Zofran “Off-Label” Uses
GlaxoSmithKline (GSK) developed the prescription drug Zofran to treat symptoms of nausea in cancer patients during chemotherapy or after surgery. However, Zofran has been prescribed “off-label” by some physicians to treat nausea and vomiting (commonly morning sickness) in pregnant women.
What is “Off-Label” Use?
“Off-label” prescribing occurs when a physician prescribes a drug for a use that has not been approved by the U.S. Food and Drug Administration (FDA). Some physicians have prescribed Zofran to treat morning sickness (generally severe and in the first trimester) when the FDA has only approved Zofran for nausea treatment in cancer patients, and has not approved Zofran for use by pregnant women.
Patients are often not aware that they are being prescribed a drug that is not approved for treatment of their condition, or that the drug was tested and approved for a certain set of conditions—which the patient does not meet.
GSK Plead Guilty to Zofran Off-Label Promotion
GSK pled guilty to federal health care code violations, and has settled a civil lawsuit claiming inappropriate “off-label” marketing of Zofran for use during pregnancy.
In June 2012, GSK (the maker of Zofran) paid $2 billion to resolve a federal whistleblower lawsuit. The lawsuit included claims that GSK promoted Zofran for “off-label” use during pregnancy, and paid kickbacks to doctors to prescribe Zofran for this “off-label” use.
GSK also paid $1 billion in criminal penalties after pleading guilty to federal criminal health care fraud charges, violating the Food, Drug, and Cosmetic Act for the branding of three of GSK’s drugs.
In total, GSK has paid $3 billion in penalties and lawsuit settlements.
You can find more information on the birth defects linked to Zofran use here, and complete the contact form on this page for a free case evaluation.
Hissey Kientz is currently taking cases and offering a free case evaluation if you have taken Zofran during pregnancy and your child has suffered birth defects from Zofran use. Please don’t hesitate to contact us using the contact form on this page, by calling toll-free at 1-866-275-4454, or by email at info(at)hkllp(dot)com.
File a Lawsuit
If you’ve taken Zofran during pregnancy and your child was born with birth defects including malformations of the mouth (cleft lip or palate), heart defects, skeletal issues, heart murmurs, jaundice or other similar side effects related to the developmental health of an infant, you may have grounds to file a lawsuit. For information about whether you may have a case, contact the attorneys at Hissey Kientz, LLP by filling out the contact form on this page.