Paragard and the History of IUDs and Product Liability in the U.S.

Yesterday, I wrote about the rising Paragard litigation and the possibility of a class-action lawsuit.  Today, I’m writing about the history of IUDs for birth control.

How long has Paragard been around? Paragard was first approved by the U.S. Food and Drug Administration (FDA) in 1984. Paragard is known for being hormone-free and can provide long-term contraception for up to 10 years, making it a popular choice for those looking for a long-lasting and non-hormonal option. The device works by releasing small amounts of copper into the uterus, which creates an environment that is toxic to sperm.

The Paragard IUD is the most recent intrauterine contraceptive device to find itself embattled in a wave of product liability lawsuits in the U.S. Like so many of its predecessors in the IUD market, the Paragard turned out to have a hidden defect that caused serious health problems in many users.

The recently discovered issue with the Paragard is that the device frequently breaks apart when doctors attempt to remove it, causing fractured shards of plastic to poke around inside the uterus. This defect has already prompted a wave of Paragard IUD lawsuits around the country.

The Paragard is hardly the first IUD device — or the first means of birth control, for that matter — to find itself at the center of mass tort litigation. IUDs have a long and checked history of defects, failure, and liability in this country. This troubled past has drastically limited the popularity and usage of IUD devices in the U.S. compared to other parts of the world. This post will take a brief look at the history of IUD failures and litigation in the U.S.

IUD Contraceptive Usage in the United States

Before we get into the problematic history of IUD contraceptives, it’s worth getting a big picture view of IUD usage in the United States and how it compares to other countries. The most popular form of birth control for American women is the pill and IUDs have very limited popularity.

As of 2019, IUDs accounted for only 5-6% of the female contraceptive market in the U.S. As low as this may sound, 6% is actually a major increase. In the early 2000s, IUD usage in the U.S. was at just 1%. IUDs are much more commonly used in just about every other part of the developed world. In Asia, IUDs are the most popular female contraceptive method with almost 30%. IUDs are even more common in Africa (10%) than they are in the U.S.

History of IUDs in the United States

IUD first came into existence in the U.S. in the 1950s, when the post-war baby boom started to fuel demand for effective birth control methods. The earliest IUDs were very crude and their use remained extremely limited at first. This changed drastically, however, in the 1970s when the now-infamous Dalkon Shield became the first IUD to gain widespread popularity and use in the U.S.

The Dalkon Shield was the first mainstream, modern IUD contraceptive device in the United States and its epic failure would set the tone for the troubled future of IUDs in this country. Since they were first developed in the 1950s, IUDs had very limited use in the U.S., partly because of the development of the birth control pill in the early 1960s. In the early 1970s, however, questions about the long-term safety of the pill prompted highly publicized hearings in the U.S. Senate.

This negative publicity scared many women away from the pill and sparked a widespread adoption of the Dalkon Shield. The Dalkon Shield was first released in 1971. An aggressive marketing campaign combined with fears about the safety of the pill made the Dalkon Shield extremely popular.

The Dalkon Shield was an IUD, but it differed significantly from the IUD devices we know today. Unlike the tiny, T-shaped design of modern IUDs, the Dalkon Shield looked like a crab shell with 5 plastic prongs protruding from its sides. Aside from this major design difference, however, the Dalkon Shield worked on the same principle as most current IUDs. It was implanted at the entrance of the uterus by a doctor where it releases small amounts of copper that blocked sperm from fertilizing the woman’s eggs.

The Dalkon Shield quickly became a complete disaster. The device had a host of design flaws that caused a range of very serious health problems and even deaths. The most serious problem was that the Dalkon Shield was that it caused very serious internal infections in many women. Many of these infections even resulted in fatalities. The Dalkon Shield also caused pelvic inflammatory disease (PID) and eventually infertility in a very high percentage of women.

The problems and tragic consequences of the Dalkon Shield got a significant amount of media attention and quickly led to one of the first large scale, medical device mass tort case. Just over 200,000 women filed lawsuits against the Dalkon Shield manufacturer (A.H. Robins Company). In addition to forcing A.H. Robins into bankruptcy, the Dalkon Shield disaster permanently scarred the public image of IUDs in the U.S.

Problems and Litigation with Modern IUDs

The financial and public perception damage caused by the Dalkon Shield fiasco was so significant that IUDs almost disappeared in the U.S. for a period beginning in the mid-1980s. Meanwhile, in Europe and the rest of the world IUDs rapidly expanded in popularity. Eventually, a new generation of IUD devices used this European success to make their way back into the U.S. market.

Modern IUDs are a far cry from the days of the Dalkon Shield. There are 2 primary types of IUDs today: (1) those that contain copper, and (2) those that slowly release a low dose of hormones. The popularity of these new-age IUDs has steadily grown in the U.S., but now even the modern IUDs are causing problems and generating product liability litigation on a large scale.

Mirena IUD Lawsuits:

The first modern IUD to find itself embattled in mass tort litigation in the U.S. was the hormone IUD Mirena. Mirena is a hormone-type IUD manufactured by Bayer Pharmaceuticals and one of the most popular IUD devices worldwide.

The Mirena was released in the U.S. in 2001. In recent years, however, problems with Mirena have developed and led to a wave of lawsuits. The Mirena IUD lawsuits against Bayer alleged that the device had design defects that caused the IUD to get loose and become lodged in or perforate the uterus.  This litigation is over and is not a good precedent for Paragard IUD plaintiffs.  The litigation was universally considered by plaintiffs’ lawyers to be unsuccessful.  Bayer won that one although there are still some breast cancer cases barely holding on in 2023.  Teva hopes the Paragard litigation goes the same way.  I don’t think it will.

Paragard IUD Lawsuits:

The most recent round of IUD product liability lawsuits involves the Paragard. The Paragard is a copper-type IUD that is currently manufactured and sold in the U.S. by Teva Pharmaceuticals.

How long have copper IUDs been around?  Copper intrauterine devices have been used for contraception for several decades. The first copper IUD, the Tatum-T, was introduced in the 1960s. Over time, various models have been developed and refined, ostensibly with improvements in design and efficacy. The copper IUD works is attractive because it is easy. It has a long-acting, reversible contraceptive by releasing copper ions into the uterus, which are toxic to sperm and prevent pregnancy for up to 10 years.

What is the problem with the Paragard IUD?  There are a number of problems.  The Paragard class action lawsuit focuses on the he problem with the Paragard is that the flexible plastic arms at the base of the IUD get brittle over time. This causes these arms to fracture or snap off during removal of the IUD. The broken arm pieces can then get embedded and sometimes puncture the uterus.

So the Paragard can break inside a woman’s body, causing pieces of the Paragard to remain in a woman’s body even after it is removed. Often the Paragard pieces can then be removed only through hysterectomy or other surgical procedure that often leaves a woman unable to have children.  Defendants never warned users that surgery might be required because of a Paragard breakage.

This design flaw in the Paragard has led to a new, very recent wave of IUD lawsuits. Over 2,600 women as of April 2024 have filed Paragard IUD lawsuits alleging that they were injured when the device fractured during removal. These lawsuits lead to a new Paragard MDL class action and could involve thousands of individual claims.

Contact Miller & Zois About IUD Lawsuits

If you were injured by a Paragard IUD device, you may be entitled to financial compensation. Contact the medical device lawyers at Miller & Zois for a free consultation.

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