Last August, a ruling by California Superior Court Judge Winnifred Y. Smith issued a ruling that allowed 14 Essure lawsuits to proceed against the manufacturer, Bayer.

Judge Smith found that the Essure lawsuits did not fall under the federal preemption law that Bayer was claiming. Attorneys for Bayer attempted to argue that under federal permission to market the birth control device, they could not be held liable for the injuries women allegedly suffered from its use.

Bayer stated that because Essure was an FDA approved Class III medical device, it should have immunity from Essure lawsuits. Bayer says its device went through a strict process in order to get approved in the first place, known as Premarket Approval or PMA.

According to the FDA website, “PMA is the most stringent type of device marketing application required by FDA.”

Women across the country are hoping that Judge Smith’s ruling will help to influence the pending Essure lawsuits throughout the country, and that medical device manufacturers can be held liable if their devices are found to be unsafe.

Essure is a permanent birth control device for women. It consists of two metal coils that are implanted into the fallopian tubes.

After the coils are implanted, an inflammatory reaction occurs and scar tissue begins to build around the coils until they completely block the fallopian tubes. This prevents eggs from being released and fertilized, thus preventing conception.

A number of side effects have been reported by Essure users including severe pain, autoimmune conditions, chronic migraine, heavy bleeding, ectopic pregnancy, stillbirth, metal allergies and more.

Side effects experienced by an Essure user prompted a Congressional Bill to be proposed last year. Known as Ariel’s Grace Law, this proposed legislation by Congressman Mike Fitzpatrick seeks to end the preemption defense that manufacturers can currently use in product liability lawsuits.

Essentially, manufacturers of over 360,000 FDA approved devices have had legal immunity in these civil cases. Ariel’s Grace Law seeks to close the legal loopholes and have manufacturers be held accountable for their devices.

Manufacturers say they have gone through strict procedures for FDA approval, but critics who look further note that the studies for medical devices are often flawed, not properly carried out, or don’t disclose the full results to the medical community and public, among other criticism

When digging even further, the FDA details what FDA approval means – and doesn’t mean – in its own words on its website. Most people think that devices and pharmaceutical drugs undergo strict third-party testing in order to get approval. This is a great misconception, and the FDA describes its role as follows:

• With respect to new drugs, “FDA does not develop or test products before approving them. Instead, FDA experts review the results of laboratory, animal, and human clinical testing done by manufacturers. If FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the known risks for the intended use.”
• With respect to medical devices, “To receive FDA approval for these devices, manufacturers must demonstrate with sufficient, valid scientific evidence that there is a reasonable assurance that the devices are safe and effective for their intended uses.”

So essentially, all drug manufacturers and device manufacturers carry out their own research which is not independently monitored or quality controlled in any way.

Essure lawsuits and other lawsuits against drug and device companies point out that the studies undertaken are inherently biased, because essentially “The fox is guarding the henhouse.”

Women who have filed Essure lawsuits hope that the recent California Superior Court ruling, the proposed Ariel’s Grace Law, and greater information about the inherent conflict of interest present in clinical trials conducted solely by product manufacturers themselves allows for more individuals to speak out and hold companies accountable to consumers who value safety and transparency.