A Pennsylvania federal judge has agreed to prioritize two main arguments at issue in a growing number of lawsuits over the alleged side effects of GLP-1s, a legal decision that developers of the drugs say could significantly limit the number and nature of claims.
Hundreds of plaintiffs have alleged a variety of gastrointestinal symptoms after taking Novo Nordisk and Eli Lilly’s blockbuster GLP-1 products, with the vast majority — perhaps more than 95%, according to plaintiffs’ attorneys — involving gastroparesis, or paralysis of the stomach.
In July, Novo Nordisk and Eli Lilly asked the court to focus the first phase of litigation on key questions to “help narrow the scope,” including which testing requirements to diagnose gastroparesis. Novo and Lilly also asked the court to review claims that their drug labels are inadequate or downplay gastrointestinal symptoms, arguing such claims may be preempted by federal law.
The court granted the drugmakers’ request last week, ruling that the issues are “cross cutting” and “worthy of early resolution.” Lilly said in court documents that the resolution of those first two issues could provide “essential information needed to promptly resolve nearly all of the claims against Lilly.”
Lilly and Novo argued that gastroparesis is often misdiagnosed and that most plaintiffs making the claims “do not even allege they had a gastroparesis diagnosis — let alone one confirmed by objective diagnostic testing.” They also argued that “the terms nausea, vomiting, and abdominal pain each appear more than ten times in the current Wegovy label,” and similarly “strong and repeated severe gastrointestinal warnings” are present for Eli Lilly’s medicines.
“Lilly believes it is critical that only sound science makes its way into the courtroom,” an Eli Lilly spokesperson told Endpoints News on Thursday.”Lilly does not believe these lawsuits have merit, and we are vigorously defending against these claims.”
The plaintiffs have opposed addressing the two issues upfront and argued it could amount to a delay of “at least one year and likely much longer.”
“We look forward to demonstrating why Defendants’ argument that gastroparesis can only be diagnosed with a gastric emptying study is incorrect and at odds with well accepted clinical practice in the United States. We are likewise confident that Defendants will be unable to demonstrate that Plaintiffs’ failure to warn claims are preempted,” the plaintiffs’ co-lead counsel said in a joint statement to Endpoints on Thursday.
Judge Karen Spencer Marston deferred a ruling on a third request by defendants to determine whether GLP-1s are capable of causing the gastrointestinal symptoms patients are alleging.
While there are currently 842 cases, lawyers representing plaintiffs say cases in the multidistrict litigation could “easily reach the thousands, if not tens of thousands,” according to court documents.
Novo Nordisk declined to comment.