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Zofran, a powerful anti-nausea drug marketed by GlaxoSmithKline, is coming under fire due to the potential risks of Zofran birth defect dangers. Zofran (Ondansetron) gained FDA approval in 1991 as a treatment for nausea and vomiting for patients undergoing chemotherapy, radiation and surgical procedures. While not approved for use in pregnant women, Zofran is sometimes prescribed off-label to treat severe cases of pregnancy-related nausea and vomiting.
GlaxoSmithKline paid a $3 billion settlement to the U.S. Department of Justice in 2012 over the off label use of Zofran and other drugs. That suit accused the manufacture of illegally marketing Zofran for pregnancy-related morning sickness. The lawsuit also alleged doctors had been paid kickbacks by GlaxoSmithKline for prescribing Zofran for off-label uses. Many studies have now concluded that there are significant Zofran birth defect risks such as: cleft palate, kidney defects, musculoskeletal defects, fetal growth problems, heart defects and even fetal death.
In June, 2014, the Toronto Star published an investigation into FDA Zofran reports. The investigation focused on twenty cases of Canadian women who delivered a baby with a birth defect after taking Zofran for severe nausea. Among the twenty Canadian women, physicians directly linked Zofran to one heart murmur, one musculoskeletal anomaly, several cases of jaundice, two heart defects, a heart murmur and a deformity of the mouthy. One of the Zofran heart related birth defects was atrial septal defect—otherwise known as a hole in the heart between the upper-left and upper-right chambers of the heart. Ventricular septal defects, kidney malformations and restrictions of fetal growth were also noted.
Zofran Birth Defect Lawsuits
Many women who took Zofran during their pregnancy are currently in the process of filing a Zofran heart related birth defect lawsuit, a Zofran cleft palate birth defect lawsuit or a Zofran fetal death lawsuit. Depending on how many Zofran lawsuits are filed, there could be future Zofran class action or Zofran MDL lawsuits against the manufacturer of the drug. If your child suffered a lip or palate defect as a result of Zofran, you might consider filing a Zofran cleft palate birth defect lawsuit or a Zofran cleft lip birth defect lawsuit.
A cleft palate is a split in the roof of the mouth The opening of the cleft palate may go through the gums or connect to the nose. Cleft lip is a split in the upper lip. When the tissue which normally forms the upper lip fails to grow together, a cleft lip is the result. Cleft lip generally occurs around the 7th week of pregnancy—the same time many women are experiencing severe morning sickness and taking a drug such as Zofran for relief of the nausea.
Zofran MDL and Zofran Class Action Lawsuits
Many consumers have been a part of a class action lawsuit, no matter how small. You may have at one time or another in your life, received a nominal check because you were one of thousands, or even millions or consumer harmed by the negligent action of a company. Class action suits are popular ways of reimbursing large numbers of people who purchased a defective product or were harmed by a defective or dangerous product. For people with serious injuries, a class action lawsuit can have serious disadvantages. The primary reason a class action suit could be less-than-beneficial to consumers is because they could be forced to accept a very low settlement as the monies are divided equally among all those in the class action suit.
In cases where a dangerous drug has harmed consumers, they may be better off having an individual lawsuit filed on their behalf. If enough people file lawsuits, the suits may be consolidated into a multi-district litigation. A Zofran MDL has significant benefits over a Zofran class action lawsuit. In an MDL lawsuit, various legal actions—including discovery—are consolidated for the purpose of pre-trial convenience. A Zofran MDL would speed the process of the lawsuits while allowing each client’s individual needs to be addressed. Settlements in an MDL are on an individual basis, according to the level of harm suffered.
Why You May Want to Speak to a Zofran Birth Defect(s) Lawyer
If your child was injured by Zofran, you may be able to file a lawsuit against the manufacturer of Zofran for your child’s birth defect. You may be able to pursue monetary damages for pain and suffering and past and future medical expenses. Speaking to an experienced Zofran birth defects lawyer could be helpful.