The Nebraska Supreme Court issued a gem of a Daubert opinion in an Accutane case last week, Freeman v. Hoffman-La Roche, Inc., No. S-17-800, 2018 WL 2296772, at *2 (Neb. May 18, 2018).  We don’t write much about Nebraska, but the last time we waxed on about the beauty of the Platte River Valley, we actually received a few emails.  That was when we wrote last year about the Daubert order that the Nebraska Supreme Court has now affirmed, in an opinion that is as correct and straight-headed as the order it was reviewing.  Indeed, the current opinion might actually be the end of this case, which has been kicking around in the Nebraska state courts amazingly since the late 1990s.

Nebraska keeps a low profile. Growing up in California, we were told that Nebraska is in the Midwest.  But then we went to college in New England and learned that Nebraska is just plain “West,” unqualified by any prefix.  Sandwiched in between Colorado and Iowa, we suppose that either moniker could justifiably apply.  Nebraska has the country’s largest railyard, including a tall public viewing tower from which you feel as if you are looking down on a sprawling model train set.  We know because we have been there.  We had a few hours to kill in North Platte one day (don’t ask why) and we Googled “things to do in North Platte.”

There is a city in Nebraska named Kearney and a street in San Francisco named Kearny. They are spelled differently and pronounced differently (Nebraskans say Car-nee,” while Californians say “Ker-nee.”).  But they are named after the same guy.  Go figure.

Legalwise, Nebraska is the only state with a unicameral legislature—i.e., one chamber, with no separate house and senate.  The Nebraska state motto is “Equality Before The Law.”  We like that motto a lot, and we were even more impressed when we learned that it predates the Fourteenth Amendment by one year.  We begrudgingly admit that we prefer “Equality Before The Law” over our home state’s motto, “Eureka!”  The former echoes a bedrock principle of our post-Civil War legal tradition and is both declaratory and aspirational.  California’s motto celebrates sudden wealth.  Must have been sponsored by plaintiffs’ lawyers.

We like the Nebraska Supreme Court’s opinion in Freeman v. Hoffman-La Roche a lot, too.  The plaintiff was prescribed Accutane for chronic acne and allegedly experienced Crohn’s disease in her colon and rectum as a result.  2018 WL 2296772, at *2.  There is, however, no reliable scientific evidence showing a causal relationship between Accutane and this particular condition, so when it came time to produce the expert opinions necessary to prove her claims, the plaintiff could not come through.

She banked on a single expert, whom the trial court found to have applied an unreliable methodology and who “unabashedly cherry-picked supporting studies from an overwhelming contrary body of literature.” Id. The trial court’s 42-page order is among the more thorough orders on expert opinion that you will see, and you can review our take on it here.  It’s a strong order showing that the trial court understood who this expert was and what he was offering.

The Nebraska Supreme Court agreed, and it affirmed the exclusion of the expert’s opinions and the trial court’s order granting summary judgment. The Nebraska Supreme Court must have been as impressed with the trial court’s order as we were, because it affirmed the result in just a few pages.  Under Nebraska’s standard—known as the Daubert/Schafersman framework—the court must determine whether an expert’s methodology is reliable and whether the expert applied the methodology properly to the facts. Id. at *3.

This expert employed a “weight of the evidence” methodology, under which he purported to form an opinion based on a variety of disparate data—animal tests, case reports, epidemiological studies, etc. Id. at *4.  That methodology, according to the Nebraska Supreme Court, is generally accepted.  But the problem was and remains that the expert did not apply the methodology in a reliable fashion. Id. He recognized that there was no study determining that Accutane use was a risk factor for Crohn’s disease, but theorized that it would be a risk factor for a particular type of Crohn’s disease—Crohn’s disease of the colon.

Where did he get that? Well, essentially from nowhere.  He disregarded all but one of the epidemiological studies finding no significant relation between Accutane use and irritable bowel syndrome, which is a disease of the colon.  He also found studies reporting no association between Accutane use and Crohn’s disease a “waste of time” because they did not account for the “different manifestations” of Crohn’s disease.  He admitted, though, that the scientific community does not agree that “different manifestations” of Crohn’s disease make any real difference.  He also admitted that Crohn’s disease has a different clinical presentation and different causes than ulcerative colitis, but then he still relied on one study on ulcerative colitis to support his causation opinion. Id. at *4.  So Crohn’s disease is different, except when it isn’t.

Most tellingly, the expert rejected epidemiological studies on Crohn’s disease that showed no association because they did not focus narrowly on Crohn’s disease of the colon.  But then he relied on anecdotal case reports of Crohn’s disease in Accutane patients whether they reported disease of the colon or not.  So the location of the disease was critical when it helped him, but was immaterial when it did not.  As we said before, this is called talking out of both sides of your mouth, and it is neither good nor scientific.

Taking its cue from the trial court, the Nebraska Supreme Court thus concluded:

The objective of the trial court’s gatekeeping responsibility is to make certain that an expert, whether basing testimony upon professional studies or personal experience, employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field. Clearly, cherrypicking studies from an overwhelming contrary body of literature without valid, supporting reasons for why the other studies were disregarded does not meet the standard of intellectual rigor required of expert witnesses.

Id. at *5.  Without admissible expert opinion, the plaintiff tried to fill the gap with “internal documents,” but that fell short, too.  To the extent the documents were in the record, they did not show a causal relationship.  Id.  Summary judgment affirmed.  This expert’s opinion was shallower than the Platte River itself—a mile wide at its mouth and six inches deep, as some Nebraskans like to say.  We got that saying, by the way, from Bexis.

Last week at the DRI conference in New York an especially talented lawyer delivered an especially interesting address.  Everything about the speech was riveting and splendid, until she deployed the word “fulsome” in the increasingly popular, albeit wrong, fashion, as a synonym for full or complete. About twenty heads spun around to look at us with glee, knowing we had recently railed against this misuse.  How is “fulsome” superior to the simpler, correct words?  The interesting, specific meaning of fulsome is being diluted by foolish pomposity.  Still, the message conveyed to us by this event was not so much about the increasing misuse of “fulsome” but more about our increasing reputation for crankiness.  It is a curse.  When someone hands us a draft for editing, we must pass through it at least twice. Only after clearing away the grammatical wreckage can we review for substance.  It is undeniably a weakness on our part. A misplaced “only” will throw us off and make us want to drop the draft in the trash bin.  It would be wrong to say we “only threw three fits over confusions between ‘uninterested’ and ‘disinterested’ yesterday.”  That “only” belongs next to the word it is modifying, which is “three,” not “threw.” When someone writes that the court “found” something, if the reference is to a legal holding rather than a finding of fact, we reach for the red pen and mutter about the decline of the West.  The Third Circuit “held,” not “found,” that Levine preemption is a fact issue. Of course, the pernicious thing about the Third Circuit’s Fosamax ruling is that it transformed what should be a holding into a finding.  You have probably heard all this before.

 

Are we fretting too much over silly mistakes?  Maybe.  Are we being more than a bit pompous?  Maybe.  Nobody’s perfect.  There are probably no fewer than five dopey mistakes in this post. 

 

Mistakes are not always a big deal.  That is the lesson of a recent Third Circuit ruling in Estate of Goldberg v. Nimoityn et al., No. 17-2870 (3d Cir. April 13, 2018) (not precedential).  The case was a wrongful death med-mal case.  The plaintiff claimed that the doctors and hospital erred in delaying placement of a feeding tube.  The defendants hired an expert witness doctor who opined that the delay in placing the feeding tube was appropriate.  But in that expert’s report there was a mistaken assumption that pneumonia was a factor prompting delay on a certain date when, in fact, the pneumonia diagnosis did not occur until a later date.  At trial, the defense counsel fronted the error with the expert and elicited the expert’s testimony that the mistake was a typo and did not, in any event, affect his ultimate opinion that the delay in placing the feeding tube made sense.  The plaintiff lawyer objected and explained at sidebar that the fronting of the mistake and the explanation by the expert should be precluded because such testimony wandered beyond the scope of the expert report.  The plaintiff lawyer had been salivating over the mistake.  He told the court that he had considered raising the issue before trial.  But surprise seemed more appetizing.  It would no doubt make for a devastating cross.  The problem was that the defense lawyer had surprised the plaintiff by ruining the surprise.  The district court permitted the defense expert to ruin the surprise, reasoning that the ultimate opinion was the same and there was no material surprise.  The case went to the jury, which returned a verdict for the defense.  The plaintiff asked for a new trial, again arguing that the defense expert should not have been allowed to fix his mistake and, furthermore, that the expert’s attribution of the mistake to a typo was perjury.  The district court agreed that the typo explanation was “disingenuous at best,” but continued to believe that there was no prejudicial surprise.  The district court denied the motion for a new trial.  The plaintiff appealed to the Third Circuit.

 

The plaintiff’s main argument on appeal was that the district court erred in failing to exclude the defense expert’s testimony under Federal Rule of Civil Procedure 37(c) (Failure to disclose, to supplement an earlier response, or to admit).  The defense expert never supplemented his expert report.  The expert’s repair of the mistake in his report landed like a sandbag on plaintiff counsel’s head.  So the argument goes.  The Third Circuit reviewed the district court’s decision to admit the expert’s testimony  under the abuse of discretion standard.  The issues were whether the plaintiff was surprised/prejudiced, whether there was an opportunity to cure any prejudice,  and whether the defense exhibited any bad faith.  The plaintiff lawyer acknowledged that he knew about the mistake, so the surprise element was frail.  He was more frustrated than surprised. Further, the plaintiff lawyer did have the opportunity to cross-examine the expert and force him to admit that one of the major bases for his original opinion was a pneumonia diagnosis that did not actually exist.  The point was scored, albeit with less drama than the plaintiff lawyer desired.  The point is that any prejudice was largely cured.  Finally, there was no evidence that the defense acted in bad faith by failing to supplement the report.  The mere passage of two years time between issuance of the expert report and the trial testimony did not, by itself, establish a nefarious plan.

 

The Third Circuit also agreed with the district court that the defense expert’s reference to a typo was implausible, but not clearly perjurious.  The plaintiff expert had, after all, admitted the key fact that the pneumonia diagnosis did not yet exist when he thought it had.  The expert got an important fact wrong and confessed as much.  The opinion does not mention whether the plaintiff lawyer had more than a little fun at cross-examination with the typo whopper.  He certainly could have.  As has been said more than once, and as we seem to be hearing every day now, the cover-up is often worse than the original offense.  Be that as it may, there was no reason to order a new trial just so that the impeachment could have played put just the way the plaintiff lawyer wanted.          

 

There is a certain amount of cleverness in the plaintiff’s argument.  But clever is not the same as right.  One additional fact that makes us sure the Third Circuit is right in Nimoityn is that the Third Circuit was affirming a decision by district court Judge McHugh.  Before he became a judge, Gerald McHugh was one of the preeminent litigators in Philadelphia.  We never were in a case with him, and that is probably a good thing, because McHugh probably would have been on the other side of the v, and even more probably would have beaten our brains out.  We’ve been in the Penn Inn of Court with Judge McHugh for many years, and his contributions during the question periods have been invariably insightful.  Judge McHugh possesses a superabundance of intelligence, integrity, and – well – judgment.  He does not make many mistakes.  (We cannot think of any.)  He did not make one here, and the Third Circuit did not make one in affirming his ruling.

 

 

Class actions hold our interest, even though we do not see them all that often anymore in the drug and medical device space. Maybe we are the rubbernecking motorists who can’t resist slowing down to gaze at someone else’s fender bender.  Maybe we are the children at the zoo who rush to the reptile house to gawk at creatures charitably described as unsightly.  Or maybe it’s because class actions are such odd ducks.  Our civil litigation system is conceived around concepts of due process.  Yet, a class action defendant can be compelled under threat of state authority to pay money to people who have never proved a claim or an injury, and an absent class member can be bound to the result of a proceeding in which he or she has never appeared.  What could possibly go wrong?

We expect many of you are like us, so we have gathered here a trio of significant class action opinions that caught our eye over the last few weeks. All hail from California.  All are important for unique reasons.  None involves drugs or medical devices, but the opinions are relevant generally to class settlements, expert opinion, and standing to appeal—topics that readily cross over.  So, without further delay, here we go.

Nationwide Class Settlements and Choice of Law: In re Hyundai and Kia Fuel Economy Litig., No. 15-56014, 2018 WL 505343 (9th. Cir. Jan. 23, 2018).  We will start with the opinion that has received the most attention and is probably the most important—the Ninth Circuit’s opinion reversing a nationwide class settlement because the district court did not consider the impact of varying state law. Id. at **12-13.  The procedural history for these multiple class actions resulting in a nationwide settlement is long and dizzying.  The important point is that the district court certified a settlement class that offered benefits to class members (automobile purchasers allegedly defrauded by representations regarding fuel mileage) and substantial fees to class counsel.

However, in certifying the class, the district court overly relied on a well-worn principle—that the inquiry on whether common issues of law predominate is relaxed with a settlement class.  Because the district court was certifying a class for settlement only, it ruled that a choice-of-law analysis was unnecessary. Id. at *11.

That was the district court’s mistake. As the Ninth Circuit explained:

Because the Rule 23(b)(3) predominance inquiry focuses on “questions that preexist any settlement,” namely, “the legal or factual questions that qualify each class member’s case as a genuine controversy,” a district court may not relax its “rigorous” predominance inquiry when it considers certification of a settlement class.  To be sure, when “[c]onfronted with a request for settlement-only class certification, a district court need not inquire whether the case, if tried, would present intractable management problems, for the proposal is that there be no trial.” But “other specifications of the Rule—those designed to protect absentees by blocking unwarranted or overbroad class definitions—demand undiluted, even heightened, attention in the settlement context.

Id. at *5 (emphasis added, citing Amchem Prods., Inc. v. Windsor, 521 U.S. 591 (1997)).  The district court’s error therefore was threefold.  First, it failed to conduct a choice-of-law analysis to determine the controlling substantive law. Id. at *12.  Second, the district court failed to acknowledge that laws in various states materially differed from California law.  Third, the district court did not consider whether material variations in state law defeated predominance under Rule 23(b)(3).

This is not to say that the district court lacks discretion on remand to certify another nationwide settlement class. We do know, however, that the district court will have to subject any newly proposed nationwide settlement to choice-of-law analysis and will have to decide whether state laws differ and whether any differences defeat the predominance of common legal issues.

Class Certification and Admissibility of Expert Opinions: Apple, Inc. v. Superior Court, No. D072287, 2018 WL 579858 (Cal. Ct. App. Jan. 29, 2018). Our second case held that a trial court can consider only admissible expert opinion evidence submitted in connection with a class certification motion and that California has only one standard for admissibility of expert opinion, Sargon Enterprises, Inc. v. University of So. Cal., 55 Cal. 4th 747 (2012).  In other words, Sargon applies at the class certification stage, a point about which we have often wondered, but for which we never had a clear answer.

Until now.  We wrote about Sargon here when it came out in 2012.  The opinion moved California away from its unique “Kelly/Leahy” test and toward a more Daubert-like standard.  In the new California Court of Appeal case, the trial court certified a class of consumers, but expressly refused to apply Sargon to the declarations of the plaintiffs’ experts. Id. at *1.  You will not be surprised to learn that the experts in question were damages experts who offered the opinions that damages could be calculated on a classwide basis.  Id. at **2-5.  Over multiple rounds of briefing, the defendant objected to the opinions and urged the trial court to apply Sargon.  The plaintiffs resisted.

In the end, the trial court ruled that “[t]he issues [the defendant] raises with respect to the materials Plaintiffs’ experts will rely upon in forming their opinions and whether Plaintiffs’ experts’ analyses rely on accepted methodologies and whether the analyses are correct are issues for trial.” Id. at *6.  The court therefore certified the class. Id.

In reversing, the California Court of Appeal issued a very straightforward holding:

[T]he court may consider only admissible expert opinion evidence at class certification.  The reasons for such a limitation are obvious.  A trial court cannot make an informed or reliable determination on the basis of inadmissible expert opinion evidence.  And certifying a proposed class based on inadmissible expert opinion evidence would merely lead to its exclusion at trial, imperiling continued certification of the class and wasting the time and resources of the parties and the court.

Id. at *8 (internal citations omitted). The Sargon case involved expert opinion presented at trial, but the Court of Appeal saw “no reason why Sargon should not apply equally in the context of class certification motions.” Id. at *9.

Moreover, although the plaintiffs argued that the result would have been the same even if the trial court had applied Sargon, the Court of Appeal disagreed.  The experts’ opinions were crucial to the trial court’s order, and there were significant individual issues for each consumer that the experts attempted to brush over. Id. at *11.  The Court of Appeal found that if the trial court had applied Sargon to these opinions, “there is a reasonable chance it would have excluded these declarations and found plaintiffs’ showing to be lacking.” Id. The Court of Appeal found similar deficiencies with the experts’ estimate of the size of the class, making it “difficult to see on the current record how plaintiffs’ formula could be found reliable.” Id. at *12.

Class Actions and Standing to Appeal: Hernandez v. Restoration Hardware, Inc., No. S233983, 2018 WL 577716 (Cal. Jan. 29, 2018). Our final class action opinion for today is Hernandez v. Restoration Hardware, where the issue was whether an unnamed class member has standing to appeal from a class action judgment under California procedure.  The California Supreme Court decided that an unnamed class member does not have standing to appeal without first intervening as a party in the trial court.  In Hernandez, the plaintiff sued a retailer for violating credit card laws, and after several years of litigation, the trial court certified a class and held a bench trial resulting in a substantial award.  An unnamed class member received notice of the class action, but she neither intervened as a party nor opted out.  Instead, her attorney filed a notice of appearance on her behalf. Id. at *1.

The controversy began when class counsel requested a 25 percent fee. Again the absent class member did not formally intervene, but instead appeared through counsel at the fairness hearing and argued mainly procedural points. Id. at *2.  The trial court nonetheless granted the fee request, and the unnamed class member appealed. Id. at *3.

In holding that the unnamed class member was not a “party aggrieved” and had no standing to appeal, a unanimous California Supreme Court followed Justice Traynor’s 75-year-old decision in Eggert v. Pacific Sales S&L Co., 20 Cal. 2d 199 (1942).  The Court’s main point was that absent class members have ample opportunity to become parties of record in class actions, either by filing a complaint in intervention or by filing an appealable motion to set aside and vacate a class judgment. Id. at *4.  This appellant did neither, making her neither a “party” nor “aggrieved.”  The Supreme Court also rejected the invitation to follow Rule 23 of the Federal Rules of Civil Procedure, which gives class members who informally object to settlement the right to appeal. Id. at *5.  The federal approach does not address California’s statutory requirement for appeal, and it cannot be reconciled with the controlling authority, Eggert.  As the California Supreme Court concluded,

Following Eggert and requiring intervention does not discourage unnamed class members from filing a meritorious appeal.  Rather, it continues a manageable process under a bright-line rule that promotes judicial economy by providing clear notice of a timely intent to challenge the class representative’s settlement action.  Formal intervention also enables the trial court to review the motion to intervene in a timely manner. . . .  By filing an appeal without first intervening in the action however, [the appellant] never became an “aggrieved party” of record to the action as our law requires.

Id. at *7. According to the California Supreme Court, this absent class member made the strategic decision to wait and see if she agreed with the result in the trial court, and that was not sufficient to perfect the right to appeal. Id. The Court also reasoned that the prevailing rule protects against wasteful and meritless objections, recognizes the fiduciary duties of class representatives and their counsel, and respects the doctrine of stare decisis. Id. at **7-8.

There you have it—all you need to know about three important decisions. Someday you might need them.

This year’s Academy Award nominations came out last week. That means that we have spent the past few days setting a schedule for seeing all of the Best Picture nominees (well, most – we don’t do war movies and tend to opt out of love stories involving semi-animate objects) and scouring recipe blogs for perfect Oscar party buffet items.  We have also reminisced, with amusement, about the climactic moments of last year’s show, during which the presenters announced the wrong Best Picture winner before an Academy official shoved them out of the way and corrected the error.  As we recall, it turned out (not surprisingly) that the mistake was caused by sloppiness.  The Academy’s accountant handed the presenters a duplicate envelope for an award that had already been presented, starting the embarrassing domino cascade.  We recall that heads rolled in the ensuing days.

Today’s case also involves the consequences of sloppiness, along with a couple of interesting legal rulings. In its unpublished decision in Small v. Amgen, Inc., et al., 2018 WL 501354 (11th Cir. Jan 22, 2018), the Eleventh Circuit considered the plaintiff’s appeal of two summary judgment orders:  a grant of partial summary judgment for the defendants, and a later grant of summary judgment on all of the remaining claims.

The plaintiff was prescribed the defendants’ drug to treat her rheumatoid arthritis. She took the drug for nearly six years then suffered a perforated bowel and a diverticulitis infection, for which she underwent multiple surgeries.  She sued the drug’s manufacturers, asserting all of the usual claims. In 2014, the district court granted summary judgment on the plaintiff’s failure-to-warn claims, holding that Florida’s learned intermediary doctrine precluded the claims.  Later, when the plaintiff’s expert disclosures revealed her sloppy omissions — although she identified five treating physicians she intended to use as non-retained experts, she had no expert to testify to general or specific causation — the defendants moved for summary judgment on the plaintiff’s remaining claims.  In 2017, the district court granted the defendants’ motion.

On appeal, the plaintiff did not dispute or even address the 2017 summary judgment order. Instead, she argued that the 2014 dismissal of her warnings claims was improper because there were factual issues “regarding the district court’s treatment of [her prescriber] as a learned intermediary.” Small, 2018 WL 501354 at *2.  She also argued that “the district court incorrectly decided that the direct ‘patient labeling requirement’ in the FDA medication guidelines did not preempt Florida’s learned intermediary doctrine.” Id.

With respect to the prescriber-as-learned-intermediary argument, the court explained that the plaintiff’s prescribing physician had 22 years of experience in rheumatology and “intentionally selected [the drug] for [the plaintiff], despite the risk of possible infections, because other forms of rheumatoid arthritis therapy had failed.” Id. What’s more, the prescriber was involved in clinical trials with the drug, and the plaintiff was a participant, giving the prescriber “more reason to know of and discuss possible side-effects or concerns” associated with the drug.” Id. The prescriber “knew that infections were possible but prescribed the drug anyway . . . because the benefits outweighed the risks.” Id. As such, because “the prescribing physician had substantially the same knowledge as an adequate warning from the manufacturer should have communicated,” the plaintiff could not prove warnings causation and her warnings claims failed as a matter of law. Id. (internal punctuation and citation omitted).   In other words, “the failure of the manufacturer to provide the physician with an adequate warning . . . is not the proximate cause of a patient’s injury if the prescribing physician had independent knowledge of the risk that the adequate warning should have communicated.” Id. (citation omitted).

Next, the plaintiff argued that Florida’s learned intermediary doctrine was preempted by the FDA’s requirement that the manufacturers provide patients with a “medication guide” for the drug. The court emphasized that “the historic police powers of the State [were] not superseded unless that was the clear and manifest purpose of Congress.” Id. at *3 (internal punctuation and citation omitted).   To discern such “clear and manifest purpose” in cases of implied preemption, the court explained that it considered “the promulgating agency’s contemporaneous explanation of its objectives as well as the agency’s current views of the regulation’s preemptive effect.” Id. (internal punctuation and citation omitted).

In the case of the medication guide regulation, the FDA had specifically addressed concerns that the regulation would alter the framework for manufacturers’ liability by abrogating the learned intermediary doctrine.  In response, the agency stated that “the written patient medication information provided did not alter the duty, or set the standard of care for, manufacturers [or] physicians . . . .” Id. (citation omitted).   Given this “contemporaneous explanation” from the FDA, coupled with the reality that “courts have not recognized an exception to the learned intermediary defense in situations where the FDA has required patient labeling . . . ,” the court held that there was no preemption.  We love this holding, and we believe this is the first time that an appellate court has so held.

No preemption, no warnings causation – summary judgment on warnings claims affirmed. And, because the plaintiff did not address her inexplicable failure to identify causation experts, the court held that she had waived any appeal of the 2017 summary judgment order.   Case (tidily) dismissed, in a no-nonsense decision we like very much.  We’ll let you know if we are similarly pleased by this year’s Oscars.

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.

 

 

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.