Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others. We specialize in Personal Injury trial litigation and focus our energy and efforts on those we represent.

Articles Tagged with Zofran Birth Defects

Several lawsuits filed against the makers of Zofran, GalxoSmithKline, suggest that Zofran may cause birth defects.

In 1991 the Food & Drug Administration (FDA) approved the use of Zofran to treat extreme nausea arising from radiation therapy, chemotherapy, and for some post operative procedures. However, FDA never approved Zofran as a safe drug for pregnant women to use.

Nonetheless, Zofran manufacturers almost immediately began marketing the drug as a “safe” solution to nausea, vomiting, and morning sickness during pregnancy.

A Kansas woman, Samantha Brosseau, filed a personal injury and product liability lawsuit against GlaxoSmithKline (GSK), the manufacturer of the blockbuster drug Zofran. Brosseau took the drug to treat pregnancy-associated morning sickness.

Allegations: Zofran Caused Hole in the Heart

According to Brosseau, Zofran caused her daughter to be born with an atrial septal defect or a hole in the heart. Atrial septal defect can be a serious life threatening heart condition, which can only be corrected by invasive cardiology procedures or in severe cases, open heart surgery.

Brosseau alleges that GSK failed to warn pregnant mothers about the congenital heart defect risks with Zofran. Brosseau claims that her daughter, K.C., was born with hole in the heart from intra-uterine exposure to Zofran during the first trimester of pregnancy.

What is Zofran?

Zofran is a drug developed by GSK, and approved by the FDA in 1991, only for the treatment of nausea and vomiting in cancer patients after chemotherapy, and radiation therapy. GSK through aggressive marketing aimed at pregnant women and their doctors, has made Zofran the single most popular drug for the treatment of morning sickness.

Pharmaceutical companies are not allowed to promote or market drugs to patients beyond their approved use by the FDA. This is known as “off-label” marketing.

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Recently, earlier in October after hearing arguments, the U.S. Judicial Panel on Multidistrict Litigation (JPML) has consolidated and centralized all federal Zofran lawsuits before U.S. District Judge Dennis Saylor, in the District of Massachusetts, for coordinated discovery and pretrial proceedings.

What is Zofran?

Zofran (ondansetron) is a drug approved for treatment of nausea and vomiting associated with chemotherapy and surgery. Zofran is manufactured by pharma powerhouse, GlaxoSmithKline.

But it has been prescribed increasingly “off-label” to treat morning sickness and hyperemesis gravidarum among pregnant women. In other words, prescribed by doctors for other uses, other than those medical indications approved by the FDA.

Many Zofran birth defect lawsuits, share similar allegations that the popular anti-nausea medication was illegally marketed for use among pregnant women, even though the manufacturers failed to notify the FDA that it was safe or effective for pregnant women and fetuses.

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