The Granuflo/Naturalyte MDL (“G/N”) was created a decade in the past, in 2013.  In re Fresenius Granuflo/Naturalyte Dialysate Merchandise Legal responsibility Litigation, 935 F. Supp. second 1362 (J.P.M.L 2013).  However a settlement in 2016, it’s nonetheless up and operating, it seems.  Over the previous decade, the G/N MDL had distinguished itself for – not a lot, actually.  We wrote a grand complete of one publish about it throughout that point, which collected a number of one-off state-law rulings, however zero preemption, knowledgeable admissibility, or core product legal responsibility points determined.

Till a short time in the past.

That modified with In re Fresenius GranuFlo/NaturaLyte Dialysate Merchandise Legal responsibility Litigation, ___ F. Supp.3d ___, 2023 WL 5807340 (D. Mass. Sept. 7, 2023).  This G/N resolution adjudicated 4 abstract judgment motions involving 13 opt-out plaintiffs – most of whom had been topic to greater than one of many motions.  All 13 plaintiffs had their claims dismissed.  That’s good.  However why it took a decade to resolve factual points that might have been handled way back, with respectable early vetting of plaintiffs’ claims, left us shaking our heads.

All these plaintiffs superior the identical common medical causation principle – that the composition of the 2 merchandise at subject led to a “harmful improve” of blood “bicarbonate ranges,” which in flip might trigger “cardiac arrest and sudden cardiac demise.”  G/N, 2023 WL 5807340, at *1.  This medical causation principle was outlined in a 2011 memo authored by the defendant’s then-chief medical officer, which touched off the following storm of litigation.  Id. at *2.  Plaintiffs 4 medical knowledgeable witnesses “all depend on the information mentioned” in that memo.  Id. at *3.

Abstract Judgment #1 – Inadequate Pre-existing Danger

The defendant’s first abstract judgment movement was towards these plaintiffs (10 of them) whose bicarbonate ranges by no means reached the extent recognized within the 2011 memo as making a cardiac threat.  These plaintiffs had been in hassle as a result of all of their consultants slavishly relied on the memo.  G/N, 2023 WL 5807340, at *9 (plaintiffs’ consultants “performed no impartial research” and “explicitly relied on” the memo as the premise of their opinions). 

Though plaintiffs should not essentially certain by the [2011] Memo, it’s related in assessing their principle of causation, not least as a result of their consultants all explicitly presupposed to depend on it in rendering their opinions. . . .  [W]ith appreciable testimony from their very own consultants that the entire plaintiffs fell inside a suitable vary, they’ve did not adduce competent proof in help of their claims.

Id. at 11.

Thus, “none of their consultants purported to vary a prescription on numbers” in these plaintiffs’ ranges, and “none testified that she or he was involved about [those] numbers.”  Id. at *10.  The whole lack of knowledgeable help for causation exterior the scope of the 2011 memo required dismissal.  “[P]laintiffs have did not set forth any competent proof in help of their claims that primarily any pre-dialysis quantity comports with their principle of common causation.”  Id.

That’s nice, however why is that this solely being addressed after a decade of litigation?  Whether or not these – or another – plaintiffs had a “pre-dialysis quantity” too low to qualify for the 2011 memo is one thing that ought to have been instantly obvious from their medical data.  Such a purely goal factual data is exactly the type of factor that ought to have been produced on the outset of the litigation in order that plaintiffs with facially bogus claims wouldn’t have, as these ten plaintiffs did, stay in litigation for a decade.  Thus, whereas this side of G/N was a win for the defendant, it was inexcusably delayed.  This MDL demonstrates, but once more, that MDLs require way more rigorous early vetting than is at present being proposed within the little-better-than-nothing draft Fed. R. Civ. P. 16.1.

Additionally in opposition to the bicarbonate stage abstract judgment, some plaintiffs trotted out a brand new principle of legal responsibility − “that any pre-dialysis bicarbonate stage, low or excessive, might nonetheless result in a cardiac occasion solely based mostly on the administration of” the focused merchandise.  Id. at *11.  Nevertheless:  (1) plaintiffs by no means pleaded that principle, (2) none of their consultants supported it; (3) it contradicts their fundamental principle; and (4) it’s an assault on dialysis as a process, not on any explicit product.  So these plaintiffs chalked up one other fail, making an attempt to make up one thing new on the fly.  Id.

Lastly, the low bicarbonate stage plaintiffs additionally misplaced on failure to warn.  Their “consultants testified {that a} doctor wouldn’t be anticipated” to vary a any therapy earlier than utilizing the product with a low bicarbonate stage affected person.  Id. at *12.  Thus, no warning as to those plaintiffs might presumably have made a distinction, because the purported warning was inapplicable to their decedents.  No “treating physician[s] would have performed one thing in another way had they been forewarned.”  Id.

Abstract Judgment #2 – Causation

Eleven of the 13 G/N plaintiffs additionally misplaced outright on causation.  Both they may “not proven that their decedents died because of this” of the situations alleged, or their accidents had been “not proximate in time to their final dialysis therapies.”  G/N, 2023 WL 5807340, at *13.  Each common and particular causation are, in fact, important components of any tort.  Id.  As to the primary causation level, the 2011 memo was restricted to sure arrhythmias.  4 plaintiffs, nevertheless, claimed quite a lot of different deadly situations.  Id.  As to the second, the 2011 memo was restricted to “speedy” adjustments (<7 hours), and eight of the plaintiffs fell exterior of that timeframe (between 8 ½ hours and eight days).  Id.

The defendant received once more.  Plaintiffs cooked up one other new principle a couple of supposed a “delayed bicarbonate ‘spike’” purportedly “resulting from slower metabolism.”  Id. at *14.  Nevertheless, the examine they relied upon didn’t embody any affected person with a “spike,” id. at *15 (“[n]both of these two outliers had a belated ‘spike’”), and “there is no such thing as a proof within the document that any of the decedents at subject had been gradual to metabolize.”  Id.

Whereas we applaud this consequence, we level out that, as soon as once more, the premise for abstract judgment consisted of goal info that might be instantly obvious from a assessment of those plaintiffs’ medical data – the reason for demise and the period of time after these plaintiffs’ final use of the product that demise occurred.  Any rudimentary early vetting of those plaintiff would have found these info, thereby prevented having these bogus claims stay on the MDL docket for a decade.

Abstract Judgment #3 – Naturalyte

Defendant additionally received abstract judgment towards 5 plaintiffs who claimed publicity to solely one of many two merchandise at subject within the MDL – not Naturalyte.  Once more, causation was the difficulty.  Mainly, this victory was as a result of the plaintiff’s knowledgeable testimony was blatantly contradictory.

Though [plaintiffs’ expert] endorses plaintiffs’ allegations that NaturaLyte is harmful and faulty resulting from the truth that it accommodates [a specific level of its active ingredient], his personal testimony and practices reveal that such a cost is unsubstantiated.  On quite a few events, as outlined above, [this expert] testified that [this exact level] isn’t thought-about extra.

G/N, 2023 WL 5807340, at *15.  Certainly, the knowledgeable himself used this product for his sufferers and by no means gave them the warning that plaintiffs declare was required.  Id.  A number of different p-side consultants testified equally.  Id. at *16.

Given each these info, and the “conclusory” nature of all of the plaintiffs’ consultants opinions as to this product, abstract judgment was granted on all claims involving this product.  Id.

Abstract Judgment #4 – Discovered Middleman Rule

All 13 plaintiffs’ warning claims had been additionally barred by the realized middleman rule, which holds that “the prescribing doctor is the related viewers for warnings a couple of medical machine or prescription drug.”  G/N, 2023 WL 5807340, at *16 (citations omitted).  Plaintiffs’ medical doctors had been adequately and well timed warned.  They obtained “a number of memoranda” from the defendant “over the course of a decade” that “particularly point out the circumstances complained of” and knowledgeable them methods to monitor and deal with sufferers below these circumstances.  Id. at *17.

The realized middleman rule thus barred all plaintiffs’ warning claims for 2 causes.  First, defendants’ warnings to the treating physicians had been enough as a matter of regulation as a result of they particularly warned of precisely what plaintiffs claimed occurred, “no matter how the physicians responded to these warnings.”  Id.  Second, there is no such thing as a responsibility to warn the medical neighborhood about issues that physicians are anticipated to know.

Plaintiffs declare that prescribing physicians had been unaware of such data and wanted to learn of it by way of warnings.  [Defendant] has proffered proof, together with testimony from plaintiffs’ personal consultants, that every one competent nephrologists perceive that acetate converts to bicarbonate and might learn the labels on the merchandise and see that they include acetate.  Plaintiffs, then again, have failed to supply any proof to point out that physicians would have modified their prescribing selections if completely different disclosures had been made.

Id.

Thus, the authorized lead to G/N was glorious.  4 abstract judgment motions leading to wins towards the entire plaintiffs at subject on all 4 points.  So cheers to that.  However this MDL was ten years outdated, and most of it had been settled.  Two of the grounds for abstract judgment had been based mostly on goal info that had been obvious from these plaintiffs’ medical data, which ought to have been produced on the outset of the litigation, some ten years in the past.  That they weren’t – and that such info had been solely used to do away with settlement holdout plaintiffs’ claims – signifies one more abject failure of MDL early vetting.