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Legal Action for Zofran Birth Defects


Hundreds of birth defects have been tied to Zofran, a popular anti-nausea medication prescribed to pregnant women since the mid-1990s. A growing number of lawsuits accuse pharmaceutical giant GlaxoSmithKline (GSK) of marketing the drug to treat morning sickness without the approval of the U.S. Food and Drug Association (FDA). The list of associated Zofran birth defects is long and includes serious and potentially fatal conditions. Heart defects are among the most common complications, which include cleft deformities and musculoskeletal abnormalities.

Over the past year, more than 220 Zofran cases have been filed by plaintiffs across the U.S. and in Canada.

If your child suffered a birth defect after you were prescribed Zofran or a similar medication while pregnant, your family may be entitled to compensation. Experienced defective pharmaceutical attorneys are offering complimentary consultations to review your case and explain your legal options. Even if the affected child was born years ago, you may still have legal standing in this case. Please contact our legal team today.

Birth Defects Tied to Zofran

In 1991, Zofran was approved by the FDA to prevent nausea and vomiting in cancer patients, but was never tested or cleared for use by pregnant women. In the mid-1990s, Philadelphia-based GSK began aggressively marketing the drug to physicians as an off-label treatment for morning sickness, which affects over 80% of pregnant women.

A 2015 investigation of complaints reported to the FDA counted 475 reports of birth defects and other adverse fetal outcomes related to Zofran. There were multiple references to congenital heart defects, craniofacial defects, respiratory defects, and many other complications. This data coincides with the allegations detailed in numerous lawsuits naming GSK as a defendant.

Over the past year, more than 220 Zofran cases have been filed by plaintiffs across the U.S. and in Canada. Plaintiffs include a North Dakota boy born with only one, low-functioning kidney, as well as missing connective tissue expected to affect his fertility. Another case filed in Mississippi in July 2015, claims that a baby boy’s cleft palate was caused by his mother’s first-trimester Zofran prescription.

Adverse fetal conditions and events reportedly connected to Zofran use in pregnancy include:

  • Heart Defects – Many congenital heart defects have been reported, primarily atrial septal defects and other structural abnormalities. Surgery is typically required to prevent further complications, which can be as severe as heart failure or pulmonary hypertension.
  • Cleft lip or palate – Congenital cleft defects are another commonly reported condition. A cleft lip creates an opening in the upper lip that may extend to the nose, while a cleft palate leaves a hole in the hard and/or soft palate inside the mouth. Both conditions cause feeding difficulties and other complications and require correction with one or more surgeries.
  • Respiratory defects – Various respiratory problems have been reported to the FDA, with many references to neonatal respiratory distress syndrome. This is a breathing disorder caused by the infant’s underdeveloped lungs and requires oxygen support. More serious is pulmonary hypoplasia, a rare congenital lung malformation, which the baby may not survive. An extended period of hospital intervention can sustain the infant until the lungs are able to grow to their appropriate size.
  • Microcephaly – FDA adverse event reports include this rare neurological condition that can affect cognitive abilities. Babies who suffer from this condition are born with a smaller than normal head, which may be a sign of inadequate brain growth and is often accompanied by developmental disorders.
  • Pierre Robin syndrome – In addition to cleft palate, babies born with Pierre Robin syndrome have an abnormally small lower jaw, which may be set further back than normal. The tongue is often set far back in the throat, partially obstructing the airway. This condition has been reported to the FDA as potentially connected to Zofran use during pregnancy.
  • Kidney Defects – Missing and malformed kidneys and connective tissue have been cited in several lawsuits. Zofran has been associated with increased risk of kidney defects described as “obstructive defects of renal pelvis and ureter.”
  • Clubfoot – Some Zofran lawsuits allege a clubfoot birth defect, which is marked by the baby’s foot turning inward instead of straight. Casting, braces, special shoes, and corrective surgery is employed to treat this condition and improve the child’s ability to walk.
  • Abdominal Malformations – Abdominal birth defects have also been cited by Zofran plaintiffs. The most common congenital abdominal birth defects are gastroschisis or omphalocele, which are both marked by intestines protruding through a hole in the baby’s abdominal wall.

Other cases have reported incidences of spina bifida, skull deformities, stillbirths, spontaneous abortions, and fetal growth restriction - and the list of complications may continue to grow.

Widespread Off-Label Use

In a December 2014 article in the American Journal of Obstetrics & Gynecology, it was estimated that one million pregnant American women take some form of ondansetron each year. Zofran has been marketed to pregnant women during a time period (until 2013) when there were no similar FDA-approved medications available. Doctors are legally free to prescribe drugs for off-label use, and commonly do so when they believe the medication to be safe and effective. GSK’s tactics, however, have not been lawful. Pharmaceutical manufacturers are not allowed to market and advertise drugs for unapproved purposes to physicians and their patients.

If you have been injured by a defective drug, Speak with an Attorney

Evidence shows GSK had reason to believe that there could be adverse effects for the baby if a pregnant mother ingested Zofran. Animal studies conducted in the 1980s found that the drug’s active ingredients were able to cross the placental barrier to the fetus, resulting in preterm deaths and obstructed fetal development. GSK’s continued claims that Zofran is a safe treatment for morning sickness are baseless, as they never conducted any additional research into the drug’s effect on pregnancies.

By 1992, the company had received the first reports of birth defects tied to Zofran, and there had been 32 reports by early 2000. Today, updates on the status of the case reveal more than 200 reported incidents, yet GSK has still not issued warnings to pregnant women and their doctors.

Zofran Litigation

Lawsuits related to Zofran began to arise in early 2015, and many plaintiffs have continued to file suit. As of February 2016, there were more than 220 individual U.S. lawsuits consolidated into multidistrict litigation (MDL) before Massachusetts District Judge F. Dennis Saylor.

MDL is common in product liability cases, which often involve multiple plaintiffs with similar allegations. This litigation differs from class action lawsuits because MDL plaintiffs are treated as individual cases. In class action suits, the larger group of plaintiffs is legally bound to accept the outcome of the trial for a smaller, representative group.

GSK paid over three billion dollars in fines and restitution for allegations that included illegally marketing Zofran and other drugs for off-label uses.

Recently, 12 plaintiffs filed a class-action lawsuit against GSK in Canada. All of the numerous Zofran lawsuits include similar allegations of wrongdoing and liability. The corporation is accused of producing a defective drug, fraudulent marketing, and failing to provide adequate warnings about the potential dangers to a developing fetus.

In 2012, GSK settled a noteworthy lawsuit stemming from multiple criminal and civil allegations brought by the U.S. Department of Justice. The company paid over three billion dollars in fines and restitution for allegations that included illegally marketing Zofran and other drugs for off-label uses. A specific allegation stated that GSK “promoted certain formulations of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women.”

Arrange a Complimentary Case Evaluation

Innocent children and their parents should not suffer because of the negligence or willful actions of a pharmaceutical corporation. If you were prescribed Zofran or a similar drug during your pregnancy and your baby was born with birth defects, you may be entitled to significant compensation. Your damages might include medical expenses, lost wages, and anticipated future costs, as well as pain and suffering.

Our legal team is participating in the MDL lawsuit, assisting Zofran victims from all over the country. State laws differ on the statute of limitation deadlines for this type of legal action, so it is important to seek legal help as soon as possible. Please contact an experienced attorney to schedule a free consultation.

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