In 2002, Organon pharmaceutical company introduced a new product, which was seen as the greatest advance in birth control since the ‘pill’ in 1960. Their product, NuvaRing, was the first hormonal contraceptive vaginal ring ever. No longer would there be the inconvenience of having to remember to take a pill every day to prevent unwanted pregnancies.
As all new drugs and medical devices in the United States, the NuvaRing required approval from the U.S. Food and Drug Administration (FDA) before it could be marketed. The FDA had some concerns. Most hormonal contraceptives carry a risk of blood clots, with a higher risk of cardiovascular events among women who smoke, more so in women over the age of 35.
One of the NuvaRing studies revealed a 27-year-old, healthy, single mom from Cleveland, Lyndsey Agresta. After using NuvaRing for only one month, she began experiencing severe migraines. Unbearable pain sent her to the emergency room where doctors determined that Agresta was hemorrhaging in her brain, the result of a blood clot. She suffered a stroke and had two thirds of her right cerebral hemisphere removed in surgery, leaving her paralyzed and confined to her bed. She was then sent to a long-term acute care hospital, where she underwent additional surgeries, to no avail. In January 2009, doctors determined that Lyndsey had fewer than six months to live and recommended hospice care. One week after being admitted to hospice, Lyndsey died, leaving her six-year-old son without a mother. Lyndsey’s mother is one of the plaintiff’s in this suit.
Another young woman experienced hemorrhaging from NuvaRing. Although she survived, she is now permanently speech-impaired and couldn’t think of the right words to speak during the reporter’s interview.
Although other methods of birth control release hormones, NuvaRing releases the hormones estrogen and progestin. Earlier versions of progestin were called etonogestrel, a form of desogestrel. Researchers have found that these newer, so-called third and fourth generation progestins, including those containing desogestrel, carry a higher risk of blood clots. Lawyers in the multidistrict litigation (MDL) have also suggested that NuvaRing’s unique delivery system may make blood clots more likely than with other hormonal contraceptives. NuvaRing distributes hormones directly into the bloodstream. Some NuvaRing users may experience spikes of estrogen that may expose them to a higher risk of blood clots. This information was not listed in Organon’s 30-page summary report to the FDA.
Diane Agresta is one of more than 1,500 plaintiffs who are currently suing Merck over their NuvaRing in mass litigation in federal court. They allege lack of adequate testing and inappropriate labeling to warn women and health care providers about the increased risk of blood clots.
The FDA requested Organon to include a label statement in NuvaRing’s packaging insert, specifically detailing the clinical trial and warning women, as well as health care providers, that the ring might carry a higher risk of blood clots, also known as venous thromboembolism or VTE, compared with other hormonal contraceptives.
But Organon executives were opposed to the label statement. They didn’t want anything to stand in the way of their new device with its secured patent with big hopes of bringing in billions. They wanted to market NuvaRing as not only convenient, but also as delivering lower, safer doses of hormones. If they added the warning label, this could discourage women from trying the NuvaRing and perhaps doctors would be less likely to prescribe it, crushing the drug maker’s plans of huge profits.
Today, NuvaRing is marketed in more than 50 countries and is one of the most popular forms of birth control worldwide. Approximately 1.5 million women use NuvaRing, and it has been prescribed more than 44 million times in the past decade. NuvaRing is currently manufactured by Merck & Co., since Organon was acquired by Schering-Plough in 2007. In 2009, Schering-Plough merged with Merck.
The first trial in the consolidated MDL is scheduled for April in the Eastern Division of Missouri.
If these big drug companies continue to market their products without proper testing and warnings, many people will continue to be injured or even lose their lives. The drug makers need to be held accountable and put the safety of the consumers before their profits. So many young women lost their lives or were left permanently impaired due to the manufacturers greed.
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