Photo of Eric Alexander

 

Not terribly long ago, we had a series of posts—too many to link—that recounted court decisions rejecting efforts to impose liability on a generic manufacturer for the standard design and labeling claims and/or on an NDA holder for injuries allegedly caused by the use of the generic version of its drug. When the conjunctive held, we called it a one-two punch. We cannot say that we coined the term as used here, but we repeated it more than a few times. It has since become fairly standard for most claims against generic manufacturers to be held preempted by the frightful duo of Mensing and Bartlett. Save abominations like the T.H. case, the concept of innovator liability has largely been put to bed like a kid crashing after a sugar high. Still, plaintiffs sometimes try to impose liability on both the generic manufacturer whose drug they took and the branded manufacturer whose drug they did not.

When they do and a court rules, we pull the one-two punch from the back of our metaphor closet and see how it lands. In Preston v. Janssen Pharms., Inc., No. 158570/17, 2018 WL 5017045 (N.Y. Sup. Ct. Oct. 12, 2018), the plaintiff claimed vision loss from her off-label use of the generic version of Topiramate, a well-established anti-convulsive. For more than a decade before she began her three year course, the label for the branded version contained warnings and precautions about ocular conditions that could result in permanent vision loss if untreated. After waiting more than two years to sue, she sued both the branded and generic manufacturers, claiming the records were unclear as to which drug she took for three years.

The branded manufacturer moved to dismiss, contending the complaint only asserted claims based on the generic drug that it did not make. It is not clear that the plaintiff tried to assert innovator liability in addition to claiming that the branded dug might have been used, but the court looked at the evidence and ruled on the merits. Because the evidence was clear that only the generic drug had been used, the next step to first punch was whether New York recognizes innovator liability. Citing the same cases we have before, the Preston court held that “named-brand drug manufacturers . . . cannot be held liable to the user of the generic form of that drug, since the manufacturer of the brand named drug owes no duty to the user of the drug’s generic form.” Id. at *3.

That takes us to the motion to dismiss of the generic manufacturer, the potential second punch. Plaintiff conceded, and the court accepted, that design claims are preempted because the generic manufacturer cannot change the drug’s design. Id. at *6. The plaintiff disputed that the warnings claim was preempted based on an alleged failure to update the generic label to match the branded drug’s label. For about eight months after the plaintiff started the generic drug, its label allegedly did not match. When the plaintiff alleged suffered her injuries, it did. A few years later, it allegedly did not match again. Plaintiff claimed that the later mismatch knocked out preemption for any warnings claim, but the court parried that argument. Following Mensing, the court held preempted claims based on any period when the warning of the generic drug matched, but allowed at the pleadings stage any claim based on the pre-injury period when there was an alleged failure to update. Id. at *5. So, the second punch did not quite land flush. It may be difficult for the plaintiff to sustain a claim about the warning when the plaintiff was first prescribed the drug when she kept receiving it when the warning was updated and her injuries allegedly developed during this later period. We suppose the warning claim might get kicked at the summary judgment stage. Preston also addressed the adequacy of pleading of various other claims that tend to be thrown into a product liability complaint, but she will have a chance to try to correct what was inadequately pled. Nothing too decisive or interesting about that, at least to us and at this stage.

There was a time when we paid quite a bit of attention to the circumstances under which a participant in a clinical trial could impose liability on the sponsor of the clinical trial. We even tried a case to a defense verdict for the sponsor of a clinical trial in a case where the plaintiff claimed, as to our client and the investigator defendant, that his HIV misdiagnosis should have been reversed during the clinical trial, which involved a medication switch for patients well controlled under an existing treatment regimen. Leading up to that trial and after it, we gained a pretty good understanding of the law on liability related to clinical trials. For instance, cases have looked at whether the learned intermediary doctrine is somehow disrupted when the prescription is written by a clinical trial investigator.  (Like here and here)  Cases have also looked at whether participants in a clinical trial can compel the sponsor to continue providing them the study drug after the trial ends.  (Like here and here)  (Legislative efforts to encourage drug manufacturers to sponsor clinical trials for rare conditions have been discussed before, like here.)

For some reason, and with one recent exception, it seems like there have been fewer of these cases in the last few years. There are certainly lots of clinical trials going on and, presumably, patients in them who might claim some injury, physical or otherwise, from their participation. Could it be that the putative plaintiffs have backed off of trying to sue clinical trial sponsors? Could it be that the plaintiff lawyers have read the rulings and decided these cases are not worth bringing? Could it be that the cases still exist, but we are not seeing decisions from them caught in the net Bexis uses to find blogworthy decisions?

We may never know the real answer, but we did see an appellate decision from New York last week in Wholey v. Amgen, Inc., — N.Y.S.3d –, 2018 WL 4866993 (N.Y. App. Div. Oct. 9, 2018). Wholey involved claims of injury from the use of a well-known and often-studied FDA-approved prescription drug both during and after a clinical trial. The defendants filed motions to dismiss, which were granted in part and denied in part, and an appeal ensued. This is the part we care about:

As the sponsors of a clinical trial, defendants owed no duty to the plaintiff Lauren Wholey, as enrollee in the trial (see Sykes v. United States, 507 Fed. Appx. 455, 462 (6th Cir. 2012); Abney v. Amgen, Inc., 443 F.3d 540, 550 (6th Cir. 2006)). Thus, her claims concerning the drug Enbrel must be limited to those that allegedly arose after she stopped participating in the trial and was prescribed the drug as a patient.

Id. at *1. When we said that was the part we care about, we meant it. That is the full discussion of the issue of liability for the sponsors of a clinical trial. No duty means no liability. We appreciate the finality and brevity of the analysis. We emulate the brevity here.

 

Just two weeks ago, we largely praised an MDL court’s handling of sanctions for a plaintiff’s stonewalling in response to discovery obligations, but thought the plaintiff got off pretty light for some really egregious conduct.  Today, we report on a circuit court’s affirmance of discovery sanctions against a plaintiff counsel’s conduct for being overly aggressive in the pursuit of discovery. In light of the holiday today, we will be extra careful in how we describe the plaintiff’s counsel’s conduct and refrain from drawing any conclusion about what the conduct here says about the counsel. We will leave to the reader to decide whether the sanction imposed here—about $25,000 in costs and fees—will have a sufficient deterrent effect and whether the cost of an appeal of a $25,000 sanction after the plaintiff lost summary judgment was worth it.

As you might expect for a case that got to an appeal on a sanction order, the history of Vallejo v. Amgen, Inc., — F.3d –, 2018 WL 4288360 (10th Cir. Sept. 10, 2018), is complicated. Our summary of the pertinent facts is just a summary, with more flavor in the actual case. The case involves an estate suing over a fatal blood cancer called myelodysplastic syndrome (“MDS”) in a patient taking a well-known biologic for psoriasis. Perhaps because of the track record of the medication and the relative novelty of the claimed injury, the court ordered that the first phase of discovery should focus on whether the medication can cause MDS. (It appears that the medication has been studied in the treatment of MDS in multiple studies among the hundreds completed over decades.) After disputes arose on the scope of such general causation discovery, the magistrate held a hearing at which plaintiff presented an expert, who claimed he needed every clinical trial on the drug and all information relating to possible effects on “red blood cells, white blood cells, platelets, or any precursor cells for these blood cell lines.” The magistrate concluded that the scope of discovery sought by plaintiff was unreasonable. Ignoring that, plaintiff served broad discovery requests and the defendant objected on scope, burden, and proportionality, offering to produce a range of documents focused on the medication and MDS. Plaintiff sought to require the defendant to search adverse events for 206 terms, but the magistrate “limited discovery to 15 search terms that provided the most specificity to MDS.”

Plaintiff also sought discovery on other medications of the same class and the defendant objected. The magistrate ordered the defendant to produce non-public studies on the possible relationship between the medication and MDS. Defendant also offered up a global safety officer for deposition and plaintiff demanded the names of everyone who ever worked on adverse event handling for the medication or who had responsibility for any evaluation of its relationship to MDS. The magistrate allowed the plaintiff to depose the safety officer to find out other witnesses as needed. Because the defendant had not submitted affidavits to prove the burden of coming up with a list of everyone who had worked on the medication over decades, the magistrate advised the parties that they would need to “quantifiably explain the burden of providing the requested information” going forward. Plaintiff sought clarification from the magistrate and appealed the discovery order to the district judge. The district judge denied the appeal, noting the role of proportionality in discovery.

Meanwhile, plaintiff noticed up the safety officer for deposition beyond what the magistrate had ruled was permissible, and the magistrate had to issue a protective order until the district court could rule. When the deposition started after the district court’s ruling, plaintiff sought to question beyond the scope of the rulings. The magistrate suspended the deposition for more briefing and to set a time to supervise the deposition when it reconvened. When that happened, plaintiff’s counsel tried to reargue prior rulings, argued with the magistrate, and “asked the witness questions which were explicitly beyond the scope of discovery as ordered by the court.” Thereafter, the magistrate denied a motion to compel additional depositions and document production, noting that plaintiff’s counsel had plenty of information on causation from what had been produced and from other sources. The magistrate also directed plaintiff to disclose the general causation experts that her counsel had claimed to have when arguing with the magistrate during the safety officer’s deposition. Plaintiff again appealed and the district court again denied it.

After all this and some more jockeying, the defendant moved for sanctions for plaintiff’s counsel’s “repeated attempts to circumvent the court’s limitations on the first stage of discovery and abused the judicial process.” Defendant sought about $141,000 in fees and costs and the magistrate awarded about $25,000 for a variety of sanctionable conduct. The district court came to the same conclusion on its de novo review after appeal. After summary judgment was granted because plaintiff failed to name a causation expert, despite the claims of her counsel that she had retained one, the appeal to the Circuit Court followed. If are not exhausted after that recap, then you have more tolerance for discovery fights than do most courts we know. You might also reflect on the question of whether the burdensome discovery plaintiff sought and the fights that she initiated on discovery issues were part of a scheme to force some kind of settlement before having to prove general causation.

In affirming, the Tenth Circuit not only reinforced the limits on what counsel can do when they keep losing discovery fights, but provided guidance on some recurring issues in discovery. We start with the final word:

Attorneys are entitled to advocate zealously for their clients, but they must do so in accordance with the law, the court rules, and the orders of the court. The district court properly exercised its inherent power to sanction Vallejo’s counsel, and we find no abuse of discretion.

Focusing on the motion to compel that plaintiff filed after the first attempt at deposing the safety officer, this was easily characterized as “relitigation of issues already decided by the court.” It did not matter whether plaintiff had a basis for the positions that it took initially. As the magistrate held—within its discretion per the Circuit Court—“absent any change in circumstances, filing additional motions raising the same arguments was harassing, caused unnecessary delay, and needlessly increased the cost of this litigation.”

On the issue of proportionality, the Circuit Court affirmed that proof of burden can be established by means other than sworn statements. While statements in a brief (signed by counsel) are not proof, a court may consider “common sense” in evaluating the burden part of proportionality. In this case, it also had plaintiff’s counsel’s demonstration of how many hits a small portion of plaintiff’s preferred search terms produced. So, plaintiff’s counsel could not excuse misconduct by claiming no limits should have been imposed in the first place.

Plaintiff’s efforts to turn the focus to alleged misrepresentations by the defendant’s counsel were similarly rejected, as the Circuit Court was “satisfied that the district court did not rely on misrepresented facts by [defendant] in issuing its discovery orders.” Nor could she shift the focus to how the magistrate conducted the discovery hearing in terms of questioning of defendant’s expert, whose core opinion was that the Biologic License Application had relevant information on causation. Among other things, the district court did not rely on the defendant’s expert in limiting the scope of discovery. Plaintiff also tried to claim that she should have had access to all the information FDA might consider in evaluating medical causation, but this was a red herring given the difference between FDA standards and court standards, the absence of any MDS signal, and the court’s discretion to limit discovery on general causation. Plaintiff’s last gasp was to claim her case was prejudiced by the sanctions against her, but it was her counsel’s decision to claim she had general causation experts and her failure to name even one when required, instead trying to get by with a designation of an unspecified employee of one of the companies involved with the medication.

In short, plaintiff’s counsel conduct was sanctionable because the court set limits on discovery within its discretion and then plaintiff’s counsel chose to relitigate them and flaunt them until plaintiff lost for the fundamental reason of having no general causation expert. The fact that plaintiff ultimately lost despite pursuing these tactics reinforces that the tactics were obstructionist rather than excusing the tactics themselves. Even on the defense side, where we have been known to litigate aggressively on issues like the scope of discovery and the sufficiency of general causation, Vallejo can be instructive on the need to respect final rulings as the law of the case.

Stop us if you have heard this before. A novel or movie depicts litigation in which a large corporate defendant is sued for causing a plaintiff or plaintiffs significant injuries through a frivolous or non-beneficial product. In defending the litigation, the corporation and its unscrupulous lawyers hide important documents from the scrappy plaintiff lawyer, who, depending on the fiction’s direction, never discovers or miraculously discovers the key evidence. Perhaps informed by this view of corporate defendants and their lawyers as less than honorable, a number of courts have imposed significant sanctions against defendants when, despite producing millions of pages of documents created well before the litigation started and gathered from around the world, fail to preserve and produce some number of documents that the plaintiffs contend should have been produced. The importance of the documents to the case and the overall merits of the case tend not matter to the award of sanctions. To the contrary, the sanctions can themselves affect the outcome of the litigation. We know you have heard about these litigations, as we have described them in a number of posts through the years.

The situation where a plaintiff is sanctioned for her refusal to disclose information and produce documents in litigation is far less common. Mind you, we do not think the conduct is less common. We think it happens all the time, but rarely goes to motion let alone a published decision about a bellwether plaintiff in a product liability MDL. In re Taxotere (Docetaxel) Prods. Liab. Litig.¸ MDL No. 2740, 2018 WL 4002624 (E.D. La. Aug. 22, 2018), presents a sanctions order that may not signal a trend toward equal treatment for plaintiffs and defendants on discovery obligations and sanctions because this plaintiff’s conduct was just so obviously bad.

The plaintiff was suing over hair loss from a chemotherapy drug for her cancer. She was also a medical doctor and bellwether plaintiff. (We pause just on these facts in case our readers want to ponder how litigation now is different than the “old days,” whenever that might have been.) The MDL had a Plaintiff Fact Sheet requirement and an order explaining discovery obligations for electronically stored information apply to them too. After bringing her suit and for over a year thereafter, the plaintiff treated with, or at least sought advice from, a physician on how to regrow her hair through an unspecified regimen.  She documented her progress with photographs and, when the treating physician asked for permission to use them to promote his treatment, squarely stated she “[w]ould rather not have the lawyers for the other side put two and two together just yet.” She failed to identify this physician on her fact sheet, provide authorizations for him, or identify the treatment she was receiving at his suggestion. When she realized that her produced emails—like we said, the court realized plaintiffs have to produce ESI too—included information about this undisclosed physician, she directed him to resist discovery: “just tell them that you weren’t really my doctor . . . you don’t have any records [and] you never saw me.” Meanwhile, plaintiff (who had a lost wages claim) directed her former employer, a particular Veterans Affairs Medical Center, to refuse to produce any employment or medical records.

The decision focused on the plaintiff’s conduct regarding her undisclosed physician. Plaintiff’s primary defense was that the doctor recommending her a treatment regimen she was utilizing and corresponding with about its progress was not really “her doctor.” She supported this argument with an affidavit from the doctor to the effect that he did not consider the plaintiff to be his patient. This argument did not hold water because the PFS required disclosure not just of treating physicians, but any healthcare provider consulted over the prior eight years, including any “hair loss specialist.” It also required disclosure of “over-the-counter medications, supplements, or cosmetic aides for your hair loss.” We assume it also required production of photographs documenting the extent of any claimed injury (i.e., hair loss over time). It was easy to find that plaintiff had failed to comply with her discovery obligations, especially because “she has encouraged at least [two] potential witness[es] to be less than forthcoming in this litigation.”

What was the sanction? She had to produce the stuff she was supposed to produce anyway, sit for further deposition on the withheld evidence, and pay the defendant’s cost for the motion for sanctions. Yawn. The order was supposed to be a warning for her or “any other plaintiff who might be considering adopting evasive tactics like those discussed in this opinion.” We think she got off light and, particularly in the context of a big MDL—this one has more than 9000 pending cases—the sanction lets plaintiffs and their lawyers make calculated decisions about whether it pays to avoid discovery obligations. We cannot see a defendant in a litigation like this getting off nearly so lightly had it done anything like what plaintiff did here.

 

A few weeks ago, we reported on another in a line of Missouri appellate decisions rejecting the ability of Missouri courts to try the claims of non-Missouri residents against non-Missouri manufacturers of baby powder not used in Missouri.  The next day a jury in the same trial court awarded billions in a trial of 22 baby powder users. This was all part of a long saga of litigation tourism to the Show Me State.

It turns out that some plaintiffs prefer to go ever upwards with their baby powder claims in New York state court. We are not talking about New York residents suing in their friendly neighborhood court, we are talking about litigation tourists coming to the Big Apple with hopes of big awards. The problem–for them–is that New York state courts are supposed to apply personal jurisdiction according to the same standards that the Missouri appellate courts and the United States Supreme Court have been lately. We received two very similar decisions from a friend of the blog, Thomas Kurland of Patterson Belknap, that address personal jurisdiction for claims against the manufacturers of baby powder by people with no particular connection to where they were suing. The difference from the baby powder cases from Missouri and New Jersey that we have discussed before is that these plaintiffs claimed mesothelioma from asbestos allegedly in baby powder they had used.

The first case, Hammock v. Avon Prods., Inc., No. 190215/2016, 2018 WL 3601393 (N.Y. Super. Ct. July 27, 2018), has been published and came out a few days before the second, Crozier v. Avon Prods., Inc., No. 190385/2016 (N.Y. Super. Ct. July 31, 2018). The issues and analyses were almost identical, so we will discuss them together and skip pinpoint cites. The plaintiff in Hammock claimed exposure to the decedent from use of baby powder on herself, her children, and patients where she worked over the span of more than 35 years. All of the exposure, and any purchasing the decedent did, occurred in Virginia, where she lived. The plaintiff in Crozier claimed use of baby powder and a related cosmetic product when she was an infant and a teenager.  All use and purchasing of the products was in Texas, Oklahoma, and Kansas.

Both plaintiffs brought suit in New York state court against a number of defendants. We report on the motion in each case of the manufacturer and distributor of the baby powder, Johnson & Johnson Consumer Inc., and its holding company parent. Neither of those entities was incorporated in New York, had its principal place of business in New York, or was registered to do business in New York. The subsidiary did not manufacture or develop the baby powder in New York. Despite these facts, the plaintiff in each case claimed the court could exercise general personal jurisdiction over both entities or, at least, should allow jurisdictional discovery to proceed.

Based on a straightforward application of Bauman, Walden, and BMS, the court rejected both general and specific personal jurisdiction in each case. On general jurisdiction, each plaintiff pointed to “several isolated events that Johnson & Johnson was involved in (including industry meeting that Johnson & Johnson employees attended in the 1970s, four (4) letters sent from Johnson & Johnson representatives to New York-based scientists, and two statements make to the New York Times).” This was clearly not enough, as “isolated” is not a synonym for “continuous” or “systematic,” both of which are required for contacts to establish general personal jurisdiction. While it is not clear that either plaintiff even offered an argument on specific jurisdiction, the court went ahead and addressed that issue anyway. With all alleged exposure in each case hundreds of miles away from New York, “there is no articulable nexus or substantial relationship between the J&J Entities’ New York conduct and the claims asserted.” Holding off on dismissal to allow for jurisdictional discovery was also not in the cards as any discovery either plaintiff could seek would be futile.

We say the plaintiffs were sent packing, but the truth is that we do not know about the substance or disposition of any claims against other defendants—as there appear to be based on the captions. There may be other defendants, maybe even ones over which New York could exercise general personal jurisdiction, who are alleged to be liable for some separate asbestos exposure that allegedly caused the respective plaintiffs’ alleged injuries. While we may be accused of being defense hacks—we were so labeled just yesterday—we do see the difficulty of picking the right place to sue multiple defendants who are not residents of the plaintiff’s state. Suing in New Jersey, for instance, would have allowed the court to exercise jurisdiction over the New Jersey defendants, but maybe not over defendants from New York or somewhere else. Of course, if there really were acts by the defendants that arguable created liability in the states where these plaintiffs used products and live(d), then a Hammock case in Virginia and a Crozier case in Texas might not have been caught in jurisdictional snags. They probably would have been removed to federal courts, however, and been subject to substantive law and procedures the plaintiff lawyers wished to avoid. So, before you say we have something against New York or some other litigation tourism destination, think about whether the plaintiffs who hit the road are looking for a fair venue or a favorable one.

Even if Bexis and McConnell like to sport overalls and tool around in souped-up tractors, we are not farmers.  We have grown enough heirloom tomatoes, ghost peppers, rainbow chard, purple basil, and other suburban garden staples, however, to know that “you reap what you sow” is usually true, assuming the levels of hydration, sunshine, and soil pH are appropriate.  (There are pleasant exceptions, like asparagus from prior owners or berries spread by critters, and undesired interlopers, like Japanese hops and any number of leafy weeds.)  It is often true in litigation too.  When the Bauman and Walden decisions came down in early 2014, it should have been apparent that the sort of litigation tourism that had driven so many verdicts and settlements based on fear of verdicts in plaintiff-friendly places was going to be a risky proposition going forward.  While we and many others touted these rulings and proclaimed what should happen with personal jurisdiction in such cases, the plaintiffs’ bar did not give up on what had been such a lucrative approach.  Instead, they continued filing multi-plaintiff cases in their desired jurisdictions, even though almost all of the plaintiffs had no ties to the jurisdiction and the defendants were not “at home” there.  They also fought against motions and appeals with sometimes creative arguments that generally flew in the face of what the Supreme Court had already ruled.  While these packaged tour cases remained in these dubious jurisdictions, they sometimes progressed to trial and, aided by lenient views of the admissibility of junky causation evidence or other rulings that tend to drive up verdicts, scored some really big verdicts.  While some defendants surely settled along the way, others stuck it out to get to appellate rulings that would undo everything with a pronouncement that “this plaintiff’s case never belonged here in the first place.”

If you are reading this and thinking about the talc litigation in Missouri, then you would be right.  It is not the only litigation to follow this pattern, but it has been one of the most visible.  The timeline implicated by Ristesund v. Johnson & Johnson, — S.W.3d –, 2018 WL 3193652 (Mo. Ct. App. June 29, 2018), is where we will start, because it shows the sowing to which we alluded so awkwardly above. Bauman and Walden come out in February 2014, signaling a tightening of the general personal jurisdiction standard and a refusal to expand the specific personal jurisdiction standard.  In September 2014, plaintiff, a South Dakota resident, filed a lawsuit in Missouri state court about alleged ovarian cancer from talc in cosmetic products along with a Missouri resident and seventy-three other non-Missouri residents.  Plaintiffs pushed forward through discovery and motions to a series of trials.  Motions to dismiss for lack of personal jurisdiction for the claims of the non-Missouri residents were denied based on the conclusion that the court’s jurisdictions over the claims of the sole Missouri resident was enough.  In February 2016, the estate of a non-Missouri plaintiff named Fox won a large verdict and then defendants appealed.  In May 2016, Ristesund won her own large verdict and then defendants appealed.  In June 2017, the Supreme Court issued the BMS decision, essentially rejecting reliance on the ties of (misjoined) plaintiffs to establish specific personal jurisdiction over the claims of a plaintiff who would not otherwise be able to establish general or specific personal jurisdiction.  In October 2017, the Missouri Court of Appeals ruled in Fox v. Johnson & Johnson, 539 S.W.3d 48 (Mo. Ct. App. 2017), that plaintiff did not establish personal jurisdiction consistent with constitutional requirements and should not get a chance to do so on remand.  (We detailed the decision here.)  The same court considered almost the same issues in Ristesund about two weeks ago.

Pretty straightforward, one would think.  Plaintiff, to her credit, even conceded that BMS controlled and the trial court lacked personal jurisdiction over defendants as to her claims. Ristesund, — S.W.3d –, 2018 WL 3193652, *2.  That meant the verdict could not stand.  The only issue left was plaintiff’s argument that “fairness requires” that she have an opportunity on remand to develop arguments and evidence support personal jurisdiction.  This is where that timeline mattered.  As in Fox, the plaintiff “had a full and ample opportunity to discovery and introduce any and all evidence that she believed would establish personal jurisdiction over the Defendants.” Id. at *3.  While not all plaintiffs try to gather and introduce evidence of personal jurisdiction, recall that this case was filed after Bauman was decided.  It went to trial after a personal jurisdiction motion was denied, an appeal on a companion case focused on personal jurisdiction, and scores of cases (see our cheat sheet) had been decided around the country on applications of Bauman that anyone would have realized undercut personal jurisdiction in this case.  The plaintiff lawyers pursuing all of these cases took a calculated gamble to work up these cases and win big verdicts in a court where personal jurisdiction was tenuous at best, as long as the defendants were willing to sustain the trial losses and get to appeals. Ristesund could have sued in South Dakota—where she lived—or in New Jersey—where the defendants were based—but she chose the litigation tourist route.

Her last gasp was to claim that BMS being decided after her trial verdict somehow entitled her to another chance to prove personal jurisdiction.  The court’s rejection of this contention can stand on its own.

Principles of fairness do not dictate or warrant remand. The pronouncement in BMS neither introduced new concepts in the law nor relied upon new principles of law. BMS was not a decision that “came out of nowhere.” To the contrary, the parties in BMS, as in Daimler, argued long standing principles of personal jurisdiction in our jurisprudence. The parties before us were well aware of the legal principles being argued before the Supreme Court, as evidenced by their pleadings and argument before the trial court.  Ristesund was not precluded from broadening the scope of her claims for personal jurisdiction while her case was before the trial court . . . . Similar to our reasoning in Fox, we are not persuaded that the law either warrants or permits us to now return this matter to the trial court for a “do-over.”

Id. at *5.  That sounds pretty fair to us.

It has been said, with maybe a bit of sarcasm, that a company developing a drug hopes that its drug will become successful enough to attract frivolous lawsuits.  OK, so maybe only outside lawyers have offered such an aphorism, but bear with us.  Imagine that a drug is developed to treat a really common condition, like high cholesterol, it becomes accepted as a first-line treatment, and becomes one of the most widely used prescription drugs of the last few decades.  Imagine then that the patient population that would take this drug has lots of co-morbidities and that, while the drug is being used on a long-term basis, some predictable portion of the drug’s users will develop a new condition, like diabetes.  Imagine then that, because the drug has been widely used for so long, there are lots of studies, published and unpublished, that look at measures like blood glucose and new diagnosis of diabetes, among many other things.  It should not be hard to imagine that thousands of the patients taking the drug would develop diabetes on the drug in the absence of any relationship and that plaintiff lawyers would round many of them up to sue based on the expectation that the lawyers and their favorite experts could gin up proof of causation that would survive a Daubert challenge if the manufacture did not pay to get rid of the litigation first.  This is hardly fancy as we have posted on multiple orders from Lipitor MDL (here, here, and here) that excluded plaintiffs’ causation experts and then granted summary judgment for the manufacturer across the board.

Much like the Zoloft MDL affirmance we lauded last year, all of this went up on appeal to either revive or affirm the end of an entire litigation.  We are pleased to say that In re Lipitor (Atorvastatin Calcium) Mkt’g, Sales Pracs. & Prods. Liab. Litig. (No. II), MDL No. 2502, — F.3d —, 2018 WL 2927629 (3d Cir. June 12, 2018), did the latter.  Without repeating the history of all of the decisions below that we detailed previously, there were five basic issues on appeal, the admissibility of each of the three experts plaintiffs offered, whether plaintiffs could use other evidence to establish causation without experts, and whether plaintiffs’ responses to show cause orders were sufficient to avoid summary judgment.  Each deserves some attention.

Plaintiffs’ statistician was up first.  His approach was to re-analyze clinical trial data to suggest that there was an increase in blood glucose levels and infer that as proof of causation for diabetes.  The disconnect here is fairly obvious, but the statistician compounded the problem by including both patients with a single instances of elevated glucose levels during the trials and patients with elevated glucose levels before the study began. Id. at *4.  Plaintiffs, their statistician, and other experts had agreed that a single increased glucose level did not indicate diabetes. Id. The statistician also agreed, as the MDL court put it, that he “lacked the expertise to opine about any implications that single glucose readings might have about the possibility of new-onset diabetes.” Id. This might have been enough to exclude his opinions, but he also relied on one test of statistical significance after the standard test failed and presented calculations of average blood glucose increases in a misleading and result-driven fashion. Id. at **5-6.  He also re-analyzed a study that had found no increased in the rate of diabetes with the drug compared to placebo based on a applying a new definition of diabetes after the fact and by someone who lacked relevant expertise. Id. at **6-8.  The Fourth Circuit affirmed the exclusion of his opinion, noting that the MDL court “properly discharged its gatekeeping duty” by weighing “classic concerns regarding reliability and relevance.” Id. at *6.

Plaintiffs also offered an internist to interpret the medical literature and perform meta-analysis of select studies, which he attempted to dress up with a purported application of the Bradford Hill criteria.  Noting the importance of dose to these analyses, the MDL court asked the internist to provide an analysis specific to each commercially available dose of the drug.  The MDL court ultimately excluded his causation opinion as to all but the highest dose because he acknowledged there was not a statistically significant increased risk of diabetes for the other doses. Id. at *9.  On appeal, plaintiffs challenged that their internist could not just lump all the doses together and offer a single causation opinion.  Given the facts here—like a 10 mg low dose, a 80 mg high dose, and studies specific to each dose—we do not think this requirement should have been the least bit controversial.  The Fourth Circuit, however, while holding that the MDL court did not “abuse its discretion in asking the expert to produce a dose-by-dose analysis,” cautioned that this was not a new requirement for all cases. Id. at *10.  The more serious, and recurring, issue was whether statistical significance was required for a causation opinion based on epidemiologic evidence and the Bradford Hill criteria.  Again, we think the Fourth Circuit could have gone a little farther—like you always or almost always need epidemiologic evidence as a starting point for causation in a product liability case and epidemiologic evidence must be statistically significant (with multiple studies with an increased risk greater than 2.0) to count—but its conclusion that the MDL court had not abused its discretion on the record here was good enough.  Specifically, the internist’s purported application of the Bradford Hill criteria and failure to establish that reliance on non-statistically significant results was accepted by epidemiologists were enough for the court to find his causation opinions unreliable. Id. at *12.

Plaintiffs also offered another internist to opine on specific causation for one of the bellwether plaintiffs.  While the plaintiffs touted that this expert had used a differential diagnosis to come to her opinion, the expert herself did not say that she did and claimed to use a methodology for her opinion in litigation that she had never used in her own practice. Id. at *13.  She also could not rule out other causes like the plaintiff’s weight and weight gain and relied too heavily on the post hoc ergo prompter hac fallacy. Id. at *15.  Again, this exclusion was within the MDL judge’s discretion.

Like the MDL court, the Fourth Circuit did not a bright line rule on whether general medical causation for product liability cases involving a pharmaceutical could ever be established without any expert testimony from the plaintiff.  We think the better approach, as spelled out in some state’s law, is to require expert testimony on these issues.  However, the Fourth Circuit’s conclusion that the specific non-expert evidence offered by plaintiffs—principally snippets from U.S. and foreign labeling—was not enough to establish causation is fine by us.  The causation issues are “complex and manifold” and the non-expert evidence from plaintiffs “isn’t especially strong.” Id. at *17 (contraction in the original).  So, the bottom line was more than fine by us:  “To hand to the jury the evidence here and ask it to reach a conclusion as to causation with any amount of certainty would be farcical and would likely result in a verdict steeped in speculation.” Id. Put another way, if a court is supposed to be the gatekeeper for expert evidence on key issues, it cannot just allow dubious non-expert evidence to suffice on an issue that would require an expert under Rule 702.

The last issue for the Fourth Circuit to address was whether the MDL court could require the remaining plaintiffs to come forward with evidence showing they could prove specific causation after the Daubert and summary judgment orders.  Plaintiffs’ argument on this was essentially that the MDL should have remanded all the cases rather than fulfilling the mission of the MDL court to decide common pretrial issues.  This argument was a bit disingenuous, because the plaintiffs surely would have been comfortable with summary judgment or Daubert motions being denied across the board had the rulings on the bellwether cases gone their way.  “Here, it was the district court’s prerogative to determine whether it could dispose of the cases before it on the merits.” Id. at *18.  We may not always be a fan of the direction MDL courts have taken in the last decade or so, but they are supposed to do what the MDL court did here.  At the end of the day, this MDL court “discharged [its] duties meticulously and thoughtfully” an ended a litigation as it should have been – with the manufacturer winning without facing the uncertainty of jury trials or succumbing to the pressure of a large number of pending cases.

Since Conte in 2008, we have not made a secret of our view that innovator liability is a bad idea, contrary to traditional tort law principles and to sound public policy.  We, especially Bexis, may even be accused of being somewhat obsessed with chronicling the decisions, big and small, on this issue over close to a decade.  We have kept a scorecard of the decisions and commemorated the one-hundredth decision.  We tracked when the Alabama legislature got sick of the turbulent expansion by the courts and kept product liability limited to the product designed, manufactured, or sold/leased by the defendant.  We have peppered our top and bottom ten lists with these decisions and we expect they will find places on our august enumerations for the eleventh year in a row this December.

The decision in In re Zofran (Ondansetron) Prods. Liab. Litig., MDL No. 1:15-md-2657-FDS, 2018 WL 2317525 (D. Mass. May 21, 2018), has familiar ring to it.  Among the claims presented in this MDL are those against the branded manufacturer from the offspring of women who received generic versions of a prescription antiemetic.  These plaintiffs sought to impose innovator liability on the theory that the branded manufacturer had made misrepresentations to unspecified doctors that somehow encouraged the off-label prescription to pregnant women for morning sickness without disclosing a purported risk of birth defects.  (As an aside, while not in the decision, this is considered an essential medication by WHO and the current labeling suggests that FDA rejects that any birth defect risk has been established.)  Last year, the court ruled on a motion to dismiss this version of innovator liability under Georgia, Indiana, Kentucky, Massachusetts, New York, and Oklahoma law.  We discussed it here  and it took on honorable mention on last year’s top ten list.  Other plaintiffs persisted with these claims and the branded manufacturer defendant filed a motion for judgment on the pleadings.  After some voluntary dismissals, the court considered the issue under the law of Oklahoma (again), Connecticut, and New Jersey.

Why is this worth a post instead of just an update to our scorecard? Well, there have been two really big, bad decisions on innovator liability since the court’s prior decision and we like to make sure the majority position continues to hold after such dreck.  The first innovator abomination was T.H. v. Novartis Pharm. Co., which we railed about here and took over the spot of worst case of 2017 in a rare supplemental shuffling of the list.  We have said quite a bit about why this decision, and the Court of Appeals decision before it, were especially bad, extending innovator liability into perpetual liability under the guise of foreseeability.  A few months later, the Massachusetts Supreme Judicial Court a mile away from the Zofran MDL issued its own stinker in Rafferty v. Merck & Co., Inc., reversing a lower court rejection of innovator liability.   Even with the “limitation” that innovator liability would only for “reckless” conduct in failing to update the branded drug’s label, there is a good chance that this will find a place on the list of 2018’s worst come December.  There was also a good decision a few weeks ago from the West Virginia Supreme Court soundly rejecting innovator liability in McNair v. Johnson & Johnson, which may end up with a place on 2018’s best list.  More important than our lists—breathe, Bexis, breathe—is that the Zofran court reviewed and considered these decisions before addressing the merits.

The Oklahoma plaintiff’s claim was easy, given the court’s evaluation of Oklahoma law less than a year ago. “While it is true that the minority view has gained ground in the last year with the California and Massachusetts opinions, that is not sufficient under the circumstances to tip the balance.”  2018 WL 2317525, *4.

The court had not previously considered Connecticut law and the Connecticut state courts had not previously considered the issue. The Sixth Circuit had, though.  Connecticut was one of the 22 states at issue in In re Darvocet, which we lauded here before giving it the top spot in our 2014 list.  The Darvocet analysis was that the Connecticut Product Liability Act provided the sole remedy for misrepresentation claims asserted and it required the product at issue to be the defendant’s to impose liability.  While not binding, “In re Darvocet is a 2014 decision by a federal appellate court that addresses the issue in comprehensive terms, and there appears to be no Connecticut authority suggesting a contrary result.” Id. at *5.

Predictably, In re Darvocet (in the district court) had addressed New Jersey law and New Jersey lower courts have addressed the issue a few times, even if the New Jersey Supreme Court has not.  They all came out against innovator liability, with pre-Conte cases followed post-Conte.  (See here and the New Jersey part of this.)  The New Jersey PLA also limits liability to the manufacturer or seller of the product that allegedly hurt the plaintiff and misrepresentation claims like the plaintiffs assert against the branded manufacturer are subsumed by the NJPLA. Id. Thus, there is no innovator liability under New Jersey law.

Despite our retrospective here, we do not see this decision making this year’s top ten list. However, the First Circuit could certainly take high honors by affirming this or the prior Zofran MDL decision.  Just saying.

Prescription drug manufacturers are not insurers of injuries sustained while taking their products. Even in the most plaintiff-friendly jurisdictions, there needs to be some fault—whether framed in negligence, strict liability, or something else—and causation between the fault and the injury. It is surely not easy to stomach for someone who sustains such an injury while taking a drug, but sometimes there is no fault even if there is a significant injury related to the use of the drug. If the drug’s manufacturer warned about the risk of plaintiff’s ultimate injury consistent with the available evidence, which it examined and shared with FDA appropriately in connection with approval and after approval, and the prescribing physician(s) gave due consideration to the risk in treating the patient, then the manufacturer did what it was supposed to do and the patient might suppress the urge to sue someone. Often, of course, such patients become plaintiffs and courts are faced with deciding summary judgment in cases with a real injury, related in some way to the use of the drug, but no real claim against the manufacturer. In those situations, the courts often get it wrong and allow some claim to get past summary judgment. Nelson v. Biogen Idec, No. 12-7317 (JMV) (MF), 2018 WL 1960441 (D.N.J. Apr. 25, 2018), got it right. Joe Blute and Yalonda Howze of Mintz Levin, who defended the case and told us about it, deserve some credit for that.

The facts of Nelson do not exactly scream failure to warn, even with the severity of the injury claimed by the plaintiff, who received Tysabri, a prescription medication for his multiple sclerosis. He claimed to have developed progressive multifocal leukoencephalopathy (“PML”), a condition about which the drug’s labeling contained black box warning, multiple other warnings in physician labeling, and warnings in a medication guide that the drug’s Risk Evaluation and Management Strategy (“REMS”) program required the patient acknowledge when receiving the drug through infusion provided by a healthcare provider. With such extensive warnings also comes the expected developed record of interacting with FDA about PML, which we will attempt to summarize. The medication was approved in 2004, but withdrawn because of PML cases the next year. PML results from exposure to the JC virus, which is prevalent in humans but only causes PML in vulnerable patients. Before seeking to bring the drug back to market, the manufacturer conducted FDA-requested research on testing for the JC virus. After taking an advisory committee recommendation, FDA re-approved the drug in 2006 with a slew of robust warnings on PML and a REMS program that essentially documented understanding and/or acceptance of the PML risk at each step of the prescribing chain every time the patient received the drug. The label was updated in August 2008, November 2009, and July 2010 to provide more information on the PML risk. Meanwhile, the manufacturer worked to develop a better assay to detect exposure to the JC virus. After years of research and interaction with FDA, in 2012, a new assay was approved and the label was amended to reference it.

Meanwhile, plaintiff was prescribed the drug for his MS in April 2008 after being advised of the PML risk. Plaintiff moved and continued on the drug when prescribed by two other physicians, each of whom also warned him of the risk of PML. Plaintiff was negative for the JC virus in 2009, but started demonstrating signs of PML in 2010, which was confirmed later that year by brain biopsy. Plaintiff sued and was on the fifth version of his complaint when the court considered summary judgment on plaintiff’s remaining claim for failure to warn under the New Jersey Product Liability Act (along with a Daubert motion that was denied as moot).

The court started its analysis with a discussion of three prior decisions on similar claims with the same drug. We will skip that, partly because we have discussed these cases before.  Because this was under the NJPLA, the first issue was whether the “super-presumption” of the adequacy of the PML warnings would apply given plaintiff’s argument about post-approval compliance. The presumption did not look to be dispositive, as the court noted that the substance of the warnings to both the prescribing physicians and the patient were clear, strong, and effective. Yet, the court found that there was no evidence of “manipulation of the post-market regulatory process,” the basis of the so-called “McDarby exception,” noting the interaction between the manufacturer and FDA on an assay that could be used to detect the JC virus in connection with the use of the drug. (The court also assumed without deciding that the McDarby exception could apply.) In the face of this presumption, plaintiff relied on proposed expert testimony that only indirectly addressed the adequacy of warnings. His expert claimed a better assay could have been developed and approved in time to affect the various physicians’ decision to prescribe the drug to plaintiff. Even if his testimony were admissible and if he took the next step of connecting a new assay to the content of the drug’s label—which he did not and could not as a non-physician—there were still obvious issues with relying on this testimony to establish an inadequate label and proximate cause for failure to warn, including that the prescribing physicians were aware of the PML risk and discussed it with the plaintiff on multiple occasions. Put it all together and there was no evidence to carry a failure to warn claim, with or without a presumption of adequacy

As a bit of overkill, the court went ahead and considered the manufacturer’s preemption defense, which argued that the proposed changes to the drug’s label would have been impossible to make during the relevant time. The prior decisions that we elided above also found impossibility preemption, but they were not decided in the Third Circuit after the Fosamax decision tried to make the application of Levine’s once-novel “clear evidence” standard just a question for juries. Even acknowledging the high standard and the decision in Fosamax (albeit with a recurring, and surely unintentional, misspelling), the court still found “There is clear evidence that FDA would not have approved an earlier change to the Tysabri label or have approved the JC Virus assay.” FDA specifically rejected similar proposals twice in 2010, before approving the assay and corresponding labeling change in 2012 after additional research had been committed. That was pretty clear evidence of impossibility back when plaintiff was taking the drug.

So, the manufacturer won summary judgment thrice over. The co-developer also won because it had no ability to change the label, a useful nugget as innovator liability and other theories to impose liability on other defendants continue to get raised when the logical defendant is not liable. In Nelson, no defendant was liable to an injury that, while unfortunate and serious, was warned of about as thoroughly as is possible with a prescription drug. We would prefer such a case never to have been brought or to have been dismissed for failure to state a claim, but summary judgment is still the right result.

 

Today’s post is another guest post from friend of the Blog Kevin Hara, of Reed Smith, who channels our resident movie critic in this wide-ranging discussion of pleading and procedural weirdness.  As always with our guest posts, the author deserves 100% of the credit, and any blame, for what follows.

**********

If ever one wanted to feature a case where the plaintiffs and their attorneys fumbled and stumbled around like Keystone cops, it would be Paulsen v. Abbott Laboratories, 2018 U.S. Dist. LEXIS 50256 (N.D. Ill. March 27, 2018), involving the prescription drug Lupron, used to treat endometriosis.  The case really reminded me of the madcap, masterful ensemble movie, “It’s A Mad, Mad, Mad, Mad World” (hereinafter, “Mad World”) (yes, it’s a bit dated in some ways, but it still merits watching if you haven’t) with a veritable Who’s Who of 1950s-1960s Hollywood comedy royalty, including Edie Adams, Sid Caesar, Milton Berle, Ethel Merman, Jonathan Winters, Terry Thomas, Mickey Rooney, Phil Silvers, and Buddy Hackett.  Not to mention two time Oscar Winner Spencer Tracy and Jimmy Durante, who literally kicks the bucket as his character passes away and starts the mayhem.  Even if one does not consider the film a classic, its cultural relevance is beyond debate, as in addition to the headliners, the supporting cast included Peter Falk, Eddie “Rochester” Anderson, the 3 Stooges, and the great Arnold Stang.  Moreover, it bears mention that the renowned director of Mad World, was Stanley Kramer, more recognized for his social dramas, including Guess Who’s Coming to Dinner, The Defiant Ones, and Judgment at Nuremberg.  With such an accumulation of talent, it comes as no surprise that Mad World received six Academy Award and two Golden Globe nominations, and is categorized by many as an all-time classic in American movie history.  The plot is full of twists and turns, but beautifully elevated, with stellar writing and acting to match: 5 strangers witness an accident, and simultaneously learn about a large sum of money hidden in a park, buried beneath a large “W,” with Durante’s last gasp.  At first, they agreed to equal shares of the $350,000, but soon each plots to recover the loot on his own, and everyone begins a mad dash with assorted partners in crime (spouses, friends, relatives, etc.) to be the first to reach the cash.  In so doing, each of five groups tries to undermine the others, and they all encounter setbacks from being locked in the basement of a hardware store, stranded on a highway with a child’s bicycle, sinking in a river, a drunken airplane pilot, and more.  (For those of you from younger generations who are Googling the names or the movie above, you might be more familiar with a newer iteration of a similar story in the movie Rat Race, starring Whoopi Goldberg, Dean Cain, John Cleese, Cuba Gooding, Jr., Cathy and Kathy Bates, among others.)

If you have not seen the movie, you certainly should, but one iconic scene essentially captures the film, a sequence in which Winters demolishes an entire gas station, mostly by hand, in several hilarious, frenetic minutes. The movie ends with all of the misguided, money hungry adventurers in the hospital with multiple injuries, but none of the treasure.  In a last, desperate (and shameless) grab for the bounty, the hapless male contingent is catapulted, one by one, from the ladder of a fire engine attempting to rescue them, as the terrified crowd below watches and the entire haul slowly floats to the now delighted onlookers.  In short, grasping for money, at the expense of ethics, morality, and intelligent planning gets you nowhere.

Procedural History

Much like the film, Paulsen has misdeeds galore, with seeming chaos at every turn, thanks to its beginning as a multi-plaintiff, misjoined complaint with a California resident, and a Georgia resident (Ms. Paulsen) bringing an action in the Eastern District of New York in April 2010. See Cardenas v. Abbott Labs., 2011 U.S. Dist. LEXIS 116879 (N.D. Ill. March 7, 2011).  Plaintiffs alleged injuries as a result of injections of the drug, and asserted negligence, strict liability, failure to warn, breach of warranty and fraud causes of action against various defendants.  In homage to the movie, it is fitting to provide aliases for the defendants using the names of the actors in the movie – because it is the plaintiff’s shenanigans that are the focus here – not the defendants’ titles and actions. Therefore, in that regard, the defendants are now dubbed Abbott Laboratories (hereinafter “Sid”), Takeda Pharmaceuticals of North America, Inc., (“Ethel”),Takeda Chemical Industries, Inc., (“Milton”) and TAP Pharmaceutical Products, Inc. (“Jonathan”) (collectively, “Defendants”). Id. at *3.  The Defendants filed a motion to dismiss, objecting to venue, so plaintiffs amended their complaint, adding New York and New Jersey plaintiffs.  Didn’t matter.  The case was transferred to the Southern District of New York. Id. Defendants again filed a motion to dismiss, and the Southern District of New York transferred the action to the Northern District of Illinois in 2011, addressing issues of venue and personal jurisdiction, and dismissing defendant “Milton” because it was not served with the complaint. Id. (but more on that later). Id. Finally, the Illinois federal court considered a substantive (Rule 12 (b)(6)) motion to dismiss, and found that plaintiffs provided “nothing but the fact that [they] received Lupron injections ‘on several occasions.’” Id. at *12-13.  For example, the complaint failed to indicate “whether Plaintiffs [were] women, nor [did] it establish whether Lupron was prescribed to Plaintiffs” for on- or for off-label use.  All these omitted facts were, obviously, “particularly within Plaintiffs’ control.” Id. Therefore, the court dismissed the complaint, with leave to amend to allow plaintiffs to put “some minimal amount of flesh” on their bare-bones allegations. Id. at *13-14.

Plaintiffs filed an amended complaint in October 2011, and discovery commenced, but with Paulsen the only remaining plaintiff, in August 2013 her counsel moved to withdraw. See Paulsen, 2018 U.S. Dist. LEXIS 50256, at *8.  The judge granted the motion, allowing plaintiff 30 days to file an appearance.  That didn’t happen either.  The action was dismissed for lack of prosecution in October 2013 after plaintiff failed to appear. Id.

Plaintiff’s Second Action

Undeterred, plaintiff filed a new complaint on May 11, 2015, alleging claims for negligence, strict product liability, failure to warn, breach of warranty, and fraud against “Sid”, “Ethel”, “Milton” and “Jonathan”. Id. at *9.  Plaintiff alleged that she had been injected with Lupron twice for on-label treatments, and had suffered various injuries, all of which occurred in Georgia. Id. at * 3-4.  Defendants moved to dismiss, claiming that the lawsuit was untimely and seeking application of the six-month limitation in Georgia’s savings statute [Ga. Code Ann. § 9-2-61(a)], while plaintiff maintained that Illinois’s one-year period governed the issue, 735 ILCS 5/13-217.6. Id. at *10.  After determining that the only Illinois citizen, Sid, was a real party in interest (a dispositive issue, because if not, Georgia’s statute controlled time-barring the case), the judge denied the motions to dismiss without prejudice. Id. at *10-11.

Dismissal of Milton and Jonathan

Defendants resubmitted their motions to dismiss in April 2017, arguing that Milton and Jonathan were not properly served, an interesting issue that itself could be the subject of its own post. Id. at *17-18.  Suffice it to say that the court ruled that service on Jonathan’s surviving corporation (because Jonathan no longer existed at the time the case was originally filed in 2010) was improper because in essence, “[p]laintiff cannot effectively serve one corporation by serving a completely different corporation.” Id. at *19, 25.

As to Milton, the court did not reach the service issue because plaintiff voluntarily dismissed Milton on July 9, 2011, − but refiled the action, again, on May 11, 2015, well outside the one-year limitation of Illinois’s savings statute. Id. at *26-27.  Thus, the court dismissed the claims against Milton with prejudice. Id. at *27.

Rule 12(b)(6) Motion

At long last, the court turned to the Rule 12(b)(6) motion to dismiss for failure to state any cognizable claims, pursuant to TwIqbal.  By now, it should hardly surprise anyone (even plaintiff herself, one would think) that the claims were almost all poorly pled, and most were dismissed.  For example there was “nothing in the complaint that connect[ed] Ethel to Jonathan and its alleged responsibility for Lupron-related activities beyond their shared parent company.” Id. at *30.  The familiar catchall of “Defendants” failed to state a plausible claim against Ethel and was “therefore insufficient to satisfy Rule 8’s pleading the claims,” resulting in the court’s dismissal of all claims without prejudice. Id.

Merits of Plaintiff’s Causes of Action

Turning to the merits, court next conducted a choice of law analysis, using Illinois’s “most significant relationship test” to determine whether Illinois or Georgia law applied. The court ultimately decided that Georgia law would apply, largely because plaintiff resided in, and suffered her alleged injuries in that state, which had the strongest interest in the litigation. Id. at *35-37.

After determining that plaintiff sufficiently alleged that Sid played a role in manufacturing Lupron beyond its ownership of Jonathan, the court declined to dismiss strict products liability and failure to warn claims against Sid. Id. at *40.  However, it ruled that plaintiff’s allegations that Sid failed to adequately test the product before approval, did not advise “Plaintiffs and their physicians,” and misrepresented “the dangers associated with the use of Lupron,” failed to allege either that Sid owed or breached a duty to plaintiff. Id. at *45.  The allegations could not support plaintiff’s negligence claims against that defendant. Id. Nor could plaintiff state a claim for express warranty through statements that Defendants “expressly represented” that Lupron was “safe and efficacious,” “safe and fit for its intended use,” or “of merchantable quality.” Id. at *46-47.  In dismissing plaintiff’s claim, the court observed that “Plaintiff [did] not identify any specific warranty that Sid made to her … “nor [did] she identify the content of any statement by Abbot.” Id. at *47.  Similarly, plaintiff’s breach of implied warranty claim failed because she could not establish privity – as the complaint stated only that she used Lupron, and was devoid of allegations “that she purchased it.” Id. at * 49.

Further – and utterly unsurprisingly by this point − plaintiff’s fraudulent misrepresentation claim was not pled with the heightened particularity required by Rule 9(b), “[t]he who, what, when, where, and how: the first paragraph of any newspaper story.” Id. at *50 (citation omitted).  Rather, the complaint merely claimed that Defendants generally misrepresented the product’s safety in its labeling, marketing, and advertising over several decades. Id. However, plaintiff failed to articulate “who made these statements (other than Defendants, without specifying which Defendant made which statement), where and when these statements were made (other than to say sometime in the 1990s-2000 in Georgia and elsewhere), or how exactly Lupron’s safety was misrepresented.” Id. at *51.  Finally, her negligent misrepresentation claim was also doomed absent “allegations pointing to [defendant’s] statements on which Plaintiff relied” prior to her Lupron injection. Id.  Therefore, the court concluded that plaintiff’s negligent misrepresentation claim could not proceed “under Rule 8’s pleading standard,” and it too, was dismissed. Id. at *52-53.

In a nutshell, plaintiff ran afoul of every tenet of basic pleading 101 by repeatedly offering only threadbare allegations without specific facts; generalized and conclusory allegations leveled only at “Defendants;” and rote recitations of the elements of a claim without the facts to support it. However, to our chagrin, and much more to that of the Defendants, the court dismissed all of plaintiff’s claims, except for strict product liability and failure to warn, with leave to amend, despite seven years of failed pleadings. Id. at *54.  At least, the court issued plaintiff a none too subtle warning, stating it was “cognizant of the long procedural history,” and conditioning its leave for plaintiff to file an “amended complaint consistent with this opinion, if Plaintiff believes that she can overcome the deficiencies identified above for the dismissed claims.” Id. at *55 (emphasis added).

Given Plaintiff’s history of inartful pleading, repeated procedural errors, and other tactical blunders, one can expect, and hope, that like the buffoons in “Mad World,” when this case finally does end, plaintiff and her attorneys will wind up empty-handed.