Arcelia Sandobal Gomez had the Essure metal coils implanted in her fallopian tubes in 2014 and claimed she suffered intermittent and severe abdominal pain and chronic and abnormal vaginal bleeding afterwards. Gomez sued Bayer in 2017, claiming negligence, breach of warranty, failure to warn, fraud and misrepresentation.
A trial court dismissed Gomez’s claims with prejudice in 2018, agreeing with Bayer that federal law pre-empted New Jersey product liability law and that Gomez failed to state a claim that would allow relief to be granted. Gomez appealed.
The appeals court ruled that the trial court was correct in its preemption reasoning, and that “even when read indulgently,” Gomez’s claims fall short. Her manufacturing defect claim was “comprised of mere bald assertions” and was properly dismissed, the appeals panel ruled.
“We are mindful of the large number of reported problems experienced by women who had Essure birth control devices implanted,” the judges wrote in a unanimous opinion. “We are also aware of the non-binding cases in other jurisdictions which reach a different conclusion and which are not subject to New Jersey precedent. Our Supreme Court has spoken on the subject of federal preemption and the stricter pleading requirements pertaining to claims involving (devices granted FDA premarket authorization), and we follow its guidance here.”