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GlaxoSmithKline’s Zofran, which is FDA approved to treat severe nausea and vomiting only in cancer patients and those undergoing surgical anesthesia, has also become a leading treatment for morning sickness, despite the fact that its effects during pregnancy have never been adequately studied. Four lawsuits have now been filed, claiming that Zofran has the potential to cause birth defects and that GlaxoSmithKline was aware of the drug’s potential dangers but marketed it to pregnant women’s physicians anyway. In total, plaintiffs allege that GlaxoSmithKline’s medication caused twelve separate birth defects. Continue reading
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Apr 13, 2015 /prREACH/ -- In four recently-filed lawsuits, American mothers have claimed that the anti-nausea drug Zofran caused their children to develop severe congenital defects.
Manufactured by international pharmaceutical conglomerate GlaxoSmithKline, Zofran was approved by the FDA in 1991 to treat severe nausea and vomiting in patients undergoing chemotherapy, radiotherapy and surgical anesthesia. GlaxoSmithKline did not, and has never, pursued its approval as a treatment for morning sickness in pregnant women. The company has never conducted clinical trials to determine the drug’s effects on pregnant women or their developing babies.
Despite these facts, Zofran has become one of America’s leading treatments for the nausea and vomiting of pregnancy. Now, several large-scale epidemiological studies have begun to establish an association between Zofran taken during the first trimester and an increased risk of congenital defects. To read summaries of the studies, click here.
In February and March of 2015, Four mothers brought the nation’s first Zofran birth defect lawsuits against GlaxoSmithKline. These complaints were filed in Massachusetts, Minnesota, Oakland and San Francisco, California under the case numbers 1:15-cv-10429, 2:15-cv-00709PD, R615761042 and CGC-15-544524 respectively. The four complaints describe a wide range of congenital defects allegedly caused by exposure to Zofran.
In docket 1:15-cv-10429, a mother from Massachusetts claims that she was prescribed and took Zofran beginning early in her first trimester to ease the symptoms of morning sickness. Her child was quickly diagnosed with what court documents call “numerous congenital defects.” Of these abnormalities, three are congenital heart defects: atrial septal defect, right ventricular hypertension and aortic arch hypoplasia.
Atrial septal defect is a hole between the heart’s uppermost chambers that can lead to congestive heart failure and high blood pressure. Plaintiff’s daughter also suffers from right ventricular hypertension, a form of high blood pressure that strains arteries in the lungs. Over time, these arteries can narrow, increasing pressure and forcing the heart’s right ventricle to increase in size. When untreated, the condition can lead to right heart failure. Aortic arch hypoplasia occurs when the aorta, a large artery that carries blood from the heart to the body, becomes blocked. This extremely serious condition almost always requires immediate surgical intervention.
The plaintiff also claims that her daughter was diagnosed with webbed toes, sensitivity to light, hearing loss and low set ears. According to court documents, she was subsequently diagnosed with inguinal hernia, in which contents of the abdominal cavity protrude further than normal, and facial dysmorphia.
The plaintiff claims that her daughter has undergone ten separate surgical procedures as a result of these birth defects. She suffers substantial developmental delays that impair her enjoyment of a normal life.
In docket 2:15-cv-00709PD, a mother from Minnesota claims that her two daughters were both born prematurely after she was prescribed and took Zofran for morning sickness. She alleges that her children were both diagnosed with congenital heart defects shortly after birth. In court documents, one of these defects is referred to as a “hole in the heart.” Both children have suffered abnormally slow physical growth and other developmental delays. One of the newborns, unable to breathe adequately, was placed under 24-hour surveillance.
Docket R615761042 describes the complaint of a mother from Oakland, California. After being prescribed Zofran for nausea and vomiting of pregnancy, she claims that her child was born with supraventricular tachycardia, an abnormally fast heartbeat caused by improper electrical signalling. According to court documents, her child was prescribed a medication called Digoxin to alleviate symptoms that included rapid breathing and shortness of breath.
In the most recent lawsuit, filed under docket number CGC-15-544524, parents from San Francisco claim that their child was born with bicuspid aortic stenosis as a result of Zofran exposure. In this congenital heart defect, the aortic valve, which allows blood to flow from the heart to the rest of the body, has only two flaps, rather than the three seen in hearts free of abnormalities. Over time, the abnormal valve can calcify, becoming stiff and forcing the heart to work harder. In many cases, the valve itself will leak, allowing blood to flow backwards. Court documents state that plaintiffs’ child “will require continued monitoring and future surgeries to repair or replace his damaged [heart] valve.” To check on the latest filed lawsuits visit: http://zofranlegal.com
Each plaintiff alleges that GlaxoSmithKline marketed Zofran as a safe and effective morning sickness treatment directly to physicians, despite the absence of any clinical data to support those claims. In fact, they allege the opposite, claiming that GlaxoSmithKline was aware of Zofran’s potential risks during pregnancy, but did nothing to warn the public or health community.
If these allegations prove true, any mother who was prescribed Zofran for morning sickness and then delivered a child with birth defects may be entitled to bring a claim for compensation against GlaxoSmithKline. Families interested in learning more are urged to contact Monheit Law, a firm currently investigating claims against GlaxoSmithKline with the assistance of a national coalition of distinguished plaintiffs’ attorneys.