For many years, the Langharts ran a popular restaurant in Durango, Colo., and their daughter Erika grew up there. Soon after they retired, Erika, then 24 years old and living in Virginia, suffered blood clots and died.
The Langharts say the doctor who treated their daughter told them the cause of the fatal blood clots was a form of birth control, called NuvaRing, which Erika had been using. NuvaRing and other forms of hormonal birth control are known to increase the risk of such clots. Now, the Langharts are part of a mass tort lawsuit, in which several plaintiffs are suing Merck, the maker of NuvaRing. Many of the victims in the lawsuit did not die, but say they suffered injuries from using the product. Their story was documented in a recent article in Vanity Fair.
Merck has offered a $100 million settlement to split among about 3,800 families. In 2013, the company had a net profit of more than $4.4 billion.
The victims and families have until March 10, to decide whether they will accept the settlement. Ninety-five percent of the plaintiffs have to accept for the settlement to go through.
The Langharts say they won't be part of it.
"It was never about the money," Rick Langhart says.
"We can't in good conscience settle when Merck is not admitting any fault in this," Karen Langhart adds. The Langharts say they want to take the case further through the judicial process to try to hold Merck accountable for their daughter's death. They believe Merck is ultimately responsible, in part because of the way the drug company markets the product to doctors.
CPR requested an interview with Merck, but the company declined. Merck provided a written statement: "Nothing is more important to Merck than the safety of our medicines and vaccines and the people who use them. Merck employees, and our families, use Merck medicines, too. Our deepest sympathies go out to those who are suffering from an injury or loss of a loved one.
"There is substantial evidence to support the safety profile and efficacy of NuvaRing. We encourage women to work jointly with their healthcare providers to discuss benefits and risks of any contraceptive method before choosing an option that is right for them. Among other considerations, women should understand important information about venous thromboembolic events (VTE), such as deep vein thrombosis and pulmonary embolism, when making their choice of contraception." The full text of the company's statement is below.
While they wait for their legal case to move forward, the Langharts are joining with other families who lost loved ones to campaign for changes.
They want better labeling on hormonal birth control medications, to make the risks of using them more obvious. On the website for NuvaRing, blood clots are listed as the first item under "Possible Risks and Side Effects," but the Langharts say that's not enough. They also want Merck to be held criminally responsible. And they want better tracking of the number of women who have suffered blood clots as a result of using hormonal birth control, which includes a patch (called, simply, "The Patch,") and several kinds of birth control pills in addition to NuvaRing.
First, though, the Langharts want women everywhere to know that they have birth control choices other than medications that contain hormones.
Dr. Stephanie Teal is a practicing obstetrician/gynecologist who teaches at the University of Colorado School of Medicine. She’s also a family planning consultant for the Colorado Department of Public Health.
Teal says many of the most effective forms of birth control don't contain estrogen, which is the primary factor in the increased risk of blood clots. Those include intra-uterine devices, known as IUD's; a sub-dermal implant, which slides under the skin of the arm; and an injection. Teal says that many of her patients choose one of those forms after learning about all of the options.
Teal says from the earliest forms of the pill it's been known that using drugs that contain hormones increases the risk of blood clots, although that risk is still small statistically. She says it's the health care provider's responsibility to educate patients about those risks.
"Women can walk in and say, 'Hi, I need birth control, can you give me the pill?' And we're not car mechanics. It's not like, 'Sure, here you go,'" Teal says. "It's really the duty of the health care provider to review with the patient what all the options are, the risks, the benefits. I feel like I have special knowledge about this. Hopefully I can help my patient make a good decision," Teal says.
And ultimately, Teal says, there are risks and benefits to each form of medication. "Most women can use any birth control method very, very safely. And very effectively. However, it's important to recognize that any single medication will have a devastating effect for somebody," she says.
Teal adds that despite the increased risk of blood clots, hormonal forms of birth control can be good for women who want control over their medications, for example, since many other forms, particularly IUD's, can't be stopped and started by the patient. Moreover, she says, hormonal birth control methods are highly effective -- and that's an important factor in a woman's choice of method. Hormonal birth control products can also be useful treatments for certain health conditions beyond just preventing pregnancy, Teal says. That includes reducing the risk of ovarian cancer in women who have a higher risk for it.
Still, some people believe the NuvaRing and other products with so-called third- and fourth-generation hormones, particularly progestin, have an inherently higher risk of blood clots. They point to a study published in the British Journal of Medicine in 2012, which found that women who use vaginal rings are 90 percent more likely to suffer serious blood clots than are women who use birth control medications with earlier forms of progestin.
Teal says that study is somewhat controversial because of its methodology. She says it lumps together women who are newly on birth control with women who have been on it for years. The risk of blood clots is much higher in women who are just starting out on birth control, Teal says.
Teal recommends women consider two other recent studies, which found birth control medications with newer forms of progestin do not have a higher risk of clots than medications with older forms of progestin. Those studies were published in the journal Obstetrics and Gynecology and the journal Contraception. Still, Teal points out, all forms of hormonal birth control increase a woman's chances of getting blood clots.
IUD's carry their own risks, Teal says, particularly when the devices are first inserted. Insertion has been known to result in an infection or damage the uterus. Teal recommends talking to the doctor about his or her experience with the procedure before getting it, and says doctors should make sure patients don't have certain sexually-transmitted diseases to reduce the risk of infection.
Teal has acted as a scientific advisor to several drug companies on various medications. But she has had no involvement with Merck, maker of NuvaRing, or the product.
Teal recommends two websites where women can find out more information about birth control medications: the website of the Association for Reproductive Health Professionals, and Bedsider, from the National Campaign to Prevent Teen and Unplanned Pregnancy.
Full statement from Merck
Nothing is more important to Merck than the safety of our medicines and vaccines and the people who use them. Merck employees, and our families, use Merck medicines, too. Our deepest sympathies go out to those who are suffering from an injury or loss of a loved one.
There is substantial evidence to support the safety profile and efficacy of NuvaRing. We encourage women to work jointly with their healthcare providers to discuss benefits and risks of any contraceptive method before choosing an option that is right for them. Among other considerations, women should understand important information about venous thromboembolic events (VTE), such as deep vein thrombosis and pulmonary embolism, when making their choice of contraception.
Additional Background
All combined hormonal contraceptives (CHC), including NuvaRing and combined oral contraceptives (COC), are associated with an increased risk of VTEs. Two recent studies – a prospective, large cohort study sponsored by the company and a retrospective observational study sponsored by the U.S. Food and Drug Administration (FDA) – found that the risk of blood clots for new users of NuvaRing is similar to the risk for new users of COCs.
All CHCs in the U.S., including NuvaRing, have a Boxed Warning on the increased risk of serious cardiovascular events, especially in women who smoke. Both the FDA-approved patient information and physician package labeling for NuvaRing have included this information since the product was approved in 2001 and were updated in October 2013 to include the information noted above showing that the risk of blood clots for new users of NuvaRing is similar to the risk for new users of combined oral contraceptives. The absolute VTE rates are increased for women who use CHCs compared to those who do not use CHCs. However, the rates of VTEs associated with pregnancy are even greater than those for women who use CHCs, especially during the post-partum period.
To put this risk in perspective, as described in the PI for NuvaRing, it is estimated that:
- If 10,000 women who are not pregnant and do not use CHCs are followed for one year, 1 to 5 of these women, will develop a VTE;
- If 10,000 women who use a CHC are followed for one year, 3 to 12 women will develop a VTE;
- If 10,000 women who are pregnant (and not taking a combined hormonal contraceptive) are followed for one year, 5 to 20 women, of every 10,000 women will develop a VTE
- If 10,000 women who are postpartum (12 weeks after delivery) are followed for one year, 40 to 65 will develop a VTE.
We stand behind the research that supported the approval of NuvaRing, and our continued work to monitor the safety of the medicine. Merck is pleased to be able to offer an alternative to the pill for women seeking to avoid unintended pregnancy and for whom a CHC is deemed medically appropriate by their prescribing physicians.
Additional Background on the Safety Profile of NuvaRing from Clinical Trials
Organon, with academic and other researchers, conducted and published well-controlled clinical trials involving more than 3,700 women that demonstrated the medicine's efficacy and safety. The results of these trials were provided to regulatory agencies, and the medicine was approved as safe and effective by the FDA in 2001. Since June 2002, more than 44 million prescriptions for NuvaRing have been filled in the U.S., and NuvaRing is currently available in more than 50 countries around the world.
The risk of thrombotic events (which includes VTE) associated with the use of NuvaRing was studied in a large observational trial of 33,295 women, a study funded by Merck. The study investigated the risk of VTE for new users, and women who were switching to or restarting NuvaRing or COCs in a population representative of routine clinical users. In this study, more than 16,800 women used NuvaRing. The study, Transatlantic Active Surveillance on Cardiovascular Safety of NuvaRing (TASC), was recently published in Obstetrics & Gynecology in 2013 and was presented at American Congress of Obstetricians and Gynecologists in 2012. The results of TASC indicated that use of NuvaRing (etonogestrel/ethinyl estradiol vaginal ring) and COCs were associated with similar VTE risk.
A separate, FDA-funded study in Kaiser Permanente and Medicaid databases, which was a retrospective cohort study using data from four health plans in the U.S., also examined the risk of thrombotic events in new users of NuvaRing. In that study, the risk of VTE for new users of NuvaRing, relative to new users of COCs, was not increased.
Following completion of the TASC study, Merck worked closely with regulatory agencies to update labels for NuvaRing worldwide to include these results. The label for NuvaRing was updated in 2013 in the U.S., Canada, and Europe to reflect these results.
Resolution of Litigation
Merck has reached an agreement to resolve all of the existing NuvaRing product liability claims in the U.S. as of February 7, 2014, including cases filed in the federal multidistrict litigation; in the New Jersey state coordinated proceedings; and in other state and federal proceedings.
Merck denies fault under the agreement, and the company will pay $100 million to resolve the claims filed in federal or state court, as well as certain unfiled claims, provided that various contingencies and requirements are met, including a 95 percent participation rate among the approximately 3,800 eligible participants overall and in certain categories. Claimants will need to provide sufficient evidence to satisfy specific eligibility requirements.
