NuvaRing: a Big Headache for Women & Merck
(CN) - More than 1,500 women have sued Merck in the past decade, claiming its NuvaRing contraceptive device causes potentially fatal blood clots, and that the company hid this during the U.S. FDA approval process. But how does Nuva Ring work?
NuvaRing is similar to oral contraceptive products that use estrogen and progestin in tandem to prevent ovulation and induce physiological changes that decrease the likelihood of conception.
Merck's product is inserted vaginally, releasing ethinyl estradiol, a form of estrogen, and etonogestrel, a third-generation progestin, over time.
The FDA approved it in 2001. Merck began marketing the product in 2002 as "the first and only, once-a-month vaginal birth control ring."
But the numerous plaintiffs claim the pharmaceutical giant did not warn them that NuvaRing fails to deliver the hormones consistently. At times it releases dangerously high doses of estrogen, which increases the risk of blood clots, the women say.
Citations in this article will come from a recent lawsuit against Merck in Cheyenne, Wyo. Federal Court.
Jasmine DeShaw, 32, says was not aware of the risks of using NuvaRing until Dec. 26, 2013, when she awoke with a migraine headache, chills and vomiting.
She got pain medication from a clinic near her hometown of Daniel, Wyo., but the symptoms persisted. DeShaw returned to the clinic two days later, but eventually had to be driven 150 miles west to Idaho Falls, where she was admitted to a hospital's intensive care unit.
A CT scan and MRI revealed blood clots that DeShaw claims were caused by NuvaRing.
"The product that was inside DeShaw's body released a surge of hormones that altered her blood's clotting properties," according to her 19-page lawsuit.
"This caused a life-threatening series of blood clots to form inside her circulatory system. The clots lodged in various organs, including DeShaw's brain."
DeShaw remained in the ICU until Jan. 2, and still has clots in her shoulder and brain, and could be forced to take blood thinners the rest of her life, according to the complaint.
What Did Merck Know?
DeShaw claims Merck and its subsidiaries marketed the contraceptive device to doctors and users knowing its inherent risks.
Named as defendants are Organon USA and three Organon subsidiaries, Akzo Nobel, Schering-Plough, Merck & Co., and McKesson Corp. Organon is a wholly owned subsidiary of Akzo Nobel, which itself was acquired by Schering-Plough in 2007, all of which in turn were bought by Merck in 2009, according to the complaint. All those companies owned patent rights to NuvaRing, according to the lawsuit, which describes defendant McKesson as a pharmaceutical marketing and distribution complaint.
DeShaw says in the complaint that the defendants "marketed the product as providing the same efficacy as birth control pills in preventing pregnancy, but with 'more convenience because it offers month-long protection against pregnancy, so women who use NuvaRing don't have to think about contraception every day.'"
But DeShaw claims that Merck put warnings on the label that were developed for oral contraceptives.
She says that specific warnings and other data for the NuvaRing were indicated, and necessary, because "its delivery route - and therefore its metabolism - differs from oral contraceptives."
The company also failed to examine the effect of exposing the product to temperatures above 77 degrees, according to the complaint: "Such heat exposure renders the product more likely to cause sudden hormonal spikes in its users, which in turn leads to an increased risk of clotting side effects."
DeShaw claims the NuvaRing's inconsistent delivery of hormones was revealed in Merck's in-house studies, and in independent studies, conducted "before and after" U.S. Food and Drug Administration approval.
"During the FDA approval process, defendants actively suppressed, concealed and downplayed information about the danger of the product, including its propensity to cause sudden, unpredictable and massive hormonal spikes in women using the product, which in turn dramatically increased the incidence of clotting side effects," the complaint states.
In addition, DeShaw claims, Merck actively sought, and obtained, approval for warnings that omitted or minimized the product's risks.
She claims that even after increased evidence of blood clotting, Merck has failed to update warning labels in the United States - but has done so in Canada.
DeShaw's attorneys, R. Daniel Fleck and Michael Lutz of Jackson, Wyo., did not immediately return phone calls.
More than 1,000 NuvaRing lawsuits have been filed against Merck in Missouri, alone, some of them involving death, according to a news reports.
DeShaw seeks damages for strict liability, negligence, fraud, negligent and fraudulent misrepresentation, breach of express and implied warranty, past and future physical injuries, medical expenses, and pain and suffering.