Is Zofran Manufacturer GSK Talking from Both Sides of Its Mouth?
|March 27, 2015, 08:00:00AM. By Gordon Gibb|
Pittsburgh, PA: Twenty-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.”
READ MORE ZOFRAN BIRTH DEFECT LEGAL NEWS
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.
Zofran Lawsuit Alleges GSK Failed to Disclose Zofran Dangers
Posted: Mar 06, 2015 8:06 AM GMT
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Zofran lawyers at the Onder Law Firm have expanded their website to provide information about the allegations made in a new Zofran lawsuit filed in Pennsylvania.
St. Louis, MO (PRWEB) March 06, 2015
A new Zofran lawsuit has been filed in U.S. District Court in Pennsylvania, according to attorneys handling Zofran lawsuit claims alleging birth defects.* The lawsuit alleges that the plaintiffs two children suffered congenital heart defects and other birth defects after fetal exposure to Zofran, according to court documents.
This Zofran lawsuit alleges that the defendant, pharmaceutical company GlaxoSmithKline (GSK) was aware of evidence supporting a link between Zofran use during pregnancy and the increased incidence of congenital heart defects and other birth defects, according to court documents:
Since at least 1992, GSK has had mounting evidence showing that Zofran presents an unreasonable risk of harm to babies who are exposed to the drug during pregnancy.* According to court documents, the lawsuit cites numerous pieces of evidence in support of this statement, saying GSK was aware of the following:
- Zofran readily crosses human placental barriers during pregnancy.*
- Animal studies conducted on Zofran indicate that Zofran cannot be used safely or effectively in pregnant women.*
- Since 1992, GSK has received hundreds of reports of major birth defects associated with prenatal Zofran exposure.*
According to court documents, the plaintiff alleges that GSK knowingly marketed Zofran to pregnant women, without issuing a birth defects warning, despite evidence suggesting this was not a safe application of the drug: 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, but GSK also illegally and fraudulently promoted Zofran to physicians and patients specifically for the treatment of morning sickness in pregnancy women.*
The FDA has never approved Zofran as safe for pregnant women, yet women are still being prescribed Zofran during pregnancy, believing the drug is safe, according to court documents: “Women ingested the drug because they innocently believed that Zofran was an appropriate drug for use in their circumstance. 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.”*
A few women have now stepped forward to file Zofran lawsuits. As more families learn about the allegations of birth defects from Zofran, we anticipate hearing from others interested in filing Zofran lawsuits, said Jim Onder of the Onder Law Firm.
The Onder Law Firm, nationally-renowned as a leading family safety and consumer liability law firm, provides legal representation for families seeking to file Zofran lawsuits for allegations of birth defects. Zofran attorneys representing clients nationwide offer Zofran lawsuit news and updates at their website. The firm provides no-cost, no-obligation case evaluation for mothers and families whose babies wer born with a birth defect following prenatal exposure to Zofran. Individuals who fit this description may contact a lawyer to discuss whether they have grounds for a Zofran lawsuit. The firms Zofran lawyers believe persons who meet this description may be entitled to real compensation. For more information, visit the Zofran lawsuit website.
The Onder Law Firm welcomes Zofran case inquiries from law firms in regards to handling them or working as co-counsel.
About The Onder Law Firm
Onder, Shelton, OLeary & Peterson, LLC is a St. Louis based personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. The pharmaceutical and medical device litigators at The Onder Law Firm have represented thousands of Americans in lawsuits against multinational conglomerates from products liability for manufacture of defective or dangerous products to deceptive advertising practices. Other firms throughout the nation often seek its experience and expertise on complex litigation. It is also a recognized leader in products liability cases such as window blind cord strangulation. The Onder Law Firm offers information on Zofran lawsuits at http://www.247LawsuitNews.com.
*Cheri Flynn vs. GlaxoSmithKline LLC, Case 2:15-cv-00709-PD, United States District Court of the Eastern District of Pennsylvania
For the original version on PRWeb visit: http://www.prweb.com/releases/zofran-birth-defects/zofran-lawsuit/prweb12564236.htm
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