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 general 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] “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 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.

This guest post is by Kevin Hara, an associate at Reed Smith and relatively frequent contributor to the Blog.  Here, he discusses two recent favorable procedural developments in further appeals from two really awful decisions by intermediate courts of appeals.  As always, our guest posters are 100% responsible for what they write – due 100% of the credit, as well as any blame.  Take it away Kevin.


SCOTUS Calls For Solicitor General’s Views In Third Circuit Fosamax Case

Friday December 8 was a day with two items that are particularly noteworthy because of their potentially momentous implications. Remember the Blog’s previous lambasting of the Third Circuit’s unprecedented Fosamax preemption decision and the haymaker that court unleashed on the drug and device industry, in In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017)?  Now, there is positive news to report. The Supreme Court has invited the Solicitor General “to file a brief in this case expressing the views of the United States.” Merck, Sharp & Dohme Corp. v. Albrecht, et al., No. 14-1900 (Order, Dec. 8, 2017).

What is that? Here is SCOTUSBlog’s description:

“CVSG” stands for “call for the views of the Solicitor General.”  In most cases in which someone is seeking review of the lower courts’ decision, the Court will issue a straightforward grant or denial.  But sometimes the Court will want the government’s views on what it should do in a case in which the government isn’t a party but may still have an interest — for example, because the interpretation of a federal statute is involved.  So the Court will issue an order in which it “invites the Solicitor General to file a brief expressing the views of the United States.”  It isn’t an “invitation” in the sense that the federal government gets to decide whether it wants to file a brief at all, because the Court expects the government to file.  There is no deadline by which the government is required to file the brief, however.  And the government’s recommendation, although not dispositive, will carry significant weight with the Court.

In Fosamax, this development is important because it signals that the case stands out from the general certiorari pool, meaning that review is more likely to be granted.  Statistics are surprisingly hard to come by, but a law review article, Thompson & Wachtell, “An Empirical Analysis of Supreme Court Certiorari Petition Procedures:  The Call for Response and the Call for the Views of the Solicitor General,” 16:2 G. Mason L.R. 237 (2009), analyzed ten years of Supreme Court cases (1994-2004) and concluded:

The overall grant rate increases from 0.9% to 34% following a CVSG from the Court; in other words, the Court is 37 times more likely to grant a petition following a CVSG.  For petitions on the paid docket, the grant rate increases even more, to 42%; a paid petition is 47 times more likely to be granted following a CVSG.

Id. at 245 (emphasis added).  If those somewhat dated statistics are even close to currently accurate, the Fosamax CVSG is a big deal.

Recall that the Third Circuit grossly misinterpreted the “clear evidence” preemption test from Wyeth v. Levine, which held that without clear evidence that the FDA would not have approved the label change, a court cannot rule a manufacturer’s compliance with federal and state law is impossible, and thereby preempted, already an exacting defense.  As the Blog explained in praising the petition for certiorari, the Third Circuit distorted Levine, applied an unprecedented standard, and ruled that a manufacturer could not invoke preemption without “clear and convincing” evidence that the FDA would have rejected a proposed warning.  Thus, not only did the Third Circuit reverse summary judgment for the manufacturer in more than 1000 cases, it rendered impossibility preemption even more difficult than the anti-preemption justices in Levine intended.  The Blog also discussed the Product Liability Advisory Council’s amicus brief in support of the petition here, which explained that the Third Circuit’s decision invites further lower court confusion, obliterates the district court’s ruling that was supported by undisputed evidence, encourages pharmaceutical manufacturers to flood the FDA with proposed label changes, and threatens to stifle the innovation necessary to develop new, potentially life-saving drugs.

This latest development raises defense hopes that SCOTUS will grant the petition, and finally reverse one of the worst decisions of 2017, which would be a huge win for the manufacturer in particular, and of greater significance for the big picture for pharmaceutical companies and consumers in general. Stay tuned.

New Jersey Supreme Court Grants Review of Accutane Cases

Also on December 8, the New Jersey Supreme Court granted the appeals in all of the Accutane cases that the appellate court revived back in July. The Blog has monitored the Accutane litigation through many of the twists and turns of its tortuous existence for more than a decade, first with the Accutane MDL, and then with the New Jersey cases.  As a resident of the San Francisco Bay Area, when I think of the Accutane litigation, I automatically picture Lombard Street, often touted “The Crookedest Street In The World,” with its eight hairpin turns and switchbacks that span the 600 feet of the street’s natural 27° grade.  In fact, Lombard Street is not even the most crooked street in San Francisco, because Vermont Street, has a greater sinuosity at 1.56 versus 1.2 for Lombard, though Vermont at seven turns, has one fewer than its more famous cousin.   Lombard Street and its adornment of brick red and beautiful flowers attracts thousands of tourists per year.  This meandering avenue is difficult to traverse, requires careful navigation, has been around a long time, and produced extreme frustration for those who occupy it: if it sounds familiar, bear in mind that the Accutane litigation likewise has a lengthy history, ongoing since 2003, has zigged and zagged, and neither side is particularly thrilled with the results.  The Blog has discussed many of the good aspects here, (vacating plaintiff verdicts) here, (dismissals based on learned intermediary doctrine) here, (MSJ granted) and here (warnings adequate as a matter of law), as well as the very bad Appellate Division decisions earlier this summer, when the court reinstated more than 2000 causation based dismissals.

With that in mind, here is a very brief summary of the mind-bending history of the Accutane saga and the battle over the proper expert testimony that has hopefully neared its dénouement.  As already discussed at length, the Appellate Division reversed the trial court’s decision that excluded plaintiffs’ expert causation testimony, reviving more than 2000 lawsuits.  Not surprisingly, the manufacturer appealed, supported by amicus briefs from 21 of New Jersey’s largest employers, including many Roche competitors, the HealthCare Institute of New Jersey, the New Jersey Chamber of Commerce, the American Medical Association, and eight scholars and professors of law.  When it comes to expert testimony, New Jersey unfortunately travels The Road Not Taken, applying a “relaxed” standard of expert testimony in toxic tort cases, as set forth in Rubanick v. Witco Chemical Corp., 125 N.J. 421 (1991), rather than the more rigorous federal Daubert standard.  Under Rubanick, expert testimony may be admitted “even though it is controversial and its acceptance is not widespread,” only if “it is based on a sound methodology that draws on scientific studies reasonably relied on in the scientific community and has actually been used and applied by responsible experts or practitioners in the particular field.”  Id. at 447.  In Kemp v. State, 174 N.J. 412, 425-426 (2002), the court ruled that the inquiry was not based on reasonableness, but instead examines “whether comparable experts in the field [would] actually rely on that information.  Kemp, 174 N.J. at 426 (citations and quotations omitted).  Since Rubanick and Kemp, New Jersey courts have continued the state’s unique application of scientific expert testimony with an approach distinct from the more exacting federal standard, resulting in inconsistency, confusion, and the morass of the Accutane litigation.

As the Blog discussed, and the amici explained, the Accutane trial judge applied a standard similar to Daubert, but the Appellate Division reversed the decision based on Rubanick. In so doing, the appellate court essentially ignored the gold standard of scientific evidence, epidemiological studies all but one which failed to “demonstrate[] a statistically significant increased risk of developing Crohn’s disease.”  In re Accutane Litigation, 451 N.J. Super. 153, 168  (App. Div. July 28, 2017).  Nonetheless, the Appellate Division allowed the plaintiffs’ experts to rely on evidence that should have been excluded as unreliable, such as animal studies, anecdotal case reports, and analogous medicines – in other words, scientifically unsound data.  Id. at 165-166.  Similarly to the Fosamax decision, this represents not only bad law and bad precedent, but also has far-reaching implications.  Pharmaceutical manufacturers and health professionals resoundingly decried the Accutane decision as one that will stifle research and development, and the practice of medicine out of the uncertainty of scientific evidence, and fear of legal reprisals.  The amici implored the New Jersey Supreme Court to adopt Daubert’s methodology to reaffirm the trial court’s role as a gatekeeper to ensure that only reliable scientific evidence informs the jury’s decision.  Again, the industry can take heart in the court’s order granting review of the Appellate Division’s abysmal decision, and hope that the New Jersey Supreme Court will allow modern scientific principles, rather than the unreliable and questionable methods, to govern expert testimony.  If that occurs, no doubt will the New Jersey high court reinstate the trial court’s ruling, and order dismissal of the more than 2000 cases for lack of  causation evidence.

Those of us who practice in the mass tort space spend vast portions of our professional lives dealing with our opponents’ experts. In our minds, we seek only to enforce the dictates of the Federal Rules and of the United States Supreme Court (and their esteemed state counterparts); to wit, to ensure that experts are  qualified to render the opinions they offer and that they arrived at those opinions through reliable methodologies.  But, so very often, we face the fact that experts can say virtually anything they want with impunity (and most often without even being excluded).  We say “virtually” because we learned today, with horror (and, we confess, with some amusement), that even this regrettable reality has its limits.

Today’s case, Ruehl v. S.N.M. Enterprises, 2017 WL 5749560 (M.D. Pa. Nov. 28, 2017), is not a drug or device case.  It is a slip-and-fall case, but it illustrates the outer limits of a court’s tolerance for an expert’s misconduct and the consequences of straying beyond those bounds.  In Ruehl, the plaintiff’s decedent, his elderly wife, died as she attempted to pass through automated sliding glass doors into the defendant’s hotel.  The plaintiffs alleged that the sliding glass doors struck the decedent as she passed them, knocking her off balance so she fell and hit her head on concrete.  The defendant contended that the decedent simply lost her balance and fell.

The plaintiffs hired an expert who asserted that he was “a premier expert witness in the field of automated sliding glass door technology.” Ruehl, 2017 WL 5749560 at *2.   The expert’s retention agreement provided that he “retain[ed] the right to approve video deposition[s],” but, as the court noted, did not “foreshadow[] [the expert’s] curious and categorical refusal to comply with court orders, or attend video depositions.” Id. After the fact (and we’ll tell you more about what led up to this), the expert filed a declaration stating that he “generally refuse[d] to allow videotaped depositions” but “on one occasion allowed such a deposition provided that [his] face was not shown,” id. (internal punctuation omitted), a condition that “apparently stem[med] from some concern on [the expert’s] part that unknown and unnamed persons [would] digitally alter the video in ways that [would] be detrimental to [him].”  The court commented, “In nearly four decades of legal practice devoted exclusively to federal court litigation, we have never encountered such an idiosyncratic view by any lay or expert witness . . . .” Id.

But, to get back to the story, the plaintiffs’ counsel apparently learned of the expert’s opposition to being videotaped about two years into the litigation, after they had paid the expert more than $20,000 for his services. Some months later, the defendant scheduled a videotaped deposition of the expert, which, as the court emphasized, “they were entitled to do under the Federal Rules of Civil Procedure.” Id. at *3.   The expert demanded from the defendant, and accepted, a $3,050 prepayment of his fee for the deposition, while simultaneously notifying the plaintiffs’ attorneys that he would not voluntarily agree to participate in the deposition.

The plaintiffs’ attorneys moved for a protective order and “vigorously advocate[ed] on [the expert’s] behalf.” Id. at *3.  But the court reached the obvious conclusion, denying the protective order and ordering the expert to sit for a videotaped deposition.  And the court limited use of the deposition to the litigation, thereby (lol) “address[ing] [the expert’s] odd and speculative concern that his words and visage would be digitally altered by unknown sinister actors . . . .” Id.

As the court explained, the order gave the expert the choice among complying with the order, seeking timely reconsideration of it, or initiating motion practice (for a protective order or to quash the deposition subpoena) through an attorney of his own. “The one thing he could not do, however, was to engage in some unilateral, passive-aggressive course in which he ostensibly agreed to schedule a deposition, while privately evading his basic obligation owed by all witnesses by failing to appear for that deposition.  Yet that is precisely the path that [he] chose.” Id.

First, according to “testimony and contemporaneous notes of plaintiffs’ counsel,” when the expert was informed that the court had denied the protective order, he responded, “I don’t care about you or [the decedent] or some a****** judge.” Id. And, when the plaintiffs’ counsel implored the expert to cooperate because the family of the decedent was counting on his testimony, he replied, “Nothing will bring her back, so I don’t give a s***.” Id. But “at the same time that [the expert] was presenting his refusal to participate in the videotaped deposition in profane terms as some matter of principle, he was also willing to forego that principle for a price.” Id. at *4.  Specifically, as the expert admitted, he told the plaintiffs’ counsel that he would sit for the deposition if they provided him with a $10,000,000 Lloyds of London indemnity bond.  “Plaintiffs’ counsel understandably discounted this bizarre and extortionate suggestion.” Id.

Simultaneously, and in spite of all of this, the expert’s office manager – also his wife – was making scheduling arrangements for the deposition, on a date and at a location that the expert specifically approved.   Deposition time arrived, and – wait for it – the expert didn’t show up.  Ultimately, the plaintiffs were “compelled to negotiate a settlement of [the] lawsuit from a highly disadvantageous position,” since their expert had abandoned them. Id. The defendant moved for sanctions, and the plaintiffs ended up joining the motion.  That’s right, both sides were seeking sanctions against the same expert.  The expert responded and (lol lol) filed a motion for sanctions against the plaintiffs’ law firm.

In a victory for all that is good and right – and obvious – the court granted the parties’ joint motion for sanctions and denied the expert’s cross-motion. The court found that the expert’s conduct “involved a dual dereliction of the duty of candor and cooperation that [he] owed to [the] court, as well as the duty of loyalty [he] owed to his clients who had paid him more than $20,000 and were relying on him to provide crucial expert testimony in this case.” Id, at *7.  The court concluded,

Thus, [the expert’s] pattern of misleading conduct designed to frustrate this court’s order and the discovery process, coupled with his openly voiced contumacious disdain for his responsibility to the court and his own client, is sanctionable as contempt . . . . But perhaps most egregious of all is the disservice which [the expert] did to his clients, . . . an elderly couple who had retained his services to assist them in this litigation. . . . While [the expert] may be completely indifferent to the plight he created for the [plaintiffs], we are not. Therefore, [we will impose sanctions] in an effort to assist [the expert] in locating his moral, legal and ethical compass . . . .

Id. at *8.   (Note to selves:  look for other opinions by this awesomely pithy judge.)

The court did not order the expert to repay his entire $20,000 fee, finding that such a sanction would not be “narrowly tailored, as required by law,” because the expert had provided some professional services before the episode began. But the court asked the plaintiffs’ attorneys to submit an accounting of all time and expenses broadly related to the expert’s misconduct.  In addition, the court ordered the expert to repay the defendant for deposition fees and expenses totaling almost $5,000.  Finally, and best of all, finding that “[the expert’s] conduct in the instant case may be relevant to a consideration of his continued licensure by the state and membership in [the American National Standards Institute (ANSI)],” the court ordered that a copy of the decision be forwarded “to the appropriate licensing and professional association officials for whatever action they may deem appropriate.” Id., at *9.

All in all, a horror show, and we feel sorry for all of the parties. But kudos to the judge for decisive action (and cool rhetoric), and a cautionary flag to any other expert whose sense of omnipotence may be similarly ballooning.  We’ll watch for other decisions of this ilk, and we’ll keep you posted.

It is not as if we are delighted to see efforts to resuscitate breast implant litigation, but we won’t groan when the rulings are as good as they are in Laux v. Mentor Worldwide, LLC, No. 2:16-cv-01026-ODW(AGR) (C.D. Cal. Nov. 8, 2017).  Here, we are talking about Daubert rulings.  (The court also issued good preemption rulings that might be the subject of a separate post.)  The Laux court’s Daubert order is not up on Westlaw or Lexis yet, but it will be, and that is good news for defendants and bad news for plaintiffs.

The plaintiff in Laux alleged that she suffered pain and other injuries as a result of moldy silicone breast implants.  Her allegations depended upon opinions by a three experts:  Kolb, Blais, and Brawer.  At least two of these experts are repeat players. The other might be as well, but we confess to being a little out of touch with this litigation. One plaintiff expert (Kolb) explanted the implants and concluded that they were leaking bilaterally.  Another (Blais) examined the implants and concluded that they had defective valves, causing them to leak bilaterally. The moldy saline implant theory has persisted since the turn of the century, largely propped up by a book, The Naked Truth About Breast Implants, written by – ta da! – one of these experts.  Another one of the experts testified long ago at the FDA panel hearings and raised the theory back then that breast implants contained a manufacturing defect that either (1) allowed bi-directional flow of saline and bodily fluid in and out of the valves such that the saline became contaminated by “toxic mold” that then colonized and leached “biotoxins” into plaintiff’s body; or (2) allowed the silicone shell or toxins/metals to flake off in plaintiff’s tissue.  To our moldy eyes, this theory seems driven more by litigation than science.  Is our cynicism based at all on the fact that these selfsame experts seem to be actively working with plaintiffs’ counsel to resurrect breast implant litigation, claiming breast implants cause systemic autoimmune disease despite dozens of epidemiological studies to the contrary?  Yes.  Yes, it is.

In any event, these experts’ sparkling resumes did not dazzle the Laux court. Their methodologies were even weaker than their qualifications, which, as you will see, is really saying something.

By the way, this is hardly our favorite trio.  Here are just a few we prefer:

  • Harry, Hermione, and Ron
  • Kirk, Spock, and Bones
  • The Three Musketeers (literary or candy version)
  • The Three Fates
  • Three Dog Night
  • Three’s Company
  • The Three Amigos
  • Tinkers to Evers to Chance
  • The Good, the Bad, and the Ugly
  • The Dude, Walter, and Donny
  • Willie, Mickey, and The Duke
  • ZZ Top
  • Cream
  • Emerson, Lake, and Palmer
  • The Police
  • Destiny’s Child
  • The Three Tenors
  • Workaholics
  • Moe, Larry, and Curly.  (Heck, we also prefer Moe, Larry, and Shemp to any assortment of litigation/expert stooges.).

Anyway, here, in brief, is how the Laux court concluded that the three plaintiff expert (three blind mice?) opinions could not survive a Daubert challenge:


The court deemed Kolb to be insufficiently qualified to provide the proposed testimony. Big surprise: a plastic surgeon is not competent to testify about immunology, mycology (the study of fungi), or infectious disease. Moreover, Kolb’s methodology, such as it was, was unreliable.  Yes, the “differential diagnosis” incantation was muttered by this expert, but to no effect. Kolb’s expert report stated that the plaintiff had developed biotoxin disease from defective implants, and that “Plaintiff had no other environmental mold exposure to account for these symptoms.”  Oops. That premise was directly contradicted by the plaintiff’s earlier statement that she was exposed to mold found in her bedroom closet and mother’s home. Further, Kolb’s failure to test for TGF beta 1 also prevented her from ruling out environmental exposure from an objective perspective.  The court decried Kolb’s “[u]nexplained selective use of the facts” which failed “to satisfy the scientific method.” None of Kolb’s theories had been tested, peer reviewed, or generally accepted by the scientific community.  Her “inferential leap” from the plaintiff’s symptoms to the conclusion that the plaintiff suffered from biotoxin disease was unsupported by any peer-reviewed scientific literature or research.  Adios, litigation expert amigo #1.




Blais is a chemist, not a microbiologist, pathologist, medical doctor, or engineer.  Blais has not published any of his theories on bacterial or fungal colonization of saline implants in peer-reviewed literature.  So much for qualifications.  Reliable methodology was also lacking.  Blais supplied a “Failure Analysis Report,” but the real failure was in the expert’s purported analysis, not the product. In developing his opinions for this case, Blais did not test the plaintiff’s breast implants, tissues, or blood, and did not establish a scientific basis for his conclusion that the plaintiff’s injuries were caused by the defendant’s breast implants.  The defendant argued that Blais’s “‘methodology’ essentially consists of looking at explanted breast implants, sometimes with the aid of a microscope, making a few notes and drawing pictures of what he claims to see.”  Not so impressive.  Blais took no measurements of the valves to support his opinion they contained manufacturing defects.  Rather, Blais stated that he “eyeball[ ed]” the valves to determine they were faulty.  Still not impressive. In addition (or subtraction?), Blais did not possess the defendant’s valve design specifications when he concluded that the valves on the plaintiff’s implants were defective. Instead, Blais utilized old documents and his own memory.  The Laux court concluded, as had other courts in earlier decisions, that Blais’s proffered testimony should never reach a juror’s ears. As Harry Potter might say, expulsus expertous hackus nonsensicus.




There were some technical problems with Brawer’s expert report.  It recited “a toxicology opinion with no data in support of that opinion whatsoever.” (emphasis in original)  Brawer opines that there was “breast implant toxicity,” but neglects to state what toxic substance was at issue.  That would seem to be a problematic gap in the analysis.  The Laux court could find no support for Brawer’s “because I said so” – in lawyerese, we sometimes call it ipse dixit — conclusion regarding breast implant toxicityThus, the court held that Brawer’s report “fails to satisfy several requirements of Rule 26, and his report is so lacking of scientific principles and methods that the Court cannot find his opinions reliable or helpful in this case.”


Three up, three down.  It reminds us of a typical inning thrown by the late Roy Halladay.


Meanwhile, three cheers to Dustin Rawlin and Monee Hanna of Tucker Ellis, who brought this ruling to our attention.

We are sure you all heard about the $417 million verdict returned recently against a talcum powder manufacturer in Los Angeles, and we are equally sure you heard about the trial court’s order setting the verdict aside a couple of weeks ago and entering judgment in favor of the defendants. See In re Johnson & Johnson Talcum Powder Cases, No. BC628228, 2017 WL 4780572 (Cal. Superior Ct. Oct. 20, 2017).  We will repeat that result because it’s really important:  The trial court did not just grant a new trial.  It found that there was no substantial evidence to support the verdict and entered judgment for the defendants.  Not another trial; a complete win on a post-trial motion, which is relatively rare under California procedure.

It is an important order for many reasons. In today’s world of mass litigation, we often see cases involving the same products and similar allegations result in verdicts that vary—and sometimes they vary substantially.  In cases alleging that talc products cause ovarian cancer, the results have been striking—ranging from a defense verdict in one case to the aforementioned nine-figure wreck in another.

What gives? Well, the trial court’s order vacating the verdict paints a pretty clear picture of what happened in Los Angeles:  The jury, goaded by improper argument from the plaintiff’s counsel, ignored its instructions and spun out of control.  We will explain the court’s order in some detail below, but consider these nuggets:

  • The jury assessed 97 percent responsibility and $408 million in damages against a holding company for negligent failure to warn even though the company never made or sold one of the two products at issue and had not made the other since 1967, if ever.
  • The jury awarded “compensatory” damages of $68 million against the holding company and $2 million against the product manufacturer—figures that are exactly proportional to each company’s net worth. Hmm.
  • It was undisputed that no study has ever shown that talc can cause ovarian cancer, and some studies on which the plaintiff’s expert relied showed a relative risk in the range of 1.3, which tends to disprove causation. Yet, the jury found the products caused the disease.
  • The plaintiff had one expert on specific causation—the plaintiff’s treating physician, who conducted a hopelessly inconsistent “differential etiology” designed to reach her desired conclusion.

There is much more to the order, but suffice it to say that this trial court exercised its duty to right a wrong. The plaintiff alleged that she used one of two talcum powder products daily from about 1965 to 2016 and that she developed high grade serous ovarian cancer as a result. Id. at *1.  She sued the manufacturer of the products and its holding company, which itself may have made one of the products before changes to the business in 1967 (the evidence is not definitive on this point, but you get the gist). Id. at **1, 5.  According to the court, there is an ongoing debate in the scientific community as to whether talc usage can cause ovarian cancer or whether the science supports only an association, which is a profound difference. Id. To resolve this issue, the parties presented the jury with evidence focusing largely on epidemiological studies, and when all was said and done, the case went to the jury on the theory that the defendants negligently failed to warn regarding a known or knowable risk. Id.

After the jury returned its verdict, both defendants moved for judgment notwithstanding the verdict and a new trial. We’re not going to cover everything, and because the middle of the order (addressing the reliability and sufficiency of the plaintiff’s specific causation case) is the most important part, we will start there.

The manufacturer’s motion for judgment notwithstanding the verdict.  It’s all about the experts, and that is where the plaintiff failed to prove her case.  Her only expert on specific causation was her treating physician, who conducted a “differential etiology” analysis and opined that it was more probable than not that the products caused the plaintiff’s high grade serous ovarian cancer. Id. at *3.  The opinion, however, unraveled from there.  We have at times criticized the “different diagnosis” or “differential etiology” as a method for determining causation.  The approach was developed as a diagnostic method, not a method for attributing cause.  And because it is a process of elimination, it can result in a causation opinion by default—the expert says she “ruled out” everything else, so it must have been the product.

Despite our reservations, we understand that courts have accepted causation opinions based differential diagnoses. The method, however, must be applied in a reliable way, and that is where the trial court here got it right, including by citing one of our favorite cases, Glastetter v. Novartis:

In performing a differential diagnosis, a physician begins by “ruling in” all scientifically plausible causes of the plaintiff’s injury. The physician then “rules out” the least plausible causes of injury until the most likely cause remains.

In re J&J Talcum Powder, at *13 (citing Glastetter v. Novartis Pharms. Corp., 252 F.3d 986 (8th Cir. 2001) and Cooper v. Takeda Pharm. Am. Inc., 239 Cal. App. 4th 555 (2015)).  The “rule in” part is the most important because unless the expert has a reasonable scientific basis for “ruling in” the potential cause, it does not matter what else is “ruled out.”  The potential cause is not on the differential to begin with.

The plaintiff’s specific causation expert did not properly “rule in” talc products as a cause of the plaintiff’s ovarian cancer. Her only basis was epidemiology and a general reference to inflammation, which the plaintiff did not have. Id. at *14.  But none of the four studies on which the expert was permitted to rely showed odds ratios in excess of 2.0 that a woman using talc would develop serous ovarian cancer.  (A relative risk exceeding 2.0 would indicate that a women has more than a 50 percent greater chance of developing cancer than women who did not use talc, i.e., more likely than not.)  Two of the studies did not break out serous ovarian cancer, and the two that did placed the relative risk at 1.7. Id. Other studies on which the expert relied showed relative risk ratios “in the range of 1.3,” which tends to disprove causation. Id. The most recent study showed a relative risk of 1.0—i.e., women like the plaintiff had no greater risk and no lower risk of developing serous ovarian cancer than women of the same age in the general population. Id.

This is a long way of saying that the expert could not cite scientific evidence that talc caused the plaintiff’s disease. The plaintiff protested that epidemiology is not required to prove causation, but epidemiology is what the expert cited to “rule in” talc.  As the court said, “Although Yessaian testified that epidemiology was just one of the factors she looked at, she did not mention any others.” Id. The expert also did not “rule out” other causes, such as age and ovulatory cycles.  But the ruling that she could not “rule in” talc is the key take away from this order, along with the trial court’s very disciplined approach to the evidence and the law.

The holding company’s motion for judgment notwithstanding the verdict.  Although we are addressing this motion second, don’t underestimate how important it was that the trial court entered judgment for the holding company.  The lion’s share of the verdict was attributed to the holding company—no doubt because of its predictably robust net worth.  Call us jaded, but we are guessing the holding company’s net worth is the only reason the plaintiff sued that company to begin with.

The order granting judgment notwithstanding the verdict is the correct result. The holding company never made or sold one of the products at issue and it may have sold the other only until 1967.  There was no evidence that the company knew or should have known that talc probably would cause cancer during any time that it may have sold the product, and thus it had no duty to warn. Id. at **5-6.  Remember, failure to warn is the only theory upon which this case was tried.  The plaintiff tried to hold the holding company responsible for its subsidiary’s products through a hodgepodge of company documents, but they did not come close to showing that the companies shared an alter ego or agency relationship.  The court therefore granted JNOV for the holding company on the duty to warn, and also on punitive damages.  There simply was no clear and convincing evidence that a managing agent acted with malice either. Id. at *11.

Both defendants’ motion for new trial.  The court also granted the defendants’ motion for new trial.  You might wonder why the court granted a motion for new trial when it had already granted the motions for judgment notwithstanding the verdict and entered judgment in the defendants’ favor.  The reason is the inevitable appeal.  If the California Court of Appeal reverses the order granting JNOV for either defendant, it can still affirm the order granting a new trial and remand the parties to try the case again, rather than reinstate the original verdict.

Let’s hope it does not come to that, but regardless, the court accepted many (but not all) the proffered arguments for granting a new trial. First, because the plaintiff’s specific causation opinion was unreliable, the defendants’ motions to exclude or strike that opinion should have been granted. Id. at *20. Second, the court should not have allowed introduction of a newspaper article on condoms, which said that concern about talc and ovarian cancer “goes back 50 years” in the medical literature and that condom manufacturers removed talc from condoms in the 1990s for that reason.  It was rank hearsay, and although it came in through an expert, it should not have.  Compounding the error, the plaintiff’s counsel ignored the court’s limiting instruction and referred to the article several times in closing. Id. at **21-22.

Third, counsel ignored another limiting instruction by arguing to the jury that the defendants “prevented regulation” and prevented the government from listing talc as a carcinogen—so-called “lobbying.”  The “lobbying” evidence did not go so far, hence the limiting instruction, which counsel violated. Id. at **22-23. Fourth, two jurors executed declarations stating that the jury considered taxes and attorneys’ fees in reaching its verdict, which was contrary to instructions and improper. Id. at **23-24. Fifth, although the $2 million compensatory verdict against the product manufacturer was not so excessive as to require a new trial, the $68 million verdict against the holding company plainly was. Finally, because there was insufficient evidence to support punitive damages against either defendant, the punitive damages award was plainly excessive, too.

That is all you really need to know, maybe more. The trial court here gave every inference to the plaintiff, yet still found the evidence lacking, and now comes the appeal.  The parties will not get a result in 2017, so we will set our gaze to 2018 and wait and see.  Whatever the result, we have a feeling that this case will appear on one of our top ten lists for 2018.

This guest post is by Reed Smith‘s Devin Griffin.  It deals with an important pending appeal in New Jersey’s version of Jarndyce v. Jarndyce – Accutane litigation.  As always with our guest posts, the author is 100% responsible for what follows, deserving of all the credit, and any blame.  Take it away Devin.


The Accutane litigation in New Jersey has been covered closely by this Blog for its duration. The Blog’s most recent Accutane post evaluated the Appellate Division’s decision to reverse the trial court’s order excluding certain plaintiff causation expert witnesses—a ruling that resulted in the revival of over 2000 cases.  That post explained that the Appellate Division has proposed a “relaxed” standard for the admissibility of expert opinions, and that the application of this standard (i.e., the types of evidence that experts may rely upon in rendering their opinions) should evolve as more epidemiological studies (or the “gold standard” of scientific evidence) become available.  The post explained that this has not occurred in the Accutane litigation.  With the recent Appellate Division decision, it is clear that the New Jersey appellate court is attempting to impose its own unique standard that disregards the hierarchy of evidence, allowing animal studies and single-person case studies to be afforded the same weight as vast epidemiological studies.  With the submission of four separate amicus curiae briefs to the Supreme Court of New Jersey by companies and groups spanning different industries and health-related interests, it has become clear that this Blog is not alone in feeling displeasure over the Appellate Division’s recent decision.  This is something that the New Jersey Supreme Court definitely needs to review, both as to the questionable legal basis for the decision and its negative impact on some of the state’s largest employers.

Before delving into the substance of the amicus briefs, it is useful to revisit court decisions relevant to this case. In Rubanick v. Witco Chemical Corp., 125 N.J. 421 (1991), the New Jersey Supreme Court established the applicable standard for reviewing expert testimony in toxic tort cases.  Rubanick stated that an expert’s opinion may be admissible “even though it is controversial and its acceptance is not widespread,” but only if “it is based on a sound methodology that draws on scientific studies reasonably relied on in the scientific community and has actually been used and applied by responsible experts or practitioners in the particular field.”  Id. at 447.  Rubanick created the so-called “relaxed” standard – with the “relevant field” seeming to be litigation testimony − declining to adopt the standard set forth in Rule 703 of the Federal Rules of Evidence.  Then, in Kemp v. State, 174 N.J. 412 (2002), the court stated that “the appropriate inquiry is not whether the court thinks the expert’s reliance on the underlying data was reasonable, but rather whether comparable experts in the field [would] actually rely on that information.  Kemp, 174 N.J. at 412 (citations and quotations omitted).  Since Rubanick and Kemp, New Jersey courts have continued to approach scientific expert testimony under a “Daubert lite” analysis that diverges significantly from the science-based federal approach to expert testimony.  As a result, much confusion and inconsistency in New Jersey case law has ensued.

The Accutane litigation represents the culmination of the resulting confusion and inconsistency in the New Jersey expert witness standard.  In addressing the admissibility of expert witness testimony, the Accutane trial court applied a standard ostensibly similar to the federal Daubert standard without expressly adopting the federal test.  However, the Appellate Division reversed the trial court decision, citing Rubanick’s “relaxed” standard.  By applying that relaxed standard, the Appellate Division effectively disregarded the hierarchy of evidence and gave equal weight to the Plaintiff experts’ evidence, which mostly consists of animal studies and case reports, as it did to the extensive body of exhaustive and robust epidemiological studies relied upon by Roche’s experts.   That result is a poor parody of the scientific method.

The practical effect of this Appellate Division decision will result in the admission of expert witness testimony that deserve to be excluded as unsound, and that has in fact been excluded in federal court on precisely that ground.  Since the Blog’s last Accutane litigation post, the defendant has sought further review in the New Jersey Supreme Court.  Recent amicus brief filings indicate that we are not alone in our worry.  Amici from various life science and medical industries recently joined forces to urge the court to reconsider the Appellate Division decision—specifically the decision of what standard should be applied to the admissibility of expert witness testimony.  Notably, a remarkable array of groups including the HealthCare Institute of New Jersey, the New Jersey Chamber of Commerce, twenty-one of New Jersey’s largest employers, the American Medical Association, and eight scholars and professors of law have joined forces to file amicus briefs that urge the New Jersey Supreme Court to abandon the anachronistic and peculiar “relaxed” standard for the federal standard.  The perspectives of amici claiming a stake in the litigation are detailed below.

New Jersey’s business sector weighed in two separate briefs. In one brief, twenty-one of New Jersey’s largest companies (many of whom are each other’s competitors) submitted an amicus brief supporting Defendant Roche.  The twenty-one signatory companies include the likes of Allergan, Bayer, Bristol-Myers Squibb, C.R. Bard, Merck, Honeywell, GlaxoSmithKline, Quest Diagnostics, Pfizer, and Verizon.  These businesses provided their perspectives on the Appellate Division’s decision.  The companies argue that the decision would have the effect of allowing inconsistent rulings.  The companies stated that they as companies choose to conduct extensive business in New Jersey and should not suffer the uncertainty and inconsistency in causation rulings that the “relaxed” standard’s dumbing down of the scientific method encourages.  The companies explain that the Appellate Division’s standard would allow plaintiffs experts to “cherry-pick” data, or rely on studies that support their result-oriented opinions while ignoring the sweeping and conclusive studies that conflict with their propounded opinions.  Ultimately, the companies highlight the importance of expert admission standards to New Jersey business, stating that over the past two years alone, companies have been forced to spend nearly $4 billion defending against New Jersey products liability suits.  These amici warn that, should the Appellate Division’s decision be upheld, the impact would be felt far beyond the courtroom.  Loose admission standards for expert testimony will adversely affect the “very real public benefit derived from the products” that these companies manufacture.

In the other business sector brief, the HealthCare Institute of New Jersey, New Jersey Business and Industry Association, the Commerce and Industry Association of New Jersey, and the New Jersey Chamber of Commerce weigh in on the errors of the Appellate Division.  Notably, these amici address the confusion in New Jersey case law regarding what standard to apply in assessing expert witness testimony.  These amici state that the New Jersey Supreme Court and its Committee on the Rules of Evidence have studied the question presented by the recent Appellate Division decision as early as 2000, but the court failed to provide a conclusive answer, because it was waiting for a hard-fought adversarial case to address this question.  To these amici, it is abundantly clear that this is exactly the zealously litigated adversarial setting that the court has been waiting for.  In their critique of the Appellate Division decision, the organizational amici state that by allowing the Appellate Division decision to stand, the court is allowing “junk science” to be presented to lay juries.  Most significantly, the amici discuss how the Appellate Division’s proposed standards for the admissibility of expert testimony would subject defendants to extensive civil liability by allowing juries to challenge exhaustive, FDA-approved, scientific evidence with opinions based on novel and unsupported theories that the FDA would never permit.  Ultimately, these amici urge the court to adopt Daubert to reinstate the court’s role in gatekeeping to prevent further litigation-driven expert opinion testimony from clouting this science-based field.

Next, eight legal scholars and professors of law (“the scholars”) urge the New Jersey Supreme Court to clear up the confusion that has ensued as a result of the “relaxed” standard.  The scholars detail the benefits of New Jersey adopting rule 702 of the Federal Rules of Evidence.  The scholars contend that adoption of the federal Daubert test is especially important in toxic tort cases because a jury will likely be unable to wade through the sophisticated terminology and standards that these cases present.  By depriving the jury of the tools it needs in complex litigations of this type, the “relaxed” standard allows precedent that equates the scientific value of anecdotal evidence with gold standard epidemiology.  The scholars point out  that, while the Appellate Division freely cites to federal decisions such as Daubert in its decisions, it simultaneously unmoors those decisions from their foundation by disregarding the very federal gatekeeping requirements that make those decisions persuasive – thereby adding to the confusion within New Jersey case law in this area.  The scholars warn that if this decision is upheld, the role of court in excluding unreliable testimony will effectively be eliminated.

Finally, organizations representing physicians, both in New Jersey and nationwide, weigh in with their own amicus brief.  Six different federal and state-based medical societies join to urge the New Jersey Supreme Court to reconsider this decision.  These amici argue that the Appellate Division’s decision is not only contrary to legal precedent, but more importantly does violence to well-established scientific principles.  The medical amici explain that the hierarchy of evidence is vitally important to evidence-based medicine and science.  According to these amici, whether evidence being considered in expert opinions has been subject to peer review is key to assessing its reliability.  Notably, the medical amici establish that scientific consensus is a strong indicator of good science and that the Appellate Division erred in ignoring the consensus relied upon by Roche’s expert witnesses.  These medical amici warn strongly of the profound impact that this decision could have on medical practice in New Jersey.  These amici discuss that this decision will further complicate the patient-doctor relationship because now doctors will be forced to address and debunk unproven theories during informed consent discussions with their patients.  Doctors will likely feel the need to address these unsupported theories for fear of being sued.  Lastly, doctors may simply choose to forgo certain reliable treatments altogether.  The medical amici state that this decision endangers patients who need treatments, especially where there is a lack of other treatment options as is the case with Accutane and severe cystic acne.

This Blog has been quite critical of the latest twist in the seemingly unending saga of Accutane litigation in New Jersey. Thus, it is gratifying to find amici representing such a large cross-section of New Jersey’s business, life science, and healthcare industries coming together to voice their disapproval as well.  The Appellate Division’s decision nullifies any meaningful gatekeeping role for the New Jersey judiciary and, if allowed to stand, will have the harmful effect of letting any hired expert share scientifically unsupported opinions with all future juries.  With this kind of support, the odds increase that the New Jersey Supreme Court will appreciate the importance of removing junk science from state courts and will accept review in Accutane to reinstate the fundamental principles of science and the hierarchy of evidence in New Jersey courts.