Thursday, September 20, 2012

Chantix Daubert Leaves Us Wanting More

Here's another guest post from Reed Smith's Eric Alexander.  Maybe we'll get him his own account next time.

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After the overwhelming response to our first post last week – the list of the recipients of those firm holiday cards we never actually send got a bit longer – we agreed to do another this week.  We also vowed to make this post more positive than the first.  We would not want to get an unfounded reputation for being unduly negative, critical, and crotchety.  A well-founded reputation is fine, but we wanted to try to find a case with something to praise.  It seems that finding a praiseworthy case some weeks is about as hard as resisting a cheeky alliterative title for our posts.  (There sure are some b-words to pair with “bayou” when discussing a Louisiana case.)  So, we found a case with some good parts and some bad parts.  Like many meals out.  On an MDL-wide Daubert, getting a satisfying entrée is sufficiently unlikely that you often have to make sure you enjoy your salad - butter lettuce, pear, blue cheese, and walnuts or pecans is nice, but lay off the raspberry vinaigrette.


The decision in In re Chantix Varenicline Prods. Liab. Litig., MDL No. 2092, 2012 U.S. Dist. LEXIS 130144 (Aug. 21, 2012), is like that.  The defendant took a shot at the whole ball of wax - general causation - “whether Chantix [a prescription drug for smoking cessation] is capable of causing the adverse neuropsychiatric events alleged,” as the Court put it.  It missed.  A definitive “no” on general cause would have pretty much ended the MDL, and MDLs (other than Seroquel) have a way of lasting past Daubert decisions.  Similarly, most restaurants tend to like you to order some apps and sides with your entrée, have a few drinks along the way, save room for dessert and a nice aperitif, and maybe offer you a wafer thin slice of beef to finish you off.  It is a rare joint that says, in essence, “You really came here for the porterhouse, so have that first and we’ll see if you have any room left after that.”  But we digress.  The entrée here was not prepared too well.  Maybe it was how it was ordered.  Maybe it should have been sent back.  Maybe it was because the chef/court was confused about what it was preparing/deciding.  We’ll get to that.  Since we are trying to be positive, we will discuss the tasty part first.

The court precluded plaintiffs’ experts – three of them were challenged specifically and addressed in the opinion, but the Conclusion suggests the ruling applies to all of plaintiffs’ experts – from offering testimony about what the defendant knew or that it misled the FDA.  For one of the experts, the court said she could not testify to “labeling changes based on that knowledge.”  In the Conclusion, the exclusion is of testimony “whether defendant ‘intentionally misled the FDA.’”  Since we are still being positive, we will not dwell on the lack of consistency.  We will praise something not normally praised – lack of detailed analysis.  The court kicks this testimony from the first expert up, Dr. Furberg, with “as such opinions are necessarily based on speculation.”  The other two experts challenged for such “opinions” fell without elaboration.

There are a bunch of other reasons why an expert should not be able to testify about – or opine about, which is not really the same thing – these subjects, but speculation is a good reason.  So, the court stops discussing it.  No authority is cited; the case defendant cited In re Rezulin Prods. Liab. Litig., 309 F. Supp. 2d 531, 543 n. 32, 560 (S.D.N.Y. 2004), is actually brushed aside a few pages earlier.  We recall writing the challenge to an expert offering testimony on corporate intent that was granted in In re Diet Drugs (Phentermine, Fenfluramine, Dexfenfluramine) Prods. Liab. Litig., No. MDL 1203, 2000 WL 876900 (E.D. Pa. June 20, 2000), and later expanded in In re Diet Drugs Prods. Liab. Litig., MDL No. 1203, 2001 WL 454586 (E.D. Pa. Feb. 1, 2001), and later adopted in said Rezulin opinion – yes, the Rezulin court did preclude the same Dr. Furberg and others from offering testimony on the “intent, motive or state of mind of corporations or regulatory agencies.”  Back then, we had to look to a range of non-products cases to cobble together support for a proposition that seemed obvious – an expert in regulatory matters, pharmacology, epidemiology, or whatever should not be allowed to get on the stand and offer up their take on what the drug manufacturer, its employees, FDA, or its employees knew, thought, or intended at a point in time.  We used to have spend time in briefs explaining all the reasons why this was so.  As courts have fallen in line on this, including, it seems, just about every drug or device MDL court to offer up a Daubert decision on the plaintiffs’ experts since Diet Drugs – because the plaintiffs’ expert keep offering intent testimony – we now have an established proposition the adoption of which required the Chantix court no analysis or citation.  Like food – we are just not going to make analogies to smoking – simple can be better than complicated.

Taking this same approach on whether the experts can testify FDA was misled is similarly logical and avoids some thorny issues.  If an expert is speculating when offering up a testimony on what the company knew, then she is certainly speculating when she says the FDA was misled, which necessarily involves a guess at what FDA knew and thought.  Even former FDA officials who become experts do not get to speculate on what another specific FDA official would have done with additional or different information.  In re Diet Drugs Prods. Liab. Litig., 2001 WL 454586, *19 (yeah, did that, too).  We do think that the line of cases that exclude evidence, expert or otherwise, offered to show that FDA was misled – starting with Bouchard v. American Home Products, 213 F. Supp.2d 802 (N.D. Ohio 2002) – is right even after Levine.  We also see why a court would be hesitant to rely on preemption to exclude evidence in a pharmaceutical products case these days.

While the Chantix court excluded the “knew” and “misled” testimony, it hastened to add that the experts could say what the defendant “should have known” and what information it provided to FDA.  We will be curious to see how those lines are held at trials, as the veteran testifiers for plaintiffs do have a way of suggesting what they cannot say directly.  But “should have known” and therefore “should have” taken some action does not sound like a basis for punitive damages and “knew” and “decided not to” take some action does.  Similarly, you feel much better about avoiding punitives when no witness has testified that FDA was “misled” into taking or not taking some regulatory action based on what the company submitted or “failed” to submit.  (We would urge that words like “failed,” “chose,” and “decided” are a way that impermissible knowledge and intent testimony actually gets offered by the cagey experts and lawyers.)  So, we would take these exclusions, even with the clarifications about what can be offered.

That said, the rest of the opinion was grounds for indigestion.  Every challenge to opinions from the seven experts at issue on “general causation,” “biological plausibility,” and mechanisms for causation was shot down.  In so doing, the court permitted speculation and theories (without any showing of general acceptance) and never identified any study relied upon by the challenged experts that had the hallmarks of reliable evidence of causation, at least as the court explained it . Rule 703 is never mentioned.  In general, the court took the opposite approach of the Steve McConnell's Seventh Circuit idol in Rosen v. Ciba-Geigy Corp., 78 F.3d 316, 319 (7th Cir. 1996) (Posner, J.), ironically another smoking cessation aid case, which famously declared, “But the courtroom is not the place for scientific guesswork, even of the inspired sort. Law lags science; it does not lead it.”  The basic approach was to criticize the defendant’s challenge, pump up the expert’s qualifications and number of citations in the expert’s report, and cite caselaw (sometimes miscite) for the propositions that the judge’s gatekeeper role under Daubert does not supplant cross-examination, that most criticisms go to weight, and expert testimony can still be admitted if it fails multiple Daubert factors.  It also fundamentally misunderstood the task at hand, often seeming to be rejecting a “no evidence” summary judgment motion rather than a Daubert challenge to specific experts’ testimony.

How did this happen?  We weren’t there and haven’t read the briefs, but a few things leap out.  First, the day before the Daubert hearing, the court issued a partial summary judgment ruling that the Chantix label as changed in 2009 “is sufficient as a matter of law for warnings regarding neuropsychiatric injuries” (and the SOL would start running as of that change) and the court “the court considers the pending motion to exclude certain of plaintiffs’ experts in light of its prior ruling on the label sufficiency.”  That had two implications as we read it:  1) that the court thought it was now established that Chantix can cause a range of neuropsychiatric injuries and 2) that the court did not understand – luckily, we do get to speculate on what judges understand – the relationship between labeling and causation.  Even if Chantix does have the potential to cause neuropsychiatric injuries, an expert’s opinion that it does may still not be admissible.  He may not base his opinion on reliable studies or he may apply an unreliable methodology in evaluating the studies, as by contending that an odds ratio less than 1.0 favors causation.  He may have good qualifications in one area, but base his opinion solely on the type of studies he would never come across in his day job (e.g., a rat study guy trying to rely on epidemiologic studies).  The reverse is also true: an expert can have admissible but incorrect opinions that Chantix can cause neuropsychiatric injuries.  Here, however, because the court clearly felt Chantix can cause neuropsychiatric injuries, the challenge to each expert was treated as something of an affront and the burden of demonstrating the reliability and admissibility of the expert’s opinions was not placed on the plaintiffs, who should have had it as the proponents of the evidence.

In addition, the court seemed to think the fact that warnings in the Chantix label, or in FDA’s communications, became more forceful and prominent over time was important to the analysis of causation.  There was no discussion of the well-known disclaimers in labeling regulations that “a causal relationship need not have been definitely established” or various FDA statements that labeling (and reporting of adverse events) should not be viewed as admissions of causation.  Although the court discussed whether actions by FDA – its mission is to protect public health, after all – are based standards relevant to consideration of causation evidence under Daubert, its insistence on looking at FDA actions and inconsistency in how it did so was befuddling.  Unfortunately, it appears that the defendant may have pushed the court to keep blurring the lines between admissibility under Daubert and what FDA has done/said, as it raised (according to the court) various arguments about how the plaintiffs’ experts interpreted studies or adverse event data different than how FDA did.  The record also included defendant’s “Introduction and Statement of Facts Relevant to all Daubert Motions,” 154 exhibits from defendant, plaintiffs’ “Omnibus Memorandum of Facts and Law,” and 215 exhibits from plaintiffs, plus more stuff with the reply.  With a dash of hindsight, we can certainly question whether all the background not really relevant to the admissibility of the opinions of the challenged experts ended up distracting the court from the real issues.

Second, for whatever reason, after three years of presiding over the Chantix MDL, the judge did not like the defendant or its motions, at least as we read the opinion.  When the first sentence in the “Relevant Factual Background” is that “this is a multidistrict product liability action concerning Chantix, touted by defendant to aid in smoking cessation” (emphasis added), you might get a hint at where the court is going.  If the court really was “consider[ing] only whether Chantix is capable of cause the adverse neuropsychiatric events alleged,” then marketing conduct does not matter.  Nor does how “severe” the events are being alleged, something the court notes several times.  The standards for admissibility of expert evidence do not change based on whether defendants marketed aggressively (or misleadingly) or whether the injuries alleged are really bad.  As Mike Tomlin says, “The standard is the standard.”

We said a “few things” leap out at us to why the portion of the opinion on causation was so bad.  We have given two, really three if you count subparts like the Federal Rules of Civil Procedure require.  There are more, but to go into them would come across as too negative, which we are resisting.  Anyway, we started by saying that the Chantix opinion was like a meal out with some good parts and some bad parts.  It was really like a meal that left us nauseated, but we thought back and remembered that we liked the bread.  And maybe the butter.

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