Zofran

Cleft Lip and Cleft Palate - Common Zofran Related Birth Defects.

November 4, 2015 

A 2011 National Birth Defects Prevention Studyfound that pregnant women taking Zofran in their first trimester more than doubled their risk of giving birth to an infant with a cleft lip or palate deformity.

Zofran (Ondanestron) is a prescription medication used to treat nausea and vomiting, predominately in cancer patients treating with chemotherapy. Drug manufacturer, GlaxoSmithKline (GSK), marketed the drug off label to pregnant women as a safe treatment for morning sickness. GSK failed to conduct a single clinical trial before marketing Zofran to pregnant women, and did not seek FDA approval to market the drug for treatment during pregnancy. 

Cleft lip and cleft palate are birth defects that usually manifest themselves between 8 and 12 weeks into pregnancy, when the lip and mouth fail to completely fuse. Cleft deformities can be genetic in nature or caused by a drug taken during pregnancy. The deformity is diagnosed by way of ultrasound during pregnancy or at the time of child birth. A cleft lip occurs when a thin portion of skin tissue does not form in the upper lip. A soft cleft palate occurs in the back of the roof of the mouth whereas a hard cleft palate occurs in the front of the roof of the mouth. A child may be born with a cleft lip and/or cleft palate bilaterally, on both side of the mouth, or unilaterally, on one side of the mouth.

Children with cleft deformities face medical and growth complications throughout their lives. These complications start with simple tasks such as eating. Food and liquid can pass through a cleft palate and make it difficult for an infant to absorb necessary nutrients. Clefts also contribute to ear and hearing problems by allowing fluid to collect in the middle of the ear. Cleft deformities can create speech problems for children where the only remedy may be surgery or therapy with a speech pathologist. Additionally, children that suffer from a cleft usually require braces and experience dental issues such as cavities and missing, extra, or displaced teeth. 

Medical professional recommend that clefts be surgically repaired early on in a child's life. A cleft palate should be repaired within the first two years and a cleft lip within the first year. Additional surgeries are usually required later in life as the child continues to grow. These surgical procedures can include bone grafting, gap filling, and plast surgery to remove the scar. 

If your baby was born with a congenital birth defect after taking Zofran during pregnancy, we may be able to help your family get the financial compensation you need and deserve to ensure your child gets the very best medical attention available for the rest of their lives. Kelley, Bernheim, and Dolinsky, LLC is not a class action law firm; we are experienced products liability attorneys who bring individual personal injury lawsuits against the manufacturers of dangerous pharmaceutical drugs. If you or your family are considering pursuing compensation, we would like to educate you about your rights in a free legal consultation with an experienced products liability attorney. Contact us today to learn more.


Zofran Pregnancy and Birth Defect Lawsuits Centralized in Massachusetts Federal Court

November 3, 2015

Over 50 lawsuits, concerning the anti-nausea medication Zofran, have been centralized in Massachusetts Federal District Court.

Zofran is a drug that was marketed off label and prescribed to pregnant women experiencing morning sickness. The drug manufacturer, GlaxoSmithKline (GSK), is being sued by families whose infants were born with severe birth defects, and in some cases stillborn, after their mothers had taken Zofran during pregnancy.

Cases against GSK are being filed in Federal District Courts across the country. The mothers and families have accused GSK of failing to adequately warn them about the pregnancy risks associated with the consumption of Zofran. Multidistrict Litigation (MDL) cases occur when civil actions involving one or more common questions of fact are pending in different districts across the country. To efficiently handle large amounts of these cases, the United States Judicial Panel on Multidistrict Litigation (JPML) may decide to consolidate the cases under the MDL by transferring all of them to the same district. 

After hearing oral arguments in October, the JPML recently decided to centralize all pending Zofran lawsuits in a Massachusetts Federal District Court, with Judge Dennis Saylor.

GSK had originally filed a motion to have the pending cases transferred to the Eastern District of Pennsylvania, where GSK is headquartered. Based on Judge Saylor's experience with Zofran cases, the JPML determined that Massachusetts was the appropriate venue in which to centralize the MDL, and avoid any advantage that GSK may have had in Pennsylvania. 

The U.S. Food and Drug Administration (FDA) approved Zofran in 1991 for use in cancer patients who required chemotherapy or radiation therapy. Although the only FDA approval for this drug was for seriously ill patients, GSK marketed Zofran off label as a safe and effective treatment for the very common side effect of a normal pregnancy, pregnancy related nausea and vomiting. 

Since 2006, studies have proven that Zofran can cross the placenta when taken by pregnant women and increase the likelihood of a child being born with a cleft palate or heart deficiency, such as, a murmur, septal defect, or hole in the heart. 

Many potential Zofran cases are time sensitive and should be filed as soon as possible to avoid being barred by the court. If your baby was born with a congenital birth defect after taking Zofran during pregnancy, we may be able to help your family get the financial compensation you need and deserve to ensure your child gets the very best medical attention available for the rest of their lives. Kelley, Bernheim, and Dolinsky, LLC is not a class action law firm; we are experienced products liability attorneys who bring individual personal injury lawsuits against the manufacturers of dangerous pharmaceutical drugs. If you or your family are considering pursuing compensation, we would like to educate you about your rights in a free legal consultation with an experienced products liability attorney. Contact us today to learn more. 


Zofran Lawsuit Allegations

Zofran is a powerful drug developed by GSK to treat only those patients who were afflicted with the most severe nausea imaginable –that suffered as a result of chemotherapy or radiation treatments in cancer patients.

The U.S. Food and Drug Administration (“FDA”) approved Zofran in 1991 for use in cancer patients who required chemotherapy or radiation therapy.

Although the only FDA approval for this drug was for seriously ill patients, GSK marketed Zofran “off label” as a safe and effective treatment for the very common side effect of a normal pregnancy-pregnancy related nausea and vomiting otherwise known as “morning sickness”.

GSK did this despite having knowledge that such representations were utterly false, as GSK had never once undertaken a single study on the effects of this powerful drug on a pregnant mother or her growing child in utero. Unlike another anti-nausea prescription drug available on the market which is FDA approved for treating morning sickness in pregnant women GSK never conducted a single clinical trial before marketing Zofran to pregnant women. GSK simply chose not to study Zofran in pregnant women or seek FDA approval to market the drug for treatment during pregnancy. GSK avoided conducting these studies because they would have hampered its marketing of Zofran and decreased profits by linking the drug to serious birth defects.

GSK’s conduct was tantamount to using expectant mothers and their unborn children as human guinea pigs.

As a result of GSK’s fraudulent marketing campaign, Zofran was placed into the hands of unsuspecting pregnant women throughout the United States. These women ingested the drug because they innocently believed that Zofran was an appropriate drug for use in their circumstance. When they ingested the drug, these pregnant women had no way of knowing that Zofran had never been studied in pregnant women, much less shown to be a safe and effective treatment for pregnancy-related nausea.

By contrast, GSK knew that Zofran was unsafe for ingestion by expectant mothers. In the 1980s, GSK conducted animal studies which revealed evidence of toxicity, intrauterine deaths and malformations in offspring, and further showed that Zofran’s active ingredient transferred through the placental barrier of pregnant mammals to fetuses. A later study conducted in humans confirmed thatingested Zofran readily crossed the human placenta barrier and exposed fetuses to substantial concentrations.

GSK did not disclose this information to pregnant women or their physicians.

In 2012, GSK pled guilty to criminal charges lodged by the United States of America, through the Department of Justice, for its “ off label” promotion of it’s drugs for uses never approved by the FDA. At or around the same time, GSK also entered civil settlements with the United States GSK that included more than $1 billion in payments to the federal government for its illegal marketing of various drugs, including Zofran specifically.

GSK’s written agreement with the United States reports GSK’s settlement of claims that GSK: (a) “promoted the sale and use of Zofran for a variety of conditions other than those for which its use was approved as safe and effective by the FDA (including hyperemesis and pregnancy-related nausea)” (b) “made and/or disseminated unsubstantiated and false representations about the safety and efficacy of Zofran concerning the uses described in subsection (a) [hyperemesis and pregnancy-related nausea]” (c) “offered and paid illegal remuneration to health care professionals to induce them to promote and prescribe Zofran”(Settlement Agreement, p. 5, July 2, 2012.)

GSK’s conduct has caused devastating, irreversible, and life-long consequences and suffering to innocent newborns and their families, like Plaintiff herein.

Had Plaintiff known the truth about Zofran’s unreasonable risk of harm, long concealed by GSK, she would never have taken Zofran, and her child would never had been injured as a result.