We have an adorable, pigtailed, toddler grand-niece. We play a game with her that involves placing one building block on the table and asking her how many blocks there are.  She answers, “One.”  We take that block away and replace it with another.  Again, the answer is “one.”  Then we place both blocks on the table and ask, “How much is one plus one?”  As brilliant as she is beautiful, she answers, “Two!”   Simple, right?  But those of us who practice in the mass tort space are far too accustomed to reading opinions laying out the building blocks of an obvious holding then failing to conclude that one plus one equals two.

Not so the lovely opinion on which we report today. In Young v. Mentor Worldwide LLC, 2018 WL 2054591, — F. Supp. 3d — (E.D. Ark. May 1, 2018), the plaintiff was implanted with the defendant’s sub-urethral sling in 2003 to address her stress urinary incontinence.  In two subsequent surgeries, in 2006 and 2008, portions of the sling were removed.   In 2013, more than five years after the last revision surgery, the plaintiff filed suit, asserting all of the usual claims and alleging permanent injury from the defendant’s product.

Because Arkansas law, which governs the plaintiff’s claims, imposes a three-year statute of limitations on product liability lawsuits, the defendant moved for summary judgment, alleging that the plaintiff’s claims were time-barred. The court denied the motion, finding a question of fact as to when the plaintiff’s cause of action accrued under the applicable discovery rule.

Motion to Bifurcate Trial

Flash forward to the eve of trial. Arguing that resolution of the statute of limitations defense would require only a few witnesses and would likely take only two days, the defendant asked the court to bifurcate the proceedings in a novel manner, holding a preliminary trial on the statute of limitations and moving on to a full trial on the merits of the plaintiff’s claims only if necessary.  The plaintiff opposed the motion, arguing that resolution of the statute of limitations issue would require admission of evidence of the defendant’s alleged fraudulent concealment and that a single jury should resolve all of the issues at the same time.

The court disagreed, holding,

Regardless of whether the [plaintiff is] entitled to pursue a fraudulent concealment claim, [the defendant’s] statute of limitations defense is potentially dispositive, and preliminary trial will not consume the time and expense necessary for a trial on the merits.  The Court finds that a separate, initial trial on the statute of limitations question is especially warranted in this case, as it will promote judicial economy, avoid confusion of the issues, and prevent possible undue prejudice.

Young, 2018 WL 2054591 at *2.

Motions to Exclude Expert Testimony

The defendant also moved to exclude the testimony of two of the plaintiff’s experts, a biomedical engineer and a pathologist.

Biomedical Engineer

The biomedical engineer sought to testify about the mechanical structure of the defendant’s product “and to offer his opinion that the design and testing of [the product] was inadequate, that the product was defective for its intended use, and that [the defendant] failed to warn about the significant risk of complications and adverse events from the use of the product.” Id. at *3.  The defendant moved to exclude the expert’s testimony about the adequacy of the warnings, arguing that the expert was not qualified to offer such opinions.  The court agreed, holding, “The record is void of information indicating that [the expert’s] expertise in the area of biomedical engineering and product design qualifies him to opine as to the adequacy of warnings at issue or that his opinion on this ultimate issue of fact would be helpful to the jury.” Id.

The expert’s report also included statements to the effect that the defendant was “fully aware” of a high rate of complications associated with the product. The defendant moved to exclude these statements on the ground that they were inadmissible expressions of “corporate intent and legal conclusions.”  Again, the court agreed, holding, “The Court finds that a jury is capable of making its own determinations as to [the defendant’s] intent, motive, or state of mind, and that [the expert’s] opinion on these subjects does not meet the helpfulness criteria of Rule 702.” Id. (citation omitted).

Pathologist

The pathologist’s report stated that his general causation opinions were “based on his review of over 300 explanted mesh samples, which include[d] hernia meshes, pelvic organ prolapse meshes, and slings used to treat urinary incontinence.” Id. at *4.  He acknowledged that only ten of the 300 samples he examined were manufactured by the defendant, and those were samples he received from plaintiffs’ attorneys.

The defendant argued that the expert’s opinions about other types of mesh and other manufacturers’ products were irrelevant and unreliable. In deposition, the expert testified that “all of this background” was necessary to “interpret accurately case-specific material.”  The court disagreed, holding, “The Court finds that neither [the expert’s ] explanation nor [the plaintiff’s] arguments demonstrate that information about various types of polypropylene mesh products . . . is relevant in this case, which deals with a specific mesh product, used for a specific purpose.” Id. Further, the expert “admit[ted] that he [had] no knowledge as to how the mesh implants he has examined were selected, thus there is no assurance that they were randomly selected and no way of projecting the potential rate of error.” Id. The court concluded, “After careful review, the Court cannot find that [the expert’s] proposed opinion testimony is the product of reliable principles and methods, and [the defendant’s] motion to exclude will be granted.

We love this opinion – logical, correct, and elegant in its simplicity. We hope that others follow suit, and we will keep you posted.

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.

 

 

On Wednesday, the Fifth Circuit was finally able speak to what’s been going on in a Dallas courtroom that has racked up over $1.7 billion—that’s billion—in jury verdicts over the last two years in the Pinnacle Hip Implant MDL. And the Fifth Circuit entered the room loudly. It ordered a new trial of the plaintiff’s very first victory, the one that produced a half-billion dollar verdict. The court did not hold back, making it perfectly clear that it vacated the judgment due to “the district court’s evidentiary errors and [plaintiffs’ attorney Mark] Lanier’s deception.” Slip Op. at 6.

The “evidentiary errors” have been a controversial part of these MDL trials since the time of our first post about them two years ago. Even then, we were struck by the “number and nature” of these evidentiary rulings, which in the aggregate suggested “an almost uninterrupted flow of unduly prejudicial and irrelevant information to the jury.”  The Fifth Circuit now agrees, highlighting two of them as the basis to order a new trial.

First, the Saddam Hussein evidence. Slip Op. at 43-46. That’s right. The court allowed evidence concerning Saddam Hussein into a hip implant trial. Its decision was based on a deferred prosecution agreement, one in which J&J took responsibility for the actions of affiliates who had bribed officials in the Iraqi government. These affiliates had nothing to do with the Pinnacle Hip Implant device. Regardless, after defendants elicited testimony on their own positive internal culture and marketing, the district court ruled that the defendants had thereby “opened the door” to Saddam Hussein, the deferred prosecution agreement and all sorts of other stuff. With light now green, the plaintiffs’ attorney thereafter featured Saddam Hussein and bribes and prosecution in his questioning of witnesses and closing argument. Mind you, this was a hip implant medical device trial.

The Fifth Circuit rejected the trial court’s “open door” ruling. It held that “the rules of evidence do not simply evaporate when one party opens the door on an issue.” Id. at 44. Prior bad acts cannot be used to convince a jury that defendants acted as wrongdoers in the case before it. Id. The Fifth Circuit held, however, that the plaintiffs’ attorney asked the jury to do just that. To illustrate this, the Fifth Circuit quoted the paragraph below from plaintiffs’ closing argument. Note that the italicized emphasis in the paragraph was placed there by the Fifth Circuit, as was the single word “Indeed” after that paragraph:

If you go back and look at the DPA, that’s the deferred prosecution agreement where the company paid money one time because of kickbacks to doctors in America, the other time because of the bribes to Saddam Hussein’s government, the bribes in Greece, Romania, Poland and other places where they were bribing people to put in . . . their products. The DPA has [J&J] admitting its responsibility in it. J&J is admitting that they’re responsible. They have already taken this issue out of your hands realistically. That alone is a winner. . . . [J&J] has admitted their responsibility for this. That ought to be enough.

Indeed.

Id. at 45. The Fifth Circuit wrote that this closing argument and the earlier questioning “tainted the result by inviting the jury to infer guilt based on no more than prior bad acts . . . . That alone provides grounds for a new trial.” Id.

The second evidentiary ruling rejected by the Fifth Circuit was the trial court’s decision to allow plaintiffs to use hearsay in a resignation letter from a DePuy employee alleging racism within the company. Slip Op. 46-48. Again, this was a hip implant trial. Calling it a “spectacle,” the Fifth Circuit ruled that reading this letter to the jury “refocused its attention on serious, and seriously distracting, claims of racial discrimination that defendants had no meaningful opportunity to rebut via cross-examination. This spectacle fortifies that a new trial is required.”

These evidentiary rulings alone were enough to upend the judgment. But there were more. As we laid out in our previous posts, the trial court made multiple other questionable evidentiary rulings that allowed questioning and argument on things like suicide, cancer, connections to the tobacco industry, transvaginal mesh suits, and so on. Having already overturned the judgment, the Fifth Circuit declined to address these other evidentiary rulings. But it did warn the trial court to “weigh carefully the application of Rule 403 and 404(b)” when considering these issues at future trials. Slip Op. at n. 71.

Next, the Fifth Circuit found additional grounds to overturn the judgment due to what it called “deception” by the plaintiffs’ attorney regarding plaintiffs’ experts, something we wrote about last year. Plaintiffs classified two of its experts as “non-retained,” meaning not paid. At trial, plaintiffs’ attorney contrasted this with what he called the “bought testimony” of the defendants’ expert. The problem is, however, that plaintiffs’ experts were “bought” too. Before trial, plaintiffs’ attorney donated $10,000 to St. Rita’s Catholic School, the favorite charity of one of the two experts. More blatantly, after trial, plaintiffs paid $65,000 in total to the two experts.

It would be difficult to overemphasize how hard the Fifth Circuit came down on this, labeling it “deception.” Slip Op. at 6. The court was clearly displeased. Its opinion (see pages 49-57) is littered with snide comments. Noting that Mr. Lanier mentioned to the jury that he had shared the “best apple pie in the world” with one of the two experts, the court wrote, “St. Rita’s and the $10,000 check went unmentioned.” Id. at 50. After quoting Mr. Lanier contrasting the supposedly “bought testimony” of the defendants’ experts with the supposed “real life” testimony of his two experts, the Fifth Circuit wrote: “As between ‘real life’ and ‘bought testimony,’ [the jury] chose the former by a margin of $502 million. But that choice was a false one, manufactured entirely by Lanier.” Id. at 52.

With the unmistakable intent to drive its point home, the Fifth Circuit clarified in just about every way possible that this type of maneuvering was improper:

This is the rare case in which counsel’s deceptions were sufficiently obvious, egregious, and impactful to penetrate the layers of deference that would ordinarily shield against reversal.

Lanier’s failure to disclose the donation, and his repeated insistence that Morrey Sr. had absolutely no pecuniary interest in testifying, were unequivocally deceptive.

Lawyers cannot engage with a favorable expert, pay him “for his time,” then invite him to testify as a purportedly “non-retained” neutral party. That is deception, plain and simple.

We find, by the “clear and convincing” evidence of common sense, that Lanier misled the jury in creating the impression that Morrey Jr. had neither pecuniary incentive nor motive in testifying. Neither our double deference nor counsel’s specious reasoning can alter that conclusion.

Calculated or not, falsehoods marred plaintiffs’ victory. The Verdict cannot stand.

Got it. This lambasting by the Fifth Circuit could change the game in the Pinnacle Hip Implant MDL. Proper boundaries may now be back in place, or at least some of them. There are more appeals to come, and they involve serious procedural and jurisdictional issues that were front and center in the two trials that followed this one. In fact, there may be more to come from this opinion, at least from us, as it also granted DePuy judgment on two plaintiffs’ failure to warn claims and J&J judgment on plaintiffs’ aiding and abetting claims—something for us to address another day.

One thing is already clear from this opinion, though. Two years of this MDL may have been wasted on defective jury trials. But, if a reset is needed, it must be done. The goal of an MDL is not to hammer defendants with every possible negative piece of evidence, relevant or not, so as to produce large verdicts. It is to establish a framework under which the parties can properly litigate and value the hundreds or thousands of cases within a complex mass tort. The Fifth Circuit’s opinion is an important step toward that proper construct.

This morning, our commuter train was packed with overjoyed Villanova students headed for the NCAA Championship Victory Parade.   It was the second time in a few months that our fair city has been lifted by a huge sports triumph.  And, though our heads were ringing by the time we reached our stop (“Indoor Voice” is apparently not a course offered at Villanova), we love the infectious joy of these victories.

We also love a good Daubert victory, like today’s decision.  In Tsao v. Ferring Pharms., Inc., 2018 U.S. Dist. LEXIS 49173 (S.D. Tex. Mar. 26, 2018), the defendant manufactured a drug designed to stimulate women’s ovaries to produce eggs to be used for in vitro fertilization (“IVF”).  The plaintiff, an oncologist, underwent fertility treatments using the defendant’s drug.  Alleging that she purchased “defective, adulterated, and misbranded” vials of the drug, she sued the defendant for economic damages for breaches of express and implied warranties and violations of the Texas Deceptive Trade Practices Act.   The defendant had earlier voluntarily recalled certain lots of the drug because routine stability testing indicated that the lots “did not meet potency specifications and were out of specification . . . at the time of testing (twelve months or more into their shelf life.” Tsao, 2018 U.S. Dist. LEXIS 49173 at *1.   The plaintiff “complain[ed] that [the defendant] failed to inform her that [the drug] lacked the potency described in the drug’s Prescribing Information” and that she would not have purchased and used [the drug] had she known it did not meet those product specifications.” Id. at *3.  Claiming that the reduced potency adversely affected her fertility treatments, she sought recovery of money she spent to purchase the drug, money she spent on other medications used in conjunction with the drug, and the costs of her IVF treatments.

Among her designated experts, the plaintiff designated herself to offer a number of opinions, among them opinions related to the alleged “sub-potency” of the drug she purchased, the likelihood that this “sub-potency” would cause her IVF treatments to fail, and multiple issues related to ovarian stimulation, including the “usual” period of stimulation, the “prolonged” period necessary because the drug was “sub-potent,” and the supposed negative effects of this “prolonged stimulation.”  The plaintiff also designated a regulatory expert to testify about causation as well as the defendant’s “alleged lack of compliance with FDA regulations regarding drug recall and misbranded or adulterated drugs.” Id. at *11.  The defendant moved to exclude the plaintiff’s “expert” testimony and the testimony of her regulatory expert.

Motion to Exclude the Plaintiff’s Expert Testimony

The defendant moved to strike the plaintiff’s expert testimony on the grounds that: 1) she was not qualified as a reproductive endocrinologist; and 2) her opinions lacked the indicia of reliability required for medical expert testimony.  The court resoundingly agreed.  First, the court held that the plaintiff had “failed to demonstrate knowledge, skill, experience, training, or education with respect to reproductive endocrinology and drug recalls . . . .” Id. at  *17.   To wit, the plaintiff testified in deposition that “many of her opinions regarding [the drug] and reproductive endocrinology [were] based on internet research that she conducted using Google  and Wikipedia” as well as “the websites of different fertility clinics and online patient forums to research the average stimulation period” for women undergoing this type of therapy. Id. at *17-18.   In addition, the plaintiff testified that her opinions about issues related to the drug’s recall were “based on her general understanding of ow pharmaceutical companies work. Id. at  *19 (internal punctuation omitted).   And so, the court found, the plaintiff had not met her burden to demonstrate that she was qualified to offer her expert opinions.

Because it had excluded the plaintiff’s opinions based on her lack of qualifications, the court emphasized that it didn’t need to reach issues related to the reliability of her opinions. But it stated for the record that the plaintiff’s own opinion that she would have produced more eggs if the drug were “fully potent” was not reliable because: 1) it “did not “fit” with the scientific literature, the data contained in the medical record, or her treating physicians’ testimony,” id. at *21; 2) was not the product of the same rigor the plaintiff would use in her own practice (the court commented that it “[didn’t]  believe that [the plaintiff ] would base her opinions regarding treatment of an oncology patient on Wikipedia research”); id. at *24-25; and 3) her repeated deference to her treating physicians confirmed her lack of expertise in reproductive endocrinology. Id. at *26.

And so, while the plaintiff was obviously permitted to testify about her own experience, she was not permitted to offer her own “expert” opinions.

Motion to Exclude Regulatory Expert

The defendant challenged the testimony of the plaintiff’s designated regulatory expert on three topics: 1) the potency of the drug purchased and used by the plaintiff; 2) FDA labeling requirements; and 3) the recall of the drug.  After recounting the expert’s qualifications at length, the court held that she was generally qualified to testify as an expert, and, specifically, was qualified to testify about FDA regulations and recalls.  But the court held that the expert’s opinions that the drug was “misbranded” and “adulterated” were impermissible legal conclusions and were contrary to FDA regulations.  Specifically, the FDA had set a potency range within which the drug was required to fall – 80%  to 125% of the labeled potency —  and the drug was not “misbranded”  or “adulterated” or “out of specification,” according to FDA regulations, as long as it fell within this  range.  And there was no evidence that any lots of the drug that the plaintiff used were “out of specification” at the time she used them.  As such, the expert’s opinion that certain vials of the drug “may have” fallen out of specification by the time the plaintiff used them was “speculative, contrary to the evidence, and inadmissible ipse dixit.” Id. at *37.   Finally, the court held that the expert’s opinion that the drug’s potency was a key factor affecting the quality of retrieved eggs was unreliable because it was “contrary to the labeled indications for [the drug], her own deposition testimony, and the testimony of Plaintiff’s treating physicians.” Id. at *43.

Regular readers are familiar with our frustration with the too-frequent admission of expert testimony that should never see the light of day.   While many of the challenges to the Tsao opinions were, dare we say, a slam-dunk, it’s still nice to see an opinion come out the right way.  Let’s hope for more, and, on the day of the Phillies’ 5-0 victory in their home opener, hope springs eternal that they can harness some of the city’s “sports karma” for the long upcoming season.

We write this as key elements of the Drug and Device Law Passover Feast languish in the oven. Tomorrow, the Drug and Device Law Bubbie will force four generations of our family – the devout and the not and everyone in between – to read (aloud) the lengthy prayer service that precedes the meal.  The ritual includes much laughter, enthusiastic (if discordant) singing, and predicable misbehavior from those of us at the “kids’ table” (the 50- and 60-year-olds, as distinguished from our parents) that provokes sharp rebukes from the elders.  And, these days, the gathering is a little bit bittersweet (cue “Sunrise, Sunset”), as time’s toll on the eldest members of the clan is softened by the presence, each year, of more of our babies’ babies.  We complain about the cooking.  We grouse about the most troublesome relatives.  But we wouldn’t miss it for the world, though we should mention that “feast” is something of a misnomer, as many Passover staples are notorious for barely crossing the line into “palatable.”

Speaking of misnomers, earlier this week, one of our co-bloggers termed causation the “MVP” of mass tort practice. While we heartily agree in principle, we have read (and participated in) too many scenarios in which a passive judge “benched” this “player” to allow meritless cases to queue up in settlement inventories. On the flip side, we are heartened by the increase in Lone Pine orders demanding early causation evidence and by judges who refuse to allow plaintiffs lacking proof of causation to escape summary judgment.

Such was the result of today’s case, a Risperdal case out of the Northern District of Alabama. In Drake v. Ortho-McNeil-Janssen Pharms., 2018 U.S. Dist. LEXIS 47164 (N.D. Ala. Mar. 22, 2018), the plaintiff was an obese 36-year-old man who was diagnosed as schizophrenic at age 17.  He was initially prescribed Risperdal but was switched to other drugs several months later.   He was switched back to Risperdal about two years after that and then remained on the drug for about thirteen years before different drugs were again substituted.

Shortly after the plaintiff stopped taking Risperdal, a social worker noticed that he had large breasts and told his mother that he should be tested for gynecomastia, benign enlargement of glandular breast tissue in males. Antipsychotic medications have been associated with gynecomastia, which “is distinct from pseudo-gynecomastia, which is breast enlargement due to fat deposits in overweight males.  The two conditions may be differentiated only with a physical exam.” Drake, 2018 U.S. Dist. LEXIS 47164 at *4.  No exam took place.  The plaintiff was never diagnosed with gynecomastia, though his levels of prolactin were elevated.  Prolactin is a hormone that induces lactation, but it “does not have a direct grown-stimulating effect on the breast glandular tissue.” Id. at *6 (citation omitted).  Many of the drugs prescribed to the plaintiff were known to cause prolactin elevation.

The plaintiff’s complaint, asserting all of the usual causes of action, alleged that Risperdal caused him to develop gynecomastia. The defendant moved for summary judgement, arguing that the plaintiff could not meet his burden of establishing causation.  The judge emphasized that the plaintiff was required to prove both general and specific causation and that expert testimony was required for both.  The plaintiff’s expert was a certain former FDA commissioner who has testified that the risk of gynecomastia in children and adolescents was higher than Risperdal’s labeling represented.  But, as the court pointed out, while the expert’s “report and deposition testimony from other  cases might be sufficient to raise a question of fact regarding general causation, . . . his report and testimony contain[ed] no evidence regarding the cause of [the plaintiff’s] alleged injuries. Id. at *13.  And the plaintiff had no other causation expert.

As such, as the court put it, “the plaintiff’s evidence concerning specific causation [was] threadbare.” Id.  There was no evidence that the plaintiff had even been diagnosed with gynecomastia.  And while the plaintiff argued that, if his elevated prolactin level had caused “testosterone level drops leading to estrogen expression,” then Risperdal could “theoretically [have caused] gynecomastia,” there was “no evidence in the record regarding [the plaintiff’s] testosterone or estrogen levels, and evidence that Risperdal could theoretically cause gynecomastia [was] not sufficient to raise a disputed issue of material fact concerning specific causation.” Id. The court concluded, “In the absence of medical or expert evidence, a fact finder must speculate about the cause of [the plaintiff’s] enlarged breasts, and a verdict may not rest on speculation.” Id.  

In other words, maybes on top of maybes do not proof of causation make. If the plaintiff cannot be bothered to get a diagnosis or an expert, that plaintiff should not be in court.  Unassailable, although we’ve all seen too many such “easy” decisions go wrong.  We like this case.  We will continue to keep you posted on the good and the bad, and we wish happy gatherings to all celebrating any holiday this week.

All of us – defense lawyers, plaintiff lawyers, and judges – tend to assume that the federal Daubert standard for admissibility of expert testimony is more rigorous than competing standards, particularly the Frye standard, which lingers in a minority of jurisdictions (and not even where it originated).  In simple terms, Frye merely asks whether the expert opinions find general acceptance in the relevant expert community, whereas Daubert digs into the reliability of the particular opinions.  Put another way, Frye makes judges count experts, whereas Daubert makes them become experts.  Maybe that is why there are so many judges that hate Daubert and apply it in name only. When application of the Daubert standard results in exclusion of an expert opinion, it is usually the reliability component, not, say, qualifications, that does the excluding.  Daubert’s reliability component, in turn, contains several components.  Some are highly technical, such as rate of error.  Others are a little easier to understand, such as whether the expert opinions are litigation-driven, whether peer review literature supports the opinions, and – ta da! – whether the opinions find general acceptance in the field.  That is, Daubert incorporates Frye to a certain extent.  But whereas general acceptance is the whole ballgame in Frye, general acceptance is only one among several factors, and is not by itself dispositive.  Consequently, one can dream up a scenario where an expert opinion might get knocked out by the Frye standard but would make it to the jury under Daubert.  Think of an expert opinion that lacks general acceptance but otherwise can lay claim to other indicia of reliability.  You might not find it terribly easy to conjure up such an expert opinion.  After all, how has a reliable opinion not achieved general acceptance?  Is it just too new?  Would you be surprised to learn that the Daubert standard was initially created by courts to liberalize Frye? Be that as it may, the point drilled home by today’s case, In re 3M Bair Hugger Litig., 2018 WL 894021 (Minn. Dist. Ct. Jan. 8, 2018), is that, every once in a while, the old Frye standard really cooks.

 

It appears from the introduction to the state court’s opinion that a hearing on expert admissibility was held jointly before the state and federal courts in the Bair Hugger litigation.  Such state-federal coordination is a welcome dose of efficiency in aggregated litigation.  The plaintiffs and defendants moved to exclude each other’s expert opinions, and the defendants moved for summary judgment with respect to general causation.  The medical device in question was the Bair Hugger, which is used to maintain a patient’s normal body temperature during surgery.  The court pointedly tells us that “[m]ore than thirty years ago, it became generally accepted within the relevant scientific community that maintaining a patient’s normal body temperature (“normothermia”) during surgery led to decreased infection rates, a shorter period of post-operative recovery, and improved healing. This theory remains generally accepted, and various manufacturers compete to market their warming devices.”  Nice job foreshadowing the “general acceptance” issue.  The issue in the litigation was whether the Bair Hugger’s forced-air system of temperature regulation increased the chances of infection.   That was the opinion proffered by the plaintiffs’ three medical experts, and the issue was whether such opinions were generally accepted.  And now we will do a little foreshadowing ourselves:  they weren’t.  Hug the Bair Hugger litigation goodbye.

 

But first you will want a bit of background.  That background is a bit tawdry, and it is hard to think such background did not make it a little bit easier for the court to drop both the plaintiffs’ expert opinions and complaints into the trash bin.  The Bair Hugger had been invented by a fellow named Augustine.  The Bair Hugger became the leading warming device in the world.  Then came bad news.  That inventor was notified by the United States Department of Justice that he was under investigation for Medicare fraud. Augustine resigned from the company.  He later pled guilty, was fined $2 million, and was prohibited from participating in federal health-care programs for five years.  The Bair Hugger device continued to be successful. 

 

Augustine later invented a competing normothermia device, this time employing electric conduction rather than forced air.  He called this new device “the HotDog.” As if the reference to a delicious meat snack was not enough to win over customers, Augustine then did his best to attack his old device.  In 2008, he began to impugn the safety of the Bair Hugger overseas. He issued a press release criticizing forced-air warming systems such as the Bair Hugger. Augustine claimed that such devices increased the risk of surgical infections. The United Kingdom National Institute for Health and Clinical Excellence rejected this claim, concluding that forced-air warming devices were not associated with an increased risk of infection.

 

Then things got even nastier.  Augustine hired a law firm to promote the use of HotDog patient warming, and he agreed to work with the law firm as a “non-testifying expert.” That law firm eventually began to represent individuals in lawsuits to be brought against the Bair Hugger.  But meanwhile, the efforts to besmirch the Bair Hugger’s safety were as unsuccessful in the United States as in the United Kingdom.  The FDA investigated the allegation that the Bair Hugger increased the risk of bacterial contamination. It did not agree with the allegation.  And now we get a wonderful little observation from the Minnesota court that captures so much about what is wrong with mass tort drug/device litigation:  “The FDA exercises a more stringent approach to product safety than state and federal courts…. The FDA will remove drugs from the marketplace upon a lesser showing of harm to the public than the preponderance-of-the-evidence or more-likely-than-not standards used to assess tort liability.”  Just so.  And yet we spend the major portion of the day defending claims against drugs and devices that the FDA chooses to leave on the market.  We think of the Jeremiad: “And still we are not saved.”  (We have a post about the FDA enforcement standards being less than the common law tort “more likely than not” standard.  Where do we have it?  Here.) 

 

Back to our story.  The bad turns ugly.  In 2012, the inventor-turned-competitor-turned-adverse-expert tried “to coerce” a defendant into purchasing his HotDog system by warning that the defendant “would suffer a significant loss of market share and ‘a lot of negative marketing rhetoric’” about the Bair Hugger causing infection if the sale did not occur.  It’s as if the inventor was trying to make the defendant an offer it could not refuse.  But guess what?  The defendant refused. 

 

Then Augustine began to market the HotDog as reducing the rate of surgical infections when compared to forced-air systems. In response, the FDA sent a warning letter to Augustine in 2012, stating that his claim was without clinical support and made without FDA approval. Meanwhile, the Hotdog in-house counsel proposed to prepare a “detailed guide” to sue the Bair Hugger. Even so, Hotdog again proposed a marriage with the Bair Hugger.  Again, the proposal was rejected.  Again, the FDA was forced to respond to the inventor’s attempts to impugn the safety of the Bair Hugger, by issuing a letter endorsing the continuing use of forced-air warming devices and the beneficial effect of such devices on patient safety. 

 

We remember once hearing a jury consultant say that every product liability lawsuit is a romance novel.  The story goes like this: you seduced me, you harmed me, and now you have abandoned me.  Well, this normothermia saga is the weirdest kind of romance novel.  It as if the Hotdog inventor was stalking the Bair Hugger, mixing entreaties of “marry me” with the most hateful invectives and assaults.  Fabio is nowhere in sight.  Even the Lifetime Network would take a pass on this improbable narrative.

 

Naturally, this narrative culminates in mass litigation.  Augustine and his law firm saw 60 cases get filed in Minnesota state court and thousands of cases in federal court.  Those cases rested on a three-legged stool of three iffy general-causation medical expert opinions.  Notably, “[n]one of these experts had studied the efficacy of forced-air warming devices prior to being retained by Plaintiffs. They have not published any peer-reviewed articles relevant to the claims made in this litigation. They do not claim that their general-causation opinions are generally accepted within the relevant scientific community.”  The experts were named Samet, Stonnington, and Jarvis, and odds are that you have encountered at least one of them in the long inglorious history of plaintiff experting.  You will hardly be surprised to hear that the defendants argued that the opinions were not generally accepted within the relevant scientific community and, therefore, were inadmissible under Minnesota law.  There was no mention of Daubert, since Minnesota is not a Daubert state. Don’t worry; Daubert was not needed. 

 

The plaintiffs’ only argument to save the expert opinions was that the general-acceptance requirement does not apply to an expert’s opinion. Rather, the standard applies only to the “methodology” an expert uses to arrive at his or her opinion.  We have to give the plaintiffs credit.  They placed their finger on the key issue in many Frye jurisdictions.  What has to be generally accepted, the bottom-line, ultimate opinion, or the methodological bits utilized to arrive at that opinion? Mind you, it’s not as if separating one from the other is perfectly obvious. The Minnesota court consulted both precedents from its own state as well as a Florida case desperately seized upon by the plaintiffs, and then announced its own bottom-line, ultimate opinion: the opinion itself, not just the methodology, must find general acceptance.  The general-acceptance prong under Minnesota law applies to “opinion or evidence” that “involves novel scientific theory,” and requires that the “underlying scientific evidence” be generally accepted.  The opinion that forced-air warming devices increase the rate of surgical site infections “is undisputedly novel and not generally accepted. Plaintiffs’ attempt to narrowly apply the rule must be rejected.”  The court reasoned that if the plaintiffs’ “interpretation were applied to its extreme, a witness would be able to opine that the earth is flat, or the center of the universe, if the person’s methodology for arriving at those opinions was generally accepted.”  True, and one can be sure that such extreme application will show up before the year is out. Interestingly, the Minnesota court quoted an earlier Minnesota precedent to the effect that the application of the Frye [in Minnesota it is called FryeMack] standard “avoids the problem that many commentators see as inherent in Daubert, namely, that such an approach “takes from scientists and confers upon judges *** the authority to determine what is scientific.”  But when most other courts praise the superiority of Frye, it is whilst they are in the process of waving by junk science.  What is so important and powerful about this decision is that it shows how Frye can be applied to bar junk science at the courthouse steps.  You should definitely have this opinion in your pocket the next time you visit Minnesota.  You should probably use it in any Frye jurisdiction.  You can probably exploit it here in the Commonwealth of Pennsylvania, where we have heard references to “Fraubert.”  Heck, you can probably be clever enough to use this opinion in the right circumstances in a Daubert jurisdiction.   

 

By the way, there was a second argument supporting summary judgment for the defendants. (When you win in the trial court, there is nothing better than provision of alternative grounds by the court.  It makes the appellate adventure so much more pleasant.)  Even if the general-causation opinions of the plaintiffs’ experts were admissible, the plaintiffs “have failed to establish that it is generally accepted that the risk of infection associated with forced-air warming devices is greater than the risk of infection associated with hypothermia during surgery or when compared to other warming devices.”  It is a double whammy.  There was no generally accepted scientific evidence that the risk of infection associated with forced air normothermia devices was greater than that associated with patients who are not warmed during surgery, and there is no scientific evidence that warming devices other than forced air warming devices have a lesser rate of infection.  There is no there there.

 

After an application of Frye so robust as to call to mind former Minnesota Governor Ventura, the court ends by dispensing a couple of other goodies to the defense bar.  First, the court praises the general acceptance test because it “values the primacy of science over litigation-driven opinion by allowing the medical and other scientific communities to abide by those generally accepted practices that promote patient safety, and marginalizes the effect of other opinions and efforts that might be unduly influenced by litigation and/or competition.”  Or, as we’ve said more than once before, law must lag science, not try to lead it.  (Thank you, Judge Posner.)  Second, the court observes that “the history leading to this litigation also demonstrates the importance of the general-acceptance standard when the threat or fear of litigation is used as a competitive tool.”  Amen. But while the abuse of science is especially obvious in this case, it exists in some significant form in most drug or device litigations, whether or not a vengeful inventor or romantic pursuer lurks just offstage.

 

 

When a drug or device case goes to trial, who is the most important witness?  Let’s straightaway eliminate the plaintiff as a possible answer to that question.  Based on what we’ve heard from jurors (both real and mock), when plaintiffs prevail it is often despite themselves.  So then who?  A credible company witness can turn things around and defuse jury anger over company conduct.  Or that witness can make things much worse by squirming or fencing.  Or the plaintiff lawyers could overplay their hand by overplaying videotaped testimony, thereby boring the jurors into catatonia. What about experts?  Most jurors will tell you they discounted the experts from both sides, viewing paid-for testimony with measured skepticism. 

 

For our money, the most important witness is often the plaintiff’s prescribing or treating physician.  People trust doctors.  It is easy to see a particular plaintiff’s doctors as practicing medicine, not litigation.  They talk about what they actually did to treat a patient.  It seems that they truthfully recount reality, not merely mouth a script authorized by the lawyers.  Perhaps it is a vast oversimplification, but when we assess cases as being favorable or unfavorable, as being a good or bad case for bellwether trial selection, or when we assess settlement valuation, whether the plaintiff’s doctors offer a thumbs up or thumbs down on the product ranks near the top of the criteria.

 

Sometimes figuring out what the plaintiff treaters will say amounts to a game of chicken.  We can read the medical records.  That part is easy.  We can depose the doctors on the obvious medical questions about what happened.  But it becomes a bit terrifying when it comes to asking doctors the bottom line questions of whether the product in question actually caused the injury, or whether the doctors would still use the product knowing what they know now.  It’s nice to get helpful testimony, but one is always wary about eliciting testimony that kills one’s case.  If things go kablooey, it is time for the dunce cap and time for a difficult conversation with the client.  So you nibble a bit with your questions here and there, and pounce only if things look really promising.

 

And then what?  Is the doctor’s opinion – for that is where we are now – admissible?  Can we label it as an expert opinion?  Do we need to disclose the doctor as an expert?  If so, what does the disclosure need to say?  This process can also amount to a game of chicken.  How much or how little of a preview is required?  Playing this game wrong can have severe consequences.

 

That was certainly the case in Webb v. Zimmer, Inc., 2018 WL 836366 (E.D.N.Y. Feb. 12, 2018).  It is a knee replacement product liability case.  What do we learn from the Webb case?  To begin with, it doesn’t pay to be less than forthcoming with opposing counsel about your expert witnesses.  The plaintiff side did not inform the defense that a treater would also testify as an expert on a key issue, and then tried to bring the witness in as an expert at the last minute, after a summary judgment motion was filed.  That is a classic backfilling operation. The Webb court provides a solid discussion of what treaters can and can’t testify to when no expert report is provided.  Ultimately, the plaintiff was allowed to get away with belated testimony about the doctor’s own response to different warnings, but only at the price of having to pay for having a second deposition of the doctor.  Other non-treatment opinions were excluded. The Webb case offers a decent list of do’s and don’ts.

 

Let’s flesh out the particulars. 

 

 

The physician/maybe-expert was Dr. Unis, who performed a right total knee replacement on the plaintiff using the defendant’s knee flex system.  At the time, Dr. Unis was using this product for all of his primary knee replacements, regardless of the specifics of his patients’ conditions.  That was because Dr. Unis felt “comfortable with the nuances of the system which [he believes] contributes to the success of putting in an implant.”  Ten days after the initial knee surgery on the plaintiff, Dr. Unis remarked that the plaintiff “really looked great.”  But that greatness did not last.  Dr. Unis later performed three revision surgeries on the plaintiff’s knee.  The plaintiff was displeased and filed a lawsuit alleging the usual array of product liability claims.  After discovery and the usual pretrial skirmishes, the plaintiff abandoned her design defect theory and confined her claims to those based on a failure to warn theory.  What was the relevant warning?  It actually seems pretty complete.  It informed the surgeon that soft tissues should be balanced and components positioning confirmed to minimize edge loading.  Under “Patient Counseling Information,” the insert stated that because prosthetic joints are not as strong, some might need to be replaced at some point.

 

 

The defendants filed a motion for summary judgment.  In her opposition papers, the plaintiff included an affidavit from Dr. Unis that, among other things, addressed the failure to warn theory, including what Dr. Unis would have done if the warning had been improved. The defendants then sought to exclude the Unis affidavit on the grounds that the plaintiff did not disclose Dr. Unis as an expert witness on the failure to warn elements, and because the plaintiff did not provide the required disclosures under Rule 26(a).

 

Now let’s turn to a bit of history.  Prior to 2010, when Rule 26(a)(2)(C) was added, as a general rule, parties did not need formally to designate treating physicians as experts or serve expert reports summarizing their opinions in order to bring those treaters in to testify.  Rather, the treating physician was considered a special species of fact witness and could offer medical opinions only if such opinions were formed during the course and scope of treatment of the plaintiff.  Information or opinion that was acquired by the treating physician from an outside source was out of bounds.  Things changed significantly after the adoption of Rule 26(a)(2)(C) in 2010, though not many lawyers seem to know it.  Under the new rule, a treating physician may offer factual testimony as well as opinion testimony regarding his patient’s diagnosis, treatment, prognosis, or causation as long as the proper disclosure is served on the other side.  Rule 26(a)(2)(C) requires a statement regarding “(i) the subject matter on which the witness is expected to present evidence under 702, 703, or 705; and (ii) a summary of the facts and opinions to which the witness is expected to testify.” Fed. R. Civ. P. 26(a)(2)(C). This requirement is much more extensive than formerly had been required for treaters, though still less extensive than expert reports and disclosures required under Rule 26(a)(2)(B) for retained experts.  Without the required disclosure under either Rule 26(a)(2)(B) or Rule 26(a)(2)(C), a treating physician may testify only as a fact witness regarding patient treatment.

 

In the Webb case, the plaintiff tendered an expert disclosure for Dr. Unis as an expert witness, but provided no summary of his expert opinions, as required by Rule 26(a)(2)(C). Instead, that disclosure revealed that Dr. Unis’s testimony would be confined to his care and treatment of the plaintiff, as well as “causation” and “any other questions that relate to the issue of plaintiff’s damages.”  Not a word was whispered about the effect of the warnings.  Following the initial disclosures, the plaintiff withdrew her initial expert reports for revision, based on her revised theory of the case. Remember, that revised theory centered on failure to warn.  The defense counsel asked about the scope of Dr. Unis’s expert opinions, and made clear that the defense assumed that Dr. Unis would not offer opinions related to the adequacy of the product warnings or that a failure-to-warn caused the injuries.  The plaintiff’s counsel responded that “I am not sure we disagree,” and that Dr. Unis’s opinions would “not be as an expert but as a fact witness to what he observed and concluded about the product and the plaintiff’s physical condition based on his personal experiences in this case.”  Again, there was no hint about warnings. 

 

The Webb court held that this expert disclosure provided no indication that Dr. Unis intended to testify as to the plaintiff’s failure to warn theory, or that he would utilize outside information to form his expert opinions.  That conclusion seems utterly inescapable. By contrast, the Unis affidavit submitted by the plaintiff in opposition to the summary judgment motion contained Dr. Unis’s “thoughts regarding the adequacy of Zimmer’s warnings or what he would have done differently had he known about any alleged improper warning or contraindication.”  Significantly, the Webb court concluded that “these statements constitute an expert opinion. These paragraphs do not contain treatment explanations or opinions as to the Plaintiff’s diagnoses; these are statements of hypothetical thoughts or actions that involve outside information.”  Wow.  We have always thought that it was pure speculation for a physician to offer post hoc testimony about what he or she would have done had the warnings said what the plaintiff’s lawyer – with 20/20 litigation and medical hindsight – now says the warning should have said.  But Webb now gives defense lawyers an additional ground to repel such testimony:  it is expert testimony that implicates the disclosure requirements of Rule 26(a)(2)(C).  Check your file.  We bet that the plaintiff lawyer did not supply the requisite disclosure.

    

Unfortunately, the Webb court did not flat-out preclude the belated “expert” testimony about warning causation.  The court held that the plaintiff’s failure to comply with Rule 26(a)(2)(C) did not automatically preclude the affidavit under Rule 37(c). A district court has wide discretion to impose sanctions, including severe sanctions, under Rule 37.  The typical sanctions analysis militated in favor of some sort of sanctions in the Webb case for the plaintiff’s expert shell-game, because the plaintiff offered “no persuasive explanation for not appropriately disclosing Dr. Unis’s expert testimony, which is beyond what is properly given by a treating physician.”  Moreover, the defendants would be prejudiced if the court were to allow portions of the Unis Affidavit to be admitted  — without allowing the defendants to conduct additional discovery.  Thus, the court decided to reopen discovery only to allow the defendants to re-depose Dr. Unis on the failure to warn theory and his affidavit.  The Webb court further ordered plaintiff’s counsel pay the defendants’ reasonable attorney’s fees associated with the renewed deposition of Dr. Unis, as well as reasonable attorney’s fees that the defendants’ incurred in bringing the motion to strike.  Literally, the plaintiff lawyers paid the price for failing to disclose the true scope of the treating doctor’s opinion.  Time will tell whether that price was high enough. 

 

 

 

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.

Last week, we took a short Western Caribbean cruise to celebrate a jarringly-advanced birthday. While the weather wasn’t an asset (it was 43 degrees when we departed Fort Lauderdale, and hovered in the 60s for most of the trip), we left behind record cold and treacherous ice in Philadelphia, so we had no climatic complaints.  We were slightly apprehensive, however, because we were sailing on the very ship that had been in the news a few weeks earlier for a norovirus outbreak that sickened a couple hundred passengers.  But we convinced ourselves that the adverse publicity surrounding the recent outbreak would ensure that pre-sailing sanitation and onboard precautions were at an all-time high.  And we were correct:  the entrance to every venue on the ship was blocked by crew members bearing giant bottles of hand sanitizer, application of which was required for passage.  Even at the 24-hour soft-serve frozen yogurt machine (if we were assured this would be operational at all times, we could happily exist without dining rooms), the crew member manning the controls would not hand over a cone to anyone who did not sanitize first.  It apparently worked:  we came through unscathed and heard of no reports of illness on the ship.  (We also had a blast — played round after round of trivia, “clear kayaked” off the coast of Cozumel, drank many glasses of wine, and spent hours and hours motionless except for turning the pages of our book.)  Bottom line was that the cruise line did all that it was supposed to do to protect its passengers.  Beyond that, people had to be smart and careful, because the ship’s duty only extended so far.

Today’s case also involves questions of duty and of whether the defendant’s duty extended as far as the plaintiff said it did.   In Liu v. Janssen Research & Development, LLC, No. B269318, 2018 WL 272219 (Cal. Ct. App. Jan. 3, 2018), an unpublished decision from the California Court of Appeal, the plaintiff’s son and decedent died after briefly participating in a clinical trial for a long-acting injectable form of the defendant’s antipsychotic medication.  The decedent had begun treatment for mental illness nine years earlier, and had been taking another antipsychotic medication for five of those years.  His treating psychiatrist was the doctor selected to be the principal physician/investigator for the defendant’s clinical trial, and it was she who invited the decedent to participate in the study.

The decedent underwent a screening EKG, which revealed several abnormalities, and a blood test, which revealed slightly elevated liver enzymes. The treater concluded that the results were not clinically significant, and “based on [the decedent’s] otherwise normal physical examination and denial of a family history of cardiac disease,” she admitted him to the study. Liu, 2018 WL 272219 at *1.

Three days later, after a second blood test, the decedent was injected with a non-therapeutic one-milligram dose of the study drug to test for adverse reactions. A second EKG was performed within two hours.  The next day, the results of this EKG and the pre-injection blood test were analyzed, and they indicated worsened cardiac function and much higher liver enzymes than four days earlier.  The decedent was admitted to an acute-care hospital, where he was diagnosed with cardiomyopathy, pneumonia, failing liver function, and altered mental state.  He died two days later.

The plaintiff sued a host of study defendants, including the treater and the drug manufacturer, for negligence, product liability, and negligent failure to warn. After much motion practice, the case proceeded to trial on only the negligence claims and against only the drug manufacturer.  The defendant moved in limine to exclude the plaintiff’s cardiology and pharmacology experts’ opinions that the one-milligram test dose contributed to the decedent’s death, but the trial court admitted the testimony.

At the close of evidence, the trial judge granted a partial directed verdict, finding that the physician/investigator (the treater) was not the agent of the defendant for purposes of finding the defendant vicariously liable for her medical negligence. This left two issues for the jury to consider: 1) whether the defendant manufacturer had an independent duty to intervene in the decedent’s medical care, even if the medical issues “preexisted, or were unrelated to, the study itself,” id. at *5; and 2) the defendant’s duty to monitor the administration of the study drug, including the issue of whether the one-milligram test administration caused the decedent’s death.  The jury found that the defendant was negligent and that its negligence was a substantial factor in causing the decedent’s death, assessing the defendant’s fault at 70% and awarding $5.6 million in damages.

On appeal, the Court of Appeal considered whether the defendant had a duty to intervene in the decedent’s treatment for his preexisting heart disease, and whether there was sufficient evidence that the single one-milligram test dosage was a substantial factor in causing the decedent’s death. With respect to the first question, the court held, “We agree as a matter of law that defendant, as the drug manufacturer/sponsor of a clinical trial, undertook a general duty not to harm the study participants as part of the clinical trial protocols. Administration of the [test dose] fell within the scope of this duty, and we will discuss the sufficiency of the evidence to support liability under this duty of care . . . . But the significant legal question . . . is whether the general duty not to harm study participants encompassed a duty to diagnose or treat [the decedent’s] preexisting, life-threatening heart disease and to intervene in the medical care and decisions precipitated by [the decedent’s] abnormal test results.  . . . [W]e conclude that it did not.”  Id. at *6.

The court’s holding turned on the question of foreseeability. It explained that the general duty FDA regulations impose on study sponsors – to ensure compliance with study protocols and the participants’ safety – is intended to “protect participants generally from foreseeable harm caused by the drug studies themselves, including participants’ adverse reactions to study medications.” Id. at *7.   But it cited state law decisions standing for the proposition that “it is not foreseeable to a study sponsor that study physicians with the primary responsibility for participants’ health and safety will fail to recognize, diagnose, and properly treat preexisting, life-threatening conditions that first manifest during drug studies,” as did the decedent’s heart and other conditions. Id. (citations omitted).  Simply put, “it is not reasonably foreseeable to a drug study sponsor that the response by study physicians . . .  would fall below the standard of care for a medical practitioner.” Id. at *8.

That left the question of medical causation. As noted, the jury’s verdict was based on the testimony of the plaintiff’s cardiology and pharmacology experts. Both experts testified on direct examination that the test dose was a substantial factor in causing the decedent’s death.  But, while the pharmacologist testified that the drug could cause heart arrhythmias, she admitted that there was no evidence that the decedent died from an arrhythmia.  And, while the cardiologist “unequivocally concluded the administration of any amount of the test drug . . . was sufficient to push the decedent ‘over the edge,’ [he] did not provide a reasoned explanation that illuminated for the jury how or why such a low dose of [the drug] could have had such a substantial effect on [the decedent’s] life-threatening heart disease.” Id. As such,  the appeals court found that, “at best, [both] causation experts opined as to a theory that might have contributed to [the decedent’s] death, [they] did not provide the necessary factual basis to qualify that theory as substantial evidence.” Id. at *12.

Judgment for the plaintiff reversed. And though the decision is unpublished and can’t be cited, it reinforces the reality that duties are not unlimited and drug companies aren’t responsible for medical care and aren’t liable for everything that happens to everyone who takes their drugs.  We like this decision and wish it were published – we’ll keep our eyes open for one that is.  And now, we’d gladly use a gallon of hand sanitizer for one more stroll around the deck with a frozen yogurt cone.

This post is from the non-Reed Smith side of the blog.

Be specific. Be focused. Be detailed. All good things to keep in mind when requesting just about anything, including relief from a court. That is what today’s decision got us thinking about. It’s a Daubert ruling from the Bard IVC Filters MDL and it’s a bit of a mixed bag. In re Bard IVC Filters Prods. Liab. Litig., 2017 U.S. Dist. LEXIS 211400 (D. Ariz. Dec. 22, 2017). What caught our attention the most, however, was the number of times the court reflected that the specific opinions or documents he was being asked to rule on were not specified. We are NOT taking issue with how defendants handled the motion. First, we don’t know enough. Second, the requests may have been broadly presented because the expert reports were simply that deficient or that improper. We just thought it worth pointing out that the court seemed to have some difficulty making definitive rulings citing a lack of specificity in the request. It’s not that unusual for courts to defer some rulings for trial wanting context to support the decision. What we don’t want is for the lack of ruling to be due to a lack of detail that could have been provided (again, not saying that is what happened here).

We often struggle with the proper level of detail to provide a court. Too much can be overwhelming; too little and you haven’t made your case. Too narrow and specific of a request risks an overly narrow or specific ruling and perhaps missing something altogether.  We don’t have a magic formula that solves this problem. So, we offer our observation and reflection and with that move onto the substance of the ruling.

Defendants in the Bard IVC Filter MDL challenged four categories of opinions offered by plaintiffs’ interventional radiologist experts which the court ruled on as follows:

Reliance on Other Experts’ Reports: While addressed in the opinion as a fairly broad request, we gather this had a lot to do with medical experts parroting the conclusions of plaintiffs’ regulatory expert Dr. David Kessler. See In re Bard IVC Filters, 2017 U.S. Dist. LEXIS 211400 at *280-82. It appears Dr. Kessler’s report discussed a litany of internal company documents – the types of documents an interventional radiologist would never see or be asked to interpret. But citing cases that allow experts to rely on other expert’s conclusions, the court denied defendant’s motion to exclude on this basis. While the Federal Rules are liberal regarding what an expert can rely on, including things like business records, we posit that the appropriate limitation on that be things that are within the expert’s area of expertise. Simply because another expert relies on the documents doesn’t make them something germane to or within the expertise of another expert.

Summaries and Editorials of Deposition Testimony and Company Documents: Defendants asked the court to prohibit this type of testimony by plaintiffs’ experts, but the court found it couldn’t rule on the issue because no specific testimony was identified that should be excluded. Id. at *283-84. So, the court instead offered an advisory opinion stating that experts “will not be permitted to engage in lengthy factual narratives that are not necessary to the jury’s understanding of their opinions, nor will they be permitted to gratuitously comment on factual evidence or present what are essentially lawyer arguments with regard to factual testimony.” Id. at *284.

Reasonable Physician Opinions: Plaintiffs sought to offer testimony from their experts both on what a reasonable physician expects to be told about risks and what a reasonable physician would do upon receipt of that information. Defendants challenged these opinions as not tested or peer reviewed, not published, and not generally accepted in the medical community. Id. at *285. But the court determined that was the wrong analysis. Rather, plaintiff’s experts are relying on personal knowledge and experience which can be an acceptable basis for certain types of opinions, such as professional medical opinions. Id. at *286. Because the experts are practicing radiologists, what type of information a physician expects to receive about a product is within their knowledge and therefore, the court concluded was permissible expert testimony. Id. at *289. However, what a reasonable expert would do in response to receiving certain risk information is “more problematic.” Id. at *289-90.

Whether and when to use a particular product appears to be a more fact- and patient-specific decision, not amenable to broad generalizations. The propriety of testimony on this subject will depend heavily on the context and relevancy of the question. The Court will need to draw these lines during trial.

Id. at *290.

Engineering and Testing Opinions: Certainly these are topics outside the expertise of clinical physicians. For the most part, the court agreed. The court exclude testimony on straightforward technical issues. Id. at *292. But was unwilling to say that some technical matters wouldn’t be within the doctor’s expertise – technical issues that they are familiar with based on their experience “implanting, monitoring, and removing IVC filters.” Id. at *293. Unfortunately, the court found it couldn’t be more specific before trial.

Although not much was excluded pre-trial, the forecasting on how the court would rule and limit plaintiffs’ experts at trial is mostly favorable. While the court seems to have wanted more details about the opinions defendants wanted to exclude, it’s hard to know if that would have made any difference. More details may just have meant more complexities that couldn’t be resolved pretrial. So, the devil is certainly in the details and there is simply no way of knowing what the devil might lead to.