In New Zofran Lawsuit, Massachusetts Family Says Heart Defects Caused By Drug

September 03, 2015 – – Several months ago, GlaxoSmithKline asked a panel of federal judges to transfer all Zofran birth defect lawsuits to a single court. According to statements made in the company’s motion, at least 34 claims have been filed against the multinational pharmaceutical corporation; all say the anti-nausea drug Zofran caused major birth defects.

But many of these lawsuits have been slow to surface. In new court documents obtained by attorneys at Monheit Law, a firm in Pennsylvania investigating potential claims, a separated couple from Massachusetts says the common “off label” morning sickness treatment exerted its potential effects on their unborn daughter.

Born in 2008 and named M.M. in the complaint, the girl allegedly developed two severe congenital heart defects as a result of the exposure.

The family’s lawsuit, filed on July 22, 2015 in the US District Court for the District of Massachusetts, was registered under case number 1:15-cv-13002-FDS. The court documents have been made publicly available on Zofran.Monheit.com, a website sponsored by Monheit Law.

Recent Zofran lawsuits have claimed a causal link between the nausea drug and a range of different birth defects; kidney and limb abnormalities have all been blamed on prenatal Zofran exposure, in addition to at least one instance of an abdominal defect. But according to Michael Monheit, Esquire, managing partner at Monheit Law, the “vast majority” of Zofran-related claims, like this latest Massachusetts complaint, seek compensation for congenital heart defects.

“That’s the state of the science right now,” Monheit says, noting two major epidemiological studies that have found a statistically significant association between the drug and cardiac septal defects, a subcategory of heart abnormalities.

One of these papers, reviewing over 900,000 Danish birth records, found that babies exposed to Zofran during the first trimester were anywhere between 2 and 4 times more likely to be born with a form of cardiac septal defect. The other, a Swedish study that looked to more than 1 million records, found exposed infants 2.05 times more likely to have cardiac septal defects.

Monheit also notes an early study, conducted at Harvard in 2012, that found a more than doubled risk for cleft palate. He says at least three Zofran lawsuits have claimed the drug caused that defect, which often requires multiple procedures to repair. On his website, Monheit has provided an overview of the current research cited in Zofran lawsuits.

In the recent Massachusetts complaint, a mother says she was prescribed Zofran “early in her first trimester” to reduce the symptoms of morning sickness. The drug has become an increasingly common treatment for this indication, despite being approved only to treat the severe nausea and vomiting experienced by cancer and surgical patients. M.M., her daughter, was born in 2008. According to the parent’s complaint, their daughter’s appearance, a blue tint to the skin and lips linked to inadequate oxygen distribution, raised immediate alarms in the delivery room. “Hours later” the child was diagnosed via echocardiogram with Transposition of the Greater Vessels (TGV) and Pulmonary Stenosis.

In children born with TGV, the heart’s two major arteries are reversed. Connected to the wrong chambers, the defect creates a “loop”: blood flows out to the lungs for oxygen, returns to the heart, but is pumped right back to the lungs. Without treatment, the condition is universally fatal, according to the Mayo Clinic.

Plaintiffs say their daughter underwent a corrective surgery within the first five days of her life. Now seven, the child allegedly underwent a more recent procedure in an attempt to improve blood flow from her heart to her lungs. But the surgery “failed” and, according to her parents, “M.M.’s blood pressure [remains] unimproved.” Her cardiologist appointments were recently increased, from an annual to a bi-annual basis, Plaintiffs write.

Monheit says the family’s story has become an increasingly common one. With more than 30 Zofran lawsuits filed against GlaxoSmithKline, the legal community expects more to come in the approaching months. Joined by an alliance of experienced plaintiffs’ lawyers, Monheit Law continues to provide free consultations to families who believe that Zofran may have caused a child’s birth defect. For more information, call 1-877-620-8411.

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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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