05/05/2008- Denville, NJ: She was young, healthy and fit; a runner and a vibrant mother of two. So it was a complete shock when, one morning in February of 2006, 31-year-old Rosana Mariconda collapsed onto her bed while getting ready for work. She died of a stroke, and her husband Frank suspects the NuvaRing birth control device she was using.

NuvaRing is the vaginal ring contraceptive that women have until now embraced as a worthy alternative to the Pill, or derma patch contraceptives. Placed near the cervix, NuvaRing releases a cocktail of the synthetic hormones etonogestrel (a progestin) and ethinyl estradiol (an estrogen), each day over a twenty-one day usage window. The ring is removed during a woman's menstrual cycle, and a new one is inserted several days later.

Approved in 2001 by the US Food and Drug Administration (FDA), the NuvaRing has proven a hot seller for busy women who have trouble remembering to take a contraceptive pill every day, or prefer not to bother with the fuss of a patch. Instead, the idea of 'set-it-and-forget-it' has proven to have merit.

However, it appears that the drug has also proven to be a hazard for many women. Hundreds of adverse reaction reports have suggested an identifiable risk for blood clots, and there have been 12 deaths reported so far, linked to NuvaRing.

The death of Rosana Mariconda is thought to be linked to the NuvaRing that the woman had begun using several weeks before. With no prior concerns, or family history for stroke or blood clot, it seemed inconceivable that a young, healthy and fit non-smoker could be felled by a stroke. However, as the New York Post reported in early July of last year, an insert that came with the NuvaRing stated on Page 27 that 'Hormonal contraceptives may increase your risk of stroke (blockages of blood flow to the brain) or heart attacks (blockages of blood flow to the heart).'

The product literature also suggested that the biggest risks are for those who smoked.
Frank Mariconda makes the point the mother of his two children neither smoked, nor drank, was a regular runner and in great shape. An autopsy revealed no blood disorders.

Since becoming available by prescription in July of 2002, the market for NuvaRing has grown to encompass a base of 4.5 million women worldwide. That translated to $96 million in sales for the first quarter of 2008 alone for Schering-Plough, the pharmaceutical giant that now books the revenue after acquiring NuvaRing manufacturer Organon BioSciences N.V. this past November.

It should be noted that the recent acquisition went ahead without any apparent concern for dozens of lawsuits that were launched back in the summer of 2007, on behalf of individuals who have been negatively impacted, or indeed have lost their lives allegedly due to NuvaRing. If first quarter results are any indication, NuvaRing is on its way to becoming a half-billion-dollar moneymaker for Schering-Plough this year. With revenue like that, lawsuits (it might be argued) are simply a cost of doing business.

The most recent label change for NuvaRing is just a few days old—April 29th, to be exact. Product labeling was also updated in October of last year, as well as February and March of 2004.

Meanwhile, the alarm bells continue to ring over NuvaRing. Liz Larson of Bloomington, Minnesota, was on the Pill for ten years and had no health problems whatsoever until she switched to the NuvaRing. Within two months, the 26-year-old was in the ER, with blood clots in both of her lungs.

In Larson's case, a smoking habit (a half-pack per day) might have had an impact on her problems. However, while the in-depth product literature targets smoking as a concern, Larson claims that she was not warned about the medication even though she was upfront regarding the fact that she smoked, and for how long.

Larson's story is mirrored by countless others—smokers, and non-smokers alike who have experienced blood clots soon after adopting a NuvaRing regimen, even though there has been no evidence of other risk factors. "I really have to keep reminding myself how lucky I am that it turned out this way," Larson says, "...and not, you know, could've went a lot worse."

Bouncing 4-year-old Jake on his knee, Frank Mariconda knows all too well that it CAN turn out a lot worse. In the blink of an eye his hale, hearty and healthy bride and the mother of his children was gone. He blames NuvaRing, and is pursuing a claim.

"If there is something that can be done to pull it off the market, that's what Rosana would have wanted," Mariconda told the New York Post. "I can't bring her back, but I can save someone else the heartache."