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We just returned from our annual “girl trip” to a lovely spa in the mountains of Pennsylvania. And we stared our decrepitude full in the face. For the first time, we set off enthusiastically on a bike ride (cool “fat tire” bikes we’d never seen before) and found ourselves falling behind on hills and struggling to catch up with the 25-year-olds who composed the rest of the group. Don’t get us wrong – we rowed the hell out of the rowing machines and acquitted ourselves nicely in boxing class. But we were forced to admit that the legs and knees, challenged by tough terrain and compared to those belonging to others with much fresher faces, just didn’t work the way they were supposed to anymore.

So we are heartened to present a case in which implied conflict preemption—“warnings preemption” under Wyeth v. Levine—worked just the way it was supposed to. In Maze v. Bayer Health Care Pharm., Inc., 2019 WL 1062387 (E.D. Tenn. Mar. 6, 2019), the plaintiff alleged that the defendant’s contraceptive pill caused her to suffer a stroke. She asserted the usual warnings claims, alleging that the defendant’s warnings of the risk of thromboembolism were inadequate, though admitting in the same breath that the defendant “devoted substantial space to warning of the risk of venous thromboembolism.”   Maze, 2019 WL 1062387 at *1. The defendant moved to dismiss, arguing that all of the plaintiff’s claims were preempted.

The court explained that, under Levine, state law can still hold a manufacturer liable for failing to update a prescription drug label with “newly acquired [risk] information or even a new analysis of previously submitted data.” Id. (citation to Levine omitted). But changes “not based on new information—and thus necessarily based on the same information already considered by the FDA—require prior FDA approval.” Id. (citation omitted). That is what initial FDA approval is all about. So federal law preempts any claim that the manufacturer should unilaterally have changed a label based on information the FDA had at the time it approved the label. As the court explained, this “lets the FDA be the exclusive judge of safety and efficacy based on information available at the commencement of marketing, while allowing states to reach contrary conclusions when new information not considered by the FDA develops.” Id., quoting In re Celexa & Lexapro Mktg. & Sales Practices Litig., 779 F.2d 34, 41 (1st Cir. 2015).

Under that reasoning, the court continued, “[i]t follows . . . that any claim asserted by [the plaintiff] and based on information known to the FDA as of April 2012—when the label at issue here was approved—is plainly preempted by federal law.” In her complaint, the plaintiff alleged that the defendant was aware, at the time the label at issue was created, that the medication increased users’ stroke risk by 500% (the defendant disputed this fact), and did not set forth “any newly acquired information or even new analyses of previously submitted data,” id. at *3 (internal punctuation and citation omitted). She argued, in her motion, that such information existed, but, the court held, her “blanket statements [were] merely conclusory allegations and [did] not count as a sufficient showing that the plaintiff is entitled to relief.” Id. (internal punctuation and citation omitted).

The court continued,

Finally, and what seals the deal here, is that the label in effect during the entire relevant time repeatedly warned about the risk of stroke. Thus, even assuming the science marshaled by [the plaintiff] is newly acquired and says anything at all about the risk of stroke (as stated above, it is not and does not), nothing indicates that the risk is any higher than what is reflected in the . . . label that the FDA approved in 2012.

Id. In Levine, in contrast, the “main question [was] whether a nonexistent warning should be included in the label at all,” not whether “an FDA-approved, repeated stroke warning that the . . . label has included all along” is adequate. Id. “The former,” the court stated, “is heads-or-tails, the latter involves matter-of-degree questioning with respect to something that was clearly known and considered by the FDA in 2012.” The court concluded, “Without some indication that the science available now is somehow different, the Court will not second guess the adequacy of [the] warning label with state tort law.” Id.   And because the manufacturer could not unilaterally change the label’s stroke warnings, any claim the plaintiff might have had under state law was preempted by federal law.   Case dismissed.

This is how preemption is supposed to work, in the hands of the still-too-rare judge who is not afraid to dismiss a tort suit on preemption grounds. We like this decision, and we will continue to keep you posted on the good, the bad, and the very bad in the world of preemption jurisprudence.

First of all, in response to some comments on our last post, we wanted to close the loop on our dog show narrative. We liked the Wirehaired Fox Terrier, though we have no explanation for the inordinate number of times this breed has won Best in Show (twenty-two, we think we heard). Truth be told, once a dog has won over all of the other entries in its breed, and all of the other breed winners in its group, it is pretty hard for there to be a “wrong” choice. We will say that the Dachshund and the flashy Boxer bitch (featured, by the way, in Netflix’s “7 Days Out” segment on Westminster) showed their hearts out, whereas the Wire seemed a little tired to us. But, unless there is a Standard Poodle (the breed of our heart) among the final seven, we are always happy for whichever gorgeous example of its breed takes the top honor.

In today’s case, federal law takes the top honor. In the Eleventh Circuit’s unpublished decision in Markland v. Insys Therapeutics, Inc., — Fed. Appx. —. 2018 WL 6666385 (11th Cir. Dec. 19, 2018), the plaintiff’s decedent died after being administered the defendant’s pain medication for an allegedly off-label use. The plaintiff filed a wrongful death suit, asserting a single claim for “negligent marketing.” The plaintiff alleged that the defendant engaged in “fraudulent” and “unlawful” marketing to convince doctors to prescribe the drug for off-label uses.

Explaining that, under the FDCA and Buckman, only the United States government may enforce the FDCA’s provisions, the court emphasized that state law tort claims are preempted to the extent that they “seek to privately enforce a duty owed to the FDA.” Markland, 2018 WL 6666385 at *2 (citation omitted).  While the plaintiff in Markland styled his claim as one for “negligent marketing,” the court explained that that is not a recognized tort under Florida law. The plaintiff’s complaint included the allegation that the defendants had “intentionally violated requirements imposed by the FDA” regarding the proper use of the drug.  Id.

The district court had held that the substance of the plaintiff’s complaint was an allegation that the defendant had violated the FDCA, and the Eleventh Circuit agreed. The court held, “A critical premise of [the] complaint is that [the defendant’s] promotion of off-label uses was improper, a proposition that can only be established by pointing to federal law.”  Id.  Moreover the plaintiff did not “point[] to any traditional state-law duty owed by [the defendant] to [the plaintiff’s decedent] that was breached by the company’s marketing of [the drug] for off-label use.”  The court concluded, “It is only because of the FDCA and FDA enforcement decisions that the promotion of off-label uses is prohibited.  Indeed, the very concept of a drug use being ‘off-label’ is derived from the FDCA and FDA policymaking decisions. . . . As with the Buckman plaintiffs, Markland seeks to enforce a duty that exists solely by virtue of the FDCA.  That kind of claim is preempted.”  Id. (internal punctuation and citation to Buckman omitted).

Hornbook stuff, and we like it that way.

Regular readers of this blog may recall that, each year at this time, we report on our cherished annual trip to the Westminster Kennel Club dog show. This year, the trip was modified at the outset by a work conflict (an argument in Kentucky that we knew we would keep us from attending any part of the first day of the two-day event). We hoped to make it to Madison Square Garden for the Tuesday evening group judging and Best in Show, but that plan was affected (read, “doomed”) Tuesday afternoon by a weather-related flight cancellation. Disappointed, we arranged for our ticket to be re-printed and held at Will Call for a friend who was delighted by the unexpected treat. But then we re-grouped. We figured out that we could make it to the Garden for the last hour, if everything went just right, by taking a still-on-time flight to Philadelphia and a train to New York. We got on the flight as they were closing the boarding door, and ended up standing at the door to the Garden at 9:35 pm. BUT WE NO LONGER HAD A TICKET. And the box office was closed, and Security was unimpressed by our near-tears offer to “pay anything” if we could just get into the building for the last hour. So we hovered outside for a while looking pathetic, and eventually hung our head and headed toward our hotel. Whereupon we encountered a scalper with a ticket for sale. And you can figure out the (very, very happy) ending.

So sometimes it pays to grasp at an unlikely straw when all logical avenues have been exhausted. Not so in today’s case. In Mitchell v. Wyeth Pharms., Inc., 2018 U.S. Dist. LEXIS 220946 (W.D. Tex. Dec. 17, 2018), the plaintiff alleged that her decedent died from complications of taking the generic drug amiodarone for non-life-threatening atrial fibrillation. But amiodarone is a generic drug, and all ordinary product liability claims against generic drugs are preempted. Thus, plaintiff was forced to be creative. Under federal law, pharmacies must provide Medication Guides to patients filling amiodarone prescriptions. The plaintiff’s original complaint, naming both the innovator drug manufacturer and the manufacturer of the generic version, included a claim that the generic manufacturer failed to supply the pharmacy with a Medication Guide that could be provided to the plaintiff. It also included warnings claims and the usual litany of product liability claims. All of the product liability claims were dismissed on the defendants’ predictable preemption motion. The plaintiff filed an amended complaint against the generic manufacturer, asserting only a single substantive claim for failure to provide the required Medication Guide. The defendant moved for summary judgment again, arguing that the uncontroverted testimony established that the pharmacy had been provided with an adequate quantity of FDA-approved Medication Guides along with its amiodarone supply. In response, the plaintiff argued that, beyond sending the Medication Guides to the pharmacy, the manufacturer was required play nanny to pharmacies − to take reasonable steps to ensure that each and every pharmacy actually distributed the Medication Guides to patients − and that the manufacturer had not taken such steps.

The court disagreed, quoting federal regulations that required only that the manufacturer provide enough Medication Guides to the pharmacy (or provide the pharmacy with the ability to print additional copies). The court held, “The text, contrary to Plaintiff’s contention, does not place a duty upon [the manufacturer] to take steps to ensure that the Medication Guides are distributed to patients beyond providing them in “sufficient numbers” to the pharmacy. Mitchell, 2018 U.S. Dist. LEXIS 220946 at *9-10. Nor did FDA regulations require the manufacturer to monitor pharmacies practices to ensure that they were providing Medication Guides when required. In the absence of any evidence that the manufacturer had failed to supply the pharmacy with the required Medication Guides, the court granted summary judgment for the manufacturer. Id.

This is not the first time plaintiffs have tried to force the pharmaceutical industry to superintend the professional practice of pharmacy, and we doubt it will be the last. Bottom line: regardless of the difficulty of imposing liability for injuries allegedly caused by a generic drug, a plaintiff can’t plead around the generic preemption/innovator liability framework by asserting a duty that doesn’t exist. At least under a judge, like the Mitchell judge, who is committed to applying the law correctly. What more can a defendant ask?

 

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.