Rachel Lietzke Payne started using NuvaRing in 2008, when she was a 20-year-old college student. The contraceptive device appealed to her because it was easy to use. Birth control pills have to be taken every day, but NuvaRing, which came onto the market in 2001, is inserted into the vagina and removed each month—and is just as effective at preventing pregnancy.
One Monday in October of 2010, more than a year after she first began using the vaginal ring, Payne met her father for a standing lunch date at Buffalo Wild Wings in Casselberry, north of where they lived in Orlando. When she and her dad walked out of the restaurant, Payne suddenly fell ill and spat up quarter-size chunks of blood onto the cement.
Payne was rushed to the hospital, where she spent 10 days being pumped with anticoagulants to thin her blood. She was diagnosed as having developed a blood clot in her lung, a condition that could have been fatal. “It took them a while to figure out that it was blood clots, because I was 22 at the time,” said Payne, who is now a married 25-year-old aspiring air traffic controller with a toddler son. She was also a nonsmoker and fit, and she had no family history of blood clots, all potential risk factors.
But the doctors landed on what they believed might have caused the clotting: the NuvaRing.
Payne is now one of more than 1,000 women suing Merck & Co.—the pharmaceutical company that manufactures the birth control—in a federal district court in Missouri. They allege that the company’s device caused them to suffer blood clots—in a few cases, fatal ones—the risks of which they say they were inadequately warned about.
The suits are the latest in a pricey legal backlash over a variety of hormonal contraceptives that have come to the market in the past 10 years. Thousands of women sued over the Ortho Evra patch, citing studies that showed a higher blood clot risk compared to traditional birth control pills, costing Ortho McNeil, a Johnson & Johnson subsidiary, millions of dollars. And as of 2012, more than 10,000 suits had been filed against Bayer, the makers of Yaz and Yasmin birth control pills, which has set aside more than $1.5 billion to settle claims.
Roger Denton, the lead counsel for the multidistrict litigation against NuvaRing in Missouri, said he thinks the case could be as lucrative for his clients as Bayer’s litigation over Yaz and Yasmin. (Bayer has settled for an average of $216,000 with each plaintiff in that case.)
Hormonal contraceptives inhibit ovulation by releasing a combination of estrogen and progestin. While earlier iterations of progestin have shown only a slight increase in blood clot risk, recent studies have shown that newer forms of progestin—called third- and fourth-generation progestins, which were developed in the 1990s and 2000s—are associated with higher rates of blood clotting among women who take them compared to second-generation iterations of the hormone.
In fact, more than a dozen studies conducted over more than a decade have shown that women taking contraceptives containing a third-generation progestin—such as that used in NuvaRing and some birth control pills—have a 1.4 to 4 times higher risk of developing blood clots than women on contraceptives containing second-generation progestin.
The studies include a recent one funded by the FDA that tracked the health records of more than 835,000 women. It found that those who used the vaginal ring were more likely to experience venous thrombosis than women who took oral contraceptives. But the researchers warned that the finding is “new and raises concern” and “needs to be replicated in other studies.”
A handful of other studies, however, have shown no increased risk. Overall, the risk is still very low, with only around 6 to 10 out of 10,000 women developing blood clots over a year.
The plaintiffs in the NuvaRing case allege it's not just the hormone in the device that caused their blood clots, but also the delivery system. Unlike other forms of birth control, NuvaRing dispenses hormones directly into the bloodstream, which the plaintiffs' expert witness argues could cause "spikes" of hormones that make women more susceptible to blood clots. There's currently no large study that backs up that claim.
Some experts, however, warn that the results of the studies are being overblown by the media and trial lawyers, and may be scaring women away from effective birth control. More than 20 international researchers published an open letter in the Journal of Family Health and Reproductive Planning earlier this month saying the media and attorneys are creating a “scare” that is not based on adequate research and could create more harm than good. They argue that large database studies, such as the one funded by the FDA, can be inaccurate because they don’t take into account all the confounding variables, such as obesity, that could affect blood clotting.
The letter notes that third- and fourth-generation hormonal contraceptives overall contain a very low risk of blood clots, and that more studies are needed before that risk can be determined. Overall, it notes, about 4 to 6 additional women out of every 10,000 on the newer forms of birth control would suffer a blood clot compared to women taking the older form of birth control. The risk of blood clotting goes up dramatically for pregnant women: 29 per 10,000 pregnant women develop a blood clot, meaning that the risks of unintended pregnancy are far greater than that of any hormonal birth control on the market.
The plaintiffs in the NuvaRing case say Merck did not adequately test or label the NuvaRing product to warn of these risks. Merck has disputed this, saying the company is confident its product is safe, and that it followed U.S. Food and Drug Administration guidelines for its packaging.
The company was awarded a judicial victory last week, when a judge in New Jersey threw out seven separate suits against NuvaRing, saying the plaintiffs did not prove that NuvaRing was the cause of their blood clots. New Jersey courts have tougher standards for suing an FDA-approved product than the federal court system, however, where some of the more than 1,000 suits face trial beginning in October.
“We are confident the company has provided appropriate and timely information about NuvaRing to consumers and the medical, scientific and regulatory communities,” Lainie Keller, a spokeswoman for Merck, said in a statement. “We remain confident in the efficacy and safety profile of NuvaRing, and will continue to always act in the best interest of patients.”
But Denton, the lead attorney for the plaintiffs, said he’s sure his cases in the district court won’t be dismissed.
“That’s what all these drug companies say,” Denton said. “'It’s good enough for the FDA, that’s the end of the story.’ But under our law, that doesn’t matter. The jury decides.”