Two Women File Class Action After Study Exposes Ineffectiveness of Preterm Birth Drug Makena [UPDATE]

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A lawsuit filed against Makena manufacturer AMAG, Inc. claims the “exorbitantly-priced” preterm birth medication is “no more effective than a placebo.” According to the lawsuit, the defendant charged expecting mothers hundreds of dollars per injection of the hydroxyprogesterone caproate drug despite knowing the medication could neither effectively prolong their pregnancies nor mitigate the risk of miscarriages and stillbirths.

The 20-page complaint out of New York explains that the FDA, despite concerns that the statistical review supporting Makena’s ability to reduce preterm births was “not convincing,” fast-tracked approval of the treatment in 2011 based on a single clinical trial published in 2003. The approval, however, was conditioned on an eight-year follow-up clinical trial to confirm hydroxyprogesterone caproate’s efficacy in preventing preterm births, the case says.

Non-party KV Pharmaceutical Co. purchased the rights to sell Makena soon after the drug received FDA approval, the lawsuit goes on. Notably, only a few years prior, the Justice Department filed lawsuits against KV Pharmaceutical for allegedly manufacturing and selling morphine tablets that contained more morphine than was stated on labels, the suit adds. The company eventually filed for bankruptcy and re-emerged as Lumara Health, Inc. in 2013, according to the complaint.

As for defendant AMAG, the suit says the company acquired Lumara Health in 2014 for $675 million and an additional $350 million contingent on sales milestones, with Makena serving as the “flagship product” in the acquisition. AMAG, the lawsuit says, advertised the drug as a hormonal medication for pregnant women at risk for preterm delivery while assuring expecting mothers that Makena “helps you get closer to term” and “gives moms an extra layer of support.”

According to the lawsuit, the defendant knew Makena could not effectively prolong pregnancies, nor reduce the risk of neonatal mortality or morbidity, as advertised yet continued to market and sell the drug at inflated prices. When Makena first hit the market, it was allegedly priced at a “breathtaking” $1,500 per injection as compared to the $10 to $15 generic price. The lawsuit claims that though the price of the drug was eventually reduced to $690, AMAG has continued “price-gouging” customers ever since it began selling Makena.

On March 8, 2019, the company announced the results of the FDA-mandated follow-up trial for Makena, which reportedly revealed that there was no “statistically significant difference between the treatment [Makena] and placebo arms for the co‐primary endpoints.” In other words, the case says, the study showed that the drug, though expensive and painful to take, “is no more effective than a placebo.”

With regard to the plaintiffs, both women say they paid out-of-pocket for Makena injections during their pregnancies yet still delivered their children preterm. According to the complaint, the first plaintiff’s child was born at 36 weeks, while the second plaintiff delivered four children preterm (two at 35 weeks, one at 34 weeks, and one at 32 weeks).

The lawsuit argues that proposed class members—anyone who was prescribed and injected with Makena in New York since January 1, 2011—suffered “an ascertainable loss” by paying a premium price for a product that was worth “zero or close to zero.”