This past August, the Honorable Judge Winifred Y. Smith of the Superior Court in Alameda County, California, made a ruling that spells bad news for corporate defendant Bayer, manufacturer of the Essure contraceptive device. A ruling that also proves to be a real help to the thousands of women who are suing the company over injuries caused by the product.
Bayer has been trying to hide behind a law known as “Federal Preemption.” Because Essure had the approval of the FDA to market Essure, its corporate attorneys have been arguing that Bayer cannot be sued or otherwise held accountable for the injuries caused by the device.
Essure was approved by the FDA in November of 2002. At that time, it was manufactured and distributed by Conceptus, which was taken over by Bayer in 2013. That approval was questionable for a number of reasons. First of all, Essure was given “Pre-Market Approval,” or PMA – meaning that all a manufacturer had to do is demonstrate that the device is “substantially similar” to a device that is already on the market.
The FDA’s Center for Devices and Radiological Health (CDRH) granted Conceptus an “expedited review” because “it offers significant advantages over existing approve alternatives” for contraception, the primary reason being that it could be inserted without the need for surgery.
Since that approval, many questions have been raised about the entire process – particularly, the manufacturer’s lack of follow-up, which was required by the original PMA. That approval was contingent upon Conceptus conducting two additional Post-Approval Studies over the next five years. Over the decade following the original FDA approval, Conceptus received more than 30,000 adverse event reports involving Essure. Based on those reports, Conceptus could have revised the warning label – and indeed, had an obligation to do so. The company was also obliged to notify the FDA of these reports.
Conceptus failed on both counts. In this, Conceptus and Bayer “concealed and misrepresented” the safety of the device as it continued to market Essue as “safe and effective.”
In addition to its failure to warn and its misrepresentation of the product’s safety, plaintiffs allege that Bayer failed to “appropriately certify and train physicians” in how to insert the device and determine whether or not the patient was a suitable candidate.
As for Bayer’s claim that they are immune to legal action because of the preemption doctrine, an attorney for the most recent plaintiff says the company’s position is “untenable.” Rand Nolen represents Kristiana Burrell, who filed a wrongful death lawsuit on behalf of her stillborn daughter in mid-December. Nolen says, “[Bayer] will have a difficult time arguing that under the specifics of this case.” He explains that when a medical device manufacturer such as Bayer claims preemption, they are in essence telling plaintiffs that they have no recourse. “We don’t believe that anybody ever intended that that would happen,” Nolen says.