In 2012, U.K.-based pharmaceutical company GlaxoSmithKline (GSK) paid $1 billion to resolve criminal charges (misbranding two products and failing to report safety data on another). The company also paid out an additional $2 billion to settle civil liabilities with the U.S. government for violations of the False Claims Act. Among these violations was the off-label promotion of Zofran, a medication originally intended to treat post-operative nausea in cancer patients undergoing chemotherapy and radiation treatments. GSK is also alleged to have paid kickbacks to physicians as an incentive to prescribe Zofran as well as other products. (Naturally, GSK was not required to admit to any wrongdoing.)
“Off-label” is a term describing the use of a medication for purposes for which it was not intended. Physicians may legally use their own discretion in making off-label prescriptions, but drug makers may not market their products of off-label uses unless they have FDA approval. In this case, the executives at GSK apparently didn't think Zofran was making enough money for them. They decided since morning sickness among pregnant women was far more common than cancer, it might be a good idea to market it for that purpose. The result: Zofran birth defects, including cleft palate and congenital heart problems.
Back to the Zofran lawsuit: it should be noted that at no time was this medication ever approved by the Food and Drug Administration (FDA) for off-label use as required by federal law. Allegedly, GSK never even bothered doing any studies or clinical trials for this purpose.
Now that GSK has settled its case with the federal government, it's facing increasing numbers of lawsuits from women who attribute their children's health problems to having taken Zofran for their morning sickness during the initial weeks of their pregnancies. According to allegations, GSK not only failed to conduct clinical trials (fearing the results would affect the company's profit margin), but in fact knew that the product was able to cross the placental barrier and affect the fetus. This knowledge is based on animal studies as well as over 200 reports of fetal deaths and birth defects among women who took Zofran during pregnancy.
Over the past year and a half, studies from Denmark, Sweden and Australia that examined thousands of patient using Zofran and they showed an increased risk to fetuses for a range of birth defects when exposed to Zofran during the first trimester of pregnancy. The Danish group discovered that infants whose mothers that taken the drug were nearly five times more likely to suffer from atrioventricular septal defects. This is a condition in which there are perforations between the chambers of the heart, forcing the heart muscle to work harder to supply blood to the rest of the body. The Australian researchers discovered that kidney malformations were seven times greater in infants exposed to Zofran.
Nonetheless, GSK said nothing to patients nor their physicians.
The question remains: did GSK know, or should it have known, about these risks? That's what plaintiffs' attorneys in the most recent lawsuits filed across the nation will attempt to prove.
Given the track record of Big Pharma and its long, tragic history of putting profits over (natural) people, one shouldn't bet on the defendant.