Update, January 2017: we are no longer accepting Mirena perforation cases, but we are representing clients in a Mirena intracranial hypertension lawsuit.

Contraceptives are perhaps the most commonly discussed medications in the United States, usually as a matter of politics. When it comes to contraceptive safety, contraceptives should be discussed like any other drug or medical device, and that’s the same way as the big pharmaceutical companies see them: as a profitable product in a large consumer market.


The Terrible Legacy Of The Dalkon Shield Intrauterine Contraceptive

For women of a certain generation, and medical device lawyers of any age, the term “intrauterine device” conjunctures up images of the horrific damage inflicted by the Dalkon Shield IUD on thousands of women in the 1970s. The defective design made the Dalkon Shield a conduit for bacteria into the uterus, causing pelvic inflammatory disease (PID), damage to the fallopian tubes, ectopic pregnancies, sterility, and more. Hundreds of thousands of lawsuits were filed and the company declared bankruptcy; eventually, $3 billion was paid out of the company’s remaining assets.


The Financial Motive Behind The Rapid Growth In Mirena Marketing And Prescribing

More than 12 million American women take oral contraceptives, a multi-billion dollar market in which the largest player is Bayer HealthCare, the manufacturer of Yaz / Yasmin.  But Bayer faces two problems with Yaz. First, the main patent for Yaz expires in June 2014, and other companies have started selling generic versions of it. (Unsurprisingly, Bayer has sued them all.) Second, Yaz causes blood clots far more frequently than Bayer claimed it would, prompting thousands of lawsuits (thousands of them filed right here in Philadelphia) that are projected to settle for a billion dollars or more.

Bayer has thus long been on the hunt for a new product to replace the dwindling profits from Yaz, and the company may have found one in the Mirena, an intrauterine device (technically a “levonorgestrel intrauterine system”) that’s supposed to be more effective than the pill, because there’s no chance of making a mistake “missing a pill” while using it.


Mirena Is Safer Than Dalkon Shield — But Over 45,000 Women Have Reported Problems, Including Severe Complications After The IUD Migrated And Perforated Internal Tissues

As an article in the June 2011 edition of Wired magazine explained, Mirena isn’t Dalkon Shield. Studies as recently as November 2012 confirm that modern IUDs don’t have nearly the same risk of pelvic inflammatory disease, so long as implanting physicians follow the recommended protocol. Some reproductive health researchers have found that family physicians and obstetrician-gynecologists don’t really know much about IUDs beyond the Dalkon Shield debacle, and have started advocating for increased awareness about Mirena and the other IUD on the US market, Paragard — which the IUD manufacturers are more than happy to encourage.

But Mirena has its own problems. Since 2008, the FDA has received more than 45,000 “adverse event reports,” i.e., individual submissions from patients or doctors suggesting the device failed or caused an injury. It seems that a third of these involve a patient reporting that the IUD came out on its own, which is frustrating, but it’s also usually harmless.  Of greater concern, more than 10,000 women have reported their Mirena migrated to a different position in their uterus, eroded the vaginal wall, and perforated their uterus, becoming embedded elsewhere. Thousands more women reported worrying signs of a migration, like heavy vaginal bleeding, severe abdominal pain, or peritonitis.

It thus seems Mirena might have a problem totally separate from the Dalkon Shield; the Mirena IUD is unusually prone to perforated the uterus, causing damage and requiring surgery to remove it. While some of the Mirena lawsuits arise from other allegations, we focus our legal representation on patients who have suffered a migration or perforation requiring surgery.


Bayer Has Already Been Reprimanded By The FDA Over Mirena Marketing

As I mentioned above, Bayer has a huge financial incentive to boost Mirena sales (already well over $1 billion), because sales of their Yaz / Yasmin pill birth control are falling, and will fall dramatically in 2014 after the main patent expires. We already know the company is skirting the line on FDA regulations: back in late 2009 / early January, the FDA issued a Warning Letter to Bayer, noting that the company’s “Simply Style” marketing materials and scripts for sales representatives including a variety of false, misleading, and scientifically unsupportable statements.

For example, Mirena sales representatives were told to say “Mirena has no daily, weekly, or monthly routines to comply with as compared to the negatives associated with other birth control methods,” when in fact Mirena’s prescribing information for physicians says: “Patients should be reexamined and evaluated … 4 to 12 weeks after insertion and once a year thereafter, or more frequently if clinically indicated.”  The prescribing information also says that patients should check that the threads attached to Mirena are in place after each menstrual cycle, and thus on a monthly basis, to ensure that Mirena has not become displaced or expelled — something critically important for identifying and treating IUD migration.

The FDA concluded “the claim that there is no ‘monthly routine to  comply with’ is a false statement.” This incident — and the extent to which Bayer dragged its feet to avoid updating the warning label on Yaz and Yasmin — lead us to doubt that Bayer is being entirely candid about the risk of perforations with Mirena.


The Growing Number Of Mirena Lawsuits Alleging Perforation And The Need For Surgical Removal

As of late 2012, nearly three dozen lawsuits had been filed by women alleging Bayer Pharmaceuticals and Berlex Laboratories were negligent in the design, testing, and manufacture of Mirena, and demanding compensation for these injuries. Some of these lawsuits complications as far-ranging as Lupus, but the core of the litigation is in New Jersey — where Bayer is based (and one of the states in which I’m licensed to practice law, hence my close interest in these cases) — and those cases primarily allege that the Mirena implant migrated from its appropriate position in the uterus, typically by perforating surrounding tissues, causing severe symptoms and requiring surgical removal.

Bayer filed an application in August 2012 requesting the New Jersey courts order “consolidated” handling of the numerous claims against them, because they expect many more claims to be filed. We certainly expect more cases to be filed, as we’re investigating and preparing some now.