Epidemiology

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This week, as Drug and Device Law Jews, we are preparing for Passover, which, like most Jewish holidays, begins with a multi-generational dinner at the home of the Drug and Device Law Bubbie (our mother). Although we of the second generation (there are now four) still fancy ourselves to be the “kids’ table” at this dinner – giggling at the solemn points of the reading, singing endless choruses of our favorite Passover song in defiance of the “just one time” edict, and generally disrupting the proceedings as much as possible – the reality is that we are all upper-middle-aged adults. And, as our matriarch ages (at least on paper), we assume more and more of the food preparation for the Seder dinner. And there’s the rub. For, much as we would enjoy the occasional stroke of rogue creativity, we know that nothing unfamiliar will be allowed on the table and that each of the traditional dishes must taste exactly as it has tasted for the past 50-plus (if not 2,000) years. Every ingredient and every step of preparation is subject to scrutiny, and Bubbie is the gatekeeper. (You know where this is going).

As everyone knows, under SCOTUS’s Daubert decision, the trial court is the gatekeeper when it comes to admitting or excluding the testimony of expert witnesses. We who practice in the mass tort space have gratefully experienced judges who take this responsibility seriously and have endured those who “punt” these determinations, nearly always to the benefit of plaintiffs whose dime-store experts – lacking qualifications, methodologies, or both – are permitted to peddle their wares to unsuspecting juries.

The Lipitor MDL judge falls resoundingly into the former camp. In In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices, and Prods. Liab. Litig., 2016 WL 1251828 (D.S. C. Mar. 30, 2016), considered the defendant’s Daubert motions addressed to the plaintiffs’ four causation experts, and wholly or partially excluded all four. But there is backstory. Lipitor is prescribed in four different doses – 10 mg, 20 mg, 40 mg, and 80 mg. This is an MDL, so our readers can guess which doses most of these plaintiffs took. While several studies show a statistically significant association between higher doses and new-onset diabetes, none shows such an association at the lowest dose. After the plaintiffs’ experts submitted their initial reports, the court “was concerned as to whether Plaintiffs’ experts had sufficient facts and data to support their causation opinions at all doses . . . , and even whether the experts would be willing to offer an opinion at low doses, given the available data.” In re Lipitor, 2016 WL 1251828 at *3. Over the defendant’s objections, the court allowed all four of the plaintiffs’ experts to submit supplemental reports addressing whether the drug caused diabetes at particular doses. Id. at *5. The defendant’s Daubert motions followed submission of the supplemental reports.

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Everybody knows that it is three strikes and you are out in baseball.  (Bexis and Ken Burns could discuss the history of baseball’s rules on balls and strikes in the nineteenth century, but we will stick with the public consciousness at least since “Take Me Out to the Ball Game” became popular.)  In MDL product liability litigation, there is no magic number of times that proffered general causation experts must get knocked out before it is apparent that no plaintiff suing over the injury at issue will have a viable case.  In boxing, many jurisdictions have a three knockdown rule, where a knockout victory is awarded if the opponent is knocked down to the canvas three times in the same round.  In litigation, there is no such rule, nor would the parties ever agree on what constitutes the same round.

The Zoloft MDL in the Eastern District of Pennsylvania has been playing this out.  First, the MDL court excluded the generic causation opinion of the plaintiffs’—all of them, since this is common discovery—epidemiology expert.  Next, the court excluded the general causation opinions of three separate experts who focused on purported mechanisms.  It looked like plaintiffs were dead in the water.  Then, plaintiffs got a mulligan—yes, we are mixing sports metaphors like some courts mix up the standards for expert evidence on medical causation—and were allowed to put up another expert on general causation, this time a late-designated, frequent flyer biostatistician.  (Along the way, a motion to reconsider was denied and, across town, a state court excluded the causation opinions of an epidemiologist and mechanism expert in an individual case.)  Now, after every apparent opportunity for plaintiffs to do better, the court also excluded the general causation opinion of the new expert in In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., MDL No. 2342, 2015 U.S. Dist. LEXIS 161355 (E.D. Pa. Dec. 2, 2015).

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A couple of weeks ago, we talked about Westminster Kennel Club Dog Show.  We were eagerly anticipating the Best in Show competition, which was slated to feature a Standard Poodle – the breed of our heart – along with a Portuguese Water Dog whose record of wins was unprecedented in dog show history.  Based on this past record, the “PWD” was heavily favored to “take the Garden.” The Best in Show judge (few assignments in dogdom carry more prestige) built the tension in the sold-out stadium to a fever pitch.  The dogs submitted to painstaking “hands on” examinations, they “free-stacked,” they gaited.   And they gaited again.  Finally, the judge, flanked by AKC officials, strode purposefully to the table to “sign the book,” then returned to the center of the ring, microphone turned on, purple and gold rosette and trophy in hand.   He made a moving speech about the history of the event, and he praised the lineup of seven gorgeous group winners.   Pausing one more time for effect, he announced, “Best in Show at the 139th Westminster Kennel Club Dog Show is . . .  the Beagle!”  The Beagle? Make no mistake – “Miss P” is a spectacular show dog, with many Best in Show wins to her credit.  She is a striking example of her breed.  And she is very, very cute.   But it just wasn’t what we expected.

We also thought we knew what to expect when we began reading the recent decision of the Superior Court of New Jersey – Atlantic County — in the Accutane Multicounty Litigation. This litigation, in which plaintiffs allege that Isotretinoin (Accutane’s chemical name) causes Inflammatory Bowel Disease (“IBD”) and Crohn’s Disease (“CD”), has been pending since 2003, and we have been troubled, at times, about an apparent plaintiff bias. Appellate courts have agreed with us, overturning a number of plaintiffs’ verdicts. (See here and here, for example.)  But we were most pleasantly surprised this time.

In In re Accutane Litigation, 2015 WL 753674 (N. J. Super. Law. Feb. 20, 2015), the Court considered defendant’s motion to exclude plaintiffs’ general causation and biostatistics experts.  The Court explained that New Jersey applies a standard less stringent than Frye’s “general acceptance” standard, in determining whether expert testimony is admissible.  Under the guiding Rubanick decision of the New Jersey Supreme Court (125 N.J. 421 (1991)), “if the methodology by which the expert reached a conclusion is sound, the conclusion may be introduced into evidence.”  Accutane, 2015 WL 753674 at *4 (citation to Rubanick omitted).  Later, in Kemp v. The State of New Jersey,  174 N.J. 412 (2002), the Supreme Court held that the trial court was obligated to conduct an evidentiary hearing “any time an expert’s theory has not attained ‘general acceptance,’” and that the failure to do so is “plain error.” Accutane, 2015 WL 753674 at *6 (citations to Kemp omitted).  Hence the moniker “Kemp hearing” to describe hearings such as the one that was the subject of the Court’s decision.

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We saw the movie “Whiplash” last weekend.  In this Oscar contender, a drum student at a prestigious music conservatory seeks the approval of a harsh and punishing conductor, as well as a berth in the conductor’s competition jazz band.  The film is so tense and so consistently painful to watch that it would not be accurate to say that we “enjoyed” it, but we wouldn’t have missed it for the world.

Early in the movie, the conductor demands that the student play several measures over and over and over again in a relentless and seemingly futile attempt to find the correct tempo. In today’s decision out of the Denture Cream MDL pending in the Southern District of Florida (thanks to David Walz at Carlton Fields for sending it to us)  Plaintiffs are back, beating the same drum, in a repeat attempt to surmount defendant Procter & Gamble’s (“P & G’s”) Daubert challenges to their general causation experts.  In re Denture Cream Prods. Liab. Litig., No. 09-2051-MD-Altonaga, 2015 U.S. Dist. LEXIS 9653 (S.D. Fla. Jan.. 28, 2015).  In these cases, Plaintiffs allege that, with long-term use of Fixodent denture adhesive, the zinc in the product causes copper deficiency and, ultimately, a neurological condition known as copper deficiency myeloneuropathy (“CDM”).  In 2011, the court granted P & G’s Daubert motions to exclude Plaintiffs’ general causation experts. See In re Denture Cream Prods. Liab. Litig. (Chapman, et al. v. Procter & Gamble Distributing, LLC), 795 F. Supp. 2d 1345 (S.D. Fla. 2011), aff’d, 766 F.3d 1296 (11th Cir. 2014) (“Chapman’).  As we discussed at the time, the Court held, “[Plaintiffs’] theory is not ridiculous, but neither is it necessarily true; it is ripe for testing.  . . . [T]aking everything together, there is enough data in the scientific literature to hypothesize causation, but not to infer it.”  795 F. Supp. 2d at 1367 (emphasis in original).  This past September, as we reported here, the Eleventh Circuit affirmed the District Court’ Chapman decision.

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Imagine this: The only published article in the medical literature reaching a statistically significant result concerning a drug and an outcome turns out not to have been what it seems. Rather, over a third of the subjects in the relevant category turn out to be misclassified. When properly reclassified, the statistical significance between the drug…

One of the ways we feed this blog is doing what comes naturally to us lawyers – reading recent cases – and hoping that something inspires us. Sometimes that works. Sometimes that doesn’t. This week it worked too well. We’ve seen several decisions that bring back memories of stuff we’ve had to deal with over…

Today we’re boldly going where lawyers usually fear to tread (at least alone) – into the realm of epidemiology, albeit perhaps loosely defined. Why? Well, we do have to come up with things to write about, and there’s only so much preemption theorizing that even we can do before it sounds like we’re babbling.

Also,…

The New York Times ticked us off again this morning.

Not as much as it did last month, but it annoyed us nonetheless.

The front page of the Week in Review section has a piece titled “Making Sense of the Great Suicide Debate.” Here’s a link.

The article quotes (and appropriately identifies as…