March 2016

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We’ve been watching competing interlocutory appeals in a couple of post-Bauman personal jurisdiction cases out of Delaware: Acorda Therapeutics, Inc. v. Mylan Pharmaceuticals, Inc., 78 F. Supp.3d 572 (D. Del. 2015), and AstraZeneca AB v. Mylan Pharmaceuticals, Inc., 72 F. Supp.3d 549 (D. Del. 2014), that had reached conflicting results regarding whether general personal jurisdiction by consent could be imposed on a non-resident corporation simply because it registered to do business in a state. Recently, the Second Circuit ruled on this same issue, finding that to impose such jurisdiction on a foreign corporation merely for doing something that every state in the country requires would be the sort of “exorbitant” and “grasping” exercise of personal jurisdiction that the Supreme Court rejected in Bauman on Due Process grounds. The Second Circuit stated, as to general jurisdiction by consent:

[W]ere we to accept [plaintiff’s] interpretation of [the] business registration statute, we would risk unravelling the jurisdictional structure envisioned in [Bauman] based only on a slender inference of consent pulled from routine bureaucratic measures that were largely designed for another purpose entirely. In [Bauman], the Court criticized as “unacceptably grasping” plaintiffs’ request that it “approve the exercise of general jurisdiction in every State in which a corporation engages in a substantial, continuous, and systematic course of business”. . . . The Court rejected such an “exorbitant exercise[ ] of all-purpose jurisdiction”. . . . [Plaintiff] proposes that we infer from an ambiguous statute and the mere appointment of an agent for service of process a corporation’s consent to general jurisdiction, creating precisely the result that the Court so roundly rejected in [Bauman]. It appears that every state in the union-and the District of Columbia, as well-has enacted a business registration statute. . . . If mere registration and the accompanying appointment of an in-state agent-without an express consent to general jurisdiction-nonetheless sufficed to confer general jurisdiction by implicit consent, every corporation would be subject to general jurisdiction in every state in which it registered, and [Bauman’s]ruling would be robbed of meaning by a back-door thief.

Brown v. Lockheed Martin Corp., ___ F.3d ___, 2016 WL 641392, at *17 (2d Cir. Feb. 18, 2016) (citations omitted).Continue Reading Breaking News – No Circuit Split (Yet) Over Post-Bauman General Jurisdiction by Consent

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We have closely followed the development (or perhaps more accurately, stagnation) of so-called “innovator liability.” It started with the wrongly reasoned and wrongly decided opinion from the California Court of Appeal in Conte v. Wyeth, 168 Cal. App. 4th 89 (2008), where the court held that an innovator drug company could be liable for injuries allegedly caused by generic products it did not make and did not sell. We rolled our collective eyes at this unmooring of tort law, where lines of cases dating back to cars with wooden wheels placed responsibility with parties who made and sold the allegedly offending product.

In the eight years since Conte, courts throughout the country in more than 100 different cases have roundly rejected innovator liability, with only a few exceptions. You can view our innovator liability scorecard here, and you can click on the “Conte” link on the side of the page to see all of our commentary on the subject. There is a lot of it. Our 50-state survey of innovator liability is here, which is as good a place to start as any. The upshot is that innovator liability should become another Sindell v. Abbott Labs, which introduced market share liability in 1980, only to become nothing more than a curious historical footnote in product liability law.

We revisit the issue now because the California Court of Appeal has gone off the rails again. In T.H. v. Novartis Pharmaceuticals Corp., No. D067839, 2016 Cal. App. LEXIS 179 (Cal Ct. App. Mar. 9, 2016), the court held that a listed drug manufacturer can be liable for injuries alleged caused by a generic version of the drug terbutaline sulfate, even though the listed manufacturer divested itself of the product six years before the plaintiff even used it. At least in Conte the plaintiff alleged that Wyeth still held the NDA. Here, the listed manufacturer had been completely out of the terbutaline business for several years.Continue Reading Another Outlier From California On Innovator Liability

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A lot of firms have already expended a lot of ink discussing the proposed memorandum of settlement filed on March 8, 2016 in Amarin Pharma’s First Amendment litigation against the FDA Here’s a link to Reed Smith’s. We’ll try not to be repetitive of what everybody else has been saying. Four points that we haven’t seen elsewhere:

Agreement to be “bound”

Sure, the FDA has “agreed to be bound,”− but to what? The phraseology preserves agency options:

Defendants agree to be bound by the Court’s conclusion that Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa and, under United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), such speech may not form the basis of a prosecution for misbranding.

Proposed Amarin Settlement, first numbered paragraph. In the first clause, the FDA simply binds itself to a “conclusion” regarding “speech promoting the off-label use of Vascepa” (the drug in question). That’s very case specific.

The second clause, however, is capable of a different meaning. In that clause, the FDA binds itself to the conclusion that “under [Caronia], such [truthful and non-misleading] speech may not form the basis for misbranding.” By its terms, this second conclusion is not tied to the facts of the Amarin case. It looks like a general agreement to be bound, broad enough to be invoked by other companies. Maybe it is; maybe it isn’t, but anyone who might later seek to argue that the FDA is collaterally estopped by the decision in Amarin Pharma, Inc. v. FDA, 119 F. Supp. 3d 196 (S.D.N.Y. 2015) – to the extent that’s even possible under United States v. Mendoza, 464 U.S. 154, 162-63 (1984), something that would take more time to examine than we have at the moment − can find support in this clause. In any event, since courts rather than the FDA now have the last word on the First Amendment question, any limitation that the FDA might try to put on this concession will end up being litigated.

Continue Reading Examining The Amarin/FDA Off-Label Promotion Settlement

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We’re pleased to report that good things continue to happen in Atlantic County product liability proceedings following recent judicial turnover. On February 19, 2016, the Reed Smith Bard/Davol defense team scored a hat trick – going three for three on summary judgments in New Jersey hernia mesh litigation. The three decisions are: Goodson v. C.R. Bard, Inc., 2016 WL 743478 (N.J. Super. L.D. Feb. 19, 2016); Utech v. C.R. Bard, Inc., 2016 WL 743477 (N.J. Super. L.D. Feb. 19, 2016); and Yakich v. C.R. Bard, Inc., 2016 WL 743476 (N.J. Super. L.D. Feb. 19, 2016).

A bit of background. These three are not mass tort cases. They are examples of what happens when there is indiscriminate plaintiff-side advertising. People call up these 800 numbers because they had “mesh” implanted. They don’t have the targeted product but – what the hey? – it’s mesh and some of the raw materials are the same, so rather than turn away a potential plaintiff, the same attorneys file one-off cases against virtually every mesh product that exists, even if (as is true here) the particular product has been the medical standard of care for the relevant surgical procedure for decades.

As one might expect with pattern litigation, these three lawsuits, and thus these three opinions, look a lot alike. So we’ll concentrate on the Goodson opinion – if for no other reason than alphabetical order.Continue Reading New Jersey Mesh Summary Judgment Hat Trick

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

The issue of the of plaintiffs’ ability to have unfettered ex parte conversations with treating and prescribing doctors before those doctors are deposed as critical fact witnesses is litigated in just about every mass tort and has been for decades. This has remained a hotly contested issue for two primary reasons.  First, in most mass torts where plaintiffs are permitted unrestricted access to the physicians, defendants are not afforded the same.  Second, plaintiffs’ counsel are not just interviewing the doctors about their care and treatment of the plaintiffs. They preview to the doctors litigation strategies and themes, they provide the doctors with internal company documents of a type that no doctor would ever see in the ordinary course of his/her medical practice. In the past, we’ve talked about this imbalance as creating an uneven playing field for the defendants. More recently, the ex parte contacts issue has been likened to “woodshedding” – the process by which plaintiffs seek to unfairly coach or prejudice a witness during ex parte communications. And we don’t disagree with the courts that see it that way and therefore impose restrictions or limitations on such communications.Continue Reading Out to the Woodshed in Louisiana

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We spend a large portion of our professional life preparing motions to exclude the testimony of plaintiffs’ experts in mass tort litigation.  Our pleasure in reading today’s decision is no doubt a function of the frequent futility of this effort and the consequent inflation of plaintiffs’ settlement demands.  As such, we offer an enthusiastic tip of the hat to Tarek Ismail for sending us a nearly great (we’ll explain the qualification later) opinion out of the Mirena MDL.  In a voluminous opinion in In re Mirena IUD Prods. Liab. Litig., 2016 WL 890251 (S.D.N.Y. Mar. 8, 2016), the United States District Court for the Southern District of New York considered both sides’ Daubert motions.

Defendant’s Medical ExpertsContinue Reading Good Things Sometimes Come in Big Packages: Mirena Rule 702 Rulings Favor the Defense — Big Time

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This post does not come from the Reed Smith side of the blog.

After two grueling months, the second bellwether trial in the Pinnacle Hip Implant MDL has gone to the jury.  The last time that happened—in 2014—the jury came back with a defense verdict.  It was a resounding and, to some, upset victory for the defense in a plaintiff-selected case in a Texas court against Texas plaintiffs’ lawyers.

But that was then.Continue Reading Trouble in Texas?: The Latest Pinnacle Hip Implant Trial Goes to the Jury

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With Spring Training well underway, we took notice of the solid base hit delivered last month by the Northern District of California in La Paz v. Bayer Healthcare LLC, No. C 15-03995, 2016 U.S. Dist. LEXIS 13058 (N.D. Cal. Feb. 2, 2016).  The district court dismissed all the plaintiff’s claims, mainly on preemption grounds, but the more interesting part of the order is the district court’s treatment of causation.

Here is what we mean.  In La Paz, the plaintiff was treated with a permanent contraceptive device that works by inserting one device into each fallopian tube.  Significantly, the FDA had approved the product as a Class III device under the rigorous scrutiny of the premarket approval process, which of course signals the application of express preemption under Riegel v. Medtronic.  We’ll get to that in a minute.  Following implantation, the plaintiff allegedly experienced complications, including bleeding and pain.  She therefore sued the manufacturer and alleged a full raft of claims:
Manufacturing defect, design defect, negligence, failure to warn, strict liability, implied warranty, express warranty, and a variety of fraud claims.  Id. at *7.

Continue Reading Preemption And Causation Do Away With Contraception Lawsuit

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A little over four years ago we reported on our visit to the Mass Torts Made Perfect conference in Philadelphia.  MTMP is a plaintiff lawyer organization.  Every year it conducts a conference in Las Vegas, where plaintiff lawyers get together and plot our clients’ destruction  (Okay, that was a bit too melodramatic)  That Las Vegas…

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Spring seems to be finally here in the mid-Atlantic region and we could think of nothing better to usher in spring than some personal jurisdiction and procedural wrangling.  Every year, we see new cases with multiple plaintiffs thrown together filed in places the plaintiff lawyers want to litigate.  Laws are enacted and big cases are decided that should curtail this practice, yet the cases keep popping up like longer-lasting and worse-smelling crocuses.  The options available to defendants to break up, remove, transfer, or dismiss some or all of these multi-plaintiff state court actions have grown, but the plaintiff lawyers keep coming up with arguments for why their cases should stay put in the form and forum of their choosing.  The case we are discussing today rejects one of the major recent arguments from the plaintiff lawyers to try to impose personal jurisdiction where it should not exist—“pendent jurisdiction.”  Combined with the recent defense win on “jurisdiction by consent,” 2016 is starting out pretty well on this front.
Continue Reading MDL Decision Debunking the Pendent Jurisdiction Fallacy Post-Bauman

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Bexis’ Book

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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