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Zofran litigation raises issue of physician liability for off-label prescriptions

Readers may have heard of the medication Zofran and the current litigation going on with respect to its safety for use by pregnant women. GlaxcoSmithKline, the manufacturer of the drug, is reportedly being accused of failing to warn patients about the potentially dangerous effects of the drug during the first three months of pregnancy.

In support of their claims, plaintiffs are pointing to previous research suggesting the drug may cause musculoskeletal deformities and heart defects. The big legal issue in the cases, as already mentioned, is that Glaxo failed to provide adequate warning about the risks of Zofran with respect to possible heart and musculoskeletal issues. What we want to ask here, though, is: what liability do doctors assume in the prescription of this medication for pregnant women?

From a legal perspective, doctors cannot be held liable for injuries that occur in connection with risks of which they were unaware. Under federal law, drug manufacturers have a duty to warn patients and their physicians of all known risks of a drug. If a drug manufacturer doesn't provide a warning about potential birth defects, for instance, the doctor cannot be held accountable for prescribing the medication, as long as the prescription itself was within the accepted standard of care.

With Zofran, it is important to point out that the use of the drug for the treatment of morning sickness and hyperemesis gravidarium--or severe pregnancy-induced nausea--is off-label, meaning that it is not a use recommended by the manufacturer and is not approved by the Food and Drug Administration. To be sure, prescribing a medication for an off-label use is perfectly acceptable, but physicians do have to cover their bases when doing so.

In our next post, we'll continue this discussion, focusing particularly on what factors could contribute to medical malpractice liability in cases of off-label drug prescriptions.


Courthouse News Service, Mom Claims Anti-Nausea Drug Caused Defects," Tracy Dalzell Walsh, April 7, 2015., "Dr. Christian Pope: An update on nausea and vomiting in pregnancy," Dr. Christian Pope, April 9, 2015.

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