ContraceptionThu Mar 13, 2014 - 5:06 pm EST
Former Olympic hopeful calls Merck’s NuvaRing settlement offer ‘laughable’
ROXBURY, CT, March 13, 2014 (LifeSiteNews.com) – Two years ago, Megan Henry was one of the nation's top athletes. A skeleton racer, she was training for the 2014 Olympics, with dreams of gold medals going through her mind.
Only months later, those dreams were dashed after Henry began using the contraceptive NuVaRing. She told local news that "within 10 days of taking it, I had a hard time breathing." She eventually went to several doctors and a hospital, where she found out she had “multiple blood clots in both lungs.” Henry says she missed a year of training, and would be at high risk should she become pregnant.
Made by Merck Pharmaceuticals company Organon USA – acquired in 2009 after a merger with Schering-Plough Corp. – NuVaRing works through insertion into the vagina, and is supposed to remain inserted for three weeks at a time. According to the NuvaRing website (graphic content warning), side effects include blood clots, stroke, or heart attack. The website says that “the most common side effects reported by NuvaRing users are: vaginal infections and irritation, vaginal secretion, headache, weight gain, and nausea.”
After her 2012 experience, Henry joined nearly 4,000 other people in a class-action lawsuit against Merck, including plaintiffs who had lost family as a result of NuVaRing use. Last month, all plaintiffs were offered a $100 million national settlement.
Henry told LifeSiteNews that amount isn't good enough. “Plaintiffs can either opt in or not, but the settlement is a laughable offer to rectify damages, considering Merck brings in over $4 billion in profit. A settlement offer of $100 million across nearly 4 thousand people is hardly compensation.”
“Just for comparison's sake, other birth controls such as Yaz paid out over a billion dollars in settlements,” says Henry. She also pointed to how “95 percent of the victims have to accept the settlement. If 95 percent do not accept, there is no settlement.” Merck spokesperson Lainie Keller verified this to LifeSiteNews, noting that “if at least 95 percent of eligible participants as specified in the settlement agreement do not opt into the Settlement, Organon (Merck) is not obligated to proceed with the Settlement or fund the Settlement.”
In 2013, Merck competitor Bayer AG agreed to a settlement worth more than $1.6 billion over accusations its Yaz and Yasmin contraceptive pills caused blood clotting.
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According to Merck's settlement website, NuVaRing was created in 2001 and put on the market the following year. The class-action lawsuit was launched in August 2008, after multiple lawsuits were put into one larger effort.
It appears that the full $100 million will not be seen by plaintiffs. The lead negotiatior for the plaintiffs, St. Louis attorney Roger Denton, said in a written statement that while he thinks the settlement is “an outstanding result and in the best interests of all the women who have suffered an injury associated with the use of NuvaRing,” between $30 million and $40 million will be spent on lawyer fees and expenses.
“It will be hard [to accept the settlement],” said Henry. “A lot of families who lost daughters are just heartbroken. They feel they cannot morally accept the compensation, and other people just feel they can not accept knowing that Merck is essentially getting away with murder.”
“But there is not likely to be any opportunity to fight this in the future,” she admitted. “It is a very tangled web. You either accept, knowing that Merck is able to keep this product on the market with no repercussions, or you don't accept, and they still win. They win either way.”
The “opt-in” deadline for the settlement was March 10, but Merck's settlement website says that “several parties have requested brief extensions” that “have been granted.”
Henry told LifeSiteNews that “Merck should have been more honest with the dangers of NuvaRing, specifically by providing warning that represented the increased risk compared to other second and third generation birth controls.”
“NuvaRing has a doubling of the risks for blood clotting incidents compared to other second and third generation contraceptives,” says Henry. She claims Merck, via Organon, knows this fact, but “continues to market the product in such a way that there is no increased risk," which she says "is not fair to the consumer.”
Keller flatly denied Henry's claim, saying that “Merck has always acted responsibly with the marketing of NuVaRing, as we have with all of our medicines and vaccines.”
“All combined hormonal contraceptives, including NuVaRing and combined oral contraceptives, are associated with an increased risk of [VTE],” said Keller. A VTE is a “venous thromboembolic event,” which Keller says includes “deep vein thrombosis and pulmonary embolism.”
She cited a company study and a U.S. Food & Drug Administration (FDA) study she says “found that the risk of blood clots for new users of NuVaRing is similar to the risk for new users of” combined oral contraceptives.
She also said “all [combined hormonal contraceptives], including NuVaRing, have a Boxed Warning on the increased risk of serious cardiovascular events.” She pointed to how “the FDA-approved patient information and the physician package labeling for NuVaRing” have provided such information “since the product was approved in 2001.” Keller says updates were made in October 2013 to account for how NuVaRing's new users are at “similar ... risk [of blood clots]” as “new users of combined oral contraceptives.”
In a previous e-mail correspondence, Merck spokesperson Keller did tell LifeSiteNews that out of 10,000 women who might take NuVaRing and are not on “combined hormonal contraceptives” (CHC), a year later “1 to 5 of these women will develop a VTE.”
She also told LifeSiteNews that “if 10,000 women who use a CHC” do so in addition to using NuVaRing, “3 to 12 women will develop a VTE.” Women at highest risk are those “who are postpartum,” meaning 12 weeks past delivery. Of 10,000 women, “40 to 65 will develop a VTE” in one year.
According to the World Health Organization (WHO), generations of contraceptives are separated by hormonal types and dosages, as well as time of release. WHO says “pills with first-generation progestogens are more likely to produce unacceptable side-effects,” and were released over 40 years ago. Second-generation contraceptives were put on the market in the 1970s, and third-generation in the 1980s. WHO says second-generation contraceptives are more expensive, but “are similar in terms of effectiveness and of side-effects.”
Henry believes “the FDA should make [Merck] beef up their warning label, so women will think twice about using NuVaRing.” She also says “doctors are unaware of [NuVaRing's] dangers, so it is frightening to think what the consequences may be for patients if the doctor does not seem to have any worry about the risks.”
The Merck settlement offer comes at a time of increased public awareness about the dangers of contraception, including a documentary from TV star Ricki Lake about hormonal contraceptives and a 10,000-word essay in Vanity Fair about the NuVaRing lawsuit.
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