Summary judgment briefing filed in MDL 3094 on warnings adequacy and preemption
Drugmakers filed summary judgment papers in the federal GLP-1 injury litigation on April 30, 2026, arguing defenses that could end thousands of gastroparesis and bowel-obstruction claims before any trial.
Manufacturers of GLP-1 drugs filed summary judgment briefing on April 30, 2026 in MDL 3094, the consolidated federal litigation over alleged gastrointestinal injuries, with full briefing set to run through July 2026 [1]. The filings press cross-cutting defenses that apply across the case pool rather than to individual plaintiffs — including the argument that federal drug labeling law preempts state-law failure-to-warn claims. The specific contents of the briefs are not laid out in the sources available here.
The litigation is before Judge Karen S. Marston in the U.S. District Court for the Eastern District of Pennsylvania, where the MDL was created in February 2024 [1]. Defendants include Novo Nordisk, which makes Ozempic, Wegovy and Rybelsus (semaglutide) plus Victoza and Saxenda (liraglutide), and Eli Lilly, which makes Mounjaro and Zepbound (tirzepatide) and Trulicity (dulaglutide) [1].
What the case pool looks like
As of September 2026, 4,022 cases were pending in MDL 3094, out of 4,056 total filed, after growth of about 202% since January 2025 [1]. Roughly 75% of complaints allege gastroparesis, sometimes called stomach paralysis; about 18% allege ileus; and about 8% allege gallbladder injuries [1].
The April 30 filing came days after the April 28, 2026 deadline for Daubert motions, which challenge whether expert testimony is reliable enough to reach a jury, and after expert depositions wrapped up in April 2026 [1]. Both sets of motions are now fully briefed [1].
Summary judgment and Daubert rulings are gatekeeping steps. A preemption ruling in the manufacturers' favor could knock out failure-to-warn claims broadly, on the theory that companies could not have changed their FDA-approved labels on their own. A ruling for plaintiffs would push cases toward trial.
The warnings timeline at the center of the dispute
Plaintiffs argue the labels did not adequately warn that delayed gastric emptying — a known mechanism of these drugs — could become severe or persistent [1]. The labels have changed repeatedly during the litigation: FDA added an ileus warning in September 2023, added a pulmonary aspiration warning tied to general anesthesia in January 2025, and in October 2025 updated the Ozempic label to state the drug "is not recommended in patients with severe gastroparesis" [1].
An October 2023 JAMA analysis by Sodhi and colleagues reported that people using GLP-1 drugs for weight loss had 9.09 times higher risk of pancreatitis, 4.22 times higher risk of bowel obstruction and 3.67 times higher risk of gastroparesis compared with another weight-loss drug [1].
In August 2025, after more than 3,700 pages of briefing and evidentiary hearings, Judge Marston issued a 78-page ruling on how gastroparesis must be diagnosed in these cases, and she continues to require objective diagnostic testing — typically a gastric emptying study — for gastroparesis claims [1].
Vision-loss claims are handled separately. In December 2025 the JPML created MDL 3163 for NAION, a form of sudden vision loss; it had about 200 cases as of September 2026 and is also assigned to Judge Marston [1].
Why it matters for patients
For people taking or considering semaglutide or tirzepatide, this filing does not change anything on the label or at the pharmacy counter. Court rulings about preemption and expert evidence decide who can sue and what a jury may hear; they do not add or remove warnings. The label changes that have already happened — ileus in 2023, aspiration risk in 2025, and the October 2025 severe-gastroparesis language — are the parts of this story that affect prescribing conversations [1].
For people who believe a GLP-1 drug caused a serious gut injury, the practical consequence is timing and proof. The court's insistence on objective testing means medical records showing a gastric emptying study carry weight [1]. And no settlements have been announced; analysts quoted by the source estimate combined liability across both MDLs could exceed $2 billion, but that is a projection, not a payout [1].
What happens next
Summary judgment briefing runs through July 2026 [1]. Bellwether trial selection was still expected around mid-2026, with first trials possible in late 2026 depending on how the pending motions are decided [1]. Mass settlements are considered unlikely before late 2027 [1]. How the court will rule on preemption is not yet known.
This article is legal and regulatory news, not medical or legal advice.
Sources
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