Merck & Co. may pay $100 million to settle thousands of lawsuits over the safety of its NuvaRing contraceptive, a New Jersey judge held, as long as enough women agree to participate in the agreement.
The settlement may resolve as many as 3,800 cases in federal and state courts in New Jersey and Missouri, Judge Brian Martinotti said at a hearing last week in Hackensack, N.J. More than 200 women sued Merck in New Jersey, accusing the drugmaker of selling NuvaRing while knowing it posed a higher risk of heart attack-inducing blood clots than competing products.
The family of an Omaha woman who used a NuvaRing device sued Merck in 2010 after the woman, 43-year-old Ann Tompkins, was found dead on Feb. 23, 2009, with a blood clot in her lung. Tompkins' family alleged in its lawsuit that Merck misled users about the device's health risks.
Martinotti gave preliminary approval to the settlement, subject to 95 percent of the plaintiffs participating, said Steven Blau, a lawyer for women suing over the device. If more than 5 percent of plaintiffs refuse the offer, Merck can walk away from the deal, Martinotti said.
“The settlement is a fair resolution of this litigation,” the judge said. “This is a lump-sum settlement of $100 million that covers the entire litigation nationwide.”
The settlement, which includes cases filed in St. Louis federal court, means Merck, the second-biggest U.S. drugmaker by sales, is paying a fraction of what rivals such as Bayer AG did to resolve lawsuits over their contraceptives.
Bayer said last year it has paid more than $1.6 billion to settle claims over its Yasmin and Yaz lines of birth-control pills. Women said Yaz also caused blood clots that led to strokes and heart attacks.
“Merck may be getting out much more cheaply than its competitors because proving the liability case against the NuvaRing device appears to be more difficult,” Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia, said.
NuvaRing is a hormonal-vaginal contraceptive that combines estrogen and progestin in a ring to prevent pregnancy. The product, which was linked in a 2011 U.S. Food and Drug Administration report to a higher risk for blood clots, has been sold in the U.S. since 2001.
Lainie Keller, a spokeswoman for Whitehouse Station, N.J.-based Merck, said the company isn't admitting wrongdoing under the settlement and continues to believe NuvaRing is a safe contraceptive.
Lawyers for women suing over the NuvaRing product contend there are almost a dozen studies showing the type of progestin used in the device is twice as likely to cause blood clots.
Women argued in court filings that Merck failed to provide proper warnings about Nuva- Ring's higher clot risks on the device's label in order to protect sales.