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.
‘Little miracles’: Mom gives birth to naturally-conceived quintuplets after refusing ‘selective reduction’
AUSTRALIA, February 5, 2016 (LifeSiteNews) -- A 26-year-old Australian mom has given birth to five healthy babies, all conceived naturally, after refusing the doctor’s advice that she must abort three of them in order to give the remaining two a better chance at life.
“After my initial ultrasound I was told I could consider the selection method to give 2 babies the best chance in life,” wrote mom Kim Tucci in a Facebook post last September.
“I watched a YouTube video on the procedure and I cried. I could never do that! Was I selfish for not giving two the chance of 100% survival? All I knew is that I already love them and that every heart beat I heard I connect with them more. For me life starts when a heart starts beating and all I know for sure is that I will do whatever it takes to bring them into this world healthy,” she wrote.
Last Thursday Kim and her husband Vaughn welcomed the five new members into their family — one boy and four girls —increasing the number of their children from 3 to 8. The babies were born at 30 weeks, 10 weeks early, due to insufficient space in Kim’s womb. They weighed on average about 2.5 pounds.
The quintuplets’ story began last March, after Kim and Vaughn had been trying for six months to conceive just one more child for their family. Due to health complications, Kim wondered if she would ever become a mother again.
After what she thought was an extra long cycle, she decided to take a pregnancy test.
“I was feeling tired and a little nauseated and thought I would take a pregnancy test just to get the ‘what if’ out of my head. To my shock and utter excitement it was positive,” she wrote on a Facebook post.
The parents got the shock of their lives when doctors confirmed in an ultrasound examination that there was not one baby, but five.
“After a long wait for the ultrasound we finally went in. The sonographer told me there were multiple gestational sacks, but she could only see a heart beat in two. I was so excited! Twins!”
“I was moved to another machine for a clearer view and had the head doctor come in and double check the findings. She started to count, one, two, three, four, five. Did i hear that correctly? Five? My legs start to shake uncontrollably and all i can do is laugh. The sonographer then told me the term for five is ‘quintuplets,’” Kim wrote.
Even though Kim began to feel stretched to the limit with all those human lives growing inside her, she chose to focus on her babies, and not herself, referring to them as “my five little miracles.”
“It's getting harder as each day passes to push through the pain, every part of my body aches and sleeping is becoming very painful. No amount of pillows are helping support my back and belly. Sometimes I get so upset that I just want to throw my hands up and give in.”
“Sometimes my pelvis becomes so stiff I can barely walk and my hips feel like they are grinding away constantly. I'm finding it hard to eat as I basically have no room left in my stomach, and the way it is positioned it's pushed all the way back with the babies leaning against it.”
“My skin on my belly is so stretched its painful and hot to touch. It literally feels like I have hives! No amount of cream helps relieve the discomfort. I have a lot of stretch marks now. Dealing with such a huge change in my body is hard.”
“Is it all worth it? Yes!!!! I will keep pushing through,” she wrote in one Facebook post days before the babies were born.
The newborns' names are Keith, Ali, Penelope, Tiffany, and Beatrix. They were born at King Edward Memorial Hospital in Subiaco, Western Australia. Mother and babies are reported to be doing well.
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UN rights chief tells Catholic countries to legalize abortion over Zika virus: bishops and cardinal react
GENEVA, February 5, 2016 (LifeSiteNews) -- The United Nations, following the lead of international abortion activists, is now urging Latin American countries hit by the mosquito-borne Zika virus to lift restrictions on abortion for pregnant women who have contacted the virus and whose pre-born children may be at risk for birth defects, including having smaller than normal heads.
The UN human rights office said today that it is not enough for South American countries to urge women to postpone pregnancy without also offering them abortion as a final solution.
“How can they ask these women not to become pregnant, but not offer… the possibility to stop their pregnancies?” UN spokeswoman Cecile Pouilly told reporters.
UN human rights chief Zeid Ra’ad al-Hussein said that governments should make available contraception and abortion services.
“Laws and policies that restrict (women’s) access to these services must be urgently reviewed in line with human rights obligations in order to ensure the right to health for all in practice,” he said.
But Brazil’s bishops strongly asserted yesterday that efforts should be made to eradicate the virus, not the people who may be infected by it.
The disease is “no justification whatsoever to promote abortion,” they said in a statement, adding that it is not morally acceptable to promote abortion “in the cases of microcephaly, as, unfortunately, some groups are proposing to the Supreme Federal Court, in a total lack of respect for the gift of life.”
Honduras Cardinal Oscar Rodriguez Maradiaga has also come out strongly against the notion of “therapeutic abortions” as a response to the problem. Unlike Brazil where abortion is legal in the case of rape or health of the mother, abortion remains entirely illegal in Honduras.
“We should never talk about ‘therapeutic’ abortion,” the cardinal said in a homily at a February 3 Mass in Suyap. “Therapeutic abortion doesn’t exist. Therapeutic means curing, and abortion cures nothing. It takes innocent lives,” he said.
While the World Health Organization (WHO) declared an international public health emergency February 1 on account of concerns over the virus, critics have pointed out, however, that not one death as resulted from the virus. Even on WHO’s own website the virus is described in mild terms.
“It causes mild fever and rash. Other symptoms include muscle pain, joint pain, headache, pain behind the eyes and conjunctivitis. Zika virus disease is usually mild, with symptoms lasting only a few days,” the website states. “To date, there have been no reported deaths associated with Zika virus,” it added.
Critics suspect that the crisis is being manipulated to advance an anti-human agenda on the pre-born.
“Is Zika, actually, a hideous virus that threatens to spread uncontrollably across the world creating an army of disabled children with tiny heads and low IQ’s? Or might this be a willful misinterpretation of the scarce data to manipulate public opinion and legislatures?” wrote pro-life critic Mei-Li Garcia earlier this week.
“It becomes very clear that the publicity surrounding this story has a very little to do with medicine and a lot to do with a convenient crisis that is being used by those pushing for the legalization of abortion around the world,” she wrote.
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Hillary’s litmus test for Supreme Court picks: They must ‘preserve Roe v. Wade’
DERRY, NH, February 5, 2016 (LifeSiteNews) - Hillary Clinton has a litmus test for Supreme Court nominees - several, in fact. At a Democratic event on Wednesday, Clinton unveiled her criteria in selecting a judge for the nation's highest court.
“I do have a litmus test, I have a bunch of litmus tests," she said.
"We’ve got to make sure to preserve Roe v. Wade, not let it be nibbled away or repealed,” she said.
That echoes her recent call to arms speech before Planned Parenthood last month, when she stated that taxpayers must fund abortion-on-demand in order to uphold the "right" of choice.
“We have to preserve marriage equality,” Clinton said, referring to last summer's Obergefell v. Hodges case, a 5-4 ruling that redefined marriage nationwide. “We have to go further to end discrimination against the LGBT community."
Her views differentiate her from the Republican front runners. Ted Cruz has called the court's marriage ruling "fundamentally illegitimate," and Donald Trump told Fox News Sunday this week that he would "be very strong on putting certain judges on the bench that I think maybe could change things." Marco Rubio has said he won't "concede" the issue to the one-vote majority.
All Republican presidential hopefuls say they are pro-life and will defund Planned Parenthood.
Her husband, Bill Clinton, raised the makeup of the Supreme Court early last month in New Hampshire, saying it receives "almost no attention" as a campaign issue.
On Wednesday, Hillary said "the next president could get as many as three appointments. It’s one of the many reasons why we can’t turn the White House over to the Republicans again.”
Clinton said her judicial appointees must also reverse the Citizens United ruling on campaign finance and oppose a recent decision striking down a portion of the 1965 Voting Rights Act. In 2013's Shelby County v. Holder, justices struck down Section 4(b) of the act, which said that certain states and jurisdictions had to obtain permission from the federal government before changing their voting laws.
At one time, most politicians frowned upon any "litmus test" for judicial nominees, emphasizing the independence of the third branch of government. "I don't believe in litmus tests," Jeb Bush told Chuck Todd last November.
But with the rise of an activist judiciary in the middle of the 20th century, constitutionalists have sought to rein in the power of the bench.