Will the court deny Lilly's summary judgment motion in MDL 3094 (tirzepatide litigation), allowing claims to proceed to trial?

The legal standard for summary judgment heavily favors plaintiffs in MDL pharmaceutical litigation. The court must deny if there is ANY genuine dispute of material fact on ANY major claim category. With 8,096 FAERS serious adverse events and 283 deaths, plaintiff experts will have substantial data to construct causation arguments. The resolution criteria only requires denial on one of three claim categories. Failure to warn is the strongest plaintiff theory despite label disclosures, because claims center on adequacy of warnings and off-label promotion. Historical MDL precedent shows full summary judgment grants are uncommon when substantial FAERS data exists. However, off-label use defense and existing label disclosures are genuine mitigating factors.

Summary judgment requires showing no genuine dispute of material fact. In pharma MDL, the key battleground is expert testimony on causation. Expert depositions (March 27) precede summary judgment (April 16). If plaintiff experts survive Daubert challenges and establish any plausible causation mechanism, summary judgment denial on at least failure-to-warn claims is likely. The FAERS database showing 8,096 serious events provides epidemiological support, though FAERS is unreliable for causation inference due to reporting bias. The committee notes causation is 'difficult to prove' per the Regulatory Reader, but the legal standard for surviving summary judgment is much lower than proving causation at trial. The broad resolution (denial on ANY claim category) increases probability.

Base rate for MDL summary judgment outcomes: in major pharmaceutical MDLs, defendants rarely obtain complete summary judgment on all claims when there are thousands of plaintiffs and published adverse event data. Vioxx, Yaz/Yasmin, Risperdal, Xarelto - in most major MDLs, at least some claims survive. Exceptions (Zoloft, Lexapro) typically involved weaker epidemiological evidence. Here, 283 reported deaths and 8,096 serious events provide sufficient basis for plaintiff experts to construct plausible causation theories. Key risk is whether existing label disclosures preempt failure-to-warn claims. Mixed off-label and on-label use means at minimum some on-label cases likely survive. Meaningful probability of full grant if Daubert excludes plaintiff expert testimony, but this is minority outcome.

MDL 3094 has 3,063 claims. The legal bar for surviving summary judgment is 'genuine dispute of material fact' - not proof. With 8,096 FAERS events and 283 deaths, plaintiff experts will have data to work with. Resolution requires denial on just ONE of three categories. Failure-to-warn is the strongest path for plaintiffs. The off-label use defense helps Lilly but does not cover all claimants who used tirzepatide on-label. Base rate in major pharma MDLs favors at least partial survival. The committee's 62% probability of adverse regulatory development aligns with summary judgment denial as one component of regulatory risk.

Summary judgment in pharmaceutical MDL with 3,000+ claims and substantial FAERS data is an uphill battle for defendants. The 'any major claim category' resolution criteria is broad. Failure-to-warn will likely survive - some claimants used tirzepatide on-label and experienced adverse events beyond what labels adequately warned about. The real risk for plaintiffs is a Daubert challenge knocking out their expert testimony, which would enable summary judgment. But with 283 reported deaths and specific alleged injuries (gastroparesis, ileus, pancreatitis), finding qualified experts willing to testify causation is feasible given the known GLP-1 mechanism of gastric slowing.

The key tension is FAERS data volume (8,096 events) versus causation difficulty. The committee's Regulatory Reader notes causation is 'difficult to prove' while Gravy Gauge emphasizes FAERS volume. For summary judgment purposes, the relevant standard is not 'prove causation' but 'show genuine dispute about causation' - very different bars. A plaintiff expert who can articulate a plausible biological mechanism (tirzepatide's GLP-1 agonism slowing gastric emptying leading to gastroparesis) creates a fact dispute even if evidence is contested. The fact that GI effects are known and labeled actually supports the biological mechanism theory. Label adequacy then becomes a fact question inappropriate for summary judgment. Risk: September 30, 2026 resolution deadline - judicial delays are common, adding ~5% probability of timeout-based NO.

Summary judgment in pharma MDL with 3,000+ claims and FAERS data (8,096 events, 283 deaths) - historically, defendants rarely get full summary judgment in this scenario. Resolution requires denial on just one claim category. Failure-to-warn is the likely survivor. Off-label use defense does not cover all plaintiffs. The September 30 deadline introduces small risk of delay-based NO resolution.

Strong FAERS evidence (8,096 events, 283 deaths) creates plausible causation arguments sufficient to survive summary judgment. Summary judgment standard favors plaintiffs - court views facts in light most favorable to non-movant. Resolution broadly defined (any claim category). Key risk is Daubert exclusion of expert testimony, but with specific alleged injuries and known biological mechanism (GLP-1 gastric slowing), experts likely survive Daubert. High probability of at least partial denial.

Base rate: major pharma MDLs more often have partial summary judgment denial than full grant. FAERS data provides ammunition for plaintiff experts. Label disclosure defense is Lilly's strongest argument but does not resolve all claims, particularly for on-label users alleging inadequate warnings. September 30 deadline adds approximately 5% risk of timeout. Probability weighted toward denial but accounting for defense strength and delay risk.