Today’s guest post is from friend-of-the-blog Sarah Bunce, a partner at Tucker Ellis.  It’s about the 8th Circuit finally having before it aspects of the effects of the current, bizarrely applied Missouri joinder and venue rules (see here) on federal jurisdiction.  Not only is it about time, though, it may be past time.  By the time that the 8th Circuit gets around to deciding the case, either (1) the Missouri Supreme Court might have overturned the current reading of those rules, (2) the United States Supreme Court may held the exercise of personal jurisdiction allowed by those rules unconstitutional, or (3) the Missouri legislature might have rewritten the rules to eliminate the basis for the current bizarre judicial rule constructions.  But, in any event, that there’s finally movement on another piece of the litigation puzzle.

As always, our guest poster is entitled to 100% of the credit, and any blame, for what follows.

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While most of us wait anxiously for the Supreme Court to hear the issue of litigation tourism at the end of this month in Bristol-Myers Squibb Co. v. Superior Court of California, the Eighth Circuit got a sneak peek on April 5 when it heard oral argument in Robinson v. Pfizer Inc.  Although the Eighth Circuit may well defer decision until the Supreme Court decides the issue, the background of this case and its potential impact on the future of litigation tourism in the Eighth Circuit—particularly in the Eastern District of Missouri—is worth noting.

For those of us who have attempted to remove multi-plaintiff “litigation tourist” complaints from the City of St. Louis to the Eastern District of Missouri, the Eastern District’s response is all too familiar. With the exception of the faint glimmer of hope from Judge Webber in Addelson v. Sanofi S.A., 2016 WL 6216124 (E.D. Mo. Oct. 25, 2016), the court has been rather hostile to such removals, swiftly remanding case after case for lack of subject matter jurisdiction.

The decision in Robinson v. Pfizer Inc. is no exception.  There, sixty-four plaintiffs (only four of whom were Missouri residents) joined in filing suit against Pfizer Inc. in the City of St. Louis alleging injuries as a result of ingesting Lipitor.  As any defendant would do, Pfizer removed the case to the Eastern District of Missouri.  Pfizer argued, under Ruhrgas, the court should first decide personal jurisdiction and dismiss the out-of-state plaintiffs for lack of personal jurisdiction, which would result in complete diversity between the remaining parties.  Pfizer also argued that even if the court considered subject matter jurisdiction first, there would be diversity in light of the fraudulent joinder of the out-of-state plaintiffs.

In granting plaintiffs’ motion for remand, the Robinson court would hear none of it.  Skipping directly to the issue of subject matter jurisdiction, the court (incorrectly) characterized Pfizer’s argument as one based on fraudulent misjoinder rather than fraudulent joinder.  Ignoring entirely the issue of whether there was personal jurisdiction over defendant to support each individual plaintiff’s claims, the court instead viewed the “real issue” to be whether plaintiffs’ claims were properly joined under Rule 20.  Finding the joinder of all sixty-four plaintiffs’ claims proper, the court ordered the case remanded to state court for lack of subject matter jurisdiction.

As those of us who have tried (and failed) to successfully remove multi-plaintiff complaints to the Eastern District of Missouri are keenly aware, this is where the story usually ends. Because these remand orders are not appealable, we’re stuck in an infinite loop of removing cases and being remanded, hoping that the next time will be the time the court decides personal jurisdiction first or thoughtfully considers the fraudulent joinder doctrine (or maybe stays the case pending transfer to an MDL).

But that’s where things get interesting in Robinson.  Plaintiffs (maybe a little too greedily, hindsight being what it is) sought attorney’s fees and costs under 28 U.S.C. § 1447(c), which grants courts the authority to order payment of costs and fees incurred as a result of the removal.  The Robinson court obliged.  Citing nine other cases involving Pfizer and referencing “at least twenty-five other cases” in the district that had been remanded for lack of subject matter jurisdiction, the court determined that, in light of the “repeated admonishments and remands,” Pfizer had no objectively reasonable basis for seeking removal and plaintiffs were entitled to costs and expenses.  Robinson v. Pfizer Inc., 2016 WL 1721143, at *4 (E.D. Mo. April 29, 2016).

This was just the hook that Pfizer needed. While the remand order was not appealable, the sanction order was.  So Pfizer appealed.  In challenging the sanctions and defending its right to remove as objectively reasonable, Pfizer cited Daimler and Goodyear and argued that the Eastern District of Missouri was repeatedly and consistently ignoring those holdings.  Thus, while the removal itself technically may not be before the Eighth Circuit, in the course of ruling on the sanctions issue the Eighth Circuit will have the opportunity to consider the due process merits involved.

And the oral argument demonstrated that the issue of sanctions cannot be divorced from the underlying issue of the removal of multi-plaintiff complaints involving out-of-state plaintiffs. This is because to decide whether the court abused its discretion in awarding costs and fees, the Eighth Circuit necessarily must decide if it was objectively reasonable for Pfizer to challenge the joinder of these plaintiffs and the lack of personal jurisdiction over the out-of-state plaintiffs’ claims.

The Eighth Circuit panel recognized that Pfizer might have had better luck with its argument in other jurisdictions, and on two occasions the panel questioned why the district court had cited only other Eastern District authority and not any authority from other jurisdictions. (Indeed, there is much contra authority outside of the Eastern District of Missouri. See, e.g., Simmons v. GlaxoSmithKline LLC (In re Zofran (Ondansetron) Prods. Liab. Litig.), 2016 WL 2349105 (D. Mass. May 4, 2016); Liggins v. Abbvie Inc. (In re Testosterone Replacement Therapy Prods. Liab. Litig.), 2016 WL 640520 (N.D. Ill. Feb. 18, 2016).)  The Eighth Circuit panel also seemed attuned to the underlying issue of allowing joinder to substitute for personal jurisdiction in these multi-plaintiff complaints, referring to it as “osmotic jurisdiction.”

At the end of rebuttal Pfizer requested that the court not only reverse the sanctions order, but also correct the error of law on personal jurisdiction perpetuated in the Eastern District of Missouri—expressly asking the Eighth Circuit to confirm that when looking at personal jurisdiction, it must be done plaintiff by plaintiff. If the Eighth Circuit accepts the invitation, it may be the final nail in the coffin for litigation tourism in the Eastern District of Missouri.

Imagine a conspiracy so vast that it includes not only your usual plaintiff-side fantasy of the FDA conspiring with a drug company, but also high FDA officials, President Obama, Robert Mercer (noted Trump supporter and reputed Breitbart financier), a number of other investors, and just for good measure President and Hillary Clinton.

Larry Klaman could, and thus brought the lawsuit that recently resulted in Aston v. Johnson & Johnson, ___ F. Supp.3d ___, 2017 WL 1214399 (D.D.C. March 31, 2017).

Nobody else did, though.

In particular, and fortunately for everyone on the defense side, the judge in Aston could not.  Reading the Aston opinion, it is evident that the court is beyond skeptical of the vast, or even half-vast, conspiracy claims.  In a nutshell, five plaintiffs who claimed a great many personal injuries (the opinion lists 74 separate alleged injuries, 2017 WL 1214399, at *1) from their use of the drug Levaquin, brought suit alleging that the drug’s manufacturer and the FDA were in cahoots to cover up the drug’s risks, in order to increase the value of the manufacturer’s stock, to the advantage of various investors.  As for the political officials, according to the opinion:

Amazingly, former presidents Barack Obama and Bill Clinton also make cameo appearances in plaintiffs’ alleged scheme, together with former Secretary of State Hillary Clinton, and the Clinton Foundation; these actors are alleged to have solicited, or received, “gratuities” from defendants in exchange for securing [another alleged conspirator’s] appointment as FDA Commissioner.

Id. at *2.  We admit, this is an extreme oversimplification – the opinion took two Westlaw pages just to sort through the Aston plaintiffs’ labyrinthine conspiracy allegations.

Plaintiffs’ legal theories were almost as numerous as their injury allegations – twenty-two counts, including RICO, state-law (Arizona (?)) RICO, strict product liability, negligence, fraud, express and implied warranty, unjust enrichment, Lanham Act, and a bunch of state consumer fraud claims (D.C., New York, Maryland, Pennsylvania, Illinois, Arizona, and California). Id. at *3.

Aston threw everything out on the many defendants’ motions to dismiss. The half-vast conspiracy, and all its subsidiary theories of liability went down in a hail of defense-friendly rulings, and that’s why – aside from its humor value – the Aston opinion is well worth reading.  We’ll list the rulings so our readers will have an idea of what this goodie basket contains.

RICO – The deficiency in the RICO counts was rather basic. RICO does not allow recovery for personal injuries.  “The overwhelming weight of authority discussing the RICO standing issue holds that the ‘business or property’ language of Section 1964(c) does not encompass personal injuries.” Aston, 2017 WL 1214399, at *4 (citation and quotation marks omitted).  For a compilation of that authority, see Bexis’ Book, §2.15, footnote 3.  Further, “as plaintiffs’ counsel is well aware, courts in this District and elsewhere have consistently rejected the argument that pecuniary losses derivative of personal injuries are injuries to ‘business or property’ cognizable under RICO.”  Aston, 2017 WL 1214399, at *4 (citing, inter alia, Klayman v. Obama, 125 F. Supp.3d 67, 88 (D.D.C. 2015)).  Aston also distinguishes “tobacco litigation [RICO] precedents” because those cases arose from a federal prosecution that was not limited by the “business or property” requirements of RICO’s private cause of action.  2017 WL 1214399, at *5.

Nor did the Aston plaintiffs satisfy RICO’s causation requirements – for another very basic reason.  Even the most recent of the five plaintiffs’ injuries arose before the conspirators allegedly acted:

Barring some sort of temporal paradox, there is no way that suppression of an FDA report in 2013 could have caused plaintiffs to be injured in 2012 or earlier.  Because plaintiffs’ allegations, taken as true, are insufficient to establish proximate causation, their federal RICO counts must be dismissed.

Id. (citing H.G. Wells, The Time Machine, 22–23 (1895)) (other citation omitted).  On this basis alone, we’re rooting for the defendants to obtain recovery of their counsel fees, since the underlying premise of the entire litigation was physically impossible.

Arizona RICO – Same basis:  “[P]laintiffs have failed to plead facts that make possible − let alone plausible − the conclusion that the alleged cover up by defendants was the proximate cause of plaintiffs’ injuries.”  Id. at *6.  Unfortunately, the relatively terse dismissal of does not answer the burning question − Why Arizona?

Lanham Act – Another fundamental basis for dismissal.  “[T]o come within the zone of interests in a suit for false advertising under [the Lanham Act], a plaintiff must allege an injury to a commercial interest in reputation or sales.”  Id. (quoting Lexmark International, Inc. v. Static Control Components, Inc., 134 S. Ct. 1377, 1390 (2014) (emphasis original in Aston).

Now comes the most useful stuff – dismissal of the common-law claims.  For the record, Aston applies the law of the District of Columbia rather than the law of the plaintiffs’ (Maryland, Pennsylvania, Arizona, Illinois, California) or defendants’ (New Jersey) domiciles.  Aston, 2017 WL 1214399, at *6.

Product Liability (both strict liability and negligence) – Manufacturing defect is TwIqballed.  For all its factual prolixity, the Aston complaint was utterly devoid of any allegations that the drug wasn’t made precisely as intended.  Id. at *7 (“for all these recitals of the term ‘manufacture’ and its derivatives, plaintiffs plead no facts that would appear to relate to manufacturing defects”) (citation and quotation marks omitted).

Warning related claims were also dismissed, in a usefully rigorous application of TwIqbal.  Dismissal in Aston occurred because plaintiffs failed to plead:  (1) “the contents of the warning label” when the drug was taken (2) “how the contents of the label were inadequate,” (3) “the timing of each plaintiffs use of” the drug, including “when each individual plaintiff was prescribed,” (4) “the onset of [plaintiffs’] injuries,” (5) “how the alleged distinctions in the warnings would have had a causal effect,” (6) “what injuries each individual plaintiff experienced,” (7) “why [plaintiffs] think [the drug] was the cause of the[ir] injuries,” and (8) “why [plaintiffs] think inadequate warnings contributed to their injuries.”  Id. (various quotations omitted).  That’s a spicy TwIqbal – without even having to get into the learned intermediary rule.

As to warnings, we also note that the court held that all warnings publicly available on the FDA’s website are subject to judicial notice.  Id. at *2 n.1.

Design defect claims were preempted under Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466 (2013), and Aston rejected the well-worn plaintiff argument that, for some reason, implied preemption is different in generic, as opposed to branded (as in Aston) drugs:

Plaintiffs are mistaken.  [Bartlett] expressly found that “[o]nce a drug − whether generic or brand-name − is approved, the manufacturer is prohibited from making any major changes to [its formulation]” by federal law.  133 S. Ct. at 2471.  Thus, even though [Bartlett] arose from a state-law design-defect claim against a manufacturer of a generic drug, its holding applies to both types of drugs, and plaintiffs’ design-defect claim must be dismissed.

Aston, 2017 WL 1214399, at *8. Preemption is “fully consistent with the well-established tort law principle, ‘especially common in the field of drugs,’ that an unavoidably unsafe product is ‘not defective, nor is it unreasonably dangerous’ where it is ‘properly prepared, and accompanied by proper directions and warning.’”  Id. at *8 n.7 (quoting Restatement (Second) of Torts §402A, comment k (1965)).

Fraud/Misrepresentation – Perhaps predictably, plaintiffs’ fraud-based claims failed under Fed. R. Civ. P. 9(b).  Id.  Allegations broadly “span[ning] the more than twenty-year period” alleged could not possibly allow defendants to file a response.  Id.  Plaintiffs “do not even specify which corporate entity they believe was responsible.”  Id.  Nor did any of the five plaintiffs allege their own circumstances with the required specificity.  Id.  “In sum, plaintiffs fall woefully short of pleading any specific allegations that would support a claim of fraud or misrepresentation.”  Id.

Warranty – Again, perhaps predictably, plaintiffs’ express warranty claims failed for not “plead[ing] any express promises.”  Id. at *9.  Here, Aston made another good TwIqbal ruling:

[T]o state a claim for breach of express warranty in cases involving prescription drugs, Plaintiffs must allege facts demonstrating that Defendants’ affirmations formed the basis of the bargain, i.e., facts regarding how the warranties were made to Plaintiff’s physician, and that Plaintiff’s specific physician relied on them.

Id. (citations and quotation marks omitted).  Implied warranty claims “cannot be independently maintained in a case involving prescription drugs.”  Id.

Unjust Enrichment – As against the investor defendants, merely “earn[ing] profits” from allegedly more valuable stock was “far too remote and speculative to support an unjust enrichment claim.”  Id. at *9.  As against the drug manufacturer defendants, the plaintiffs did not allege “that they conferred a benefit” on those defendants.  Id. at *10 (emphasis original).

[Plaintiffs] do[] not allege that [they] paid any money for [the drug], rather than relying on an insurer, as most patients do.  This omission is significant because there is no authority demonstrating that benefits received from third-parties can be the proper subject of an unjust enrichment claim.

Id. “Because plaintiffs have not pleaded any facts showing that they paid for [the drug], I must dismiss their unjust enrichment claim.”  Id.

Obamacare to the rescue.

Readers should remember this point; we don’t remember ever seeing an individual (as opposed to TPP) unjust enrichment claim that contains the allegations – personal, as opposed to third party payer – required by Aston and the precedent it follows.

Consumer Fraud Claims

Seven states’ laws were implicated − D.C., New York, Maryland, Pennsylvania, Illinois, Arizona, and California. “Each count fails to state a claim.” Id.

Six of the states (all but Arizona) did not recognize consumer fraud claims involving prescription drugs.  Some states’ statutes did not allow personal injury damages (Pennsylvania, California, D.C.).  Others did not consider prescription drugs to be “consumer” goods (Maryland, New York).  Still other statutes simply had been held inapplicable to prescription drugs (California, Pennsylvania, Illinois).  Id.  Beyond that, all of the consumer fraud claims were dismissed as inadequately pleaded under Rule 9(b), which Aston applied to all consumer fraud claims.  Id. at *11.  In prescription drug cases, Rule 9(b) required specific pleading of prescriber reliance:

[T]he circumstances of those prescription decisions, and plaintiffs’ reliance on them, are particularly important − yet plaintiffs allege no information about them. The absence of detail about Plaintiffs experiences leads to the conclusion that Plaintiffs have not pleaded these claims with the requisite particularity.

Id. (citations and quotation marks omitted).

Finally, none of the plaintiffs resided in D.C. or New York.  Thus, claims under those two states’ consumer fraud statutes were also “dismissed because neither statute applies extraterritorially.”  Id. at *10 n.9.  We’ve always been interested in extraterritoriality.

So that’s Aston for you – an example of really poor facts (for the plaintiffs) making some quite excellent law for our side of the “v.”  Our only quibble with Aston is grammatical – in a couple of places, “principle” is used where “principal” is meant.  Id. at *2 (“principle role”); *6 (“principle place of business”).  But apart from a law clerk needing to repeat fifth grade English, the legal rulings in Aston are truly vast, and not half-vast at all.  In Ashton all too many defendants were made to spend all too much money to hire all too many of us lawyers.  With Aston now dismissed in its entirety, we certainly hope that all the defendants so inconvenienced seek to recover their fees as a sanction against such frivolous litigation.

Kentucky –sure, it gets pretty sticky in the summer, and the bluegrass isn’t really blue, and Wildcats fans – well, they’re a breed of their own. But give us the bourbon, the chicken, and the Derby and we’ll be singing “My Old Kentucky Home” and “Coal Miner’s Daughter” with the rest of the Kentucky natives.

DeMoss v. Eli Lilly & Co., 2017 U.S. Dist. LEXIS 19142 (W.D. Ken. Feb. 10, 2017) is a bit like the commonwealth it’s from — we like some pieces and others we could certainly do without. The case involves an anti-clotting drug which plaintiff alleges led to her husband’s fatal internal bleeding. Plaintiff asserted claims for design, manufacturing, and failure to warn defects under both strict liability and negligence; breach of implied warranties; negligent misrepresentation; and violation of the Kentucky Consumer Protection Act. Id. at *5. On the defendant’s motion to dismiss, all claims except design defect and failure to warn were dismissed without prejudice.

On strict liability, Kentucky has adopted comment k’s exception for unavoidably unsafe products such as prescription drugs and devices, but has not adopted it across the board. Rather, applicability of comment k is determined on a case-by-case basis using a risk-utility test. Id. at *6-7. So, at the pleadings stage, the court was unwilling to toss out plaintiff’s strict liability claim as a matter of law finding the inquiry too fact dependent. Id. at *8. This approach kicks a comment k analysis to the summary judgment stage.

Defendant also argued that plaintiff’s pleading of strict liability design defect was insufficient under TwIqbal. The court disagreed finding that plaintiff’s allegation that the drug carried “an unreasonably high bleeding risk without any reversal agent” and that plaintiff’s husband died as a result of that injury, was more than just regurgitating the basic elements of a design defect claim. Id. at *9. And on the issue of pleading an alternative design, the court allows a different drug to serve as the alternative design. Id. There isn’t much discussion of this and so we hope it’s something that can be more fully explored later in the case – after all, a different drug is a different drug, not an alternative design for the drug at issue. The court similarly found that plaintiff had pleaded enough for her failure to warn claim to survive. Id. at *12. In addition to alleging a failure to adequately warn about the increased risk of bleeding, plaintiff also alleged a failure to adequately test which the court found was not an independent cause of action, but was subsumed in the failure to warn claim. Id. at *15. Based on very similar reasoning, the court allowed both negligent design defect and negligent failure to warn to stand as well. Id. at *13-14.

Strict liability and negligent manufacturing defect claims, however, were both dismissed. Unlike with design defect and failure to warn, plaintiff’s manufacturing defect claims were nothing more than a recitation of the elements of the claim with no specificity or factual support. Id. at *10-11. The complaint fails to allege how the drug taken by plaintiff’s husband deviated from the defendant’s specifications or standard processes or how any such failure caused her husband’s injury. Id. at *11; *13-14 (negligent manufacturing claim dismissed).

Next the court dismissed plaintiff’s breach of implied warranty claim for lack of privity. Id. at *15-16. The same lack of privity was the downfall for plaintiff’s claim for violation of the Kentucky Consumer Protection Act (“KCPA”). Id. at *21. The KCPA, however, has a privity exception when a plaintiff alleges express representations were made. Plaintiff here tried to claim her failure to warn allegations demonstrated express representations that would allow her to fall within the exception. But those allegations did not rise to the level of being “affirmations of fact or promise” that qualify as express representations, so the claim was dismissed. Id. at *23.

On negligent misrepresentation, while plaintiff attempted to argue that she had made out the who, what, where, when and why to satisfy even the heightened pleading standards of Federal Rule 9(b), all of those allegations were about concealing or omitting facts. Under Kentucky law, a claim for negligent misrepresentation “requires an affirmative false statement; a mere omission will not do.” Id. at *20. Essentially, plaintiff wasn’t allowed to re-package her failure to warn claim as an additional negligent misrepresentation claim.

While it’s not a slam dunk (something Wildcats fans are seeing a lot of recently), it’s a much smaller complaint that advances to the next round. Not perfect, but good enough for now.

 

It took us a long time to understand how off-label promotion of prescription drugs had anything to do with the False Claims Act, and we’re still not so sure that the two are a fit. The FCA penalizes anyone who presents, or causes to be presented, to the federal government “a false or fraudulent claim for payment or approval.”  31 U.S.C. § 3729(a)(1).  Easy, right?  As we explained just last month in this quick primer on the FCA, Congress enacted the FCA after the Civil War to curb abuses in government procurement.  That part we get.  If you sell the Army 1,000 horses and send them a bill for 2,000 horses, that’s a false claim.

We’re writing about this today because the First Circuit issued an opinion last month that comes to the correct result and also illustrates how FCA claims are alleged in connection with off-label promotion—and how they fail. In Lawton v. Takeda Pharmaceuticals Co., No. 16-1382, 2016 U.S. App. LEXIS 20943 (11th Cir. Nov. 22, 2016), a patent lawyer filed a qui tam action against the manufacturer of a prescription diabetes medication.  He did not actually use the medication, nor did he buy or sell it.  So what did he allege?  He alleged that the manufacturer engaged in an elaborate scheme to promote the drug for un-approved uses—off-label promotion—and that the manufacturer thereby induced medical providers to make allegedly false claims for reimbursement to Medicare and Medicaid. Id. at **4-7.

It’s a two-step process. The manufacturer did not itself make a false claim, but rather engaged in alleged conduct that induced someone else to make a claim, whether the claimant knew it was false or not.  The problem for the plaintiff (or more accurately, the “relator”) is that he alleged neither falseness nor a claim.  We call that a double whammy.  Or maybe it’s a double fault.

Continue Reading This Is How A False Claims Act Case Works—And Fails

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

“He who knows others is wise; he who knows himself is enlightened.” — Lao Tzu

This may not be exactly what the court in Moore v. C.R. Bard, Inc., 2016 U.S. Dist. LEXIS 156923 (E.D. Tenn. Nov. 14, 2016) had in mind when it authored its recent opinion dismissing the complaint in this case, but the decision brought these ancient philosophical words to our mind. Of course, if we are talking about self-knowledge advice, we might be more partial to Ann Lander’s “Know yourself. Don’t accept your dog’s admiration as conclusive evidence that you are wonderful.” But, we trust you get the point. You better know yourself first before you start worrying about what you don’t know about others.

Plaintiffs tend to put the cart before the horse on this issue. When faced with a motion to dismiss for failure to state a claim, plaintiffs focus intently on what they claim they don’t know yet or can’t possibly know – but never seem interested in all of the things that they should know before filing a lawsuit. That’s a big part of where plaintiffs fell short in Moore.

During surgery to repair a hernia, two mesh products were implanted in plaintiff – one Bard product and one Ethicon product. Id. at *2-3. Plaintiff alleged that both products were made of polypropylene; that both defendants failed to adequately warn about the risks of their products; and that following surgery plaintiff’s condition worsened which he alleges is due to one or both of the mesh products. Id. at *3-4. And, that is all plaintiff alleged.

Continue Reading Excellent TwIqbal Decision — Plaintiffs Need to Look for Some Enlightenment

Drug and device cases regularly involve plaintiffs who have suffered serious injuries, the type that engender sympathy, even from defense attorneys. It’s understandable that a plaintiff who suffered such trauma would turn to the courts for redress. But bad experiences do not make a viable drug or device claim. Drugs and devices have inherent risks, so the law requires more than injury due to those risks for a viable products liability claim. Generally, the injury must result from a defect of some sort, such as a design, manufacturing or warning defect. If a plaintiff doesn’t allege such a defect, the court must dismiss the claim, no matter how traumatic the plaintiff’s injury.

Smith v. Pride Mobility Products Corp., 2016 U.S. Dist. LEXIS 149955 (N.D. Cal. Oct. 28, 2016), illustrates this. The plaintiff was wheelchair-bound and claimed that, while attending a Renaissance Fair, the power to her wheelchair gave out as she was trying to climb a steep hill. Ultimately, the wheelchair went into a free-wheel fall at a sharp angle down the hill, throwing plaintiff from the wheelchair to the ground. Plaintiff claimed serious injury to her neck and knee, permanent disability to one of her toes, whiplash and serious psychological and emotional distress resulting from the event and her injuries.

These allegations no doubt suggest great trauma for the plaintiff. But do they state a claim? The initial consideration for a court is not the severity of the injuries or the trauma that led to them but whether the plaintiff’s allegations are sufficient to state a viable products liability claim. Here, the Smith court did its job. It reviewed plaintiff’s allegations dispassionately and determined that plaintiff had not made the type of allegations necessary to state a manufacturing defect claim:

In order to allege a strict products liability claim under a manufacturing-defect theory, a plaintiff “must identify/explain how the [product] either deviated from [the company’s] intended result/design or how the [product] deviated from other seemingly identical” models of the product.

Here, Plaintiff states that the wheelchair started “freewheeling down [a] hill” after Plaintiff placed the wheelchair in reverse on a hill and that the wheelchair “was either defective or . . . deliberately designed to” freewheel in such a manner. The complaint does not state how the wheelchair that Plaintiff purchased is different from the design of the wheelchair that Defendant intended or from other identical models of the wheelchair. Rather, “Plaintiff[] make[s] only conclusory allegations” that the product is defective, which is insufficient to allege a manufacturing defect claim.

Id. at *25-26 (citations omitted).

Continue Reading Bad Experiences and Serious Injury Do Not Make a Drug and Device Law Claim

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

If you’re even remotely interested in the topic of preemption in Pre-Market Approved (PMA) medical devices that were used in an off-label manner, simply search this blog for our Infuse cases. There are dozens and almost all are complete victories for the defense. What occasionally survives are fraud or misrepresentation claims, although they have a tough time meeting the heightened pleading standard of Rule 9(b), or failure to warn claims where a court recognizes failure to submit adverse events to the FDA as parallel to a state law duty to warn physicians. As you’ll easily see from our prior writings, we don’t understand that parallelism at all.

The most recent Infuse victory strikes a blow at each and every attempt by plaintiffs to circumvent, dodge, sidestep, and elude preemption and pleadings standards. And with each by-pass blocked, plaintiffs’ claims had nowhere to go.

As a quick refresher, Infuse is a medical device used to stimulate bone growth in spinal fusion surgeries. It is a multi-component device that received FDA PMA approval for use in single-level, anterior, lumbar surgeries. Aaron v. Medtronic, Inc., — F. Supp.3d –, 2016 WL 5242957, *1-2 (W.D. Ohio Sep. 22, 2016). Aaron is actually a consolidation of the claims of several hundred plaintiffs who alleged they were injured by their surgeon’s use of the Infuse device in an off-label manner. Specifically, they allege the device was either implanted without all of its component parts, implanted posteriorly, implanted at multiple levels, or implanted in their cervical or thoracic spines. Id. at *2. Plaintiffs’ causes of action are fraud/misrepresentation, strict liability failure to warn, strict liability design defect, negligence, and breach of express and implied warranties. Id. Defendants moved to dismiss all claims on several grounds, including most predominantly preemption.

Before getting to the substantive analysis, the court had to consider what pleadings standard to apply. Wait. Isn’t it TwIqbal? What’s the issue? The answer is the Seventh Circuit decision in Bausch v. Stryker. The Aaron plaintiffs alleged that they did not need to plead the specific federal law or regulations that defendant allegedly violated because medical device products liability cases should have a “more permissive” review standard. Id. at *3. Plaintiffs got that idea from Bausch which held that particularity in pleading the specific FDA regulations violated was not necessary due to much of the “critical information” being kept confidential. Id. at *3-4. Many courts disagree with Bausch, including the Sixth Circuit which held in a non-medical device case that a “natural imbalance of information” does not warrant lowering Rule 8’s pleading standards. Id. at *4. The discovery process cannot be used to find sufficient factual support for plaintiffs’ pleadings after the fact. So, Aaron applies TwIqbal, not some watered down version (although the court does state that some of plaintiffs’ claims might not have withstood application of that lesser standard).

Continue Reading Another Slam Dunk Infuse Win – Preemption and More

When we think of prescription medical devices, we usually think of the sorts of devices that are implanted during surgery and tend to end up in litigation—artificial joints, pacemakers, surgical meshes, and bone cements, to name a few.  Devices according to the FDCA also include “in vitro reagent[s] . . . intended for use in the diagnosis of disease or other conditions.”  There are a whole slew of diagnostic devices that are used to test blood, tissue, or other stuff from the body to provide useful health information.  Some of them get used directly by health care professionals, some can be purchased over-the-counter, and some need a prescription for the patient to use it at home.  We know that plaintiffs sue over just about every kind of device under a range of theories, but we do not recall seeing consumer fraud claims over prescription diagnostic devices.  That is what we have in Andren v. Alere, Inc., No. 16cv1255-GPC(NLS), 2016 U.S. Dist. LEXIS 124252 (S.D. Cal. Sept. 13, 2016), and we thought the issues were interesting enough to spend a little time sharing them with devoted readers.

Andren is a decision on a motion to dismiss a purported class action complaint brought by two plaintiffs, each of whom claimed to have suffered thrombotic events from inadequate anticoagulation as a consequence of inaccurate readings on a defendant’s test kit, which checks blood clotting times for people on anticoagulation therapy.  We have some guesses about why they did not just pursue product liability claims for personal injury and some of the hurdles that they would stumble over on the way to class certification.  None of that really mattered yet, because they tried to assert claims sounding in fraud and Fed. R. Civ. P. 9(b) requires heightened pleading for such claims.  Some background on the device is in order first.  Unlike the court, which had a discussion of what beyond the complaint it could consider—which we will omit here—we can say that the defendant recently elected to discontinue and withdraw the device that plaintiffs claim to have used, which followed the earlier recall of lots of the product made since 2008 because of issues with accuracy in certain patient populations or settings.  Plaintiffs’ allegations were not limited to the particular device they used and were predictably broad.  They alleged that the defendant and its predecessors received thousands of complaints of “malfunctions,” including some number that results with their devices differed significantly from what independent laboratories found on the same samples. Id. at **3-4.  They alleged that FDA issued warning letters about adverse event reporting and other issues after 2005 and 2006 inspections of defendant’s predecessor in 2005 and 2006—well before the device at issue was cleared or sold. Id. at **4-5.  In April 2014, the test strips portion of the test kit were recalled.  In December 2014, the monitor portion and other products in the line were recalled.  The recalls were because readings with the kits were sometimes significantly lower than they would have been if tested by laboratories. Id. at **5-6.

They way that these readings (of the International Normalized Ratio or “INR”) work is numbers that are lower than the expected range for someone on anticoagulation therapy (with the range depending on the underlying condition and other factors) should result in increased anticoagulation therapy.  Having too much anticoagulation therapy can put a patient at risk for undesired bleeding.  Each plaintiff claimed that their readings from the defendant’s test kits were incorrectly high, so they either failed to take a dose of anticoagulation on a certain day or reduced his regular dosage of anticoagulation over time—with each plaintiff apparently taking these actions without consulting health care providers. Id. at **7-9.  So, the alleged product issues here were the opposite of the reason for the recalls.  And then the plaintiffs claimed to have suffered a stroke (not specified as ischemic or hemorrhagic, but the former is about seven times more common and this one was apparently followed by transient ischemic attacks) or a transient ischemic attacks. Id. Based on the recounting of the medical allegations, then, the plaintiffs claimed the sort of injuries that were also the opposite of the risk implicit in the recall.

Continue Reading Consumer Fraud Allegations For A Prescription Medical Device Do Not Pass The Test

Inferior vena cava filters resemble what we used to call “daddy long legs.” You know what we mean:  the spider-like creatures with small centers, from which long, bent legs emanate in all directions.  That is sort of what IVC filters look like, although any resemblance ends there.  Manufactured from thin flexible metal, IVC filters can be implanted in the big vein that returns deoxygenated blood to your heart—the vena cava—to trap clots (or anything else) and prevent them from traveling to your heart and lungs, where they can cause serious mischief.  They are potentially life-saving devices.  They last came to our attention the other day when we received a robotic phone call asking us if we knew anyone with an IVC filter who might want to sue.  Ye gods.

An order granting a motion to dismiss in an IVC filter case crossed our desks this week, and its discipline and thoroughness caught our eye. The case is Dunson v. Cordis Corp., No. 16-06-03076, 2016 U.S. Dist. LEXIS 94873 (N.D. Cal. July 20, 2016).  The complaint in Dunson included the claims of six different plaintiffs whose claims appear to be unrelated, except that they have the same lawyers and were treated with similar filters made by the same manufacturer. Id. at **3-4.  They all alleged complications from filter implantation, and they alleged the full range of product liability claims.  Only the express warranty claim survived, and here is why:

Strict liability for design defect:  Guess what.  The plaintiffs sued in California, and California does not permit strict liability design defect claims in prescription medical device cases.  Plaintiffs tried to get around this by asserting in their opposition, for the first time, that some of them had their filters implanted in Arizona and Pennsylvania and that those states’ laws therefore should apply. Id. at **9-12.  This position raises so many questions:  If they were treated outside California, do they also reside outside California?  If so, why are Pennsylvania and Arizona residents suing a Florida corporation with an Ohio headquarters in California’s courts?  If they are from out of state, why did they conceal those facts and wait until opposing a motion to dismiss to admit them?  The answers are that these are forum-shopping plaintiffs who are importing their claims along with hundreds of others into California for no legitimate purpose.  Their choice-of-law argument did not work this time around.  The district court still dismissed their design defect claim, and it admonished the out-of-state plaintiffs to allege facts in their amended complaint to support their choice of law. Id. at **12-13.  The court was “skeptical.”

Continue Reading California Federal Court Dismisses Inferior Complaint

We ran across a Ninth Circuit decision last week that, while non-precedential, made interesting rulings. See Fisher v. Monster Beverage Corp., 2016 U.S. App. Lexis 12608 (9th Cir. July 8, 2016). It was a class-action filed under California’s trio of plaintiffs-lawyer-attracting statutes, the Consumer Legal Remedies Act (CLRA), the False Advertising Laws (FAL) and the Unfair Competition Law (UCL). While the court allowed portions of these class action claims to move forward under these incredibly plaintiff-friendly statutes, its ruling on off-label promotion and failure to warn claims may be helpful in drug and device product liability litigation.

The three named plaintiffs alleged that the defendant manufacturers made all sorts of misrepresentations about the safety of its products, certain Monster energy drinks. Only one named plaintiff made an off-label claim. But he couldn’t get out of the gate with it. He claimed that the defendants’ marketing of its energy drinks targeted kids. Id. at *2. He claimed to have seen this alleged marketing and to have come away believing that the Monster energy drinks were safe—yet, according to him in his lawsuit, they were not. These allegations may or may not have been true. But they didn’t matter. He failed to allege that he ever relied on this alleged off-label marketing. With no injury caused by a misrepresentation, he lacked standing: “That is not a sufficient allegation of injury-in-fact to support standing.” Id. at *3 (citing Kwikset Corp. v. Superior Court, 246 P.3d 877, 890 (Cal. 2011)). Accordingly, the Ninth Circuit upheld the trial court’s dismissal of this off-label claim with prejudice. Id. at *3, 8.

Continue Reading The Ninth Circuit Issues Helpful Decision Addressing Standing and Preemption