Merck May Pay $100 Million to Settle All US NuvaRing SuitsMerck May Pay $100 Million to Settle All US NuvaRing Suits

A New Jersey judge has given preliminary approval to a proposal by Merck & Co. (Whitehouse Station, NJ) to pay $100 million to settle as many as 3800 lawsuits over the safety of its NuvaRing contraceptive device, according to a report on Bloomberg. The suits claim that Merck knowingly misled users about the health risks of the product.

Judge Brian Martinotti in Hackensack gave preliminary approval to the settlement, subject to the participation of 95 percent of the plaintiffs, according to Steven Blau, an attorney for women suing over the device. If more than 5 percent of plaintiffs refuse the offer, Merck can walk away from the deal, the judge said.

"The settlement is a fair resolution of this litigation," Martinotti is reported to have said. "This is a lump-sum settlement of $100 million that covers the entire litigation nationwide."

The cases, filed in federal and state courts in New Jersey and Missouri, claim that Merck sold NuvaRing although it knew that the birth control ring posed a higher risk of heart attack-inducing blood clots than competing products. The plaintiffs argued in court filings that Merck failed to provide proper warnings about NuvaRing's higher clot risks on the product's label to protect sales.

The Associated Press (AP) reports that Merck said the agreement will resolve all US litigation over the product, including some patients who are eligible to bring a lawsuit against the company but haven't yet filed suit. Additional cases have been filed in state courts in California and Illinois.

NuvaRing is a hormonal-vaginal contraceptive that combines estrogen and progestin in a flexible ring that is worn for up to three weeks at a time. The product has been sold in the U.S. since 2001. In 2011, an FDA report linked the device to a higher risk for blood clots.

Lainie Keller, a Merck spokesperson, said the company isn't admitting wrongdoing under the settlement and continues to believe NuvaRing is a safe contraceptive. She said Merck continues to "monitor the safety of the medicine," which is still being sold by prescription.

The settlement compensates women for three classes of injuries - deep-vein thrombosis, pulmonary embolisms and death - arising from blood clots, Blau said. The settlement is set up so that women with more severe injuries will qualify for larger payments.

Roger Denton, a lawyer for the plaintiffs, told AP the settlement was reached after nearly a year of negotiations and is "an outstanding result and in the best interests of all the women who have suffered an injury associated with the use of NuvaRing."

"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, told Jef Feeley and David Voreacos in a phone interview for Bloomberg.

Blau said women suing over NuvaRing had to overcome the legal hurdle of showing that a device approved by the FDA as safe had flaws and that Merck officials didn't properly warn about its risks.

"That's a very hard burden to overcome," Blau said.