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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

Sometimes it takes a lot of words to say something.  The Iliad.  War and Peace.  SCOTUS’s Obergfell decision.  But sometimes, in just a few words, it is possible to create an image, or stir a memory, or underscore a point.  Call me Ishmael.  I have a dream.  A rose by any other name would smell as sweet.  And, apropos of sweet-smelling roses, today’s very short Georgia Supreme Court decision makes the point that expert opinions are expert opinions even when clothed as fact testimony, and must be excluded from evidence unless they meet the relevant admissibility standards. Yugueros v. Robles, 2016 WL 6407314 (Ga. Oct. 31, 2016), is not a drug or device decision.  It is a medical malpractice case, but its holding is relevant for anyone who deals with opposing experts.  Which we do, regularly and painfully.  (You can see a recent post on a similar issue here.)

In Yugueros, the appellant performed extensive cosmetic surgery on the appellee’s decedent (his wife).  Subsequently, Mrs. Robles went to the emergency room suffering from severe abdominal pain.  After an abdominal x-ray, which the E.R. doctor determined to be “unremarkable,” Mrs. Robles was discharged.  A radiologist who later saw the abdominal film could not rule out the presence of free air in the abdomen, which “could be a normal post-operative condition or could indicate a more serious issue.” Yugueros, 2016 WL 6407314 at *1.  The radiologist recommended a CT scan and posted his opinion in Mrs. Robles’s electronic medical record.

Continue Reading Expert Testimony in Sheep’s Clothing is Still Expert Testimony, Says Georgia Supreme Court

Last week, the Drug and Device Law Lifelong BFF asked us if we were interested in a quick trip to New York to use tickets for an early morning taping of “Live with Kelly.” Sure, we said – sounds like fun.  And so, after nearly two hours in line and significant drama over whether we were in front of or behind the “make it into the studio” line we were told would be drawn, we  were seated.   And we had a great time.  Kelly is as adorable and effervescent as she appears on television.  Her guest co-host interjected continuous comments from the “intelligent and engaged host” playbook.  And the guests were bona fide celebrities whom it was fun to observe at a distance of a scant ten feet.   But what was most impressive about the whole exercise was the opportunity to see what goes into the daily illusion that the hosts and the guests are responsible for the “workings” of an interview show.  Because, in fact, the stage was swarming with people who kept the machine operating, and the familiar faces were a tiny nucleus at the center of it all.  There were stylists and producers and directors and cameramen everywhere – so much so that they often blocked our view and we resorted to watching on monitors or on the screens mounted on the huge cameras.  And we realized that there would be no final product without every piece of this puzzle.

In today’s case, the absence of a requisite puzzle piece – a qualified specific causation expert – doomed the plaintiff’s case. In In re Zoloft Litigation, 2016 WL 5958372 (W. Va. Cir. Ct. Oct. 5, 2016), the court considered the defendants’ motion to exclude the plaintiff’s (general and specific) causation expert, who was a research scientist and not a medical doctor..  The expert had designated the expert to render the opinions that the defendants’ product could cause “deleterious effects both in developmental autonomy, neuroautonomy, and neurological function including the development of autism and other neurodevelopmental disorders,” 2016 WL 5958372 at *1 (emphasis in original), and that the plaintiff’s mother’s ingestion of the product while she was pregnant caused a seizure disorder and “cognitive and neurobehavioral disorder” in the plaintiff. Id.

The expert was deposed, on successive days, in four pending cases including this one. After the first day of his deposition, when he testified on behalf of two other plaintiffs, he met with plaintiffs’ counsel for several hours and drafted an updated disclosure in this case, omitting all references to autism and deleting the opinion that the defendants’ product caused the plaintiff’s seizures.   Instead, the new disclosure stated that the expert would testify that the plaintiff’s mother’s use of the product during pregnancy was a cause of the plaintiff’s developmental delays. Id. at *2.   Asked to explain why he revised his disclosure, the expert testified that, after “going back over the [plaintiff’s] records in preparation for” his deposition, he “felt it was prudent to focus on the developmental delay” and to delete the opinions that the defendants’ product caused autism and epilepsy. Id. Why?  Because the plaintiff had not been clinically diagnosed with autism, and because there was not a “good differential diagnosis” concluding that the plaintiff’s seizures “occurred at the right time to be related to his mother’s use” of the defendants’ product.” Id.

Continue Reading Expert Who Admitted That He Was Unqualified and That His Opinions Lacked Methodology Not Allowed to Testify in Zoloft Litigation.

This past weekend, we paid a return visit to Cleveland, the home of our best law school friend, who braved the (figurative) waters of New Haven with us so many years ago.  In deference to the Drug and Device Law Traveling Companion, we visited the Pro Football Hall of Fame.  In contrast to the stunning rotunda of our beloved Country Music Hall of Fame, the Football Hall stacks all of the inductees’ busts against a single wall – sort of a warehouse of disembodied heads.  We felt like we were in the parts department of Dr. Frankenstein’s laboratory.  But we enjoyed the visit and paid fond homage to the bust of Tommy McDonald.  We also visited the Rock and Roll Hall of Fame, which we had seen before and which we continue to find both impressive and tons of fun.  This time, we lingered at the “One-Hit Wonders” display, commemorating so many recording artists who disappeared after just a bit of noise, never to be heard from again.

The plaintiff in today’s case followed the same trajectory, albeit after his apparently meritless case languished on an MDL docket for eight years.  In Wilhelm v. Pfizer, Inc. 2016 U.S. Dist. LEXIS 127269 (D. Nev. Sept. 19, 2016), the complaint was originally filed in 2006 in the District of Nevada by fourteen plaintiffs alleging that the defendant’s product caused suicidal ideations.  The JPML transferred the case to the Neurontin MDL after it was filed, and remanded it back to the transferor court in July 2013 with three plaintiffs remaining.   One month later, the court permitted counsel for these plaintiffs to withdraw.  Two of the plaintiffs dropped out, leaving a single plaintiff, proceeding pro se. In February 2014, the defendant moved for summary judgment, arguing that the plaintiff could not produce any expert evidence proving that the defendant’s product caused his injuries.  The plaintiff filed for Chapter 7 bankruptcy in June 2014.  He never disclosed his product liability lawsuit in the course of his bankruptcy proceedings.

Continue Reading The End of the Road for Pro Se Neurontin Plaintiff with No Evidence of Causation