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Zofran Lawsuits

Zofran (ondansetron) is an antinausea drug. It is intended for significant nausea issues caused by things like chemotherapy. However, Glaxo SmithKline also marketed it for use with pregnant women. The problem was that Glaxo SmithKline had failed to do any testing of the drug with pregnant women.  In 2006, prior to its becoming available in a generic form, Zofran was among the top selling drugs in the United States. The FDA estimated that number nearly a quarter of Zofran prescriptions were given to pregnant women.

As early as 2006, in a study published in Hong Kong, concerns were raised about the use with pregnant women. The Hong Kong study concluded that Zofran cross the placenta to the fetus. More studies were done. In 2011 a British study concluded that women who took Zofran were over twice as likely to have babies with congenital defects, including cleft palates. In August 2013 a Danish study found that children were to four times more likely to have babies born with congenital heart defects. It is clear that additional studies are needed.

Glaxo Smith Kline engaged in illegal conduct in its off label marketing of Zofran. Giving Zofran to pregnant women is considered off label use.  In July 2012 Glaxo Smith Kline entered into a settlement agreement with the United States Department of Justice to resolve claims that it illegally marketed Zofran, among other drugs. It agreed to pay a fine of $1 billion, which included a criminal fine and a forfeiture. It also agreed to pay another 2 billion to resolve claims by the government under the False Claims Act. The settlement resolves criminal issues, alleged by the federal government, that Glaxo Smith Kline had paid kickbacks to healthcare providers to get them to prescribe drugs.

Lawsuits are now being filed against Glaxo SmithKline regarding it’s conduct in marketing Zofran to doctors. The lawsuits claim that birth defects, including cleft pallet and heart malformations, are the results of Glaxo SmithKline’s failure to study the drug before marketing it to doctors for use with pregnant women. Lawsuits claim Zofran caused “hole in the heart” types of malformations, which are medically known as septal defect, and cleft palate, among other things. The suits claim that Glaxo SmithKline should have warned the public and its users that these problems could result when pregnant women took the drug, rather than marketing the drug as safe, especially for morning sickness.

It is believed by many that doctors are still not recognizing the significance of the use of Zofran in pregnant women.

Ackerman Law Office, we find these cases very interesting. If you have an injury claim, contact us.  In a Zofran suit, if we got involved, we would act as local counsel.  As local counsel we would give you the service you deserve.  We would split the fee with another firm with no additional charge to you.  You would pay the same as if you just hired one law firm.  At Ackerman Law Office, we take cases on a contingent fee. This means we do not get paid unless and until you do. We also try to limit the number of cases we take so that the people we represent are given good service.  We have an extremely high success rate with the cases we take.