Woman Says Mirena Birth Control Trial Led to Permanent Injury
A St. Louis woman has filed a lawsuit against Washington University and their CHOICE contraceptive program after her Mirena IUD led to serious personal injury.
Deanna Delancy, 27, used the CHOICE service through Washington University’s medical center to receive free birth control just after she gave birth. The program provides birth control options to teenage girls and women in the St. Louis area for up to three years, especially if they are low income or uninsured. Their research through the program shows that access to birth control does not increase risky behavior or the spread of STDs.
Delancy’s lawsuit, however, alleges that the university used the program unethically to study effects of certain birth control devices, including the Mirena IUD, which Delancy had implanted just after she gave birth. She says that, because she used the device, she ended up with serious injuries that led to two heart valve surgeries and a chronic illness, which requires her to take blood thinners to prevent blood clots.
“I don’t feel like they were informative about it,” Delancy, a lab associate, said. “If I knew it was a clinical trial or research, I wouldn’t have joined. I basically feel like they bribed me with free birth control and gift cards.”
As part of the program, Delancy received gift cards for groceries, gas, and convenience items for filling out medical surveys. Delancy had the Mirena IUD implanted just after she gave birth in April 2011, but shortly after that she developed endocarditis – a serious inflammation of the heart valves or chambers – and began experiencing pain and sickness. Ten days after delivery, she was rushed to the emergency room.
However, Washington University denies the allegations that they conducted unethical research, saying that they placed the highest priority on the safety of CHOICE participants. The university pointed out, in a written statement, that “all participants went through a consent process that involved a one-on-one discussion of the risks and benefits as well as a written consent form that addressed the risks and benefits. All participants signed the consent prior to the onset of labor.”
“Research has to be done, but I question the wisdom of people participating in off-label medical experiments without being fully apprised of the risks,” said Alvin Wolff Jr., a Clayton attorney who represents Delancy.
The lawsuit alleges that researchers ignored prescribing information published by Bayer HealthCare Pharmaceuticals, the company that manufactures the Mirena IUD. The Mirena IUD can cause a host of severe complications like organ perforation and infection. As of November this year, the FDA reports 70,072 reports of Mirena IUD failures, including 6,000 that involve organ perforation when the device migrates. According to court documents, there are at least 408 claims against Bayer’s Mirena device filed in the Southern District Court of New York alone. There are at least 630 similar lawsuits in a court in New Jersey.
The Strom Law Firm Defends Consumers Against Dangerous Devices Like the Mirena IUD
Since the Mirena IUD was originally approved for use, numerous exceptions to its use have been discovered. Bayer claimed the Mirena IUD should be used in women who have at least one child and only one sexual partner, but reportedly, some doctors in the Boston area say that the device is only safe for women who have never had children. The Mirena device is also not recommended for use in women with uncontrolled pelvic inflammation, breast, cervical, or uterine cancers (past or present), liver disease, or a weak immune system.
If you or a loved one have used the Mirena IUD for contraception and have experienced pain, infection, bleeding, ovarian cysts, intrauterine pregnancy, kidney stones, pelvic inflammatory disease, or organ perforation due to the device, you are not alone. The Strom Law Firm offers free, confidential consultations to discuss the facts of your Mirena personal injury case. Contact us today for a free consultation. 803.252.4800.