Earlier this week, we posted on the Ninth Circuit’s conversion of the Daubert’s gate (that the trial court should keep) into more of a swinging saloon door.  A week before the Ninth Circuit ruled that a trial court had erred in excluding unreliable causation testimony (and granting summary judgment as a result), the Third Circuit had affirmed a trial court’s exclusion of unreliable causation testimony (and grant of summary judgment as a result).  Even though we are discussing In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., __ F.3d __, 2017 WL 2385279 (3d Cir. 2017), second, it really is a bigger deal because it reaffirmed the end of an entire MDL.

We followed the district court’s Daubert rulings on the epidemiology and mechanism experts offered for all the plaintiffs.  We watched in amazement as the plaintiffs got to try again and still could not offer reliable expert testimony on general causation.   With our typical restraint, we applauded the court’s subsequent decision that no plaintiff could make out a case for general causation between maternal use of the drug and the cardiac birth defects claimed without the excluded experts and that was fatal to their claims.  We found that the plaintiffs, maybe because of the sympathy associated with their claimed injuries, got plenty of leeway before the court determined that there was simply no there (i.e., good science) there.  (Along the way, we saw that Pennsylvania and West Virginia state courts came to similar conclusions.)

The appeal to the Third Circuit focused on whether the biostatistician offered as a back-up expert on epidemiology was properly excluded, with plaintiffs conceding that they should have lost if he was.  Plaintiffs’ central contention was that the district court created a standard that requires general causation opinions to be “supported by replicated observational studies reporting a statistically significant association between the drug and the adverse effect.”  We think that standard, similar to Havner and Daubert II, is a fine standard, but the district court did not create or apply such a standard in knocking out the biostatistician.  Likewise, the Third Circuit declined to “state a bright-line rule” that “statistical significance is necessary to prove causality.”  (We think it is, because the Bradford Hill Criteria, which the biostatistician purported to apply, starts with an association demonstrated through epidemiologic studies.  We will try to resist arguing for the tighter standard given the result.)  The district court considered the lack of multiple statistically significant studies supporting an association to be contrary to what teratologists generally require and thus relevant to whether an opinion without such support was unreliable.  A flexible approach to evaluating the reliability of a general causation opinion was fine with the Third Circuit and its reading of the Bradford Hill Criteria.  (There is flexibility, but only when there is an association from epidemiologic studies as a predicate.  OK, we will have to try harder.)

The Third Circuit “accept[ed] that the Bradford Hill and weight of the evidence analyses are generally reliable.  We also assume that the ‘techniques’ used to implement the analysis (here, meta-analysis, trend analysis, and reanalysis) are themselves reliable.”  That assumption is dicta—which is a good thing—because the court concluded that the biostatistician did not reliably apply the methodology or techniques that he claimed to be applying.  First, he gave lip service to analyzing “multiple positive, insignificant results,” but he really just eyeballed trends.  Second, his trend analysis was based on cherry picking and inconsistent application of basic statistics principles.  Third, his meta-analysis was also result-driven, as he could not justify why he included some studies and excluded others.  Fourth, his reanalysis was done for no reason but to conclude that a published study reporting no association should have found one.  Altogether, “the fact that Dr. Jewell applied these techniques inconsistently, without explanation, to different subsets of the body of evidence raises real issues of reliability.  Conclusions drawn from such unreliable application are themselves questionable.”

The court probably could have stopped there.  It went on to detail how the biostatistician’s purported application of Bradford Hill was riddled with errors that he could not explain.  This was more than enough to conclude that the district court had not abused its discretion in excluding the expert.

Along the way, however, it noted that it may be possible to have a reliable reanalysis that draws a different conclusion than the original published study and that an expert can make unsupported assumptions in connection with doing an “informational” reanalysis.  It offered that “[t]hese inquiries are more appropriately left to the jury.”  We disagree and think the broader context has to be considered.  A plaintiff’s expert offered on the epidemiologic evidence who cannot offer a reliable opinion that there is an association between the exposure and the type of injury the plaintiff claims, let alone that there is a causal relationship, should not be talking to the jury about anything.  A plaintiff’s expert offered on the epidemiologic evidence who can offer a reliable opinion that there is a causal relationship between the exposure and the type of injury the plaintiff claims can be allowed to discuss the various analyses she did to form that opinion.  And the defense can cross-examine her on whether some of her analysis was result-driven for-litigation drivel or based on unsupported assumptions.  A jury can hear that sort of back and forth and decide what weight to give to the expert’s testimony on general causation.  However, no trial court should abrogate its gatekeeping role and let juries hear about reanalysis of published studies unless plaintiffs have reliable evidence of general causation in the first place.  I guess we prefer the opinions of the district court, which took its gatekeeping seriously, even if it let plaintiffs take a few shots at entry.

Let’s start with a shameless plug: the author of this post, along with Sean Wajert (Shook Hardy & Bacon), will present a Strafford webinar on June 21 entitled, “Daubert/Frye Motions in Product Liability Litigation: Bringing or Defending Challenges to Expert Witness Evidence.”  Here is the link.  We will cover a lot of areas and a lot of cases.  Odds are good that the most recent case covered will be Wendell v. GlaxoSmithKline, LLC, 2017 WL 2381122 (9th Cir. June 2, 2017).  That’s too bad, because it is not a well-reasoned case.  It is a backwards step in Daubert analysis. For people who favor rigorous application of Daubert to keep junk science out of the courtroom, the Ninth Circuit’s Wendell decision is the worst sort, because it reverses a district court’s exclusion of expert opinions lacking support in epidemiology, animal studies or biologicals plausibility — meaning Wendell said it was an abuse of discretion for the district court to exclude the opinions.  That is the kind of precedent that can turn nervous judges from gatekeepers to matadors who grimly wave junk science along to the jury.

The plaintiffs in Wendell alleged that their son died because medicines used to treat inflammatory bowel disease (IBD) caused him to develop cancer.  The plaintiffs proffered two causation experts, but the district court found their opinions unreliable and, therefore, inadmissible under Federal Rule of Evidence 702.  The court subsequently granted summary judgment in favor of the defendants.  A key issue on appeal was the district court’s exclusion of the plaintiff experts’ opinions.  The district court had identified several problems with those opinions.  Here are some:

– The opinions were litigation-driven, were based on no independent research, and would not satisfy the standards for peer-reviewed journals.
– No animal or epidemiological studies showed a causal link.
– The studies cited by the experts did not show that the specific combination of drugs prescribed to the plaintiffs’ decedent actually caused the injury at issue.
– The experts did not present any scientific evidence excluding IBD itself as a risk factor for the injury.

The Ninth Circuit called it “a close question” in concluding that the district court erred in excluding the expert testimony. In the eyes of the appellate court, the litigation-driven, non-study-supported, non-alternate-cause-excluding nature of the expert opinions should not overcome the facts that the experts were “highly qualified doctors” who had performed a “differential diagnosis” in arriving at their opinions.  The Ninth Circuit’s analysis is unsatisfactory.  First, the qualifications of the experts is a different issue from reliability of their methodologies.  Under Rule 702, a qualified expert may testify if her testimony would be helpful to the jury, if she relied upon the appropriate facts/data, if she employed reliable methods, and if she reasonably applied those methods to the facts of the case.  That is, qualifications are a precursor to reliability, not a substitute for it.  If a Nobel prize winner renders an opinion based on astrology or phrenology, that opinion should be excluded no matter how impressed we are to be in the presence of such a luminary.  Second, the Ninth Circuit looks at each of the methodological problems identified by the district court one-by-one, and repeatedly holds that the deficiency by itself (e.g., lack of animal studies), cannot exclude expert testimony.  Maybe so, but when the opinions of an expert (no matter how well qualified) are beset by so many deficiencies, how can it be an abuse of discretion for a diligent district court to decide that the opinions do not pass muster?  In truth, the Ninth Circuit did not apply anything close to an abuse of discretion standard of review.  Rather, it engaged in a de novo review of the expert opinion issue, and did so in a remarkably wrong-headed fashion.  The results of this precedent could be seriously damaging.  If sparkling CV’s and invocations of “differential diagnosis” (and that’s not what was done by the experts by the way, but that’s a different point) can get causation opinions and a case to a jury, then Daubert has been diluted to the point of meaninglessness.

We will mimic the style of the great television critic Alan Sepinwall and end with some random observations:

– Along with two Ninth Circuit judges, the Wendell panel included a Vermont district judge who had authored an outlier opinion predicting that Vermont would adopt innovator liability.

– The Wendell opinion cites the Ferebee opinion from the D.C. Circuit.  Ferebee is seldom a harbinger of anything good for defendants.

– The Wendell opinion is sufficiently bad and problematic to merit en banc or Supreme Court reversal.

With the Phillies stinking the joint out – off to their worst start since World War II – and both of Boranian’s local teams in last place, too (not as deeply buried as the Phillies), use of baseball imagery might seem a bit painful right now.  Only our DC-based blogger has had anything worth cheering about lately, and with what’s going on there recently….  Baseball must be a welcome distraction.

But a one-two-three inning was what came to mind in looking at the new decisions that turned up last week. We were struck by three relatively easy wins for defendants.  Individually, they would not warrant separate post, but under a “totality of the evidence” standard, when added together, we found them worth discussing

The first is N.K. v. Abbott Laboratories, 2017 WL 2241507 (E.D.N.Y. May 22, 2017), a Depakote/birth defects case.  There are a number of these cases around, and we have already commented on several.  But we have to say, if the other side’s experts are as poor as they were in N.K, this litigation deservedly isn’t going anywhere.  N.K. went away on summary judgment after all of the plaintiff’s “experts” – and the term deserves to be in quotes – were excluded from testifying.  The first purported expert was the minor-plaintiff’s treating pediatrician, who was totally out of her depth:

[The witness] has never conducted research on Depakote or valproic acid. Nor has she researched the effects of in utero exposure to valproic acid (“valproate exposure”).  Prior to [minor plaintiff’s] first visit, her knowledge of Depakote was limited to refilling prescriptions for epileptic patients.  Since that initial visit, she has conducted little to no additional research on Depakote, valproic acid, or valproate exposure.

2017 WL 2241507, at *2 (record citations omitted).  Unsurprisingly, the court found this witness “not qualified to testify that Depakote caused [minor-plaintiff’s] injuries.”  Id. at *3.  She possessed no applicable medical experience nor had she bothered even to review the relevant literature.  Id. (she “did not perform any research or make any additional investigation that might qualify her as an expert on valproate exposure”).  Instead, “[h]er attempts to understand the cause of [minor-plaintiff’s] injuries were limited to a single review of a single medical book, the day of his first visit.”  Id.  This is hardly the kind of expert we would expect to see in litigation where a strong causation case is present.

The second expert in N.K. “ha[d] a more substantial background” – it could hardly have been less – but was not even a medical doctor.  Id. at *4.  Again, we would not expect to see this kind of “expert” in a strong case.  Lack of a medical degree is a problem.  “[C]ourts have consistently drawn a distinction between the qualifications of medical and non-medical doctors, noting that non-medical doctors who are qualified to diagnose a medical condition may be unable to reliably determine its cause.”  Id.  This witness was a “teratologist and toxicologist,” but had no relevant diagnostic expertise.  “[B]y his own testimony he has never evaluated children, has never been called upon to diagnose dysmorphic features or autism in a child, and is not a clinician.”  Id.

Nor did these unqualified “experts” use proper methodology.  They both purported to engage in the last refuge of a Daubert scoundrel – differential diagnosis.  The pediatrician “viewed [minor plaintiff’s] condition as either genetic or the result of prenatal valproate exposure.”  Id. at *5.  Which one didn’t she investigate?

She reached this conclusion before eliminating any genetic causes. . . .  Not only did [she] fail to eliminate alternative causes before reaching her initial conclusion, she lacked the knowledge to independently rule out genetic causes.

Id.  Genetics were a serious alternative  “[A]t least four other treating physicians have recommended further genetic testing to determine the cause of [minor plaintiff’s] injuries.”  Id.  The court could hardly be faulted for wondering what these plaintiffs were hiding in not having this testing done.

The other expert – the one that wasn’t even a doctor – was, if anything worse.  He “did not conduct his own independent investigation,” rather “[h]is opinion is based entirely on reviewing existing reports provided to him by Plaintiffs.”  Id. at *7.  Having to spoon-feed an expert is another indicator of a weak case.  Beyond that, his “attempt to rule out potential alternative causes of [minor plaintiff’s] condition is plagued by the same problems as” the pediatrician’s.  Indeed, “[h]e relied on [her] flawed report in ruling out genetic causes.”  Id.

Finally, plaintiffs failed to slip the pediatrician’s opinions in the back door, as “factual” testimony by a treater.  A treater’s testimony was equally subject to Daubert:

Even if such an opinion could be read into her records, classifying [her] as a fact expert does not relieve this Court of its duty to ensure she utilized reliable methods in reaching her opinion.  Courts in this district have found that when a treating physician seeks to render an opinion on causation, that opinion is subject to the same standards of scientific reliability that govern the expert opinions of physicians hired solely for the purposes of litigation.

Id. at *8 (citations and quotation marks omitted).  To us, this is the most significant legal ruling in N.K.

Summary judgment granted.  One away on a dribbler to the mound.

Next up, Rincon v. Covidien, 2017 WL 2242969 (S.D.N.Y. May 22, 2017). Rincon failed on a motion to dismiss, because of TwIqbal.  Rincon involved hernia mesh, and an alleged injury suffered more than six years after implantation.  Id. at *1.  Plaintiff’s complaint had a rather fundamental – and fatal – flaw.  It failed to allege that a defect caused the alleged injuries:

[Plaintiff] fails to allege any facts that plausibly establish such causation. . . .  Taken together, these facts − even liberally construed (not that there is a basis for liberal construction here) − fall far short of demonstrating that [defendant’s] mesh was a “but for” cause of [her] later injuries. . . .  Nothing in the Amended Complaint even endeavors to explain why the mesh is a more likely, let alone proximate, cause of [plaintiff’s] alleged harms.

Id.  One would have thought that, with an obvious serious timing issue, the plaintiff would have tried harder in Rincon to allege the sort of critical facts supportive of causation.  The absence of these facts is another marker of a weak case.

But not only did the plaintiff in Rincon fail to allege causation; she also failed to allege defect:

Under New York law, Rincon must prove the existence of a defect. . . .  But [plaintiff] fails to allege a defect except in the most conclusory terms:  that [defendant] manufactured the PCO mesh, that the mesh was used during her hernia surgery in 2006, that she needed subsequent medical procedures in 2012 and 2013, and thus [defendant] must not have “properly manufactured, tested, inspected, packaged, labeled, distributed, marketed, examined, sold, supplied, prepared and/or provided [ ] the proper warnings” regarding the mesh.

Id. at *2.  To make matters worse, plaintiff tried to make up her pleading defects in her brief opposing dismissal.  The court was not impressed.  Those assertions “serve only to illustrate the deficiencies in her Amended Complaint − namely, that it does not identify any actual defect in the coating and says nothing about how the coating, even if defective, caused [her] specific injuries.”  Id.

On top of that, plaintiff only “suggest[ed],” but did not actually seek, leave to amend.  Id.  Plaintiff’s notably poor pleading resulted in dismissal with prejudice.   “[E]ven if [she] were to add her new ‘facts’ . . ., her claims would all still fail for the reasons discussed above.”

Called third strike.  Two down, and add one to our TwIqbal cheat sheet.

The final out was made by Merancio v. Smith & Nephew, Inc., 2017 WL 2257124 (E.D. Cal. May 23, 2017), where summary judgment was granted after the plaintiffs failed to retain the allegedly defective implant.  The complaint itself was a mess, which certainly did plaintiffs no favors.  “[N]either factual details concerning plaintiffs’ claimed injuries nor specific legal theories of liability have been alleged in any detail.”  Id. at *1.  Having lost the device that supposedly failed plaintiffs “presented no substantive evidence concerning the merits of their claims.”  Id.  Instead, they pursued another all too common “last refuge of a scoundrel” tactics – attempting to litigate the defendant’s supposed discovery lapses.

That didn’t work this time.  Whatever deficiencies (if any at all) in the defendant’s initial disclosures were irrelevant by the time summary judgment rolled around.  Even if the identity of the affiant who supported the summary judgment motion was disclosed too late, it was disclosed “well prior to the close of discovery,” and the witness “was ultimately deposed by plaintiffs.”  Id. at *4.  Like too much pine tar on a bat, the violation, if it existed at all, was harmless.  Or, to mix sports metaphors, “no harm, no foul.”  “Plaintiffs have made no showing that they were prejudiced by the timing of defendant’s disclosures.  Indeed, plaintiffs have made no allegations of any harm − not even general, vague, and conclusory ones − flowing from defendant’s allegedly belated disclosures.”  Id.

So plaintiffs tried again, arguing that the court should ignore the defendant’s affidavit, which was factually undisputed, because the affiant “failed to include a list of cases in which he has appeared as an expert.”  Id. at *5.  The court was having none of plaintiffs’ trivial pursuit.  If plaintiffs thought this deficiency was so important, they should have done something about it earlier, rather than pursue a nitpicking litigation strategy:

[P]laintiffs’ counsel never asked defense counsel or the expert for this list and never filed a motion to compel with the court seeking the information or the imposition of sanctions. . . .  Again, plaintiffs do not even generally suggest how they have been harmed as a result of these minor deficiencies in [defendant’s] expert report.  Indeed, when asked at the hearing on the pending motion, plaintiffs’ counsel suggested he purposefully did not pursue any further efforts to obtain the list of cases in which [the affiant] had appeared as an expert because, in counsel’s view, it made defendant’s expert “attackable.”

Id. (emphasis added).

With plaintiffs’ discovery smokescreen blown away, summary judgment was inevitable.  “It [was] undisputed on summary judgment that, at the time the parts used in [plaintiff’s] knee replacement left the control of defendant, they had been inspected, passed quality control inspections, and were in compliance with all applicable FDA regulations.”  Id. at *7.  Defect at sale is a “necessary element” of strict liability.  Id.  Further, California simply does not recognize strict liability design defect claims involving prescription medical products.  Id.  Negligence failed because of a “complete failure of proof” that the device failed when it shouldn’t have.  Id. at *8.  Finally, plaintiffs’ warranty claim was dismissed (in addition to the above grounds) on an interesting legal ruling − that the personal injury damages were not available for alleged breach of contract:

Here, plaintiff seeks general damages for pain, suffering, and inconvenience, and special damages for medical expenses, future medical expenses, loss of earnings, [plaintiff] seeks here are generally not cognizable in claims sounding in contract in California.

Id. (citations omitted).  Finally, with no evidence “that the defendant negligently injured” her spouse, that wife-plaintiff’s consortium claim bit the dust. Id. at *9.

Side retired on a (very) foul popup.

Weak claims all in N.K., Rincon, and Merancio. Daubert, TwIqbal, and simple failure to prove the claim defeated these actions, and did so fairly expeditiously.   Which is as it should be.  Weak claims have no business being brought, and where plaintiffs are unable to hide weak claims in MDLs, these cases demonstrate that (at least in the federal courts), the civil justice system still works.

Discovery regarding expert witnesses can be tricky.  In our neck of the woods, the great Commonwealth of Pennsylvania, state courts almost never permit depositions of experts.  If you want to ask the expert questions – and you will – you must wait until trial.  The flip side of that restriction is that expert reports in Pennsylvania must really and truly and completely disclose the expert’s opinion.  If an expert at trial strays a millimeter past the four corners of the expert report, the court will shut such testimony down.  By contrast, in most court systems, including the federal system, discovery regarding expert witnesses is extensive, and the deposition of the other side’s expert is usually one of the most consequential moments in the litigation.

 

Mind you, we are talking about testifying experts.  Parties can retain experts who will testify at trial, but they can also retain experts who serve purely as consultants.  Those consulting experts work behind the scenes, furnishing facts and ideas.  They might, for example, help us prepare to depose the other side’s experts.  These consulting experts are usually not subjected to the discovery maw. 

 

But what if an expert transforms from consultant to testifier in the course of a litigation?  What and how much is discoverable?  That interesting scenario arose in In Re: Abilify (Aripiprazole) Prods. Liab. Litig.,  2017 U.S. Dist. LEXIS 73847 (N.D. Fla. May 15, 2017).  The plaintiff lawyers talked to an expert “informally,” then later retained him.  That expert had conducted research, resulting in an article, upon which the plaintiffs then relied.  The defendants sought to depose that expert about the article, including whether the plaintiff lawyers influenced the study.  The defense did not want the plaintiffs’ expert to point proudly to a peer reviewed study if the plaintiff lawyers had done as much reviewing as the peers.   

 

As you can imagine, the plaintiff lawyers resisted.  They argued that questions about the inputs into the article would have a chilling effect on scientific research.   The plaintiffs object to any discovery into communications between the expert and plaintiffs’ counsel because Fed. R. Civ. P. 26(b)(4)(D) protects informal consultation with experts: “Ordinarily, a party may not, by interrogatories or deposition discovery facts known or opinions held by an expert who has been retained or specially employed by another party in anticipation of litigation or to prepare for trial and who is not expected to be called as a witness at trial”  except on a “showing [of] exceptional circumstances under which it is impracticable for the party to obtain facts or opinions on the same subject by other means.”  The plaintiffs also objected because communications with the expert were protected opinion work product under Fed. R. Civ. P. 26(b)(3): the court “must protect against disclosure of mental impressions, conclusions, opinions, or legal theories of a party’s attorney or other representative concerning the litigation.”   

 

The court allowed some discovery, but within limits.  The court held that the defendants could question the expert about the plaintiffs’ influence on the study, as it is an aspect of bias.  Even if the influence occurred during the “informal” consultant period, it was fair game.  Thus, the defendants were permitted to inquire whether the expert “made any changes to the timing, methodology, or other relevant aspect of the study following communications with Plaintiffs’ counsel.”  Further, to the extent that the expert “initiated contact with Plaintiffs’ counsel, Defendants are free to inquire into his motive and the timing of such contact.”  But the court also held that the defendants could not inquire into work product (“regarding any opinions or case strategies shared by Plaintiffs’ counsel, or any other inquiries made by plaintiffs’ counsel that related to the preparation of their case”) unless the deposition established that the plaintiffs influenced the conduct of the study.  If evidence of the plaintiffs’ lawyers inputs into the study surfaces during the deposition, the parties would need to contact the Judge to determine whether a waiver of work product had taken place. 

 

This case is not really a ‘win’ for plaintiffs or defendants, because the court’s decision threads the needle fairly carefully, and because, considering the rule from an ex ante perspective, both plaintiffs and defendants might retain consulting experts who later become testifiers.  Rather, the case represents an unusual, but not impossible, situation where both sides must be especially careful.

 

 

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.

No one can be all that happy with how the Accutane mass tort proceeding has played out in New Jersey. We have no involvement in that proceeding, but we have monitored it from afar, and it has been extraordinarily contentious.  The rub is that the parties have very little to show for the effort.  The latest shoe dropped last week when the New Jersey Appellate Division vacated (again) a jury verdict in favor of an Accutane plaintiff.  The unpublished opinion in McCarrell v. Hoffmann-La Roche, Inc., No. A-4481-12T1, 2017 WL 1683187 (N.J. App. Div. May 2, 2017), is interesting, both in its treatment of expert opinion and evidence on causation under Alabama law.

But before we get to that, let’s review very briefly what has come before. When plaintiffs first started suing in earnest over Accutane, they alleged a variety of injuries, including psychiatric conditions, birth defects, kidney disorders, vision problems, and musculoskeletal problems.  There has been some litigation on these issues, but the proceedings in New Jersey and elsewhere have focused largely on gastrointestinal disease, including inflammatory bowel disease.  IBD can be every bit as bad as the name makes it sound, and we can see why patients who experience IBD can garner substantial sympathy.  But the warnings on gastrointestinal disorders are robust, and a federal court in Florida ruled in 2012 and 2013 that the Accutane warnings as to IBD were adequate as a matter of law.

But not in New Jersey, where several cases have proceeded to trial. We have not surveyed the New Jersey verdicts lately, but the last time we did, we counted about half a dozen verdicts—all of which were vacated, with others pending on appeal.  There certainly are others that we are not counting here, but the trend is unmistakable:  Multiple trials presided over by a New Jersey mass tort judge who was championed by some as a hard-working jurist and vilified by others for placing a thumb firmly on one side of the scale.  Substantial verdicts in favor of the plaintiffs.  All of them vacated.  In the mass tort context, vacated verdicts represent a massive waste of both sides’ time and money.

Which is what happened again last week in McCarrell.  The case was first tried to a jury in 2007, resulting in a verdict for the plaintiff.  But the Appellate Division vacated that award and remanded for a new trial because of erroneous evidentiary rulings. McCarrell, 2017 WL 1683187, at *1.  The parties therefore tried the case again in 2010, which resulted in a larger verdict for the plaintiff.  On appeal from the second verdict, the Appellate Division reversed again and held that the claims were time barred.  But the New Jersey Supreme Court disagreed and remanded the case back to the Appellate Division to address the remaining issues on appeal. Id. at **1-2

That remand resulted in last week’s opinion, and the Appellate Division reversed again.  First, the trial judge ordered that it would not allow duplicate expert testimony.  As a result, the defense had its expert gastroenterologist address certain studies, but was prohibited from having an epidemiologist corroborate that testimony. Id. at *2.  The rubber hit the road in closing argument when plaintiff’s counsel emphasized to the jury that the defense gastroenterologist’s opinion stood alone.  That was a problem, particularly once the Appellate Division ruled in 2013 that “trial courts should not prohibit overlapping expert testimony in complex matters on a ‘central issue of liability.’” Id. at *2 (citing McLean v. Liberty Health System, 430 N.J. Super. 156 (App. Div. 2013)).  Under that ruling, the trial judge’s decision to disallow overlapping expert testimony about scientific studies was error. Id. at *3.  And in light of counsel’s emphasis in closing on the defendants’ expert as a “lone outlier,” the error was prejudicial.

Second, the court held that the plaintiff had not met his burden of proving causation. This was a failure-to-warn case, but no one asked the prescribing physician whether her decision to prescribe Accutane would have been different if the drug had come with a stronger warning. Id. at *4.  Regular readers of the blog know this is warnings causation 101, and because the plaintiff bears the burden of proof under the applicable law (Alabama in this case), the absence of this essential evidence caused his warnings-based claims to fail as a matter of law. Id. We agree wholeheartedly with this ruling, although we are somewhat puzzled that the Appellate Division suggested going out and deposing the doctor again.  Sure, the doctor was deposed in 2007, but the burden of proving warning causation is not obscure now and was not obscure then.  It is not obvious to us that a second bite at the apple is warranted, nor do we know if the prescriber can even be re-deposed, after another decade has passed.

So what do we mean when we say that no one can be happy with this? The opinion gives parties on both sides more leeway in presenting expert testimony, and we have guidance on proving failure to warn under Alabama law.  But in the larger scheme, this case is apparently heading for a third trial, having first b een tried ten years ago.  Other verdicts from New Jersey have met the same fate.  Plaintiffs are left empty handed, and the defendants continue to bear the burden of vigorous litigation in New Jersey, whereas the federal MDL wrapped up in the defendants’ favor years ago.  In the end, McCarrell is a defense win, but the cost has been high.

We’ve all had cases where plaintiffs try to use their prescribers and treaters as their experts on everything from failure to warn and causation to design defect and company conduct. Even on the medical aspects of the case, a treater needs to offer more than just an unsupported general conclusion in order to withstand scrutiny under Daubert. But, when a surgeon or an orthopedist, for example, starts to offer opinions on product defects; when he or she has sufficiently wandered away from the parameters of their general expertise; the bar needs to be set even higher. Or, at least the proffered opinion needs to be even more carefully scrutinized. And certainly something more than — gee, I’ve never seen this before – is required.

But – gee, I’ve never seen this before – is all plaintiffs had to offer in Whybark v. Synthes, Inc., 2017 U.S. Dist. LEXIS 67988 (W.D. Ken. May 4, 2017). And that’s why defendants were awarded summary judgment. The case involves a bone screw (a product dear to Bexis and me). Plaintiff had one implanted in his foot to correct an osteoarthritis issue. Id. at *1. Two months after surgery, x-rays revealed that the plaintiff’s bones had not yet fully healed. X-rays taken four months after surgery show the bone still not completely healed and also that the bone screw had fractured. Id.

Kentucky products liability actions are governed by the Kentucky Product Liability Act which allows three potential claims: defective design, defective manufacture, and failure to warn. Id. at *4-5. Plaintiffs abandoned both their design defect and their failure to warn claims. On design defect, the only evidence in the case was that plaintiff’s surgeon testified the product was safe and effective. Id. at *5. Nor did plaintiffs challenge that the package insert contained an adequate warning about the risk of screw fracture. Id. at *6.

Plaintiffs instead decided to place their sole focus on manufacturing defect. The court begins its analysis of the claim by determining that indeed plaintiffs needed expert testimony to support it. Knowledge of the design and manufacture of bone screws is “far outside the realm of common experience” of lay jurors. Id. at *7.   But the only expert proffered by plaintiffs was the implanting surgeon. The surgeon’s only testimony regarding defect was that “he suspected the breakage of the [defendant’s] screw was due to a manufacturing defect because he had never seen a bone screw break after surgery.” Id. at *2. While it’s reassuring to know that the doctor has had such a good track record, that tells us absolutely nothing about whether this particular screw contained a manufacturing defect.

But even before getting to the substance or basis for his opinion, the surgeon’s testimony failed Daubert because he was unqualified on manufacturing issues. The first point was obvious, he had no training, education or experience in manufacturing, metallurgy, or biomedical engineering. Id. at *12. Beyond that though, plaintiff could offer no reason for why the doctor’s clinical experience and personal knowledge of bone screws qualified him to offer an expert opinion on manufacturing defect. Id. The treater/prescriber’s testimony is generally admissible as to care, treatment, prognosis – things he observed, concluded, or formed an opinion on in the course and scope of treatment. Id. This is another reason to challenge a treater/prescriber’s testimony on causation, if not supported by an independent expert report that withstands Daubert. While causation is in the realm of the doctor’s expertise, if it’s not something he opined on during care and treatment, he shouldn’t be allowed to opine on it at trial.

Even though clearly not qualified, the court went on to assess the reliability of plaintiff’s surgeon’s opinion. Here, the doctor failed to state his opinion, such as it was, to a reasonable degree of medical certainty. Id. at *13. That is because he couldn’t. He had done no research. Reviewed no company or manufacturing documents. He could cite no principles to support his conclusion. Id. at *14-15. But, he was well aware that “it is generally accepted in the medical community that bone screws can fracture secondary to fatigue when subject to loads caused by non-union [non-healing].” Id. at *14. So, even though he’d never seen it before, he knew it could happen. As if that wasn’t enough to take the wind from his sails, he also testified that he would “absolutely” defer to a metallurgist on the issue of defect. Id. at *15. As luck would have it, defendants had a metallurgist and he opined that the screw met industry standards and contained no manufacturing defects. Id. at *2.

Finally, plaintiffs attempted to argue res ipsa loquitur – they didn’t need an expert because the circumstantial evidence justified an inference that the screw would not have fractured absent some defect. Id. at *17. But that theory only works if plaintiffs can eliminate “all other reasonable explanations for the accident;” in this case the fracture. But they can’t because plaintiff’s own surgeon and sole expert witness conceded that the non-healing of the bone may have caused the screw to fracture. Id.

This case appears to have been a loser for plaintiffs from the outset. Relying on the treater as a defect expert just sealed its fate. The defense relies on prescribers as learned intermediaries and we don’t go after them unless really forced to. If they step this far outside their expertise, we’re sort of forced to.

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.