Nausea is one of the worst feelings in the world; there is no easier or cleaner way to say it. When patients experiencing nausea have the chance to make it go away, they generally will jump at the chance.
Zofran has been a popular antiemetic (nausea treatment) since its approval in 1991 with sales routinely over $1 billion per year. Produced by drug manufacturer GlaxoSmithKline, it is intended to help with nausea associated with chemotherapy, radiation, and postoperative nausea associated with recovery from the use of anesthetics.
Serious complications associated with the use of the drug are now coming to light, however, as deaths and birth defects from Zofran use are being reported from around the country.
Child Deaths from Zofran
Zofran was never intended for use in children, and there are limited studies involving children under the age of four. Still, two children, one a mere 86 days old, died recently when given Zofran to treat symptoms attributed to stomach flu.
Zofran Birth Defects
Another complication associated with the use of Zofran is occurring in pregnant mothers. Evidence seems to suggest that GlaxoSmithKline may have known that women taking Zofran while pregnant could give birth to children with birth defects, yet chose to market the drug specifically to pregnant women as a way of treating morning sickness.
Zofran birth defect lawsuits are opening up in courts across the country as a result. Some of the birth defects alleged in lawsuits include muscouloskeletel defects, cleft palate, cleft lip, and heart defects, including atrial septal defects or a hole in the heart.
Zofran Illustrates Continued Issues with Off-Label Marketing
Zofran’s approved use was to treat the intense nausea that comes with some of medicine’s most serious treatments: Chemotherapy and surgery. However, many of these birth defect lawsuits come as a result of intense off-label marketing of the drug.
Off-label marketing occurs when a drug is marketed to patients for uses other than what is expressly approved by the Food and Drug Administration. Zofran is far from the first drug to be marketed in this way and many lawsuits and settlements exist as a result of off-label marketing.
Opinions on off-label marketing are not universal, however, as settlements and prosecutions, specifically for off-label marketing have resulted in billions of dollars of fines and awards, a federal judge went so far as to issue a ruling in 2012 that protected drug companies’ rights to market drugs for uses not approved by the FDA as free speech.
You Need Legal Representation
As you can see, the issue with Zofran is a complicated one and you need the assistance and expertise of a qualified attorney to take on the drug’s manufacturer. While the decision to engage in a lawsuit is never an easy one, only a plaintiff’s attorney can help you make the decision that is best for you and those you care about.
As always, attorneys at Lopez McHugh are available if you would like to discuss your options and there is, of course, no obligation on your part.