Teva Pharmaceutical Industries Ltd. (TEVA) tried to hit the pause button on litigation involving its Paragard intrauterine device, but a federal judge wasn't having it. On Monday, U.S. District Judge Leigh Martin May denied the company's bid to delay the first trial in what's become a sprawling legal battle involving roughly 3,800 lawsuits.
The trial is set to kick off January 20 as planned, making it the first bellwether case in the consolidated federal litigation. For those unfamiliar, bellwether trials are basically test cases that help both sides figure out how juries might respond to similar claims down the road.
So what's this all about? Paragard is a copper-based, non-hormonal contraceptive device that can stay implanted for years. The problem, according to thousands of plaintiffs, is that the IUD can fracture during removal, potentially breaking inside the uterus and causing injuries, fertility complications, and the need for surgical intervention to fish out the pieces.
The Delay Strategy That Didn't Work
Teva had asked the court to pause everything while it appealed an earlier ruling that rejected the company's attempt to dismiss the claims entirely. The logic was straightforward enough: if we win the appeal, this whole thing goes away, so why waste everyone's time with a trial? Teva argued a successful appeal could end the litigation that includes those 3,800 centralized federal lawsuits.
Plaintiffs saw it differently, calling the request primarily a delay tactic designed to unnecessarily stall progress. Judge May apparently agreed, keeping the trial date intact.
The FDA Preemption Defense
Here's where things get interesting from a legal perspective. Back in November, both Teva and The Cooper Companies (COO) sought summary judgment, arguing that FDA approval preempts state-law claims about the device's design and warning labels. Their position: any changes plaintiffs want would have conflicted with FDA-approved specifications, and while design modifications are allowed when new information emerges, Paragard's risk of breakage has been known for a long time.
Judge May wasn't buying that argument entirely. She expressed particular concern about claims that Teva took five years to comply with an FDA mandate issued in 2010 to update Paragard's warning labels. The judge indicated the delay appeared intentional and suggested Teva might be trying to rely on its own noncompliance to support its preemption defense. That's a tough look.
In a December ruling, May rejected Teva's argument that federal law barred the claims because the company couldn't change the warning label without FDA approval. She found evidence suggesting Teva had received new safety information that could have supported a label update, regardless of when patients received the device.