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The Paragard is an intrauterine device (IUD) that is used by women as a form of contraception. An IUD is considered to be one of the most effective forms of contraceptives because once it is inserted by a healthcare professional, it requires little compliance for it to be effective.
It also requires little maintenance, and the product can be kept in place for up to 10 years. There are two types of IUDs available in the United States; ones that secrete hormones and ones that are made of copper. The Paragard is a copper-containing UID that became FDA approved in 1984. The copper content creates an inflammatory reaction that inhibits the sperm from fertilizing the egg.
In 2016, a female from Nebraska filed a complaint against Teva Pharmaceutical Industries for a failed Paragard IUD. The claim explained that her physician attempted to remove the Paragard and found that it had broken into pieces, some remaining within her.
The claim continues to explain how she required further medical and surgical intervention to try to locate and remove the missing broken medical device piece. The suit claimed that Teva failed to warn of the potential side effects that the Paragard IUD can cause.
The case was later dismissed in 2018 because the ruling agreed that the package insert did warn of possible breakage of the device, as well as a possible embedding or have difficulty removing. This was just one of the several lawsuits filed in recent years.
In September 2017, Teva Pharmaceuticals Industries agreed to sell Paragard to Cooper Companies for 1.1 billion dollars. Interestingly, this was the same day that new CEO Kare Schultz was announced.
According to Reuters, at that time, Teva was about 35 billion dollars in debt. Reuters also quoted “The sale of the business is the first step in the planned divestment of non-core assets and the proceeds would be used to repay term loan debt, Teva said.”
The sale agreement also included the Buffalo, New York Paragard manufacturing facility. Additionally, noted, was that as of June 30-year end; the Paragard generated a revenue of $168 million.
The purchase was completed by Cooper Companies on November 1, 2017. Since the purchase, lawsuits regarding Paragard complications have continued. One such lawsuit is a female from Louisiana who filed a suit in august 2018, with claims that her reproductive organs were permanently damaged when a piece of the device broke off inside her uterus Pennrecord.
Due to the mentioned timeline, it appeared to be ideal timing to sell Paragard and its manufacturing facility. There is no current class-action lawsuit involving Paragard however many more individual lawsuits are expected to be filed this year.
Elena Borrelli is a certified physician assistant, or PA, with 18 years of experience in health care. She has worked 11 years as a PA in diverse clinical settings, including surgery, trauma, primary care, women’s health and quality management. Over the years, she has authored several publications and lectured on various health care-related topics.