June 2013

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While we’re waiting for the Supreme Court to issue its preemption ruling in the Bartlett case (possibly as early as 10:00 a.m. today), we thought we’d examine the Court’s recent preemption decisions in non-drug/medical device cases, Hillman v. Maretta, 2013 U.S. Lexis 4167 (U.S. June 3, 2013) (also available in slip here), and in Arizona v. Inter Tribal Council of Arizona, No. 12-71, slip op.

(U.S. June 17, 2013).  Both are quite far afield from our sandbox:  Hillman involved the extent to which state legal standards can be used to change listed beneficiaries on federal government workers’ life insurance policies under a statute called the Federal Employees’ Group Life Insurance Act (“FEGLIA”); Arizona involved the Elections Clause, not the Supremacy Clause, of the Constitution, and concerned whether Arizona could restrict the ability of its citizens to register to vote in federal elections in ways not provided in the National Voter Registration Act.

In Hillman, it’s interesting that, while FEGLIA had an express preemption clause, any express preemption issue didn’t survive the march to the Supreme Court.  2013 U.S. Lexis 4167, at *13.  So Hillman only addresses implied preemption issues.
Arizona is also a conflict (and thus an implied) preemption case.  Slip op. at 12 (citing Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001)), but under a different clause of the constitution.  What do they tell us – since we don’t have any particular substantive interest – about implied preemption in general?Continue Reading While Waiting For Bartlett

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Sunday was a pretty good day. It was both Father’s Day and Bloomsday.  June 16 is called Bloomsday because that is the day that Leopold Bloom and Stephen Daedalus wandered around Dublin in James Joyce’s Ulysses.  There is an all-day reading of Ulysses every June 16 at the Rosenbach Library in Philadelphia, the home…

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Today we discuss the second summary judgment decision entered in the pelvic mesh MDL bellwether cases.  Stay tuned for a Daubert decision coming soon.  And again, these posts come solely from the Dechert side of the blog.

This summary judgment ruling can be found at In re: Bard, Inc. Pelvic Repair Sys. Prods. Liab. Litig., MDL No. 2187, 2:11-cv-01224, 2013 U.S. Dist. LEXIS 78052 (S.D.W.V. June 4, 2013).  Not surprisingly, since we are talking about the same MDL and same bellwether pool, today’s case and yesterday’s case bear some striking similarities.  To begin with, we are dealing with the same product — Avaulta Plus Biosynthetic Support System – and essentially the same challenges to plaintiff’s claims and to defendant’s affirmative defenses.

And, many of the rulings were the same.  Summary judgment granted on plaintiff’s manufacturing defect claims (no evidence of deviation from a standard or specification), Id. at *8-14, warranty claims (no privity), id. at *24-25, and negligent inspection, marketing, packaging and selling claim (no opposition).  Id. at *25.  The court’s rulings on plaintiff’s motion for summary judgment as to defendant’s affirmative defenses were nearly identical as well.  Id. at *25-35.

There are, however, two aspects of today’s case that we thought merited separate treatment. The first is an interesting choice of law twist and the second is a different result on failure to warn.

Today’s case involves plaintiff Rizzo who filed her lawsuit in the Northern District of Georgia.  It was then, of course, transferred to the MDL pending in the Southern District of West Virginia.  And, as the court points out, when deciding questions of state law, and MDL judge “must apply the state law that would have applied to the individual case[] had [it] not been transferred for consolidation.”  Id. at *5.  And choice of law is a question of state law.  So, the court had to look at Georgia’s choice of law rules.Continue Reading Pelvic Mesh Bellwethers Continued

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Four bellwether cases have been prepared for trial in the pelvic mesh MDL, and so the court has begun issuing pre-trial rulings.  Over the coming days (and later if further decisions come out), we’ll discuss a number of those rulings.  All of these posts, however, come solely from the Dechert side of the blog.

Today, we have the court’s summary judgment decision in a bellwether case that originated in Mississippi. In re: Bard, Inc. Pelvic Repair Sys. Prods. Liab. Litig., MDL No. 2187, 2:11-cv-00114, 2013 U.S. Dist. LEXIS 78059 (S.D.W.V. June 4, 2013).  The plaintiff’s doctor had implanted the defendant’s Avaulta Plus Biosynthetic Support System into plaintiff during her pelvic organ prolapse surgery.  The court’s summary judgment decision addressed all, or almost all, of plaintiff’s claims and five of defendants’ affirmative defenses.

By far, the most interesting issue, and the main reason that the opinion merits discussion, is the court’s decision on plaintiff’s failure to warn claim.  The defendant’s first argument was that Avaulta’s label, called the Instructions for Use (“IFU”), warned of the precise risks that the plaintiff was suing about.  Id. at *15.  But, while plaintiff conceded that the IFU warned about a list of possible complications, she claimed that the defendant failed to warn doctors about a particular resin used in the Avaulta product.  Id.  The material safety data sheet for the polypropylene resin, she claims, disclosed that the resin was not proper for permanent implantation in humans, and the defendant didn’t disclose that to doctors.  Id. The court accepted this argument. It held that, while defendant disclosed potential adverse events, it was a fact issue for the jury to decide whether its warnings were adequate overall.  Id. at *16-17.Continue Reading The MDL Court Has Begun Issuing Pre-Trial Decisions on Bellwether Cases in the Pelvic Mesh Litigation

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This post, being about metoclopramide/Reglan, is from the ReedSmith side of the blog only.

The Eighth Circuit decided branded and generic liability issues today in Bell v. Pfizer, Inc., No 12-1647, slip op. (8th Cir. June 14, 2013).  The innovator drug drug defendants rang the bell, their dismissal as a matter of law affirmed.  The generics did almost as well, but some issues were sent back.

Bell is a metoclopramide/Reglan case where, as usual, the plaintiff only took the generic (that is, metoclopramide).  The district court gave the plaintiff the old one-two – granting summary judgment to the generic defendant on the basis of preemption under Mensing, and to the innovator defendants because the plaintiff never used their product.

The Eighth Circuit affirmed as to the innovator defendants, since the plaintiff admitted never taking their drug.  That court had already decided the identical issue in favor of the same defendants under Minnesota law in the original Mensing opinion, which we discussed here when it came down.  The Bell court reached the same conclusion under Arkansas law:

Arkansas law compels the same result. . . .  [T]o prove her product liability claims under Arkansas law, [plaintiff] must show that a product manufactured or distributed by the brand defendants caused her injuries.  Because [plaintiff] never used [the product] the brand defendants manufactured, [plaintiff] cannot hold them liable under Arkansas law.

Bell, slip op. at 6 (citations and footnote omitted).  The court refused to recognize any causation distinction between product liability claims and other claims such as “negligence, misrepresentation, suppression of evidence and fraud” that would affect the product identification requirement.  Id. at 7.  Furthermore, even if there had been some sort of duty (which the court rejected), the plaintiff’s claims would still fail under the learned intermediary rule, which Arkansas follows.  Id. at 7-8.  That rule does not support “extending such a duty of care to the customer of a competitor using a competing product.”  Id. at 8.Continue Reading Breaking News – Innovators Ring The Bell In a Generic Case (And The Generics Do OK, Too)

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Back in 2009, we posted that a recently enacted Oklahoma tort reform statute included a provision to eliminate most class action litigation under the notorious outlier case Ysbrand v. DaimlerChrysler Corp., 81 P.3d 618 (Okla. 2003), by forbidding nationwide classes to be brought under Oklahoma law.  It seems to have worked.  We haven’t heard of any Ysbrand shenanigans since then.

Well, the Oklahoma Supreme Court was plainly out of control in Ysbrand, and unfortunately it remains out of control to this day.  Recently, in Douglas v. Cox Retirement Properties, Inc., ___ P.3d ___, 2013 WL 2407169 (Okla. June 4, 2013), the same court invalidated the entire tort reform statute, under the obscure (and rightly so) “single subject” rule for legislation.  Funny how we never seem to see that invoked except when tort reform is at issue….

Douglas thus resurrects (at least potentially) the anything goes class action practice that existed under Ysbrand – as well as the raft of other litigation abuses that the Oklahoma legislature thought it had addressed in 2009.  That’s bad news.

The silver lining is that, since practically the day Douglas was decided, legislators in Oklahoma, who passed the original bill by a substantial margins, have been quoted as saying that they would break up the original legislation into separate bills.  Moreover, with Douglas reviving tort reform as an issue, additional “measures − to limit liability for gun manufacturers, adopt federal guidelines for expert witnesses and protect restaurants [from] obesity-related lawsuits” may also be on the agenda.

Umm … guys….Continue Reading Umm . . . While You’re At It

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One of the few states where there is any doubt about the applicability of the learned intermediary rule is Wisconsin.  That’s primarily because the rule has never been addressed (one way or the other) by any Wisconsin state appellate court.  The Wisconsin cases applying the rule have been federal district courts applying Wisconsin law.  See…

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Usually when we analyze a case we skip through the preliminaries and try to cut straight to the chase.  That means reading past the standard of review and the generally applicable rules governing the procedure at hand.  Some people act the same way when they write briefs.  They assume it is all interchangeable and doesn’t much matter.  So they plug in the same-old-same-old for, say, summary judgment or Daubert.  But that is a mistake.  A lot has been said by a lot of courts on those standards, and some things we like better than others.  Shame on any brief writer who does not spend time and ink emphasizing the best bits of the relevant procedural standard.  And shame on us for not espying the hints provided by the court early on that almost make the ultimate substantive result seem inevitable.

Something like that happened in Brown v. Roche Laboratories, Inc., 2013 U.S. Dist. LEXIS (N.D. Ga. June 6, 2013), where the court came out with a very good Daubert and summary judgment decision, and where the court supplied the foundation for that decision up front.  In Brown, the plaintiff had taken Bactrim for a sinus infection.  No, this case is not about Bactrim, not really.  But the Bactrim usage ended up dooming the plaintiff’s expert’s causation opinion.  After the Bactrim usage, the Brown plaintiff experienced a fever, headache, and other symptoms.  Her doctor feared that she had developed bacterial meningitis.  Accordingly, the doctor administered doses of Rocephin.  The doctor was aware of the plaintiff’s penicillin allergy, and knew of the  potential cross-reactivity between Rocephin and penicillin.  Nevertheless, the doctor believed that the potential risk was outweighed by the benefit of treating suspected meningitis.  That is the sort of thing that doctors do.  As far as we can tell, the plaintiff in Brown had no complaint about any alleged medical malpractice.  Subsequently, the plaintiff came down with SJS/TEN, a terrible disease about which there has been much high-stakes litigation and about which we have written before.  There are many terrible consequences of SJS/TEN.  At least in Brown, bad law was not one of them.Continue Reading N.D. Ga. Rule 702 Analysis Excludes Plaintiff’s Expert and Ends SJS/TEN Case

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This post comes only from the Dechert side of the blog since Reed Smith was involved in the appeal that is the subject of the post.

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Usually plaintiffs’ lawyers have the simpler story to tell.  They’ll tell you that they drive on the highway while defense lawyers wander about on side roads.  If this is true, however, it’s usually because the defense is responding to accusations tossed out by plaintiffs, and responding is rarely simple.  But the roles were reversed in the diversity jurisdiction dispute addressed by the Third Circuit in Johnson v. SmithKline Beecham Corporation, Slip Op.(3d Cir. June 7, 2013).  The defense had the much simpler argument, an argument that won at the district court level (before two judges, losing before one other) and, as we discuss below, just won before the Third Circuit.

The plaintiffs originally filed suit in the Philadelphia Court of Common Pleas, naming a number of defendants, including GlaxoSmithKline’s operating company, GlaxoSmithKline LLC (“GSK LLC”) and GSK LLC’s sole member, GlaxoSmithKline Holdings (“GSK Holdings”).  The defendants believed that there was complete diversity and removed the lawsuit to federal court.  Plaintiffs believed otherwise, and moved to remand.  The key issue was the citizenship of the operating company, GSK LLC.  Plaintiffs argued, among other things, that GSK LLC was a citizen of Pennsylvania, the forum state, and was not diverse from one of the plaintiffs, a Pennsylvania citizen.  The defense argued that GSK LLC was a Delaware citizen, making the case removable.

The defense’s argument was simple.  GSK LLC is a limited liability company, and such non-corporate business organizations are citizens of the state or states in which each of their members are citizens.  Slip. Op. at 21 (citing Carden v. Arkoma Assocs., 494 U.S. 185, 195-96 (1990)).  GSK LLC had only one member: GSK Holding, a corporation.  So what was its citizenship?  By statute (21 USC 1332 (c)), a corporation is a citizen of both the state in which it’s incorporated and the state in which it has its principal place of business.  In both instances, that’s Delaware for GSK Holdings.  Accordingly, GSK Holdings is a Delaware citizen and so is GSK LLC.  Done.  Fairly simple.  There’s diversity.Continue Reading Third Circuit on Diversity Jurisdiction: Keep It Simple

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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