GranuFlo/NaturaLyte MDL Substantive Rulings – Higher Late Than By no means


Photo of Bexis

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 working, it seems.  Over the previous decade, the G/N MDL had distinguished itself for – not a lot, actually.  We wrote a grand whole of one put up about it throughout that point, which collected a number of one-off state-law rulings, however zero preemption, skilled admissibility, or core product legal responsibility points determined.

Till a short while 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 determination adjudicated 4 abstract judgment motions involving 13 opt-out plaintiffs – most of whom have 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 idea – 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 dying.”  G/N, 2023 WL 5807340, at *1.  This medical causation idea 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 skilled witnesses “all depend on the info mentioned” in that memo.  Id. at *3.

Abstract Judgment #1 – Inadequate Pre-existing Threat

The defendant’s first abstract judgment movement was in opposition to these plaintiffs (10 of them) whose bicarbonate ranges by no means reached the extent recognized within the 2011 memo as making a cardiac danger.  These plaintiffs have 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 “carried out no impartial research” and “explicitly relied on” the memo as the idea of their opinions). 

Though plaintiffs aren’t essentially certain by the [2011] Memo, it’s related in assessing their idea 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 an appropriate vary, they’ve did not adduce competent proof in assist of their claims.

Id. at 11.

Thus, “none of their consultants purported to alter 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 skilled assist for causation outdoors the scope of the 2011 memo required dismissal.  “[P]laintiffs have did not set forth any competent proof in assist of their claims that primarily any pre-dialysis quantity comports with their idea 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 every other – 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.  This kind of purely goal factual info is exactly the kind 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 facet 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 presently being proposed within the little-better-than-nothing draft Fed. R. Civ. P. 16.1.

Additionally in opposition to the bicarbonate degree abstract judgment, some plaintiffs trotted out a brand new idea of legal responsibility − “that any pre-dialysis bicarbonate degree, 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 idea, (2) none of their consultants supported it; (3) it contradicts their principal idea; 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 degree plaintiffs additionally misplaced on failure to warn.  Their “consultants testified {that a} doctor wouldn’t be anticipated” to alter a any remedy earlier than utilizing the product with a low bicarbonate degree affected person.  Id. at *12.  Thus, no warning as to those plaintiffs might probably have made a distinction, for the reason that purported warning was inapplicable to their decedents.  No “treating physician[s] would have executed 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 might “not proven that their decedents died because of this” of the situations alleged, or their accidents have been “not proximate in time to their final dialysis remedies.”  G/N, 2023 WL 5807340, at *13.  Each common and particular causation are, after all, important parts 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” modifications (<7 hours), and eight of the plaintiffs fell outdoors of that timeframe (between 8 ½ hours and eight days).  Id.

The defendant received once more.  Plaintiffs cooked up one other new idea a few supposed a “delayed bicarbonate ‘spike’” purportedly “as a consequence of 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 isn’t any proof within the document that any of the decedents at subject have been sluggish to metabolize.”  Id.

Whereas we applaud this end result, we level out that, as soon as once more, the idea for abstract judgment consisted of goal information that will be instantly obvious from a evaluation of those plaintiffs’ medical data – the reason for dying and the period of time after these plaintiffs’ final use of the product that dying occurred.  Any rudimentary early vetting of those plaintiff would have found these information, thereby averted having these bogus claims stay on the MDL docket for a decade.

Abstract Judgment #3 – Naturalyte

Defendant additionally received abstract judgment in opposition to 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 skilled testimony was blatantly contradictory.

Though [plaintiffs’ expert] endorses plaintiffs’ allegations that NaturaLyte is harmful and faulty as a consequence of 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] will not be thought-about extra.

G/N, 2023 WL 5807340, at *15.  Certainly, the skilled 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 information, 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 – Realized Middleman Rule

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

The discovered middleman rule thus barred all plaintiffs’ warning claims for 2 causes.  First, defendants’ warnings to the treating physicians have been sufficient as a matter of legislation 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 isn’t any obligation to warn the medical group about issues that physicians are anticipated to know.

Plaintiffs declare that prescribing physicians have been unaware of such info and wanted to be told of it through 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, however, have failed to provide any proof to indicate that physicians would have modified their prescribing selections if completely different disclosures had been made.


Thus, the authorized end in G/N was glorious.  4 abstract judgment motions leading to wins in opposition to the entire plaintiffs at subject on all 4 points.  So cheers to that.  However this MDL was ten years previous, and most of it had been settled.  Two of the grounds for abstract judgment have been based mostly on goal information that have 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 information have been solely used to do away with settlement holdout plaintiffs’ claims – signifies yet one more abject failure of MDL early vetting.


Leave a Reply

Your email address will not be published. Required fields are marked *