A Houston County woman has filed a wrongful death lawsuit related to the use of a contraceptive device.
Abigail Lane alleged in the lawsuit filed earlier this week in federal court in Macon that her son was stillborn in 2013 because of the use of the Mirena intrauterine device.
The lawsuit was filed against the device’s manufacturer, Bayer Healthcare Pharmaceuticals Inc.
The lawsuit alleged that in 2009, when Lane had the device put in place by her physician, Bayer failed to communicate risks of serious conditions from using the device. Those conditions include susceptibility to infections and the possibility of miscarriage if a woman becomes pregnant while on Mirena, the lawsuit said.
The lawsuit alleged that risks were omitted in a manufacturer’s pamphlet on the device given to Lane’s physician, who gave the pamphlet to Lane to consider whether she wanted to use it.
“Had Abigail Lane known of the actual failure rate of Mirena in preventing pregnancy and the risks to an unborn child when Mirena fails to prevent intrauterine pregnancy and cannot be removed, Abigail Lane would not have consented to placement of Mirena IUD,” the lawsuit said.
The lawsuit alleged that the design of the device is defective.
“(Bayer) knew or should have known that the design of Mirena IUD caused unreasonably dangerous risks and serious side-effects, including death of the fetus,” the lawsuit said. “(Bayer) nevertheless advertised, marketed, supplied, released, sold and distributed the drug knowing that there were safety issues for the unborn fetus when Mirena remained in place during an intrauterine pregnancy due to the defective design.
“As a proximate consequence of the (Bayer’s) said negligence and/or wantonness, Abigail Lane had a Mirena IUD inserted, it failed to prevent pregnancy, it could not be removed due to defective design of the strings and ‘T’ shaped arms, and Baby Boy Lane was caused to suffer death,” the lawsuit said.
The lawsuit alleged that the design allows for the ‘T’ shaped arms of the device to be embed in the uterine wall of the patient, causing “unreasonable dangerous risk to the fetus when Mirena fails to prevent pregnancy.”
Embedment prevents removal of the device when pregnant, the lawsuit said. When Lane learned she was pregnant in February 2009, a doctor’s attempt to remove the device was unsuccessful because it was embedded.
On April 19, 2013, Lane delivered a stillborn boy weighing 49.3 grams after experiencing bleeding and cramping, the lawsuit said.
“Upon prayer and belief, the retained Mirena IUD caused an intrauterine infection that lead to the death of Baby Boy Lane,” according to the lawsuit.
The lawsuit estimated more than 15 million women worldwide have used the device.
Bayer issued the following, written response to the lawsuit:
“We greatly sympathize with any woman who experiences injury or loss regardless of the cause. Pregnancy loss, unfortunately, occurs in 15-20 percent of pregnancies overall, according to national statistics. Bayer believes that it has strong defenses to this case and is confident that the FDA-approved information and warnings in the Mirena label are accurate and science based.
“Mirena is over 99 percent effective and has been prescribed to millions of women worldwide since it was first launched in 2001. Furthermore, the American College of Obstetrics and Gynecology (ACOG) recommends the most effective methods, including IUDs, for all appropriate patients.”
But Francois M. Blaudeau, one of the Birmingham attorneys representing Lane, said, “This company has not told the truth about problems with their product, and we think the warning labels need to change.”
He noted that the manufacturer “wouldn’t sell as many” of the devices “if they told the truth ... in the warning labels.”
Blaudeau, who is also a gynecologist-obstetrician, said the Mirena IUD is the only form of birth control that can “kill or injure a baby.”
“We don’t think that Mirena is a bad thing. It’s not like we’re saying they should never use it or take it off the market,” Blaudeau said. “We’re just saying, look, you better tell people about some of the issues with your product and not just tell them the good stuff, right, and make sure that women understand that this really isn’t for everybody.”
The lawsuit seeks a jury trial, damages in excess of $75,000 and payment of all litigation costs, including attorneys’ fees.