|Essure--Screenshot courtesy of Bayer|
A federal judge in Philadelphia ruled that a case brought against Bayer Healthcare by 5 women who claim they were harmed by the drug giant's Essure sterilization coils can continue.
The company had asked that the lawsuit be dismissed, but last week U.S. District Judge John Padova in Philadelphia ruled that two of the women's claims against Bayer--that it used misleading advertising and failed to warn about the risks of the product--were reasonable enough for the case to continue.
Bayer, which has been hit by numerous similar lawsuits nationwide, had asked the case by thrown out because the FDA gave premarketing approval in 2002 for the implantable birth control device, which is a regulatory status that protects devices from product liability lawsuits in state courts. The device is made up of two metal coils inserted into the fallopian tubes.
"He's allowing the two claims to proceed, so we're moving forward with discovery," Marcus Susen, the plaintiff's lead attorney, told the Philadelphia Inquirer.
Bayer, in a statement, responded to the ruling saying it was pleased the judge narrowed the scope of the case, noting, "two prior courts considering similar claims dismissed those suits entirely."
Essure has been under fire from consumer complaints almost from the moment it was approved. Bayer inherited the device about a year after it hit the market when the giant drugmaker acquired Conceptus in a $1.1 billion deal in 2013.
The following year, the FDA said it would begin investigating the birth control device, and in September 2015, the regulatory agency held an advisory meeting where dozens of women urged regulators to withdraw the device because too little was known about Essure's potential risks. About 750,000 women have used the product, and 70% of them live in the U.S.
Last month, the FDA slapped Essure with a black-box warning in a move that came just weeks after an outside analyst released information that indicated a startling number of fetal deaths linked to the product. The agency has ordered a clinical study to look at the risks of Essure in certain women as well as issuing the draft guidance with updated labeling recommendations that include the black-box warning label.
Prior to the regulatory action, Madris Tomes, founder and chief executive of data analysis firm Device Events, released a report that found 303 fetal deaths were linked to Essure. The report was based on searches of side-effect reports on the FDA's website. Previously, the regulatory agency said it uncovered at least 5 fetal deaths in women who used the implant.
- check out the Inquirer story
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