Post-election coverage dominated the news cycle last week. In our top stories, we looked at who could run for president in 2020, why women are rushing to get IUDs after the election, and what Donald Trump has planned for his first 100 days in office. ICYMI–check out the top stories from Law Street below!

1. Fast Forward: Who Could Run for President in 2020?

It can be hard to focus on things other than the election results right now, but there are already speculations brewing about who will run for the Democratic presidential nomination in 2020. Read the full article here.

2. Why I Frantically Started Researching IUDs the Day After the Election

The day after the election was rough to say the least. Not only had I overconfidently assumed that I’d be spending the day celebrating a woman finally breaking through the top political glass ceiling, but I hadn’t even allowed myself–up until that point–to imagine a reality where Donald Trump actually wins the 2016 presidential election. Sleep deprived and legitimately scared for my life, I then began to mentally run through all the things that could now happen under a Trump presidency.

Read the full article here.

3. Here is What Donald Trump Says He Plans to Do in His First 100 Days

Today President-elect Donald Trump met with President Obama in the Oval Office to discuss plans for the hand-off between presidencies and the peaceful transfer of power. While the meeting seems to have been cordial, it had to have been a little awkward given that Obama and Trump are bitter political rivals and Trump plans to “cancel every unconstitutional executive action, memorandum and order issued by President Obama” on his first day in office–that’s if Trump’s plan for his first 100 days in office is to be believed. Read the full article here.

Alexis Evans

Alexis Evans is an Assistant Editor at Law Street and a Buckeye State native. She has a Bachelor’s Degree in Journalism and a minor in Business from Ohio University. Contact Alexis at aevans@LawStreetMedia.com.

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In 2011, a personal injury complaint was filed in regards to Mirena, an intrauterine device (IUD) manufactured by Bayer Healthcare, one of the largest pharmaceutical companies worldwide. Since then, over a thousand lawsuits have been filed against the manufacturers of Mirena. Some Mirena users have suffered from uterine perforation, inflammation, organ damage, and a host of other medical complications. The Mirena IUD is Bayer’s most popular model worldwide, and the company markets the product as safe and efficient. Yet as the number of lawsuits continues to rise, Mirena’s reputation may take a hit. Take a look at the details behind Mirena and why these lawsuits are making the news.

Mirena by the Numbers

The three hormonal IUDs available in the United States: Skyla, Liletta, and Mirena. Both Skyla and Mirena are manufactured by Bayer while Liletta was developed by Actavis and Medicines360 specifically to be low cost and available to public health clinics. According to Mirena’s official website, Mirena is recommended for women who have already had a child. The IUD is marketed as a “hassle free” form of birth control for busy moms. The major benefits of the IUD are that it is effective, convenient, reversible (the IUD can be removed if you wish to become pregnant) and estrogen free (the IUD utilizes progestin).

However, in 2009, the FDA issued a warning letter to Bayer, arguing that the Mirena advertising campaign exaggerated the efficacy of the device, misleading consumers. The FDA singled out certain advertisements that failed to describe any of the risks associated with IUDs and sent a letter requesting the immediate termination of specific websites. The letter was meant to serve as a larger warning towards Bayer for future advertising campaigns: do not overstate Mirena’s positive effects while minimizing its negative impacts.

Despite the 2009 warning from the FDA, Mirena sales continued to rise. Once implanted by a medical professional, the Mirena IUD is expected to last for up to five years. Each Mirena IUD costs $800, which has generated over a billion dollars in revenue for the manufacturers. The risks of side effects for Mirena users is equivalent to the risk that oral contraceptive users face so many women who once relied on oral contraceptives have transitioned to the IUD, expecting minimal changes in their physical health. For the vast majority of women who have made that switch, that has held true–IUDs including Mirena largely are safe and effective forms of contraception. However, the plaintiffs in the the lawsuits filed against Mirena have experienced side effects including perforation of the uterus, pelvic inflammatory disease, and ectopic pregnancy (pregnancy that occurs outside the uterus). The most common complaint among the plaintiffs is device migration, during which the IUD shifts and eventually presses against organs or blood vessels, sometimes causing internal damage.

The Nature of the Lawsuits

Bayer is being sued in multiple states by thousands of plaintiffs, after more than 45,000 adverse event reports. These event reports usually involve medical side effects once the IUD has been inserted, but several cases have been filed regarding removal of the IUD. Mirena removal is meant to be simple but some women have needed surgical procedures to remove the device. These lawsuits are currently being filed on an  individual basis and in 2014, the US Judicial Panel on Multidistrict Litigation chose not to consolidate multiple claims into one. The differing nature of the claims against Mirena (uterine perforation, increased risk of neurological damage and painful surgical removal, to name just a few) make it difficult to consolidate the claims into a single case. However, as the number of lawsuits increases, the possibility of a class action suit has not been ruled out. According to Lawyers and Settlements,

A refusal to centralize lawsuits at this stage does not mean that the lawsuits will never be centralized. Plaintiffs in Lipitor lawsuits faced a similar situation in 2013, when their request to have lawsuits centralized was denied. At the time, the panel ruled that with only five lawsuits and 24 potential tagalongs, there was no need to consolidate. By 2014, however, the number of lawsuits had increased to 56, with 170 potential tagalongs. At that point the request to consolidate was approved. As of August 2014, there were approximately 1,000 Lipitor lawsuits filed.

If a sufficient number of Mirena users come forward with similar complaints, their cases could be combined into a single class action suit against Bayer. However, because Mirena is still a relatively new product, it may take years before a sufficient number of users come forward with similar complaints. There have been multiple online forums set up for women to discuss Mirena effects, including one established by famed activist Erin Brokovich, but for the time being, efforts to consolidate Mirena claims are at a standstill.

What Does this Mean for Bayer?

Bayer Healthcare Pharmaceuticals is a speciality pharmaceutical company that works in General Medicine, Hematology, Neurology, Oncology and Women’s Healthcare. Bayer Healthcare is one of 289 subsidiaries of the Bayer Group, based in Germany. As the parent company of Mirena, Bayer is being held liable for virtually all of the personal injury claims involving the product. Most plaintiffs have chosen to sue Bayer rather than their doctor, arguing that their medical side effects come from the IUD itself not from a poorly performed insertion. When the FDA submitted its 2009 letter to Bayer, it stated that Bayer had overstated the efficiency of the product (making unsubstantiated claims), omitted information about the risk of the product and ultimately made a serious of false or misleading statements in its advertising campaign. Bayer has claimed it was not aware of those side effects and that its marketing campaign should not be considered irresponsible.

Other Legal Concerns 

Besides the Mirena lawsuits, Bayer is also involved in a host of lawsuits regarding its birth control pill, Yaz. Research found that blood clot risk could be higher in women who used Yaz compared with women who used other oral contraceptives, and Yaz has been linked to many injuries and dozens of deaths. This is largely due to the presence of drospirenone in Yaz, which was found to “increase the risk of an embolism or thrombosis by up to three times compared to previous generations of contraceptive pill” according to DW.

A study in Denmark assessed the data of 1.6 million Danish women who took a drospirenone contraceptive pill for several years and found that the “risk of a heart attack or stroke was higher in these women than those using a non-hormonal method of contraception.”

Plaintiffs argue that Bayer downplayed the risks of the drug and exaggerated the benefits. There are further claims that the Bayer team did not complete sufficient research during product testing and failed to issue a recall once the side effects of the drug became apparent. The FDA has at least somewhat supported these claims, as it sent a warning letter to Bayer in 2008 discussing misleading marketing techniques used to sell Yaz. As of last year, Bayer had settled 8,250 cases for $1.7 billion but there are still lawsuits pending in national and state courts across the country. Onlookers point out that the number of settlements Bayer has made in the Yaz case may be promising for the plaintiffs in the Mirena cases. When Bayer’s oral contraceptives and IUD have come under significant criticism, both from the FDA and from individual users, the company has the potential to lose credibility. 

Conclusion

IUDs are a largely effective and safe form of birth control and a growing number of physicians have been recommending them to women. However, the lawsuits against Mirena should not be ignored and the manufacturers should strive to correct errors in their products in order to reduce the medical risks of their IUD. The lawsuits against Mirena do not only affect Bayer, they also affect the reputation of all versions of the IUD across the United States. If drug companies use misleading advertising to sell their products, the number of adverse event reports (and the lawsuits that accompany them) will swell in size. Birth control should not inspire fear in young women but should instead be seen as a safe and effective choice. Pharmaceutical companies have a duty to these women to present them with safe and effective products and to fully explain the medical risks associated with any form of birth control–we’ll have to see what the courts decide when it comes to whether or not Bayer took on that responsibility appropriately.

Resources

Primary

FDA: Notice of Violation Letter

FDA: Warning Letter

Additional

Injury Lawyer News: Mirena IUD Named in California Injury Lawsuit

Newsweek: The Courtroom Controversy Behind Popular Contraceptive Mirena

Lawyers and Settlements; More Mirena Lawsuits Expected with New Study

Drug Watch: Manufacturer:Bayer

The Henry J. Kaiser Family Foundation: IUDS: Access for Women in the United States

Deutsche Welle: Bayer Sued over Controversial Contraceptive Pill Yasminelle

The Richmond Legal Examiner: FDA to Review Essure Birth Control Device

Jillian Sequeira

Jillian Sequeira was a member of the College of William and Mary Class of 2016, with a double major in Government and Italian. When she’s not blogging, she’s photographing graffiti around the world and worshiping at the altar of Elon Musk and all things Tesla. Contact Jillian at Staff@LawStreetMedia.com

The post Legal Battles over the Mirena IUD: What’s Next? appeared first on Law Street.

Birth control has been a source of political controversy since its first days on the market. In recent times, the debate over reproductive health care has traveled to the highest level of judiciary power in the country.

In the June 2014 Hobby Lobby ruling, the Supreme Court favored a corporation’s religious freedom over a woman’s right to affordable reproductive health coverage. Although the ruling did not completely strike down coverage set forth in the Affordable Care Act (ACA), it did set up the possibility for some employers to deny coverage. The IUD, or intrauterine device, is one of the contraceptive methods that no longer has guaranteed coverage. What are the policies surrounding birth control in America, and how truly effective is the IUD?

Pre-Hobby Lobby Policy

Passed in 2010, the Affordable Care Act (ACA) recognizes that contraception is a necessary preventive health service for women. The ACA requires coverage without cost-sharing for women for all FDA-approved contraceptives. This benefits all women who want to use an IUD because of the high upfront costs without insurance.  All FDA-approved birth control methods must be covered by the plans, which includes: IUDs, the pill, the patch, the ring, the shot, diaphragms, sterilization procedures, and cervical caps.

Hobby Lobby Ruling

On June 30, 2014 the Supreme Court ruled in Burwell v. Hobby Lobby that for-profit corporations are exempt from government regulations that would require them to cover certain contraceptives for their female employees. Hobby Lobby and Conestoga Wood Specialties consolidated their cases to challenge the contraceptive mandate in the Affordable Care Act. The ruling is limited to closely held corporations under the Religious Freedom Restoration Act (RFRA). While some supporters of the majority’s ruling claim the decision won’t affect many women, that is simply not true. More than 90 percent of all American businesses are made up my closely held firms, and they employ approximately 52 percent of the workforce.

The companies argued that just like places of worship and non-profit organizations with religious affiliations, their religious beliefs should exempt them from covering certain emergency contraceptives. This includes IUDs, Plan B, and Ella. Hobby Lobby objected to the morning-after pills and IUDs as they believed they cause abortions. The reasoning is that these forms of contraceptives prevent conception and fertilized egg implantation in the uterus, which to them is equivalent to aborting a life. Director of Contraceptive Development for the National Institute of Child Health and Human Development, Diana L. Blithe, has stated that there is no scientific evidence that these contraceptives work beyond fertilization. Birth control pills will continue to be covered, as they are not in opposition to the employer’s beliefs. The ACA originally allowed for non-profit religious organizations to opt out of providing coverage for contraceptives and have outside insurance companies cover the women, and Justice Alito suggested that for-profit corporations adopt this method as well.

While women were denied basic reproductive health care by this ruling, the male-dominated majority ruled that  would continue to be covered. This hypocrisy has been noted by the public and Justice Ruth Bader Gingsburg in her blistering dissent.

What is the IUD?

The IUD is a small, polyethylene “T-shaped” device that is inserted by a health care provider into a woman’s uterus to prevent pregnancy. In the United States there are two types of IUDs available: hormonal (Mirena and Skyla), which released progestin, and copper (ParaGard). Mirena is effective for five years and Skyla is effective for three years; both may give the woman lighter periods. ParaGard is effective for 12 years and does not alter periods. The main way both types of IUDs work is by manipulating the way sperm moves so they are unable to join with an egg.

What are the benefits of an IUD?

The IUD and the birth control implant are the most effective reversible contraceptive methods available. By not requiring user intervention, the risk of pregnancy is less than one percent. If inserted up to five days after unprotected intercourse, copper IUDs can also serve as emergency contraception.

Hormonal methods offer supplementary health benefits in addition to contraceptive use. Similar to a birth control pill, an IUD can treat menstrual pain, menstrual bleeding, and acne.

IUDs help women avoid pregnancy coercion — pressuring one into becoming pregnant — and pregnancy due to a sexual partner’s refusal to use contraception. The device is effective, long lasting, and it’s nearly impossible for a partner to detect one.

Many other forms of birth control are advertised for how effective they are in preventing pregnancy. This is true, if they are used properly. A good example for this is the male condom. It is a common belief that they are 98 percent effective in preventing pregnancy, however the Center for Disease Control (CDC) reports that 18 percent of women experience an unintended pregnancy while using this method. The discrepancy in information lies within the mighty if. IUDs are so efficient since they remove human error and are long-lasting. From the same CDC report, it was found that copper IUDs have a significantly lower 0.8 percentage.

What are the disadvantages of an IUD?

IUDs, called the Dalkon Shield, debuted in the United States in the 1950s. However, they were later taken off the market because of complications found in early versions of the device. The previous design led to infections and unwanted pregnancies due to it’s complicated method of correct insertion. It was also not widely known by doctors that it had to be removed when a woman became pregnant in order to avoid infection. Pelvic inflammatory disease and infertility was linked to the Dalkon Shield.Alexandra Sifferlin of Time reported, “According to various reports, upwards of 15 women who became pregnant with a Dalkon IUD inside them died of infections after they miscarried.”

Some other disadvantages include:

• IUDs do not protect against sexually transmitted diseases (the male condom provides the best protection from most diseases).
• If a woman is uninsured, an IUD costs between $500 and $1500, including tests, exams, insertion, removal, and the IUD itself. The upfront costs may be a barrier for many women.

Are women using them now?

American women have the lowest rate of IUD se of any developed country and more than half have never heard of them. Laura MacIsaac, Director of Family Planning at Mount Sinai, stated, “IUD use in most of Western Europe, it’s about 20 percent, some countries 30 percent…in America, it’s about five percent.” While these numbers are low compared to other countries, since 2008 Planned Parenthood reports a 75 percent increase in IUD use among patients. In 2009, 8.5 percent of women using contraceptives relied on long-acting reversible contraception such as the IUD. This is a dramatic increase from 2.4 percent in 2002 and 5.5 percent in 2007.

Women between the ages of 25 and 29 who are married, women with no religious affiliation, and women covered by Medicaid use IUDs most frequently. Teenagers are less likely to use the IUD; only three percent of 3.2 million teenage women who use contraceptives chose this method.

Conclusion

IUDs have moved past their sullied past and become one of the most effective methods of birth control on the market. With their long-lasting effectiveness, lack of personal upkeep, and low pregnancy rate, IUDs are a favorable contraceptive option.

Resources

Primary

CDC: Current Contraceptive Use in the United States, 2006-2010, and Changes in Patterns of Use Since 1995

SCOTUS: Burwell v. Hobby Lobby

Additional

Planned Parenthood: IUD as a Form of Birth Control

Guttmacher: Changes in use of Long-Acting Contraceptive Methods in the U.S., 2007-2009

Guttmacher: IUD Fact Sheet

National Women’s Health Network: Not Your Mother’s IUD: Benefits and Risks of Modern IUDs

Time: Why is the Most Effective Form of Birth Control – the IUD – also the one no one is Using?

The New York Times: Religious Groups Equate Some Contraceptives With Abortion

Planned Parenthood: Birth Control Implant (Implanon and Nexplanon)

Washington Post: A LOT of People Could be Affected by the Supreme Court’s Birth

USA Today: Hobby Lobby Case: What Birth Control is Affected?

Huffington Post: Hobby Lobby Still Covers Vasectomies and Viagra

Alex Hill

Alex Hill studied at Virginia Tech majoring in English and Political Science. A native of the Washington, D.C. area, she blames her incessant need to debate and write about politics on her proximity to the nation’s capital.

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