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.

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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:

Kolb

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

 

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.

 

Brawer

 

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.

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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.

As we write this, our fair city remains in a blissful haze following our Eagles’ 33-10 rout of the 49’ers to go 7-1 in the NFC East, so it might be appropriate to call today’s opinion a “touchdown.” On the other hand, the World Series approaches Game 6, following a game in which twenty-five runs were scored.  So maybe the opinion is a “home run.”  In any event, the Second Circuit’s (regrettably) unpublished affirmance in In re Mirena IUD Prods. Liab. Litig., Mirena MDL, Plaintiffs v. Bayer Healthcare Pharmaceuticals, Inc., 2017 U.S. App. LEXIS 20875 (2d. Cir. Oct. 24, 2017) is very, very good.

More than a year ago , we reported that the United States District Court for the Southern District of New York granted the defendant’s motion to exclude the plaintiffs’ general causation expert in the Mirena MDL.  In the absence of expert causation testimony, the court granted summary judgment for the defendant on all pending cases, holding that the plaintiffs could not satisfy their burden of proof without expert causation testimony.  The plaintiffs appealed to the Second Circuit.

Mirena is an implanted intrauterine birth control device. (As we have commented before, plaintiff lawyers persist in choosing contraceptive devices as their targets, despite the general absence of any basis for the plaintiffs’ claims.)  The Mirena MDL plaintiffs alleged that they were injured when their Mirena devices perforated their uteruses.  As the Court explained, “At bottom, the [Mirena] MDL is about when Mirena perforated Plaintiffs’ uteruses.  Both parties agree – and [the defendant] has warned – that Mirena can injure a woman’s uterus during insertion and afterward migrate outside the uterus (what is called “primary perforation”). Mirena, 2017 U.S. App. LEXIS 20875 at *2 (emphasis in original).  But the plaintiffs alleged that their Mirena devices perforated and migrated outside their uteruses at some later time (so-called “secondary perforation”).  The defendant did not warn of “secondary perforation,” so, the Court stated, it was “exposed to liability if secondary perforation in fact occurred.” Id.

The plaintiffs offered three general causation experts to testify that secondary perforation was possible. The District Court excluded all three pursuant to Daubert, holding that their testimony was “not reliable and, thus, not helpful to the trier of fact.”

Affirmance of Exclusion of Plaintiffs’ General Causation Experts

On review of the District Court’s Daubert decision, the Second Circuit focused on three “particularly noteworthy” problems with the opinions of the plaintiffs’ experts. Id. at *5.  First, the experts’ theories were not accepted in the relevant scientific community. “Not only [did] the experts fail to identify any authorities that directly support the existence of secondary perforation, but what scientific authority there is casts doubt on the phenomenon’s existence.” Id. Second, all of the experts developed their “secondary perforation” theories solely for purposes of the litigation and lacked in the supposed phenomenon before the litigation began.  One had no specialized expertise in Mirena or uterine perforation before being hired, one had no experience with IUDs, and the third “had not even heard of secondary perforation before consulting in the litigation.” Id. at *8.  Third, “finding no direct support in the literature for secondary perforation and having conducted no prior research on the subject, the experts all assumed the existence of the very phenomenon in dispute and then hypothesized how it could occur.” Id.

In response to the third point, the plaintiffs argued that their experts were no different than experts in Kumho Tire v. Carmichael, 526 U.S. 137 (1999), who were asked to determine the mechanism that caused the blowout of a tire.  The Court gave this argument the back of its figurative hand, emphasizing, “. . . [I]n Kumho, there was no dispute about whether the tire had blown, only how it happened. . . . Here, by contrast, the parties dispute whether the secondary perforation has ever occurred.  The experts thus begged the very question they were trying to answer.”   Id. (citations omitted).

And so the Court affirmed the exclusion of all three general causation experts.   Next, the Court considered whether the plaintiffs could escape summary judgment despite the lack of expert causation testimony.

Affirmance of Summary Judgment for Defendants

Arguing that their cases could survive the exclusion of their experts, the plaintiffs “identif[ied] dicta from several cases suggesting that party admissions can sometimes substitute for expert testimony on general causation.” Id. at *9-10.  The plaintiffs proffered four categories of such supposed admissions:

  • Three short excerpts of emails authored by the defendant’s employees that purportedly “admitted” that secondary perforation could occur. But the excerpts were from emails in which the employees “reported, without necessarily endorsing, adverse event reports,” which, as a category, are “anecdotal, and thus of very limited probative value.” Id.
  • One sentence from a PowerPoint presentation suggesting that spontaneous perforation could occur unrelated to insertion. The Court agreed with the District Court that, with no knowledge of the context in which the slide was presented or what was said at the meeting, and no details of any causes of the supposed secondary perforation, the excerpt could not substitute for expert testimony.
  • Testimony from the defendant’s Global Medical Expert that “a perforation unrelated to insertion, rare as it may be . . . could happen.” The Court held that “acknowledgment of the possibility of causation does not establish that causation is more likely than not, as the District Court correctly found.” Id. at *11.
  • In 2014, the defendant changed the Mirena label to warn that perforation “may occur most often during insertion, although the perforation may not be detected until sometime later.” The plaintiff’s argued that this was an admission that secondary perforation could occur, but the Court observed that “the grammatical structure [of the warning was] cryptic at best,” at most “suggest[ing] the hypothetical possibility of secondary perforation,” and could not substitute for expert testimony. Id. at *11-12.

And so, the Court held, “We need not reach the question of whether party admissions could ever substitute for expert testimony.   Assuming arguendo that they could, the putative admissions proffered by Plaintiffs are simply not enough to establish general causation.” Id. at *10.  Summary judgment for the defendant affirmed.

Daubert embodies real standards. And the Rules of Evidence are more than suggestions.  In this case, in the hands of a decisive District Court, both contributed to a decision that was unassailable on appeal.  We will keep you posted on similar – and hopefully published – decisions.

Not even three weeks ago, back on July 28,  we discussed the court’s rigorous application of Daubert in excluding expert medical causation opinions in Smith v. Terumo Cardiovascular Sys. Corp., a federal case in the district of Utah.  The plaintiff had undergone a heart valve replacement surgery.  As is typical, the surgery required use of a perfusion heart/lung bypass machine.  At some point, the machine stopped working for 10-11 minutes.  The patient died of a heart attack 11 months later.    The decedent’s heirs brought suit against various defendants, including the manufacturer of the heart/lung bypass machine.

 

In the opinion we discussed on July 28, the court excluded most of the opinions of a cardiologist tendered by plaintiffs as an expert on causation.  That expert was refreshingly candid in acknowledging that he could not say for sure that the heart attack was caused by any machine malfunction, though he thought the malfunction probably played some role.  Because the cardiology expert himself acknowledged an “analytical gap,” because he was plainly unqualified to render opinions on neurologic issues, and because he relied on diagnostic methods that were not generally accepted, the court limited the cardiologist expert’s testimony to an opinion that the decedent’s heart was injured during the valve replacement surgery.  Not nothing, but not much, either. 

 

Today, we discuss the same litigation with the same Daubert issue with a different expert but a similar result.  Smith v. Terumo Cardiovascular Sys. Corp., 2017 U.S. Dist. LEXIS 124866 (D. Utah August 7, 2017), involves a different plaintiff expert proffered to opine on medical causation.  This expert was a licensed perfusionist.  No one disputed that this expert could opine on the standard of care applicable to perfusionists and facilities where perfusion services are offered.  What was disputed was whether the expert could testify about a potential defect in the heart/lung bypass machine that may or may not have exhibited during the surgery in question.  The expert was going to testify that a defect in the machine’s air bubble detection system led to the inadvertent 10-11 minute shutdown during the surgery.  The expert primarily relied upon a recall of the heart/lung bypass machine that occurred almost two years after the decedent’s surgery.

 

The court begins its analysis in the right place with Federal Rule of Evidence 702.  Then we get a paragraph on how the law favors admissibility of expert testimony.  We wince whenever we read about such a presumption, anticipating judicial abdication of the gatekeeping function.  But that was not the case here.  Rather, the court carefully assessed the expert’s qualifications and found them wanting.  The expert knew all about perfusion and how to operate the heart/lung bypass machine, but that does mean he possessed the requisite expertise to analyze the design and technical functionality of the machine.  The defense deposed the expert, and did a nice job of bringing out the expert’s lack of expertise in mechanical engineering or design.  The existence of the product recall might have been suggestive, but to explain why the recall was issued, and why the reason for the recall also accounted for the device’s stoppage during the surgery, required precisely the sort of engineering or design expertise that was lacking.

 

Even aside from the threshold issue of qualifications, the court concluded that the expert’s opinions were unreliable.  The expert’s report disclosed reliance on depositions, reports, system logs, and medical records.  That sounds pretty good.  But the expert never explained how the facts he reviewed, including the device recall, added up to a defect in the device that prompted the stoppage during the surgery. The expert theorized that the perfusion system might have issued a false alarm, which then resulted in the stoppage, but nothing concrete supported that theory.  Indeed, the expert admitted in deposition that no one could explain exactly how the alleged malfunction occurred.   (More refreshing candor!) The court seized upon something that plaintiffs usually emphasize: the failure to test.  The plaintiff’s expert had never attempted to test his defect theory.  Testing, of course, is one of the key Daubert factors.  In this case, the expert’s failure to test his theory kept him in the realm of speculation, and kept his opinions away from the jury.

 

 

 

 

The court may have taken a relaxed approach, but its decision has done nothing but raise blood pressures over at that DDL blog. The course of the Accutane litigation in New Jersey has been labored and we’ve posted about the whole journey. For years, we were pretty riled up. The news from the coordinated proceeding in the trial court had been very bad, including a few large plaintiff verdicts. Then the litigation got reassigned and under new management the tide began to turn. We could feel our pulse returning to normal. The new judge’s look at old issues has been more balanced (from our view), as has the Appellate Division’s review of old decisions. Indeed, the Appellate Division has vacated at least a half dozen plaintiff verdicts. After so many tortuous years, defendants in the New Jersey Accutane litigation finally had a reason to smile (actually thousands of reasons if reasons are dismissals). So we definitively can say we were unpleasantly surprised when last week the Appellate Division reversed the trial court’s order excluding certain plaintiff causation expert witnesses resulting in reviving over 2000 cases.

The to-be-published decision can currently be found at In re Accutane Litigation, 2017 N.J. Super. LEXIS 116 (App. Div. Jul. 28, 2017). It’s a long opinion with a lengthy discussion of epidemiology in general and the epidemiologic evidence pertaining to Accutane specifically. We’ll try to just hit the relevant highlights.

First a quick primer on New Jersey law on the admissibility of expert evidence. New Jersey has adopted a “relaxed” general acceptance standard for toxic tort and pharmaceutical cases. See Rubanick v. Witco Chemical Corp., 125 N.J. 421, 449 (1991). That means that if the expert’s theory is not generally accepted, it may still be admissible if it is “based on a sound, adequately-founded scientific methodology involving data and information of the type reasonably relied on by experts in the scientific field.” In re Accutane, at *47. Further, specifically in regard to reliance on epidemiology as evidence of causation, the court must address not just methodology but also the expert’s reasoning in applying or relying on that methodology to reach his/her conclusions. Id. The court should not only review the studies and other information to determine if they are the type of data experts ordinarily rely on but also “examine the manner in which experts reason from the studies and other information to a conclusion.” Id. at *51.

As we mentioned, the litigation has been handled by two different trial judges. The first judge allowed the opinions of plaintiffs’ experts based on the same type of evidence relied on by plaintiffs’ experts here. Id. at *5. But this litigation has been pending for 14 years. The science has not been stagnant during that time. From 2003 to 2009, there were no epidemiological studies regarding Accutane and irritable bowel disease (IBD) or Crohn’s disease. Id. at *8. Epidemiological studies are considered at the top of the scientific hierarchy. Experimental studies (double-blind randomized control trials) are the gold standard and observational studies (case-control or cohort studies) are the next best available evidence. Without those, plaintiffs’ experts were permitted to rely on “animal studies, human clinical studies, case reports, class effects, published scientific literature, causality assessments, and biological plausibility.” Id. In other words, they were permitted to use less reliable evidence because that is all there was.

But in 2009 and 2010, the first epidemiological studies were published – both of which found no statistically significant increased risk for developing Crohn’s disease from the use of Accutane. Id. Six more epidemiological studies followed and while the results vary, “with one exception, none of them demonstrates a statistically significant increased risk of developing Crohn’s disease.” Id. at *9. Despite the evolving state of the science, plaintiffs’ experts chose to discount the epidemiology in favor of the “other information” on which they had previously relied.

Applying even the New Jersey “relaxed” standard, the trial court found that plaintiffs’ experts reasoning and methodology “slanted away from objective science and in the direction of advocacy.” Id. at *53-54. After reviewing the evidence and conducting a full Kemp hearing (New Jersey’s version of a Daubert hearing), the trial court concluded that the epidemiologic evidence did not support a reasonable inference of a causal link between Accutane and Crohn’s disease. Plaintiff’s experts ignored the studies’ authors own conclusions, excluded the larger population based studies, and made assumptions to “bridge an analytical gap in his methodology.” Id. at *54-55.

We’ve blogged before about the risk of allowing litigation to march ahead of science. As the United States Supreme Court explained in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 597 (1993), the goal of “reaching a quick, final, and binding legal judgment” on matters that are “often of great consequence” is not advanced by accepting hypotheses and conjectures in the place of reliable scientific evidence. But that is exactly what the New Jersey Appellate Division seems determined to do. The court announced its guiding principle as the antithesis of Daubert: “legal decision making in toxic tort and similar cases may vary from scientific decision making.”  Id. at *69. This doesn’t even reconcile with the New Jersey standard that requires general acceptance in the scientific community of an expert’s methodology and reasoning.

And what happens when “legal decision making” supplants the scientific process? Experts get to do things differently in the courtroom than in practice. They can ignore big epidemiologic studies not finding a statistically significant relationship for little ones that do, as long as they come up with some critique of the larger studies that lets them.  They can use data further down the “hierarchy” even though top tier evidence is against them.  They can rely upon their clinical experience in deciding what evidence accords with it. Precisely the types of things Daubert, Rubanick, and Kemp say should not be permitted.

Further, while giving lip service to the fact that “science is constantly evolving” and that “legal decisions need to be made based on the best evidence available at the time of the decision” – the court seems to be mired in the past. Id. at *69. It concludes that despite the overwhelming epidemiological evidence that demonstrates no statistically significant increase in the risk of Crohn’s disease from taking Accutane, plaintiffs’ experts can continue to rely on “other types” of evidence – “which in this same MCL docket they were previously permitted to use.” Id. at *70. Why is that part of the equation? As much as litigation shouldn’t lead science, it shouldn’t lag it either. It should move with it. The state of the science is vastly different than it was 14 years ago, and the court seems to be willing to overlook those developments. The opinion states that the decision “must be viewed in the context of this particular MCL litigation” and “concern[s] the survival of plaintiffs’ cause of action in the face of new scientific information.” Id. at *68-69. Exactly. Plaintiffs’ claims need to be assessed on the basis of the new scientific evidence. And if the claims can no longer survive based on the evolving scientific evidence, then that is the result. Ultimately, however, what seemed to matter more than accurately applying the law to the current state of the science, was “[t]he opportunity of thousands of plaintiffs, claiming injury from Accutane, to have their day in court.” Id. at *69.

One of the wonders of parenthood is its ability to deliver interludes so sublime in their exquisite simplicity that they provoke smiles long after they end. Such was an evening last week when we journeyed to New York to celebrate the birthday of the Drug and Device Law Rock Climber, now a waxing college senior completing a summer internship at an insanely cool company in Lower Manhattan.  We were treated to a tour of the office and to the comments that colleagues and mentors reserve for interns’ mothers.  We had perfect saltimbocca at a beloved Italian bistro.  We saw Waitress (again – we love this show).  We stayed overnight on the Climber’s couch, joined at some point by a four-pound Chihuahua.  And we relished every moment with this child-now-adult.  We were awash in happiness for the entire train ride home.

We were also happy (yet another suspect segue) with the court’s evidentiary rulings in today’s case, but decidedly not with the case’s very sad facts—an all-too-frequent dichotomy in our line of work. Because we spend vast amounts of our professional time struggling to achieve the exclusion of plaintiffs’ causation experts, we are always pleased to read a Daubert opinion that layers tidy analytical segments to reach a satisfying conclusion that correctly applies the Rules of Evidence and controlling case law.

In Smith v. Terumo Cardiovascular Systems Corp., et al., 2017 U.S. Dist. LEXIS 108205 (D. Utah July 12, 2017), the plaintiff’s decedent underwent open-heart surgery in which a heart-lung machine was used to circulate oxygenated blood through the patient’s body while his heart was being repaired.  At some point during the surgery, the machine stopped working for approximately ten minutes.  The plaintiff’s decedent never left the hospital after the surgery.  Eleven months later, he suffered a heart attack and died.

The plaintiff sued the hospital and the heart-lung machine’s manufacturer, asserting the usual claims. She hired a cardiologist as her causation expert, and he opined that the malfunction of the heart-lung machine caused the decedent to suffer physical and mental deterioration and ultimately caused his heart attack and his death.  The defendants moved to exclude the expert’s testimony, arguing that: 1) his causation opinions were unhelpful and unreliable; 2) he was not qualified to opine on neurological injuries; and 3) he should not be allowed “to provide a narrative of events that can and should be provided by other witnesses and records.” Smith, 2017 U.S. Dist. LEXIS 108205 at *5 (citation omitted).

Explaining that , “to be helpful, [the expert’s] opinion . . . that the . . . surgery and related complications had any causal . . . relationship to Mr. Smith’s injuries and ultimate death must be based on a ‘valid scientific connection,’ the court held that that the expert’s own deposition testimony demonstrated that his opinion would not be helpful to a jury. To wit, in his deposition, the expert admitted that he could not testify with certainty that there was a connection “between the surgery, the ten-minute lack of flow, and the heart attack that caused” the decedent’s death. Id. at *10-11 (citations omitted).   Instead, he could only go as far as concluding that “the events that happened at the time of surgery simply made it more likely” that the decedent would die as the result of a heart attack, although the decedent’s own risk factors –hypertension, smoking, diabetes, family history – were generally considered to be “the main contributors” to the development of the plaque that narrowed the decedent’s arteries and caused his myocardial infarction.  As such, the expert concluded, “[While] I think that what happened . . . played a role in his having a heart attack and made it less likely that he would survive a heart attack, but I cannot say that it caused his heart attack.Id. at *11-12 (emphasis in original, citation omitted).

While this is refreshing (and uncommon) candor for a plaintiff’s expert, it is obviously not “helpful” to the establishment of causation. Moreover, the court held, even if the testimony had been helpful, it was not reliable, because the expert did not “provide a basis to conclude that the relationship [was] causal and not merely corollary,” leaving too large a gap between his premise and conclusion, and because he failed to account for obvious alternative explanations for the decedent’s death.   Id. at *15-16.

The expert also concluded, contrary to the results of the decedent’s autopsy, that the decedent had suffered an earlier heart attack, around the time of the surgery, before the one that ultimately killed him eleven months later. The court held that this opinion was also inadmissible because the expert’s diagnostic methods were not generally accepted.  As such, the court concluded, “To allow the jury to hear [the expert’s] opinion on this point would be to allow the jury to hear conclusions based on inferior diagnostic metrics.  This will not be permitted.” Id. at *20.

Next, the court addressed the expert’s opinion that the decedent “suffered an injury to the brain due to prolonged lack of oxygenated blood flow to the brain.” Id. at *20-21.  The court held that the expert lacked the “knowledge, skill, training, or education that would qualify him to diagnose neurologic injuries.” Id. at 21 (internal punctuation and citation omitted).  Moreover, the opinion lacked any scientific basis, as the autopsy revealed no sign of hypoxic encephalopathy.   The court concluded, “[The expert] is not being as careful as he would be in his regular professional work outside his paid litigation consulting.  A jury has no use for [this type of speculation], especially from someone whose expertise lies elsewhere.” Id. at *24.

The court did not exclude the expert’s entire report, permitting him to testify that the decedent’s heart was injured during his surgery and to indicate what he relied upon to form his opinions. It held, however, that the expert would not be permitted “to give a general narrative of Mr. Smith’s health before, during, and after the surgery.” Id.

We like this opinion. It draws the correct lines, and it does so in clear and logical fashion.  It also reinforces the oft-apparent conclusion that plaintiffs’ lawyers disserve their clients when they hire the wrong people, and pay them to say the wrong things, in their quests for big settlement paychecks.   We will continue to keep you posted on judges who properly bar the courtroom doors against such experts, and those who don’t.

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

There is always a level of uncertainty when a case gets remanded from an MDL. New judge; new interpretations of prior rulings; new rulings. It can be the cause of much anxiety on both sides. And the biggest question is – what’s left to be done? That might seem simple. The case was remanded for trial. But cases rarely go back completely trial ready. Legal issues that turn more on state law are often left to the remand court to decide, as are case specific evidentiary decisions. There are also often questions as to whether a particular issue was raised in the MDL or not. If so, what was the ruling? If not, was it waived? So, there is definitely wiggle room for remand judges to imprint their reasoning and conclusions on a case. And where you’ve made progress in the MDL, you certainly don’t want to lose momentum post-remand.

Which was likely the thinking of defendants in Walker v. Ethicon, Inc., 2017 U.S. Dist. LEXIS 112738 (ND IL Jun. 22, 2017) when faced with expert reports that went beyond the scope of what was deemed permissible by the MDL court in the mesh litigation. In this case, plaintiff served an expert report from Dr. Shull, a gynecologic surgeon. Dr. Shull had previously been challenged by defendants in the MDL but certain issues were reserved for the remand court. Certain issues had also been ruled on by the MDL court in the context of other cases and other experts – in defendants’ favor. Defendant here asked the court to apply those rulings. Generally speaking the remand court found plaintiff offered no justification not to.

First up was the expert’s opinion that different surgical procedures – ones not involving the use of the product — were safer alternatives to the defendant’s mesh product. Id. at *5. In addition to the vast body of case law holding that non-use is not an “alternative design” for the product, the mesh MDL court had so held in another case. Id. The remand court agreed. The remand court also considered the impact of Illinois state law because Illinois does not require plaintiff to prove the existence of a safer alternative design, but such evidence may be relevant. Id. at *7. Plaintiff tried to argue that because a product could be found unreasonably dangerous without evidence of a safer alternative design, it follows that a product could be found unreasonably dangerous with evidence of a safer alternative regardless of whether that was a different design or a different surgical procedure. Id. But that disregards that what is relevant but not required under Illinois law is evidence of a safer alternative design. Plaintiffs offered no support for interpreting “safer alternative design” in Illinois any differently than any other state. Nor did they explain how the alternative procedure was relevant to any element of any of plaintiff’s claims. Without relevance, the testimony was excluded. Id. at *8.

Next were the doctor’s opinion on the duties of medical device manufacturers – testing, pharmacovigilance, and training. The court excluded them all. Defendants challenged the opinion on adequacy of research and testing of the product on both the relevance and the doctor’s qualifications and competence. This is one of the topics on which the MDL court provided guidance but ultimately left the decision to the remand court. On relevance, the MDL court found it doubtful, but was willing to leave the call to the trial court based on nuances in state law. Id. at *10. Pertinent to defendants’ motion, the MDL court had also ruled that an expert “may not offer testimony that is solely a conduit for corporate information.” Id. On the qualification challenges, the MDL court did not exclude an expert on those grounds if the request for exclusion did not provide “specific content or context.” Id. at *11.

Applying those rulings to the specific case, the remand court found that defendants had properly challenged Dr. Shull’s qualifications with enough specificity and so that challenge was not denied, but reserved for the remand court. Id. So, on qualifications, Dr. Shull “is not qualified to testify regarding the standard of care for medical device testing.” Id. at *13. Plaintiffs, however, argued that they were only offering testimony from Dr. Shull regarding what testing defendants did or did not do – the extent of the testing rather than its adequacy. Id. at *12. The court took that as a concession, but went on to exclude that testimony as well. That is information found in company documents – don’t need the expert for that. Id.

Plaintiffs also wanted Dr. Shull to testify about how the defendants monitored adverse events. They claimed he was not offering an opinion as to what systems defendants should have been using just that what they were doing was “woefully inadequate.” The court found this was a “distinction without a difference.” Id. at *14-15. Dr. Shull’s experience as a surgeon does not give him the expertise to testify on the standard of care for adverse event reporting. Id. at *15. And, again if he planned to talk generally about adverse events, that’s company documents and not an area for expert testimony.

Finally, Dr. Shull’s report included an opinion on whether defendants appropriately trained physicians. On this point, the MDL court had already ruled that Dr. Shull could not testify about what should or should not be included in the Instructions for Use for the product – and that covers training of physicians. Dr. Shull could testify to the risks of the product and whether such risks were included in the product materials. Id. at *16. That’s it.

We’re not sure what remains in Dr. Shull’s report, but we certainly agree that the above portions were appropriately trimmed away.