By Dow Jones Business News,
February 07, 2014, 05:35:00 PM EDT
Merck & Co. said Friday it agreed to pay $100 million to resolve all product-liability lawsuits alleging that the
company's NuvaRing contraceptive caused blood clots which in some cases were fatal or led to heart attacks.
Merck said it denies fault under the agreement, which would resolve cases filed in state and federal courts, as well
as certain unfiled claims. Merck said 3,800 people are eligible to participate in the settlement, and 95% need to
participate for the deal to take effect.
NuvaRing is a combined hormonal contraceptive vaginal ring, a product that Merck inherited through its 2009
acquisition of Schering-Plough. Schering had acquired the product through its prior acquisition of Organon. Merck
recorded NuvaRing sales of $686 million for 2013.
A series of lawsuits filed beginning in 2007 alleged that Organon and Schering failed to adequately design and
manufacture NuvaRing and failed to adequately warn of the alleged increased risk of venous thromboembolism, or played
down the risk.
A federal judge in U.S. District Court for the Eastern District of Missouri, who has coordinated the NuvaRing cases
filed in federal court, will oversee various aspects of the settlement.
The prescribing label for NuvaRing has contained warnings about cardiovascular risk associated with contraceptives
including NuvaRing since the product was approved in 2001, especially in women who smoke. But the plaintiffs argued the
label didn't fully or accurately characterize evidence that so-called third-generation combined hormone contraceptives
including NuvaRing increased the risk of blood clots versus second-generation versions.
Merck said it stands behind the research that supported the regulatory approval of NuvaRing and its continued work to
monitor the safety of the medicine. The company said there is substantial evidence to support the safety and efficacy of
Kristine Kraft, one of the plaintiffs' attorneys in the case, said: "I believe this is an outstanding and favorable
settlement for the women who have been harmed as a result of their use of Nuvaring."
Write to Peter Loftus at firstname.lastname@example.org
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