Brigette Honaker  |  November 15, 2019

Category: Legal News

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pregnant woman taking makenaA Makena class action claims that the preterm birth medication is overpriced and doesn’t perform as advertised.

Makena (hydroxyprogesterone caproate) is an injectable medication that may be prescribed to pregnant women in order to prevent preterm labor.

Manufacturer AMAG Pharmaceuticals Inc. reportedly claims that the drug “helps you get closer to term” and “gives moms an extra layer of support.”

The drug was approved the U.S. Food and Drug Administration (FDA), but a recent Makena class action lawsuit claims that the drug is ineffective and costly.

Plaintiffs Teresa Faughnan and Jennifer Maltese reportedly paid as much as $1,500 per Makena injection while pregnant in an attempt to prevent preterm labor. Despite paying “breathtaking” prices and going through the significant pain of injection, the drug allegedly did nothing to prevent preterm births.

Faughnan reportedly paid hundreds of dollars out-of-pocket for each shot but still delivered her child preterm at 36 weeks.

Maltese reportedly had similar experiences with all four of her children. She allegedly had two children delivered preterm at 35 weeks, one at 34 weeks, and one at 32 weeks.

The women claim that they did not get the benefits advertised by the company despite paying hundreds of dollars each time they got an injection.

Although Makena was approved by the FDA in 2011, findings from a National Institute of Child Health and Human Development study reportedly cast doubt on the drug’s efficacy. In light of these doubts, the FDA required a follow-up study to be done on Makena.

The follow-up study was reportedly published by AMAG in March 2019. According to the plaintiffs, this study showed no statistic difference in outcomes when comparing women on Makena with women on the placebo.

Women on the placebo allegedly delivered their children at 35 weeks or earlier 11.5 percent of the time. In comparison, women on Makena delivered their children preterm 11 percent of the time.

The plaintiffs argue that the study “showed that Makena, which is exorbitantly‐priced and is painful to take, is no more effective than a placebo.”

AMAG Pharmaceuticals has allegedly used its exclusive rights to Makena to drive the prices from generic prices between $10 and $20, up to $1,500 per branded injection. Plaintiffs claim that this “breathtaking” price increase is not warranted considering that the drug is essentially ineffective.

In this Makena class action, Faughnan and Maltese seeks to represent a Class of New York women who were prescribed Makena and injected the product since 2011.

Did you take Makena in order to stop preterm labor? Share your experiences in the comment section below.

Plaintiffs and the proposed Class are represented by Jeremiah Frei-Pearson and Chantal Khalil of Finkelstein Blankinship Frei-Pearson & Garber LLP and Richard M. Paul III, Ashlea G. Schwarz, and Sean Cooper of Paul LLP.

The Makena Class Action Lawsuit is Faughnan, et al. v. AMAG Inc., Case No. 3:19-cv-01394, in the U.S. District Court for the Northern District of New York.

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24 thoughts onMakena Class Action Says Preterm Birth Drug Is Overpriced and Ineffective

  1. Danielle M says:

    I started my makena shot at 20 + 4 weeks. Five hours later I started having major cramping and was on my way to the hospital. It was too late, I had bulging membranes (babies foot was in my cervix). I find it weird how I took it at 10 pm and woke up around 3 am to contractions out of nowhere.

  2. Kelley Harrall says:

    I am currently pregnant and started it at 16 weeks and had to stop at 20 weeks due to an allergic reaction of hives . I am now 27 weeks and still getting hives my dermatologist said that because I developed an allergic reaction to the synthetic hormone my body could develop a reaction to my natural hormone

  3. Erica Venable says:

    In 2014 I took the shots weekly from 16wks until he was born, a day late. My insurance covered it. In 2016 I was pregnant again and my doctor wanted me on the shots again, but my insurance didnt cover it this time. I have medicaid/medicare so i had WellCare for my prescriptions. Despite numerous requests by the doctor they still denied me so i had to take the pill. Couldnt afford 1500 on a fixed income. Well my son was born at 28weeks.

  4. Danielle Nugent says:

    I took progesterone from 16 weeks until 36 weeks. I took malena every week, the shots were painful and left horrible bruises. I delivered at 38 weeks. With my last pregnancy, I opted out of taking progesterone and I delivered at 37 weeks.

  5. Christine Flaningam says:

    Don’t know what the shot was called but in April and twice in May of 2006 was given shots to stop and prevent preterm labor then after the first one in May at 30 weeks was put on terbutalene(sp?) Pills round the clock for three days until water broke at 31 wks exactly were final shot was administered then airlifted to loma linda and put on emergency bed rest until i delivered exactly one week later at 32 wks.

  6. A says:

    22 weeker without mckena
    36w0d with 16 mckena shots
    37w3d with 22 mckena shots

  7. Dyan Rydholm says:

    Pretty sure I got this in 2012.. started bleeding at 32 weeks..went in.. got one shit in the rear and then another 2r hours later on the other side.. still had my baby at 37 weeks..

  8. Hartoya says:

    I received it with both of my pregnancies in 2010 with my son and 2012 with my daughter so please include me

  9. Candace Griffin says:

    Include me

  10. Robert Goudin says:

    add me

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