Over 1,500 women have sued Merck & Co., a pharmaceutical manufacturer, in the past 10 years because of its NuvaRing contraceptive device. The NuvaRing is a plastic ring inserted vaginally that releases forms of estrogen and progestin over time, which cause physical changes that reduce the odds of conception. It was approved by the FDA in 2001. In 2002 Merck began marketing it as the “first and only, once-a-month vaginal birth control ring”.

However, women began to experience problems with the device. The device allegedly releases dangerously high levels of estrogen, which can increase the risk of blood clots. According to lawsuits filed by women who have had health problems allegedly related to NuvaRing, Merck marketed the product as providing the same effectiveness as birth control pills, but with more convenience. However, the drug company put warnings on the label that were developed for oral contraceptives. The plaintiffs believe that specific warnings were needed for NuvaRing, because they were different from oral contraceptives. In addition, Merck allegedly failed to examine the effect of exposing the product to higher temperatures, which can make the NuvaRing more likely to cause sudden hormonal spikes.

This biggest complaint many plaintiffs have with NuvaRing is that the company knew that the product inconsistently delivered hormones. Merck allegedly actively suppressed and concealed information about the dangers of the product. In particular, the company reportedly hid information that showed women who used it often experienced unpredictable and massive hormonal spikes. The spikes dramatically increased the incidence of clotting side effects. Even after increasing evidence of blood clotting issues, Merck has failed to update warning labels in the U.S., although it did so in Canada.

Thousands of lawsuits related to NuvaRing have been filed in federal and state courts, and the drug company appears to be close to reaching a settlement that would settle 3,800 of the cases. Merck may pay $100 million to settle those particular cases, as long as 95 percent of the plaintiffs participate in the agreement.

The settlement will compensate women who have three types of injuries that occur from blood clots: pulmonary embolisms, deep-vein thrombosis, and death. On average, the women will receive $58,000 each, although the settlement is set up so that women with more serious injuries will receive larger payments.

Although $100 million may seem like a huge settlement, other drug companies have paid much more in lawsuits over other types of contraceptives. For example, Bayer paid $1.6 billion last year to settle lawsuits over its Yasmin and Yaz birth control pills. Those pills were also alleged to cause blood clots which led to strokes and heart attacks. Experts say that Merck may end up paying less because proving liability against the NuvaRing device is more difficult.  Merck is not admitting wrongdoing, and continues to believe it is a safe contraceptive. It will continue to monitor the product’s safety.

As this story illustrates, it can be tough to prove liability when it comes to a defective medical device. Drug companies often have hundreds of millions or billions of dollars invested in their devices or prescription drugs, and they are often unwilling to admit when a drug or device is not effective, even when it means customers die or suffer serious health problems.

At Liberty Law, Micha Star Liberty believes that drug companies should be forced to pay for the damages they cause to customers. If you have been harmed by a defective drug or device such as the NuvaRing in the San Francisco Bay area, including Oakland, Tracy, Hayward and Fairfield, call Micha Star Liberty of Liberty Law, an Oakland defective medical devices attorney. She can be reached at 510-645-1000 or 415-896-1000.

 

 



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