Gadsden, Alabama, is known as the “City of Champions.” With a motto like that, residents and visitors alike can be confident that Gadsden is a great place to live, work, and raise a family. Gadsden’s history provides dramatic proof of its legacy. This city helped Alabama become an industrial power of the South, but that was not the last time Gadsden helped to build our state’s economy or to bring positive attention to the Heart of Dixie.
Just like anywhere else in Alabama, Gadsden residents have a reasonable expectation of care for their health and welfare due them from the local, state, and federal governments. As citizens who participate in the many systems of keeping society safe, Gadsden trusts that mandatory infrastructure regulations have been adhered to. For instance, we expect the roads and highways we take to meet code specifications. Public and private schools have minimum standards for building safety, teacher qualifications, and instruction materials. Although there are only two major hospitals in Gadsden, the expectation of the highest medical care in treatment is reasonable and correct.
The previous examples show how regulations on a state or federal level affect everyday people on the local level. Just as Gadsden plays a vital role in the state’s economy, as it has done throughout its history, the state and federal legislation affects citizens of Gadsden. This includes food and drug regulations monitored by the U.S. Food and Drug Administration (FDA). When the FDA withholds or gives its approval for prescription drugs, the entire country is affected – for good or for ill.
When prescription drug manufacturers receive FDA approval for a drug, the public should feel confident that the drugs are safe.
But what happens to the public if the drug’s effects are not fully determined at the time of FDA approval?
Such is the situation where drugs are given FDA approval for one use but then are later prescribed “off label.” This was the case with the drug cocktail Fen-Phen, where two drugs were prescribed off label to create a more powerful effect of dramatic weight loss. While the impact of combining the two was indeed powerful, the effect on many patients’ hearts devastated their health. The drug manufacturers who created both drugs were held to task in courts, despite the lack of FDA approval for the combination. Simply having the drugs available to the open market jeopardized the public’s safety.
When the population receiving the drugs is considered especially vulnerable, such as pregnant women, the drug’s impact can have an even longer-lasting effect. In any place, including Gadsden, protecting the health and viability of a newborn baby is a top concern for any family. According to the latest statistics in 2013 for Etowah County, over 10 percent of all women in the county had babies in that year. Although every family wishes for a healthy baby, not every person born in Gadsden, Alabama, is born without defect. Some of these defects are related to taking prescription drugs that may be unsafe during pregnancy, such as Zofran.
Some birth defects are, thankfully, not life threatening. A child who can continue to grow and flourish is always a blessing. Still, for children whose health is affected by any type of birth defect, the physical and emotional toll of their care can be felt for a lifetime. The family who loves that child will always be affected as well, not only in terms of care but emotionally and financially, too.
Anyone who has visited a medical professional during pregnancy knows that some prescription and over the counter drugs cause birth defects. Common examples include lithium, which treats depression, and Accutane, used to treat acne. Some drugs, however, like Zofran have not been unequivocally tied to causing birth defects.
The drug manufacturers have liability to patients for unsafe products, especially where the risk of taking the drug outweighs the benefits. For Zofran, however, the scales are still not completely tipped in one direction. Legal remedies do exist for women whose infants were born with birth defects after taking Zofran. The drug manufacturers are still liable for the safety of the drug, despite the fact that the FDA has not pulled Zofran off the market completely. Its benefit to other patients, such as those undergoing chemotherapy, is still strongly evident.
News reports about Zofran’s side effects on a fetus are mixed. Some reports suggest that taking Zofran can cause birth defects, like this widely circulated report from Canada. In it, a Canadian news outlet analyzed data from the FDA’s public database relating to drug side effects. The 2014 story focused on the Canadian women who reported their results on the database. The women reported taking Zofran and seeing babies born with side effects, including cleft-palate and “two infant deaths (plus) multiple cases of newborns with heart defects and kidney malformations.” Other possible birth defects may include:
The year prior to the Canadian news story in 2013, another news story discussed an entirely different result to using Zofran. The study, conducted in Denmark, looked at a group of 600,000 pregnant women. Researchers for the study used “nationwide health registries” to compare data on birth defects collectively, not only those resulting after taking Zofran.
Both studies reveal an underlying issue with the controversy surrounding Zofran, other prescription drugs, and even over-the-counter drugs ingested during pregnancy. Most importantly, no studies exist on the side effects of taking these drugs. The FDA and drug manufactures cannot take the risk of potentially damaging the health of the fetus or the mother during any drug trial. Nevertheless, Zofran has paid out millions in lawsuits alleging the drug causes birth defects.
If you or a loved one believe that birth defects may have resulted from taking Zofran, you may have legal rights against the drug manufacturer. Please reach out to one of our experienced attorneys for more information.