Thousands of people, who took a popular but controversial form of birth control, had until Monday, March 10 to decide whether to take a cash payout from the drug company as part of a nationwide settlement.
But many want to know why this form of birth control is still on the market? 2 Investigates obtained records showing just how many complications from the product have been reported.
“The pictures we have are like the three of us. Always the three of us,” said Ashley Malone, as she looked though pictures in her sister’s room.
Ashley is the oldest of the three Malone sisters.
“We were each other’s best friend and you know we spent every day together,” said Ashley. Ashley, Brittany, and Morgan were close in age and close to the end.
“When I see pictures like this I can hear her. Hear her voice,” said Ashley looking at picture of Brittany laughing.
It’s a drastically different sound than the day the 23-year-old collapsed while sitting between her sisters.
“I held her head back and I was giving her mouth to mouth and I remember she would go [noise of drawing shallow breaths] and then I’d breathe, but at that point her lungs were filling with blood,” said Ashley describing the efforts to help her sister.
As Brittany’s blood thinned naturally trying to pass the massive clot in her leg blood seeped into her lungs to the point where she went without oxygen and eventually became brain dead.
The Malones told KTVU that they blame NuvaRing for the clot that led to Brittany’s death.
All of the Malone girls used Nuvaring. It’s a vaginal form of birth control, which remains in the body for three weeks and then is removed for seven days before starting another ring.
Thousands of users claim it has caused serious side effects and even death. The manufacturers, Merck, have offered a conditional settlement of $100 Million dollars to alleged victims. But, 95-percent of the people with claims must opt-in or the company can withdraw the offer. As part of the settlement Merck admits no wrongdoing or legal liability.
Hunter Shkolnik of the law firm Napoli, Bern, Ripka, and Shkolnik is lead counsel for the national settlement and has fought NuvaRing cases in court for the better part of a decade. Shkolnik thinks some 4,000 or so plaintiffs will accept the settlement.
“I suspect the vast majority will because it is the best opportunity and it’s a very good deal for them,” said Shkolnik.
He couldn’t discuss the specifics of the settlement, but says the pay-out is a tiered system with higher amounts for death claims. The total settlement amount of $100 Million will be divided amongst the total number of qualifying claimants. So the amount each person will receive depends on how many people partake in the settlement. The Malone’s say they would receive somewhere around $75,000 (a death claim) if they chose to settle.
“It’s just disgusting that they can buy their way out of accountability. It’s hush money,” said Joe Malone, Brittany’s father.
He and his wife, Dana, refuse to settle, upset that Merck won’t have to admit any wrongdoing and the product will remain on the market. NuvaRing’s warning label was updated in October of 2013, after Brittany’s death and as several cases were set to go to trial.
In a statement to KTVU a Merck spokesperson writes:
“Nothing is more important to Merck than safety of our medicines and vaccines and the people who use them. Merck employees, and our families, use Merck medicines too.”
“It’s not right she was just being responsible and her life shouldn’t have been taken. I’d like to know how many people at this manufacturer if their kids use it,” said Dana Malone, Brittany’s mother.
Pregnancy carries a risk of blood clots as do all hormonal birth controls, but Kaiser Permanente researchers found the blood clotting risk is up to 56-percent higher with NuvaRing compared to earlier birth control formulas, but still only in the range of eight to 10 women per 10,000 users.
“I don’t care if it’s one-percent or if it’s a percentage of one-percent what I care about is how many women have died because of this product how many women have been hospitalized,” said Joe Malone.
2 Investigates found out by filing a Freedom of Information Act request with the Food and Drug Administration. We asked for all Adverse Events Reports related to NuvaRing. The records show from the product’s release in 2001 to February of this year more than 10,000 reports were filed. The records included 224 deaths and nearly 3,000 hospitalizations. Adverse events are voluntarily reported by doctors, health care providers, and patients so the number of people negatively affected may actually be higher. If a manufacturer receives an adverse event report, it is required to send the report to the FDA as specified by regulations, according to an FDA spokesperson.
Merck reports more than 44 Million prescriptions have been filled in the US for NuvaRing since June of 2002. The surviving Malone sisters stopped filling their prescriptions after losing Brittany.
“Thinking about our family as the five of us and when we would take pictures or whatever… having it be four people [is] very weird,” said Ashley Malone.