Drugmaker GlaxoSmithKline has been making the pharmaceutical product Zofran to help cancer patients with nausea. Most times the prescription drug would be taken by patients after cancer treatment or surgery. It helped people who had extreme nausea from the side effects of chemotherapy or who became sick or ill after taking post-op medication to help with pain or other surgical complications.
The drug Zofran for cancer patients was approved by the U.S. Food and Drug Administration but was not approved for pregnant women who suffered from morning sickness.
However, as Zofran was widely used for cancer patients to control nausea, the pharmaceutical maker Glaxo as early as 1992 offered the same drug to be used by pregnant women who were having morning sickness. The problem that Glaxo has encountered is that the FDA has never approved the taking of Zofran for pregnant women.
In fact, in 2012, Glaxo pleaded guilty to federal charges of fraud and illegal promotion of Zofran and ended up paying $3 billion to the government as part of a settlement.
Today there are multiple lawsuits filed against GlaxoSmithKline for the injuries and deaths caused by taking Zofran by pregnant women. Even though Glaxo knew as early as 1992 that there was “an unreasonable risk of harm” to developing fetuses because the drug passes through the human placenta, the company continued to market Zofran to pregnant women and to physicians prescribing the medicine.
Along with the many lawsuits filed against Glaxo for damages, many of them have asserted that Glaxo had a duty to make certain that Zofran was safe for pregnant women before offering it to the public. The company has alleged to have chosen not to determine the risks of health to an unborn child and to the mother before marketing it for sale. It has also been alleged that Glaxo failed to warn the public about all of the dangerous side effects that have been caused by the pharmaceutical when taken by pregnant women.
In addition, it has been alleged that Glaxo marketed Zofran to pregnant women as well as having paid physicians to prescribe the drug. As many as a million women were taking the medication or its generic counterpart on an annual basis.
Some of the birth defects mentioned in the many lawsuits filed against Glaxo include heart defects, cleft palate, club foot, skull deformities and cleft lip. The heart defects which are extremely serious and include septal defects which is when the heart of a fetus has not developed completely and holes develop in the heart valve.
In one case filed in Massachusetts, which was determined to be the first birth defect lawsuit, filed in February 2015, a child was born with several birth defects which included low set ears, hearing loss, webbed toes, sensitivity to light and a hernia. The child has had 10 surgeries to try to correct these many abnormalities that are alleged to have been caused by the mother’s taking of Zofran during her pregnancy. That lawsuit also claims that Glaxo concealed the side effects to patients and doctors about taking Zofran by a pregnant woman. The lawsuit claims compensatory as well as punitive damages.
As early as September 2011, the FDA issued a Drug Safety Communication which laid out some of the increased risks that had been associated with the taking of Zofran. In that communication, the FDA stated that the 32 mg dose may “increase the risk of developing abnormal changes in the electrical activity of the heart, which can result in potential fatal abnormal heart rhythm.”
Following that announcement, Glaxo conducted an FDA ordered study of the side effects to unborn babies of mothers taking Zofran. Six months later, the FDA issued another Drug Safety Communication about the use of Zofran. In that communication, the FDA warned that there were instances of electrocardiogram changes, abnormal and potential fatal heart rhythms in some patients and elevated in patients with congenital long QT syndrome, congestive heart failure, and other heart-related dangerous side effects.
That FDA warning cautioned doctors not to use the 32 mg dose.
At last, the FDA issued another Drug Safety Communication that announced the Zofran recall. The recall stated that in patients who experience shortness of breath, dizziness, faintness or irregular heartbeat while using Zofran, they should stop taking the medication and consult a physician immediately.
In the meantime, the numbers of injured children who were born to mothers who had been taking Zofran to control extreme nausea is growing at a precipitous rate. The dangers of the drug are enormous.
The lawyers at Kreisman Law Offices will assist you in obtaining just compensation for medical bills, lost time from work, pain and suffering, permanent birth defects and other compensatory damages if you, a child, a loved one or someone you know were injured or harmed by using the medicine Zofran.
If you or someone you know has been injured as a result of taking the pharmaceutical product, Zofran, please call us for an immediate free consultation. Robert Kreisman of Kreisman Law Offices has been handling pharmaceutical defect cases for more than 40 years.
With our years of experience in trying and settling pharmaceutical defect cases around the country, Kreisman Law Offices provides the best possible services to our clients. Our service is unmatched. Please call us 24 hours a day at 312.346.0045 or toll free 800.583.8002 for a free and immediate consultation, or complete a contact form online.