Makena Class Action Says Preterm Birth Drug Is Overpriced and Ineffective

A 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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