Request Legal Help Now - Free
 
Home Page >> News Articles >> Is Zofran Manufacturer GSK Talking from ..

Is Zofran Manufacturer GSK Talking from Both Sides of Its Mouth?

. By
Pittsburgh, PATwenty-three years is a long time. And yet, that’s the timespan a Zofran lawsuit alleges that Zofran manufacturer GlaxoSmithKline (GSK) has been in possession of evidence suggesting a risk of birth defects associated with the use of Zofran in pregnancy.

Various studies have offered conflicting views on Zofran, and other generic versions of ondansetron (Zofran). And there is little doubt about ondansetron’s capacity for curbing nausea - an often debilitating byproduct of pregnancy. For some women, morning sickness can be so extreme that only medication can prevent the sometimes constant vomiting, dehydration and weight loss that severe morning sickness can foster.

And yet, ondansetron was never approved by the US Food and Drug Administration (FDA) for use as a treatment for morning sickness. Zofran manufacturer GSK makes that very point, noting in a Canadian media report last June that “the safety of ondansetron for use in human pregnancy has not been established…[GSK] monitors and reports all adverse event reports…” (The Toronto Star, 6/25/14).

But is GSK talking from both sides of its mouth? That’s the way it appears, as GSK was previously accused of promoting Zofran off-label for morning sickness, or so it is alleged. The US Department of Justice asserted that GSK had not only promoted Zofran and other drugs off-label, but that the company provided kickbacks to doctors in exchange for prescribing Zofran for morning sickness. Court documents, according to The Toronto Star, alleged that GSK disseminated false and misleading information about the safety and effectiveness of Zofran.

In 2012, GSK settled with the US Department of Justice for $3 billion. As part of the settlement, GSK was not required to admit to any wrongdoing. That latter bit is a frequent feature of government settlements: the ability to escape a finding of wrongdoing in exchange for a massive payment.

One of the more recent Zofran lawsuits, filed by plaintiff Cheri Flynn in Pennsylvania, mirrors allegations contained in the US Department of Justice lawsuit: that GSK knowingly marketed Zofran to pregnant women without sharing information about the potential for Zofran birth defects - information the lawsuit alleges GSK has had in its possession since 1992, if not before.

“GSK not only concealed this knowledge from healthcare providers and consumers in the United States, and failed to warn of the risk of birth defects,” the Flynn lawsuit states, “but GSK also illegally and fraudulently promoted Zofran to physicians and patients specifically for the treatment of morning sickness in [pregnant] women.”

Drug manufacturers do not have the legal, ethical or medical authority to market a drug off-label. Ondansetron was originally approved by the FDA for treatment of nausea in cancer patients following chemotherapy. It was never indicated for pregnant women, although doctors have always had the authority to prescribe off-label should they feel it would benefit the patient. And yet, The Toronto Star last June suggested that doctors in Canada are prescribing ondansetron off-label without having all the facts.

One wonders if the same thing is happening in the US.

“Women ingested the drug because they innocently believed that Zofran was an appropriate drug for use in their circumstance,” the Flynn lawsuit contends. “When they ingested the drug, these pregnant women had no way of knowing that Zofran had never been studied in pregnant women, much less shown to be a safe and effective treatment for pregnancy-related nausea.”

The Zofran lawsuit is Cheri Flynn v. GlaxoSmithKline LLC, Case No. 2:15-cv-00709-PD, United States District Court of the Eastern District of Pennsylvania. The lawsuit alleges that Flynn’s two children suffered congenital heart defects and other birth defects following fetal exposure to Zofran.

READ ABOUT ZOFRAN BIRTH DEFECT LAWSUITS

Zofran Birth Defect Legal Help

If you or a loved one have suffered losses in this case, please click the link below and your complaint will be sent to a drugs & medical lawyer who may evaluate your Zofran Birth Defect claim at no cost or obligation.

READER COMMENTS

Posted by

on
I've been taken by ambulance to Marshall Medical Hospital in
Placerville, CA for severe kidney stone attacks three times in the past 10 years. The last time I was given Zofran in the emergency room via IV for severe nausea and had an immediate seizure/convulsion. I've never had Zofran before, or experienced a seizure, which was quite terrifying as I suddently felt extremely
freezing cold and my entire body went into jerky stiff spasms and I couldn't speak to cry out for help beause I was chocking.

This event is not related to birth defects but I wanted you to
know that it can also cause the experience I described. I felt
like I was dying.

Thank you

ADD YOUR COMMENT ON THIS STORY

Fields marked * are mandatory. Please read our comment guidelines before posting.

*Name:

Note: Your name will be published with your comment.

*Email Address:

Your email will only be used if a response is needed.
*Your Comment:

Are you the defendant or a subject matter expert on this topic with an opposing viewpoint? We'd love to hear your comments here as well, or if you'd like to contact us for an interview please submit your details here.


Click to learn more about LawyersandSettlements.com
Request Legal Help Now! - Free