Parents Contend Zofran Caused Son’s Birth Defects
A number of Zofran lawsuits have been filed against GlaxoSmithKline (GSK) with regard to the drug’s side effects on unborn children. One of the most recent cases filed against GSK alleges that the defendant’s wrongful conduct and fraudulent misrepresentation directly resulted in a minor child’s severe heart defects and ongoing pain and suffering.
The parents, who are residents of Louisiana, demand a jury trial and compensatory damages for medical expenses, past, present, and future pain and suffering, and punitive damages. The complaint is being litigated in the U.S. District Court for the Western District of Louisiana Lafayette Division.
Zofran (ondansetron) is a prescription medication that was originally intended to treat severe nausea and vomiting in patients receiving chemotherapy for cancer. It is also prescribed to relieve nausea in surgery patients. However, like many other medications, Zofran was frequently prescribed for off-label use, or for uses other than approved by the FDA. Some women who suffered from morning sickness during pregnancy used the medication as prescribed by their physicians. Some of these women later discovered that their children were born with birth defects, such as heart defects. Zofran lawsuits allege that the medication was the direct cause of these malformations.
Child suffers from debilitating medical problems
The mother who filed this recent lawsuit was prescribed Zofran for morning sickness in her first trimester. According to the lawsuit, she used the drug as prescribed and was unaware that it had the potential to cause serious birth defects. Despite having no history of birth defects in the family, the minor child was immediately forced to undergo surgery after his birth on November 7, 2012. He also required extensive follow-up medical care after the surgery.
The child was diagnosed with multiple congenital defects, including an enlarged right ventricle and pulmonary atresia. Pulmonary atresia is a type of congenital heart disease that is characterized by the malformation of the pulmonary valve. Children born with this congenital defect have a solid sheet of tissue in the area where the valve opening should be. Because the valve cannot open, blood cannot flow from the right side of the heart to the lungs. Pulmonary atresia is associated with numerous complications, including seizures, stroke, delayed growth and development, heart failure, infectious endocarditis, and death. Typically, the symptoms of pulmonary atresia develop rapidly after birth. They can include cyanosis or bluish coloring of the infant’s skin, rapid breathing, shortness of breath, and poor feeding.
According to the Zofran claim, the minor child has suffered from delayed development, has required additional surgeries, and has an impaired “enjoyment of a normal life at home and at school.”
Zofran lawsuit alleges failure to warn
The lawsuit demands compensatory damages for the defendant’s alleged negligence, fraudulent misrepresentation, failure to warn, and other counts. Among other serious allegations, the lawsuit points to the defendant’s responsibility to warn consumers of the potential for serious risks as soon as they become known. The parents claim that although GSK received hundreds of reports of adverse events, including birth defects, associated with Zofran, the company failed to disclose this critical information to expectant mothers and doctors.
- Drugs.com, Zofran, http://www.drugs.com/zofran.html
- MedlinePlus, Pulmonary Atresia, https://www.nlm.nih.gov/medlineplus/ency/article/001091.htm