ST. LOUIS—A federal judge in St. Louis has endorsed a proposed, $100 million settlement that would resolve all the claims in federal and state courts involving NuvaRing, a birth-control device linked to blood clots.
In a court hearing Friday, U.S. District Judge Rodney Sippel called the settlement agreement “a fair resolution of this litigation,” and added that “it’s intended to be a final resolution of litigation” in the lengthy case.
But, he added, the agreement is contingent on at least 95 percent of the eligible claimants opting into the program. No payouts will be made unless that threshold is met, he said. The deadline is March 10.
NuvaRing — a flexible plastic ring that is inserted monthly in the vagina — releases birth control hormones to prevent ovulation. The contraceptive device has been blamed for causing potentially fatal blood clots.
In a news release, New Jersey-based Merck & Co. denied fault under the settlement agreement and indicated that the $100 million payment is designed to satisfy all NuvaRing cases filed nationwide as well as certain claims filed in the future. Merck indicated there are about 3,800 eligible participants in the settlement plan, a number which includes more than 1,850 filed lawsuits as well as claims that have not been filed in court.
The proposed settlement was presented at court hearings in New Jersey and St. Louis, where the bulk of NuvaRing cases have been consolidated.
“Nothing is more important to Merck than the safety of our medicines and vaccines and the people who use them,” Merck said in a written statement.
“We stand behind the research that supported the approval of NuvaRing, and our continued work to monitor the safety of the medicine,” Merck said. “There is substantial evidence to support the safety and efficacy of NuvaRing, and we encourage women to work jointly with their health care providers to discuss benefits and risks of any contraception approach before choosing an option that is right for them.”
St. Louis attorney Roger Denton, the lead negotiator for the plaintiffs, said in a written statement he believes the settlement program is “an outstanding result and in the best interests of all the women who have suffered an injury associated with the use of NuvaRing.
“The settlement was reached after more than four years of litigation, after reviewing millions of pages of documents produced by Organon (Merck’s owner), and the completion of more than 100 depositions — both in the United States as well Europe,” Denton said. “The settlement negotiations were conducted for close to a year, beginning in early 2013.”
Denton said after the hearing that a substantial portion of the $100 million settlement, ranging from about 30 percent to 40 percent, is likely to be consumed by lawyers’ contingency fees and expenses.
NuvaRing, which was approved by the Food and Drug Administration in 2001, has been marketed and sold in the United States since 2002 by Organon USA Inc., a New Jersey company, and Organon International Inc., which is headquartered in the Netherlands. Both companies are currently owned by Merck.
The lawsuits allege that Organon failed to properly design and test NuvaRing — the first vaginal delivery system for hormonal birth control — and did not adequately disclose or warn of the potential hazards of using the device.
“The company did not act responsibly,” St. Louis attorney Kristine Kraft, who also negotiated the settlement on behalf of the plaintiffs, said in a brief interview. She said that Organon failed to disclose to the FDA in a timely manner the most serious adverse events found in NuvaRing’s clinical trials and “lobbied hard against the inclusion of any mention of VTE in (NuvaRing’s) labeling — the most important side effect for women.”
VTE, an acronym of venous thromboembolism, includes a blood clot in a vein that is not externally visible and can lead to a pulmonary embolism in which a blood clot breaks free and lodges in one of the lungs.
Merck says that Organon researchers conducted and published clinical trials that demonstrated NuvaRing’s safety and efficacy, and fully disclosed all known risks, including the possibility of blood clots, in its packaging and labeling.
The settlement agreement has also won the endorsement of Judge Brian Martinotti, who presided over consolidated NuvaRing cases in New Jersey, as well as a court-appointed mediator, retired federal Judge Wayne Andersen of Chicago.
However, New York plaintiffs’ lawyer Paul Rheingold, who represents about 450 of the NuvaRing cases including eight involving deaths, has voiced concern that the $100 million settlement offer may be too low to win the approval of 95 percent of clients.
Last year, one of Merck’s competitors — Germany-based Bayer AG — agreed to pay more than $1.6 billion to settle cases alleging that its Yaz and Yasmin birth control pills caused blood clotting.
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©2014 St. Louis Post-Dispatch
Visit the St. Louis Post-Dispatch at www.stltoday.com
Distributed by MCT Information Services
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Topics: t000171831,t000002827,t000003813,t000412858,t000002865,t000002870,t000002953,t000047681,t000047680,c000214350,g000362661,g000066164,g000065648
In a court hearing Friday, U.S. District Judge Rodney Sippel called the settlement agreement “a fair resolution of this litigation,” and added that “it’s intended to be a final resolution of litigation” in the lengthy case.
But, he added, the agreement is contingent on at least 95 percent of the eligible claimants opting into the program. No payouts will be made unless that threshold is met, he said. The deadline is March 10.
NuvaRing — a flexible plastic ring that is inserted monthly in the vagina — releases birth control hormones to prevent ovulation. The contraceptive device has been blamed for causing potentially fatal blood clots.
In a news release, New Jersey-based Merck & Co. denied fault under the settlement agreement and indicated that the $100 million payment is designed to satisfy all NuvaRing cases filed nationwide as well as certain claims filed in the future. Merck indicated there are about 3,800 eligible participants in the settlement plan, a number which includes more than 1,850 filed lawsuits as well as claims that have not been filed in court.
The proposed settlement was presented at court hearings in New Jersey and St. Louis, where the bulk of NuvaRing cases have been consolidated.
“Nothing is more important to Merck than the safety of our medicines and vaccines and the people who use them,” Merck said in a written statement.
“We stand behind the research that supported the approval of NuvaRing, and our continued work to monitor the safety of the medicine,” Merck said. “There is substantial evidence to support the safety and efficacy of NuvaRing, and we encourage women to work jointly with their health care providers to discuss benefits and risks of any contraception approach before choosing an option that is right for them.”
St. Louis attorney Roger Denton, the lead negotiator for the plaintiffs, said in a written statement he believes the settlement program is “an outstanding result and in the best interests of all the women who have suffered an injury associated with the use of NuvaRing.
“The settlement was reached after more than four years of litigation, after reviewing millions of pages of documents produced by Organon (Merck’s owner), and the completion of more than 100 depositions — both in the United States as well Europe,” Denton said. “The settlement negotiations were conducted for close to a year, beginning in early 2013.”
Denton said after the hearing that a substantial portion of the $100 million settlement, ranging from about 30 percent to 40 percent, is likely to be consumed by lawyers’ contingency fees and expenses.
NuvaRing, which was approved by the Food and Drug Administration in 2001, has been marketed and sold in the United States since 2002 by Organon USA Inc., a New Jersey company, and Organon International Inc., which is headquartered in the Netherlands. Both companies are currently owned by Merck.
The lawsuits allege that Organon failed to properly design and test NuvaRing — the first vaginal delivery system for hormonal birth control — and did not adequately disclose or warn of the potential hazards of using the device.
“The company did not act responsibly,” St. Louis attorney Kristine Kraft, who also negotiated the settlement on behalf of the plaintiffs, said in a brief interview. She said that Organon failed to disclose to the FDA in a timely manner the most serious adverse events found in NuvaRing’s clinical trials and “lobbied hard against the inclusion of any mention of VTE in (NuvaRing’s) labeling — the most important side effect for women.”
VTE, an acronym of venous thromboembolism, includes a blood clot in a vein that is not externally visible and can lead to a pulmonary embolism in which a blood clot breaks free and lodges in one of the lungs.
Merck says that Organon researchers conducted and published clinical trials that demonstrated NuvaRing’s safety and efficacy, and fully disclosed all known risks, including the possibility of blood clots, in its packaging and labeling.
The settlement agreement has also won the endorsement of Judge Brian Martinotti, who presided over consolidated NuvaRing cases in New Jersey, as well as a court-appointed mediator, retired federal Judge Wayne Andersen of Chicago.
However, New York plaintiffs’ lawyer Paul Rheingold, who represents about 450 of the NuvaRing cases including eight involving deaths, has voiced concern that the $100 million settlement offer may be too low to win the approval of 95 percent of clients.
Last year, one of Merck’s competitors — Germany-based Bayer AG — agreed to pay more than $1.6 billion to settle cases alleging that its Yaz and Yasmin birth control pills caused blood clotting.
———
©2014 St. Louis Post-Dispatch
Visit the St. Louis Post-Dispatch at www.stltoday.com
Distributed by MCT Information Services
_____
Topics: t000171831,t000002827,t000003813,t000412858,t000002865,t000002870,t000002953,t000047681,t000047680,c000214350,g000362661,g000066164,g000065648
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