Zofran Lawsuit Claims Newborn Underwent 3 Heart Surgeries

November 17, 2015 – – The safety of America’s most popular morning sickness treatment has been called into serious doubt and many parents may be eligible to file lawsuits. Zofran was once hailed as a “wonder drug,” promising harmless relief to the more than 80% of pregnant women who experience some degree of nausea and vomiting in the first trimester. But recent medical studies have found an association between its active ingredient, ondansetron, and major birth defects.

At the same time, federal investigations have revealed evidence that Zofran’s manufacturer promoted the drug unlawfully. While Zofran currently leads the list of drugs prescribed for morning sickness, it was never approved for that purpose. According to the US Justice Department, that lack of approval didn’t stop international pharmaceutical giant GlaxoSmithKline from marketing the product to obstetricians and gynecologists across the nation.

Families have reacted with outrage. Many believe that GlaxoSmithKline knew of Zofran’s link to birth defects, but chose to promote its use during pregnancy anyway. Parents have even started filing Zofran lawsuits. In fact, an estimated 200 Zofran birth defect lawsuits have surfaced in Federal Courts already. The legal response has proved so overwhelming that the vast majority of lawsuits are being consolidated in Boston, where evidence will be gathered in common.

In one of the most recent legal claims, a family from Texas says the drug caused their child’s heart defects. The parents filed their lawsuits in the US District Court for the Northern District of California on September 28, 2015. The complaint was initially logged as case number 5:15-cv-04455-NC, but was transferred to the US District Court for Massachusetts on November 5, 2015. It now bears the case number 1:15-cv-13762-FDS.

The family’s story is one that has become all too familiar. In court documents, the mother writes that she was prescribed Zofran during the first trimester of a 2004 pregnancy. The couple’s daughter M.R. was delivered via cesarean section on November 28 of that year, but “immediately after [she] was born, doctors told [the mother] that her daughter’s heart had not formed correctly.”

The child had been born with heart defects, specifically pulmonary atresia and a dysplastic tricuspid valve. Both of M.R.’s primary heart valves were malformed. Her pulmonary valve was closed completely, cutting off the flow of blood from her heart to her lungs, while her tricuspid valve was abnormally thick and ineffective. Recognizing an emergency situation immediately, doctors confined M.R. to the Neonatal Intensive Care Unit.

Plaintiffs’ daughter was then transferred to a local children’s hospital for expert treatment. At only two days old, M.R. underwent her first procedure, her parents claim. Using a catheter, surgeons thread a small balloon through the newborn’s veins, eventually using it to inflate and widen her undeveloped heart valves. After a critical period of observation, the child was released into her parents’ care. But their home would soon be disrupted by another procedure. M.R. underwent her second cardiac catheterization on January 14, 2005, only one and a half months later. Less than three weeks later, the child braved open heart surgery. In what must have been a terrifyingly complex procedure, doctors repaired her malformed tricuspid valve, as well as patching a partial atrial septal defect. She remained in the hospital for 11 days.

In their complaint, the family describes a future likely filled with heart specialists and anxiety. M.R. currently sees a pediatric cardiologist every six to twelve months and her health will be closely “followed for her entire life.” Her parents say she is expected to undergo further procedures in the future.

Families who have experienced similar challenges may be entitled to financial compensation. Parents who were prescribed Zofran as a morning sickness treatment and then delivered children with heart defects or a cleft palate are urged to contact an experienced attorney immediately. Monheit Law is currently offering free consultations to all families interested in learning more about case eligibility. Call 1-877-621-4809 to speak with a lawyer today.

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Contact ZofranLegal.com:

Michael Monheit
1-877-620-8411
michael@monheit.com
1368 Barrowdale Road, Rydal, PA 19046

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