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The Granuflo/Naturalyte MDL (“G/N”) was created a decade ago, in 2013.  In re Fresenius Granuflo/Naturalyte Dialysate Products Liability Litigation, 935 F. Supp. 2d 1362 (J.P.M.L 2013).  Notwithstanding a settlement in 2016, it’s still up and running, it appears.  Over the past decade, the G/N MDL had distinguished itself for – not much, really.  We wrote a grand total of one post about it during that time, which collected several one-off state-law rulings, but zero preemption, expert admissibility, or core product liability issues decided.

Until a little while ago.

That changed with In re Fresenius GranuFlo/NaturaLyte Dialysate Products Liability Litigation, ___ F. Supp.3d ___, 2023 WL 5807340 (D. Mass. Sept. 7, 2023).  This G/N decision adjudicated four summary judgment motions involving thirteen opt-out plaintiffs – most of whom were subject to more than one of the motions.  All thirteen plaintiffs had their claims dismissed.  That’s good.  But why it took a decade to resolve factual issues that could have been dealt with long ago, with decent early vetting of plaintiffs’ claims, left us shaking our heads.

All these plaintiffs advanced the same general medical causation theory – that the composition of the two products at issue led to a “dangerous increase” of blood “bicarbonate levels,” which in turn could cause “cardiac arrest and sudden cardiac death.”  G/N, 2023 WL 5807340, at *1.  This medical causation theory was outlined in a 2011 memo authored by the defendant’s then-chief medical officer, which touched off the ensuing storm of litigation.  Id. at *2.  Plaintiffs four medical expert witnesses “all rely on the data discussed” in that memo.  Id. at *3.

Summary Judgment #1 – Insufficient Pre-existing Risk

The defendant’s first summary judgment motion was against those plaintiffs (10 of them) whose bicarbonate levels never reached the level identified in the 2011 memo as creating a cardiac risk.  Those plaintiffs were in trouble because all of their experts slavishly relied on the memo.  G/N, 2023 WL 5807340, at *9 (plaintiffs’ experts “conducted no independent studies” and “explicitly relied on” the memo as the basis of their opinions). 

Although plaintiffs are not necessarily bound by the [2011] Memo, it is relevant in assessing their theory of causation, not least because their experts all explicitly purported to rely on it in rendering their opinions. . . .  [W]ith considerable testimony from their own experts that all of the plaintiffs fell within an acceptable range, they have failed to adduce competent evidence in support of their claims.

Id. at 11.

Thus, “none of their experts purported to change a prescription on numbers” in these plaintiffs’ ranges, and “none testified that he or she was concerned about [those] numbers.”  Id. at *10.  The complete lack of expert support for causation outside the scope of the 2011 memo required dismissal.  “[P]laintiffs have failed to set forth any competent evidence in support of their claims that essentially any pre-dialysis number comports with their theory of general causation.”  Id.

That’s great, but why is this only being addressed after a decade of litigation?  Whether these – or any other – plaintiffs had a “pre-dialysis number” too low to qualify for the 2011 memo is something that should have been immediately apparent from their medical records.  This type of purely objective factual information is precisely the sort of thing that should have been produced at the outset of the litigation so that plaintiffs with facially bogus claims would not have, as these ten plaintiffs did, remain in litigation for a decade.  Thus, while this aspect of G/N was a win for the defendant, it was inexcusably delayed.  This MDL demonstrates, yet again, that MDLs require far more rigorous early vetting than is currently being proposed in the little-better-than-nothing draft Fed. R. Civ. P. 16.1.

Also in opposition to the bicarbonate level summary judgment, some plaintiffs trotted out a new theory of liability − “that any pre-dialysis bicarbonate level, low or high, could still lead to a cardiac event solely based on the administration of” the targeted products.  Id. at *11.  However:  (1) plaintiffs never pleaded that theory, (2) none of their experts supported it; (3) it contradicts their main theory; and (4) it is an attack on dialysis as a procedure, not on any particular product.  So these plaintiffs chalked up another fail, trying to make up something new on the fly.  Id.

Finally, the low bicarbonate level plaintiffs also lost on failure to warn.  Their “experts testified that a physician would not be expected” to change a any treatment before using the product with a low bicarbonate level patient.  Id. at *12.  Thus, no warning as to these plaintiffs could possibly have made a difference, since the purported warning was inapplicable to their decedents.  No “treating doctor[s] would have done something differently had they been forewarned.”  Id.

Summary Judgment #2 – Causation

Eleven of the thirteen G/N plaintiffs also lost outright on causation.  Either they could “not shown that their decedents died as a result” of the conditions alleged, or their injuries were “not proximate in time to their last dialysis treatments.”  G/N, 2023 WL 5807340, at *13.  Both general and specific causation are, of course, essential elements of any tort.  Id.  As to the first causation point, the 2011 memo was limited to certain arrhythmias.  Four plaintiffs, however, claimed a variety of other fatal conditions.  Id.  As to the second, the 2011 memo was limited to “rapid” changes (<7 hours), and eight of the plaintiffs fell outside of that time frame (between 8 ½ hours and 8 days).  Id.

The defendant won again.  Plaintiffs cooked up another new theory about a supposed a “delayed bicarbonate ‘spike’” purportedly “due to slower metabolism.”  Id. at *14.  However, the study they relied upon did not include any patient with a “spike,” id. at *15 (“[n]either of those two outliers had a belated ‘spike’”), and “there is no evidence in the record that any of the decedents at issue were slow to metabolize.”  Id.

While we applaud this result, we point out that, once again, the basis for summary judgment consisted of objective facts that would be immediately apparent from a review of these plaintiffs’ medical records – the cause of death and the amount of time after these plaintiffs’ last use of the product that death occurred.  Any rudimentary early vetting of these plaintiff would have discovered these facts, thereby avoided having these bogus claims remain on the MDL docket for a decade.

Summary Judgment #3 – Naturalyte

Defendant also won summary judgment against five plaintiffs who claimed exposure to only one of the two products at issue in the MDL – not Naturalyte.  Again, causation was the issue.  Chiefly, this victory was because the plaintiff’s expert testimony was blatantly contradictory.

Although [plaintiffs’ expert] endorses plaintiffs’ allegations that NaturaLyte is dangerous and defective due to the fact that it contains [a specific level of its active ingredient], his own testimony and practices demonstrate that such a charge is unsubstantiated.  On numerous occasions, as outlined above, [this expert] testified that [this exact level] is not considered excess.

G/N, 2023 WL 5807340, at *15.  Indeed, the expert himself used this product for his patients and never gave them the warning that plaintiffs claim was required.  Id.  Several other p-side experts testified similarly.  Id. at *16.

Given both these facts, and the “conclusory” nature of all the plaintiffs’ experts opinions as to this product, summary judgment was granted on all claims involving this product.  Id.

Summary Judgment #4 – Learned Intermediary Rule

All 13 plaintiffs’ warning claims were also barred by the learned intermediary rule, which holds that “the prescribing physician is the relevant audience for warnings about a medical device or prescription drug.”  G/N, 2023 WL 5807340, at *16 (citations omitted).  Plaintiffs’ doctors were adequately and timely warned.  They received “several memoranda” from the defendant “over the course of a decade” that “specifically mention the circumstances complained of” and informed them how to monitor and treat patients under those circumstances.  Id. at *17.

The learned intermediary rule thus barred all plaintiffs’ warning claims for two reasons.  First, defendants’ warnings to the treating physicians were adequate as a matter of law because they specifically warned of exactly what plaintiffs claimed happened, “regardless of how the physicians responded to those warnings.”  Id.  Second, there is no duty to warn the medical community about things that physicians are expected to know.

Plaintiffs claim that prescribing physicians were unaware of such information and needed to be informed of it via warnings.  [Defendant] has proffered evidence, including testimony from plaintiffs’ own experts, that all competent nephrologists understand that acetate converts to bicarbonate and can read the labels on the products and see that they contain acetate.  Plaintiffs, on the other hand, have failed to produce any evidence to show that physicians would have changed their prescribing decisions if different disclosures had been made.


Thus, the legal result in G/N was excellent.  Four summary judgment motions resulting in wins against all of the plaintiffs at issue on all four issues.  So cheers to that.  But this MDL was ten years old, and most of it had been settled.  Two of the grounds for summary judgment were based on objective facts that were apparent from these plaintiffs’ medical records, which should have been produced at the outset of the litigation, some ten years ago.  That they were not – and that such facts were only used to get rid of settlement holdout plaintiffs’ claims – indicates yet another abject failure of MDL early vetting.