March 2017

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If you have been following along for a while, then you have surely run across our posts making some combination of the following points:  1) design defect claims rarely make sense for a drug because changing the design in some material way will usually make it a different drug, 2) such design defect claims, if recognized by state law, will usually be preempted because FDA approval of a different drug cannot be assumed, and 3) courts really should analyze conflict preemption by first determining that there is an actual state law duty that has been asserted or supported (depending on the procedural posture).  One such post walked through why it took so long until a circuit court held that a design defect claim with a prescription drug was preempted.   That case, Yates, has been followed a number of times, including on motions to dismiss, but there are still some glitches.

The decision in Young v. Bristol-Myers Squibb Co., No. 4:16-CV-00108-DMB-JMV, 2017 WL 706320 (D. Miss. Feb. 22, 2017), counts as a glitch on the preemption front even though the court dismissed (without prejudice) the design defect claim and eight of the nine other claims asserted.  The plaintiff claimed to have suffered ketoacidosis and renal failure from taking a prescription diabetes medication right around the time FDA issued a Public Health Advisory about the risk of ketoacidosis for the class of medications, SGLT-2 inhibitors, to which it belonged.  Several months later, the drug’s label was revised to include warnings about ketoacidosis and urosepsis, a blood infection stemming from a urinary tract infection.  Plaintiff claimed that the inherent design of the drug, like all SGLT-2 inhibitors, created a risk of ketoacidosis.  When plaintiff sued, she asserted a wide range of claims and defendants moved to dismiss on various grounds.  We will address only some of them.

Part of our point here is that the order can matter.  We do not have the briefs, so all we can go off of here is the opinion.  After the preliminary issue of whether common law claims are subsumed by the Mississippi Product Liability Act—the four here were—the court starts off the meat of the analysis with this:  “The defendants argue that Young’s claim for defective design must fail because Young has failed to plead a feasible design alternative and because federal law preempts the design defect claims.” Id. at *5. So, what gets analyzed first? Preemption. (Remember, federal courts are supposed to try to resolve disputes on nonconstitutional grounds if they can.) In so doing, the court has to hold out as unresolved whether Mississippi law imposes the very duties that might create the conflict leading to preemption. As the court recognized at the end of its, to us, flawed preemption analysis:

If there is no state law duty, the state law cause of action must certainly fail but there can be no conflict so as to justify preemption. Put differently, the absence of a state law duty is fatal to a claim but not under the doctrine of conflict preemption.

Id. at *8.  This logic suggests that the court needs to decide first whether there is a state law duty to do what the plaintiff urges was necessary.  Because the court never determined that there was such a duty, the whole discussion of preemption seems like a bunch of dictum to us.Continue Reading Another Court Tackles Prescription Drug Design Defect

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The Defendant/Petitioner has filed its merits brief in the U.S. Supreme Court in BMS v. Superior Court.  This is the case where the California Supreme Court expanded specific personal jurisdiction beyond recognition by basing specific jurisdiction on a pharmaceutical company’s forum contacts involving different products and people other than the plaintiffs.  We wrote about the opinion and its problems here, here, and here, and the opinion came in at number one on our 2016 worst ten list.

As expected, the Petitioner pharmaceutical company has put forth compelling arguments that the California Supreme Court’s version of specific jurisdiction runs against binding precedent and is an all-around bad idea. The Petitioner is also joined by a number of amici, most notably the United States of America.  (You can view all the briefs on the SCOTUSblog here.)  If we have been critical of the Solicitor General in the past, we will voice no concern this time around.  The SG hit the nail on the head, and the United States’ brief reinforces the Petitioner’s very strong arguments—and adds another, which we will get to in a minute.

First, the briefs. The general thrust of both briefs is that the California Supreme Court’s “sliding scale” approach to specific jurisdiction impossibly contradicts binding precedent.  A court simply court cannot base specific jurisdiction on a defendant’s forum contacts involving other individuals and other products, no matter how intense those contacts are.

For the Petitioner, it comes down mainly to one concept—proximate causation. That is to say, for a claim to “arise from or relate to” a defendant’s forum contacts, the defendant’s activities in the state must be a proximate cause of the plaintiff’s lawsuit.  Take, for example, this opening salvo:

The [California Supreme Court] concluded that Bristol-Myers could be haled into California on respondents’ claims merely because Bristol-Myers sold Plavix to other persons and developed other products in the State.

            That is not how specific jurisdiction works.  Since International Shoe Co. v. Washington, 326 U.S. 310 (1945), this Court has made clear time and again that “specific or case-linked” jurisdiction requires a causal connection between the defendant’s forum conduct and the litigation. Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915, 919 (2011).  That bedrock requirement ensures that a common connection links the defendant, the forum, and the litigation; that States do not assert jurisdiction over matters occurring and directed entirely outside their borders; and that any litigation to which a defendant is subject is a direct and foreseeable consequence of its in-state activities.  Courts cannot dispense with this causation requirement because a defendant has wide-ranging contacts with a State.  Only general jurisdiction allows that, and then only where the defendant is at home.

Petitioner’s Br. at 2. This is (or at least should be) an uncontroversial description of specific jurisdiction, and the Petitioner draws from it that specific jurisdiction requires a “causal connection” between the defendant’s forum contacts and the plaintiff’s claims. Id. at 14.Continue Reading Solicitor General Urges Supreme Court to Reverse California’s Ill-Conceived Version of “Specific Jurisdiction”

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We’ve seen it before.  The Southern District of Illinois will certify class actions with no real cause of action and no real damages.  While not as bad as the drive-through-class-certification state courts in southern Illinois, the nearby federal court will also perform doctrinal somersaults to benefit the local plaintiffs’ bar.  With both the lower state and federal courts in that otherwise lovely corner of the Midwest, an out of state corporate defendant must tough out absurd hijinks, then cross its corporate fingers and seek relief from the (usually) more rational appellate courts.  The Seventh Circuit, in particular, makes a full-time job out of spotting and reversing errors.

That not only happened in Eike  v. Allergan, Inc., 2017 WL 881834 (7th Cir. March 6, 2017), it happened courtesy of the pen of Judge Richard Posner.  In nine short paragraphs, with his typical absence of footnotes, Judge Posner exposes the purported class actions for the exercises in silliness they were.  So devastating is the reversal, so sharp is his prose, that Judge Posner’s miniature masterpiece must be viewed as a judicial thumb in the eye of the lower court.  The Seventh Circuit not only reversed the district court’s certification of the classes, it also ordered the case dismissed with prejudice for lack of standing.

Illinois calls itself the Land of Lincoln.  Lincoln said a lot of famous things.  One was, “Never stir up litigation.  A worse man can scarcely be found than one who does this.”  Imagine what Lincoln would have said if he had a look at a claim as batty as the one in Eike.  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.   (Woe unto the plaintiffs if it were, and then they drew Judge Posner on the panel!) 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.Continue Reading There’ll Always Be Posner: Reversal of Class Certification in the Blink of an Eye

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Back in October we posted about the Eastern District of Pennsylvania decision McLaughlin v. Bayer Corp, 2016 U.S. Dist. LEXIS 37516 (EDPA Mar. 22, 2016) saying that while we liked the ultimate result – tossing out most of plaintiffs’ claims – some pieces of the decision weren’t as strong as we would have liked. Well, McLaughlin’s back and it’s still not a slam dunk, but plaintiffs’ don’t have too much left of their cases either.

As a reminder, this is actually a decision in 5 cases each alleging injury from plaintiffs’ use of a Class III, PMA contraceptive device, Essure. McLaughlin v. Bayer Corp., 2017 WL 697047, at *1 (E.D.Pa. Feb. 21, 2017). Several of plaintiffs’ original causes of action were dismissed with prejudice, but they were given an opportunity to amend to try to salvage their claims for negligent training, negligent risk management, breach of express warranty, fraudulent misrepresentation, and negligent manufacture. Negligent misrepresentation and failure to warn premised on failure to report survived the first motion to dismiss.

The decision methodically goes through each cause of action.

Negligent Training: In its first decision, the court opined it was possible to state a parallel claim for negligent training, but since plaintiffs failed to specify how defendant’s training deviated from federal training requirements or how those deviations caused plaintiffs injuries, the claim had to be dismissed as insufficiently pled. Id. at *3. In the amended complaint, plaintiffs alleged 6 such failures by defendant. As to 3, the court couldn’t find any federal directive that required defendant to do what plaintiffs alleged it failed to do. So, as to those 3 allegations, the claim was dismissed as expressly preempted. Id. at *4-5. As to the remaining 3 alleged violations, defendant challenged them on causation grounds but was unsuccessful. The court found the complaint sufficiently alleged that because defendant failed to properly train the doctors, the doctors in turn did not properly place the device causing it to migrate and cause plaintiffs’ injuries. Id. at *5. The complaint, however, lacked any specific allegations about the actual doctors who performed plaintiffs’ surgeries. The court didn’t find that fatal at the pleadings stage – that was for discovery. Id. at *6. But if you look at what the 3 bases for the failure train claim are, they appear to all be things plaintiffs could have asked their doctors about before filing these lawsuits. Did the doctor successfully complete 5 preceptorings? Did the doctor read and understand the training manual? Did the doctor successfully complete the simulator training? If the answers to those 3 questions are yes in each case – this claim is over.Continue Reading PMA Preemption Revisited in Pennsylvania

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Regular readers of this blog know that we have a pretty jaded view of many MDLs. Obviously consolidation makes sense, at least on paper, in terms of efficiency and the best use of scarce court resources.  But, in practice, many MDLs promote a litigation “mob mentality,” in which the merits of individual cases are not important at the outset and, in the world of “settlement inventories” and “mass settlements,” may never draw the scrutiny of the judge or anyone else.   Though we continue to hope that “Lone Pine” orders will burgeon and raise the standards for plaintiffs seeking to fly under the radar and await settlement, many MDLs remain “safe havens” for plaintiffs who can’t satisfy the burden of proving their claims.

And a recent decision from the hip implant MDL does nothing to disturb this reality. In that MDL, a longstanding “Explant Preservation Order” requires preservation of hip implant devices removed from plaintiffs during explant surgeries.  The order requires plaintiffs to “make good faith efforts to ensure that [medical facilities] preserve” explanted devices and provides options for plaintiffs’ counsel to claim devices within 60 days of explant or, in the alternative, for the devices to be sent to the defendants.  It  requires all parties to handle explanted devices in accordance with a written protocol or consistent  with “methods and practices accepted by those in the field of inspection and testing of orthopedic devices,” to notify each other of devices in their possession before the date of the order, and to make devices available to each other after inspection and testing.   All of this, obviously, ensures that the critical evidence in this product liability MDL is preserved and handled in a fair and consistent manner.

In Marquis v. Biomet, Inc., et al., 2017 U.S. Dist. LEXIS 28465 (N.D. Ind.  Mar. 1, 2017), the defendants moved for summary judgment against six plaintiffs.  Five of these plaintiffs had had their devices explanted before they filed suit, or after they filed suit but before their cases were transferred into the MDL, and did not know what happened to their devices after they were explanted.  The sixth plaintiff had several revision surgeries.  During the first, the femoral head of her hip implant was replaced, and she asked for the explanted femoral head.   She explained, “I figured I paid for it.  I wanted it.”  She kept the femoral head in her closet, didn’t disclose on her fact sheet that she had kept it, and didn’t tell anyone she had it until her deposition.  The devices explanted during her subsequent surgeries were not preserved.Continue Reading Hip Implant MDL Denies Summary Judgment on Claims of Plaintiffs Who Failed to Preserve Explanted Devices

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Today’s guest post is by Aggie Lee of Tucker Ellis, about a PMA preemption win that she briefed in California.  The medical device is a hemostatic matrix, which is unusual, and this type of device isn’t usually targeted in product liability litigation.  As is always the case, our guest posters are 100% responsible for their submissions, so Aggie deserves all the credit (and any blame) for what follows.

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Judge Gonzalo P. Curiel in the Southern District of California has been in the national spotlight since then-candidate Donald Trump questioned his impartiality in the then-pending Trump University lawsuits.  While now-President Trump might not number among his admirers, we like Judge Curiel’s recent contribution to Premarket Approval (PMA) preemption, where he recently dismissed with prejudice all of plaintiffs’ claims in Weaver v. Ethicon, Inc., No. 16CV257-GPC(BGS), 2017 WL 680725 (S.D. Cal. Feb. 21, 2017).

But it took a long time and many motions to get there, specifically four complaints, one personal jurisdiction-based motion to dismiss, and three preemption-based motions to dismiss. Defendant Ethicon, Inc., finally prevailed when the Court dismissed Plaintiffs’ Third Amended Complaint with prejudice.Continue Reading Guest Post – The Matrix Preempted

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This post comes from the Cozen O’Connor side of the blog.

We’ve been following the Pinnacle MDL closely through the last two bellwether trials, starting with the news coming out of the second bellwether trial of particularly curious and prejudicial evidence being presented to the jury. Given that evidence, we expected a plaintiffs’ victory, an expectation that was borne out with a whopping $498 million verdict. It raised an immediate question: “What will the Fifth Circuit do?”

Well, we’re on our way to finding out. The defense recently filed their opening appellate brief. While it features the controversial evidentiary rulings, much more is in play. If you would like to take a look for yourself, here is the brief.  Below are some of the key issues, along with a quick description of the defense’s arguments:

Design Defect Claim against DePuy (Brief at 20-29): Claim that all metal-on-metal hip implants are defective is not viable under Texas law because a wholly different product cannot serve as a safer design; design claim is preempted because the FDA approved metal-on-metal hip implants; and design claim fails under Restatement (Second) of Torts 402A comment k (adopted in Texas), which recognizes that products like implantable devices are unavoidably unsafe and therefore not defective if properly made and warned about.

Continue Reading Briefing Underway in Appeal of Half-Billion-Dollar Verdict in Pinnacle MDL

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

Within days of each other, courts in Ohio and California entered decisions finding all claims brought against Medtronic’s pre-market approved (“PMA”) pain pump device completely preempted – Warstler v. Medtronic Inc., 2017 WL 769810 (N.D. Ohio Feb. 28, 2017) and Martin v. Medtronic Inc., 2017 U.S. Dist. LEXIS 26350 (E.D. Cal. Feb. 24, 2017). While the two courts eventually reached the same destination – the route each took to get there was a little bit different. So, let’s compare the journey.

Manufacturing defect: In both cases plaintiffs appear to attempt to base their claims on alleged violations of Current Good Manufacturing Practices (“CGMPs”) – general, open-ended, non-device specific regulations. There is a current split in authority on whether CGMPs are specific enough to support a parallel violation claim. We think not. Ohio leaned more toward our thinking on this issue. Plaintiff Warstler failed to allege that the defendant deviated from any “specific FDA-prescribed manufacturing requirement.” Warstler, at *6. Without an alleged violation, plaintiff is essentially arguing that the FDA’s manufacturing process is insufficient. That would make Ohio state law different from or in addition to federal law and therefore the claim is preempted. When the court looked at the CGMPs cited by plaintiff, it couldn’t find one that “is not so vague as to be incapable of enforcement.” Id. at *7. In California, on the other hand, the court found that plaintiff’s allegations about CGMP violations were sufficient to state a parallel claim so that plaintiff’s claim survived express preemption. Martin, at *18-19. But, because plaintiff based his claim entirely on alleged violations of federal requirements, the claim was impliedly preempted. Id. at *19. To have a non-preempted parallel claim, plaintiff must be suing for conduct that violated the FDCA but not because the conduct violates the FDCA. The Martin complaint apparently gave only a cursory nod to the state law basis for his claim, alleging only generally that plaintiff did not take reasonable care in manufacturing. Id. at *20.Continue Reading A Pair of Pain Pump PMA Preemption Cases

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A multidistrict litigation (MDL) can be a sound way of managing a mass tort.  Efficiencies are available (e.g., deposing company witnesses only once) and the U. of Chicago part of us dreams of economies of scale.  Then again, an MDL can be vexing, as plaintiff lawyers park their weak cases in the MDL and find ways to push their relatively few strong cases up front.  Think of the MDL as a vast kennel, with all of the associated dangers and bad smells.  Then again, an MDL can be an out-and-out disaster, as the old If-you-build-it-they-will-come model oft-described by blogger emeritus Mark Herrmann takes hold.  The very existence of the MDL itself makes the mass tort massive.  The MDL becomes a magnet for the meritless.  Plaintiff lawyers resist any discovery of individual cases – there are too many! – and insist on dedicating the MDL to endless discovery of company conduct, as that is common to all cases and, viewed through the MDL lens, is always proportional, no matter how intrusive or expensive.  (At least that is the plaintiff argument.  But now some courts have finally grown weary of MDLs becoming festivals of discovery about discovery, and decided that proportionality applies even when the MDL case inventory has reached four or five digits.  See here, for example.)

We have gone through this evolution of thought in the course of a single MDL, watching good intentions morph into an extortion racket.  We have also seen courts gradually catch on to what has gone wrong with the MDL system.  Is this an instance of phylogeny recapitulating ontogeny? Legislation has been revived in Congress that aims to cabin the insanity of MDLs and class actions. And, mirabile dictu, some MDL judges have started to rein in asymmetrical discovery and have even demanded that plaintiff lawyers furnish evidence of such niceties as usage of the product and medical causation.  We’re not saying let’s make MDLs great again, but can we at least make them less miserable?  Or maybe just make them less.  Perhaps we don’t need an MDL every time there’s an alarming study or an uptick in adverse events.Continue Reading JPML Refuses MDL for Proton Pump Inhibitor Kidney Injury Cases

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This is a follow-up to our post last week on the Missouri Supreme Court’s momentous personal jurisdiction decision in State ex rel. Norfolk Southern Railway Co. v. Dolan, ___ S.W.3d ___, 2017 WL 770977 (Mo. Feb. 28, 2017) (“NSRC”).  We stated last week, and we continue to believe, that NSRC will ultimately kill litigation tourism in Missouri.

However, it won’t be easy.  Nothing ever is against the rich and entrenched litigation industry.

As we would expect, the other side is talking out both sides of its mouth about NSRC.

On one hand, in the ongoing legislative push for a statutory fix to the bizarre and unfair way that courts have interpreted Missouri’s venue and joinder rules (see our post here), those supporting the other side of the “v.” are already claiming that the venue/joinder reform bill (H.B. 460 – which will be on the House floor this week) is no longer necessary; that NSRC supposedly “fixed” everything.

On the other hand, and essentially simultaneously, in the multi-plaintiff mass tort litigation that is the main reason tort reform is so desperately needed, they’re doing the opposite –  trying to get around NSRC by claiming “pendent party” jurisdiction as a result of the very same venue/joinder problems that venue/joinder reform and H.B. 460 is intended to fix.

Talk is cheap.  Watch what they do, not what they say.

They can’t have it both ways. In fact, they can’t have it either way.  The plaintiffs’ first position is garbage, and the second is devoid of legal support.

For the reasons stated in our original post, H.B.460 remains necessary after NSRC.  NSRC established that personal jurisdiction over non-resident corporations by non-resident plaintiffs over injuries not arising in Missouri is unconstitutional under the Due Process clause.  There is no general personal jurisdiction because the defendant is not “at home.”  There is no specific personal jurisdiction because out-of-state injuries to out-of-state plaintiffs are not “related to” a defendant’s Missouri activities.  There is no “consent” merely by registering to do business.

But as good as it was, NSRC was not a mass tort case.  Rather, it was an individual litigation tourist plaintiff suing a single non-resident corporation.  NSRC thus had no occasion to address either the 99-plaintiff misjoined tort complaints that have become the bane of Missouri product liability practice or the 99-defendant complaints that are typical of asbestos (and some other) product liability litigation.  Eliminating those abuses are at the core of H.B. 460, meaning that the reforms proposed in H.B. 460 remain every bit as necessary as before.  As we discussed, the court of appeals in Barron v. Abbott Laboratories, Inc., ___ S.W.3d ___, 2016 WL 6596091, at *13 (Mo. App. Nov. 8, 2016), invited the legislature to correct the venue/joinder rules, and that is exactly what H.B. 460 will do.Continue Reading More on Missouri – What To Expect and Not To Expect After Norfolk Southern v. Dolan

Drug & Device Resources

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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