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A little while ago, Bexis attended a Lawyers for Civil Justice semi-annual meeting, at which he received that organization’s “Outstanding Contributor Award” (in full disclosure, so did a half dozen other members).  With the soon-to-be-adopted amendments to Fed. R. Evid. 702 having now been approved by the Supreme Court (with only the unlikely step of a congressional veto remaining), the question was what happens next.

These amendments expressly enshrine the expert “gatekeeper” function in the text of Rule 702.  The next step is whether they can be duplicated – or paralleled − in state rules of evidence.  We think that they can, and for a state (like Pennsylvania and a number of others) that still follows the “Frye” standard looking to the “general acceptance” of expert testimony as the touchstone to admissibility, a Rule 702 state-law equivalent might look something like this:…

Continue Reading 50-State Survey of State Court Decisions Supporting Expert-Related Judicial Gatekeeping

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Last year, the federal court decision to exclude plaintiffs’ general causation expert in the In re: Onglyza and Kombiglyze XR Products Liability Litigation, MDL 2809 (E.D. Ken.),took a spot in our top ten best of 2022 (original post on that decision here).  Without a general causation expert, it is not surprising that summary judgement…

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Duh.  We apologize for the depth of our profundity, but there are some legal principles we think are really obvious.  So obvious, in fact, that we might respond to question about these principles with this most dismissive of (clean) interjections.  (We were somewhat surprised to learn from the interwebs that duh was supposedly first used…

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Just last week we updated our discussion on the 2023 amendments to Rule 702 urging our readers to start using the amendments now before their official implementation in December.  That’s because the Report of the Rules Advisory Committee confirms that the change to Rule 702 is to correct the mistakes of those courts who have…

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We’ve chronicled the path of the 2023 amendments to Fed. R. Evid. 702 pretty much from the beginning.  As we’ve discussed, those amendments reiterate what had always been (at least since 2000) the Rule’s requirements for analyzing the admissibility of expert witness testimony.  But courts had been ignoring critical elements – such as the burden of proof – that had been in comments rather than the black letter of Rule 702 itself.  So, as of December 2023, Rule 702 will provide that the proponent of expert testimony must meet all of the Rule’s substantive standards for admissibility by a preponderance of the evidence, and in particular that an adequate basis for such testimony is a prerequisite to admissibility. …

Continue Reading Don’t Wait – The Rule 702 Amendments Can Be Used Now

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As we prepare to greet 2023, we find ourselves assuming the Janus-ian posture of simultaneously looking backward and forward.  Forward is more fun, as we scan a schedule full of motions, MDL decision-trees, and trials in, er, challenging jurisdictions.  But it really is folly to plan the future without learning from the past.  It is hard to beat Bexis’s lists of the best and worst DDL cases, the latter of which graced us last week, and the former of which will adorn this blog tomorrow, for inventorying what happened and what mattered in our area of the law in 2022.  We’ve also been asked in various fora and by various inquisitors to hold forth on trends we espy.  Clients and colleagues demand analyses and prognostications.  We’ve also worked up presentations for ACI, DRI, and in-house CLEs. As we draw a curtain on a very interesting year (African safari, new house, introduction to pond management, Phillies World Series, and clients who gave us the gifts of trust and humor), so we’ll share some top-line observations and suspicions with you, our loyal readers:

  • Since Covid-19 paid our society an unwelcome, prolonged visit, we’ve heard a lot about supply-chains.  Enterprising plaintiff lawyers are exploiting the many residents of drug and device supply chains to gin up personal jurisdiction by finding local players (raw material suppliers, clinical trials, etc.) or bolstering liability theories by taking out of context Materials Safety Data Sheets that list risks relevant for OSHA but not FDA issues.
  • The assault on non-prescription products continues.  Plaintiff lawyers seem to be paying more attention to over the counter and consumer products, alleging dangers from contaminants.  These products have lots and lots of users (call them prospective clients), and there’s hardly a pesky learned intermediary in sight to get in the way of a failure to warn claim.
  • That assault is aided by “independent” laboratories that masquerade as public-spirited do-gooders, when they are actually in league with plaintiff lawyers and treat science as a game.  These labs follow good lab practices erratically if at all, and certainly not good practices that would produce bad results for plaintiffs.  The bottom line is that these not-so-independent labs would find contaminants, degradation artifacts, and/or asbestos in unicorn tears.
  • You got that reference to asbestos, right?  The plaintiff playbook du jour comes from the talc asbestos litigation, and that litigation, in turn, is only the latest wave in the asbestos wars.  If the first victim in war is the truth, then the asbestos wars have murdered truth, science, and anything approaching due process. Too many judges presiding over asbestos dockets have given up any gatekeeping, wave frail causation opinions along to juries, and grudgingly consider dispositive motions only on the eve of trial — all of which seems designed to force panic settlements.
  • As the asbestos model gets applied to other mass torts, we are starting to see an unfortunate feature of asbestos litigation crop up in those mass torts: the use of bankruptcy proceedings as a necessary refuge from a mass tort run amok.  The availability of bankruptcy as such a refuge is replete with controversy, of course.  Results have been mixed.  The consequences of such bankruptcy filings are obviously profound for the debtor and claimants, but also pose complex implications for codefendants.  Some have called such bankruptcy filings a scourge, threat, and mess, but they are really rational responses to a litigation system that has become a scourge, threat, and mess.
  • At the same time, some judges are willing to climb on top of the mountain of junk science and call a halt to the nonsense. Yesterday, Bexis summarized the Zantac MDL rulings on Rule 702 and summary judgment.  The judge in that case did a heroic job of mastering the evidence and seeing the many ways in which the plaintiff experts practiced “situational science.”  Even in advance of the new and improved Rule 702 expected to go into effect next year, the Zantac judge set the standard for testing whether plaintiffs met their burden of offering scientific opinion backed by rigor and reliability.  That result should gladden the hearts of those who care about the civil justice system, but it should also remind defense lawyers of their responsibility to do the work necessary to reveal the shortcomings of the other side’s experts and provide the judge with the basis for closing the gate.

The Zantac decision was, without a doubt, a remarkable achievement.  When a judicial opinion contains over 300 pages of erudition, one tends to sit up and take notice.  …

Continue Reading So Long to All that Junk

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What follows is from the non-Dechert side of the Blog.

In the Zantac MDL, the plaintiffs’ causation problems were plainly visible on the horizon, as we mentioned in our post last year about the Zantac ruling on medical monitoring, In re Zantac (Ranitidine) Products Liability Litigation, 546 F. Supp.3d 1152 (S.D. Fla. 2021).  The Zantac MDL plaintiffs’ claims regarding risk of injury and exposure levels to purported ranitidine-derived nitrosamines (“NDMA” for short) seemed not only trivial, but in many ways bizarre (use of extreme temperatures and other parameters).  They even relied on a retracted study.  That’s why we referred to the “wheels coming off” the plaintiffs’ scientific case in that post.

Now the plaintiffs’ wheels are fully off in Zantac MDL – as we mentioned before, all of their causation experts for the five types of cancer that plaintiffs themselves considered the most plausible have been excluded under F.R. Evid. 702, and summary judgment entered.  In re Zantac (Ranitidine) Products Liability Litigation, ___ F. Supp.3d ___, 2022 WL 17480906 (S.D. Fla. Dec. 6, 2022).  This is a lengthy opinion, 341 pages in slip form.  To keep this post as short as possible, we’ll be summarizing (at best) large parts of it.…

Continue Reading Zantac Chronicles – Concluding Chapters in the MDL

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Earlier this year we blogged about the Lone Pine order entered in the Zostavax MDL that required those plaintiffs alleging that the anti-shingles vaccine caused them to get shingles (1,189 of them) to produce evidence of specific causation by means of a PCR test.  The goal of the Lone Pine order was to winnow out non-meritorious claims.  That was Part 1.  Defendant’s motion to dismiss all 1,189 plaintiffs because not a single one produced the required test result or even asked for an extension – that was Part 2.  Without evidence of specific causation, the court dismissed about half the cases in the MDL. 

Shingles are caused by the same virus that also causes chicken pox, although the adult disease shingles is much more dangerous.  The virus remains in the body for life and can either lie dormant or reactivate and cause shingles.  Almost everyone over the age of 30 in the United States has had chicken pox and therefore carries the “wild-type virus” in their systems.  In re Zostavax Products Liability Litigation, 2022 WL 17477553, *2 (E.D. Pa. Dec. 6, 2022).  The vaccine consists of the Oka strain of the virus, a live-attenuated virus that is a weakened form of the wild-type.  Defendant presented “uncontradicted medical authority” that the only way to know whether a person’s shingles was caused by the wild-type virus or the Oka strain is through a PCR test.  In fact, plaintiffs’ own expert testified that specific causation could only be determined with a PCR test.  Id.  That is the same expert who failed to perform a differential diagnosis ruling out the wild-type virus in 5 bellwether cases that were therefore dismissed on summary judgment.  That is what led to the entry of the Lone Pine order.  If none of the bellwether plaintiffs had sufficient causation evidence, the court wanted to know which plaintiffs did.…

Continue Reading Lone Pine Stands Tall in Zostavax MDL — Part 2

Drug & Device Resources

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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