Last July, we posted our first article on the potential dangers of the NuvaRing method of birth control (manufactured by Merck) a vaginal ring that patients wear for a period of about three weeks, during which time it slowly releases hormones into the bloodstream. It was introduced in 2002, and has become very popular since; according to MSN Health, 5.5 million prescriptions were filled in 2010, generating almost $560 million in revenue.
But since 2008, the device has also come under fire for its potentially dangerous side effects. A study published in 2012 in the British Medical Journal concludes, “Women who use transdermal patches or vaginal rings for contraception have a 7.9 and 6.5 times increased risk, respectively, of confirmed venous thrombosis [a blood clot that forms within a blood vessel] compared with non-users of hormonal contraception of the same age.” Much of the time, especially with superficial venous thrombosis, blood clots are slightly uncomfortable and painful and do not carry any additional risks. The real danger comes when part of the clot (known as an embolism) breaks off and is transported to the heart, lungs, or brain. If the embolism becomes stuck in the lungs, pressure builds in the heart in a condition called a pulmonary embolism. Symptoms can be temporary, like difficult, painful breathing or heart palpitations, but they can also lead to a rapid heartbeat, low blood pressure and even sudden death.
Since the NuvaRing’s introduction, more than 1100 patients have filed suit against Merck (according to Yahoo! News, as of April 2013) claiming the drug maker did not provide adequate warnings about the dangers of their product. Consumer safety advocates point to a hormone called desogestrel, which is present in all third- and fourth-generations of birth control (NuvaRing is third-generation). The watchdog group Public Citizen even petitioned the FDA in 2007 asking them to ban all birth control containing desogestrel, preferring the time-tested second-generation of birth control that has proven to be just as effective without the inclusion of this dangerous hormone.
Law360 reports that the first NuvaRing trial (known as a “bellwether”) is due to start in late October of this year in New Jersey, and the judge in the case has indicated that the jury may be able to award punitive damages to the plaintiffs. Punitive damages are a monetary amount designed as a deterrent for reckless behavior. Not every case includes punitive damages; when they do, it is typically to send a message to the defendant and others that they should not commit similar acts in the future. This may also set a legal precedent, allowing juries in other states to award these additional funds to patients who have suffered clots, strokes, and embolisms, not to mention the dozens who have tragically died and those who’ve lost loved ones and blame complications from using the NuvaRing device.
Yet again, as we have alerted our readers on this blog of late, the FDA continues to fail to effectively enforce mandated post-market drug monitoring in which drug manufacturers are required to conduct their own safety research and report back to the Administration. Newly collected evidence suggests that while 40 percent of these studies have not begun, a full 85 percent (over the past eight years) are incomplete.