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NuvaRing Approved by FDA Despite Adverse Reactions

Zaha Irfan3 years ago

A Missouri teenager’s mother has filed a lawsuit against the manufacturers of NuvaRing after her daughter died within weeks of using the device. 

Multiple Lawsuits Filed Against Merck

La Monica Greene, 17, obtained a prescription for NuvaRing – a vaginal, once-a-month contraceptive ring. She died of a blood clot in one of her lungs weeks after she began using the device.

Greene’s case is one of over 1850 lawsuits filed against the makers of NuvaRing since 2007.

The lawsuits are based on the claim that NuvaRing was created and sold without sufficient testing and warning about the potential life-threatening injuries that have been linked to its use.

Strokes, heart attacks, deep vein thrombosis, and pulmonary embolisms are amongst the most serious side effects that have been reported by users of the device.

In addition to wrongful death cases, the makers of NuvaRing have also faced lawsuits calling for damages including disability, lost earnings, pain, suffering, and mental anguish.

NuvaRing is marketed by Organon USA Inc., Organon Pharmaceuticals USA Inc., and Organon International Inc. Both companies are owned by Merck.

Merck Responds to NuvaRing Lawsuits

Merck has denied claims of the dangers associated with the use of the device, stating that it is safer than birth control pills. The adverse side effects, its claims, are very rare among users.

Advertisements promoting NuvaRing emphasize its convenience over other, traditional forms of birth control methods.

Last month, Merck agreed to settle all NuvaRing cases nationwide for $100 million. There are currently over 3800 eligible participants in this settlement plan, which includes both those that have filed lawsuits and those that have only filed claims.

The agreement, however, is conditional on 955 of the eligible participants opting into the program. The deadline is March 10.

FDA New of Risks before Approval

According to the St. Louis Post-Dispatch, the application for the FDA approval of NuvaRing was submitted in December 1999, and took two years of negotiations before it was approved. The drug makers submitted data from two major clinical trials from both the United States and Europe to prove that the device was safe for use, and successful in preventing pregnancy.

FDA medical officers immediately identified the risk of blood clots from the use of the device, based on the adverse reactions experienced by participants in the studies. They thus approved the sale of the device, contingent on the drug makers including the risk of blood clots on the product’s warning label.

The manufacturers of the device, however, successfully persuaded the FDA that there was no need to mention the cases of the instances of severe blood clots in clinical trial patients in NuvaRing warning labels. Instead, the manufacturers went on to conduct post-marketing studies, none of which involved further studies on blood clot risks associated with the device.

Where does Responsibility Lie?

An expert witness for the plaintiff and former FDA official Dr. Suzanne Parisian stated that Organon was at fault for not conducting sufficient safety studies, playing down the product’s risks in its marketing, failing to conduct adequate post-marketing studies, and not voluntarily updating its warning labels to reflect the rising reports of blood clots caused by the device.

Kristine Kraft, a lawyer currently suing Merck, stated that the FDA should have ordered further studies on the risk of blood clots that the device posed on users.

Dr. Susan Allen, an FDA director who was involved in the NuvaRing approval, left the FDA in 2006 and joined Organon. She reportedly did not return phone calls to comment on the accumulating lawsuits against the device.

Soon after NuvaRing hit the market, the FDA began receiving hundreds of adverse reaction reports of complications from the device.

Since the growing reports and lawsuits, the FDA has ordered the drugmaker to change the warning label to indicate that women with a history of blood clots and heart disease should not use NuvaRing.

Between 2002 and 2003, Organon also sponsored studies to promote the acceptance of the use of the device among young adults.  

NuvaRing continues to be prescribed by doctors, with reported sales of $623 million in 2012.

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