March 2015

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Since Daimler AG v. Bauman, 134 S. Ct. 746 (2014), severely curtailed general personal jurisdiction, litigation tourist plaintiffs – those who file suit outside of their states of domicile (mostly in so-called litigation “hellholes”), have been thrashing about looking for some way to maintain claims against defendants that also do not reside in the forum.  As we discussed before, when Bauman was first decided, a non-resident plaintiff cannot claim “specific” personal jurisdiction unless that plaintiff was injured in the forum state (which by definition is not litigation tourism).

That leaves general jurisdiction.  As we discussed, the “at home” test as applied in Bauman cut such jurisdiction to little more than state of incorporation or principal place of business (a little more, but not much).  After Bauman it has become “incredibly difficult to establish general jurisdiction in a forum other than the place of incorporation or principal place of business.”  Monkton Insurance Services., Ltd. v. Ritter, 768 F.3d 429, 432 (5th Cir. 2014). In the intervening period, litigation tourist plaintiffs in mass torts from asbestos to Zyprexa have been casting about for something, anything, to keep non-resident defendants bogged down in the hellholes with litigation against equally non-resident plaintiffs.

One gambit we’ve seen from plaintiffs seeking to hold onto jurisdiction over non-resident corporations is to try to take a hitherto uncommon (outside of contractual forum selection clauses) form of general personal jurisdiction – by “consent” – and interpret “consent” so broadly that Bauman becomes meaningless in practice.  Their argument is that, merely by registering to do business in a state and/or appointing an agent for service of process, a company impliedly consents to general jurisdiction.  Since most large corporations are registered to do business in many, if not all, states this approach strikes us as invalid at the outset for the same reason stated by the Supreme Court in Bauman:

Plaintiffs would have us look beyond the exemplar bases Goodyear identified, and approve the exercise of general jurisdiction in every State in which a corporation “engages in a substantial, continuous, and systematic course of business.”  That formulation, we hold, is unacceptably grasping.

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Here, neither [defendant] is incorporated in [the forum], nor does either entity have its principal place of business there. If [defendants’ forum] activities sufficed to allow adjudication of this [non-forum] case in [the forum], the same global reach would presumably be available in every other State in which [defendants’] sales are sizable. Such exorbitant exercises of all-purpose jurisdiction would. . . .

134 S. Ct. at 760-61 (citations and quotation marks omitted) (emphasis added).Continue Reading No Consent To General Jurisdiction By Merely Registering To Do Business

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Today is National Grammar Day. Before anyone of our posts goes online, it dashes thorough a gauntlet of reviewers.  Those reviewers collectively possess just the right amount of neurotic fastidiousness to ensure that what emerges is mostly correct and at least intermittently coherent.  Some of us pretend to actually know Strunk & White by heart.  Still, errors occasionally evade the dragnet of dorks. In honor of National Grammar Day, we have festooned today’s post with enough errors to keep all of you grammar cops busy.  We do this as a matter of principal.

But there are no errors in the case under review.  We have a rare favorable medical device decision out of the Seventh Circuit. The case is called Kallal v. Ciba Vision Corporation Inc., 2015 U.S. App. LEXIS 2987 (7th Cir. Feb. 24, 2015).  Mind you, the Seventh Circuit is one court we think the world of. Any court that is home to legal luminaries like Posner, Easterbrook, Wood, et al. must be fairy formidable.  But the Seventh Circuit is also home to the hideous Bausch precedent.  Perhaps you remember Bausch.  Its hard to forget.  The Seventh Circuit permitted a plaintiff to vaguely state a parallel claim which lacked substance under both federal and state law.  TwIqbal pleading requirements impacted the case not at all.  Irregardless of the Supreme Court’s instruction that lame cases should be dismissed before subjecting defendants’ to expensive discovery, the Bausch court elevated the plaintiff’s desire for discovery into something sacramental.

But Kallal is much better than that is. The plaintiff claimed that defective contact lenses had hurt his eyes.  The plaintiff did not have alot of evidence. The company had recalled some of it’s contact lenses.  Courageously (after Bausch) the district court held that the plaintiff’s claims were preempted nonetheless, and that the parallel claim could not save the case.  The plaintiff argued that his suite fit inside of the Riegel exception because the company failed to list ion permeability as a “material characteristic” in its premarket approval list.  The company responded that the FDA did not require them to meet any ion permeability threshold.  The plaintiff did not offer any evidence to the contrary.  In any jurisdiction but Bausch-land, that argument would win the preemption day for the defendant.  And mirabile dictum, it managed to win for the defendant in Kallal.  At least at the lower court’s level.Continue Reading An Error-free Seventh Circuit Medical Device Case

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A couple of weeks ago, we talked about Westminster Kennel Club Dog Show.  We were eagerly anticipating the Best in Show competition, which was slated to feature a Standard Poodle – the breed of our heart – along with a Portuguese Water Dog whose record of wins was unprecedented in dog show history.  Based on this past record, the “PWD” was heavily favored to “take the Garden.” The Best in Show judge (few assignments in dogdom carry more prestige) built the tension in the sold-out stadium to a fever pitch.  The dogs submitted to painstaking “hands on” examinations, they “free-stacked,” they gaited.   And they gaited again.  Finally, the judge, flanked by AKC officials, strode purposefully to the table to “sign the book,” then returned to the center of the ring, microphone turned on, purple and gold rosette and trophy in hand.   He made a moving speech about the history of the event, and he praised the lineup of seven gorgeous group winners.   Pausing one more time for effect, he announced, “Best in Show at the 139th Westminster Kennel Club Dog Show is . . .  the Beagle!”  The Beagle? Make no mistake – “Miss P” is a spectacular show dog, with many Best in Show wins to her credit.  She is a striking example of her breed.  And she is very, very cute.   But it just wasn’t what we expected.

We also thought we knew what to expect when we began reading the recent decision of the Superior Court of New Jersey – Atlantic County — in the Accutane Multicounty Litigation. This litigation, in which plaintiffs allege that Isotretinoin (Accutane’s chemical name) causes Inflammatory Bowel Disease (“IBD”) and Crohn’s Disease (“CD”), has been pending since 2003, and we have been troubled, at times, about an apparent plaintiff bias. Appellate courts have agreed with us, overturning a number of plaintiffs’ verdicts. (See here and here, for example.)  But we were most pleasantly surprised this time.

In In re Accutane Litigation, 2015 WL 753674 (N. J. Super. Law. Feb. 20, 2015), the Court considered defendant’s motion to exclude plaintiffs’ general causation and biostatistics experts.  The Court explained that New Jersey applies a standard less stringent than Frye’s “general acceptance” standard, in determining whether expert testimony is admissible.  Under the guiding Rubanick decision of the New Jersey Supreme Court (125 N.J. 421 (1991)), “if the methodology by which the expert reached a conclusion is sound, the conclusion may be introduced into evidence.”  Accutane, 2015 WL 753674 at *4 (citation to Rubanick omitted).  Later, in Kemp v. The State of New Jersey,  174 N.J. 412 (2002), the Supreme Court held that the trial court was obligated to conduct an evidentiary hearing “any time an expert’s theory has not attained ‘general acceptance,’” and that the failure to do so is “plain error.” Accutane, 2015 WL 753674 at *6 (citations to Kemp omitted).  Hence the moniker “Kemp hearing” to describe hearings such as the one that was the subject of the Court’s decision.Continue Reading A Pleasant Surprise from the Accutane MCL

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

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We’ve already blogged about Judge Sweet’s decision last November in the Cymbalta litigation and why it was important.  McDowell v. Eli Lilly, 2014 WL 5801604 (S.D.N.Y. Nov. 7, 2014).  Its most important aspect was Judge Sweet’s holding that the label’s warning of the withdrawal risks associated with discontinuing Cymbalta was sufficient as a matter of law even though it didn’t include the clinical trial statistics that plaintiffs argued should have been included.  The language of the warning was sufficient, so the statistics were unnecessary.  Another important aspect of the decision was the nurse practitioner’s knowledge of the withdrawal risks of Cymbalta, which eviscerated plaintiff’s warnings causation case.

Judge Sweet had another opportunity to address these same issues just last week.  The plaintiff had moved for reconsideration.  See McDowell v. Eli Lilly, 2015 U.S. Dist. LEXIS 23445(S.D.N.Y. Feb. 26, 2015).  Maybe he shouldn’t have.  The court’s opinion reminds us of the ruling that Lieutenant Commander Galloway received from the bench after her follow-up “strenuous objection” in A Few Good Men.  That ruling triggered this bit of sarcasm from Lieutenant Weinberg as the court was emptying: “I strenuously object?” Is that how it works? Hmm? ‘Objection.’  ‘Overruled.  ‘Oh, no, no, no. I STRENUOUSLY object.’”

The first time around, plaintiff argued that the warning should have laid out the percentage of patients in the “Perahia” study – 44.3% – who had experienced withdrawal symptoms, rather than the descriptive language in the actual label and the list of identified withdrawal symptoms that had occurred in greater than or equal to 1% of the patient population.  The study and the argument weren’t new issues for the court.  Plaintiff used them in his opposition to summary judgment.  This time he simply attached the study to a belatedly filed expert report.Continue Reading Statistics Are Still Unnecessary for a Label To Be Adequate

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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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