The once-monthly insertion of a low-dose hormonal, vaginal ring had the manufacturer touting the fact that users didn’t have to remember a daily pill. It quickly became wildly popular, with sales last year topping $620 million and 2014 sales expected to reach somewhere around $644 million. There is even a generic drug maker scrambling to produce a knock-off prior to the 2018 expiration of the original patent.
But there is a darker side to the drug, as more than 3,500 NuvaRing lawsuits as of August 2013 reveal.
Use of the NuvaRing has been linked to:
- Blood clotting in the legs, which has been known to travel into the lungs (pulmonary embolism);
- Clotting in the blood vessels in the eye, causing vision problems.;
- Heart attack;
- High blood pressure;
About 600 of the product liability lawsuits filed against Merck Co. since 2008 were consolidated into a single multidistrict litigation action in the U.S. District Court in the Eastern District of Missouri. Parties in that action are concluding written discovery and conducting depositions, and the first of these cases is expected to go to trial sometime this year.
Meanwhile, Vanity Fair published an extensive article recently questioning why the drug is still on the market, given that young and seemingly healthy women have died after taking it.
Although the drug manufacturer does warn against possible side effects – including blood clots, particularly for older women who smoke – the position of the plaintiffs in many of these cases was that the risks were greatly understated by the company, both to physicians and patients.
The mother of one healthy 24-year-old woman who died Thanksgiving Day of a pulmonary embolism after using the NuvaRing for about four years.
Research commissioned by Merck determined users of the NuvaRing are at a nearly 60 percent increased risk of blood clots as compared to users of other forms of progestin-based birth control. The company reportedly knew this while they aggressively marketed the product to women.
Although the U.S. Food and Drug Administration is responsible for approving the drug, what plaintiff attorneys have found is that studies revealing the risks were buried by the manufacturer in thousands of pages of research provided to the federal regulator. With the FDA being so severely understaffed, it’s easy to understand why anything not provided in the several dozen pages of summary would be overlooked.
It’s worth noting that Merck’s advertising and marketing budget was 50 percent larger than its budget for research and development.
One theory as to why this particular drug is so dangerous is that it must be kept at a steady 68 to 77 degrees at all times. However, no testing is done of the product after it leaves the factory. The FDA has never required any research to find out, for example, what would happen if the plastic ring ended up sitting for hours on a hot loading dock. There is evidence to suggest that leaving the ring in these types of conditions could lead to a potentially life-threatening surge of estrogen for the user. However, there is little evidence to suggest that doctors or patients were made aware of this.
And the drug is still readily available and heavily marketed to young women. The writer of the recent Vanity Fair piece tapped several young women to reach out to local health care providers to inquire about the product, while revealing a genetic history of blood clots and diabetes. None of the health care providers warned them of the increased risk of clots with the drug.
The Ferraro Law Firm handles product liability as a result of defective medical products or dangerous pharmaceuticals. Call 1-800-275-3332 for a free and confidential consultation. Offices in Miami and Washington, D.C.
Why is Potentially Lethal Contraceptive NuvaRing Still on the Market? Dec. 9, 2013, By Marie Brenner, Vanity Fair
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Generic Cholesterol Drug Recalled for Presence of Glass Particles, Nov. 26, 2012, Product Liability Lawyer Blog