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Zofran and Birth Defects

Zofran and Birth Defects

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Mothers who used the drug Zofran while pregnant and whose children subsequently were born with birth defects have been coming forward with product liability lawsuits against GlaxoSmithKline, the drug’s manufacturer. Anyone else who had this experience may call 1-866-LAW-2400 to get a free consultation as to what her legal options are.

Proving Zofran Leads to Birth Defects

There has been a recent procedural development concerning Zofran lawsuits. A panel of federal judges Oct. 13 centralized 12 Zofran lawsuits before a single judge at the U.S. District Court for the District of Massachusetts. Additional litigation is sure to follow, which means one judge will oversee the pretrial process for many more lawsuits, thusly economizing the court’s time and resources.

The judges wrote, “These actions share factual questions arising from allegations that Zofran and its generic equivalent, a prescription medication for the treatment of nausea, causes birth defects in children when their mothers ingest the drug while pregnant.”

Plaintiffs in Zofran lawsuits may not have taken the drug had the defendant not marketed Zofran for a purpose unapproved by the U.S. Food and Drug Administration. And it’s too late for the manufacturer to deny that it did it.

3 Billion Dollar Settlement

Indeed, GSK in 2012 agreed with the U.S. Justice Department to pay a then-record $3 billion to settle its criminal and civil liability arising, in part, from the corporation’s “unlawful promotion of certain prescription drugs,” including Zofran, as the Justice Department’s 2012 statement read. Drugs marketed for unapproved purposes are said to be promoted “off-label.”

Zofran, the generic of which is ondansetron, “is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery,” according to the U.S. National Library of Medicine.

But the drug eventually was marketed for morning sickness, as well.

Research Proved Zofran Lead to Birth Defects Beforehand

In addition to promoting Zofran off-label, the company allegedly did it despite information that foreshadowed a link to birth defects, according to a petition that a plaintiff filed at federal court in Massachusetts.

“Plaintiff’s minor child, A.S., was born in 2000 with numerous congenital defects after her mother … was prescribed and began taking Zofran beginning early in her first trimester of pregnancy to alleviate the symptoms of morning sickness,” reads the complaint. “After birth, echocardiograms evidenced that A.S. suffered from an atrial septal defect, right ventricular hypertension and aortic arch hypoplasia. A.S. has also subsequently been diagnosed with facial dysmorphia, low set ears, hearing loss, sensitivity to light, ingueno hernia, and webbed toes.”

Could the manufacturer have known about the risk of birth defects associated with an expectant mother’s use of Zofran?

Reports of Zofran-Related Birth Defects

“At least as early as 1992,” according to the lawsuit, “GSK began receiving reports of birth defects associated with the use of Zofran by pregnant women. By 2000, GSK had received at least 32 reports of birth defects arising from Zofran treatment in pregnant women. These reports included congenital heart disease, dysmorphism, intrauterine death, stillbirth, kidney malformation, congenital diaphragmatic anomaly, congenital musculoskeletal anomalies, and orofacial anomalies, among others … In twelve years, A.S. has had to undergo ten surgeries to try and correct her numerous congenital abnormalities.”

Want more recent findings? Researchers in Sweden combed through the registries of child births and mothers who used generic Zofran early in pregnancy from 1998 through 2012. The study identified more than 1,300 infants.

Researchers wrote for a 2014 edition of the journal Reproductive Toxicology, “The risks for a cardiovascular defect and notably a cardiac septum defect were increased and statistically significant. Additionally, they wrote, “an increased risk for a cardiac septum defect is likely.”

Mothers who used Zofran while pregnant and whose children were born with birth defects probably owe it to their families to determine whether they may be entitled to compensation for medical expenses, which can be ridiculous for the treatment of a birth defect, and for other losses.

Consider getting a free consultation from one of the experienced pharmaceutical injury attorneys at Reich & Binstock. The law firm, which operates in every state, has been taking on big pharmaceutical corporations and getting justice for their clients since 1984.

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