In recent years, many women have switched from more traditional birth-control pills to newer, “fourth generation” combination pills. Among the brands in this category are best-sellers Yaz, Yasmin, and Ocella. Yaz and Yasmin are manufactured by Bayer Healthcare, while Ocella is manufactured by Barr Laboratories.
The drugs are approved for three purposes: preventing pregnancy, treating premenstrual dysphoric disorder, and treating moderate acne. But, as our birth injury attorneys are only too well aware, FDA approval is nowhere near the end of the story where drug safety is concerned.
The drugs contain a recently-developed form of synthetic progestin called drospirenone. They also contain ethinyl estradiol. These two hormones work in combination to prevent pregnency. These pills work in the same manner as “second-generation” pills, which used an older form of synthetic progestin.
But there is a dark side to these popular pills. As more women switched to these medicines, it became clear that there were many unintended effects, as well. It has now emerged that drospirenone (the synthetic progestin in these pills), causes several dangerous side effects – some directly, and some apparently indirectly, by causing increased levels of potassium in the blood. Some studies have shown that these side effects occur at twice the rate of other forms of birth control. Other problems from dangerous or defective birth control drugs include:
- Deep vein thrombosis (blood clots in the legs)
- Pulmonary embolism (blood clots in the lungs)
- Heart attack and stroke
- Gall bladder disease, or removal
- Liver Damage
- Anaphylactic shock
- Cervical cancer
- Hair loss
These problems can be dangerous, or even fatal. Even if a patient escapes death, she may have long-term health problems. These include pain in the area of the blood clot, difficulty getting pregnant, even after stopping the pill, the side effects of blood thinners required by their clotting condition, and increased risk of future clots. It is these side effects, and long-term problems, which may give rise to a products liability claim.
Many, many women have reported dangerous and deadly side effects from these pills. There are already thousands of lawsuits surrounding these pills and, as more women experience life-threatening side effects, that number is only growing.
Side effects are often an expected and accepted risk of taking prescription medication. The problem occurs when a manufacturer does not disclose the risk of side effects to patients, who then cannot make an informed decision about whether to take the medication – and the risk. With these birth control pills, the risks were not disclosed.
Now, however, the RDA has forced Bayer Healthcare to add a warning of the possibility of blood clots and stroke to the drug label for Yaz. But this does not go nearly far enough. This requirement does not extend to all similar prescription birth control pills. And many of the known problems with these medications are still not disclosed. Furthermore, the label suggests that the risk is no higher than that of second-generation pills – a suggestion backed up by Bayer’s own research, but not the independent studies which have looked at the problem. That is why many top products liability lawyers, including the attorneys of Passen Law Group, believe that the current labeling on these medications is still negligent.
In April 2010, the FDA required Bayer to include additional information on Yaz and Yasmin package inserts, regarding the risks of developing blood clots and stroke. Some consumer advocates say the label is still misleading since it cites Bayer-sponsored studies suggesting that Yaz does not pose a greater risk of developing blood clots than do second generation birth control pills.
The existing federal lawsuits over these pills were consolidated in October of 2009. There is now a single federal multidistrict litigation (MDL) pending, right here in Illinois, before Judge David R. Herndon of the U.S. District Court of the Southern District of Illinois. These cases are moving along, slowly but surely. The trial date for the first trial was pushed back this Spring, from September of this year to January of 2012. There are also hundreds of cases filed in state courts across the country. Although some are pending individually, some states (such as New Jersey and Pennsylvania), have consolidated some or all of these cases.
Our experienced Chicago injury lawyers represent individuals and families in defective product cases with tremendous results. To discuss a potential case with one of our attorneys, call us at (312) 527-4500 or email email@example.com.