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Michael Monheit
Michael Monheit
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In New Zofran Lawsuits, Two Women From Ohio Say Drug Caused Heart Defects


On July 20, 2015, two more women publicly accused pharmaceutical giant GlaxoSmithKline of marketing a dangerous drug to pregnant women.

Filing lawsuits in the US District Court for the Northern District of Ohio, Eastern Division, both Plaintiffs say an anti-nausea drug called Zofran can cause birth defects.

Years After Heart Defects Found, Two Ohio Mothers File Zofran Lawsuits

In their claims, filed under the consecutive case numbers 1:15-cv-01435 and 1:15-cv-01436, the mothers tell a story of wanton corporate malfeasance. Their allegations are shared by at least 34 other Plaintiffs who have filed Zofran lawsuits across the country.

In court documents obtained by attorneys at Pennsylvania’s Monheit Law, and made public at Zofran.Monheit.com, the parents say GlaxoSmithKline promoted Zofran, a drug never even studied during pregnancy, as a safe and effective morning sickness treatment.

By 2008, Zofran had overtaken its other “off label” competitors as the nation’s leading morning sickness pharmaceutical, according to statistics analyzed by Boston University researchers.

But Plaintiffs say their children were exposed to Zofran’s alleged risks long before that, in 1994 and 1998.  Even at this time, reports of birth defects with suspected ties to prenatal Zofran exposure were being hidden from regulatory officials, the women claim.

With Zofran Linked To Heart Defects, Two More Mothers Come Forward

Both residents of South Euclid, a suburb of Cleveland, Plaintiffs say they were prescribed the drug early in the first trimester of pregnancies beginning in the mid- to late-1990s. Zofran was approved, as a remedy for the nausea and vomiting often experienced after chemotherapy, in 1991.

One mother gave birth on January 20, 1995, and the other on July 3, 1999. Both children, named A.T. and A.F. in court documents, would not be diagnosed with heart birth defects for several years.

Daughter Born With Heart Defect, Mother Only Learns 4 Years After Birth

Four years after her birth, A.F.’s pediatrician would note a “heart murmur,” the characteristic sound of blood flowing improperly through the heart, and refer the family to a cardiologist.

After “multiple appointments,” Plaintiff writes, her daughter was diagnosed with a ventricular septal defect, or VSD. This so-called “hole in the heart” lay between the two lower chambers of A.F.’s heart, forcing the organ to strain ever harder in hopes of delivering oxygen and vital nutrients to other organs and tissues.

But A.F.’s cardiologist determined a non-surgical approach to treatment was appropriate, the mother relates in her lawsuit. “Frequent visits with doctors” followed, as the family waited for A.F.’s VSD to close of its own accord, a possibility for smaller hole in the heart defects.

To date, Plaintiff writes, “A.F. [birth defect] has not resolved.” The mother claims she had a second child, born without birth defects. The child was not exposed to Zofran during the critical periods of organ formation in early pregnancy, Plaintiff says.

The other mother’s daughter, A.T., was also born with a “cardiac septal” or “hole in the heart” defect, but her story is very different.

Surgeons Repair Child’s “Hole In The Heart,” But Fail To Solve Lung Issues

Following her birth in 1995, A.T. was confined to the hospital’s NICU, or neonatal intensive care unit, for nine days. What Plaintiff refers to as “lung-related issues, including pneumonia” had raised alarms, but the child was eventually released into her mother’s care. A.T.’s alleged lung issues, however, failed to improve.

A confirmed diagnosis, Plaintiff claims, would only come two years later: a severe heart defect, a “large atrial septal defect,” had irreparably damaged A.T.’s lungs. Open heart surgery, which included the use of a cardiac bypass machine, would come next, along with attempts to repair the vessels branching through the child’s lungs.

Plaintiff says the hole between A.T.’s heart chambers has now “completely mended.” But her breathing difficulties continue.

GlaxoSmithKline Promoted Zofran Unlawfully, Hid Risks From Public, Plaintiffs Claim

In their complaints, Plaintiffs note a 2012 lawsuit in which the US Federal Government charged GlaxoSmithKline for unlawfully marketing Zofran. Between at least 2002 and 2004, GSK had promoted the drug to obstetricians and gynecologists as a safe morning sickness treatment, in violation of federal law, the government claimed.

Pharmaceutical manufacturers are not allowed to promote their drugs for unapproved uses.

GlaxoSmithKline continues to deny these charges. But in the eventual settlement agreement, totaling $3 billion, federal prosecutors stood behind their claims.

Plaintiffs also contend that, over the course of Zofran’s development and marketing, GSK has concealed numerous warning signs of the drug’s potential to cause major birth defects. They reference a number of birth defect reports, which they say GSK failed to submit to the FDA, and hidden pre-approval study results.

The information, the mothers claim, threatened the company’s dominance as America’s primary provider of “off label” morning sickness treatments.

Studies Note Increase In Heart Defects After Zofran Exposure

Several major research studies are also referenced. Two, conducted recently by Swedish and Danish groups, have found an association between Zofran and an increased risk for congenital heart defects.

Both studies found increased risks specifically for “hole in the heart defects,” like those with which A.F. and A.T. were born.

For more information on the scientific link between Zofran and birth defects, click here.

As Zofran Lawsuits Mount, Other Families May Be Able To Pursue Compensation

At least 34 parents have filed claims against GlaxoSmithKline, saying the company’s anti-nausea drug caused their children’s birth defects. If their claims are true, many other families may be entitled to file lawsuits of their own.

Already experienced in complex pharmaceutical litigation, the attorneys at Monheit Law have joined forces with a number of distinguished plaintiffs’ lawyers to pursue justice for families.

For a free consultation, call 1-877-620-8411.

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