Zofran Lawsuit Plaintiffs Outline Manufacturer’s “Off-Label” Marketing Tactics

November 26, 2015 – – ZofranLegal.com reports on common allegations in lawsuits against GlaxoSmithKline regarding their anti-nausea drug, Zofran. The allegations state that pharmaceutical giant GSK knowingly marketed the drug to a consumer group for which it had not been FDA approved or safety tested: expectant mothers. This “off-label” marketing has been cited by plaintiffs as an attempt by the company, allegedly, to maximize profits.

Zofran was approved by the United States Food and Drug Administration to treat patients dealing with nausea and vomiting after undergoing chemotherapy, radiation, or anesthesia. After this approval, however, GSK allegedly marketed the drug to OB/Gyns and pregnant women as a treatment for morning sickness. The drug has since been prescribed to an estimated 1 million mothers across the U.S. annually.

This “off-label” marketing and prescribing has come into question due to many lawsuits which now allege that exposure to the drug by babies growing in utero can cause an increased risk that birth defects will develop. Many families who used Zofran while pregnant have now filed suit, after giving birth to infants with a variety of defects. Birth defects commonly alleged are cleft lip and palate, atrial septal defect and ventricular septal defect, transposition of the greater vessels, tetralogy of fallot, clubfoot, and kidney defects.

This is not the first time that GSK’s marketing practices have come under scrutiny. In 2012, they agreed to settle civil and criminal fraud charges from the United States Department of Justice by paying a $3 billion fine for promoting multiple drugs in “a manner that is false and misleading.” These drugs included Zofran.

In an October 29th, 2015 lawsuit against GlaxoSmithKline, one plaintiff noted that the company continued to market Zofran to expectant mothers despite a 1999 warning from the FDA which requested that they “immediately cease distribution” of marketing materials that promote Zofran in false or misleading ways.

Women who are prescribed the drug “off-label” to combat morning sickness are often unaware that the drug has never been approved for them by the FDA. To make matters worse, most women use the drug during their first trimester, which is when most morning sickness occurs, and also when a fetus does much of its heart, mouth, and limb development.

It is expected that lawsuits against Zofran and GlaxoSmithKline will continue to be filed until Zofran is no longer prescribed to pregnant women. The attorneys at Monheit Law are working to help anyone who has taken Zofran while pregnant and has subsequently given birth to an infant with defects to explore their legal rights concerning the matter. The mothers, families, and children affected may be entitled to substantial compensation. Monheit Law provides free consultations for anyone involved.

To request additional information on this topic, or to ask questions, please contact Michael Monheit, Esq. by calling 877-620-8411.

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Contact ZofranLegal.com:

Michael Monheit
1-877-620-8411
michael@monheit.com
1368 Barrowdale Road, Rydal, PA 19046

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