2017), is not a drug or medical device case. But it involves an attempt by plaintiffs to use local pharmacies to defeat federal diversity jurisdiction and that is something drug and device defense lawyers face on a regular basis. Plaintiff filed a complaint in state court alleging that defendants, including a local New York pharmacy, sold and distributed products containing asbestos which caused plaintiff to develop mesothelioma. Id. at *3. Defendants then removed the case to federal court arguing that the local pharmacy was fraudulently joined. Id. at *3-4. Defendants alleged that plaintiff had not pleaded any facts to support a claim that the pharmacy had ever sold or that plaintiff had ever purchased from it any products containing asbestos. Id. at *4n1.

About a month later, plaintiff filed an amended complaint dismissing the originally named pharmacy and adding five new pharmacy, non-diverse entities as parties. Id. at *4. Plaintiff admitted that the original pharmacy never should have been named. It was an “inadvertent mistake.” In the rush to meet a filing deadline, plaintiff’s counsel copied the allegations from another client’s complaint. Id. at *4-5. Talk about a flub, a botch, a bungle. And it took plaintiff almost a month after removal to fix it. Nobody’s perfect. But naming the wrong defendant – not because of inaccurate, incomplete, or unknown information – but because you didn’t bother to proofread your complaint, is something that should have been caught and remedied immediately.

Once plaintiff “fixed” the complaint, she moved to remand. But sloppiness didn’t win her any points with the court, and more importantly, it revealed plaintiff’s real motive in naming the non-diverse defendants. Which also didn’t help plaintiff’s cause.

First, the procedural posture in this case is slightly different than what we are used to seeing when talking about fraudulent joinder. Because plaintiff admitted that the original pharmacy was improperly joined, its citizenship is discounted for purposes of determining diversity. So, complete diversity existed when the case was removed. Id. at *7n3. The question before the court was whether to allow plaintiff, post-removal, to join the new non-diverse pharmacies. If joinder were permitted, the case would have to be remanded to state court. However, “[w]hen joinder after removal would destroy subject matter jurisdiction, a plaintiff must do more than satisfy the permissive joinder requirements of Fed. R. Civ. P. 20 to succeed on a motion to remand the case.” Id. at *6. That is why, in addition to the permissive joinder rules which would be satisfied in this case, the court considers three additional factors in determining whether to allow a joinder that defeats diversity: (1) whether there was a delay and the reason for it; (2) whether there is any prejudice to the defendant; and (3) plaintiff’s motivation for the amendment. Id. So, why this case doesn’t, strictly speaking, deal with fraudulent joinder, the analysis is quite similar. Id. at *9. The court must examine the “relationship of the non-diverse defendants to the controversy . . . as an independent consideration under the joinder analysis.” Id.

Now for that analysis. The court did not believe there was either a significant delay or prejudice to defendant. Id. at *7. The court recognized the possibility of multiple litigation if joinder was denied based on plaintiff’s stated intention of filing the claims against the new pharmacies in state court. But the court was unpersuaded because “none of these non-diverse Defendants were originally sued . . . even though their existence was known to Plaintiff.” Id. at *8.

But what really drove the court’s decision was the combination of plaintiff’s counsel’s sloppiness and motive for joinder. Needing to make a deadline did not excuse counsel’s inattention:

Plaintiff’s counsel, as he admits, was essentially “copying and pasting” parts of one complaint into that of another—merely lifting a defendant from one complaint and inserting it into another—even though there was no factual or legal basis to do so.

Id. at *9. This is not a trivial thing. Naming the wrong defendant in a complaint may be compared to mistakenly inviting someone to a party. The invitee is now on the hook for a gift, possibly new attire, transportation, a sitter, etc. In other words, it isn’t no harm, no foul. And that’s a modest analogy at best. Once named, a defendant at a minimum has to retain counsel and likely will have to take some affirmative action to get itself extricated from the suit. Certainly more expensive than a bottle of wine and a new tie. Moreover, being named in a lawsuit is a public event that carries with it a certain stigma. To borrow from criminal law – innocent until proven guilty. While that may be true in the courtroom, it’s not necessarily the case in the court of public opinion. One lawsuit may not mean much to a large pharmacy chain, but it can be very unsettling and disruptive to a mom-and-pop shop, or an individually named pharmacist or sales representative, or a small town doctor. So, “oops,” doesn’t cut it.

Adding insult to injury, the amended complaint naming the “correct” pharmacy defendants contained only “boilerplate allegations and is devoid of any specific allegations” about these pharmacies. Id. at *10. Plaintiff lumps all defendants together in almost every allegation with no attempt to “explain what each Defendant’s respective role was.” Id. This also means plaintiff wrongly attributes things like manufacturing and design to the pharmacy defendants. Id. Finally, while plaintiff identifies these new defendants as the locations where she purchased the products over a span of 27 years, the complaint doesn’t allege when these transactions occurred or in what quantity the products were sold. Id.

Taking all of this into consideration, the court concluded:

[W]hile it is certainly plausible that Plaintiffs motive in now seeking to join the Pharmacy Defendants may not be solely to destroy diversity, based on plaintiff’s litigation behavior to this point and the course [s]he has selected to arrive at the current motion, Plaintiff’s motives for joinder are improper and violate the principles of fundamental fairness.

Id. at *11(quotation marks and citation omitted). Joinder was denied so as not to deprive the properly named defendants of their entitlement to litigate in federal court.

We don’t know how the court would have ruled on the remand motion if plaintiff had named the correct defendants the first time around. Given the comments on the boilerplate allegations, we’d like to be optimistic that the result would be the same and the pharmacies would have been found fraudulently joined. We’ll never know because of plaintiff’s carelessness which clearly inured to the benefit of defendants. But we all copy and paste. So, another word of caution – proofread and proofread again.

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

When we say Nebraska, what comes to mind? Cornhusker football? Warren Buffet, the Wizard of Omaha? Buffalo Bill’s Wild West Show? Mutual of Omaha’s Wild Kingdom? An amazingly haunting album by Bruce Springsteen? As the Jersey Girl blogger on this site, it should be no surprise that those ten songs go right to the top of the list. And, if you too are a true fan you’ll already know that Nebraska is actually mostly demos that Springsteen recorded as an experiment on a four-track cassette recorder. When the songs were tried later with the full power of the E Street Band behind them – most of them didn’t work. Born in the USA, Downbound Train, Pink Cadillac, and Working on the Highway found a home on later albums. But for songs like Atlantic City, Highway Patrolman, and My Father’s House – a guitar and a harmonic sold those songs more than a heavy back beat. Nebraska isn’t Springsteen’s only stripped-down album (The Ghost of Tom Joad and Devils & Dust), but for this Jersey Girl, it’s the one with the power. And it was recorded in a New Jersey bedroom one day in January 1982.

Nowhere in any of that did we connect Nebraska to preemption. That is until now. Until Ideus v. Teva Pharmaceuticals USA, Inc., 2017 WL 6389630 (D. Neb. Dec. 12, 2017). Based on our review, and please correct us if we’ve missed something, this is the first case to find a complaint was deficient for failure to plead any facts to establish why the warning claim involved “newly acquired evidence” that would allow it to escape preemption under Wyeth v. Levine, 555 U.S. 555 (2009).

Plaintiff alleged that defendant failed to warn about the risks of an intrauterine device. While the device was being removed, a piece of it broke off and embedded in plaintiff’s uterus. The broken piece later had to be surgically removed. Ideus, at *1. To support her claim, plaintiff alleged that the device’s brochure and package insert, lacked any warning that the device “could break during removal, or that smaller pieces of the device (as opposed to the device as a whole) could separate and become embedded.” Id. A quick aside. This distinction between the device as a whole and a piece of the device made us look at the device’s label. As a disclaimer, we simply looked at the available label on line, but it appears that product contains a warning that the device can become embedded and require surgery to remove. So, in essence, plaintiff’s claim is that while the manufacturer did warn of embedding and surgery as to the whole device, it didn’t warn about those things with a piece of the device. And plaintiff’s other claim is that the manufacturer didn’t warn the device could break. From our perspective, that’s a claim for something that was warned about and something that is a general risk of every product in the world. We don’t think much of plaintiff’s claims.

But we told you this was about preemption, so let’s get back to that. Defendant challenged plaintiff’s claims on the grounds of preemption. The warnings were FDA approved and therefore, plaintiff’s claims don’t survive conflict preemption. Id. As non-surprising as a Jersey Girl loving Springsteen, is a plaintiff raising the FDA’s Changes Being Effected (“CBE”) regulations in response to a failure to warn preemption challenge. Because CBE regulations allow a manufacturer to change the device’s warning without prior FDA approval, per Wyeth, it is possible for a manufacturer to change its warning and not run afoul of federal law. Hence, no preemption. But, what the court said in Ideus is that CBE isn’t a “magic” word that gets plaintiff around preemption even at the pleadings stage. More is required.

A CBE is only allowed based upon “newly acquired information,” not previously submitted to the FDA. “In the absence of such information, the [manufacturer] cannot alter its product’s labeling, and any state regulation or law requiring it to do so is necessarily preempted.” Id. at *2. The court in Ideus, therefore concluded that because “newly acquired information” is a pre-requisite for a valid CBE, facts to support the existence of such new information must be affirmatively pleaded in the complaint. The court cites three cases in support of its finding. We’ve discussed all three on this blog here, here, and here. The difference between those cases and Ideus is that in the prior cases the plaintiff had alleged some facts regarding “new” evidence. The courts were able to examine those allegations and reach conclusions regarding whether they demonstrated new information sufficient to support a CBE. They did not address the specific question of “whether the plaintiff must affirmatively plead the existence of “newly acquired information” to state a cognizable claim for relief.” Id. The closest earlier case was Utts v. BMS, 251 F.Supp.3d 644, 661 (S.D.N.Y 2017) which said:

In sum, if the plaintiff can point to the existence of “newly acquired information” to support a labeling change under the CBE regulation, the burden then shifts to the manufacturer to show by “clear evidence” that the FDA would not have approved the labeling change made on the basis of this newly acquired information.

Sounds like a pleading requirement to us.  Even construing the allegations in a light most favorable to plaintiff, “dismissal is nonetheless appropriate . . . if the facts alleged in the complaint do not plausibly give rise to a claim that is not preempted.” Ideus, at *3 (citations omitted). Because “some indication of newly acquired information [is required] to trigger the applicability of the CBE regulation,” those allegations are required to be in the complaint. Id.

And, of course, they must then meet the requirements of TwIqbal. So, while plaintiff is being given an opportunity to amend her complaint, she “must plead with specificity any newly acquired evidence which may have warranted a change” in the device’s warning after the device was approved but before it was implanted in plaintiff.” Id.  Given our earlier aside about the substance of the claims, we wonder if there was nothing in plaintiff’s complaint because there is nothing. We’ll wait and see, but in the meantime Nebraska, in addition to lending its name to a classic rock album, has given us a significant ruling in our preemption arsenal.

Just two days ago, Bexis lowered the boom on the Third Circuit’s recent decision in Cottrell v. Alcon Labs, ___ F.3d ___, 2017 WL 4657402 (3d Cir. Oct. 18, 2017).   In a 2-1 decision, the Cottrell court permitted the plaintiffs to proceed on the notion that making eye drop drips bigger than they have to be is a consumer protection violation.  To Bexis’s eyes, that decision was blind to the lack of standing, the absence of any “substantial economic injury,”  and the FDA’s non-approval of eye drop drips of the “smaller” size plaintiffs claim it is somehow illegal not to make under state law.  It turns out that there is someone else out there even more unhappy with the Cottrell decision than Bexis: the defendant.  Now we have the defendant’s Petition for Rehearing and Rehearing En Banc, which makes an insightful and compelling case for undoing the panel’s decision.


Two preliminary matters are worthy of comment before we tell you what the Petition said. First, we have been so unkind about the Third Circuit’s error in the Fosamax case that we managed to attract the attention of the excellent CA3 blog.   In that blog, the author wondered whether our dissection of Fosamax was perhaps a bit more violent than necessary.  The author also wondered whether we were coming close to accusing the court of bad faith.  Yes to the former, but definitely No to the latter.  As we told the CA3 blog, we took issue with what we saw as bad reasoning, but never-ever thought there was any bad faith.  (The CA3 blog was generous enough to print our disclaimer.  Thanks for that.)  By and large, we are mighty proud of our home circuit.  We know several of the judges, and every one of them is honorable, hard-working, and much smarter than we are.  Sometimes we are not going to agree with the court’s decisions.  Luckily for us we work in a profession and live in a country where debate and criticism are allowed.  Second, succeeding on a petition for rehearing and rehearing en banc is not easy.  When we clerked for Ninth Circuit Judge William Norris, it seemed there was a presumption against such petitions.  Who wants to admit they were wrong?  And yet we remember one time our judge was on a panel where things strayed from the norm.  Another member of the panel (who will remain unnamed) loved to decide cases before oral argument and draft a memorandum disposition rather than a bench memorandum.  This judge prided himself on having almost no backlog.  He pushed for deciding a particular contract dispute via a mere memorandum disposition, not a published opinion, because he saw the issues as being too obvious and insignificant for the Federal Reporter.  And so a memo dispo issued.  But then the losing party filed a petition for rehearing that was not only insistent, but it made a lot of sense.  We met with our Judge in his chambers to talk it over.  The telephone rang.  It was the third member of the panel, who began by saying, “Bill, I think maybe we got one wrong.”  The two judges confabbed, and then set about persuading the third to change his mind and change the outcome.  It took some arm-twisting, but in the end, justice was done.  A mistake led to a proud moment.  By the way, the Ninth Circuit Judge who called our Judge was Anthony Kennedy.  He is now on the U.S. Supreme Court.  So whenever we hear criticisms of Justice Kennedy for fence-sitting, or for grounding some of his opinions in “the right to define one’s own concept of existence, of meaning, of the universe, and of the mystery of human life” or, much worse, international law, we recall his extraordinary integrity and modesty, and how he was supremely interested in getting things right.


Back to the Cottrell Petition. The main points in favor of revisiting the Third Circuit’s decision are that it is contrary to Finkelman v. National Football League, 810 F.3d 187 (3d Cir. 2016), it “radically expands Article III standing,” and that it directly conflicts with Eike v. Allergan, Inc., 850 F.3d 315 (7th Cir. 2017).  Moreover, the plaintiff’s inherently speculative theory of injury in fact was rejected by federal courts in Massachusetts and Missouri.  (When a court comes out with a more pro-plaintiffy position than courts in Massachusetts and Missouri, that’s really saying something.)  That theory was also rejected by the district court in Cottrell.  And then the Third Circuit reversed that rejection.  


Remember that the Cottrell plaintiffs did not claim that the medications caused them physical harm or were ineffective in treating their eye conditions, or that the defendants misrepresented or omitted any information about the medications or the number of doses expected.  Rather, the plaintiffs simply insist that smaller eye drops would have cost them less.  How is that any different from the Third Circuit’s earlier, controlling Finkelman case, where the plaintiffs had purchased two Super Bowl tickets on the resale market for $2,000 each, and contended that the National Football League had violated New Jersey’s ticket law by not offering at least 95% of tickets to the general public and instead withholding most tickets for league insiders?  The plaintiff in Finkelman alleged that the NFL’s conduct had caused him injury by reducing the supply of tickets, thereby driving up the cost of tickets on the resale market.  The Third Circuit in Finkelman held that the plaintiff lacked standing because the injury was wholly speculative.  Sure, maybe the NFL’s withholding of tickets increased prices on the resale market, but “it might also be the case that it had no effect on the resale market,” and indeed tickets might even have been more expensive in plaintiff’s hypothetical resale market, as members of the general public may have greater incentives than league insiders to resell at high prices.  (We have to admit that, as residents of Philadelphia, where the local team has the best record in the entire NFL, the availability of Super Bowl tickets is a much, much bigger issue to us right now than the size of eye drops.)

The Petition makes the point that, just as in Finkelman, other market effects might have produced a result very different from what the plaintiffs theorized.  In Cottrell, the plaintiffs essentially presumed that the defendants price their products solely according to volume, such that “changing the eyedropper size would not change the price of the medicine, while extending the useful lifespan of each bottle, driving down [the plaintiffs’] aggregate costs.” But it is just as likely that use of smaller drops would prompt use of different sized containers, or that smaller drops would result in a higher price – because of more doses – for the same container.  Who knows?  All we do know is that the allegations of the complaint do not “affirmatively and plausibly” add up to an “injury” caused by the defendant’s conduct.  

The Petition nicely captures the absurdity of the Third Circuit’s analysis, under which consumers suffer Article III injury from “unfairness” whenever they “walk into a supermarket and buy a product — from toothpaste, to ketchup, to deodorant, to hairspray — so long as they can then conceive of a way that the product might be dispensed more efficiently.”  The Petition also nicely exposes the weakness in the Third Circuit’s effort to distinguish away the Seventh Circuit decision in Eike.  According to the Cottrell majority, Eike “seemed to begin its standing analysis with a determination that the plaintiffs had ‘no cause of action.’” But while it is true that the Seventh Circuit did (correctly) conclude that the plaintiffs had “no cause of action,” the Seventh Circuit also separately held that there was no Article III injury, without ever suggesting a causal connection between the two.  Eike, 850 F.3d at 318.  The Seventh Circuit got it fundamentally right when it held that the fact that a seller does not sell the product that you want, or at the price you’d like to pay, is not an actionable injury; “it is just a regret or disappointment.” 

As residents in, and fans of, the Third Circuit, the Cottrell decision certainly is cause for “regret and disappointment.” We called this post a “second look” at the eye-drop litigation.  It is the second look we have taken at the Cottrell case.  We hope that the Third Circuit takes a second look.      



Last month we brought you word of an excellent result (preemption) in a ridiculous case − a class action claiming that the drops in eye-drops are too big.  That decision was in accord with an earlier decision likewise dismissing such claims on preemption grounds. See Thompson v. Allergan USA, Inc., 993 F. Supp.2d 1007 (E.D. Mo. 2014) (discussed here).

However, there is another ground on which these bottom-feeding actions have been dismissed – lack of sufficient injury to support standing.  After all, the concept of some sort of ideal “price” for a product, above which it is improper to charge is a will-o-wisp, apparently knowable only to plaintiff-side experts (just ask them, they’ll tell you).  This is called “benefit of the bargain” by such experts.  Courts tend to use a different description – “absurd.”

[Plaintiff] received the drug she was prescribed, the drug did the job it was meant to do . . ., and it caused no apparent physical injuries. Under such circumstances, there could be no ascertainable loss. . . .  The Court believes Plaintiffs’ proposed liability theory, which requires no demonstrable loss of any benefit, would lead to absurd results and holds that Plaintiffs fail to state a claim as a matter of law.

In re Avandia Marketing Sales Practices & Products Liability Litigation, 639 F. Appx. 866, 869 (3d Cir. 2016) (citations and quotation marks omitted), affirming, 100 F.Supp.3d 441, 446 (E.D. Pa. 2015), also holding  “absurdity is inherent in the nature of Plaintiff’s claimed loss” because it was “based only on the idea that [the product] is inherently worth some unspecified amount less than whatever Plaintiff might have paid for it”).

That was essentially how the Seventh Circuit reacted to these same eye drop allegations in Eike v. Allergan, Inc., 850 F.3d 315 (7th Cir. 2017) (discussed here).  We described the absurd theory that the plaintiffs were pursuing in our Eike post, and because we’re lazy, we’ll simply repeat that here:

The plaintiffs sued pharmaceutical manufacturers of eye drops used for the treatment of glaucoma because the drops were bigger than they needed to be.  The theory is that the plaintiffs were paying more than they would have if the drops were smaller.  The plaintiffs alleged no conspiracy among the defendants.  This was not an antitrust case. . . .  Nor did the plaintiffs allege any misrepresentations.  Rather, the plaintiffs simply sought, because they thought it would be less expensive, a smaller dose product that nobody made.

The Seventh Circuit essentially agreed: “The fact that a seller does not sell the product that you want, or at the price you’d like to pay, is not an actionable injury; it is just a regret or disappointment − which is all we have here, the class having failed to allege ‘an invasion of a legally protected interest.’”  850 F.3d at 318 (citations omitted).  Accord Carter v. Alcon Laboratories, Inc., 2014 WL 989002, at *4-5 (E.D. Mo. March 13, 2014) (also dismissing identical claim for lack of any cognizable injury).

Apparently, however, the inherent triviality of that claim is no deterrent to today’s class action lawyers, who seem to have nothing better to do than measure the comparative value of eye drop drips.  After several attempts, they seem to have found a couple of judges credulous enough to allow one of these non-injury cases to survive – at least on the standing/injury issue.  That’s today’s case, Cottrell v. Alcon Labs, ___ F.3d ___, 2017 WL 4657402 (3d Cir. Oct. 18, 2017).   Looking to the “scientific consensus on eye drop size,” the majority is willing to let plaintiffs proceed on the notion that making eye drop drips bigger than they have to be is a consumer protection violation.  Id. at *2.  They may proceed even though “no defendant has reduced their products’ drop sizes,” and thus there is no competing product, priced at any price, against which to ascertain the plaintiffs’ purportedly “substantial economic injury.”  Id.  Nor does it appear that the FDA has ever approved – or even had submitted to it – eye drop drips of the “smaller” size plaintiffs claim it is somehow illegal not to make under state law.

The standing question focused on “injury in fact,” and as the party bringing the claim, plaintiffs had the burden of proving standing.  Id. at *4.  To find standing here, the majority (conceding that the district court’s no-standing analysis had “some persuasive appeal”) went deep into the weeds – breaking “injury in fact” into various “components.”  Id. at *5.  The first was a “legally protected interest.”  Conveniently, this allowed the Cottrell majority to base their result on something that prior precedent had “not defined” or even “clarified whether [it] does any independent work in the standing analysis.”  Id.  Presto!  A clean slate on which to build a standing castle in the air.  “[W]hether a plaintiff has alleged an invasion of a ‘legally protected interest’ does not hinge on whether the conduct alleged to violate a statute does, as a matter of law, violate the statute.” Id.  Impressive – this is a holding that the merits don’t matter. We’ll come back to that.

The second aspect of Cottrell’s drawing on a clean slate is “that financial or economic interests are ‘legally protected interests’ for purposes of the standing doctrine.”  Id. at *6.  Well, duh.  That seems like a platitude.  Third, “legally protected interests” can be created by statute, including a state statute.  Id.  That also sounds platitudinous – except Cottrell separates that proposition from any injury.  That comes in the fourth factor – that “interest must be related to the injury in fact” as opposed to being “a byproduct of the suit itself.”  Id.

Having set up this thicket on its clean slate, the court’s actual analysis of the injury requirement’s application to overly large eye drop drips takes only a paragraph:

Plaintiffs claim economic interests: interests in the money they had to spend on medication that was impossible for them to use.  They seek monetary compensation for Defendants’ conduct that they allege caused harm to these interests.  Plaintiffs’ claimed interests arise from state consumer protection statutes that provide monetary relief to private individuals who are damaged by business practices that violate those statutes.  These claims fit comfortably in categories of “legally protected interests” readily recognized by federal courts.

Id. (citing Cantrell v. City of Long Beach, 241 F.3d 674, 684 (9th Cir. 2001)).  Wow!  At that level of generality, any claim that anything for any reason should have been made differently or priced differently confers standing.  That no such alternative product exists is of no bearing.  This breathtakingly broad holding means that the amount of harm to the “economic interest” being undefinable has no bearing.  That the “business practices” at issue were a consequence of the FDA-approved design of the product has no bearing.  These are presumably “merits questions” that court already divorced from standing by putting that rabbit in the hat in its “first” stroke on the blank slate – that merits don’t matter.

We’ve seen this sort of credulous avoidance of merits questions before in class actions before.  Remember how courts for decades misinterpreted Eisen v. Carlyle & Jacqueline, 417 U.S. 156 (1974), to find that class certification can’t look at the merits?  That was finally interred once and for all in Wal-Mart Stores, Inc. v. Dukes, 564 U.S. 338, 351 & n.6 (2011), but now we see it popping up again on this supposed standing blank slate.

It’s not really a blank slate, however.  The Third Circuit, and many other courts, have held that TwIqbal “plausibility” requirements apply to the analysis of standing questions.  “With respect to 12(b)(1) motions in particular, the plaintiff must assert facts that affirmatively and plausibly suggest that the pleader has the right he claims.”  In re Schering Plough Corp. Intron/Temodar Consumer Class Action, 678 F.3d 235, 244 (3d Cir. 2012) (applying TwIqbal pleading requirements to standing analysis in RICO drug pricing class action).  TwIqbal “teach that standing cannot rest on mere ‘legal conclusions’ or ‘naked assertions.’”  Finkelman v. National Football League, 810 F.3d 187, 194 n. 55 (3d Cir. 2016) (citation and quotation marks omitted).

Because Lujan mandates that standing “must be supported in the same way as any other matter on which the plaintiff bears the burden of proof,” it follows that the TwomblyIqbal facial plausibility requirement for pleading a claim is incorporated into the standard for pleading subject matter jurisdiction.  Lujan, 504 U.S. at 561.  Therefore, we join many of our sister circuits and hold that when evaluating a facial challenge to subject matter jurisdiction under Rule 12(b)(1), a court should use TwomblyIqbal’s “plausibility” requirement, which is the same standard used to evaluate facial challenges to claims under Rule 12(b)(6).

Silha v. ACT, Inc., 807 F.3d 169, 174 (7th Cir. 2015) (citing Schering Plough along with many other cases).  “Just as the plaintiff bears the burden of plausibly alleging a viable cause of action, so too the plaintiff bears the burden of pleading facts necessary to demonstrate standing.”  Hochendoner v. Genzyme Corp., 823 F.3d 724, 730 (1st Cir. 2016) (Iqbal citation omitted) (also providing string citation of TwIqbal standing cases).

Along these lines, we also point out that the sole citation in Cottrell supporting its one-paragraph injury in fact analysis, Cantrell, supra, is a Ninth Circuit case, and the Ninth Circuit is the only circuit that does not follow TwIqbal in standing cases. See Maya v. Centex Corp., 658 F.3d 1060, 1068 (9th Cir. 2011) (cited as lone exception in Silha).

Having thus improperly insulated the inherently ridiculous nature of the alleged injury from TwIqbal inspection on standing questions – without even mentioning TwIqbalCottrell then disagrees with Eike for precisely that reason.  To do so, Cottrell splits another hair – distinguishing business practices that are “unfair” under a consumer protection statute from those “that are fraudulent, deceptive, or misleading.”  2017 WL 4657402, at *6.

The plaintiffs in Eike explicitly alleged that the defendants’ practices in manufacturing and selling eye medication were “unfair”. . . .  The Court was obliged to take these allegations as true for purposes of the standing inquiry.


That is, to be charitable, garbage. “Unfair” by itself is your classic legal conclusion.  Under TwIqbal, legal conclusions have to be accompanied by some factual basis to survive dismissal.  Eike rightly pointed out that, in the absence of any allegation of anything false or misleading about how these products were marketed, an “unfairness” allegation amounted to mere “dissatisfaction with the defendants’ products or their prices.”  2017 WL 4657402, at *6 (describing Eike).

Having thus improperly given the plaintiffs’ inherently implausible theory on “legally protected interest a TwIqbal free pass, Cottrell also waved it through the other injury in fact factors it created.  Most interestingly – because of the dissent – Cottrell attempted to distinguish a prior standing precedent, Finkelman, supra.

[Plaintiffs’] pricing theory is far less speculative than . . . the theory of financial harm we rejected in Finkelman . . ., [where t]he plaintiff claimed that this policy reduced the number of tickets available in the resale market.  Under the basic economic principle of supply and demand then, the policy resulted in an inflated ticket price in the resale market, according to the plaintiff.  We rejected plaintiff’s theory, as the plaintiff pled no facts to support their assertion that [defendant’s] policy would actually reduce the number of tickets in the resale market.

Id. at *9.  Since a “reduced size” of the eye drop drip (produced by a different sized hole in the tip) was the “only change from the status quo” that plaintiffs’ theory in Cottrell required in the majorities eyes, it was less “speculative” than the too-remote theory in Finkleman, and thus “sufficient to satisfy the injury-in-fact requirement.”  Id. at *10.

The dissent saw things differently.  Finkleman was dispositive (“I believe that Finkelman all but decides this case”).  Cottrell, 2017 WL 4657402, at *12 (dissenting opinion).  “We properly recognized that markets operate in complex ways.”  The market forces in Finkleman “made clear that any potentially unlawful conduct by the [defendant] did not necessarily result in higher prices to the plaintiff” and “concluded that we have no way of knowing whether [defendant’s] withholding of tickets would have had the effect of increasing or decreasing prices on the secondary market.”  Id.

[F]or purposes of analyzing economic injuries in the context of marketwide effects, we cannot do precisely what the plaintiffs here ask of us:  isolate and change one variable while assuming that no downstream changes would also occur.  These cases . . . reflect courts’ skepticism about plaintiffs’ ability to satisfy the case or controversy requirement of Article III by relying on such imaginative economic theories.  Thus, contrary to the Majority’s assertion, the plaintiffs’ pricing theory does in fact depend on exactly the sort of presumption rejected by us and by other courts − namely, the presumption that no other aspects of the market would change once the defendants’ conduct did. . . .  Finkelman makes clear that [standing analysis] distinguishes “between allegations that stand on well-pleaded facts and allegations that stand on nothing more than supposition.” . . .  The plaintiffs . . . ask us to assume certain facts about other actors’ behavior − exactly the sort of assumption that cannot be proven at trial. Accordingly, I would reject the plaintiffs’ alleged economic injury as overly speculative and untenable under existing precedent.

Id. at *13 (multiple citation footnotes omitted).

The Cottrell dissent goes on to discuss multiple reasons why plaintiffs’ attenuated economic assumptions are “a particularly bad fit for the market for pharmaceuticals.”  Id.

  • Pharmaceuticals are not priced “by volume;” “unit-based pricing is too one-dimensional for the [pharmaceutical] marketplace.”
  • Pharmaceutical pricing is “value-based”; “measured in part by effective doses.”
  • This pricing “shift . . . sever[s] the link between volume and price upon which the plaintiffs’ alleged injury depends.”
  • “[T]he price of each bottle could actually increase if each bottle provided more doses.”
  • Because plaintiffs’ assumption “does not reflect market conditions and pressures in the pharmaceutical industry,” it would “draw an unreasonable inference about the downstream consequences of” the design change they are demanding.
  • “[U]nreasonable” inferences cannot be accepted “at face value.”

Id. at *13-14 (dissenting opinion).

The dissent is of the view that the majority’s decision conflicts with Finkleman.  We agree, but go further.  We think the entire construct in Cottrell conflicts with prior Third Circuit precedent applying TwIqbal in standing cases because of its holding that the merits – and thus the facts that must be pleaded to establish the “plausibility” of the claim on the merits – don’t matter in standing cases.  Cottrell thus represents, with In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017), the second abrupt pro-plaintiff lurch by the Third Circuit this year, which is less surprising than it might seem, considering the both of the judges in the majority in Cottrell also decided Fosamax.

About the only good thing that can be said about Cottrell is that it did not purport to decide that preemption issue that has also defeated these half-baked dropper drip size allegations.  Id. at *11.  That argument is that design changes affecting the dosage of medication delivered – which is necessarily what plaintiffs’ drop size allegations depend on – are “major” changes that require prior FDA approval, and thus are “impossible” to carry out with the immediacy that state law demands. See Gustavesen v. Alcon Laboratories, Inc., ___ F. Supp.3d ___, 2017 WL 4374384, at *5 (D. Mass. Sep. 29, 2017), and Thompson, 993 F. Supp.2d at 1013-13, as discussed in our prior posts.

“Legal conclusions, though, are not entitled to the assumption of truth.” If that were the only point we could take away from Wright v. Howmedica Osteonics Corp., No. 5:17-cv-459, 2017 U.S. Dist. LEXIS 168785 (M.D. Fla. Oct. 12, 2017), we would be satisfied.  We understand notice pleading and such, but we have seen all too many complaints—mainly in state court—where the allegations consist of little more than reciting the elements of the cause of action.  Thank you, we are aware that a product liability claim for the most part involves alleging a defect in the defendant’s product, an injury, and a causal connection between the two.  But merely saying it does not make it so, particularly in federal court where TwIqbal rules the day and demands factual content that allows the court actually to tell whether the defendant could be liable for the misconduct alleged.  (You can see our updated TwIqbal cheat sheet here.)

The Wright order therefore is a sight for sore eyes, in all ways but one.  (The title of this post may give you an idea of our one area of dissatisfaction, which we will get to, we promise.)  The plaintiff in Wright alleged that a prosthetic hip insert caused her injury, and she sought remedies under a number of theories—negligent manufacturing, strict liability for manufacturing defect, negligent labeling, strict liability for failure to warn, negligent recall procedures, and strict liability for recall procedures. Id. at **1-3.

The problem for the plaintiff was that she set forth the elements of these purported causes of action, but did not allege facts describing what the defendant did wrong or how it caused her any damage. The court therefore started its analysis pretty much the same way we started this blogpost—merely alleging legal conclusion will get you nowhere on the pleadings because they “are not entitled to the assumption to truth.” Id. at *3.

What did the court mean by that? The remark appears first to lead into the court’s criticism of the plaintiff’s counsel.  The plaintiff filed one complaint, then an amended complaint, which the defendant moved to dismiss.  The district court granted that motion with leave to amend on the basis that the plaintiff had “not identified the alleged defect or the unreasonably dangerous nature” of the device. Id. at *3.  The plaintiff then filed a second amended complaint—her third try at alleging claims against this defendant—so the defendant moved to dismiss again. Id. at **3-4.

In response, the plaintiff “had the audacity” to file the same unsuccessful response that she filed in response to the first motion to dismiss, changing only the title and date on the proof of service. Id. at **4-5 & n. 4.  The district court was not amused:  “While the Court does not expect perfection, it expects more of counsel who appear before it. . . than what Plaintiff’s Counsel has shown to date.” Id. at *5.

And it did not improve from there. On strict products liability for a manufacturing defect, the claim failed because the plaintiff

does not allege what is defective about the [device] or how that defect caused Plaintiff’s injuries. Instead Plaintiff alleges in ipse dixit conclusions that the [device] is defective because she had pain sometime after the [device] was implanted.  That is not enough.

Id. at *6. The district court also had these very helpful words on the plaintiff’s allegation that the device was recalled:

Plaintiff’s allegation that the [device] was recalled is not a substitute for identifying the [device’s] defect. That is because a recall is not an admission that a product is defective.

Id. (emphasis added, citing Hughes v. Stryker Corp., 423 F. App’x 878, 880 (11th Cir. 2011)).  We will bank away this clear and unambiguous statement on product recalls for future use.

The district court thought the failure-to-warn claim was came closer to stating a claim, but it still fell short: The plaintiff alleged neither why the labeling was inadequate, nor facts showing that the plaintiff was damaged by an alleged failure to warn adequately. Id. at **7-8.  The negligence claims merely recited the elements of a negligence action (and now that we have said that, you are reciting those elements in your head, aren’t you?), but they were supported “by nothing but conclusions.” Id. at *8.  Finally, the claims based on the product recall failed because Florida law does not recognize a duty of care in connection with a recall separate from a general duty to act with reasonable care, and Florida does not recognize a claim for strict liability for product recall at all. Id. at **9-10.

In all, it’s a strong order, as it dismissed claims because the plaintiff “provide[d] conclusions and parrot[ed] elements of the causes of action,” but did not allege facts in support. Id. at *9.  She did not even make a genuine effort to allege facts in support.

Which leads to the one significant problem with the order—the district court granted leave to amend, even though the plaintiff had already had three opportunities to state a claim and could not do it. Three opportunities seem quite enough, and amending will be futile in any event for claims that do not exist under the controlling law in the first place.  So what gives?  We are not sure, but perhaps counsel will make a genuine attempt to state a claim, or maybe he will again recycle his already-rejected opposition when responding to the defendant’s next motion to dismiss.  It could turn out to be a sad retelling of the movie Groundhog Day, with the same events relentlessly playing out over and over again, except with a slightly different ending.  The district court here presumably has extraordinary patience, but perhaps not the patience of a saint.  We expect the next order to dismiss will be without leave to amend.

Implied Preemption.  Off-label promotion. TwIqbal.  They make up a core of our posts, yet we never seem to tire of them.  Maybe our readers, especially interlopers from the other side of the v., tire of reading about them, but we can often find a wrinkle in a case that merits our huzzahs or inspires a rant.  Today’s case falls into the praiseworthy category, as the court dismissed a complaint predicated on violations of the FDCA in spite of sympathetic allegations that might have carried the day with some other courts. Markland v. Insys Therapeutics, Inc., — F. Supp. 3d –, 2017 WL 4102300 (M.D. Fla. Sept. 15, 2017), involved the alleged death of a patient as a result of respiratory distress from the defendant’s sublingual spray prescription painkiller drug, which she had started the day before.  Rather than offer the typical product liability claims under Florida law, perhaps because the labeling had extensive warnings on respiratory distress, plaintiff asserted only a claim for negligent marketing.  Calling it “negligent marketing” does not really identify what duty was allegedly breached, whether state law recognizes a claim for such a breach, and such a claim would be preempted.  The allegedly actionable conduct in Markland was promoting the drug for off-label use, like the chronic back pain of plaintiff’s decedent, as opposed to the approved indication for breakthrough pain with cancer.  While we do not know the merits, there were many allegations about off-label promotion, which seem to tie to the conduct at issue in well-publicized federal and state investigations.

Defendants moved to dismiss on various grounds, the most relevant of which (for our purposes) were that there was no claim under Florida law for this conduct and it would be impliedly preempted under Buckman anyway.  These had been hot topics recently in some Florida state and federal cases we have discussed, like Mink (here and here) and Wolicki-Gables, but those dealt with PMA devices and the additional issue of express preemption.  Here, with a prescription drug marketed under an NDA approval, there is no express preemption to navigate, but the plaintiff still had to walk a narrow path to state a claim that would not be impliedly preempted.  As we have said before, we think the appropriate order of analysis here would be the determine if there was a cognizable state law claim asserted and then determine if it was preempted, but the Markland court did not separate out its analysis.  It also did not weigh in on whether the allegations here were of truthful off-label promotion that might implicate First Amendment protection.  Instead, it assumed that the off-label promotion alleged violated the FDCA’s prohibition on misbranding.  2017 WL 4102300, *6 & n.4.

The court could take this approach because the plaintiff’s claim was so squarely focused on alleged violations of the FDCA.  Since Buckman, plaintiffs tend to be a bit cagier in making it look like their claims were not predicated on violations of the FDCA or fraud on the FDA.  The Markland plaintiff, however, labeled the defendant’s alleged conduct as violating the FDCA, “federal law,” and “requirements imposed by the FDA regarding the condition that this drug should be utilized to treat cancer patients with breakthrough cancer pain.” Id. at *9.  “Hence, [the claim], while framed in the language of negligence, appears to derive from [defendant’s] alleged off-label promotion of [the drug]” and “the very concepts of off-label use and off-label marketing are born out of the FDCA.” Id.   This was well phrased, as was the later statement that “it is only because of the existence of the FDCA’s restrictions on off-label marketing that Mr. Markland claims [defendant’s] actions were improper or otherwise violated a duty.” Id.

This is the recipe for implied preemption under Buckman.  It also means there is no negligence claim under Florida law, “which bars plaintiffs from using state negligence actions to seek recovery for FDCA violations.” Id. at 10 (citing negligence per se cases).  Of course, Buckman recognized that the FDCA does not provide for a private right of action, and preempts claims with FDCA violations as “critical element[s],” which should prevent such piggybacking.  So, plaintiff’s case was done and could not be revived by amending the complaint.  In other words, there was no need for a second and third strike before judgment could be entered.  This was so despite the Court’s expression of compassion:

The Court does not question for a moment the grievous nature of Carolyn Markland’s death, nor the deep sadness Mr. Markland must face on a daily basis as a result of his wife’s untimely passing. Nonetheless, the Court must act within the bounds of the law.

Id. at *11.  This a good lesson, especially for courts sitting in diversity, that the law should not be expanded to allow for recovery by sympathetic who cannot make their case under accepted tort theories.

We harbor a suspicion that half the drug/device tort cases we encounter are really medical malpractice cases in search of a deeper pocket (thank you medmal damage cap statutes).  We’ve said before (e.g., that both Levine and Riegel were really med-mal cases.   That search for a deeper pocket is undertaken by the lawyer, not the client.  We say this because we can use up all the fingers on one hand counting cases over the last year or so where it became clear that the product liability plaintiffs were certain that it was actually their doctors who erred.  The plaintiffs said so themselves.  They said so in their testimony.  They said so in contemporaneous diaries.  This evidence was hard to align with the lawyers’ strategy of making the case all about the manufacturer and its documents.  But why let reality get in the way of a game plan?  The plaintiffs’ discovery, motions, and rhetoric pretty much ignored whether the doctor met the standard of care.  Indeed, the doctors often got dropped just before trial.  Sometimes, we are sorry to say, our cynical eyes espied a shady quid pro quo, as the same doctors show up as witnesses for the plaintiffs



Why does a med-mal case turn into a product liability case?  Perhaps we should add a qualifier here.  It is product liability lawyers, not all lawyers, who contrive to turn med-mal cases into product liability cases.  There are plenty of superb med-mal plaintiff lawyers out there who are perfectly happy to practice their craft, and would sooner set their hair on fire before steering a case into comment K, the learned intermediary doctrine, or an MDL.  But product liability lawyers are at home with these lovely little bits of business.  It’s like that old saw about how a hammer sees nails everywhere.  We had lunch earlier this week with a friend who formerly worked with us at a defense firm, but who has now become a plaintiff med-mal lawyer and is doing terrifically well.  He wracks up big verdicts all the time.  His name on a complaint must up the settlement value of a case by 20%.  But he acknowledges that suing doctors isn’t easy.  He estimated that 90-95% of med-mal trials in Pennsylvania end with a defense verdict.  Of course he files his cases in Philadelphia whenever possible, but even in that benighted jurisdiction the defense win rate hovers in the 80s.  We were astonished to hear this.  We were less astonished after our friend explained that the slam-dunk med-mal cases invariably settle.  The ones that go to trial tend to be a bit on the flimsy side, or at least there is a yawning weakness somewhere in the case.  And then there is the fact that most people are willing to give the benefit of the doubt to doctors.  Unless you get the kind of stunning insider testimony that dealt Paul Newman a winning hand in The Verdict, doctors win most med-mal cases.  In addition, there are often procedural hurdles or damages caps unique to med-mal cases.  It is a different playing field from a mass torts case.  Doctors get treated like the home team.  Drug or device companies get treated like a criminal syndicate – even when the trial really is on their home turf.   


How does a med-mal case morph into a product liability case?  Failure to warn and failure to train are usually the operative theories.  Mind you, we don’t think failure to train is a legitimate theory at all. We have a whole topic thread devoted to that issue.  If there isn’t some specific law that requires such training, or that such training be carried out in a particular way, and if the company is going above and beyond what is legally required, it seems stupid and unfair to pin additional liability on a company for a voluntary undertaking or through some other specious legal theory.  In any event, at the doctor’s deposition the plaintiff’s lawyer will play the game of “wouldn’t you have liked to know x,” and whatever the x is, such as adverse event data, a footnote in a study, or the surprise ending of the new Harry Potter play, the doctor will likely say yes, because … well, because nobody with an advanced degree wants to come across as stubbornly ignorant.  Moreover, a plaintiff’s product liability case acquires enhanced sex appeal if it turns out that a company sales representative was in the operating room.  The plaintiff attorney will argue that the sales rep’s action or inaction was somehow a huge factor as to why the patient sustained the alleged injury.  Once or twice we have met sales reps who bragged about how they would use a laser pointer during an operation to ‘help’ the doctor, but most acknowledge that they would never render such ‘advice.’ Sales reps cannot and do not practice medicine.  More importantly, we have never met a doctor who said that a sales rep superseded seven-plus years of medical education.  Turning a med-mal case into a product liability case presupposes a willing suspension of disbelief, but upon that suspension of disbelief rests a huge chunk of the American tort industry. 


But here is a nifty New York County (that’s Manhattan) decision upholding the proposition that medical device manufacturers, even if they have representatives in attendance during the use of their products, are not liable for how the physician chooses to use them.  Gregory v. Tehrani, et al., 2017 N.Y. Misc. LEXIS 3491, 2017 N.Y. Slip. Op. 31963(U) (Supreme Ct. N.Y. County Sept. 15, 2017).  The Gregory case sheds light on the med-mal vs. product liability distinctions in an odd and unexpected way:  the plaintiff tried to make the manufacturer a defendant in a med-mal case.  The case wasn’t restyled as a product liability case – it was still travelling under a med-mal theory.  And therein lies the problem for the plaintiff. 


The plaintiff had undergone plastic surgery on his face.  The doctor used a facial filler during the procedure.  Representatives of the facial filler manufacturer were allegedly present during some of the treatments rendered by the doctor to the plaintiff.  Something apparently went wrong and the plaintiff sued the doctor, the facility, and the manufacturer of the facial filler for medical malpractice and lack of informed consent.  The manufacturer filed a motion to dismiss the claims against it.  The manufacturer won.


The medical malpractice claims simply did not fit against the manufacturer.  The court considered the second theory (lack of informed consent) first.  The plaintiff’s claim that the facial filler manufacturer failed to inform the patient was foreclosed by the learned intermediary rule.  The manufacturer had a duty to warn the doctor, not the manufacturer.  Put simply, informed consent is not a theory that lies against a manufacturer.  The medical malpractice claim made even less sense.  Rather than allege the classic product defect claim against the manufacturer, the plaintiff alleged that the manufacturer failed to ensure that the doctor used the device in “a safe, indicated manner … and according to their own product guidelines and the guidelines of administrative agencies and bodies including but not limited to the Food and Drug Administration.”   Gregory, 2017 N.Y. Misc. LEXIS 3491 at *5.  It sounds almost as if the plaintiff was complaining that the manufacturer had failed to practice medicine.  That is a weird theory.  It is also rare.  (Though it was alleged all the time in Bone Screw litigation.)  We have blogged about something like this before:  see  There’s a reason why the theory is rarely seen: it is fundamentally wrong.  It conflates product liability and med-mal law.  The Gregory court proceeds to un-conflate them:  “[W]hile the manufacturer of a medical device has a duty to warn a patient’s physician of the risks associated with the device, the manufacturer is not responsible for how the physician uses the device and renders the medical care.”  Id.  Further, the plaintiff didn’t allege anything wrong with the warnings themselves.  Further further, the plaintiff’s allegations did not connect any of the manufacturer’s actions or omissions to the alleged injuries.  In short, there was no reason for the manufacturer to be a defendant in this med-mal case, and after the court granted the motion to dismiss, it wasn’t.   




The district court’s order dismissing claims in Ebrahimi v. Mentor Worldwide LLC, No. CV 16-7316, 2017 WL 4128976 (C.D. Cal. Sept. 15, 2017), is a good antidote to the Ninth Circuit’s wrongly decided opinion in Stengel v. Medtronic. Stengel is where the Ninth Circuit held that the plaintiff avoided express preemption by alleging that a pre-market approved medical device manufacturer failed to report adverse events to the FDA, thus violating FDCA regulations and a “parallel” state-law duty to warn.  We have criticized Stengel any number of times, but you can read this and this to get the gist. The most obviously questionable aspect of Stengel is its application of a California state-law duty to warn the FDA, which we are not convinced exists in the first place.

Another befuddling aspect of Stengel is causation:  How can a plaintiff plead and prove that an alleged failure to report events to the FDA actually affected his or her physician’s treating decisions or the treatment outcome?  The district court’s order in Ebrahimi v. Mentor dismissing claims against a breast implant manufacturer shows that most plaintiffs can’t do it.

Here is what happened. When the FDA approved the defendant’s silicone-gel breast implants through the pre-market approval process, it required six-post approval studies “to further assess the safety and effectiveness” of the implants.  This presumably was because of the ultimately unfounded concerns about silicone-gel breast implants that led to their absence from the U.S. market for a period of years.  The plaintiff in Ebrahimi was treated with the defendant’s silicone-gel implants and later experienced complications leading to the implants being removed.

Her lawsuit alleged failure to warn, strict liability manufacturing defect (presumably because California does not recognize strict liability for design defect), and negligence per se—all of which failed. On failure to warn, the district court distilled two theories from the complaint:  “a claim based on [the manufacturer’s] failure to report to the FDA ‘adverse events’ regarding certain dangers with the Implants’ use, and (2) a claim based on [the manufacturer’s] failure to issue sufficient warnings to consumers and doctors.” Id.

There are a number of issues here—express and implied preemption paramount among them—but the failure-to-warn claim failed at this juncture because of causation. The plaintiff opposed the manufacturer’s motion to dismiss by arguing that the manufacturer knew about “reported systemic ailments which can only be attributed to gel bleed . . . but failed to report that to the FDA.”  (emphasis supplied by court).  Those failure-to-report allegations were impossibly vague and failed to allege causation.  The following quote is kind of long, but it’s the core of the order:

The problem with Ebrahimi’s allegations concerning the flawed post-approval studies is that she has not sufficiently alleged facts to support her assertion that the unreported “systemic ailments” or negative health effects that patients experienced during the post-approval studies “can only be attributed to gel bleed” or some other actual “adverse event.” . . . . Ebrahimi fails to sufficiently allege what the “systemic ailments” are that the post-approval studies revealed and merely surmises, in conclusory fashion, that they “can only be attributed to gel bleed.”

Furthermore, Ebrahimi has not sufficiently alleged a causal nexus between her injuries and [the manufacturer’s] failure to report adverse events to the FDA.  She does not allege, for instance, how any “gel bleed” issue would have caused the FDA to require different labeling, especially given the FDA—and Ebrahimi herself for that matter—was aware of the risk of gel bleeding.  Ebrahimi states she suffered injuries “[a]s a direct and proximate results of [the manufacturer’s] foregoing acts and omissions.”  . . .  .  Yet, she fails to allege how any reporting by Mentor to the FDA would have caused her surgeon to stop using Implants or her to refrain from having the breast-implant surgery with the devices at issues, considering the potential health consequences of which she was already aware.

Id.  Let’s unpack that a little bit.  The plaintiff’s theory was the alleged failure to report events from post-approval studies caused her complications.  But in trying to get from point A to point B, the allegations fall apart.  It is awfully easy to allege “unreported systemic ailments,” but which ones?  What other actual “adverse events” did the defendant allegedly fail to report?  And how do any of them have anything to do with what the plaintiff allegedly experienced.  It is similarly easy to write on paper that such “ailments” can “only be attributed to gel bleed,” but how?  If there could be link, what else could cause the “ailments” and how can we exclude them?  We don’t know, and neither did the plaintiff, who “merely surmised” these facts, in conclusory fashion.

All that is before we even get directly to proximate causation. Sure, the plaintiff alleged injuries “as a direct and proximate result” of the defendant’s alleged conduct, as all plaintiffs do.  But when the FDA already knew about gel bleed, and the plaintiff’s doctor already knew about gel bleed, and the plaintiff herself already knew about gel bleed, how could the alleged failure to report adverse events (whatever those events were) possibly have made any difference.  Would the FDA have required a different warning?  Would the physician have reviewed the adverse reports?  If so, would anything have added to the physician’s knowledge, or to the plaintiff’s own knowledge?  Would it have changed anything?  Again we don’t know—and, again, neither did the plaintiff.

Recall what we said about Stengel at the outset.  That opinion’s Achilles heel is causation, owing to the Ninth Circuit’s result-oriented acrobatics to find a claim that avoided express preemption.  It purported to find one, but one that requires a causal chain that is extraordinarily attenuated.  We offer kudos to the district judge in Ebrahimi for recognizing the plaintiff’s burden to plead causation as part of her “parallel claim” and correctly finding that the plaintiff had not met it.  Of course, we would have preferred an order finding the failure-to-warn claims preempted, but this is not bad.

The district court also dismissed the strict liability manufacturing defect claim and the negligence per se claim.  The former was implied preempted under Buckman because “it hinges entirely on conduct [the plaintiff] claims violates the FDCA as well as the FDA’s Current Good Manufacturing Practices.” Id. In other words, she was suing because the alleged conduct violated the FDCA, which is the sine qua non of implied preemption.  The negligence per se claim fell because negligence per se is not a separate cause of action under California law. Id.

Alas, the district court granted leave to amend. But given that this plaintiff alleged a known and warned-of complication of a pre-market approved medical device, she has a tough row to hoe.