Posted on Wednesday, May 4th, 2016 at 11:13 am
The following post is part of our Law Student Blog Writing Project, and is authored by James Haney, a Juris Doctor student at NKU Chase College of Law, Northern Kentucky University.
Essure Birth Control
A Look at the Lawsuits Over Complications with Essure Birth Control
Birth control has been a method of female contraception for decades. In 1960, Enovid, the first oral birth control pill for women was patented. Since then, birth control has been a billion dollar industry, with no signs of slowing, as society becomes more liberal in its view of sex. More recently, IUDs (Intrauterine Devices) have become a mainstream alternative to a daily pill, an injection, or a patch. Essure, a Bayer product, is one of the most recent designs on the market. Unfortunately, though Essure is marketed as a permanent solution to birth control, some women are finding themselves in need of even more permanent procedure, in the form of a hysterectomy.
Marketing is one of the most important aspects of the success of any product, second only to, I would argue, the effectiveness of the product. Though, there is a case to be made that marketing is the most important. Numerous studies have been done on the science of marketing, as effective marketing is inexorably linked to monetary success. An interesting aspect of the Bayer page, is the methodical use of color. Numerous studies have been done on the effects of color on the human brain. It was found, in one specific study, that people taking the same sleep aid reacted differently to it, based on the color of the pill. Blue, green, purple, and other colors on the cooler side of the spectrum have been found to produce calmness and ease of mind, even without any chemical actors. This is why the inside of life rafts tend to be blue. Conversely, red, orange, yellow, and other colors on the warmer end tend to create a sense of excitement, or action. Essure has been marketed with blues and purples, suggesting a calmness to what could be considered a minor procedure. Essure is called the “only permanent birth control with a non-surgical procedure.”
By and large, the majority of the webpage for Essure is safety information, though. On the front page of every individual webpage for various Beyer products is a full list of medical and safety warnings. From 2009 to 2010, settlements by pharmaceutical companies totaled $8.6 billion. Needless to say, avoiding lawsuits is a positive business practice for companies. Ensuring the safety of a product goes a long way towards that end. Listed in the medical warnings for Essure is a warning suggesting that it is possible for the device to migrate within the woman’s body, which could require surgery to remove. What is not mentioned, is the extent of the surgery that is often required.
The idea behind Essure is that the device is placed into the Fallopian tubes, where scar tissue will amass, blocking contraception. The IUD is made of two metal coils. This is difficult to explain without it sounding like a medieval torture device, but the procedures (even the ones requiring surgery) to implant the devices are relatively painless, and simple outpatient procedures. A hysterectomy is significantly less benign. It involves the removal of the uterus, fallopian tubes, and potentially the ovaries. It typically has a lengthy recovery process. With the advent and continued improvement of modern medicine, the surgery is much less intrusive now, but is still a procedure only performed as a last resort, when there are no other options.
While litigation against Essure has only recently begun in any official capacity, complaints about the product are far from new. Thousands of women have reportedly experienced side effects including hysterectomies as aforementioned, colon perforations, unexpected pregnancies, depression, and weight gain. Some have also reported side effects such as burning or itching due to a nickel allergy. For other women, scans have revealed that the device had, in fact, disappeared altogether.
The first lawsuit against Bayer, in regards to Essure, was filed in Philadelphia in 2014, asserting that Bayer had mislead women about the simplicity and safety of the device, and violating the conditions of its premarket approval by the FDA. Premarket approval is a process by which a company can get approval from the FDA more quickly, allowing the product to hit the market sooner. Time is money, as the adage goes. Heather Walsh, the plaintiff in the action, also claimed that the doctor who did the procedure was ill-trained by Bayer, evidenced by the fact that three metal coils, as opposed to the correct two, were inserted. According to the complaint, the coils migrated out of her Fallopian tubes and led to five hospitalizations, a hysterectomy, and auto-immune and adhesion disorders. This case then beat federal preemption on March 22, 2016. What this means, is that the federal courts have deemed cases against Essure to be actionable, and will not step in to stop litigation (at least in the realm of product liability, as is the case here).
A simple Google search of current actions being levied against Essure reveals a number of advertisements to join class-action suits against the brand, and against Bayer. In fact, Erin Brockovich, the subject of 2000 film chronicling her role in the case against Pacific Gas and Electric Company in 1993, is spearheading a campaign against Essure. Ms. Brockovich states that, “It is a woman’s right to decide for herself if she wants a certain form of birth control but when they are not told of the devastating side effects, well that isn’t right.”
There is actually a social media group, who call themselves “E-sisters,” who have bonded together over the shared experience of being injured by Essure. Another group, more easily counted, on Facebook, called “Essure Problems,” has over 27,000 members. Since 2002, the FDA has received over 5,000 complaints about Essure, dating back to before Bayer bought the rights to the product, but most of them coming after the buyout. Likely, this has more to do with the ability of Bayer to effectively market and get a product into the market than it does with Bayer being negligent. Of course there will be more complaints when more people are accessing something. In a case such as this, where so many are alleging damage incurred, a class-action lawsuit is most common. A class-action lawsuit involves a large group asserting the same claim against the same defendant. If damages are levied against the defendant, in favor of the group, the awards are then divided up equally amongst the plaintiffs. Recently, almost comically, Red Bull settled a class-action suit, and awarded anyone who had used Red Bull the ability to pick up a certain amount of products for free, through the use of a voucher. So, basically, “Since you won the case against our product, we’re going to award you free amounts of said product.” Normally, though, it’s actual money, as was the case in 2004 in a $149 million settlement with Bridgestone for its Firestone tires.
A number of different forms of damages may be sought against Essure (damages being awards, typically monetary, given to those who claim to have been injured by a product). Most often, as just stated, damages in products liability cases are monetary. The idea is to make a person “whole.” Basically, return a person to their state of being before being injured. Damages may include medical costs, wages lost, future earning potential lost, pain and suffering, emotional distress, and even punitive awards, which are designed to punish the wrongdoer, rather than make the injured person whole. These various claims all have different degrees of difficulty in proving, but they are all within the realm of possibility, and the list is not exhaustive. In a 2014 wrongful death lawsuit against RJ Reynolds, a Florida jury awarded more than $23 billion in punitive damages to the widow of a former smoker.
Bayer may not be the only person (person being used in the legal sense that corporations are considered people, for the ability to be prosecuted) in danger of being sued, though. Kim Meyers, in an interview with BBC News, claimed she was pressured by her doctor to get Essure. She then suffered pelvic pain for three years, which had farther reaching implications than simply being uncomfortable. Meyers said, “[When I complained, my doctor] told me, ‘You’re a silly little woman, you’re hormonal.’” Doctors are absolutely in the crosshairs for some of these claims.
The case in Pennsylvania really opens up the door for future claims. I would suggest that there is simply no telling where the cases will land, or even if they will be allowed to be brought, but such a conjecture has been removed from the realm of possibility. Frankly, it seems to me that Bayer is in pretty serious trouble for damage inflicted by Essure. Mass litigation is only just underway, so it will probably be years before anything of any consequence comes to pass. Major news outlets will probably begin picking up on the story before too long. Were I a betting man (I am), I would say that the cases will likely end up being settled by Bayer. The money involved in a settlement usually doesn’t make or break a major company, but the money lost due to bad press can be very detrimental. I would expect to start seeing more and more as things come more into the realm of the collective public consciousness. Right now, though, “We’ve only just begun.”