The reason that the court’s decision in Wagner v. Pfizer, 2014 U.S. Dist. LEXIS 94281 (W. D. Wisc. July 11, 2014), is useful is not because it dismisses state-law claims against generic manufacturers on the basis of preemption and other defenses we like.  It certainly does those things, and that’s good.  But we see decisions like that almost every week.  What Wagner does, however, is add to the quality of those decisions, not just their quantify.  Its opinion is clear and unhesitating.  It takes on Mensing and Bartlett preemption and the non-existence of failure-to-update claims in barely more than three crisp pages.  And, along the way, it provides uncomplicated and convincing passages that all of us can use in our future briefing.

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Ever since Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), was decided, we’ve pointed out at every opportunity that its basic principle – that an immediate state-law “duty” is incompatible with an FDA pre-approval requirement, and therefore subject to impossibility preemption – should apply to any FDA (and probably other government agency) pre-approval requirement for any product, not just generic drugs.

We’ve highlighted some success, see Thompson v. Allergan USA, Inc., ___ F. Supp.2d ___, 2014 WL 308794 (E.D. Mo. Jan. 28, 2014) (non-generic dosage claim preempted); Guenther v. Novartis Pharmaceutical Corp., 2013 WL 4648449 (M.D. Fla. Aug. 29, 2013) (non-generic black box, dosage, comparative labeling claims either preempted or probably preempted), but we hadn’t seen any case actually taking on a design defect claim in the non-generic context.  Now we have.  See Cassel v. ALZA Corp., 2014 WL 856023 (W.D. Wis. March 5, 2014).  While Cassel contains some hopeful signs, the bottom line was not good – preemption motion denied.  However, in order to avoid preemption, Cassel was forced to contort state law in novel ways that we don’t think most courts would countenance.

Cassel involved a peculiar sort of non-generic drug – at least that’s what we glean from the opinion – a fentanyl analgesic patch.  Such a product has some of the characteristics of a drug, in that there’s fentanyl in it, and that’s a substance that meets the observation in Bartlett that “as a matter of “basic chemistry,” “because of [the drug’s] simple composition, [it] is chemically incapable of being redesigned.”  133 S. Ct. at 2475.  On the other hand, the product’s mode of administration, being a patch, is capable of being redesigned, and in fact had been.  See Cassel, 2013 WL 4648449, at *1 (discussing 2009 design change).


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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

“The best lack all conviction, while the worst are full of passionate intensity.”

– Yeats, The Second Coming

We remember the early days of ESPN’s Sportscenter when Stuart Scott constantly complained about how he always had to do the summaries of the week’s crappiest football games (the bad teams back then were Tampa Bay, Green

Well, not really.  But what else were we going to call a post about class action litigation over whether honey can properly be called honey?  That’s right, since last September there have been five decisions rendered in five separate class actions over whether labeling honey as honey is fraudulent, misleading, and misbranded.  Brod v. Sioux Honey Ass’n Cooperative, 2012 U.S. Dist LEXIS 129391 (N.D. Cal. Sept. 11, 2012); Ross v. Sioux Honey Ass’n Cooperative, 2013 U.S. Dist. LEXIS 6181 (N.D. Cal. Jan. 14, 2013); Overton v. CVS Caremark Corp., 2012 U.S. Dist. LEXIS 185697 (C.D. Cal. Dec. 11, 2012); Regan v. Sioux Honey Ass’n Cooperative, 2013 U.S. Dist. LEXIS 13166 (E.D. Wis. Jan. 31, 2013); and Guerrero v. Target Corp., 2012 U.S. Dist. LEXIS 125055 (S.D. Fla. Sept. 4, 2012).  And, we believe there are other class actions with the same allegations pending (we know others have been filed and that MDL status was denied).

But before these class actions, back in 2007, there was the ultimate honey lawsuit — Bees v. Humans.  From the mind of Jerry Seinfeld we got The Bee Movie.  In it, two bees voiced by Seinfeld and Matthew Broderick sue the humans for stealing their honey and profiting from it illegally.  Frankly, we think that lawsuit has more merit than these real ones.  At least the bees suffered a real injury – they did all the work, people got all the benefit.  There are some pretty funny courtroom scenes in the movie.  John Goodman plays the over-the-top dramatic lawyer defending the humans.  The bees berate singer Sting for stealing his moniker from the bee community and cross-examine Ray Liotta about his Ray Liotta Private Select Honey.  If Ray Liotta really did market honey, you can bet today’s honey plaintiffs would be checking his product for pollen (Ray Liotta scene is also pretty funny, but couldn’t find any clips).

That’s what these class actions are all about – whether honey can still be called honey if the pollen has been removed.  Some plaintiffs seem to contend that pollen has certain health benefits and that had they been aware that the honey they purchased didn’t contain pollen, they wouldn’t have bought it.  Putting aside the seeming absurdity of the lawsuits, these plaintiffs are bringing mislabeling claims involving the FDA and FDCA, and since we are talking about food, the Nutrition Labeling and Education Act (“NLEA”).  So, at the heart, these are preemption cases and preemption cases get our attention every time.  The fact that five decisions came down so relatively close together also piqued our curiosity and so we decided to take a closer look. We are happy to report, that just like dentists who recommend Trident gum, 4 out of 5 courts got it right.


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We confess, between the unrest in Egypt and the unremitting hype leading up to the Super Bowl, we’ve let Wisconsin’s new tort reform law sit for a few days. But it is a potentially significant development – certainly far more significant than what Packers QB Aaron Rodgers had for breakfast this week (although Packer fans may disagree) – and the plaintiffs’ bar is unhappy with the result.

The Wisconsin legislature packed a lot into this bill, but here are the highlights that we found particularly relevant in the drug/device context:

(1) Punitive damages – capped at the greater of 2x compensatories or $200,000. (There’s a specific exception to the cap that won’t apply in drug and device cases – it involves a defendant whose tortious actions included the operation of a vehicle under the influence of an intoxicant).

(2) Product liability cases – The legislature enacted a number of rules specific to products cases:

Product identification – in most cases against manufacturers, plaintiffs must prove that the defendant actually manufactured the injury-causing product. This is intended to limit the effect of Thomas v. Mallett, 701 N.W. 2d 523 (Wis. 2005) (a case Bexis unsuccessfully briefed for PLAC), where the court permitted a lead-paint case to proceed against seven manufacturers even though the plaintiff could not identify the manufacturer of the paint that caused the alleged harm.


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We’re talking about the Restatement (Third) of Torts, Products Liability §2, to be precise.  Being in Pennsylvania, for quite some time we’ve had more than a passing interest in this section  of the Third Restatement and its essentially negligence (“reasonableness”)-based theory of product liability.   For decades, Pennsylvania followed a “ne’er the twain shall meet” rule that strictly separated strict liability from “negligence concepts.”  That approach was exemplified by Azzarello v. Black Brothers Co., 391 A.2d 1020 (Pa. 1978).  But in Phillips v. Cricket Lighters, 841 A.2d 1000 (Pa. 2003), three justices of the Pennsylvania Supreme Court opined that a quarter century had proven wanting the “strict liability” of the Azzarello sort, and that Pennsylvania law should move to the negligence-based standard of §2. 841 A.2d at 1015-16.  Full disclosure – Bexis filed a brief for PLAC in Phillips on the Restatement Third issue.

While three justices aren’t a majority of Pennsylvania’s seven-member Supreme Court, in Phillips they outnumbered the court’s Azzarello supporters 3-2 (there was a vacancy and an obscure concurrence in the result).  In almost seven intervening years, the court has failed to address the issue squarely, although not for want of trying.  The court thought it was going to decide the issue in Straub v. Cherne Industries, 880 A.2d 561 (Pa. 2005), but instead found there had been a waiver.  The court tried again in Bugosh v. I.U. North America, Inc., 971 A.2d 1228 (Pa. 2009), but dismissed the appeal as improvidently granted after it turned out that the defendant was an intermediate seller, not a true manufacturer (that makes a difference in the Third Restatement, but it’s not important here).

Finally, the Third Circuit got fed up with the issue remaining undecided, and after trying unsuccessfully to get the Pennsylvania Supreme Court to accept a certified question, took the metaphorical bull by the horns and predicted that the court would eventually adopt the Third Restatement in Berrier v. Simplicity Manufacturing, 563 F.3d 38, 57 (3d Cir. 2009).  As we discussed in an earlier post, that’s led to still more squabbling among the federal district courts.

Full disclosure – Bexis filed amicus briefs for PLAC in all of those other cases on the Third Restatement issue.

So the Third Restatement question has vexed Pennsylvania product liability law for quite a few years.  Well, not too long ago we (well, Bexis, obviously) was expressing his frustration with this indeterminate state of affairs with regular blog reader whom we ‘re not sure wants to be publicly identified, so we won’t, and said reader mentioned that his/her home state of Wisconsin was in somewhat of the same boat.


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We’ve posted quite a bit on the substantive due process aspects of punitive damages. Other than that, we frankly hadn’t thought about substantive due process being applicable to other aspects of product liability litigation.

Well, it’s time to start thinking.

A decision has just come down that accepts the argument that the expansion of state