An Idaho federal judge has allowed one Essure birth control lawsuit to proceed, despite Bayer’s argument that Plaintiffs’ claims are preempted by federal law. Attorneys say the decision should inject new life into the growing Essure litigation.
“Failure To Warn” Claims Survive In Idaho Federal Court
The lawsuit at issue, filed by a husband and wife, reached the US District Court for the District of Idaho on September 23, 2015. In the complaint, a woman claims that she had Essure, a permanent birth control device, implanted in her Fallopian tubes in December of 2011. Only one year later, the woman, along with her husband, discovered that she was pregnant with twins.
In an August 30, 2016 decision, Chief Judge B. Lynn Winmill held that Plaintiffs could move forward on allegations that Bayer failed to warn the US Food & Drug Administration of Essure’s potential side effects. Idaho state law, Judge Winmill noted, enforces a “parallel” requirement, which allows Plaintiffs to seek compensation if a device manufacturer withholds knowledge of dangers from the FDA.
Judge Winmill has also granted Plaintiffs’ leave to amend another claim, in which the couple alleges that Bayer failed to properly train implanting physicians on the use of hysteroscopic equipment. The lawsuit has been logged as case number 4:15-cv-00443-BLW.
Hundreds Of Essure Lawsuits Filed
Hundreds of other women have filed suit against Bayer, claiming the company’s birth control implant Essure causes severe side effects, including permanent autoimmune disorders, and often fails to prevent pregnancy. But since the device gained approval through a special FDA regulatory pathway – established for life-saving or high-risk medical devices – manufacturers can be granted a degree of legal immunity from personal injury claims. Bayer has used this defense – that state law claims over the birth control implant are “preempted” by federal law – to defend against multiple Essure lawsuits.
But in at least two other rulings, federal judges have held, like Judge Winmill, that Bayer’s preemption argument cannot be applied universally to every allegation leveled against the company. In Pennsylvania and California, federal judges have ruled similarly, holding that Plaintiffs’ “failure to warn” the FDA claims are not preempted.