The landscape for GLP-1 receptor agonists—popular medications like Ozempic, Wegovy, and Mounjaro—is shifting rapidly. While these drugs have revolutionized the treatment of Type 2 diabetes and obesity, they are now at the center of significant legal scrutiny.
As of December 2025, the litigation has expanded beyond gastrointestinal issues to include serious vision concerns. Here is an update on the Multidistrict Litigation (MDL) involving gastroparesis and the newly formed MDL for NAION.
1. The Gastroparesis Litigation (MDL 3094)
The original federal litigation, MDL 3094, is centralized in the Eastern District of Pennsylvania under Judge Karen S. Marston. This group of lawsuits focuses on severe gastrointestinal injuries.
- What is Gastroparesis? Often called “stomach paralysis,” it is a condition where the stomach takes too long to empty its contents. This can lead to persistent nausea, severe vomiting, and malnutrition.
- Current Status: As of December 2025, there are nearly 3,000 cases pending.
- Key Developments: In late 2025, Judge Marston issued critical rulings regarding diagnostic requirements. Currently, the court is requiring plaintiffs to provide objective evidence of delayed gastric emptying (such as a gastric emptying study) to proceed.
- Timeline: Bellwether trials—representative cases used to gauge how juries might react—are expected to begin in early 2026.
2. The New Vision Loss MDL: NAION (MDL 3163)
In a major development on December 15, 2025, the Judicial Panel on Multidistrict Litigation (JPML) approved a second, separate track for vision-related claims: MDL 3163.
- What is NAION? Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) is a condition caused by reduced blood flow to the optic nerve. It typically results in sudden, painless vision loss in one eye, often noticed upon waking. It is frequently permanent and has no known cure.
- Why a Separate MDL? While the drugs involved are the same, the court ruled that the medical and scientific evidence for vision loss is distinct from gastrointestinal issues. By separating them, the court aims to handle the specific complexities of ophthalmological science more efficiently.
- Coordination: Although it is a separate MDL, it has also been assigned to Judge Karen Marston. This allows for “coordinated discovery,” meaning the legal teams can share evidence regarding the manufacturers’ internal documents and marketing practices while keeping the medical experts separate.
3. Recent Scientific & Regulatory Warnings
The legal momentum follows several significant scientific findings and regulatory actions in 2025:
- Harvard/Mass General Study: Research published in JAMA Ophthalmology indicated that diabetic patients on semaglutide (Ozempic/Wegovy) were significantly more likely to develop NAION compared to those on other medications.
- WHO and EMA Action: In June 2025, the World Health Organization (WHO) issued a warning regarding the potential link between semaglutide and NAION. The European Medicines Agency (EMA) also recommended updating labels to reflect the risk of vision loss.
- FDA Label Updates: While the FDA added a warning for ileus (intestinal blockage) in late 2023, the Ozempic label was further updated in January 2025 to state it is not recommended for patients with existing severe gastroparesis.
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