Bayer is facing a number of lawsuits alleging that the permanent birth control device Essure led to injuries such as pain, bleeding and device migration. A group of 98 women recently filed a lawsuit in Missouri and over 200 lawsuits have been filed in California alone. Now, a court ruling may pave the way for additional cases.
According to an August 2nd court ruling, Judge Winifred Y. Smith of the Superior Court in Alameda County sided with plaintiffs on three separate grounds where Bayer tried to have 11 lawsuits dismissed. Bayer alleged that it was not liable for plaintiffs’ injuries because their claims were preempted by federal regulations. Judge Smith rejected these motions.
The court decision allows the 11 lawsuits, representing 14 plaintiffs, to move forward but it may also have wider implications. By ruling that Bayer may be held liable for plaintiff injuries, the action could make it easier for other individuals to file lawsuits over medical device injuries.
Lawsuits filed over Essure allege that Bayer downplayed the risks associated with the permanent sterilization device, which was marketed as a quick, straightforward procedure that does not require surgery or anesthesia. During the procedure, a tiny metal coil is inserted into each fallopian tube. As scar tissue grows around the coil, it is supposed to block the egg from being fertilized.
Concerns over Essure grew, however, as women increasingly complained of adverse events such as bleeding, device migration, organ perforation and miscarriage. Their complaints gained more attention with the growing popularity of the Facebook group “Essure Problems”. In light of these complaints, the FDA held an advisory panel of independent experts last fall. The panel concluded that there was not enough data to prove that Essure is safe, and use of the device should be limited. The FDA followed up by advising a black box warning in February.
Modern Healthcare reports that Essure concerns have raised questions about the FDA’s method of approving medical devices. In thirteen years, more than 5,000 adverse event reports were submitted over Essure. The permanent birth control device was approved as a Class III medical device in 2002, meaning it was subject to the strictest regulations before hitting the market.