Makena Drug Lawsuit Attorneys

Makena is a medication that has been used for years to prevent premature birth. However, after numerous debates over the drug’s effectiveness, whether it offers any benefits, and the potential adverse effects, the manufacturer agreed to remove it from the market. It seemingly exposes expectant mothers to unnecessary side effects and a risk of premature birth.

Covis Pharma announced its plan to take Makena off the market in a letter sent to the U.S. Food and Drug Administration (FDA) on March 6, 2023. The letter came after an FDA scientific advisory panel found the medication has a non-favorable safety profile based on post-marketing trial data.

If you took Makena during your pregnancy and you or your infant suffered harm because of the drug, call Paul LLP Trial Attorneys at (816) 984-8100 for a consultation about whether you can pursue compensation for your losses.

Background on Makena

In 2011, a drug manufacturer introduced Makena (hydroxyprogesterone), the only medication the FDA has approved to prevent preterm birth among women with a previous spontaneous premature delivery. The FDA approved the drug through its accelerated approval process since it was the first type of treatment for preventing preterm delivery. The approval came after positive findings from a placebo-controlled trial involving 463 participants.

However, later data suggested Makena doesn’t work. Some clinical trial results also showed the drug might worsen conditions pregnant women can experience, such as depression and preeclampsia. Although critics voiced concerns about the drug and the evidence about the lack of safety and effectiveness continued to pile up, the manufacturer indicated it planned to fight any recall efforts.

makena lawsuit

Why Was the FDA Approval for Makena Withdrawn?

In a significant development, the FDA announced the final decision to withdraw approval for Makena and its generic versions in 2023. The FDA bases its drug approvals on a favorable benefit-risk assessment. For Makena, this assessment no longer held up. The confirmatory study, meant to verify the drug’s clinical benefit, did not support the previous claims about Makena’s effectiveness.

The FDA’s decision recognizes the crucial need for effective treatments to reduce the serious risks associated with preterm birth. However, it also underscores that Makena and its generics did not demonstrate the necessary efficacy, and the benefits did not outweigh the risks.

Voluntary Removal of Makena from the Market

It seemed Covis Pharma had no intention of issuing a recall. However, in October 2022, the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee discussed the efficacy of Makena during a three-day hearing. The committee voted 14 to 1 to recommend the removal of the drug from the market. In a unanimous vote, the committee also recognized the post-marketing trials didn’t indicate any benefits to the babies of mothers taking the medication. After the recommendation, the FDA notified Covis Pharma to submit comments for consideration on withdrawing the drug by March 6.

Before the drug company issues an official response, the Center for Drug Evaluation and Research (CDER) issues another proposal to remove Makena and its generic versions from the market. The proposal called for an immediate withdrawal after an independent review of the post-marketing trials. The CDER believed Makena exposed patients to unnecessary risks and posed a threat to public health.

Covis Pharma agreed to the proposal and submitted its response letter to the FDA in March 2023. Although the company maintains its stance that its medication has a favorable risk-benefit profile, it agreed to remove the drug from the market during a wind-down period.

The manufacturer explained patients who stop the drug abruptly would disrupt the 21-week course regimen. Instead, Covis Pharma suggested the FDA set an effective date to end sales of the brand and generic versions so anyone in the middle of treatment can finish the recommended cycle.

Adverse Effects of Makena

In October 2019, Public Citizen, a consumer watchdog group, submitted an FDA petition calling for a recall of Makena. The argument was that it didn’t make sense to keep the drug on the market for pregnant women to inject themselves with something that could lead to unnecessary side effects and that had no apparent benefits.

Concerns over the effectiveness of the drug have grown since the results of the Progestin’s Role in Optimizing Neonatal Gestation (PROLONG) clinical trial. The findings showed side effects could increase the risk of medical conditions, such as:

  • Allergic reactions
  • Pulmonary embolism
  • Fluid retention
  • Blood clots
  • Worsening depression and preeclampsia symptoms
  • Decreased glucose intolerance

In a study presented in 2021 at an annual meeting of The Endocrine Society, preliminary findings suggested babies born to women receiving Makena containing hydroxyprogesterone caproate had up to five times the risk of developing rectal and colon cancers compared to the children of mothers who did not take the medication during pregnancy.

Understanding Preterm Labor and Birth

Preterm labor, also called premature labor, is labor that starts early. Typically, it begins before 37 weeks of pregnancy. The expected period of fetal development is around 40 weeks. However, anything less than 37 weeks is preterm.

Labor is the process an expectant mother goes through in preparation for childbirth. Common signs include the rupture of the membranes, called water breaking, and contractions, which is the tightening of the muscles in the uterus.

Preterm labor can cause the cervix to dilate earlier than usual, resulting in premature birth. Premature birth involves the baby being delivered before the 37th week of pregnancy. Babies born too soon can suffer significant medical problems, including low birth weight or difficulty breathing.
pregnant woman in hospital bed looking towards her partner with worry

Long-Term Complications of Premature Birth

Premature infants are at an increased risk of neonatal and perinatal health problems and birth injuries. A baby born prematurely has not developed completely. That leads to a higher risk of medical issues affecting the baby’s life and development.

Common complications include:

  • Underdeveloped or undeveloped lungs – One of the last organs to develop in babies during a woman’s pregnancy is the lungs. An infant’s lungs typically don’t complete development until at least 36 weeks of gestation. A baby born too soon might have lungs that don’t supply enough oxygen to the body. That can lead to a brain injury due to a lack of oxygen. Underdeveloped lungs often result in other medical complications later in the child’s life.
  • Respiratory distress syndrome (RDS) – Premature infants can develop RDS, a respiratory condition that occurs when the lungs don’t receive sufficient amounts of a protein called pulmonary surfactant. The protein keeps the lungs inflated, but without it, a newborn baby can’t breathe on their own as a child with fully developed lungs can. Treating the baby with a ventilator or respirator might be necessary.
  • Bronchopulmonary dysplasia (BPD) – BPD is when a baby needs to be on a ventilator for about a month or longer. The baby’s lungs can suffer permanent damage from the pressure from the ventilator. There is no cure for this condition, but it can be treated. Most babies can live a healthy life after treatment.
  • Neonatal pneumonia – Premature infants with underdeveloped or undeveloped lungs risk neonatal pneumonia after birth. This inflammatory infection can permanently interfere with the lung’s ability to exchange oxygen for carbon monoxide. Diagnosing pneumonia right away can prevent long-term injury so that doctors can treat it with antibiotics. However, the baby can face lifelong struggles and medical issues if pneumonia goes undiagnosed and untreated.
  • Infection – Premature babies can’t fight against infections as effectively as infants brought to term. Their immune systems haven’t finished developing, leaving them vulnerable to numerous types of infections, potentially requiring a transfer to the Neonatal Intensive Care Unit (NICU).
  • Anemia – Anemia is a condition in which there are an insufficient number of healthy red blood cells or hemoglobin in the blood to carry oxygen to tissues in the body. When it occurs in a premature infant, they might need a blood transfusion to circulate oxygen throughout the body.
  • Gastrointestinal tract immaturity – Underdeveloped digestive and gastrointestinal tracts are common in premature babies. That creates difficulties in processing and absorbing the necessary nutrition from breast milk or baby formula.
  • Patent ductus arteriosus (PDA) – PDA is a heart problem that can occur in premature infants. It results from the blood vessels not closing fully before birth. The vessel acts as a valve, separating two other major cardiopulmonary vessels. The valve stays open while the baby is in the mother’s womb to encourage the development of the lungs. Hormones should close the ductus arteriosus in the final stages of gestation. However, PDA can form in a preterm baby, causing the blood to flow into underdeveloped lungs. Heart failure can occur from fluid collecting in the lungs.
  • Intraventricular hemorrhage (IVH) – Infants born at or before 37 weeks of gestation might not have fully developed blood vessels in the brain. Underdeveloped circulatory vessels are at risk of tears or ruptures, especially if the baby experiences any stress during vaginal delivery. IVH is the rupture of the brain vessels and can lead to cognitive delays, permanent brain damage, and lifelong disabilities.

Compensation for Premature Birth Injuries

If you took Makena and suffered adverse side effects or your baby sustained injuries during preterm delivery, you might be able to hold Covis Pharma financially responsible. You can pursue a lawsuit against the drug manufacturer for compensation to cover your injuries and losses. The money you receive might compensate you for your:

  • Lost wages
  • Lost earning capacity
  • Pain and suffering
  • Hospitalization, prescriptions, surgeries, and other medical expenses
  • Mental anguish
  • Loss of enjoyment or quality of life for you or your infant

Makena Class Action Lawsuit

The ineffectiveness of Makena in preventing preterm birth, coupled with the high prices charged by AMAG, Inc. (the drug’s former manufacturer), led to a class-action lawsuit even before the FDA decided to withdraw approval. The lawsuit alleges that AMAG charged expectant mothers hundreds of dollars per injection of the drug, despite knowing that it could not effectively prolong pregnancies or reduce the risk of miscarriages and stillbirths.

The lawsuit further claims that AMAG advertised Makena with assurances that it helps expectant mothers get closer to term, even though the company knew the drug could not deliver on these promises. The plaintiffs in the class action argue that they suffered an ascertainable loss by paying a premium price for a product that was worth “zero or close to zero.”

What Is a Consolidated Class-Action Lawsuit?

A consolidated class-action lawsuit represents an efficient and powerful legal tool combining multiple similar cases into one. This form of legal action occurs when several plaintiffs, all alleging similar violations by the same defendant, join their lawsuits to form a consolidated class action.

This process allows the court system to manage a large number of similar cases more efficiently. It also lets the plaintiffs pool their resources, giving them a stronger stance against large corporations. Consolidating lawsuits into a single class action can often increase leverage during negotiations, potentially leading to larger settlements.

In the context of the Makena lawsuits, a consolidated class-action lawsuit can provide a united front for all those affected, enhancing the effectiveness of their legal pursuit for justice and compensation. If you believe you could be part of this consolidated class-action lawsuit, Paul LLP Trial Attorneys can help guide you through the process.

Contact Paul LLP Trial Attorneys Today for a Free Consultation

Choosing the right legal representation for your Makena lawsuit is crucial for your case’s success. You deserve a legal team that boasts not only experience and resources but also an unwavering dedication to its clients. Paul LLP Trial Attorneys is the firm that stands out for these very reasons.

Our firm’s focus on complex commercial and consumer contingent-fee litigation demonstrates our ability to handle sophisticated and high-stakes disputes like the Makena lawsuit. We have led nationwide teams of co-counsel in multi-faceted cases, working to protect our clients’ interests no matter the geographical scope of the litigation.

At the helm of Paul LLP Trial Attorneys are two nationally recognized attorneys who have successfully litigated against some of the country’s most powerful corporations, securing some of the largest settlements in U.S. history. Our legal team is a collective of dedicated, honest, and hardworking professionals who put our clients’ needs at the forefront of everything we do.

If you or a loved one used Makena and experienced losses due to its ineffective results, we encourage you to contact us today at (816) 984-8100 for a free consultation. Let Paul LLP Trial Attorneys fight for the justice and compensation you deserve.

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Rick Paul
Ashlea Schwarz