In a split decision in a federal appeals court this week, a Southeast Nebraska woman lost her lawsuit against the maker of a IUD that warned her physician — but not her — that it could break as it's removed and become embedded in her uterus.
It did, and the woman had to have a surgery to remove it.
In 2016, she sued Teva Pharmaceuticals USA, the Pennsylvania maker of the ParaGard IUD, saying she wasn't adequately warned by the company of the possible risks associated with it.
It's a T-shaped device placed in the uterus said to prevent pregnancies for up to 10 years.
In court, both sides agreed that the company's patient brochure didn't warn that the device could break.
But Teva's lawyers argued the company didn't have to because the woman's physician was warned.
The case prompted a debate over the so-called "learned intermediary doctrine," an exception to the general rule that a manufacturer or seller can be held liable for failing to adequately warn of risk inherent to a product's design.
"In essence, the doctrine provides that when prescription drugs are involved, a manufacturer's duty to warn is discharged so long as the manufacturer provided adequate warnings to a patient's prescribing health care provider," Chief U.S. District Judge John Gerrard wrote in an order dismissing the case in 2019.
He said some courts — particularly in Massachusetts and Michigan — distinguish contraceptives from other prescription drugs and say the doctrine shouldn't apply to them.
But the Nebraska Supreme Court hasn't yet been asked to address whether it would. So Gerrard said he was tasked with predicting the answer.
Teva's attorneys argued that a physician prescribing a drug is in the best position to assess the risks, and because contraceptives are prescribed, the doctrine necessarily applies.
Gerrard agreed and dismissed the case, prompting an appeal to the 8th Circuit Court of Appeals.
This week, in a 2-1 decision, a three-judge panel agreed.
Writing for the majority, Judge David Stras of Minneapolis said all Teva was required to do under Nebraska law was warn medical professionals about ParaGard's potential risks.
"Every indication is that the Nebraska Supreme Court would follow what has become an 'overwhelming majority' rule," he said.
Senor Judge Roger Wollman of Rapid City, South Dakota, signed on to the opinion.
Judge Jane Kelly of Cedar Rapids, Iowa, the third judge on the panel, dissented, saying she would have certified the question to the Nebraska Supreme Court before deciding the case.
"Though a federal court sitting in diversity generally has a duty to resolve state-law issues properly before it, in my view, this case presents one of the unusual circumstances where certification is necessary," she wrote.
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