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A Makena user has filed a class action lawsuit alleging that the preterm birth drug did not actually prevent preterm labor as advertised.
The Makena false advertising class action lawsuit was filed by Angele Nelson who states that she was prescribed, injected with, and purchased Makena during her pregnancy.
She says she paid out-of-pocket for Makena, which cost hundreds of dollars per shot, but the drug did not work as advertised.
Nelson seeks damages on behalf of herself and all similarly affected customers, saying that despite its high price tag, the product was “worth zero or close to zero based on its actual attributes.”
The Makena birth drug class action lawsuit says that the medication is marketed as a hormonal drug that reduces a pregnant woman’s risk of giving birth before term.
The Makena class action lawsuit notes that the Makena website advertises the drug as meant for women who have already delivered a baby too early and are now pregnant with another baby.
According to Nelson, Makena’s maker, AMAG Pharmaceuticals, touts the efficacy of the drug and advertises it with testimonials from women about how effective the drug is.
Allegedly, one such claim comes from a woman who said that “receiving the weekly injections of Makena is giving me the peace of mind knowing that I’m doing everything I can to help prolong this pregnancy.”
The goal of the drug is to give babies who are at risk of being born prematurely more time to develop before they are born. However, Nelson says that these are misrepresentations. The drug reportedly received fast-track approval from the FDA, but multiple studies showed that Makena did not actually help prevent preterm births.
Allegedly, AMAG Pharmaceuticals holds the exclusive rights to Makena. Nelson explains that Hologic is the company that originally developed Makena and held the exclusive rights to the drug, until the company sold the exclusive rights to KV Pharmaceutical in 2011. Now, AMAG Pharmaceuticals holds the exclusive rights to Makena, after the company acquired KV Pharmaceuitcals in 2014.
According to Nelson, both KV Pharmaceutical and Hologic Inc. have both previously faced lawsuits over mislabeling or misrepresenting their drugs.
The Makena class action lawsuit goes on to say that the drug is over-priced. Nelson states that KV Pharmaceuticals continued its misdeeds in the case of its sale of Makena by abusing the Orphan Drug Act to sell Makena at exorbitant prices.
Allegedly, the drug used to be available at $10 to $20 per injection when it was available in a generic form. When KV obtained exclusive marketing rights for the drug under the Orphan Drug Act in 2007, Makena prices allegedly skyrocketed to $1,500 per injection. Though the price was later lowered to $690 per injection, Nelson argues that this price is still financially damaging and inaccessible to many people.
This Makena class action lawsuit is similar to one filed by another customer in November.
Have you used Makena? What were your experiences with the drug?
Nelson is represented by Stuart C. Talley.
The Makena False Advertising Class Action Lawsuit is Angele Nelson v. AMAG Pharmaceuticals Inc., Case No. 2:20-at-00041, in the U.S. District Court for the Eastern District of California.
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24 thoughts onMakena Class Action Says Preterm Birth Drug Doesn’t Work
I’m glad I looked up all this info before my apt tomorrow even tho I had a preterm labor with my first pregnancy I think I’m doing better with my second without the shot so I don’t want my baby affected or have problems in the future is there a way I can refused treatment I read every review and I’m scared to get it n every week no I can’t .. I feel more safe not taking it plus it’s a lawsuit on this medicine
In 2018 my obgyn shamed me into taking a Makena shot at 16 weeks. I started bleeding that night. And continued to bleed until I hit 17 weeks pregnant. I was rushed to the Emergency Room in terrible pain. On the way to my pelvic exam I gave birth in a wheelchair in the hallway. That Makena shot caused me to deliver my baby at 17 weeks pregnant.
Same hear I delivered my twins preterm, and one died, the other is disabled. My son also is also autistic, I will be including my name and filing for something larger.
My baby was diagnosed with PVL after being born at 31 weeks from me taking three doses of the shots
I got the shots through out my pregnancy, I was in and out of preterm labor, the shots didn’t do anything.
I had my son at 36 weeks 1day, after being in the hospital trying to stop the labor for a week.
My son is now diagnosis with epilepsy, he started to have seizures as soon as he was born. He also doesn’t have any soft spots on his head. His doctors are trying to figure out what is wrong. His doctor is suspecting he has craniosynostosis, which requires him to have brain surgery to fix it or he will die of brain damage.
I was given weekly injections of this medication throughout my pregnancy. My son (2.5) is having complications. He isn’t talking etc. I did everything right during the pregnancy.
Ke. you and I have similar situations. I have a 2.5 year old who isn’t talking. I did everything right in my pregnancy as well. I often wonder if her complications and delay with speech is a result from my weekly Makena shots
My daughter is 3 and she isn’t talking. I started this shot at 16 weeks.
I’ve been on the shot since I was 17 weeks, preterm labor started at 18 weeks for me, she shot has not stopped me from having contractions like my doctor told me it would. On top of copay for the medication is $965, it has been constant struggles getting the medication. If I could I would stop taking it, but my doctor told me once I start I can’t stop it despite having problems getting the medication thus making me miss a dose. To correct it my doctor told me to take it as soon as I get it which means at times I’m taking two does back to back. Since my insurance won’t cover an emergency dose. My doctor prescribed me this medication telling me it’s very expensive and that my insurance will cover it. I was told copay would be $50 a month but that was not the case.
The medication also makes me extremely forgetful, tired, irritable, since it’s a hormone it is Also causing problems with my skin.
I do not recommend getting the shot. I have 6 weeks left on the medication.
Me and my sister were both on this shot and her daughter was diagnosed autistic and my son is on the spectrum as of now because he’s too young 5o test.
Tiarra I am going through the exact same thing with my 2.5 year old. Its horrible what this medication did to our babies
As of right now my wife is having this shot malena she done been in preterm labor since she was 23 weeks what should we do
I had makena shots from 3/18 to 8/18 then diagnosed with HER+ Breast Cancer in 12/19
Please add me