Two Louisiana mothers have filed a joint lawsuit against GlaxoSmithKline (GSK) alleging that use of the anti-nausea medication Zofran during pregnancy caused their babies to born with serious congenital birth defects.
Free Confidential Case Evaluation: If your child or other loved one was born with a birth defect after the mother took Zofran in pregnancy, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
Update: Louisiana Couple Claims Daughters’ Heart Defects from Zofran
March 25, 2016 – A couple from Montegut, Louisiana, has filed a product liability lawsuit (PDF) against GSK alleging that Zofran caused their 2 daughters to be born with heart defects. This case is unique in that of the hundreds of lawsuits filed against GSK alleging birth defects from Zofran, these plaintiffs are alleging they had 2 children born with defects within 1 year of each other as a result of Zofran exposure. Click here to learn more.
Louisiana Mothers Claim Zofran Exposure Led to Birth Defects
According to the lawsuit, plaintiffs were prescribed Zofran (generic: ondansetron) “off label” for the treatment for morning sickness, despite the drug never being approved for this purpose. The women allege that GSK illegally marketed Zofran directly to obstetricians and gynecologists as safe and effective for use during pregnancy, despite the drug never being tested in this capacity or receiving approval from the FDA. The lawsuit is: Coughlin and Swann v. GlaxoSmithKline, case number 15-1815, in the US District Court for the Western District of Louisiana.
GSK Fined for Illegal Marketing of Zofran
To support their allegations, plaintiffs in the Louisiana case cite a 2012 lawsuit filed by the U.S. Justice Department. In that case, the federal government charged GSK with marketing its medications for unapproved purposes. The complaint specifically named Zofran, and alleged that GSK had promoted the drug as a treatment for morning sickness in violation of federal law. While GSK has always denied the allegations, the company pled guilty to 3 other criminal charges and settled for $3 billion.
Plaintiffs Allege Zofran Caused ‘Hole in the Heart’ Defects
The first plaintiff in the joint complaint alleges that she was prescribed Zofran in Jan. 2010, during her 1st trimester of pregnancy. The woman’s daughter, referred to in court documents as L.D., was born that July and immediately diagnosed with the following heart defects:
Also referred to as ‘hole in the heart’ defects, atrial and ventricular septal defects occur when walls that separate the heart’s chambers fail to form properly in the womb. When this occurs, blood flow is impeded, requiring the need for open heart surgery. Indeed, the lawsuit claims L.D. required surgical intervention to repair the defect.
The lawsuit was filed in the U.S. District Court for the Western District of Louisiana under case number 6:15-cv-01815-RFD-PJHm, and has been assigned to Schedule A in the recently-formed multidistrict litigation (MDL) in Boston.
Second Plaintiff Alleges Ventricular Arrhythmia Caused by Zofran
Like the first plaintiff, the second mother alleges that she was prescribed Zofran for morning sickness during her first trimester of pregnancy. She says she began taking the drug around Feb. 2005, and had a daughter, “V.P.,” on Aug. 9. Soon after she was born, V.P. was diagnosed with accelerated ventricular arrhythmia, a form of ventricular tachycardia in which a problem with the heart’s electrical system causes the organ’s lower chambers to pump out of rhythm with the upper chambers.
According to the complaint, the defect “nearly caused V.P. to die shortly after birth.” Plaintiff states her daughter has “required intense and regular medical monitoring and testing for the first five years of her life.”
Both plaintiffs in the Louisiana case allege they were “unaware of the dangers posed by ingesting Zofran during pregnancy” and that, if they had known of the medication’s potential to cause birth defects, they “would not have elected to use Zofran.”
Louisiana Mom Claims GSK was Negligent
June 26 – A third Louisiana mother filed a lawsuit today alleging that her son was born with serious congenital heart defects after she took Zofran while pregnant. According to the complaint, the woman used Zofran for morning sickness from early in her first trimester through the third trimester, and gave birth to a child with an atrial septal defect and partial anomalous pulmonary venous return, a condition in which veins that transport blood from the lungs to the heart connect to a chamber on the organ’s right side rather than the left side. These defects have already required 2 corrective surgeries to treat, according to the lawsuit.
Plaintiff claims she has no family of heart defects, and blames her use of Zofran for her son’s problems. She seeks general and compensatory damages against GSK. The lawsuit is: case number 2:15-cv-02323. This case was subsequently transferred to the MDL in Boston, according to NBC News.
Complaint Alleges Zofran Marketed Illegally
November 2 – In yet another lawsuit filed against GSK, a woman from Cabot, Arkansas, claims her son was born with severe birth defects after being exposed to Zofran in the womb. According to the complaint, the baby — referred to in court documents as ‘B.H.’ — was born in 2007 with a cleft palate, bilateral clubfeet, apnea and respiratory distress syndrome. The boy, now 8-years-old, has already gone through 2 surgeries in an attempt to treat these conditions.
Plaintiff alleges GSK promoted Zofran off-label “as an established safe and effective treatment for the very common side effect of a normal pregnancy – pregnancy related nausea and vomiting – otherwise known as ‘morning sickness.'” The company allegedly did so despite not having conducted studies on Zofran’s safety or effectiveness in pregnant women.
The lawsuit cites the 2014 ‘Anderson Study’, which found that mothers who took Zofran during their first trimester of pregnancy were more likely to have a child with a congenital heart defect then women who did not use the medication.
The complaint was filed September 14 in the U.S. District Court , Eastern District of Louisiana under case number 2:15-cv-04399-SM-DEK.
Do I Have a Zofran Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Zofran Lawsuits. We are handling individual litigation nationwide and currently investigating potential settlements in all 50 states.
Free Confidential Case Evaluation: Again, if your baby was injured by Zofran side effects, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.