Teva Pharmaceuticals U.S.A. Inc. must face a woman’s suit alleging it inadequately warned that its ParaGard intrauterine contraceptive device could break during removal.
Stephanie Ideus alleged enough facts to defeat Teva’s argument that federal drug labeling law preempts her claims, the U.S. District Court for the District of Nebraska said.
The IUD is a combination product that was approved as a drug.
The ruling illustrates the evolution of courts’ preemption analysis in prescription drug cases.
Ideus had the ParaGard placed in 2010. When doctors attempted removal in 2014, part of the IUD broke off and embedded in her uterus, necessitating additional surgery and putting her at risk for reproductive health complications, she alleged.
Teva argued it was required to sell ParaGard with the label approved by the Food and Drug Administration, precluding Ideus’s suit challenging the warning.
But manufacturers may unilaterally make warning changes if they have “newly acquired information,” such as data or analyses not previously submitted to the FDA, the court said. The company would therefore be able to comply with both federal regulations and state-law warning requirements.
The requisite “new information” is reflected in 24 reports that Teva submitted to the FDA regarding incidents in which a device had broken, Ideus alleged.
Kutak, Rock represented Ideus. Ulmer, Berne and others represented Teva.
The case is Ideus v. Teva Pharm. U.S.A., Inc., D. Neb., No. 16-3086, 2/23/18.