FDA rule means Essure patients with complications can't sue
9:40 PM, Nov 8, 2013
As thousands of women join force to complain about complications with a popular birth control device they're learning there's one fight they can't win. An FDA rule means the maker of the device they've found problematic, Essure, can't be sued.
Two tiny metal coils have been generating a conversation for thousands. A Facebook page discussing Essure problems now has more than 3,500 members.
"This has really blown up and every day we have a handful of women that come and they tell us their stories and tell us their symptoms," said Bel Air resident and page administrator Krystal Donahue.
Essure's original manufacturer, Conceptus, promoted the device as a safer, cheaper, less invasive way to effectively tie your tubes. But Donahue and others say it caused them nothing but problems.
"It's hurting us and i really feel like the FDA has let us down," Donahue said.
The Food and Drug Administration approved the device in 2002 and still tracks its issues. More than 900 adverse reactions have been reported to the agency, although Bayer, which bought Conceptus back in June, says that's a tiny fraction of the more than 750,000 users worldwide.
For the women with complications, the issues they've reported have been painful. They've reported nausea, back pain, cysts and even the need for hysterectomies they hope will get their bodies back to normal. But even if they succeed at feeling better, the woman impacted by the device still can't take legal action.
The Essure patients can't sue because of a rule you've probably never heard of. It's called FDA preemption, which bars lawsuits against some approved devices.
"They've given them a pass. That's exactly what they've done," said Robert Jenner, an attorney with Janet, Jenner and Suggs in Pikesville.
Jenner has been fighting device and drug cases that involve the FDA for almost three decades. But he says law firms turn down preemption cases on a daily basis.
Devices given pre-emption are generally ones you put inside your body, things like the Essure coils, a pacemaker or pump.
Jenner says the idea behind preemption is that the companies that make approved devices get protection from the FDA and can't be sued because the agency so heavily scrutinizes their devices. But attorneys and patient advocates consider it a flawed concept.
"This is a $100-billion industry. There's simply not enough money, not enough time and not enough people in the FDA to give it the oversight, the attention that it needs," Jenner told us.
There is attention that comes during product development, during the approval process and in long-term testing. But even if a product or device turns out to be problematic or defective, Jenner says preemption means even if you tried to take the maker to court, your case would likely be thrown out.
"Unless and until the law is changed, they're just out of luck," said Jenner.
But women impacted by Essure aren't out of influence. They've drafted one of the country's most famous activists to help with their cause, Erin Brockovich.
"You know what, let's just put the truth out there and deal with what we've got," said Brockovich.
Brockovich developed a website, collecting the stories of women who've dealt with Essure side effects. She's pushing to make the FDA or Bayer to pull the product off the market.
"All this shucking and dodging and denying of responsibilities, I don't know what else it takes for us to look at a group of women, thousands of them that are having a problem, that maybe something is wrong. You can't just say now it's mass hysteria," said Brockovich.
Brockovich is trying to harness the collective effort of the women whose stories she's shared on the web. She believes their pain should be publicized, not just to shine a light on problems with Essure, but also problems with preemption.
"This is something I think needs to go to the next level, a higher level. And that's going to be in Washington," Brockovich said.
The women we spoke with want change as well. They says they want not just to end their pain but to make sure no one else ends up with the same problems they've shared.
On Saturday a group of Essure patients is meeting with physicians involved in a global gynecology congress in Washington, D.C. The women say their goal is to inform the ob-gyns they meet with about their unreported side effects. They also want to discuss what they believe are inconsistencies in the studies of Essure and spread the word to other ob-gyns so they're aware of potential issues they've experienced with the device.