July 20, 2018 Update: Bayer is halting sales of Essure after thousands of women have filed lawsuits alleging that these metal implants are causing hurting women, including perforation of both the uterus and the fallopian tubes. This could drive this litigation and make these cases easier to reach an out-of-court settlement? Why? Because Bayer is more likely to defend an existing product than one that has been taken off the market.
The Essure Permanent Birth Control System is a non-hormonal permanent birth control procedure that creates a natural barrier against pregnancy. The way it works is a soft, flexible insert is placed into a woman's fallopian tubes. Over about three months, a natural barrier is formed around the inserts. Bayer, who sells Essure, is marketing that this procedure can be done in 10 minutes, usually in doctor's office. When you compare this to an invasive procedure like a hysterectomy, it is an easy sell for many women.
How does Essure work? Essure causes a blockage of the fallopian tubes by the insertion of the device into the fallopian tubes which then anchor and elicit tissue growth. This creates the blockage that is intended to prevent pregnancy.
This artificial barrier keeps sperm at bay from the woman's eggs and prevents conception. After three months, a doctor administers a confirmation test to see if the inserts were placed correctly and the fallopian tubes are blocked appropriately. Bayer says that this is a nearly 100% effective form of birth control.Side Effects with Essure
The FDA received thousands of adverse event reports from women on Essure. In massive numbers, women were complaining that the device has caused them severe injuries. Specifically, they have claimed the following symptoms:
- autoimmune diseases
- pelvic, arm, leg and back pain
- perforated organs
- burning sensation
- abdominal pain
One way our lawyers get a feel for which drugs and medical devices are hurting people and should be recalled is: taking the pulse of patients online. There is a massive movement on Facebook with a group call Essure Problems that has nearly 25,000 members. Women are pretty private about their birth control. But when this many women are standing up; it tells you a lot about the birth control.How Bayer Has Responded to Concerns
Bayer got involved with Essure when it bought Conceptus for over $1 billion, three years ago. Many doctors now say that more research needs to be done to establish what, if any, relationship exists between the device and the problems some patients have experienced.
The British Medical Journal reports that Essure users have experienced pain, allergic reactions, and complications due to the device which has caused these women to have surgery. These women were ten times more likely to need surgery, within a year, than women who had their tubes tied.
But Bayer is standing by its new purchase. Why would Bayer stand behind Essure in light of these concerns? When you are talking about drug and medical device companies, most questions end with a single word answer: profit.
Arguably, Bayer has been acting suspiciously. Bayer has been cited for:
- failing to report and actively concealing eight perforations, which occurred as a result of Essure which makes you wonder what else they have been hiding
- using non-conforming materials in the making of the device;
- manufacturing Essure at an unlicensed facility and without a license to do so.
Bayer has also had all sorts of problems with Essure's conditional Premarket Approval ("CPMA") which later became invalid because Bayer did not comply with all of its obligations, including reporting problems women have had with the device.
Does this mean that Bayer is knowingly standing behind a defective device that should not be on the market? No. But where there is smoke, there is often fire and Bayer certainly has financial incentives to defend Essure, which has already been sold to 750,000 women.
If Bayer's mistakes with Essure at some point lead to a class action settlement, no one will be surprised; including Bayer's shareholders - who have just gotten past settlements related to its birth control drug Yaz. One notable feature of the Yaz cases is the Bayer's Mirena IUD is also the subject of many ongoing lawsuits.
How can all of these Bayer birth control products end in disaster? Does Bayer just not know what it is doing? Or does it know exactly what it is doing and these lawsuits just an accepted part of doing business? When Bayer bought Conceptus, there were already Essure lawsuits percolating. You have to wonder how important these lawsuits are when you are a company like Bayer that is bringing in around $46 billion a year in revenues. Can Bayer make more money recalling Essure or just paying the class action settlements like it did with the Yaz cases?What is Next for Essure?
The first big issue for the Essure litigation was whether federal preemption. Plaintiff's lawyer climbed over that hill in McLaughlin v. Bayer Corp. The court rejected Bayer's contention that there is implied preemption. This was big because it kept the cases moving forward.
There was a big FDA meeting to discuss Essure, the growing concerns of women, and the best path for public safety moving forward. Bayer was wildly criticized at that FDA meeting for not providing the data to give the FDA -- and women and their doctors -- the information to make the right call. Will the FDA act? Anyone who understands the history of the FDA knows that it is almost invariably behind the curve. So it is reasonable to expect lawsuits, litigation, and settlements before the FDA finally catches up.
There is also a bill in the House of Representatives ordering the FDA to pull Essure off the market. Of course, Congress can barely tie its shoes, much less pass a bill to protect women. It has been referred to the Subcommittee on Health where it will almost certainly die without a vote. Thankfully, Bayer has decided to stop selling Essure. Unfortunately, it took until 2018 for this to happen after nearly 30,000 adverse event reports with Essure.
Plaitniff's lawsuits have four key claims:
- Essure is defectively designed;
- Bayer made material misrepresentations concerning Essure;
- Bayer inadequately warned of the risks of Essure; and
- Essure devices were defectively manufactured.
It is a little premature to be talking how much victims can expect to receive in any Essure lawsuit. But, again, these cases are now a lot easier to settle with Bayer pulling this birth control device off the market.
If there are settlements, and we are likely a good ways from that even if things go well for plaintiffs. Nothing has been proven yet and it will take a lot of work in the ramp-up to these lawsuits to see just how strong these cases are. If there is a mass settlement in the Essure cases, it will likely be based on the injuries suffered. So a perforated organ case is likely to be worth a great deal more than someone who has limited abdominal pain.