Federal Court Mandates Gastric Emptying Studies for All Ozempic Gastroparesis Claims
On August 15, 2025, Judge Karen Spencer Marston of the United States District Court for the Eastern District of Pennsylvania issued a 78-page memorandum that reshapes the legal requirements for gastroparesis claims involving GLP-1 receptor agonist medications. This decision affects the consolidated MDL proceedings that now include over 2,400 cases.
Court Mandate: All plaintiffs must demonstrate gastroparesis diagnosis through gastric emptying scintigraphy, breath test, or wireless motility capsule (WMC) performed at the time of diagnosis showing delayed emptying. Those seeking to understand eligibility to file an Ozempic lawsuit must meet these new requirements.
The Court's Analysis of Expert Testimony
The court conducted extensive Daubert hearings examining three medical experts. Judge Marston systematically evaluated each expert's methodology against Federal Rule of Evidence 702, finding that the plaintiffs' proposed diagnostic approaches failed to meet reliability standards. This hearing followed the rescheduled MDL science day proceedings.
Dr. Daniel L. Raines, MD, FACG
Chief of Gastroenterology, LSU Health Sciences Center
18 years experience • ~2,000 patients annually
Court's Finding:
Dr. Raines claimed retained gastric food was "pathognomonic" of delayed emptying. The court found this contradicted peer-reviewed studies showing only 32-67% positive predictive value.
"The references on which Dr. Raines relies do not support his ultimate assumption." — Judge Marston, Page 40
Dr. Eliot L. Siegel, MD
Radiologist, Nuclear Medicine Specialist
37 years experience • ~2,000 gastric emptying studies interpreted
Court's Finding:
Despite extensive imaging experience, Dr. Siegel had never diagnosed drug-induced gastroparesis. His opinions were based solely on literature review for litigation.
"Portions of his opinion... were solely based on a literature review that he conducted to prepare his report." — Judge Marston, Page 64
Dr. Linda Nguyen, MD
Clinical Professor, Stanford; Interim Chief of GI/Hepatology
Co-author 2022 ACG Guidelines & 2025 Rome Consensus
Court's Finding:
Dr. Nguyen's methodology aligned with established medical guidelines. The court found her opinion that objective testing is mandatory to be reliable and scientifically supported.
"A diagnosis of gastroparesis cannot be made based on clinical presentation alone." — Dr. Nguyen's Report, Page 15
Scientific Evidence: Retained Gastric Food Study
The court examined the Bi 2020 study, which revealed that retained gastric food has varying predictive values for delayed gastric emptying depending on patient population:
General population (Bi 2020)
Diabetic patients (Bi 2020)
Type 1 cohort (Bi 2020)
The court found these predictive values insufficient for reliable diagnosis, particularly for the GLP-1 patient population who typically have Type 2 diabetes or obesity.
Medical Guidelines Cited
Rome Foundation Consensus
"By definition, gastroparesis implies an objective delay in gastric emptying... requires both an assessment of gastric emptying and confirmation of the absence of gastric outlet obstruction."
ACG Clinical Guidelines
"Gastroparesis is a motility disorder characterized by symptoms and objective documentation of delayed gastric emptying of solid food without mechanical obstruction."
UEG & ESNM Consensus
"The panel agreed that an upper endoscopy and a gastric emptying test are required for diagnosis."
Accepted Diagnostic Tests
Gastric Emptying Scintigraphy
Method: Radiolabeled meal tracked over 4 hours
Standard: Gold standard, most widely accepted
Gastric Emptying Breath Test
Method: 13C-labeled meal with breath sampling
Standard: FDA approved alternative
Wireless Motility Capsule
Method: SmartPill technology
Note: No longer manufactured (2023) but historical tests valid
Tests Rejected by the Court
CT Scan / MRI with Retained Food
Court found: "Not diagnostic of delayed gastric emptying"
Endoscopy with Retained Gastric Food
Court cited: "Lacks accuracy" per 2025 Rome Consensus
Ultrasound / Barium Swallow
Finding: "Unsuitable for solids, operator dependent"
Symptoms Plus Temporal Association
Ruled: "Symptoms are nonspecific and overlap with many conditions"
Affected GLP-1 Medications
Understanding the risks of Ozempic and other GLP-1 medications has become increasingly important. This ruling applies to all eight medications in the MDL:
Novo Nordisk
- Ozempic (semaglutide)
- Wegovy (semaglutide)
- Rybelsus (semaglutide)
- Victoza (liraglutide)
- Saxenda (liraglutide)
Eli Lilly
- Trulicity (dulaglutide)
- Mounjaro (tirzepatide)
- Zepbound (tirzepatide)
Court's Recognition of Impact
"The Court recognizes that given this ruling, some Plaintiffs in this MDL will be unable to prove that they suffered from gastroparesis because their diagnosis was not based on a properly performed gastric emptying study. Although unfortunate, it would be perhaps more unjust to hold Defendants potentially liable for damages based on an unreliable diagnosis."
— Judge Karen Spencer Marston, Page 77
This decision follows months of proceedings including the April 2024 status conference and the establishment of new direct filing and service processes for the MDL.
Access the Complete Court Ruling
Official Court Memorandum
Case: In Re: GLP-1 RAs Products Liability Litigation
MDL No.: 3094 | Document 467
Date: August 15, 2025
Length: 78 pages
Download Full Court Ruling (PDF)Have a Gastroparesis Diagnosis with Proper Testing?
If you do have a gastroparesis diagnosis through gastric emptying study and would like to further discuss your rights, feel free to contact The Levensten Law Firm, PC, to further discuss your rights to compensation.
Our experienced legal team can review your medical records to determine if your diagnosis meets the court's requirements.
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