Interestingly, it’s a case that is almost a year old that has us thinking about litigation tourism post Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017). We know that plaintiffs’ forum shopping gamesmanship isn’t over. It’s just gotten a lot more difficult now that the Supreme Court has said non-resident plaintiffs
Bexis, who took some lumps in probably the worst Wisconsin product liability decision ever (he filed PLAC’s amicus brief in Thomas v. Mallett, 701 N.W.2d 523 (Wis. 2005)), just read what we believe is the best Wisconsin law decision ever – at least in the drug/medical device sandbox that we inhabit. The decision is In re Zimmer Nexgen Knee Implant Products Liability Litigation, 2016 WL 6135685 (N.D. Ill. Oct. 21, 2016) (since the caption is a mouthful, we’ll call it “ZNKI“).
Here’s why ZNKI is favorable on Wisconsin legal issues.
First, as our longstanding 50-state survey on the learned intermediary rule points out, Wisconsin is one of nine states in which only federal courts predicting state law have had occasion to adopt the learned intermediary rule. Looking more closely at these nine, Wisconsin is one of only two states (South Dakota being the other) where only federal district courts have reached this holding. What isn’t there, but is discussed in ZNKI, is that some courts have (without much reasoning) refused to predict Wisconsin’s adherence to the rule. Refusing to dodge the issue, ZNKI forthrightly examines both Wisconsin precedent and the general state of the law and concludes that Wisconsin would join the nationwide learned intermediary consensus:
[F]ederal courts applying Wisconsin law have reached different conclusions about the doctrine’s applicability. The vast majority of states, however, do employ some version of the doctrine. In addition, this court’s research suggests that those courts that have declined to apply the doctrine under Wisconsin law have done so in cases involving prescription drugs, not medical devices, and those courts offer no reason to believe that the Wisconsin Supreme Court would not adopt this majority rule if presented with the issue.
In the context of . . . surgery, a patient must rely on the experience and judgment of his or her surgeon, who selects the appropriate implant and educates the patient about the particular risks − based on the patient’s particular circumstances and physiology. . . . Given that context, and given the widespread acceptance of the doctrine throughout the country, the court believes it is likely that the Wisconsin Supreme Court would apply the learned intermediary doctrine in this case.
ZNKI, 2016 WL 6135685, at *19-20 (numerous citations omitted). As we’ve pointed out recently, the learned intermediary rule is, if anything, enjoying a renaissance, with thirteen straight state high court adoptions since the infamous Karl case (since overruled by statute) was the only supreme court to go the other way.
A federal judge in Wisconsin issued an order a few weeks ago that covers two topics on which we often write—negligence per se and implied preemption. The two concepts are not unrelated. We most commonly see negligence per se when plaintiffs try to privately enforce a provision of the FDCA, i.e., by using an alleged violation of a safety-related provision of the FDCA as the basis for their state law claim. State law does not always allow this, but even when it does, such a claim should not withstand implied preemption under Buckman. That is because Buckman and section 337(a) of the FDCA make it clear that litigants cannot privately enforce the FDCA, and a negligence per se claim based on a purported violation of the FDCA is an unveiled attempt to accomplish exactly that.
It seems pretty straightforward to us, but some courts still resist. That is what happened in Marvin v. Zydus Pharmaceuticals (USA) Inc., No. 15-cv-749, 2016 U.S. Dist. Lexis 112047 (W.D. Wis. Aug. 23, 2016), where the plaintiffs based their negligence per se claim on the defendants’ alleged failure to provide medication guides for distribution with amiodarone prescriptions. The basis for the claim was the federal regulation requiring manufacturers of some prescription drugs to make medication guides available either by providing a sufficient number of guides to distributors and dispensers or by providing the means to produce guides in sufficient numbers. Id. at **2-3 (citing 21 C.F.R. §§ 208.1, 208.24(b)).
The defendants allegedly did not provide medication guides to the decedent’s pharmacy, but do the decedent’s heirs have a private right of action? The defendants justifiably did not think so, and they moved to dismiss on the basis that the plaintiffs’ claims were impliedly preempted. Along the way, the district court ordered supplemental briefing on whether Wisconsin law would recognize a claim of negligence per se in the first place.
We are fond of Wisconsin. We once drove from a deposition in Marquette, Michigan, to visit family in Minneapolis. As students of the geography of the Upper Midwest will tell you, that took us across the entire width of Wisconsin. One day we will return to partake of “fresh cheese curd,” which we saw advertised at multiple roadside markets along the way. We have more recently learned that it is commonly deep fried and served at carnivals and county fairs across the region.
But for now, we will respectfully state that the district court in Marvin came to the wrong result. The district court held first that federal law did not impliedly preempt the negligence per se claim, and in reaching that result, it cited and quoted extensively from the Seventh Circuit’s abominable Bausch opinion. Faithful readers will be familiar with the disdain we have heaped on Bausch for, among other things, its recognition of a “parallel claim” based on even the most general FDA regulations and its blithe rejection of implied preemption without citing or even acknowledging section 337(a). The posts are too numerous to list, but you can get the gist here and here.Continue Reading Wisconsin Preemption Ruling Makes Our Cheese Curdle
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
A bit of a rant today.
We’ve just read Gibson v. American Cyanamid Co., ___ F.3d ___, 2014 WL 3643353 (7th Cir. July 24, 2014), and we have to say that it’s one of the most constitutionally arrogant decisions we’ve ever read. Stripped to its essentials, Gibson is the judicial branch thumbing its nose at the supposedly co-equal legislative branch and saying “we can do it but you can’t.”
Gibson involves one of these seemingly one-way legal doctrines that only protects plaintiffs, but for some reason never defendants, the concept of so-called “vested rights.” Here’s the back-story.
Thirty years ago, the Wisconsin Supreme Court, in a judicial exercise of social policymaking, decided to adopt a peculiar form of an already peculiar doctrine – market share liability. See Collins v. Eli Lilly Co., 342 N.W.2d 37 (1984). The court breached a hitherto (mostly) sacrosanct defense – product identification − that a defendant can’t be liable unless the plaintiff first proves that s/he actually used the defendant’s product. The reason was … well, the usual fuzzy-headed logic that the common law can change and we think it’s better that the plaintiff wins. Id. at 45 (we can change the common law), 49 (we’re gonna change the law and let the plaintiffs win because of “interests of justice and fundamental fairness”). Despite the fact that the product was off the market and plaintiffs had taken it many years earlier, the court in Collins had no compunction in extending this new theory of liability retroactively to defendants whose conduct had previously been protected by the product identification defense.
Collins, as most of our readers probably already know, was a DES case. DES was, for all intents and purposes, the world’s first generic drug. Its patent had expired, so anybody who wanted to go to the time and effort to do so (this was the pre-1962 FDA, before NDA requirements were made a lot tougher) could set up shop and make the drug. Scores of companies did, and “DES” became the reference of choice for most doctors and pharmacists. Given the peculiarly long latency period for the peculiar injury – suffered in utero − in DES cases, product identification was a mess. Collins decided to let the plaintiffs win anyway by shifting the burden of proof, contrary to decades (at least) of precedent.
At least in Collins there was a real product identification problem. In the next case (the one ultimately at issue in Gibson), a bunch of class action lawyers decided to gin up a product identification problem. They wanted to sue on behalf of everybody theoretically injured by lead paint, which had been off the market for a quite a while by the time suit was brought. Since causation was an individualized issue that could defeat aggregated litigation, they created an impossible ID problem by skipping over the manufacturers of lead paint (some of whom might have been identifiable in building maintenance records) and sued only the bulk suppliers of lead paint pigment.Continue Reading Court: It’s Only Unconstitutional If You, Not We, Do It
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.
Continue Reading Preemption Made Easy
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).Continue Reading Nice Try, But No Brass Ring
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…