Established in 2004, Minnesota’s Birth Defects Monitoring & Analysis Program (BDMAP) is one of America’s newest state-funded programs tasked with investigating the prevalence and potential causes of congenital anomalies. One of only 14 state birth defect programs to receive federal funding from the Centers for Disease Control & Prevention, BDMAP’s mission is to understand the impact of birth defects on Minnesota families, and establish critical connections between these families and the local services they need.
In 2005, BDMAP began tracking the incidence of 45 separate major birth defects. At that time, the program looked only at live births delivered in Hennepin and Ramsey counties, including all hospitals in Minneapolis and St. Paul. Five years later, Minnesota’s congress voted to expand birth defect tracking throughout the state, although BDMAP has not yet released a report with new information that covers this expansion.
How Common Are Birth Defects In Minnesota?
According to the Centers for Disease Control, more than 4,000 babies in Minnesota were diagnosed with major birth defects between 2006 and 2010, making the state’s total prevalence roughly equivalent to the nation’s: about one out of every 33 babies.
Of those over 4,000 babies, around one out of every three was born with more than one major birth defect.
Most Common Major Congenital Abnormalities
From 2006 to 2010, mothers in Hennepin and Ramsey counties gave birth to children with hypospadias more frequently than any other birth defect.
BDMAP calculated that 49.8 out of every 10,000 babies delivered in the two counties were diagnosed with the condition, in which a male baby’s urinary opening is not at the normal location on his penis. In male newborns nationwide, hypospadias is the second most common birth defect.
Down syndrome was the second most frequently diagnosed congenital abnormality in the five year period under investigation, affecting around 15.4 out of every 10,000 babies.
Isolated cleft palate was third most common, followed by cleft lip, with or without an associated cleft palate. Together, about 15.5 out of every 10,000 Minnesota babies were born with an orofacial cleft.
Fifth most frequent was gastroschisis, a condition in which contents of the abdomen (including organs like the stomach and liver) protrude through a hole near a baby’s belly button.
Following gastroschisis were two congenital heart defects:
- Tetralogy of Fallot, an association of four CHDs that are commonly found together, affected around 4.4 out of every 10,000 births.
- Transposition of the Great Arteries, in which the heart’s two main blood vessels, the aorta and pulmonary artery, are switched from their normal locations, was the seventh most common birth defect. 3.8 out of every 10,000 babies in Minnesota were born with TGA between 2006 and 2010.
Orofacial Clefts & Congenital Heart Defects In Minnesota
Between 2006 and 2009, a total of 96,859 babies were born in Hennepin and Ramsey counties.
- 97 were born with cleft lip (with or without cleft palate)
- 55 were born with isolated cleft palate
- 444 were born with an atrial septal defect, in which walls of the heart fail to form properly, leaving a hole between its top two chambers
- 324 were born with a ventricular septal defect, another “hole in the heart” abnormality. In this cardiac anomaly, a hole remains between the heart’s bottom chambers
You can learn more about ventricular and atrial septal defects here.
- 171 were born with patent ductus arteriosus. The ductus arteriosus is an open blood vessel that becomes unnecessary for proper cardiac function after birth. In most babies, the vessel closes on its own several days after delivery. In newborns with PDA, the patent ductus failed to close, causing abnormal blood flow.
In the closing remarks that followed one of the BDMAP’s most recent reports, researchers noted that the rates of Down syndrome, Transposition of the Great Arteries and Tetralogy of Fallot were slightly higher in Hannepin and Ramsey counties than they were nationwide.
What Causes Birth Defects?
In a 2006 report published on birth defects, Minnesota’s Environmental Public Health Tracking program wrote:
“Some birth defects are caused by genetic factors, some are caused by maternal factors such as the use of alcohol, cigarettes, illicit drugs; obesity and diabetes. Other birth defects are caused by use or exposure of some medications, infectious diseases and chemicals.”
Minnesota & Zofran Birth Defect Lawsuits
Concerns have been raised recently over the safety of anti-nausea drug Zofran, which is FDA approved for the treatment of extreme nausea and vomiting in some cancer patients, as well as some patients undergoing surgery. While the drug is not approved for this use, doctors have also been prescribing Zofran to pregnant women as a treatment for morning sickness.
In fact, Zofran has been used “off-label” to treat morning sickness for at least two decades. And while it is not illegal for physicians to prescribe drugs for unapproved uses, pharmaceutical manufacturers are prohibited from marketing their products for unapproved purposes.
Did Zofran’s Manufacturer Promote The Drug For Unapproved Use?
In 2012, the US Department of Justice charged Zofran’s manufacturer with doing precisely that.
Among multiple civil and criminal charges, the federal government alleged that the company had promoted Zofran as a “safe and effective” treatment for nausea and vomiting during pregnancy, without even conducting clinical trials to investigate the drug’s potential effects on pregnant women or their unborn babies. Such clinical trials would be required before seeking Zofran’s approval as a morning sickness treatment, something the company never even attempted.
Zofran’s manufacturer continues to deny these allegations. Even so, it eventually settled the government’s case for a total of $3 billion.
Researchers Find Possible Link Between Zofran & Major Birth Defects
Meanwhile, Zofran’s “off label” prescription has become increasingly common, and several independent research teams have set out to investigate the drug’s possible effects during early pregnancy.
Funded by the Centers for Disease Control, researchers at Harvard and Boston Universities found that babies born to women who had been prescribed Zofran’s active ingredient, ondansetron, during the first trimester were more than twice as likely to have cleft palates.
Reviewing birth records over the course of more than a decade, teams in Sweden and Denmark both found a notably increased incidence of congenital heart defects among babies exposed to ondansetron during early pregnancy. And a group in Western Australia found a 7-fold increase in kidney malformations among babies born to women prescribed ondansetron in the first trimester.
For an in-depth look at these studies that have found a possible association between Zofran and birth defects, click here.
Birth Defect Lawsuits Filed Against Zofran’s Manufacturer
During the first months of 2015, at least seven American families have brought legal claims against Zofran’s manufacturer. These parents allege that exposure to Zofran during early pregnancy caused their children to be born with congenital abnormalities.
They claim that Zofran’s producer marketed the drug to doctors as a morning sickness treatment, without ever investigating its effects during pregnancy. In fact, they say that the company has been aware of Zofran’s alleged potential to cause birth defects for decades, but did nothing to warn the public or health community.
Can Minnesota Families File Zofran Birth Defect Claims?
If these allegations prove true, any mother who was prescribed Zofran during the first trimester, and then delivered a baby with birth defects, may be able to bring a legal claim against the drug’s manufacturer.
You can find a general overview of the ongoing Zofran litigation here.
Monheit Law has been joined by a national alliance of plaintiffs’ attorneys to investigate the claims of families who believe that Zofran may have caused their child’s birth defects. We are currently offering free consultations to parents and birth defect survivors interested in learning more about their legal options.
While our attorneys are not admitted to practice in Minnesota, we are licensed in Delaware, where Zofran’s manufacturer is headquartered. As a result, our lawyers may be able to file a claim on your behalf in that state. We may also be able to refer you to local counsel in Minnesota.
Contact our attorneys today to schedule a free consultation. Call 1-877-620-8411 or fill out our contact form.