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We just returned from four days of depositions in Roswell and Carlsbad, New Mexico. We were pleased to cross this state off of the “not yet visited” list on our bulletin board. But it seems that we found the least picturesque cities in the entire state. At this time of year, the 75-mile drive from Carlsbad to Roswell is entirely beige and barren.   No foliage, except for scrub brush. No buildings. No slopes. That is why the “Welcome to Roswell” mural on the side of Highway 285 was an especially delightful surprise.   You can see it and read about it here.   Not so delightful, on the other hand, was the Roswell waitress who told us that we “look good for our age.” Made us think, half-seriously, about wrinkle removal.

Which brings us to today’s pair of cases.   Allow us to explain. Four or five mass torts ago, we were in the early stages of a mass tort and were trying to remove as many state court cases as we could.   Because we represented a forum defendant, we did this by removing a case when we learned about the complaint but before we were officially served. We called these “wrinkle removals,” because they capitalized on a “wrinkle” in the language of 28 U.S.C. § 1441(b)(2), which provides that a case cannot be removed on the basis of diversity if any “properly joined and served” defendant is a citizen of the forum state. In its 2018 decision in Encompass Ins. Co. v. Stone Mansion Rest. Inc., 902 F.3d 147 (3d Cir. 2018), the Third Circuit resolved a split of authority in favor of permitting such pre-service removals. Some of you may have learned about this removal technique from the Blog’s posts. You can read them here, including our Breaking News Post about the Encompass decision.

The first of today’s cases, Anderson v. Merck & Co., Inc., 2019 WL 161512 (D.N.J Jan. 10, 2019), involves 104 cases filed in New Jersey state court, alleging injuries caused by the defendant’s shingles vaccine. The defendant, a citizen of New Jersey, removed the cases to the District of New Jersey before it was officially served with the complaints. The plaintiffs moved to remand, and remand was denied pursuant to Encompass.  Stay tuned – more on this in a minute.

In the second case, Breitner v. Merck & Co., Inc., 2019 WL 316026 (D.N.J. Jan 2019), eighty-nine individual plaintiffs were joined in a single complaint again alleging injuries by the same defendant’s shingles vaccine. Five of the plaintiffs were New Jersey residents and the other eighty-four were not. Before the defendant was officially served, it removed the case on the basis of diversity jurisdiction, arguing that the five non-diverse plaintiffs were fraudulently misjoined. The court explained that “fraudulent misjoinder” occurs when a plaintiff “attempts to frustrate a defendant’s right to remove by joining a non-diverse party in violation of the applicable joinder rule.” Breitner, 2019 WL 316026 at *2 (citation omitted). The analysis is twofold:   the court first determines whether the plaintiffs’ claims were misjoined under Fed. R. Civ. P. 20, and, if so, whether the joinder was “egregious.”

In Breitner, the court answered both questions in the affirmative. First, it held that the claims were misjoined because, although all of the plaintiffs alleged that they were injured by the same drug, “the injuries manifested at different times, with each Plaintiff likely suffering different complications and different unknown recurring health issues.” Id. at *4. In addition, there was no allegation that all of the plaintiffs received vaccinations “from the same lot number, at the same time, [or] by the same health care providers.” Id. Second, the court held that the misjoinder was “egregious” because the complaint was structured specifically to defeat diversity jurisdiction. The court severed the claims of the five non-diverse plaintiffs and remanded them back to state court. That left eighty-four plaintiffs and complete diversity but left the question of the forum defendant rule for the court to resolve. Citing Anderson, the court held that removal was proper because the defendant, though a citizen of New Jersey, removed the case before service was effected. Remand denied. As we continue to struggle to keep mass tort cases in federal court, we like both layers of this decision, and we will keep you posted on similar cases. Meanwhile, we hear Santa Fe and Taos are pretty, and we are angling for depositions there.

We just returned from a four-night cruise that included a stop in Havana, Cuba.  We won’t bore you with too many details about the dinner tablemate who proclaimed, “Let’s kill all the lawyers,” when we told her what we do for a living.  And who commented, when we talked about an onboard trivia contest, “Well, cheating is in your DNA, since you are a lawyer.”  But we will tell you that there was something magical about Havana.  We toured the city in a cherry-red and white 1956 Chevy Bel Air.   We walked, on a gorgeous sunny day, through cobblestone streets framed by buildings unchanged for hundreds of years.  Change is now afoot, but its imprint is spreading slowly.  For now, large portions of the city appear frozen in time.

But time does not stand still in litigation.  Back in the summer, we published a guest post that included a 50-state survey of statutes of repose, those statutes that cut off the right to file suit a prescribed number of years after a product was manufactured or sold, regardless of whether a plaintiff’s cause of action has accrued when the repose period expires.  Today’s case, Nunn v. Biomet, Inc., 2018 U.S. Dist. LEXIS 215395 (N.D. Ind. Dec. 21, 2018), involves Indiana’s statute of repose.

In Nunn, the plaintiff filed suit in the Biomet hip implant MDL pending in the Northern District of Indiana.  The plaintiff’s claims accrued in Nebraska, so Nebraska law applied.  Nebraska product liability law borrows the statute of repose of the state in which the product was manufactured – in this case, Indiana.  Indiana’s statute requires suits to be filed within ten years after the product is delivered to the ultimate user.   The plaintiff’s artificial hip joint was implanted on March 8, 2004.  The plaintiff did not file her complaint until April 15, 2014, just over a month after the repose period expired.  The defendant moved for summary judgment, arguing that the statute of repose barred the plaintiff’s claims.  The plaintiff responded that her claims were tolled by the defendant’s fraudulent concealment of facts related to the prosthetic hip.

The court explained that, to survive summary judgment, the plaintiff was required to point to evidence supporting her fraudulent concealment claim.  The only exhibit attached to the plaintiff’s brief was a 2006 communication in which the defendant informed surgeons about the possibility of unknown side effects caused by metal-on-metal articulating surfaces of the defendant’s artificial hip devices.  But, the court held, “[N]either this statement, or [sic] any other statement that Ms. Nunn refers to, is accompanied by anything that would allow a reasonable trier of fact to find that it (or any other statement) caused her to delay filing suit.”  Nunn, 2018 U.S. Dist. LEXIS 215395 at *6-7.   Duh.  And because the record did not allow a finding that any concealment by the defendant induced any delay in the plaintiff’s filing of her complaint, there was no tolling, and the defendant’s motion was granted.

Short and sweet (like our cruise) and unassailable (unlike our tablemate).  We like this tidy little decision, and will keep you posted on others like it.

We are old enough to treasure the memory of sitting in a darkened movie theater with our mother and sisters watching the original “Mary Poppins.”  We were transfixed and transported by the sheer magic of the film, and we spent the next many months playing our souvenir cast album over and over on our tiny phonograph until the record was so battered that it was lovingly retired to the shelf.   This coming weekend, fifty-plus years later, our now 84-year-mother and her three aging daughters will go together to see the new Mary Poppins “update.”  We feel excited and nostalgic about this outing, but we harbor a suspicion that there can never be another Mary Poppins.   Mary was adventurous, courageous, resourceful, mysterious, resolute, and dauntless.  She was way ahead of her time — “practically perfect in every way.”

As is the tidy personal jurisdiction and venue decision on which we report today.  In Carney v. Guerbet, LLC, 2018 WL 6524003 (E.D. Mo. Dec. 12, 2018), the plaintiff  alleged that he was injured by a linear gadolinium-based contrast agent with which he was injected, in New Jersey, before he underwent an MRI.   He filed suit in the Eastern District of Missouri asserting diversity jurisdiction and naming several corporate defendants, among them Guerbet, LLC (“Guerbet”) and Liebel-Flarsheim Company, LLC (“Liebel’).

Guerbet, LLC’s Motion to Dismiss

The plaintiff alleged that Guerbet was a Delaware LLC with is principal place of business in Indiana and that it had contracted with co-defendants Mallinckrodt, Inc. and Mallinckrodt, LLC to purchase their Missouri-based company which, the plaintiff alleged, produced the contrast agent in question.  The plaintiff alleged that the court had specific personal jurisdiction over Guerbet because the company “engaged in the business of designing, licensing, marketing and/or introducing [the contrast agent] into interstate commerce,” either directly or through third parties.  Carney, 2018 WL 6524003 at *3.  The plaintiff did not allege that he was injected with the contrast agent in Missouri, suffered his injury in Missouri, or received treatment in Missouri.  Guerbet moved to dismiss, asserting the court lacked personal jurisdiction over it.   Guerbet denied that it purchased a Missouri-based business from Mallinckrodt, that any of its members or managers resided in Missouri, that the contrast agent was produced in Missouri, that it received any sales revenue for the contrast agent in Missouri, or that it advertised in any Missouri medium or any medium targeted at Missouri.  Guerbet also submitted an affidavit attesting to the fact that its principal place of business is in New Jersey, not Indiana.

The  court cited BMS for proposition that, “[i]n order for  court to exercise specific jurisdiction over a claim, there must be an affiliation between the forum and the underlying controversy, principally,  an activity or an occurrence that takes place in the forum State. .  . . When there is no such connection, specific jurisdiction is lacking, regardless of the extent of a defendant’s unconnected activities in the State.  Even regularly occurring sales of a product in a state do not justify the exercise of jurisdiction over a claim unrelated to those sales.”  Id. at *4 (internal punctuation and citations omitted).   As such, the court emphasized, allegations that “a non-resident pharmaceutical company researches, designs, tests formulates, inspects, markets or promotes a drug within the forum state are not enough to establish specific personal jurisdiction.”  Id. (citations omitted).    The court concluded that, even if Guerbet had acquired Mallinckrodt’s Missouri-based business, which Guerbet denied, sufficient minimum contacts would not arise from that ownership to confer specific personal jurisdiction over Guerbet.  But rather than dismiss the plaintiff’s claims against Guerbet, the  court found that it was “in the interest of justice”  to transfer the case to the District of New Jersey pursuant to the transfer statute, 28 U.S.C. § 1406(a), “to avoid the costs and delay associated with requiring [the] plaintiff to refile the case in the transferee district.”  Id. at *5.

Liebel’s Motion to Dismiss

Liebel did not challenge the court’s jurisdiction over it.  Instead, it moved to dismiss for improper venue.  Under 28 U.S.C. § 1391(b), venue is proper in a judicial district in which any defendant resides if all defendants are residents of the state in which the district is located, or in a district in which a substantial part of the events giving rise to the action occurred.  If there is no district that qualifies under either of these standards, “any judicial district in which any defendant is subject to the court’s personal jurisdiction” is a proper venue for the action.

Always remember: jurisdictional objections are waivable.  If a party fails to object to a court’s exercise of personal jurisdiction over it, it waives the objection and suffers the ripple effects of that waiver.  Because Liebel did not move to dismiss for lack of jurisdiction, it waived that defense and was deemed to have submitted to the court’s jurisdiction.  In turn, because Liebel was subject to the court’s jurisdiction, venue was proper under the final catch-all provision of 28 U.S.C. § 1391(b) and Liebel’s motion to dismiss was denied.  As the court emphasized, “[i]t would defy logic to deem [a defendant] subject to [the court’s] personal jurisdiction yet dismiss the plaintiff’s claims against it for improper venue for want of personal jurisdiction.”  Id. (internal punctuation and citations omitted).

Instead, the court granted Liebel’s alternative motion to transfer venue to the District of New Jersey, holding that the transfer was appropriate under 28 U.S.C.  § 1404(a) because the convenience of the parties, the convenience of the witnesses, and the interests of justice were best served by transfer.

And so, in the wake of statutes and precedents correctly applied, the case ended up where it belonged in the first place.  We like this decision.  We’ll let you know how we feel about “Mary.”

It took us more than a week, but we finally put away the last serving pieces from last week’s family Hanukkah celebration.  We love Hanukkah, a festive holiday that celebrates victory over a tyrant king, a reclaimed temple, and a small quantity of oil that should have lasted only one night but that miraculously burned for eight nights.  In commemoration, we light candles for eight nights. And we use oil.  Lots and lots of oil.  Like, eight dozen potato latkes-worth of oil.   Though the holiday has far less religious significance than does Christmas, it is a time for family and gifts and food and song and celebrating the “miracle” of the bit of oil that improbably shed eight nights of light.

In a similar vein (pun intended), today we celebrate a very short, but surprisingly bountiful, decision out of the inferior vena cava (“IVC”) filter MDL pending in the Southern District of Indiana.  We love warnings causation, a potent doctrine too often rendered toothless by passive judges.  Not so in In re Cook, Inc. IVC Filters Marketing, Sales Practices, and Prods. Liab. Litig. (Tonya Brand), 2018 WL 6415585 (S.D. Ind. Dec. 5, 2018).   In the IVC filter MDL, the plaintiffs allege that the filters are prone to tilting, migrating, fracturing, and perforating the inferior vena cava.  In Brand, the defendants’ IVC filter was inserted in the plaintiff’s inferior vena cava to prevent pulmonary embolism during an upcoming spine surgery.  Two years later, the plaintiff began to experience pain on the inside of her right thigh.  Shortly thereafter, the plaintiff noticed something protruding from her thigh and pulled out a portion of her IVC filter.  The plaintiff was required to undergo open surgery to remove the rest of the filter.  The plaintiff sued, alleging that the instructions for use (“IFU”) that accompanied her filter did not adequately warn her physician of the risks associated with the filter.

The court explained that, under Georgia’s learned intermediary doctrine, the plaintiff could prevail on her warnings claims only by proving both that the warnings in the IFU were inadequate and that the inadequate warnings proximately caused her injuries.  The court emphasized, “Where the learned intermediary has actual knowledge of the substance of the alleged warning and would have taken the same course of action the plaintiff contends should have been provided, . . .  the causal link is broken and the plaintiff cannot recover.”  2018 WL 6415585 at *3.  The plaintiff’s physician testified that he was aware of all of the relevant risks when he implanted the Plaintiff’s IVC filter.  His knowledge of the risks was not based on the IFU; rather, it was based on his “education, training, and experience.”  Id.    Moreover, the doctor testified that he continued to use the defendant’s filter even after the plaintiff’s filter fractured, and that nothing about the plaintiff’s experience changed his mind about IVC filters in general or about the specific filter he used in the plaintiff.  The court held, “In the face of this devastating testimony, Plaintiff fails to raise a genuine issue of material fact on the proximate causation element” of her failure-to-warn claims.  Id.  at *4.

The plaintiff also argued that the defendants breached Georgia’s continuing post-sale duty to warn because they did not warn her physician, after he implanted her filter, of the filter’s propensity to  perforate and fracture.  She alleged that, if the defendants had provided such a warning, her doctor “potentially could have removed the filter before it fractured and pieces migrated throughout [her] body.” Id.   The court rejected this argument as well, holding that it was based on speculation and that the evidence, including the fact that the plaintiff’s physician continued to use the same filter in patients even after the plaintiff’s filter fractured, suggested that no post-placement warning would have prompted the doctor to retrieve the plaintiff’s filter any earlier.  As such, the plaintiff “fail[ed] to raise a genuine issue of material fact that any post-implant failure to warn caused her injuries.”   Id.   Because the plaintiff failed to sustain her burden of proving the causation element of her warnings claims, the court granted summary judgment for the defendants on those claims and on the claims that were based on them.

We make these same arguments over and over and over again in our medical device cases.  We often don’t prevail, even on clear records.  We wish that more courts had the clear-eyed approach to warnings causation that this MDL judge employed.  We will keep you posted on similar decisions.  And we still have a couple dozen potato latkes in the freezer, in case you are in our neighborhood.

A couple of weeks ago, we reported on the terrific Daubert decision in the Mirena IIH MDL in the Southern District of New York, In re Mirena IUS Levonorgestrel-Related Prods. Liab. Litig., 2018 WL 5276431 (S.D.N.Y. Oct. 24, 2018), in which the court granted the defendants’ motions to dismiss all seven of the plaintiffs’ remaining general causation experts.  In that post, we explained that all seven opined that the defendants’ intrauterine contraceptive device caused idiopathic intracranial hypertension (“IIH”), a rare and potentially serious condition market by increased cerebrospinal pressure in the skull.  Only one study had ever found a causal link between Mirena and IIH.  That study was by Dr. Mahyar Etminan, who was on the plaintiffs’ payroll at the time he published the study, a fact he failed to disclose.  After a prominent scientist in the field attacked the methodology of the Etminan study because it failed to control for age and gender, Dr. Etminan repudiated much of the study’s analysis and withdrew as an expert.

Of the seven remaining experts, four drew their general causation conclusions largely by drawing on existing sources, including varying combinations of case reports regarding Mirena, case reports regarding other contraceptive products containing LNG, another product’s warning label, the repudiated portions of the Etminan study, and another study (the “Valenzuela study”) that reported a statistically significant association between LNG-containing devices and IIH but which, the authors emphasized, found only a correlation, not a causal link.  The other three experts were “mechanism” experts, each of whom postulated a supposed mechanism by which the defendant’s product could cause IIH.   In our last post, we reported on the court’s decisions regarding two of the experts in the first group but we promised to tell you more.  Today, we focus on one more expert in that group as well as highlights of the court’s decisions about the “mechanism” experts.

The former, the plaintiffs’ ophthalmology expert, was the only one of the plaintiffs’ experts who had written about the relationship between levonorgestrel (“LNG”), the synthetic hormone in  the defendants’ contraceptive device, and IIH, and was the only one of the plaintiffs’ experts who had written an expert report on the supposed causal  link before the MDL was formed.      In a 2015 book about drug-induced ocular side effects, the expert had stated that he believed there was a “possible,” but not a “probable,” association between LNG and IIH.  In the book, he explained that he assessed causation as possible “when there is a temporal relationship, but the association could also be explained by concurrent disease or other drugs or chemicals,” and dechallenge data (information about what happens when the treatment is withdrawn) is “lacking or unclear.”  Mirena, 2018 WL 5276431 at *47 (citation omitted).   In contrast, causation is “probable” or “likely” when “there is a temporal relationship unlikely to be attributed to a concurrent disease or drugs” and there is positive dechallenge data.  Id.   The book’s conclusion that there was a “possible” causal association between LNG and IIH was based largely on case reports involving the defendants’ product and other LNG-containing products and upon two publications discussing several of those case reports.  The book did not consider the Etminan and Valenzuela studies, which had not yet been published.

Unlike the other experts in the first group, the ophthalmologist did not claim to have performed a Bradford Hill analysis.  Instead, in support of the expert’s causation conclusion, his report cited case reports, discussion of another LNG-containing product, case reports, and citations to both the Etminan and Valenzuela studies.  In addition, the report included a vague discussion of broad propositions from which he suggested that there was a biological mechanism for LNG to cause IIH.  In his deposition, however, he repudiated this “mechanism” opinion, testifying that the mechanism was “unknown” and that he was not being offered as a “mechanism” expert.

Analyzing the expert’s opinion, the court stated, “[The] proposed testimony amounts to a blend of disparate items that [the expert] contents together show that Mirena causes IIH. . . . [The expert] does not purport to use the flexible Bradford Hill methodology to guide his analysis.”  Instead, he used a “non-replicable mode of analysis” consisting of “listing factors that he argues support his conclusion.”  Id. at *50.   The court held that the expert’s proposed testimony “fails to meet any of the Daubert reliability factors.”   The expert’s causation conclusion “has not been tested; it has not been subject to peer review; it has no known error rate and there are no standards controlling its operation; and it has not been generally accepted by the scientific community.”  Moreover, the expert’s “handling of virtually every one of the individual items on which he relies” was “methodologically suspect.”  Id.   This included overlooking the fatal flaws in the Etminan study, the expert’s failure “to engage with consequential evidence contrary to his outcome.”   Id.  at *51-52.  Finally, though the expert “[made] his mechanism opinion an important component of his expert report,” he “repeatedly distanced himself” from that opinion at his deposition, “repudiate[ing] any mechanism opinion as beyond his expertise.”  The court held, “”The removal of that pillar alone is fatal to [the expert’s] weight of the evidence analysis;” moreover, the “mechanism” opinion would have been inadmissible in any event because the expert was not qualified to offer it.  Id. at *52.   And so, holding that the expert’s opinions failed to satisfy Daubert’s reliability standards, the court excluded the opinions in their entirety.

The plaintiffs’ “mechanism” experts fared no better.  One, an OB/GYN and the founder of a clinical and epidemiological research organization devoted to reproductive health issues, “embrace[d] the ‘androgen theory’ by which Mirena purportedly causes IIH—specifically that androgens cause IIH and that because LNG, while a progestin, has androgenic effects, LNG in turn may cause  IIH.”  Id.  at *53.  The court held, “As a threshold consideration, [the] theory that Mirena  causes IIH through androgenic side effects does not satisfy any of the four Daubert reliability factors.”  Id. at *58.   But beyond the flaws in the opinion’s premises, the court “discern[ed] a broader overarching lapse of methodology” affecting the mechanism opinion: the expert’s report did not address the threshold issue of “what IIH is and how this condition comes about.”   Id.  In addition, the court criticized (in extensive and thorough detail that is beyond the capacity of these pages) the expert’s “scant attention to the pharmacokinetic process that must underlie the causal sequence that he postulates” and his “speculative leaps in support of his two central premises:  that androgens can cause IIH, and that LNG, a progestin with androgen receptor affinity, can cause IIH.”  Id.   The court concluded,

“In the end, while [the expert’s] credentials are sterling, the methodology underlying his opinion in this case is not.  He relies on supposition and attempts to link disconnected studies by others.   And he uses some of his source material for more than it can fairly support.  The result is a hypothesis that may or may not bear up when and if it is ultimately tested, not a reliable expert opinion admissible under the governing standards.  The Court therefore must exclude his testimony.”  Id. at *62.

The court similarly dispatched the plaintiffs’ other two mechanism experts because their methodologies were unsound and their theories failed to satisfy Daubert’s reliability standards.  Both discussions are lengthy and we cannot do justice to them here, but we again recommend that you read the whole opinion when you have time to appreciate its rigor and its unflinching confrontation and dissection of the technicalities underlying all of the experts’ opinions.  Doing justice to Daubert analysis of opinions like these is a monumental task.   All too frequently, and perhaps understandably, courts decline even to try, counting on juries (or, more likely, settlements) to do their work for them.   The Mirena court displayed rare dedication to the principle that the system can work only if courts properly discharge their duties as “gatekeepers.”  We applaud this decision, urge you to read it and cite it, and we hope that more courts will accept similar challenges.  We will keep you posted.

Kudos to the multifirm defense counsel team that brought home the decision on which we report today, a victory that may well end up on our “best” list for 2018.

In April 2017, we posted about Dr. Mahyar Etminan, then an expert in the Mirena MDL pending in the Southern District of New York.  Plaintiffs in the MDL claimed that the defendant’s product, an intrauterine contraceptive device containing the synthetic hormone levonorgestrel (“LNG”) caused them to develop idiopathic intracranial hypertension (“IIH”), also known as pseudotumor cerebri, a rare and potentially serious condition marked by increased cerebrospinal fluid pressure in the skull.   In 2015, Etminan had published a study designed to assess the risk of IIH.  Although the study did not definitively conclude that defendant’s product caused IIH, Etminan concluded that one of the two analyses, a “disproportionality analysis” of adverse events in the FDA’s FAERS database, identified an increased risk of IIH associated with LNG and that this result was statistically significant.  Etminan concluded that the results of the second analysis, a retrospective cohort study, did not find an increased risk but that this result was not statistically significant.   No other study has ever established a causal link between LNG and IIH.

Subsequently, a prominent scientist in the field attacked the methodology of Etminan’s disproportionality analysis because the study failed to control for age and gender, resulting in erroneous and misleading conclusions.  At the same time, it was revealed that Dr. Etminan was on the plaintiffs’ payroll at the time that he published his study, a conflict of interest he had not disclosed.  Ultimately, after defendants served Dr. Etminan with a notice of deposition in one of the cases in the MDL, Dr. Etminan repudiated much of his study’s analysis and withdrew as an expert.   When we reported this, we told you to “stay tuned,” commenting that plaintiffs’ other experts, all of whom relied on Etminan’s results, had not withdrawn.

The other shoe dropped a couple of weeks ago.  In In re Mirena IUS Levonorgestrel-Related Prods. Liab. Litig., 2018 WL 5276431 (S.D.N.Y. Oct. 24, 2018), the court considered the defendants’ Daubert motions to exclude the plaintiffs’ seven remaining general causation experts.  And it granted them all.   The opinion is very long – seventy-two pages on Westlaw – and we commend it to your weekend reading, as we can’t begin to do justice to the court’s detailed analysis of each expert’s methodology.  But we wanted to bring this terrific decision to your attention and to focus its most important takeaways.

The court began its analysis by emphasizing, “In the face of [the] historical record, with no medical organization or regulator or peer-reviewed scientific literature having found that Mirena or any contraceptive product using LNG is a cause of IIH, an expert witness who would so opine . . . necessarily would break new ground in this litigation.”  Mirena, 2018 WL 5276431 at *20.  All seven of the plaintiffs’ general causation experts “so opined.”  Four of these experts “arrived at this result largely by drawing upon existing sources.”  These included varying combinations of case reports regarding Mirena, case reports regarding other contraceptive products containing LNG, another product’s warning label, the repudiated portions of the Etminan study, and another study (the “Valenzuela study”) that reported a statistically significant association between LNG-containing devices and IIH but which, the authors emphasized, found only a correlation, not a causal link.  The remaining three experts were “mechanism” experts, each of whom postulated a supposed mechanism by which the defendant’s product could cause IIH.   In this post, we will focus on two of the experts in the first group, which included an epidemiologist, a toxicologist, an OB/GYN, and an ophthalmologist, but we urge you to read the court’s dissection of the second group as well.

The plaintiffs’ epidemiology expert was a professor of biostatistics with experience in conducting and analyzing large clinical trials.   He claimed that the nine Bradford-Hill criteria supported his causation conclusion.  As many of you know, the criteria are “metrics that epidemiologists use to distinguish a causal connection from a mere association.” Id. at *23 (citation omitted).  They are:  statistical association (also known as “strength of association), temporality, biological plausibility, coherence, dose-response effect, consistency, analogy, experimental evidence, and specificity.

The court first held that the epidemiologist’s opinion did not satisfy any of Daubert’s four reliability factors, because the expert “has not tested his theory.  He has not subjected it to peer review or had it published.   He has not identified an error rate for his application of the nine Bradford Hill factors. . . . And [his theory] has not been generally accepted by the scientific community.”  Id. at *27 (internal punctuation and citation omitted).  With respect to this last, the court again emphasized, “Outside of this litigation, there is a complete absence of scholarship opining that Mirena, or, for that matter, any LNG-based contraceptive, is a cause of IIH.”   Id.  As such, the court undertook to “take a hard look” at the expert’s methodology, scrutiny that was “particularly warranted” because:

 [I]t is imperative that experts who apply multi-criteria methodologies such as Bradford Hill . . . rigorously explain how they have weighted the criteria.  Otherwise, such methodologies are virtually standardless and their applications to a particular problem can prove unacceptably manipulable.  Rather than advancing the search for truth, these flexible methodologies may serve as vehicles to support a desired conclusion.

Id.  (citations omitted).    Citing four examples of how the expert’s assessment of individual Bradford Hill factors “depart[ed] repeatedly from reliable methodology,” the court held, “Measured against these standards, [the epidemiologist’s] report falls short.  Id. at *28-29.

First, the expert used the “analogy” factor, basing his causation conclusion in part on an analogy to another contraceptive product.  But, the court explained, this analogy was based on an “unestablished hypothesis” about the other contraceptive product, for which a causal relationship with IIH had never been substantiated.  Id. at *29.  With regard to the “specificity” factor, the court explained that the factor “inquires into the number of causes of a disease,” id., with the difficulty of demonstrating a causal association escalating along with the number of possible alternative causes.   “In finding the specificity factor satisfied,” the expert “devote[d] two sentences to his discussion.”  Id.   He relied on a conclusory statement to the effect that alternative causes could be ruled out.   And he relied on the Valenzuela study, which had actually disclaimed a finding of causation.   The court explained that the “consistency” factor required “similar findings generated by several epidemiological studies involving various investigators” reaching the same conclusion.  Id. at *30.    Again, the epidemiologist claimed that the Valenzuela study satisfied this criterion because it considered two separate populations.  But, as the court stated, both studies were conducted by the same investigators, and neither found a causal relationship.  Finally, as to the biological plausibility factor, the epidemiologist postulated a biological mechanism by which he said LNG could cause IIH.  The court stated, “ . . . [B]y any measure, [the expert] is unqualified to give an expert opinion as to a biological mechanism of causation of IIH.”   Id. at *30.   This lack of qualifications compromised the expert’s assessment of the biological plausibility factor as well as of related factors.   The court concluded,

Each of [the expert’s] departures from settled and rigorous methodology favors the same outcome.  Each enables him to find that the Bradford Hill factor at issue support concluding that Mirena is a cause of IIH. . . . [His] unidirectional misapplication of a series of Bradford Hill factors is concerning – it is a red flag.  Rather than suggesting a scholar’s considered neutral engagement with the general causation question at hand, it suggests motivated, result-driven, reasoning. . . . Methodology aimed at achieving one result is unreliable.

Id. (internal punctuation and citation omitted.    The court went on to further eviscerate the epidemiologist’s methodology, criticizing his reliance on the Valenzuela study, his nearly-exclusive use of case reports to support three of nine Bradford Hill factors, his failure to consider evidence that undercut his opinions, and his cherry-picking of case reports that supported his desired conclusion.   The court concluded that the expert’s testimony was “compromised by a range of serious methodological flaws,” and failed to satisfy Daubert’s reliability standard.

The court voiced similar criticisms of the methodology of the plaintiffs’ toxicology expert.  Like the epidemiologist, the toxicologist failed to meet any of the four Daubert reliability standards  In applying the Bradford Hill factors, she failed to identify support for her conclusions, distorted or disregarded evidence that undercut her opinions, failed to articulate a plausible biological mechanism to support her causation conclusion, and drew an inapposite analogy to another contraceptive product.   And her opinions were plagued by additional methodological flaws.   She relied on the portion of the Etminan study that was discredited and that Etminan himself repudiated.  And she cited the Valenzuela study as her sole support for finding several Bradford Hill criteria satisfied without acknowledging the study’s methodological limitations and failure to find causation.   The court concluded, “[The toxicologist’s] proposed testimony is beset by methodological deficiencies.  It falls far short of satisfying Daubert’s standard of reliability.  Her testimony, too, must be excluded.”  Id. at *40.

And so it went with the court’s discussion of the rest of the plaintiffs’ experts.   The opinion does the best job we’ve ever seen of demonstrating how an expert can attempt to create the illusion of reliability by paying lip service to the Bradford Hill criteria and how those criteria can be manipulated to mask wholly result-driven ipse dixit opinions plagued by fatal methodological flaws.   In this case, a committed and rigorous judge stemmed the tide.  But we all know that this is not always the case.

We love this decision.  There is a lot more to say about it, and we look forward to telling you more in an upcoming post.

J.P.M.L. Denies Request for New Gadolinium MDL

“Eventually, all things merge into one, and a river runs through it. The river was cut by the world’s great flood and runs over rocks from the basement of time. On some of the rocks are timeless raindrops. Under the rocks are the words, and some of the words are theirs. I am haunted by waters.”  Norman Maclean, “A River Runs Through It.”

Last weekend, we stood on the banks of the Flathead River, just outside of Glacier National Park.   We retreat to Montana, every now and then, when we need to restore our soul.  This we have in common with Maclean, for this is where he wrote his novel about fly-fishing and life, to the extent that there is a distinction between the two.  As we stood under the aptly-named “big sky,” with the river at our feet and the mountains in the distance, we felt tucked into our proper berth in the cosmos and all of the proportions felt right.

In the very short decision about which we report today, a group of plaintiff lawyers needed the J.P.M.L.’s smackdown to be relegated to their proper place in the jurisprudential universe.  In In re Linear Gadolinium-Based Contrast Agents Prods. Liab. Litig., 2018 WL 4905435 (J.P.M.L. Oct. 10, 2018), plaintiffs in seventeen gadolinium cases moved to centralize the suits in a new MDL. This would be the second MDL go-round for gadolinium.   You can read some of our posts about the first MDL here.

Gadolinium is a contrast agent.  Plaintiffs allege that it causes injury when it is retained in the body after it is used for radiological testing.  This time around, the plaintiffs argued that their suits should be centralized either in the Northern District of California or in the District of Massachusetts.   The defendants argued that the cases should not be consolidated, or, in the alternative, that the J.P.M.L. should stay its decision until general causation discovery was completed in actions pending in the District of Arizona.

The J.P.M.L. concluded that “centralization would not serve the convenience of the parties or further the just and efficient conduct of [the] litigation.”  Gadolinium, 2018 WL 4905435 at *1.  First, the Panel held that the plaintiffs had “failed to demonstrate that any common questions of fact and law [were] sufficiently complex or numerous to justify centralization.”  Id.  This was because several different product formulations, from different manufacturers, were involved, and the injuries “appear[ed] to be highly plaintiff-specific. . . .”  Id.  In addition, because most plaintiffs were represented by a single law firm or by other firms working with that firm, centralization was unnecessary.  As the Panel stated, “Given the significant overlap of plaintiffs’ counsel, alternatives to transfer exist that may minimize [the] possibilities . . . of duplicative discovery and/or inconsistent pretrial rulings.”  Id. at *2.  And then came the music to the ears of all of us who spend our professional lives watching plaintiffs abuse the MDL framework:  “. . . [C]entralization under Section 1407 should be the last solution after review of all other options.”  Id. (citations omitted).  Bexis tells us that this seems to be the first time the Panel has issued this admonition in the context of prescription medical product liability litigation.   We hope it’s not the last, and we’ll keep you posted.

In the meantime, thumb through “A River Runs Through It.”  It’s magic.  We promise.

Next week, under pressure from the Drug and Device Law Lifelong Best Friend, we are participating in a “murder mystery dinner theatre” in the “conservatory” of a local cemetery.   (We didn’t know cemeteries had “conservatories.”) It is a Halloween-themed event, with costumes encouraged, and we may or may not wear our eerily-lifelike Standard Poodle mask/hood. In any event, the premise of the event is that actors are scattered among the paying audience “guests.” At some point during the cocktail hour, one of the actors will “die.” During the ensuing dinner hour, clues are revealed and everyone tries to solve the “murder” in time for dessert. We think this sounds like fun, and we like the idea of not knowing what to expect and not being able to predict the result.

But sometimes a predictable result (to the extent that preemption jurisprudence is ever predictable) is just fine. In In re Bard IVC Filters Prods Liab. Litig. (Hyde v. C. R. Bard, Inc.), 2018 WL 4356638 (D. Ariz. Sept. 12, 2018), the plaintiff was implanted with the defendant’s inferior vena cava (“IVC”) filter. Three years later, the plaintiff learned that the filter had perforated the IVC wall and had fractured. The filter was removed shortly thereafter. The plaintiff filed suit, asserting the usual panoply of product liability claims. After the court granted summary judgment for the defendant on several claims, the plaintiff’s claims for strict liability design defect and negligent design remained pending, along with a claim for negligence per se.

Under Wisconsin law, which governed the plaintiff’s substantive claims, a claim for negligence per se arises from violation of a statute, where the plaintiff can show that “(1) the harm inflicted was the type the statute was designed to prevent; (2) the person injured was within the class of persons sought to be protected; and (3) there is some expression of legislative intent that the statute become a basis for imposition of civil liability.” Hyde, 2018 WL 4356638 at *2. In her negligence per se claim, the plaintiff asserted that the defendants violated provisions of the Federal Food, Drug, and Cosmetic Act. As the court commented, “Far from containing an expression that FDA regulations are intended to form the basis of civil liability, . . . [t]he FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions.” Id. (citing Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 349 n.4 (2001)) (internal punctuation and additional citations omitted).   “Thus,” the court continued, a private litigant cannot bring a state-law claim [that] is in substance . . . a claim for violating the FDCA – that is, when the state claim would not exist if the FDCA did not exist,” because, under Buckman, such claims are impliedly preempted by the FDCA.  Id. (citations omitted). All correct, even if it conflates Buckman preemption with the plaintiff’s simple failure to state a negligence per se claim under the requirements of Wisconsin state law.

The court held that, as in Buckman, the plaintiff’s negligence per se claim was more accurately characterized as a “negligence claim based solely on violations of FDA regulations,” id., and was therefore impliedly preempted. As the court emphasized, “. . .where the plaintiff was not suing under state law for conduct that happen[ed] to violate the FDCA, but instead [was] suing solely because the conduct violate[d] the FDCA,” the claim was preempted by federal law. Id. (emphasis in original, internal punctuation and citation omitted). The court contrasted such claims to traditional tort claims like plaintiff’s negligent design claim, which arose from a duty owed under state law and which was not subject to Buckman preemption.

We like this correct, methodical, predictable decision.   We’ll let you know how the mystery thing goes.

Recently, the Enviably Youthful Drug and Device Law Mother has been pushing us to plan a mother/daughter vacation.   Her longtime companion no longer enjoys travel, and few of her friends share her sense of adventure. So we set about finding a suitable trip for next spring. Threshold categorical decisions proved troublesome. Our normal instinct, given the pace of our everyday life, is to sit still on vacation. We are fond of cruises, and we don’t care to where because we don’t get off of the boat.   The EYDDM prefers an eight-cities-in-seven-days pace. If we have to move, we prefer to rent a car and explore – we are not fond of printed itineraries. And we lean toward countries with national languages other than English. So, in the spirit of compromise, we booked eight days on a bus in Ireland over Memorial Day. Yeah, we know. But you should have seen the EYDDM’s smile. Sometimes, the answer is simple.

As it was in today’s case.   In Romer v. Corin Group, PLC, et al., 2018 WL 4281470 (M.D. Fla. Sept. 7, 2018), the plaintiff alleged that he was injured by when the defendant’s artificial hip implant released metallic contaminants into his body, causing pain and malfunction of the device and ultimately requiring another surgery. He sued in state court on the usual product liability theories, and the defendants removed the case on diversity grounds. After removal, the defendants moved to dismiss the negligence, negligence per se, and strict liability claims.

Listing seven alleged manufacturing defects in the hip implant, the negligence per se claim alleged that the defendants failed to comply with the manufacturing standards the FDA approved as “conditions of FDA’s approval [as well as] the general regulations applicable to Class III medical devices.” Romer, 2018 WL 4281470 at *3. A second negligence per se count alleged that the defendants’ simulator testing of the device was inadequate and violated federal regulations related to the compliance with Approved Design Standards. Id.   The defendants argued that both counts failed as a matter of law because Florida does not recognize a claim for negligence per se based on alleged violations of the federal FDCA or its implementing regulations. The court agreed, holding that, “[u]nder Florida law, the violation of a federal regulation does not create civil liability based upon a theory of negligence per se in the absence of a legislative intent to create a private cause of action.”   Id. at *4 (citations omitted). Because the FDCA and its implanting regulations do not “expressly create civil liability for non-compliance, strongly suggesting a legislative intent not to create a private cause of action,” id., the plaintiffs could not base negligence per se claims on the violations they alleged.

The defendants argued that the design defect claims sounding in both strict liability and negligence were preempted under Riegel because the hip implant device was a Class III medical device subject to pre-market approval (“PMA”) by the FDA. While the plaintiffs argued that the design defect claims escaped preemption because the claims were “based on defendants’ alleged failure to comply with federal laws after the FDA already approved the design of the device,” id. at *5, they made no allegation that the defendants had altered the design approved by the FDA during the PMA process.   The court concluded, “To the extent plaintiffs are asserting parallel claims, . . . . a valid parallel claim cannot challenge the rigorous PMA process itself or the requirements imposed by the FDA pursuant to that process. However, plaintiffs’ design defect claim does just that,” id at *6, and it was therefore expressly preempted.

Similarly, the defendants argued that the plaintiff’s negligence claims, based on the defendants’ alleged failure to warn of defects in the hip implant device or to report adverse events to the FDA, were expressly preempted because they sought “to second-guess the FDA’s determination that the warning language [was] adequate and [to] force [the defendant] to meet an additional standard beyond what the FDA requires.” Id. The defendants also argued that the reporting violations claims were impliedly preempted.

The court held that the warnings claims “imposed requirements that [were] different from, or in addition to, the federal requirements under the MDA,” and were thus expressly preempted. To the extent that the plaintiffs claimed that the defendants failed to comply with FDA reporting requirements, the claim was “simply an attempt to recast a claim for violation of the FDCA as a state law negligence claim.” Id. at *7. As such, it was “premised upon an FDA-reporting requirement that [was] not paralleled by a Florida law duty,” and was impliedly preempted under Buckman, which permits such claims to survive only to the extent that they “do not seek to privately enforce a duty owed to the FDA.” Id.

And so the court dismissed the plaintiffs’ design defect, failure to warn, and “failure to report” claims, leaving manufacturing defect claims pending. The dismissal was without prejudice, and the plaintiffs were given fourteen days to file an amended complaint. We’ll keep you posted

We have always had a soft spot for zebras.   They are the equine world’s version of some of our favorite acquaintances — the ones who always dress a little outlandishly and always stand out from the crowd. (Fun facts:   1. Although most zebras have black stripes on a white background, a white-on-black specimen shows up every now and again.   2. All zebras have dark-pigmented skin under their coats, and the stripes are only hair-deep. Compare Dalmatians, whose spots are visible on their skin from the birth, though the spotted fur comes later.)   Zebra fondness aside, we often find ourselves, in our ongoing occupation of the mass tort space, arguing that plaintiffs hearing hoof-beats should have thought “horses,” not “zebras.” Less obtusely, we mean that judges should apply the discovery rule correctly and should hold that suits are time-barred when plaintiffs with adequate information fail to make obvious causal connections within the correct limitations period.

That is why we were so happy to read today’s case. We rarely report on statute-of-limitations decisions, but Adams v. Zimmer, 2018 U.S. Dist. LEXIS 136707 (E.D. Pa. Aug. 14, 2018), is a worthy exception.   In Adams, the plaintiff underwent surgery to replace her right hip joint, and was implanted with the defendant’s prosthetic hip, in January 2011. Eight months after surgery, in September 2012, she began experiencing pain in the region of the artificial hip. When the pain didn’t abate, the plaintiff’s doctor performed blood tests to test her metal ion levels because there had been reports of adverse local tissue reaction to the metals used in the artificial hip. There was no definitive diagnosis at that time, but the plaintiff’s doctor testified that, by February 2013, he informed the plaintiff that the prosthetic hip might be causing her symptoms.

The plaintiff dislocated her right hip in November 2014.   She testified in deposition that she knew that the prosthetic hip had dislocated and that this was “abnormal.” On January 7, 2015, her doctor noted in his records that he recommended “further investigation of the right hip,” and that the plaintiff might require surgery to replace the femoral head. 2018 U.S. Dist. LEXIS 136707 at *9. In deposition, the doctor testified repeatedly that he had informed the plaintiff of his recommendation and of the possible need for revision of the artificial hip. Testing performed on January 12, 2015 confirmed a tissue reaction to the artificial hip, and, by January 30, 2015, the plaintiff had decided to proceed with hip revision surgery. In her deposition, she testified that she understood that the surgery would involve replacing the defendant’s device with a new prosthesis. She underwent surgery on February 12, 2015 and filed her complaint on February 10, 2017. The defendant moved for summary judgment, arguing that Pennsylvania’s two-year statute of limitations barred the plaintiff’s claims.

The plaintiff argued that she “did not make the factual connection” between her injury and the defendant’s device until the date of surgery.  Id. at *20. If this were true, then she would have beaten the statute by two days. But the judge wasn’t buying it. Explaining that “as soon as, through the exercise of reasonable diligence, the injured party should be able to link her injury to the conduct of another, the clock begins to run,” id. at *23-24, the court held that the plaintiff “knew or should have known that the [defendant’s device] was a factual cause of her injury by the time she decided to proceed with hip revision surgery on January 30, 2015.” Id. at *26. In other words, “once [the plaintiff] knew for certain that [her doctor] needed to remove the [device], she had received enough facts to make the connection between her injury” and the device, and “no reasonable juror could conclude otherwise.” Id. at *27. Nor was the court swayed by the plaintiff’s argument that, even if she knew that the device was causing her symptoms, she did not know it was “defective” until it was removed. The court emphasized, “This misstates the legal standard,” which required only that the plaintiff connect her injuries to the device to start the clock running on her claims. Id. at 31. Finally, while the court acknowledged that the plaintiff hadn’t missed the running of the statute by much, and that granting summary judgment would deny the plaintiff recourse for serious injuries, it held that it could not “arbitrarily enforce the statute of limitations,” however sympathetic the plaintiff, and that it was “constrained to grant the motion for summary judgment.” Id. at *33-34.

We have been on the receiving end of all of the arguments the plaintiff made in Adams. And we have fought – not always successfully – for decisions that apply the law rigorously and aren’t swayed by sympathy. We are pleased that the Adams court did just that.