PHOENIX, AZ, June 4, 2014 (LifeSiteNews.com) – The bereaved parents of a 24-year-old woman have turned down their part of a $100 million settlement from the makers of the NuvaRing, because they want to campaign for the FDA to improve the labeling of the contraceptive device they say killed their daughter.
Erika Langhart, a 24-year-old Phoenix native, died of a pulmonary embolism in 2011. The young woman, who was on the verge of entering Georgetown Law School, had already distinguished herself by handling logistics on John McCain's 2008 presidential campaign. Sen. McCain told her mother, Karen, “I was stunned when someone told me Erika was only 21” at the time. “She ran an entire arm of my campaign.”
Karen got a very different call when her daughter collapsed in her apartment. Erika's boyfriend rushed her to Virginia Hospital Center. Karen told Vanity Fair that the doctor who treated her girl asked, “Was your daughter using birth control?” After she said Erika was using the NuvaRing, he said, “I thought so, because she’s having a pulmonary embolism.”
That Thanksgiving Day, their daughter died.
The NuvaRing, which releases hormones through the bloodstream after being inserted into the vagina, has been linked to such serious side effects as heart attacks, blood clots, strokes, and elevated breast cancer levels. Complaints filed with the FDA indicate 2,955 women say they have been hospitalized and 224 women have been killed from side effects caused by the contraceptive device.
After grieving their daughter's loss, Karen Langhart and her husband, Rick joined thousands of others in filing a lawsuit against Merck, the parent company of its manufacturer, Organon.
In February, U.S. District Court Judge Rodney W. Sippel approved a $100 million settlement from Merck, conditional on 95 percent of all claimants – some 4,000 worldwide – agreeing to its terms. “Organon and Merck deny any liability for the claims in the lawsuit and make no admissions of any wrongdoing by agreeing to this settlement,” the company's website states.
Lead counsel Roger Denton said the ruling is “an outstanding result and in the best interests of all.” If successful, Denton and fellow attorneys stand to earn $30 to $40 million in legal fees.
But the Langharts and other parents grieving their lost daughters want nothing to do with it.
“It's just disgusting that they can buy their way out of accountability,” said Joe Malone, who lost his 23-year-old daughter Brittany told KTVU-TV. “It's hush money.”
The Langharts are instead lobbying the FDA to change the label to indicate the NuvaRing carries a higher risk of side effects, like the ones that killed their daughter, than other forms of contraception. Kaiser Permanente says its research indicates the risk of developing blood clots is 56 percent higher with NuvaRing than with some other forms of hormonal contraception. But the Food and Drug Administration is not certain a new warning is necessary.
“We think Merck has control over the FDA. We think they have undue influence within the FDA,” Karen said.
Kristine Kraft, a lawyer representing plaintiffs in a batch of NuvaRing claims, told the St. Louis Post-Dispatch, “The company did not act responsibly” when it “lobbied hard” to remove mention of deep vein thrombosis (VTE) from its label.
In October 2000, a full year before the drug went on the market, FDA officers Dr. Daniel Davis and Dr. Gerald Willett noted the possibility of VTE. A 26-year-old woman developed blood clots in her legs after “only eight days” of use during its clinical study. Two other women had to stop using the NuvaRing during that time because of blood clots, as well. But the doctors said they did not have enough information to rule on the possibility of VTE “due to lack of follow-up” by the company.
Rather than run additional tests about the long-term impact the drug would have on women, Wim Mens of Organon’s regulatory affairs division said, “We should really try to get” mention of VTE taken “out of the text” of the NuvaRing's label. An Organon marketing manager, David Stern, asked, “What are the chances that this section can be removed altogether?”
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FDA Director Dr. Susan Allen said the device needed greater labeling warnings – but she left the federal regulatory agency in 2006 and soon began doing consultation work for Organon.
Following an aggressive marketing campaign that plaintiffs say downplayed potential complications, the sales – and injuries – kept piling up. Monica Greene lost her 17-year-old daughter, La Monica, in June 2009, just weeks after the girl started using the NuvaRing.
Others lost their dreams, like Megan Henry, who was in heavy training for the 2014 Olympics when she developed blood clots that sidelined her from training for a year. Henry rejected the $100 million offer. “The settlement is a laughable offer to rectify damages, considering Merck brings in over $4 billion in profit,” Henry told LifeSiteNews. “A settlement offer of $100 million across nearly four thousand people is hardly compensation.”
The NuvaRing label was revised in October 2013 to include a company-funded study but exclude an independent study conducted by Dr. Øjvind Lidegaard published in the British Medical Journal, which concluded that users of NuvaRing had nearly double the risk of suffering VTE than users of second generation contraception.
Meanwhile, the device remains on the market. Merck made $686 million in global sales of the NuvaRing in 2013, up from $623 million in 2012. Ironically, the company's stock rose one percent on the day the $100 million settlement was announced.
While NuvaRing produce a higher proportion of health concerns, all parties involved are quick to point out that similar side effects are found in all forms of hormonal contraception.
“As more and more women are injured or killed by hormonal contraceptives and their grieving families sue drug companies, the dangers of contraception become harder and harder to hide,” Rita Diller, director of the American Life League’s The Pill Kills project, told LifeSiteNews.
“The first question medical personnel often ask when they see a young woman present in the emergency room with blood clots is, 'Are you using birth control?'” she said. “They ask about contraceptives in general, because they see over and over again the devastating results of the hormonal contraceptives on women.”
“The real question here is, how many women have to die before the truth is known?” Diller concluded.