Zofran Birth Defect Lawsuits | Drug Injury Attorneys

Zofran Lawyer

Child Injured By Medication? Turn to Our Nationally Recognized Drug Injury Attorneys.

The Zofran lawyers at Pintas & Mullins Law Firm are now accepting clients who took Zofran during pregnancy and whose children suffered birth injuries such as heart defects and cleft lip or palate. Zofran is not approved to treat pregnancy-related nausea and vomiting, but its manufacturer marketed the drug to pregnant women anyway, knowing it wasn’t safe. The company has known Zofran posed dangers to fetuses since the 1990s.

We know how devastating it is to watch your child struggle with conditions caused by the greed of Big Pharma. We’re here to fight for your family.

Our drug injury lawyers have an unparalleled level of experience—we have handled more than 10,000 injury cases since our firm’s founding in 1985. We serve clients around the nation by partnering with the top litigation firms in your state, giving you the power of two remarkable firms behind your case. Our research, seasoned litigators, and access to leading experts in the field, combined with the courtroom prowess of our partner firms, has allowed us to secure tens of millions of dollars for our clients nationwide—including millions for people who have been injured by defective drugs, including Zofran.

Call (800) 794-0444 today to let us hear your story. We can determine your legal options and help you take the next step in a free, confidential legal consultation.

Why Is Zofran Causing Injuries?

Zofran (ondansetron) was approved in 1991 to relieve nausea and vomiting in patients undergoing chemotherapy and other cancer treatments. Its manufacturer, GlaxoSmithKline (GSK), wanted to increase Zofran’s sales, but the cancer patient market remained stagnant.

GSK was quick to promote Zofran to treat morning sickness in pregnant women, even though this was blatantly illegal, unconscionable, and unsafe for mother and baby. GSK even paid doctors to prescribe Zofran to pregnant women, despite never being tested for fetal safety.

An estimated 80% of pregnant women experience nausea and vomiting during pregnancy. The most severe form of morning sickness is called hyperemesis gravidarum, which may require hospitalization.

GSK illegally advertised Zofran to expectant mothers and their treating doctors, eventually making it the most-prescribed drug for morning sickness in the country. Currently, about one million pregnant women in the United States take Zofran every year.

In 2012, GSK pled guilty to charges of illegal marketing and fraud involving Zofran, paying $3 billion to the U.S. government.

Studies Link Zofran to Birth Abnormalities

In 2011, a study by the Centers for Disease Control (CDC) and a health center in Boston identified an association between Zofran use during pregnancy and major birth defects. Researchers found that women who took Zofran had double the risk of birthing a child with a cleft palate.

That same year the FDA announced that Zofran could change the electrical chemistry of the heart, leading to fatal heart rhythms. The agency recalled the drug, later re-releasing it but requiring smaller doses.

In 2013, a Danish study of nearly 900,000 pregnant women found that those taking Zofran had a 30% increased risk of birthing a child with major malformations, including a two-fold increased risk of cardiac defects.

Links to these studies can be found at the bottom of this page, under Resources.

Zofran birth defects include:

  • Club foot
  • Cleft lip & palate
  • Heart malformations
  • Hearing loss
  • Skull deformations
  • Webbed toes

GSK always knew Zofran was unreasonably dangerous to developing babies. The company’s own data showed Zofran passed through placenta tissue in significant amounts, leading to clinical signs of incomplete bone growth, premature births, heart defects, developmental problems and fetal deaths in animal studies.

Largest Drug Fraud Settlement in U.S. History

When taken during pregnancy, certain medications, such as SSRI antidepressants, are known to reach the fetus and cause harm. Since Zofran was not approved to treat morning sickness, the FDA never required GSK to provide any safety information on fetal risks. Despite total lack of safety data, GSK aggressively advertised Zofran to expectant mothers and paid doctors to prescribe it to their pregnant patients.

GSK’s $3 billion settlement for its illegal Zofran marketing was the largest healthcare fraud settlement in American history. The company pled guilty to three counts of criminal behavior.

Zofran Birth Injury Lawsuit Update

There are hundreds of Zofran lawsuits currently pending lawsuits against GlaxoSmithKline. About 100 cases are consolidated in the District of Massachusetts in Multidistrict Litigation (MDL No. 2657) with Judge F. Dennis Saylor IV presiding over the cases. Many more cases are expected to join. Call our Zofran attorneys to see if you qualify to join the Zofran MDL.

An MDL structure allows families to bring their birth injury cases against GSK more efficiently. Since Zofran has harmed so many families, an MDL structure is the most effective and efficient way to bring birth injury claims to court, speeding up the process to compensate families who so desperately need it.

GSK recently asked Judge Saylor to dismiss all Zofran birth defect lawsuits. Judge Saylor ruled in favor of the families, who “deserved a chance to develop facts supporting their claims.” He called the bid premature, and allowed the families to continue bringing their lawsuits forward.

For more information, read our blogs and MDL documents:

Do not let GSK get away with this. Call Pintas & Mullins Law Firm today at (800) 794-0444 for experienced, compassionate, and effective help that has changed lives of thousands of families all over the U.S.

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