Photo of Rachel B. Weil

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

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

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

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

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

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

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

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

 

When last we wrote, we were about to embark on a journey to Budapest and Vienna to visit the Drug and Device Law Rock Climber. We mentioned that we were thrilled to hold tickets to see the Lipizzaner stallions perform at the Spanish Riding School in Vienna, as we had wished for this since we were very small. And in the phrase “hold tickets” lies the rub.  Though our companion warned us, as we locked the door and departed for the airport, to be sure we had the tickets, we somehow arrived in Europe without them and descended into panic.  For, unlike virtually every other admission credential we had used in the past five years, these were not e-tickets or pdfs but were actual, cardboard tickets, mailed to us in a postal envelope.  And they were missing.  Luckily, in this age of e-mailed confirmations and of people everywhere speaking perfect English, we were able to secure duplicate tickets and to see the stunning white horses of our dreams.  But we were warned, so we would have had no one to blame if the outcome had been different.

As was the case in today’s decision. Ford v. Riina, et al., 2017 N.Y. Misc. LEXIS 1649 (N.Y. Sup. Ct. May 2, 2017), is an unpublished opinion out of the Supreme Court of New York County. The facts are quite tragic.  The plaintiff was being treated for a brain aneurysm by the physician defendant when “a coil escaped” and migrated further into the plaintiff’s brain. Ford, 2017 N.Y. Misc. LEXIS 1649 at *1.  The doctor attempted to retrieve the coil using the manufacturing defendant’s device after another method failed.  “Retrieval of foreign bodies misplaced during interventional radiologic procedures in the neuro . . . vasculature” was one of the indications in the device’s Instructions for Use (“IFU”), which contained warnings about, inter alia, using the proper size of the device (available in a range of sizes) and not performing more than six retrieval attempts in the same vessel using the device.   The IFU also reported that one fracture of the retriever had occurred during clinical trials and provided instructions for reducing the risk of fracture.

The doctor first tried one size of the retriever in the plaintiff. He captured the errant coil, but the retriever fractured when he attempted to retract it.  He tried a larger retriever, which also fractured.  Ultimately, the doctor was able to capture one of the fractured retrievers with a snare but was unable to capture the second retriever or the coil.  The plaintiff was taken for an emergency craniotomy and suffered a major stroke that left him severely brain-damaged.  He sued the doctor and the device manufacturer, and stipulated that claims against the manufacturer would be limited to design defect and failure to warn, and the manufacturer moved for summary judgment on both claims.

In support of its motion, the manufacturer submitted four affidavits.   The first was the affidavit of an engineer employed by the manufacturer’s successor.  The engineer stated that he was able to determine the lot number of each device opened by the doctor and that he was able to determine that there were no reported fractures of any devices in the relevant lots except the fractures to the devices used in the plaintiff.  The second affiant was a bioengineer, who stated that the retriever was the state-of-the-art medical device for foreign body removal from the time of the plaintiff’s procedure up to the present time.  He also stated that fracture was exceptionally rare in the device in question and that the benefits of the device outweighed the risk of fracture, which is inherent in all retrieval devices. The third affiant, a neurologist, opined that the retriever’s IFU expressly warned of the risk of fracture and of vessel damage, that the warnings – including the warning of the precise event that occurred in the plaintiff – were clear an adequate, and that the risks of fracture and vessel damage were “generally known and accepted in the relevant medical community.” Id. at *13-14.  Finally, a registered professional engineer opined that “no other commercial engineering or biomedical alloy can come close” to the elasticity and shape memory of the alloy used in the defendant’s device, id. at * 15-16, that there is no other material commercially available to manufacture the device for its intended use. Id. at *17.

In opposition, the plaintiff submitted the affidavits of two witnesses. The first, a materials scientist, claimed that he tested the retrieval device under a variety of conditions, that the testing confirmed that cracks and fractures could occur with much greater ease and frequency than the IFU suggested and under conditions of which the IFU did not warn, and that, as such, the IFU did not contain adequate warnings related to the potential for fracture. The second witness, a biomedical engineer, opined, inter alia, that the IFU did not adequately warn of the potential for the device to become entangled or stuck in a vessel and of the difficulty of disengaging it once it was stuck.  He also claimed that there were feasible alternative design features that would have prevented the plaintiff’s injury.

The court held that the manufacturer had “establishe[d] prima facie that the IFU conveyed to physician-users the most current knowledge concerning the potential risk of fracture associated with the [device], which is all the law requires.” Id. at *33 (citation omitted).  In addition, the IFU “set forth various steps which the physician-user could take to reduce that risk.” Id. Finally, the manufacturer “establishe[d] its prima facie entitlement to summary dismissal of plaintiff’s design defect claim by establishing that the [device] was state of the art for removing . . . foreign bodies from the neurovasculature, that the device was properly designed and manufactured . . . and . . . incorporated changes made to the [device’s predecessor] as well as other modifications that minimized the risk of fracture.” Id. at *34 (citations omitted).

Once the manufacturer made its prima facie showing, the burden was on the plaintiff to identify a triable issue of fact. And the court held that the plaintiff did not satisfy this burden.  The court stated, “An expert’s affidavit – offered as the only evidence to defeat summary judgment – must contain sufficient allegation to demonstrate that the conclusions it contains are more than mere speculation and would, if offered alone at trial, support a verdict in the proponent’s favor.” Id. at *35 (citations omitted).  In this case, the plaintiff’s experts made “repeated reference to various tests and experiments they performed which they contend[ed] replicated the foreseeable event of the [device] being ‘fully stuck’ within a patient’s cerebral vasculature.  However, noticeably absent . . . is any description . . . of the actual tests and experiments they performed or the conditions under which they performed them . . . [including whether] the tests and experiments . . . were based on accepted industry standards. Id. at *36 (citations omitted).  The court concluded, “Simply stated, there is nothing in the experts’ affidavits from which the validity of their ultimate conclusions about the design of the [device] and the adequacy of the IFU can be inferred. . . .In the absence of any reference to a foundational scientific basis for their conclusions, [the plaintiff’s experts’] opinions lack sufficient probative value to raise a triable issue of fact” as to design defect or the adequacy of the warnings.”  Claims dismissed, summary judgment for the manufacturer.

Ford is a well-reasoned and correct decision that fits nicely into our self-styled crusade against the opinions of experts who should never darken the courthouse steps.  We will keep our eyes open for similar holdings in published, precedential opinions, and we will keep you posted.

Next week, we are traveling to Budapest, with a side trip to Vienna. We are visiting the Drug and Device Law Rock Climber, who is spending this semester abroad studying computer science (in Budapest) and climbing rocks (in Majorca, etc.).  Aside from the beloved visage of our only child, we are most excited about seeing the Lipizzaner stallions perform at the Spanish Riding School in Vienna.  When we were eleven years old, we read “My Dancing White Horses” by Colonel Alois Podhajsky, director of the School.  This wonderful autobiography recounts Podhajsky’s extraordinary efforts to save the Lipizzaners during World War II.  It was (and is) a compelling read, and it led us to “My Horses, My Teachers,” Podhajsky’s homage to his stunning equine mentors.  Since that time, the Lipizzaners have occupied a permanent spot atop our bucket list, and we are beyond thrilled to hold tickets to one of their performances.  Beyond that, we had to start from scratch to plan this trip.  We Googled and researched, and our takeaway was how much we didn’t know about Budapest’s history and culture.

Perhaps the plaintiff’s would-be experts in today’s case should have engaged in similar assessments of their knowledge bases. Regular readers of this blog are familiar with our ongoing rant against “experts” who aren’t, and with the cases that nonetheless ride on the “experts’’ unqualified shoulders.  In this case, the Court agreed with us.

In Hale v. Bayer Corporation, 2017 WL 1425944 (S.D. Ill. Apr. 20, 2017), the plaintiff alleged that the defendant’s product, an over-the-counter (“OTC”) non-steroidal anti-inflammatory drug (“NSAID”) caused him to develop a permanent kidney injury known as “Minimal Change Disease” (“MCD”). He asserted the usual product liability claims sounding in strict liability and negligence, and identified three experts.  The defendant moved to exclude all three – the plaintiff’s primary care physician, the plaintiff’s treating nephrologist, and a pharmacist — under Daubert, arguing that none had rendered an opinion that was “properly founded in or based upon sufficiently reliable medical, scientific, or other specialized knowledge.” Hale, 2017 WL 1425944 at *1 (citation omitted).

Plaintiff’s Primary Care Physician

The plaintiff’s primary care physician testified that he referred all kidney patients to a nephrologist and that he had never studied whether NSAIDs may cause particular kidney injuries. Naturally, the defendants moved to exclude him because he was unqualified to offer causation opinions and because he relied on the plaintiff’s treating nephrologist’s opinions and diagnosis as the basis of his opinions.  In their response, the plaintiffs stated that they would not offer the expert to testify about causation,  but only to discuss his care and treatment of the plaintiff.  The Court agreed that the doctor would be permitted to testify about his treatment of the plaintiff but would not be permitted to offer causation opinions.

Plaintiff’s Treating Nephrologist

Next, the plaintiff offered his treating nephrologist, who diagnosed the plaintiff with NSAID-induced MCD.  The defendants argued that the nephrologist’s opinions were “insufficiently supported by medical science” and that he was “not able to definitively establish by any medical or laboratory test that the plaintiff’s consumption [of the NSAID] was the cause of his MCD.” Id. at *3.  They also argued that the nephrologist’s purported “differential diagnosis” was based on insufficient scientific data.  The plaintiffs argued that the doctor had 30 years of experience as a nephrologist, that he managed the plaintiff’s case, and that he relied on scientific literature in reaching his causation conclusion.

The court cited case law confirming that, while a properly-performed differential diagnosis can constitute a reliable methodology, such diagnosis must go “beyond the mere existence of a temporal relationship” between the plaintiff’s ingestion of the defendant’s product and the onset of his symptoms. Id. at *4.  Analyzing the doctor’s methodology, the court observed that the doctor had ruled out certain diseases that can cause MCD.  He also ruled our food poisoning and some infections.  But most MCD is idiopathic.  (Idiopathic means nobody knows what causes it.)  To rule out idiopathic MCD in the plaintiff’s case, the doctor testified that he relied on the temporal relationship and on scientific literature that had acknowledged “for the last 25 years that NSAIDs can cause renal injury or renal malfunctions.” But the data the doctor cited involved prescription-strength NSAIDs, and he testified that he did not know of studies involving lower-strength OTC NSAIDs and had never read an article linking the defendant’s specific NSAID to renal injury.  The court concluded that the doctor could not “provide any scientific and/or medical data with regard to the relationship of over-the-counter NSAIDs and kidney disease,” let alone any specific data related to the defendant’s product.  As such, the doctor’s opinions were “unreliable based on the lack of supporting medical science as required by” Fed. R. Evid. 702.  Moreover, though the doctor had general knowledge about the diagnosis and treatment of kidney disease, he lacked “expert knowledge with the specific subset of over-the-counter NSAIDs” and MCD.  And so, like the PCP, the nephrologist was permitted to testify about his care of the plaintiff but was precluded from offering causation testimony.

The Pharmacist

Finally, the plaintiff offered a pharmacist to testify, as an element of Illinois’s “consumer expectation test,” that the plaintiff’s particular kidney injury was foreseeable to the defendant and that the danger of this injury went beyond that which would be contemplated by the “ordinary patient with ordinary knowledge common to the community.” The pharmacist was qualified to offer this opinion, they argued, “based on many years of educating and working with healthcare providers and providing healthcare services to patients.” Id. at *6.  He said that he “regularly interacted with [patients] and understood their level of awareness regarding OTC . . . NSAIDs and kidney injury.” Id. at *7.

The court pointed out that the pharmacist was not a physician, had never participated in clinical trials involving any NSAID, and was not aware of any cases of MCD associated with OTC use of the defendant’s product. Though he had reviewed 203 case reports, none involved MCD, and, in any event, the court had previously rejected expert opinions based on case reports.  As the court emphasized, “Because of their limitations, case reports have been repeatedly rejected as a scientific basis for a conclusion regarding causation. Such case reports are not reliable scientific evidence of causation, because they simply describe reported phenomena without comparison to the rate at which the phenomena occur in the general population or in a defined control group. . . [T]hey do not isolate and exclude potentially alternative causes . . . and do not investigate or explain the mechanism of causation.”  Id. at *8 (citation omitted).

Finally, the court held that the pharmacist “clearly [did] not have the necessary background to offer an opinion of whether the risk and danger of [the product] outweighed its benefits.”  His entire opinion was “based on the fact that there are alternative [products] that may achieve the same relief benefit.  That is like saying that an individual could safely ride the train to work and thus have avoided a car accident, [but] . . . there is no indication of a complete risk/benefit analysis being conducted by [the pharmacist] or that [he] relied on any studies” conducting such an analysis.  Id. at *7.  (We have posted on this issue before.  You can see some of the posts here.)  The court concluded that the pharmacist had “provided no support – other than his general experience – of the opinions” he had offered. As such, the court held that the pharmacist’s opinions were “unreliable based on the lack of supporting data as required by Federal Rule of Evidence 702.” Id. at *8.

And then there were none. And with no experts, the plaintiffs could not meet their burden of proof of causation.  Moreover, while the court acknowledged that Illinois had not decided whether the consumer expectation test required expert testimony, the plaintiff had not demonstrated that the defendant’s product was unsafe, because “every expert deposed stated that they believed [the product] to be safe when used as directed.” Id. at *11.  Check and mate – summary judgment granted for defendants.

Sometimes, when we write this stuff, we have trouble keeping a straight face because the plaintiffs’ arguments so lack merit as to verge on silliness. It continues to puzzle us that these experts – and these cases – even see the light of day.  But we are grateful for the sensible judges who extinguish them.

We’ll be back in a week or so, with pictures of beautiful white stallions (and one beautiful daughter) in hand. E-mail us – we’ll send you copies.

 

We spent Sunday evening in the familiar confines of a top-notch local professional theatre. The production was a short (80-minute), two-character play.  It was entirely dialogue-driven, so everything the audience learned came out of a character’s mouth – there was no action to speak of.  It was also perfectly cast, well-acted, and absorbing.  By the end of the first 75 minutes, we cared a lot about the characters and were anxious to learn how their story ended.  Then came the revelation (residents of our neighborhood who intend to see this play should skip this spoiler) that nothing we had seen and heard had actually happened, at least in anything like the fashion we had come to understand.  The (mostly glowing) reviews described this as a “plot twist.”  This wasn’t a plot twist.  A plot twist is when something unexpected happens, taking the story in a new direction.  This was a gimmick – a dishonest device that relieved the playwright of the burden to maintain plot integrity and create a plausible dramatic arc.  And we felt angry and betrayed, and somewhat “fool me twice” duped, as this was the second play in a single year that employed a “Bobby Ewing in the shower” ploy like this one.  (Only readers who share our dotage will understand that reference.)  We love the theatre more than almost anything, and we are sad to see this sort of trickery gain traction.  From now on, we will try to remember that we can’t rely on anything that any character says.

Of course, we already knew that about a lot of plaintiffs’ mass tort causation experts. Last month, we blogged about the exclusion of one plaintiff’s experts in a hernia mesh case.  Today’s case, like the Bowersock case that was the subject of our last post, is a case that was remanded to its transferor court when the hernia mesh MDL shut down.  In Olmo v. Davol, Inc. and C.R. Bard., Inc., Case No. 13-62260-CIV-COHN/SELTZER, United States District Court for the Southern District of Florida, the court recently decided the defendants’ motion to exclude the plaintiff’s causation expert and their Motion for Summary Judgment.   You can see the order here.

In Olmo, the plaintiff’s abdominal hernia was repaired with the defendants’ Composix Kugel (“CK”) hernia repair patch in 2005.  In the CK patch, the mesh patch is attached to two memory recoil rings intended to stabilize the device.  Six years after her CK patch was implanted, the plaintiff experienced abdominal pain, and her CK patch was explanted and replaced with a different hernia mesh product.  The explanting physician observed that a corner of the CK patch had lost fixation and folded under, causing mesh to erode into the plaintiff’s bowel.  The explanter did not observe buckling in the explanted device, did not determine whether the rings had broken, and did not discern what had caused the mesh to fold.  The explanted patch was not preserved and was not photographed before it was discarded.

In her complaint, the plaintiff alleged that a break in one or both of the memory recoil rings in her CK patch caused the mesh to come into contact with her bowel. She submitted the report of a biomedical engineering expert who briefly chimed in with his assent to the plaintiff’s theory, stating, “The fact that the mesh had folded such that the porous polypropylene layer contacted internal organs, unequivocally leads to the conclusion that the outer and perhaps also the inner memory recoil rings did not prevent folding, which is only possible subsequent to . . . [ring] breakage . . . .”  Order, p. 7.  But, as the court noted, the remainder of the expert’s report was “devoted almost entirely to explaining why [he] believes that [the defendants’] product testing and design of the CK patch were unsatisfactory,” and did not explain “why folding necessarily leads to the conclusion that a ring break occurred.” Id. (citation omitted).  Nor did the expert clear this up at his deposition.  Instead, when asked how he reached his conclusion that a ring had broken, the expert responded that “major folding of the device,” such as that described by the plaintiff’s explanter, is only possible when a ring breaks.  The expert did no tests to confirm his theory.  He did no tests to rule out an alternative theory.  He was not aware of any scientific studies or literature supporting his conclusion.  And he could point to no evidence that “engineering or medical communities would accept the premise that the folding described by [the explanter] is only possible with a ring break.”  The expert did add that the folding of the plaintiff’s patch was greater than he had observed in cases in which a ring break was documented, but he couldn’t identify any of those cases.  Citing Joiner, the court concluded that there was “too great an analytical gap” between the data on which the expert relied and his “broken ring” conclusion, and excluded the expert’s testimony in its entirety.

With no admissible evidence of medical causation, the plaintiff could not satisfy her burden of proof of her warnings and design defect claims, and her remaining claims – punitive damages and loss of consortium – could not survive alone. So the court granted summary judgment and dismissed all of the plaintiff’s claims with prejudice.

We love this. You have heard us rant and rave enough times about mass tort plaintiffs who get money for claims they can’t prove.  It was nice to see aggressive lawyering and a brave and sensible judge lock the vault with this plaintiff’s open hand safely outside.  And, just maybe, plaintiff lawyers will someday think twice about relying on experts who skip the step of employing reliable (or any) methodology.  We can always hope.  Just as we will the next time the house lights dim, the curtain opens, and a theatrical journey begins.

We have blogged before about the Mirena IUD litigation. Cases alleging injuries from device migration and uterine perforation were centralized in an MDL in the Southern District of New York, but, as we reported here, summary judgment was granted for the defendants in all of those cases when Daubert motions disposed of the plaintiffs’ causation experts.  There is another group of Mirena plaintiffs, this time alleging that Mirena caused them to develop idiopathic intracranial hypertension (“IIH”), a serious brain disorder marked by increased pressure in the brain and central nervous system.

Exactly one published study has ever linked Mirena to IIH. The lead author was Mahyar Etminan, Pharm. D. – much more about him in a minute.  You can read the Etminan article here. The Etminan article reported the results of two analyses:  an epidemiological study and an analysis of adverse events reported in the FAERs database.  The epidemiological study – that is to say, the unbiased statistics – did not demonstrate an increased risk of IIH associated with Mirena use when compared to combined oral contraceptives.  But the article reported that the FAERs analysis demonstrated a higher-than-expected proportion of IIH reports with Mirena as compared to all other products in the FAERS database.  (We’ve devoted an entire post (and cheat sheet) to why adverse event reporting doesn’t, and can’t, demonstrate causation.)

The Etminan article was published in 2015 and included a standard “no conflict of interest” statement. In the ensuing months, Mirena IIH plaintiffs in a half-dozen district courts disclosed their experts.  Among them was none other than Mahyar Etminan, who, it turns out, had been on plaintiffs’ payroll all along in a blatant conflict of interest not disclosed in his article.  Etminan, along with three other causation experts, cherry-picked the results of the FAERs analysis to allege a causal relationship between Mirena and IIH but never dealt with the conflicting epidemiological data from the same article.

And it gets even better.   In December 2016, Etminan executed an affidavit, which you can see here.  In it, Etminan explained that the methodology of the FAERs analysis was flawed and did not support its conclusion.  Specifically, in comparing the proportion of IIH reports among Mirena users with the proportion among non-users in his FAERs analysis, Etminan failed to limit the comparator groups to women of reproductive age.  Because women of reproductive age have a higher background incidence of IIH than other age groups, failing to limit the comparator groups to these women introduced a bias against the Mirena group.  When the analysis was re-done with the correct comparator groups, the affidavit explains, the results did not support a claim that Mirena increases the risk of IIH.

And so Etminan, the source of the only published study claiming that Mirena causes IIH, publicly renounced his published conclusions. (Earlier, when the flaws in the FAERs analysis came to light, Etminan withdrew from the seven cases in which he’d been named as an expert.)  We don’t know that we have ever seen anything like this in all of our days litigating mass torts.  And we love watching the collapse of a house of cards erected on a foundation of paid (and undisclosed) advocacy.

But the story isn’t over yet. None of plaintiffs’ other causation experts – all of whom also relied on Etminan’s published FAERs analysis – has yet withdrawn.  And, just days ago, IIH cases were centralized in an MDL in the Southern District of New York.  (Plaintiffs had sought such an MDL in 2014, but the JPML rejected that request.)  Regular blog readers are familiar with our views of many MDL plaintiffs and their lawyers, spawned during countless hours fighting hordes of meritless claims that MDL judges allow to remain pending.  By rights, with no evidence of causation, plaintiffs should be out of court.  And, certainly, some threshold determination of merit should precede the formation of an MDL.  But mass torts exist for the masses, who queue up for settlement handouts that don’t depend on meritorious claims.  Can the new IIH MDL proceed very far down the litigation path when the plaintiffs’ causation claim has been debunked by its primary supporter?  Back in November, we learned never to say never.  So stay tuned.

Regular readers of this blog know that we have a pretty jaded view of many MDLs. Obviously consolidation makes sense, at least on paper, in terms of efficiency and the best use of scarce court resources.  But, in practice, many MDLs promote a litigation “mob mentality,” in which the merits of individual cases are not important at the outset and, in the world of “settlement inventories” and “mass settlements,” may never draw the scrutiny of the judge or anyone else.   Though we continue to hope that “Lone Pine” orders will burgeon and raise the standards for plaintiffs seeking to fly under the radar and await settlement, many MDLs remain “safe havens” for plaintiffs who can’t satisfy the burden of proving their claims.

And a recent decision from the hip implant MDL does nothing to disturb this reality. In that MDL, a longstanding “Explant Preservation Order” requires preservation of hip implant devices removed from plaintiffs during explant surgeries.  The order requires plaintiffs to “make good faith efforts to ensure that [medical facilities] preserve” explanted devices and provides options for plaintiffs’ counsel to claim devices within 60 days of explant or, in the alternative, for the devices to be sent to the defendants.  It  requires all parties to handle explanted devices in accordance with a written protocol or consistent  with “methods and practices accepted by those in the field of inspection and testing of orthopedic devices,” to notify each other of devices in their possession before the date of the order, and to make devices available to each other after inspection and testing.   All of this, obviously, ensures that the critical evidence in this product liability MDL is preserved and handled in a fair and consistent manner.

In Marquis v. Biomet, Inc., et al., 2017 U.S. Dist. LEXIS 28465 (N.D. Ind.  Mar. 1, 2017), the defendants moved for summary judgment against six plaintiffs.  Five of these plaintiffs had had their devices explanted before they filed suit, or after they filed suit but before their cases were transferred into the MDL, and did not know what happened to their devices after they were explanted.  The sixth plaintiff had several revision surgeries.  During the first, the femoral head of her hip implant was replaced, and she asked for the explanted femoral head.   She explained, “I figured I paid for it.  I wanted it.”  She kept the femoral head in her closet, didn’t disclose on her fact sheet that she had kept it, and didn’t tell anyone she had it until her deposition.  The devices explanted during her subsequent surgeries were not preserved.

Continue Reading Hip Implant MDL Denies Summary Judgment on Claims of Plaintiffs Who Failed to Preserve Explanted Devices

We loved La La Land.   We were enchanted by the colors and the music and the dancing.  We were transported by the dreams-come-true and saddened by the could-have-beens.  We disappeared into the characters’ world for two hours and were not ready when the lights came up.   For us, it was the epitome of a movie experience, and we were thrilled – momentarily – when it was announced as Best Picture.  But, as all who witnessed Oscargate (and anyone who didn’t spend the last week in a submarine) can attest, simply saying it didn’t make it so.

Last week, in Bowersock, et al. v. Davol, Inc. and C.R. Bard, Inc., 2017 WL 711849 (S.D. Ind. Feb. 23, 2017) the United States District Court for the Southern District of Indiana reached the same conclusion, excluding the plaintiffs’ experts in a hernia mesh case.  The plaintiffs claimed that a component of the defendants’ hernia mesh patch – a polyethylene terephthalate ring – perforated the intestines of the plaintiffs’ decedent, ultimately resulting in sepsis and death.

An autopsy was performed and concluded that the decedent’s small bowel and colon were intact, without perforation. But the hernia mesh patch was not retrieved from the decedent’s body before she was buried, so, seven years later (!!!), the plaintiffs had the body exhumed so the patch could be retrieved and analyzed, after which they submitted the reports of two causation experts – a surgeon and a biomedical engineer – to opine that components of the mesh patch caused the decedent’s injuries.

The Surgeon

The plaintiffs’ first expert, a general and gastrointestinal surgeon who used the defendants’ patch in his own practice, reviewed the patch explanted from the decedent’s exhumed body. He opined that the ring, though not broken, had buckled, creating a sharp edge that rubbed against the decedent’s bowel and perforated it.

Continue Reading Southern District of Indiana Excludes Plaintiffs’ Experts in Hernia Mesh Case

Regular blog readers may recall that, every year, we eagerly await a Monday and Tuesday right around February 14th.  This has nothing to do with Valentine’s Day (though we like a dozen roses and a box of chocolates as much as the next person.)  No, at this time every year (for the past eighteen or so) we cross our fingers that there is no blizzard, beg everyone in our work life to cover any emergencies, and head to New York for the Westminster Kennel Club Dog Show.  This year was the 141st annual show, and, as always, it was a mecca for all things dog.  As we ate breakfast in our hotel, we were visited by Mobius, a red Doberman so tall he had to lean down to attempt to taste our complimentary make-it-ourselves waffle.  To board the shuttle from the Hotel Pennsylvania (worthy of its own post) to Piers 92 and 94 for the daytime breed judging, we had to step over “Sky,” a 140-pound Greater Swiss Mountain Dog sprawled in the aisle of the bus, calmly oblivious to accidental bumps and kicks and happily kissing anyone who asked.  We live for this stuff, even if our chosen favorite almost never wins.

For the atmosphere is rarified. A few years ago, the show stopped being “champions only” and admitted “class dogs” – dogs still working their way through point-earning breed classes to achieve their championships – for the first time.  But, save for the infrequent upset, the group competition (the televised portion, in which the single winner of each breed competes against the winners from the other breeds in its “group” – sporting, herding, toy, etc.) is dominated by the very top-winning show dogs in the country.  Last year, we fell in love with a gorgeous German Shepherd Dog named Rumor.  She was a heavy favorite to win it all (“Best in Show”), but was upset by C.J. the German Shorthaired Pointer and settled for Reserve Best – second place.  And she retired, to raise beautiful puppies and live the life of a cherished house pet.

But, alas, said puppies did not get made on the first attempt. And, come January, Rumor’s owner/handler decided to give her one more shot at the big one.  So she “came back out,” showed at ten shows in January, and took one more run at the Garden.  And, this time, after upsetting the favorite, Preston the Puli, to take the Herding Group, she won it all.  It was very, very cool to witness.  And we already can’t wait ‘til next year.

And there was a blog-worthy lesson to be gleaned from it all (at least if you stretch a little): if you haven’t achieved everything you want, think about taking another shot.  And H.R. 985, a bill that passed the House Judiciary Committee this week, would pick up where CAFA left off (and then some) to correct still-rampant abuse of the system by class action and MDL plaintiff lawyers, to the detriment of our clients, the judicial system as a whole, and all too often, to the plaintiffs the lawyers ostensibly represent.

Under “Purposes,” the bill states: “The purposes of this act are to – (1) assure fair and prompt recoveries for class members and multidistrict litigation plaintiffs with legitimate claims; (2) diminish abuses in class action and mass tort litigation that are undermining the integrity of the U.S. legal system; and (3) restore the intent of the framers of the United States Constitution by ensuring Federal court consideration of interstate controversies of national importance consistent with diversity jurisdiction principles.”  Worthy goals all, if a trifle ambitious. The bill’s key points read like a set of nesting boxes – just when you think you’ve opened the last, there is another present inside.  Here are some highlights:

Class Actions

  • Injury allegations: this provision requires a court to deny certification unless “the party seeking to maintain such a class action affirmatively demonstrates that each proposed class member suffered the same type and scope of injury as the named class representative.” This is ascertainability something for which we’ve advocated, and also something that our side tried unsuccessfully to get fixed through the Federal Rules Committee. Thus, the judiciary had its chance to fix this. Nothing happened, so now Congress is poised to step in. About time.
  • Conflicts of interest: this provision requires class counsel to state, in the body of the complaint, “whether any proposed class representative or named plaintiff in the complaint is a relative of, is a present or former employee of, is a present or former client of (other than with respect to the class action) or has any contractual relationship with . . . class counsel” and shall “describe the circumstances under which each class representative or named plaintiff agreed to be included in the complaint and shall identify any other class action in which any proposed class representative or named plaintiff has a similar role.”
  • Attorneys’ fees: “[N]o attorneys’ fees may be . . . paid . . . until the distribution of any monetary recovery to class members has been completed,” and “[u]nless otherwise specified by Federal statute, . . . the portion of any attorneys’ fee award to class counsel . . . shall be limited to a reasonable percentage of any payments directly distributed to and received by class members [and in] no event shall the attorneys’ fee award exceed the total amount of money distributed to and received by all class members.” We particularly like this because it would effectively put an end to cy pres, against which we’ve railed for years. By limiting the denominator for fee awards to “payments directly distributed to and received by class members” it prevents cy pres sums from being used to inflate fee awards.

There are other provisions, requiring stringent accounting provisions for settlement funds forbidding certification of issue classes unless all relevant Rule 23 prerequisites are satisfied (another thing our side tried first to fix through a change to Rule 23), and most significantly providing for severance of misjoined plaintiffs for purposes of jurisdictional determinations. This legislative elimination of fraudulent misjoinder is a key point, since it addresses the multi-plaintiff complaints we love to hate.

We note that since the “effective date” of this act provides for its application to all “pending” civil actions, cases currently in state court can be removed (or removed again) under the provision negating misjoinder as a means of preventing diversity-based removal to federal court.

Finally, in an issue close to our hearts as we daily encounter plaintiffs unwittingly victimized by so-called “litigation funders,” the bill provides, “In any class action, class counsel shall promptly disclose in writing to the court and all other parties the identity of any person or entity, other than a class member or class counsel of record, who has a contingent right to receive compensation from any settlement, judgment, or other relief obtained in the action.” A sunshine law for third-party funding is something else for which we’ve advocated.

Multidistrict Litigation:

  • Proof of exposure and injury: We were thrilled to see a “Lone Pine”-esque provision build into the MDL portion of the bill. It provides, in pertinent part, “In any coordinated or consolidated pretrial proceedings . . . , counsel for a plaintiff asserting a claim seeking redress for personal injury [in the MDL] shall make a submission sufficient to demonstrate that there is evidentiary support (including but not limited to medical records) for the factual contentions in the plaintiff’s complaint regarding the alleged injury, the exposure to the risk that allegedly caused the injury, and the alleged cause of the injury . . . within 45 days after the civil action is transferred to or directly filed in the proceedings. That deadline shall not be extended. Within 30 days after the submission deadline, the judge . . . shall [determine] whether the submission is sufficient and shall dismiss the action without prejudice if the submission is found to be insufficient.” Thirty days later, in the continued absence of a satisfactory submission, the action is to be dismissed with prejudice. Not long ago, we advocated for amending the MDL statute to require early factual disclosure, with dismissal as the sanction for not disclosing enough to satisfy Rule 8. This is the functional equivalent.
  • Trial Prohibition (“waiving Lexecon”): MDL judges “may not conduct any trial in any civil action transferred to or directly filed in the proceedings unless all parties to the civil action consent to trail of the specific case sought to be tried.” This provision would remove the threat of MDL trials as a tool to force defendants to settle. It is something else for which we have advocated.
  • Ensuring Proper Recovery for Plaintiffs: MDL plaintiffs “shall receive not less than 80 percent of any monetary recovery obtained in that action by settlement, judgment or otherwise.”

While most of the press coverage seems to focus on class actions, to us the removal and MDL provisions are at least as important. The vast bulk of our professional life is spent in the mass tort space – mostly MDLs these days, with the occasional class action thrown in. We have become accustomed (but never inured) to plaintiffs without injuries herded by counsel who are their friends or bosses into mass actions in which they don’t belong. On the other end of the spectrum, we encounter severely injured plaintiffs who will recover next to nothing because lawyers and litigation funders own most or all of the plaintiffs’ stakes in the inevitable settlements. And, at every turn, we sit across the table from tanned and affluent plaintiff attorneys who are the only ones apparently immune to the vagaries of the system and who are the sole beneficiaries of its inequities. H.R. 985, as drafted, attempts to address many of these issues. We do have questions. Who defines “the same type and scope of injury,” for example? And we have doubts: can a bill possibly survive the powerful plaintiff attorney lobby when it attempts to resurrect the integrity of mass litigation by hitting those attorneys squarely in their pocketbooks? But we heartily and excitedly support this bill, and we know that some of its provisions are way, way better than none. We will keep you posted.

For those of us who spend large chunks of our professional lives in mass tort MDLs, expressions like “settlement inventory” are ubiquitous. It is too easy to lose sight of the fact that these expressions put the rabbit in the hat, assuming that resourceful plaintiff lawyers will necessarily queue up for settlement payments at the end of the day and disregarding the fact that plaintiffs are supposed to be able to prove injury and causation before money changes hands.  And so we were especially pleased to read last week’s decisions in the Lipitor MDL, in which the  cautious and relentlessly thorough MDL  judge granted defendant Pfizer’s omnibus summary judgment motion, dismissing all but a single newly-filed case, because the plaintiffs could not meet their burden of proving that Lipitor caused their diabetes.  (There are two decisions relating to different dosages of Lipitor.  You can read them here and here.)

The Lipitor MDL, created in February 2014, centralized cases in which female plaintiffs alleged that Lipitor – prescribed in dosages of 10 mg., 20 mg., 40 mg., and 80 mg. – caused them to develop Type 2 diabetes.  In March and April of 2015, as trials of two bellwether cases approached, the plaintiffs served common expert disclosures of general causation experts, followed, in May and June, 2015, by specific causation expert disclosure in the two bellwether cases.  After full expert discovery, Pfizer moved to exclude all of these experts.  Ultimately, the court excluded the plaintiffs’ expert testimony on general causation with respect to Lipitor dosages of 10, 20, and 40 mg.  The court  also excluded the testimony of the bellwether plaintiffs’ specific causation experts, finding that the experts failed to rule out other possible causes of diabetes and relied impermissibly on temporal relationships, and granted summary judgment  for Pfizer on the claims of both bellwether plaintiffs.  (You can read our posts on these Daubert decisions here and here.)

However, the court left one general causation “window” open, based on one study finding that it was more likely than not that patients with certain characteristics who took 80 mg of Lipitor would not have developed diabetes in the absence of Lipitor. Thus, though neither of the bellwether plaintiffs had the requisite characteristics, it was possible that a plaintiff existed who took Lipitor at the 80 mg dosage and who could proffer a specific causation opinion that would survive Daubert.

Continue Reading Lipitor MDL Court Grants Pfizer’s Omnibus Summary Judgment Motion: No Evidence of Causation

Last week, along with many of you, we attended the ACI Drug and Medical Device Conference in New York City. The quality of the presentations was uniformly high, and the collegiality and camaraderie were welcome, refreshing, and a lot of fun.  There was plenty to drink.  There was lots of food.  Oh, and we got to see Hamilton!  We should preface our comments by pointing out that we were skeptics – we knew how pricey (really, really pricey) tickets are, and we weren’t even positive we would enjoy this immensely innovative rap musical.  To wit, one of our best beloved musicals of recent years was the wonderful, if short-lived, revival of Finian’s Rainbow that played the Great White Way a couple of years ago.  We go for the traditional stuff, and had neither resources nor plans to spring for Hamilton.

But we got very lucky. A generous friend had bought four tickets a full year earlier in anticipation of the annual conference.  And there was a last-minute cancellation.  And we got to go.  And it was worth all of the hype (and all of the money, if you have it).   We enjoyed it so much that we came home and researched ticket availability to return with the Drug and Device Law Long-Suffering Companion.  Tickets are on sale for next year, and we thought that we could avoid the crazy street prices by planning way ahead.   Not so – even this far in advance, tickets (from official ticket sources, not ticket agencies) are way out of the reach of normal consumers.  Sometimes, the early bird does not get the worm (or the greatest financial benefit).

And, with just a bit of creativity, we can glean the same message (among others) from today’s case. Dobbs v. DePuy Orthopedics, — F.3d —, 2016 WL 7015648 (Seventh Cir. Dec. 1, 2016), is an appeal of an attorney’s fee decision from the United States District Court for the Northern District of Illinois.  (We’ll explain how it got there in a minute.)  The plaintiff/appellant had direct-filed a product liability claim in the Hip Implant MDL in the Northern District of Ohio.  Believing that the promised compensation was too low, he opted out of the global settlement and fired his lawyers, who had advised him to accept the global settlement, which included a 35% attorneys’ fee.   (The global settlement provided one level of payment for unrepresented plaintiffs, and a second level, 35% higher, for represented plaintiffs.)

Less than two months after his lawyers withdrew their appearance, the plaintiff accepted the global settlement. Because he was considered “represented” for purposes of the settlement, he was paid the larger amount.  (Not clear why he was considered “represented” when his lawyers had been fired.)  His former lawyers asserted a lien on the award and sought to recover attorney’s fees.  The MDL judge tried unsuccessfully to mediate the fee dispute in the Northern District of Ohio then transferred the case to the Northern District of Illinois, where the case would have been filed if the MDL had not been pending.

Continue Reading Court of Appeals Applies Law of Would-Be Filing Court in Fee Dispute in Hip Implant Case Filed Directly Into MDL