Ozempic MDL Court To Evaluate Need for Gastroparesis Diagnostic Testing in GLP-1 Lawsuits

The U.S. District Judge presiding over all federal lawsuits being pursued by former users of Ozempic, Wegovy, Mounjaro and other GLP-1 medications indicates that before any individual cases are prepared for trial, the court will first rule on preemption motions and determine whether plaintiffs must have specific diagnostic testing to establish they developed a gastroparesis injury.

Hundreds of Ozempic lawsuits, Wegovy lawsuits and Mounjaro lawsuits are currently being pursued against the manufacturers of popular GLP-1 diabetes and weight loss drugs, each raising similar allegations that users were not adequately warned about the risk of serious gastrointestinal problems, which may result in complete paralysis of the stomach, known as gastroparesis.

Given the widespread use of the drugs in recent years, it is ultimately expected that tens of thousands of claims may eventually be pursued by former users diagnosed with gastroparesis, each presenting similar allegations that the drugs’ propensity to delay gastric emptying can result in permanent and long-term health problems.

Since February 2024, the cases have all been consolidated as part of an Ozempic lawsuit MDL, which centralized claims brought throughout the federal court system before U.S. District Judge Karen S. Marston for coordinated discovery and pretrial proceedings, including a series of early “bellwether” trials, which will be used to help gauge how juries may react to certain evidence and testimony that will be repeated throughout the GLP-1 lawsuits.

However, before moving forward with case-specific discovery and preparing any individual cases for trial, Judge Marston recently agreed to adopt a proposal submitted by the drug makers to bifurcate discovery in the litigation, prioritizing pretrial proceedings that will allow the court to issue early rulings about whether the claims are pre-empted by federal law and whether plaintiffs must provide specific gastroparesis diagnostic testing evidence in the Ozempic, Wegovy and Mounjaro lawsuits.

In addition, the court is still considering whether the first phase of discovery will also include an examination of whether there is sufficient evidence that Ozempic causes gastroparesis, or whether general causation issues will be addressed during the work up of individual bellwether claims for trial.

GLP-1 Lawsuits Phased Discovery Order

Early in the Ozempic MDL, the drug makers urged the court to split the discovery process into two distinct phases, first addressing a number of what they refer to as “cross cutting issues”, which they suggest may lead to the dismissal of large numbers of lawsuits.

Although plaintiffs opposed the request, arguing that a phased discovery process will only extend the amount of time it will take to get the first Ozempic lawsuits before a jury, Judge Marston issued a case management order (PDF) on August 23, agreeing to address at least two of the three “cross cutting issues” before allowing the parties to move forward with case-specific discovery.

The first phase of early discovery and motion practice will include an examination of whether the plaintiffs’ claims are preempted by federal law based on FDA-approved warnings included on the drug label about gastrointestinal side effects.

The Court also found that it will be pivotal to focus early in the litigation on whether plaintiffs must provide gastroparesis diagnostic testing to reliably establish they had the 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.

“Given the proportion of Plaintiffs alleging gastroparesis and the potential importance of diagnosis to Plaintiffs’ failure to warn claims, the Court finds this issue is cross cutting and an early decision on how to reliably diagnose that condition is appropriate,” said Judge Marston in the order.

Dispute Over Timing of Discovery About Link Between Ozempic and Gastroparesis

The drug makers have also urged Judge Marston to focus the first phase of discovery and motions practice on a third “cross cutting” issue, involving general causation, and whether plaintiffs can produce sufficient scientific evidence to establish that GLP-1 drugs are capable of causing the gastrointestinal injuries experienced by plaintiffs.

In the order issued late last month, the Court indicated that it was reserving judgment on whether this will be addressed during the first phase or later during a bellwether process, requesting that the parties submit additional briefing on the issue.

In a letter (PDF) submitted on August 28, the drug makers argued that including general causation in the first phase of discovery will further streamline the litigation, since issues will overlap substantially with information that will need to be exchanged regarding the preemption issues about the adequacy of the warning labels.

The drug makers also indicate that addressing general causation early in the litigation will help the parties and the Court select a more representative group of claims for early bellwether trials at a later date, which will more effectively promote potential Ozempic settlements or another resolution for the litigation.

Plaintiffs also submitted a letter (PDF) on August 28, urging the Court to address the issue of general causation during a bellwether process, indicating the they will need a “fulsome discovery across all issues” to fairly litigate the issue.

“In this case, the significant amount of discovery required to litigate general causation for each of the Defendants’ drugs and each of the Plaintiffs’ injuries removes any efficiencies gained by litigating ‘cross cutting’ general causation issues,” according to the letter submitted by plaintiffs’ lawyers. “However, should the Court decide that general causation should be litigated outside of a bellwether context, Plaintiffs request the full record fairness requires.”

It is expected that Judge Marston will issue a comprehensive scheduling order after considering the parties’ joint proposal at a case management conference scheduled for September 16, 2024.