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Late last year, we published two posts (here and here) about the gutsy and laudable Daubert decision in the Mirena IIH (idiopathic intracranial hypertension) MDL, in which Judge Paul Engelmayer of the Southern District of New York excluded all seven of the plaintiffs’ general causation experts.   At that point, we assumed that it was a foregone conclusion that the plaintiffs’ claims would be dismissed—that no plaintiff could get to a jury without general causation evidence. But the plaintiffs weren’t going down without a fight, as set forth in today’s case, In re Mirena IUS Levonorgestrel-Related Prods. Liab. Litig. (No. II), 2019 WL 2433552 (S.D.N.Y. June 11, 2019)

After the Daubert decision was issued, Bayer moved for summary judgment, arguing that: 1) expert testimony is required to establish general causation in a pharmaceutical product liability case; and 2) even if lay testimony could, in theory, establish general causation, there wasn’t such testimony on the record of the case. Mirena, 2019 WL 2433552 at *1.   In response, the plaintiffs argued that 1) general causation is not a required element of proof; 2) expert evidence is not required to establish general causation; 3) a factfinder could find general causation through non-expert evidence in the record; and 4) granting summary judgment without case-specific discovery would violate the Seventh Amendment to the Constitution. Id.

The court wasn’t having any of it. First, the court emphasized that New York law requires a plaintiff to prove both general and specific causation, and that, in the absence of admissible evidence of general causation – that a product can cause a particular injury – there is no basis for a conclusion that the product caused the injury in a particular plaintiff. Id. at *9. In response to the plaintiffs’ argument that that the laws of certain states did not include this requirement, the court stated, “. . . [P]laintiffs’ portrait of state law as absolving a products-liability plaintiff from a need to establish general causation . . . is simply wrong.” Id. To the contrary, “all relevant jurisdictions require some evidence of general causation in products liability cases involving complex . . . medical issues.” Id.

Next, the plaintiffs argued that expert testimony is not always required to establish general causation – that general causation can be established by “alternative forms of evidence, for example, a corporate admission.” Id. at * 11.   The court conceded that, while “summary judgment is . . . commonly granted . . . where plaintiffs fail to adduce reliable expert testimony establishing general causation,” courts, including the Second Circuit “have left open the possibility that . . . lay evidence could possibly substitute for expert testimony.” Id. at *12-13.   But the court held that the plaintiffs’ argument – that a lay factfinder could connect snippets of the expert testimony the court had already excluded to piece together a general causation conclusion – was an attempted “end run around Rule 702” and the court’s Daubert ruling, and was “unsustainable.” Id. at *13. Nor, contrary to the plaintiffs’ argument, had “admissions” by the defendant’s own experts established general causation; rather, “the concatenation of scientific propositions from which plaintiffs construct a causal chain [fell] far short of a . . . corporate admission of general causation.” Id. at *20 (internal punctuation and citation omitted).

The plaintiffs also argued that the label warnings on a different contraceptive product containing the same hormone, LNG (levonorgestrel), created a fact issue on the issue of general causation and defeated summary judgment.   The court rejected this argument as well, noting that the other product was a subdermal implant, not an intrauterine device, and produced substantially higher systemic levels of LNG than did Mirena. Moreover, the other product’s label did not reflect a determination by FDA that LNG caused IIH but merely that IIH had “been reported on rare occasions” in users of the product.

Finally, the plaintiffs argued that granting summary judgment before plaintiff-specific discovery took place would be unconstitutional because it would violate the Seventh Amendment’s right to a jury trial. The court “easily dispatched” this argument, holding that it was “long established that summary judgment does not violate the Seventh Amendment,” notwithstanding the court’s “decision to stage discovery, consistent with the guidance of the JPML, so as to front-load discovery on the potentially dispositive issue of general causation.” Id. at *24.

We love this decision, and we congratulate Bayer on this final nail in the coffin of this MDL. In a world in which so much seems broken these days, the progression from the Daubert decision to this summary judgment decision is just the way this is supposed to work. Experts are supposed to be excluded when their methodologies are not reliable.   And cases are supposed to be dismissed when plaintiffs can’t prove causation. We wish it happened more often.  And we’ll keep you posted when it does.