January 2015

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This is a guest post prepared by Rachel Weil of Reed Smith, who has graced us with guest posts before and, we hope, will do so again.  This post concerns the latest of several recent appellate decisions that have imposed limits on the questionable practice of cy pres distributions in class action settlements.  As always, Rachel deserves all the credit, and whatever blame accrues from her post.

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Readers of this blog are familiar with our antipathy toward the remedy – or non-remedy – known as cy pres. If not, recollections can be refreshed here.  “Cy pres” is a French term that roughly translates to “next best” or “as near as possible.”  When class counsel can’t or won’t identify all class members to whom damages are owed, cy pres purports to allow the court to award remaining settlement funds to third parties – usually charities.  These funds are commonly included in the “lodestar” used in the calculation of class counsel’s fee.  “Next best” means, in theory, that non-class member recipients of settlement funds have some logical nexus to the litigation.  In practice, nothing in Rule 23 governs cy pres distributions and there is no institutional mechanism for vetting proposed recipients or ferreting out conflicts of interest.  As a result, class counsel and judges have been known to steer cy pres funds to charities they support or that provide benefits to them (or bestow honors on them), notwithstanding the charities’ lack of any relationship to the settled litigation.

In recent years, real pundits – actual judges − have chimed in to question cy pres awards and related practices.  See Marek v. Lane , 134 S. Ct. 8 (2013) (Justice Roberts, in a concurrence in a denial of certiorari, commenting that a differently-postured petition might have afforded the Court the opportunity to address “fundamental concerns” about the use of cy pres remedies in class action litigation); Holtzman v. Turza, 728 F.3d 682 (7th Cir. 2013) (Judge Easterbrook rejecting trial judge’s unilateral decision to seize residue of a settlement and award it to Legal Aid as “cy pres”); Cf Redman v. Radio Shack, 768 F.3d 622 (7th Cir. 2014) (non-“cy pres” decision condemning inflation of denominator used in calculation of attorneys’ fees by including funds not actually received by class members) (Judge Posner, this time).Continue Reading Guest Post – Sayonara, Cy Pres

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This post strays from our usual posts in a few respects.  First, it is about a Florida state intermediate appellate court opinion in a slip and fall case.  You will not find us posting on many of those.  Second, while we do post on discovery issues, it is usually about the scope of discovery that can be pursued against drug and device manufacturers.  This is about discovery on the plaintiff, which is less common (but not unique).  Third, and most significantly, this is about social media, specifically something called “Facebook.”  We understand that many, many people who are young, social or both—we (in the singular form of that pronoun sometimes utilized in our posts) are neither—spend quite a bit of time with their Facebooking.  Indeed, this Facebook thing is so popular that it has taken on several verb forms.  Based on our research, but not personal experience, many spend large parts of their waking time updating their “friends” (as the term is used broadly) on details of their life, reviewing posts/updates from others, and adding value to society by “liking” or commenting on what others have posted.  Sometimes, these Facebookers post photographs of themselves doing all sorts of things, including things that rational people might not memorialize through digital photography, let alone share with others through a medium where everything pretty much lasts forever.  Some of these photo-posting Facebookerists happen to be plaintiffs in civil litigation.  Hence, this post.
Continue Reading A Day In The Real Life Of A Facebooking Plaintiff

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We like Velveeta, frozen yogurt, and Pringles—just never all at the same time.  Anyone who has ever encountered or consumed these products knows that the creamy orange substance known as Velveeta is not cheese, but is a “pasteurized prepared cheese product.”  We all know that frozen yogurt is not ice cream.  Pringles are not potato chips.  They are “potato crisps,” not to be confused with the potato “crisps” that our readers in the U.K. purchase at the shop.  (“Crisps” in the U.K. would qualify as “chips” in the U.S., but the Brits already use the word “chips” to refer to French fries, which may or may not have anything to do with British-French relations, but we digress.)

Why do these foods suffer from identity crises?

Because the FDA says so. The rules are known as food “standards of identity,” and in them the FDA sets forth the criteria that foods must meet to bear certain monikers.  Velveeta, Pringles, and frozen yogurt do not meet the identity standards to be called the foods that they aspire to be, so their sellers cannot use those names on their labels.  William Shakespeare wrote that a rose by any other name would smell as sweet.  The FDA would not agree.  You can call a chip a Pringle, but in the regulators’ minds, those are two different things, even if they smell somewhat the same.

The tie-in to the Drug and Device Law Blog is federal preemption, because the FDA’s identity standards are federal laws that have strong preemptive impact over state laws imposing different requirements.  In Nemphos v. Nestle Waters N. Am., Inc., No. 13-2146, 2015 U.S. App. Lexis 275 (4th Cir. Jan. 8, 2015), the product at issue was bottled water.  The plaintiff alleged that the bottled water, infant formula, and baby food that her baby consumed contained fluoride, resulting in a condition known as dental fluorosis.  Id. at **1-2.  According to the plaintiff, the food sellers failed to warn about the risks of dental fluorosis and engaged in misleading marketing in connection with their fluoride-containing product.  Id. at **4-5.Continue Reading Preemption: How Do You Define Water?

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This is probably not the first you have heard of the recent ED Pa Daubert do-over in the Zoloft litigation, and it probably won’t be the last.  In re Zoloft Products Liability Litigation, 2015 U.S. Dist. LEXIS 1598 (E.D. Pa. January 7, 2015), was issued on Orthodox Christmas Day and the day after the feast of the Epiphany. If it were a Christmas present we’d return it for a bag of tube sox.  If it offered an epiphany, it was merely further proof that large plaintiff case inventories too often distort the law.  We do not like the decision one bit, but it is by a careful judge and it highlights a general litigation problem we’ve mulled over before, so it is worth a few extra words.  A couple of months ago, the judge had rendered a well-reasoned Daubert decision that completely precluded one plaintiff causation expert and limited the remaining three to opine only on biological plausibility.  We wrote about that opinion here, where we praised the judge for being “brave.”  We don’t know enough about the litigation to know if the earlier Daubert ruling amounted to a death blow, but it was obviously not the sort of thing that the plaintiff lawyers would brag about on their websites or Youtube telenovelas.

We cannot pretend to be surprised that the plaintiffs belatedly offered yet another general causation witness.  (For all we know, that lack of surprise might be construed as absence of prejudice to defendants.  Now that would really be perverse.)  The plaintiffs cited studies that existed when the earlier experts had been proffered (so why weren’t they used by the earlier experts?) as well as some newer studies.  But of course this was all too late.  The deadline for naming experts was passed and was retreating fast in the rear view mirror.  Accordingly, the plaintiffs sought to amend the scheduling orders so as to permit their expert-come-lately to enter the case and save the plaintiffs’ causation bacon.  We also cannot pretend to be surprised that the defendant pointed out that the plaintiffs had had ample opportunity to select expert witnesses and were now simply seeking a Daubert do-over after an unfavorable outcome.  But we must confess to being surprised that the judge permitted the Daubert do-over.  It is not a pleasant surprise.Continue Reading Darned Daubert Do-over

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Johnson v. Hologic, Inc., 2015 U.S. Dist. LEXIS 1105 (E.D. Cal. Jan. 5, 2015) is a case brought by a pro se plaintiff alleging she was injured by a mammography machine which happens to be a Pre-Market Approved, Class III medical device.  Given that even the best of plaintiffs’ counsel have difficulty putting together…

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We’re doing it again.

As readers know, every year we post the top ten best, and worst, drug/device product liability-related decisions of the year.  Like we did last year, we’re once again doing something extra in this respect.  Bexis, Steve McConnell and Steven Boranian of the Reed Smith side of the blog will…

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If anyone gave out prizes for the most incomprehensibly named multi-district litigation, the one currently proceeding as “In re Fresenius Granuflo/Naturalyte Dialysate Products Liability Litigation” would be right up there.  Rarely have we encountered a case name with four words in a row that, without a dictionary, we didn’t know what they meant.  Basically, this is product liability litigation about two dialysis solutions (Granuflo and Naturalyte) over alleged serious adverse reactions related to effects on blood chemistry.

This MDL is currently pending in the District of Massachusetts.  Just after the new year the Fresenius MDL (that’s all the designation really needed) made some news with a quartet of decisions.  We’ll describe them for you briefly.

First Decision

In In re Fresenius Granuflo/Naturalyte Dialysate Products Liability Litigation, ___ F. Supp.3d ___, 2015 WL 44589, at *1 (D. Mass. Jan. 2, 2015), the court denied remand to a batch of California plaintiffs.  As is so often the case in removal/remand, there was a lot of gamesmanship going on.  The defendant proved, to the court’s satisfaction, that the principal place of business of the target defendant, Fresenius, USA, had been its Massachusetts for almost a decade, since a merger.  Id. at *2.  It satisfied the relevant “nerve center” test (see here for more on that) for personal jurisdiction.Continue Reading Fresenius Potpourri

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Ever since we rejected the concept of a constitutional “life interest” creating a right to use investigational, or even experimental, drugs in connection with the Abigail Alliance litigation back in 2007, we’ve been interested in what can be called “duty to supply” cases.  Our beef with the postulated constitutional right was that, if such a right were recognized, the next lawsuit would be against a pharmaceutical company to “enforce” that right.

Well, even without a right, precisely such a “duty to supply” claim was made in a case called Gunvalson, which because it was in our back yard, we covered extensively.  Our ex-colleague and co-founder, Mark Herrmann, even filed an amicus brief in Gunvalson, successfully urging the Third Circuit to reverse an order that would have required a manufacturer to supply an investigational drug outside of its investigation.

There have been a few more such suits, all thankfully unsuccessful.  In this post, we want to let any of our readers who share our eclectic interest in this topic know that the best law review article that we’ve ever seen on this topic has recently been published.  Here’s a link.  See William M. Janssen, “A ‘Duty’ to Continue Selling Medicines,” 40 Am. J.L. & Med. 330 (2014).  Free copies can also be obtained at the SSRN site here.  The article is comprehensive, indeed “comprehensive” doesn’t do it justice.  We’ve looked through it, and it discusses every major case on this topic.  It definitely goes far beyond the
usual function of law review articles of filling much needed gaps in the literature.Continue Reading New Law Review Article About Duty To Supply Issues

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This will be an odd post for us – a research-heavy discussion that doesn’t cite to drug/medical device case law.  However, the nonsensical “innovator liability” is a clear and present danger.  Generic drug plaintiffs, refugees from generic preemption, are looking for any deep pocket to sue, no matter how contrary to existing law and the economic justifications for product liability.  Thus they continue to peddle this jurisprudential snake oil.  Defense counsel need every available arrow in their quivers to combat its possible spread.

Today we discuss asbestos “bare metal” cases.  In asbestos-land widespread bankruptcy of asbestos manufacturers has had much the same effect as preemption is having in generic drug product liability litigation.  Thus, most major manufacturers of asbestos-containing products can’t be sued.  In addition to searching for minor actual manufacturers, asbestos plaintiffs have also turned to suing manufacturers of products that don’t contain asbestos at all.  These defendants made turbines, boilers, engines, pumps, valves – you name it.  None of these products contained asbestos when sold.  They were simply “bare metal.”  However, purchasers of these products attached various asbestos-containing products to them, such as insulation or gaskets, which helped the products run better and/or longer.

While those parts were made by others (usually harder to identify), the asbestos plaintiffs claim it was “foreseeable” to the bare metal equipment manufacturers that these other products would be added.  Some products, plaintiffs claim, couldn’t be operated at all without the addition of asbestos-containing components.  Because third-party addition of asbestos-containing components was “foreseeable,” these asbestos plaintiffs allege that bare metal defendants had a duty to warn about that risks from addition of other products that those defendants never made.Continue Reading More Support in the Fight Against Innovator Liability

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We’ve liked the Ortho Evra MDL.  We’re going to miss it.  It provided us with more than its share of good learned intermediary rule/warning causation decisions, since the risk of stroke associated with chemical contraceptives has been known about, and warned about, for years.  Thus, it was really
hard for plaintiffs making the contrary assertion to get around their prescribers’ testimony.  We reported on such wins here (Minnesota and Mississippi), here
(New York), here (Tennessee), here (Illinois), here (Missouri), and here (Tennessee).  So Ortho Evra improved the learned intermediary rule law of a half-dozen states (that we blogged about).

In the long run, however, the biggest contribution of the Ortho Evra MDL to prescription medical product jurisprudence is probably in the field of preemption.  Booker v. Johnson & Johnson, ___ F. Supp.3d ___, 2014 WL 5113305 (N.D. Ohio Oct. 10, 2014), which just made #7 on our top ten list of 2014 decisions, provided us with one of the first – and to date the most thoroughly reasoned – opinions applying preemption under Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), to design defect claims involving non-generic prescription drugs.

But the MDL has come to an end.  The very last of the 1,518 cases in the Ortho Evra MDL was what was left of Yates v. Ortho-McNeil Pharmaceutical, Inc., No. 3:09 oe 40023, slip op. (N.D. Ohio Jan. 5, 2015).  The MDL judge had already dismissed the warning-related claims in a decision we discussed here.  What was left were design and manufacturing-related claims under various theories, and an express warranty claim.  Not any longer.Continue Reading Ortho Evra MDL Goes Out with a Bang

Drug & Device Resources

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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