Hagens Berman filed this class-action lawsuit against AMAG Pharmaceuticals related to Makena, a drug marketed in the U.S. to prevent preterm birth in at-risk patients. The lawsuit alleges that AMAG unlawfully marketed and sold Makena knowing that clinically meaningful evidence showed the drug was ineffective for its use.
WHAT’S THE ISSUE?
The lawsuit alleges that AMAG and other defendants knowingly marketed, promoted and sold a “worthless drug product,” Makena, in the United States. According to the complaint, defendants’ objective was that their intended victim of this conduct — health plans across the country that pay for their members’ prescription drugs — would be forced to pay for Makena despite the fact that defendants knew there was no evidence showing the product’s effectiveness. In 2015, Makena generated $251 million in revenue for AMAG. Attorneys say AMAG sought every advantage to generate profits from a drug it had not developed, including by aggressively marketing Makena for the reduction of recurrent preterm birth, even though proof of the utility of Makena was the subject of a mandatory follow-up study, called the PROLONG study.
THE TRIAL BEHIND MAKENA’S APPROVAL
According to the complaint, Makena was allowed to be marketed in the United States in 2011 to prevent preterm birth in at-risk patients based on a controversial 2003 study that ostensibly showed reduced risk of recurrent preterm birth prior to 37 weeks.
The approval of Makena was expressly conditioned on the results of a confirmatory clinical trial demonstrating that the drug was safe and effective. That trial was sponsored by AMAG Pharmaceuticals, the owner of the marketing rights to Makena, and thus AMAG had control of and authority over the study. The authors of the study included AMAG employees.
AN ALLEGED SCHEME TO SELL MAKENA
“From 2011 through 2019, AMAG aggressively marketed Makena throughout the United States for the reduction of risk of recurrent preterm birth,” the lawsuit states. “While proof of the potential utility of Makena remained the subject of the mandatory follow-up study that was still underway, AMAG treated the drug, and the representations it made about it, as already proven.”
Attorneys say AMAG built an elaborate network of pharmaceutical marketing companies, doctors, and professional associations to maximize sales of Makena with the express goal to supercharge its sales. Marketing efforts allegedly targeted expectant mothers, physicians and others, all while charging high prices for the only FDA-approved drug to prevent preterm birth. A single dose could cost upwards of $1,500, while a course of treatment could cost tens of thousands of dollars.
This campaign lasted eight years until 2019 when the FDA concluded that the PROLONG study deemed Makena no better than a placebo in treating or preventing the risk of recurrent preterm birth and its effects. “…hundreds of millions of dollars had been spent by U.S. health plans paying for a useless drug,” according to the lawsuit.
AMAG “DOUBLED DOWN”
The class action states that despite this evidence, AMAG recommitted to its alleged false claims of Makena’s efficacy for three and a half years, until April 2023 when the FDA withdrew approval of Makena.
“AMAG kept marketing the product as effective (when it was not), disparaged the PROLONG study results (when those results were sound), failed to counter its years of prior false marketing (while knowing those falsehoods had succeeded in increasing sales in the past), dragged out proceedings with the FDA over formal withdrawal of the product (while knowing the end was inevitable), and milked sales of Makena quarter after quarter,” the lawsuit states.
After the release of the PROLONG study, the company merged with Covis Group, which had a major investment to protect and so carried out a plan to help foster sales of Makena, despite its uselessness, according to the lawsuit. The FDA withdrew its approval of Makena in April 2023, leaving health plans and other third-party payors having spent millions of dollars on the drug.
TOP PHARMA LAW FIRM
Hagens Berman is one of the most successful litigation law firms in the U.S. taking on pharmaceutical companies and has achieved total settlements valued at more than $320 billion against the world’s biggest corporations, including Big Pharma’s largest sellers and manufacturers for antitrust schemes, pay-for-delay, IP shams, marketing fraud and other forms of wrongdoing that drive up the costs of prescription drugs for consumers and others.
