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 can’t go suing non-resident defendants anywhere they want. The most straight forward way for plaintiffs to stay out of federal court, assuming that is their goal, is to sue in defendant’s home state. Per the forum defendant rule, even where diversity exists, a defendant cannot remove a case to federal court if one of defendants (properly joined and served) is a citizen of the state in which the case was filed. See 28 U.S.C. § 1441(b). Stuck in state court, which isn’t always a bad thing, defendants then need to carefully consider forum non conveniens and choice of law issues.

Those were both key issues defendant decided to move on in Yocum v. Biogen, Inc., 2016 WL 10517110 (Mass. Super. Dec. 14, 2016). The case only recently popped up in our searches but with the likelihood of seeing more litigation filed in defendant’s backyards, we thought it worth a quick mention. Plaintiff brought a wrongful death suit in Massachusetts alleging that his wife died as a result of side effects from defendant’s drug used to treat her multiple sclerosis. Id. at *1. Plaintiff resides in and decedent received treatment and died in Wisconsin. Defendant’s principal place of business is in Massachusetts. Id. Just because defendant couldn’t remove the case to federal court, it still had some decisions to make. Such as, would it prefer the case to be litigated in Wisconsin. And, if it couldn’t move the case west, should Wisconsin law still apply. Yes and yes were the answers for this defendant.

First up was a motion to dismiss on the grounds of forum non conveniens.   Defendant’s argument was that not only was Wisconsin an available alternative forum, but that both public and private interests favored litigating there as opposed to Massachusetts. Generally speaking, all things being equal, courts don’t disrupt a plaintiff’s choice of forum. So, where case-specific witnesses like treaters and prescribers are in plaintiff’s home state and company witnesses are in defendant’s home state – most courts see that as a wash. See id. at *3. One set of witnesses or another are either traveling or being put on video. That’s not to say that this is always equal. For instance, if significant depositions of company witnesses have already occurred and won’t need to be repeated, maybe that helps tip things toward the plaintiff’s home state. Or, if the relevant company witnesses have changed jobs, retired, or otherwise moved, the defendant home state connection becomes more attenuated. Likewise, depending on the issues, a large company’s principal place of business might not be where the key company witnesses are located. These are likely the types of things a defendant is going to have to address to move the scales on the private interests.

Turning from the private interests to the public interests, defendant raised two arguments – the court would need to apply Wisconsin law and Wisconsin has a significant interest in regulating tortious conduct alleged to have occurred within the state. Taking them in reverse, the court found that Massachusetts has an equally significant interest in regulating the conduct of a resident business. Id. Another push. Left then with only choice of law, that alone is not enough to warrant a forum non dismissal. Defendant’s motion was denied.

That brings us to choice of law. If defendant can’t get to Wisconsin, it wanted to bring Wisconsin to it. Here the court agreed with defendant. We don’t usually take a definitive position on choice of law issues because frankly, our choice is likely to change case to case. So, we’ll just say that defendant did a good job of explaining why Wisconsin has the more meaningful contacts with the issues and the parties and that it is not an unusual conclusion for a court to decide to apply the law of the place where the injury occurred. Id. at *4-6.

Then we get to the substantive issues. Applying Wisconsin law, the court dismissed plaintiff’s breach of warranty and punitive damages claims. Wisconsin does not recognize breach of warranty for products liability suits. Id. at *6. Nor does Wisconsin recognize claims for punitive damages in wrongful death actions. Id. Both categories of claims, however, were dismissed without prejudice. Plaintiff was given an opportunity to try to re-plead the breach of warranty allegations as cognizable Wisconsin claims. And, since Wisconsin does recognize punitive damages for survival actions, plaintiff was getting another shot at that one too.

Finally, defendant also sought dismissal of the failure to warn claims as preempted. Defendant argued that the risks of the drug were considered by the FDA at the time of approval and that there was no newly acquired information that would have allowed defendant to change its label under the CBE regulations. Id. at *7. Therefore, it was impossible for defendant to comply with both federal and state requirements. But, this case is still at the pleadings stage and the court found that plaintiff had alleged enough to survive preemption. Specifically, plaintiff alleged that there were factual developments post-approval regarding the risks that would not have been considered at the time the FDA reviewed the drug and its labeling. Id. Further, the court found that defendant had not presented “clear evidence” that the FDA would not have approved a labeling change. Id. at *8.

It is worth noting, however, that the court did say that if plaintiff was pursuing a fraud-on-the-FDA type claim (failure to disclose risks to the FDA), that claim was preempted. Id. at *8n.12. Given that the court’s preemption decision was based on a very sparse record, we wouldn’t be surprised to see a round 2 on this issue after some discovery.

If defendants are going to see more home state litigation, even if forum non conveniens is a bit of an uphill battle – establishing choice of law early on may have several benefits. Dismissing claims is certainly one of them, but knowing what law is going to apply on issues such as learned intermediary and causation before discovery gets underway can be invaluable.


Last week, like most weeks during the past year, we spent a lot of our time on airplanes. One of those trips fell on a day with “lots of weather.”  All of our flights were delayed, although we were luckier than many.  When we landed at Dulles for our connecting flight home, the queue at the customer service booth comprised hundreds of stranded passengers looping around and around like the approach to Space Mountain, hoping, with varying degrees of impatience and panic, to reschedule canceled flights.  But our connecting flight was only late – very late.  We sat at our gate for almost three hours, then were finally allowed to board.  We buckled in, we watched a taciturn flight attendant demonstrate the seat belts we were already wearing, and then we sat.  For forty more minutes.  (By now, it was 12:30 a.m.)  Finally, the “flight deck” made an announcement:  we were sitting still because the trash can in the galley lacked a lid, and this was a “safety hazard” that had to be rectified before we could take off.  And so we were waiting for the “caterer,” a contractor, to bring a new trash can.  Eventually, a truck pulled up, but it was carrying the wrong type of trash can.  Ultimately, someone went next door to a plane that was done flying for the night — as all sane people were, by that point – and stole a trash can.  And we were on our way.

So who was at fault?   Was it the contractor, which (twice) provided the wrong trash can? Or was it the airline, which shall remain nameless because (trust me) it doesn’t need any more bad publicity and which specified and installed the trash can?  Depends on the nature of the claim, under a (very very) loose interpretation of today’s decision from the Eastern District of Wisconsin.

In Janusz v. Symmetry Medical, Inc., 2017 U.S. Dist. LEXIS 88895 (E.D. Wis. June 9, 2017), the plaintiffs alleged that the femoral neck of their artificial hips systems broke, requiring additional surgeries to replace the hip system.  The femoral neck was a component, manufactured by the defendant according to specifications and instructions provided by the hip system’s fabricator (which was bankrupt by the time of suit).  The plaintiffs asserted claims sounding in negligence and strict liability against both companies, and the component manufacturer moved for summary judgment, asserting the so-called “contract specification defense” to the plaintiffs’ claims.  This is a component part manufacturer’s defense, and not one we have ever discussed here.  Hence, our interest in Janusz.

Under this defense, a manufacturer that “makes a product strictly in accordance with the design specifications of another is not liable in negligence unless the specifications are so obviously defective and dangerous that a contractor of reasonable prudence would have been put on notice that the product was dangerous and likely to cause injury.” Januscz, 2017 U.S. Dist. LEXIS 88895, at *11 (citation omitted).  And, while this defense is not among the five defenses listed in Wisconsin’s product liability statute, the court held that the statute supplemented but did not supersede common-law doctrines that weren’t inconsistent with it.  While Wisconsin common law had not adopted the contract specification defense, either, it had adopted the “government contractor defense,” the underlying principles of which — declining to hold a contractor liable when it manufactured a product according  to the specifications of another – overlap those of the contract specification defense.  Under the government contractor defense, a contractor that “makes a product strictly in accordance with the design specifications of another is not liable in negligence unless the specifications are so obviously defective and dangerous that a contractor  of reasonable prudence would have been put on notice that the product was dangerous and likely to cause injury.” Id. at *12 (citation omitted).  This is essentially the same test used in the contract specification defense generally. See Restatement (Third) of Torts: Products Liability §5, Reporters’ Note to Comment a (1998) (a “majority of courts” hold “that a manufacturer of a component part . . . cannot be held strictly liable . . . so long as the specifications provided are not so obviously dangerous that it would be unreasonable to follow them”) (citation and quotation marks omitted).

In Januscz, however,  the court drew a distinction between negligence and strict liability that does not exist generally.  It held that, “[i]ntuitively,” it made sense that “an entity that has no role in designing a product should bear no liability if the product is defectively designed.” Id. at *12.  But “that intuitive  reaction follows only when plaintiff’s theory of recovery is negligence.” Id. (citations omitted).  And, “in Wisconsin, product liability was and is a matter of strict liability.” Id. at *13 (citations omitted).  In the strict liability context, unlike in negligence, “the focus is on the dangerousness of the product regardless of the defendant’s conduct.  Thus, a defendant may be blameless but strictly liable.” Id. (internal punctuation and citations omitted).  The court concluded that, given  the  “recent codification of product liability law reaffirming Wisconsin’s commitment to  the principles of  strict liability, if  presented with a question of whether the contract specification defense applies to a question of strict liability under Wisconsin law, the Wisconsin Supreme  Court would hold  that it does not.” Id. at *24. Januscz declared that “strict liability means strict liability.   It exists to shift costs associated with unsafe products to those  who are in the best position to disperse  those costs (be it through insurance, indemnification,  or some other means.” Id. at *25.  And, the court held, the “contract specification defense significantly undermines the policies underlying strict liability.  Therefore, the court concludes that the defense does not exist  under Wisconsin law.” Id. at *26.

This result is simply wrong under Wisconsin law. The Januscz court completely failed to cite the most relevant case, Schreiner v. Wieser Concrete Prod., Inc., 720 N.W.2d 525 (Wis. 2006), in which the Wisconsin Supreme Court expressly adopted Restatement Third §5 as “consistent with Wisconsin law.” Id. at 530.  Thus, Wisconsin law does not distinguish between negligence and strict liability, particularly in the context of product specifications and component parts. See also Spychalla v. Boeing Aerospace Operations Inc., 2015 WL 3504927, at *3 n.2 (E.D. Wis. June 3, 2015) (recognizing Wisconsin’s adoption of §5 after enacting of tort reform statute).  Indeed, after correctly holding that the Wisconsin tort reform statute only “supplements” the common law Januscz failed even to cite Restatement Third §5 – the relevant Wisconsin common law for component parts under Schreiner.  If anything, the statute reinforces use of the Third Restatement in Wisconsin, since the statute generally adopted that Restatement alternative design defect test and its “not reasonably safe” defect terminology. See Wis. Stat. §895.047(1)(a) (“A product is defective in design if the foreseeable risks of harm posed by the product could have been reduced or avoided by the adoption of a reasonable alternative design by the manufacturer and the omission of the alternative design renders the product not reasonably safe.”).

Rather than actually follow Wisconsin law, the court simply repeated the truism that “strict liability does not mean absolute liability.”  2017 U.S. Dist. LEXIS 88895, at *26 (emphasis in original).  To wit, a component manufacturer could escape liability if its component part underwent substantial change when it was included in the assembled device.  But, the court held, the defendant’s femoral neck component did not undergo such change.  And so the court denied summary judgment on the plaintiffs’ strict liability claims, though it granted summary judgment for the component manufacturer on the plaintiffs’ negligence claims.

While this interesting decision appears thorough at first glance, in fact it completely omits essential Wisconsin law, Schreiner and Restatement Third §5, and thus its discussion of the philosophical underpinnings of strict liability, based on Restatement Second §402A, which Wisconsin no longer follows, is (to be polite) open to question.  We hope that the defendant eventually convinces the court of the error of its ways.


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.

Continue Reading Probably the Best Wisconsin Law Decision We’ve Ever Seen

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 Menges v. Depuy Motech, Inc., 61 F. Supp.2d 817, 830 (N.D. Ind. 1999) (applying Wisconsin law); Monson v. AcroMed Corp., 1999 WL 1133273, at *20 (E.D. Wis. May 12, 1999); and Lukaszewicz v. Ortho Pharmaceutical Corp., 510 F. Supp. 961, 963 (D. Wis. 1981), modified on other grounds, 523 F. Supp. 206 (D. Wis. 1981).

We’ve recently learned that a Wisconsin state trial court followed the learned intermediary rule in a fairly extensive opinion.  We’d give a shout out to our source, but then we’d have to complain about how the opinion was kept under wraps for a decade.  We, of course, sent that along to Westlaw, so now it has a citation.  Straub v. Berg, 2003 WL 26468454 (Wis. Cir. Jan. 6, 2003).
That being accomplished, we pass it along to our readers, in the event they have any litigation under Wisconsin law.  Straub is another case alleging that a drug caused the plaintiffs’ decedent to commit
suicide.  These are not easy cases for plaintiffs to win, and Straub was no exception.  Plaintiffs did manage to stave off summary judgment under the defendant’s first argument, that suicide was an ipso facto superseding cause, due to facts that did not “foreclose the possibility” that the drug could have “create[d] a mental condition capable of resulting in behavior manifested by uncontrollable impulses.”  2003 WL 26468454, at *6.  Maybe later, once all the facts are in, this could be ruled on as a matter of law, but not yet.  Id.

Yes!  Pagination in WL trial orders!  At least going forward.

That’s when the learned intermediary rule rode to the rescue.  Liability would have to be based on warnings of this alleged inherent drug risk, but such warnings, where the drug is by prescription only, go to prescribing doctors, not patients:

Although Wisconsin courts have not addressed the application of the learned intermediary doctrine, courts of numerous other jurisdictions almost universally hold that in the case of prescription drugs, a manufacturer’s provision of proper warnings to a prescribing physician will satisfy the manufacturer’s duty to warn since the patient cannot obtain the drug except through the physician.

Id. at *6 (citing Lukaszewicz).  So there it is.

And in Straub, the rule was dispositive.  The label, right on its face, warned of “depression” (in its own paragraph) as well as mood changes and malaise.  Discontinuation and seeing one’s doctor were recommended.  Id. at *7.  That was exactly the condition plaintiffs alleged in the complaint.  Id.  Plaintiffs responded with a flurry of hearsay documents, most of which were irrelevant to the prevailing state of the art because they post-dated the suicide in the case, and some of which involved foreign regulatory matters.  Id.  None was admissible evidence:
Plaintiffs’ submissions . . . offer no admissible factual basis to support their argument that [defendant] failed to advise treating physicians of the severity of the risk of depression, that is,
that it could induce a depression so severe that it could lead to suicidal thoughts, attempts and suicide.

Plaintiffs’ final Hail Mary in Straub also failed.  Plaintiffs advocated the direct-to-consumer exception to the rule (although how that would have changed anything is unclear).  In any rate, the court found no basis for it.  “This exception has been addressed by only a few jurisdictions.”  Id. at *7.  Moreover plaintiffs did “not allege[] that [the drug] was advertised directly to consumers and their submissions fail to provide any evidence that [it] was directly marketed to consumers.”  Id.   Summary judgment granted on the basis of the “learned intermediary doctrine defense.”

Now, we know and you know that the learned intermediary rule is not a “defense” in the sense that the defense beard the burden of proof, only in colloquial terms is it a defense in that it provides, as in Straub, a basis for our side to prevail, but with that nit, we’re happy with the decision.
There doesn’t seem to have been any appeal.  Anyway, Straub is another piece on the Wisconsin board for the good guys concerning the learned intermediary rule.  May there be more.

“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
Bay, and Pitt Bay). Lately, we’ve been feeling the same way, as Bexis seems to
open the kennel doors when it comes time for us to do a post. This week
continues the trend, as we visit with a wretched-failure-to-warn analysis in
Maynard v. Abbott Laboratories, 2013 U.S. Dist. LEXIS 26068 (E.D. Wisc. Feb.
20, 2013).  If Maynard was a football game, the final score would be 5-2,
the field would be muddy, both quarterbacks would leave the game with
concussions, and the cheerleaders would all look like Clint Howard


In Maynard, the pro se plaintiff brought a failure-to-warn
action, alleging that he suffered neurological damage from using Humira. The
plaintiff took Humira “on a consistent basis” between 2003 and 2009. 2013 U.S.
Dist. LEXIS 26068 at *2.  On September 16, 2009, the plaintiff began
experiencing vision loss in his left eye. Doctors determined that the plaintiff
was suffering from demyelination disease from his Humira use.  (We in the
defense business would call that a bad specific causation fact.) The plaintiff
also exhibited symptoms of optic neuritis and multiple sclerosis.


The central issue in the case was the adequacy of the Humira
label. Under “WARNINGS,” the October 2003 Humira label stated:


Neurologic Events

Use of TNF blocking agents, including HUMIRA, has been
associated with rare cases of exacerbation of clinical symptoms and/or
radiographic evidence of demyelinating disease. Prescribers should exercise
caution in considering the use of HUMIRA with preexisting or recent-onset
central nervous system demyelinating disorders.


In 2005, the Humira warning was updated to state that in
addition to being associated with rare cases of exacerbation of clinical
symptoms and/or radiographic evidence of demyelinating disease, use of Humira
has also been associated with rare cases of new onset of such symptoms.


As is typical, risks are referenced in other places in the
label .  Thus, the Humira label also stated that the most serious adverse
reactions include “neurologic events” and referred to the neurologic events
explained in the warnings section. Further, the Humira patient insert warned
that patients should tell their doctor before starting to take Humira if they
have experienced “any numbness or tingling or have or have ever had a disease
that affects [the] nervous system like multiple sclerosis.”
 Nevertheless, the plaintiff argued that the Humira warnings “were
misleading because they omitted material information regarding the severity of
the potential side effects and were not clear in explaining that patients
without preexisting neurological conditions could also be at risk.”  Id.
at *11.   


The defendant  filed a motion to dismiss on the grounds
that the label warned of the neurologic risks at issue. Normally a court sticks
to the pleadings in resolving a motion to dismiss, but since the Complaint
referred to the Humira label, that label was fair game in deciding the
issue. So far so good.  But the Maynard court then engaged in a myopic analysis.  It purported to apply Twombly and Iqbal and held that the
plaintiff’s reading of the label was “plausible” insofar as the warning
regarding adverse neurological side effects “reasonably appears to be
applicable only to patients with preexisting demyelinating disorders or other
existing symptoms of central nervous system disorders.”  Id. at *12. 
The court goes on to say that “[a]t the very least, before 2005, the WARNINGS
section of the label was arguably unclear.” Id. Hmmm. But the plaintiff kept
taking Humira even after the label was revised in 2005, so how can the
pre-existing-only point be material?  Don’t we have clear evidence that a
label that warned of potential onset of neurological conditions would not have
dissuaded the plaintiff from taking Humira?  Further, is there any way to
say that it was the plaintiff’s pre-2005 ingestion that played a role in the


The Maynard opinion indulges in a nit-picking approach that
renders any label vulnerable to post hoc attack. We’d criticize the reasoning,
but we’re not sure “reasoning” is quite the right characterization when the
court relies on Wisconsin authority holding that “[i]mplicit in the duty to
warn is the duty to warn with a degree of intensity that would cause a
reasonable man to exercise for his own safety the caution commensurate with the
potential danger.” Id. at *13 (quoting Schuh v. Fox River Tractor Co., 63 Wis.
2d 728, 739 (1974)).   How to assess intensity?


This outcome is both good news and bad news for us. It is
bad news because intensity is such a slippery notion and it is all too easy for
plaintiff lawyers to complain that even warnings that address the very risks at
issue lack the requisite intensity. Under this “standard,” every label is
susceptible to attack. Maybe a label warns of a rash, but it does not say it is
a really, really bad rash. However many “reallys” do reside in the label, the
plaintiff lawyer can argue that there should have been at least one more. But
here is the good news: we’ve been worrying about how the Drug and Device Law
Daughter is taking classes in college on creative writing and poetry. Until this moment, we could
not foresee how that curriculum would end in employment. Now we are relieved
to learn that she might get a job with a drug or device company, applying her
poetic skills to label-writing and ensuring that warnings emit intensity.
Adverse events, meet Dylan Thomas.   Or William Butler Yeats. 


Creative writing, indeed. What’s annoying about the Maynard court’s
reasoning is that it indulges in the vast fiction that the intensity, or,
indeed, the literal words of the warning, had any effect on the plaintiff at
all. We know of cases where a warning listed death as a possible consequence,
but the plaintiff got through the pleading stage and even summary judgment
merely by arguing that the label did not lay out other risks with sufficient
detail or color. If a label does not describe a particular pain with enough
purple prose, or if it does not go into ghoulish detail about a neurological
consequence or rash, then any plaintiff can assert that they were misled and
that they would have steered clear of the product if only the label contained
that one thing it did not have. Maynard is an exercise in hindsight, but it is
through a glass, dumbly.


The reality is that patients tend to listen to their
doctors, not the label and all its lack of intensity. And now we arrive at the
fundamental problem with Maynard. It says that “Wisconsin does not apply the
learned intermediary doctrine. “ Id. at *15. 

Really?  In fact, several other federal
courts have predicted that the Wisconsin Supreme Court would follow the learned intermediary
rule.  See Menges v. Depuy Motech, Inc., 61 F. Supp.2d 817, 830
(N.D. Ind. 1999); Monson v. AcroMed Corp., 1999 WL 1133273, at *20 (E.D. Wis.
May 12, 1999); Lukaszewicz v. Ortho Pharmaceutical Corp., 510 F. Supp. 961, 963
(D. Wis. 1981), modified on other grounds, 523 F. Supp. 206 (D. Wis. 1981).  See our prior post offering a head count on which jurisdictions have adopted the learned intermediary rule. 

Moreover, Maynard is an example of why
we need the learned intermediary rule.  A plaintiff has every litigation
interest in asserting that he or she would have made medical decisions based on
the intensity of a warning.  It is utter nonsense, but if a court is
desperate to cobble together a disputed issue of fact, there it is.  But in reality, a
learned intermediary is unlikely to hinge a prescribing decision on intensity.

We dislike the Maynard decision.  We dislike it