NuvaRing Blood Clots Recall – DVT & Pulmonary Embolism Lawsuits And Compensation
If you are currently using NuvaRing and have found this website looking for information about symptoms like sudden problems with vision, severe headaches, shortness of breath, bloody cough, chest pain, swelling in your legs or arms, then please get medical assistance immediately. You might be having the first signs of a blood clot.
This website answers frequently asked questions about NuvaRing’s undisclosed risk of blood clots, thrombosis, and embolism complications and the law, including:
- What happened with NuvaRing?
- Who might have a claim for compensation or a settlement?
- Has NuvaRing been recalled by the Food and Drug Administration?
- What scientific studies have been done on NuvaRing’s safety and side effects?
- Is there a class action lawsuit against the makers of NuvaRing?
- Which NuvaRing lawyers run this website?
What happened with NuvaRing?
The NuvaRing hormonal birth control (contraceptive) device is one of the most popular non-pill forms of contraceptive, with over 5 million prescriptions annually in the United States. NuvaRing, however, has been shown to have a higher risk of blood clotting injuries than bill control pills, and a higher risk of serious side effects than disclosed by the warning label and prescribing information provided by the device’s manufacturer. All hormonal contraceptives slightly increase the risk of blood clots, but medical studies have shown that women who use NuvaRing have a much higher risk of blood clots, stroke, deep vein thrombosis, pulmonary embolism, and even death.
As of 2012, more than 1,000 NuvaRing-related blood clot injuries and deaths have been reported to the FDA, and over 700 lawsuits have been filed by women alleging they suffered a stroke, a blood clot in their legs, or a blood clot in their lungs as a result of NuvaRing’s increased risk of side effects. Deep-vein thrombosis and pulmonary embolism are both life-threatening conditions requiring immediate treatment, and a stroke can immediately cause permanent disabilities; many NuvaRing lawsuits involve patients who died as a result of the blood clot traveling to their lungs or their brain.
Who might have a claim for compensation or a settlement?
Although every patient who was prescribed NuvaRing could have a theoretical legal claim for consumer fraud or the like (because they paid for a medical device that was not as safe as advertised), our law firm focuses on serious personal injury and wrongful death claims. We screen for cases in which the patient was diagnosed with a blood-clot injury, such as stroke, deep vein thrombosis, or a pulmonary embolism that required follow-up medical care, such as hospitalization, or which resulted in a disabling injury or death.
In many cases, the symptoms are so severe — such as sudden loss of vision, partial paralysis, swelling in one leg or one arm, bloody cough, or severe difficulty breathing — that medical treatment will be sought immediately and the patient will be diagnosed with one of the above conditions. In some cases, though, a patient will have symptoms that aren’t as obviously an emergency, like headaches, chest pain, shortness of breath, or swelling in one leg. If you have those symptoms but have not seen a doctor, please get medical assistance immediately. You can read more from the Department of Health and Human Services about preventing and treating blood clots here.
In many instances, medical malpractice may have also played a role in causing the patient’s injuries. In addition to screening for NuvaRing injuries, we examine every NuvaRing case for the possibility of malpractice. Patients who have inherited thrombophilias, hypertension, hyperlipidemias, obesity, and diabetes, should not be prescribed NuvaRing in the first place. Patients who developed signs and symptoms of a blood clot, stroke, DVT, or pulmonary embolism should be treated immediately, though some doctors negligently fail to diagnose the condition, resulting in delayed treatment. If our client’s injuries appear to be caused by malpractice, then we will handle the case as a malpractice case rather than a defective medical device case.
Has NuvaRing been recalled by the Food and Drug Administration?
Despite efforts by consumer organizations like Public Citizen, patient advocates, medical researchers, and patient’s lawyers, NuvaRing has not been recalled by the Food and Drug Administration, or by the companies that manufacturer it, Merck, Schering-Plough, and Organon Pharmaceutical. Unfortunately, in recent years the FDA has taken a lax attitude towards unsafe drugs, even when pharmaceutical manufacturing plants have been proven to have fabricated safety data.
NuvaRing is thus likely to stay on the market for the foreseeable future. Our hope, as safety advocates, is that the FDA will at least order NuvaRing to carry a “black box” warning, like it eventually did for Ortho Evra. A “black box” warning is the strongest warning the FDA can issue; if properly worded, the “black box” sends a clear warning to prescribing physicians and to patients of the real risks of the drug.
Like NuvaRing, Ortho Evra was a non-pill method (a patch) billed as a safer, more convenient way for women to take birth control. In time, it became clear that the patch caused women to receive 60% higher levels of hormones than they would through pills, dramatically increasing their risk of blood clots, strokes, DVTs, and pulmonary embolisms. Ortho Evra’s “black box” now includes this warning:
Risk of Venous Thromboembolism The risk of venous thromboembolism (VTE) among women aged 15-44 who used the ORTHO EVRA® patch compared to women who used oral contraceptives containing 30-35 mcg of ethinyl estradiol (EE) and either levonorgestrel or norgestimate was assessed in four U.S. case-control studies using electronic healthcare claims data. The odds ratios ranged from 1.2 to 2.2; one of the studies found a statistically significant increased risk of VTE for current users of ORTHO EVRA®
In sharp contrast, the NuvaRing prescribing information simply says:
The use of oral contraceptives is associated with increased risks of several serious conditions including venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, and stroke), hepatic neoplasia, gallbladder disease, and hypertension, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors.
We believe that “warning” fails to give prescribing physicians and patients accurate information given the scientific data showing an increased risk for users of NuvaRing as compared to users of oral contraceptives.
For more about why the information given to physicians is so important in a lawsuit, please read this article of mine about the “learned intermediary doctrine,” a legal doctrine often invoked by the drug companies to dismiss plaintiff’s claims the company negligently failed to warn patients of the risks of the medication.
What scientific studies have been done on NuvaRing’s safety and side effects?
Starting in the 1980s, birth control manufacturers started moving to “third-generation” hormones like desogestrel (marketed sometimes as Desogen or Cyclessa) under the mistaken belief that these hormones would reduce minor side effects like acne and facial hair. The third-generation hormones, however, didn’t have fewer minor side effects, and studies in the 1990s began showing they were more likely to cause major side effects like blood clots and strokes.
Even worse, NuvaRing exacerbates the problem of third-generation birth control hormones by delivering the hormones directly into the bloodstream, rather than through the stomach, like pills do, which ends up reducing the quantity of hormones entering the bloodstream and ensures the hormones enter more slowly.
In 2011, an internal FDA study (“Combined Hormonal Contraceptives and the Risk of Cardiovascular Disease Endpoints“) found a 48% higher risk of venous thrombosis in women using a NuvaRing compared with those using combined oral contraceptives containing levonorgestrel, a second-generation hormonal contraceptive common referred to as “Plan B.” A Danish study published in the British Medical Journal in May 2012 (“Venous thrombosis in users of non-oral hormonal contraception: follow-up study, Denmark 2001-10“) found that NuvaRing users had nearly double the risk of venous thrombosis as users of second-generation oral contraceptives.
A four-year study sponsored by Merck (“Transatlantic Active Surveillance on Cardiovascular Safety of NuvaRing,” summarized here) found no difference in the rates of blood clotting risks. That paper, however, has not been peer-reviewed or published by a journal (it was, instead, presented before the American College of Obstetricians and Gynecologists Annual Clinical Meeting on May 7, 2012) and so has not been subject to scrutiny and review by other scientists.
In 2012, a “meta-study” reviewed over 625 studies on combined hormonal contraceptives, then chose the 25 most thorough studies on the differing risks between second generation and third generational hormonal contraceptives. That study found the evidence was clear that hormonal contraceptives that contained desogestrel, like NuvaRing, were nearly twice as likely to cause blood clotting injuries like DVTs and pulmonary embolisms.
Is there a class action lawsuit against the makers of NuvaRing?
There are nearly 700 individual pending lawsuits relating to NuvaRing, but no pending class action lawsuits. Class action lawsuits are rarely used in personal injury and defective medical device cases, because the compensation that should be awarded to each patient is an individual matter that depends upon each individual’s circumstances. Instead, many individual cases are filed, and sometimes the court consolidates the pre-trial proceedings for those cases. For NuvaRing, over 500 claims have been consolidated in federal court in Missouri, and just under 200 claims have been consolidated in state court in New Jersey (where Merck is based).
Patients who have suffered blood clotting injuries such as stroke, disability, or the family members of patients who died as a result of their clotting injury, may be entitled to compensation if the manufacturers of NuvaRing are found to have been negligent in the design, testing, manufacturing and marketing of their products. I’ve previously written articles on this blogs about the types of claims available against pharmaceutical and medical device manufacturers, like “failure to warn.”