Carroll indicates that he was prescribed Ozempic in 2022 for the treatment of type 2 diabetes. However, he quickly began to suffer from abdominal pain and vomiting.
After persistent pain and suffering, Carroll was given a gastric emptying test, which revealed he was suffering from gastroparesis.
Following the diagnosis, he was told to discontinue using Ozempic. However, he has still suffered severe and potentially permanent injuries, the lawsuit notes, which could have been avoided if the manufacturer had added adequate warnings to the Ozempic label.
“From the date Novo Nordisk received FDA approval to market Ozempic until the present time, Novo Nordisk made, distributed, marketed, and/or sold Ozempic without adequate warning to Plaintiff’s prescribing physician(s) and/or Plaintiff that Ozempic was causally associated with and/or could cause gastroparesis and its sequelae,” Carroll’s complaint states. “Defendants knew or should have known of the causal association between the use of GLP-1RAs and the risk of developing gastroparesis and its sequelae.”
Ozempic Gastroparesis Testing Requirements at Issue in Litigation
Carroll’s diagnostic testing for gastroparesis may provide critical evidence in his lawsuit, which many other plaintiffs pursuing the litigation do not have, since doctors often do not order gastric emptying tests.
Given common questions of law and fact raised in hundreds of claims similar to the one filed by Carroll, the U.S. JPML established an Ozempic lawsuit MDL in February 2024, which centralized claims brought throughout the federal court system before U.S. District Judge Karen S. Marston for coordinated discovery and pretrial proceedings.
As part of the coordinated management of the litigation, Judge Marston recently indicated that the court is prioritizing pretrial proceedings that will allow early rulings about whether the claims are preempted by federal law and whether plaintiffs must provide specific gastroparesis diagnostic testing evidence in the Ozempic, Wegovy and Mounjaro lawsuits.
The Court has determined that it will be pivotal to focus early in the litigation on whether plaintiffs must provide proof of gastroparesis diagnostic testing to reliably establish they actually experienced that specific injury, which is expected to be the claimed diagnosis in over 95% of the Ozempic lawsuits.
The drug makers argue that objective testing is needed to reliably diagnose gastroparesis, yet most doctors do not order that testing, since it does not impact the course of treatment. Therefore, defendants are likely to push for the dismissal of large numbers of claims if the Court determines that gastroparesis diagnostic testing is necessary to establish their case.
On October 10, Judge Marston issued a case management order (PDF) outlining deadlines for the submission of expert reports from all parties over the importance of gastroparesis diagnostic testing, and what kind of testing qualifies. The deadlines lay out the schedule for the parties to serve and respond to expert reports, with all parties to complete expert depositions on gastroparesis diagnostic issues by February 4, 2025.
The parties will have until February 20 to submit motions to exclude certain expert opinions, with opposition briefs due by March 17, 2025, and submission reply briefs due by March 25, 2025. Therefore, any ruling on the requirement for gastroparesis diagnostic testing is not expected until the second half of 2025.
After this and several other “cross cutting” issues are addressed, the court is expected to establish a bellwether program, where a small group of representative claims will be prepared for early trial dates to help gauge how juries may respond to certain evidence and testimony that will be repeated throughout the litigation.
While the outcomes in these claims will not be binding on other claimants, the average lawsuit payouts may impact the amount of Ozempic and Mounjaro settlements the drug makers may later need to offer to avoid the need for each individual case to go before separate juries in future years.