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Five women who are suing Bayer Healthcare over health complications associated with the Essure birth control device can proceed with their lawsuits, a federal judge recently ruled. The women will be able to move forward with their claims that Bayer failed to properly warn about the risks of Essure and also used misleading advertising.
This is a major development in the case, because it means the process of obtaining pretrial evidence, or “discovery,” can proceed. It could also open the doors for other Essure lawsuits to be filed.
In addition, U.S. District Judge John Padova’s ruling means he believes the plaintiffs’ improper warning and misleading advertising claims have merit. Even though Essure received premarket approval from the U.S. Food and Drug Administration (FDA) – which will typically protect a medical device or drug from litigation – this approval will not prevent the plaintiffs from pursuing their claims.
Hundreds of women across the country are filing lawsuits against Essure for complications, claiming they suffered severe health complications after implantation of the Essure device. These include painful menstruation, pain during sex, migration of the device to other areas of the body and more. Some women have needed extensive surgery to remove the Essure and find relief from their discomfort.
The five cases addressed by Judge Padova have been consolidated in a Philadelphia court. Observers are keeping a close eye on these cases, because they have advanced the farthest and may eventually serve to help shape the strategy of future Essure litigation.
Judge Padova rejected many of the plaintiffs’ claims, but ruled that two of them were reasonable – that Bayer’s Essure advertising was misleading and the company failed to properly warn healthcare providers and patients of the potential dangers of the device. As a result, the case will be able to move forward.
More than 5,000 adverse events associated with Essure have been reported to the FDA. The Facebook group “Essure Problems” has 28,000 members.