Litigators jockey for advantage as MDL 3094, 3163 GLP-1 court cases maneuver through pretrial
Attorneys on both sides of MDL 3094 and MDL 3163 are maneuvering and jockeying for position as multi-district litigation against the makers of GLP-1 drugs including Ozempic, Wegovy, Rybelsus, Trulicity and Mounjaro edges closer to actual testimony.
The cases break down into two categories: those claiming gastrointestinal injury and those claiming damages to vision among users of the blockbuster weight-loss drugs that were originally developed to fight diabetes.
The manufacturers, including Novo Nordisk and Eli Lilly deny all the allegations and are expected to challenge the underlying scientific basis of the charges while also impugning the reliability of the expert witnesses called by each side.
Multi-district litigation (MDL) is similar to class actions in that large numbers of plaintiffs are wrapped into a single proceeding except that in class actions, all of the plaintiffs are consolidated into a single case. In an MDL, cases from various court districts are heard by a single judge during pretrial sessions but remain separate cases.
Gastrointestinal and vision issues
In the GLP-1 cases, MDL 3094, consolidated in September 2023, focuses on gastrointestinal injuries while another, MDL 3163, deals with vision loss allegedly caused by an interruption of the blood supply to the optic nerve. Both are being handled by Judge Karen S. Marston in the Eastern District of Pennsylvania.
There have been no rulings on the merits of the allegations yet, as Judge Marston wades through a thicket of motions, pleadings and other tactics used by litigators to eke out a strategic led up. Among her actions so far:
On April 30, Judge Marston set deadlines for expert challenges and summary-judgment motions on “cross-cutting” issues involving warning adequacy, federal preemption and general causation.
Novo Nordisk filed a May 19 “roadmap” brief seeking to knock out key plaintiff causation theories. Novo says it filed five motions targeting plaintiff experts on ileus/intestinal obstruction, persistent gastroparesis, gallbladder disorders, “class effect” opinions, and animal-study opinions. It also seeks summary judgment based on FDA-approved labeling and alleged lack of admissible general-causation proof.
Eli Lilly also filed a May 19 roadmap brief aimed at expert testimony and summary judgment. Lilly’s filing identifies motions to exclude opinions on gastroparesis, warning adequacy/preemption, ileus and obstruction, gallbladder claims, class-effect opinions, and animal studies. Lilly also says it is seeking summary judgment on gastroparesis, ileus/obstruction, gallbladder and other gastrointestinal or miscellaneous injury claims.
The allegations
As of May 20, the FDA has received more than 207,000 adverse event reports related to Ozempic, Wegovy, Zepbound and Mounjaro, among the most popular of the GLP-1 medications. Intestinal complications made up the bulk of the initial complaints, with allegations of vision loss developing later.
The earliest Ozempic lawsuits focused on stomach paralysis (gastroparesis) and intestinal blockages (ileus). Patients often report severe nausea, vomiting that can last for weeks, abdominal pain and significant weight loss that they did not expect.
Vision loss (NAION) is the second main category. This rare condition can cause sudden and typically permanent vision loss in one eye. Research has suggested a link between semaglutide drugs and a higher risk of NAION.
Current status
The case now appears to be at a major pretrial inflection point. The important next event is not a trial but the court’s handling of expert challenges and summary-judgment motions, expected to occur at several sessions over the next several months.
Those rulings could narrow the MDL substantially, especially if Judge Marston excludes key causation experts or accepts defendants’ warning/preemption arguments.
