On June 8, 2015, two women in Louisiana filed a lawsuit against the pharmaceutical conglomerate GlaxoSmithKline. Alleging that prenatal exposure to the anti-nausea drug Zofran caused their unborn children to develop severe congenital heart defects, plaintiffs claim damages for medical expenses, emotional distress, pain and suffering. In filing their claim, they have added their voices to a litigation that now includes at least ten individual lawsuits.
Their lawsuit, registered under case number 15-1815, has been brought in the US District Court for the Western District of Louisiana. A copy of their complaint can be found at ZofranLegal.com, an informational resource sponsored by Monheit Law. Together with a multi-state alliance of experienced plaintiffs’ attorneys, Monheit Law is investigating the claims of families who believe that exposure to Zofran may have caused their children to develop birth defects. The lawyers are offering consultations at no charge to parents interested in learning more about the Zofran litigation.
In case 15-1815, both plaintiffs claim that they were prescribed Zofran to alleviate the symptoms of morning sickness during the first trimester of pregnancy. The first plaintiff gave birth to her daughter, named as L.D. in court documents, on July 15, 2010. Soon after delivery, L.D. was diagnosed with three severe congenital heart defects: ventricular septal defect, atrial septal defect and intermittent tachypnea.
Two of these abnormalities, ventricular septal defect and atrial septal defect, fall under the category of cardiac septal defects. Plaintiffs note that three separate epidemiological studies have found an association between prenatal exposure to Zofran and increased risks for cardiac septal defects. One study, conducted by researchers from Copenhagen University, found that women who were prescribed Zofran during early pregnancy were over twice as likely to deliver babies with atrial septal defects or ventricular septal defects. Another study, published in the journal Reproductive Toxicology, substantiated these findings, concluding that babies exposed to Zofran were more than twice as likely to be born with a cardiac septal defect.
Plaintiff states that her daughter’s third congenital heart defect, intermittent tachypnea, is “reflective of congestive heart failure.” This condition, an abnormally rapid heart beat diagnosed immediately after birth, is commonly associated with severe cardiac septal defects, which can lead to congestive heart failure. Plaintiff says that her daughter underwent surgery to repair the ventricular septal defect.
After taking Zofran as an unapproved morning sickness treatment, the complaint’s second plaintiff gave birth to a daughter on August 9, 2005. Named V.P. in court documents, plaintiff’s child was quickly diagnosed with accelerated ventricular arrhythmia. This heart condition involves a fault in electrical systems that control heart contractions; the heart’s upper chambers beat out of sync with lower chambers. Plaintiff says that her daughter’s “serious heart defect […] nearly caused V.P. to die shortly after birth.” She claims that her daughter required intensive medical surveillance for the first five years of her life.
As in previous complaints, plaintiffs claim that GlaxoSmithKline (GSK) unlawfully promoted Zofran for use as a morning sickness treatment and concealed evidence of the drug’s potential to increase birth defect risks from the Food & Drug Administration, physicians and public.
They cite a 2012 lawsuit in which the US Federal Government charged GSK for marketing Zofran as “safe and effective” during pregnancy. But as plaintiffs note, Zofran is not approved as a morning sickness treatment, and GlaxoSmithKline has never studied the effects of its drug in pregnant women or those it may cause in unborn children. In fact, plaintiffs claim that GlaxoSmithKline has been aware of Zofran’s potential risks for over two decades. Along with at least 9 other plaintiffs, these mothers say that GlaxoSmithKline concealed evidence of Zofran’s potential to adversely affect fetal development from the FDA, health community and public.
Any parent who was prescribed Zofran during the first trimester and then delivered a child with birth defects may be eligible to bring their own claim against GlaxoSmithKline. Led by Michael Monheit, Esq., Monheit Law has gathered an alliance of plaintiffs’ attorneys to investigate the claims of parents who believe that prenatal exposure to Zofran may have caused their children to develop major birth defects. Their attorneys are providing free consultations and case eligibility evaluations to families and birth defect survivors.
Name: Michael Monheit
Source URL: http://www.prreach.com/pr/18093
Release ID: 84365