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Zofran Complications, Birth Defects & Litigation

Zofran Lawyers Provide an Introduction to Compliations and Birth Defect Lawsuits

The Zofran injury attorneys at the Drug Law Center are currently looking to accept new cases with those who have experienced serious complications after they were prescribed the medicaZofrantion as an off-label treatment for morning sickness. This medication was developed for the primary purpose of helping patients suffering from nausea following operative procedures or chemotherapy and radiation treatments and was never approved by the FDA for the treatment of morning sickness or deemed safe for pregnant mothers. As a result, countless children have been born with deformities attributed to the adverse effects of this drug on the fetus during development.

Zofran’s Storied History

 GlaxoSmithKline developed Zofran for the treatment of severe nausea and vomiting and received FDA approval for the medication in 1991. For its original intended purpose, it was an effective medication that was often prescribed for patients suffering from adverse effects of anesthesia medications, chemotherapy and radiation treatment and other causes of nausea. Doctors are allowed to prescribe medications off-label if they believe that those medications will have a positive effect and this is where the Zofran scandal had its roots.

In order to bolster sales, GlaxoSmithKline saw an opportunity in marketing the medication to children and pregnant mothers who were suffering from severe morning sickness. The company decided to offer doctors incentive for doing so since the FDA never provided approval for this specific use. To this day, about one million women are prescribed Zofran as an off-label treatment of severe morning sickness.

The campaign was an incredible success and the drug maker reported over $100 million in sales of the drug every single year. The patent on the medication expired in 2006 and since then Novartis has developed a generic through its subsidiary, Sandoz. Novartis purchased the rights to market the original Zofran in 2015, even though disturbing reports have surfaced linking the medication to serious and gruesome birth defects.

Families caring for children impacted by birth defects and medical complications arising from the use of Zofran are now filing lawsuits with the allegation that GlaxoSmithKline’s own research linked the medication to the possibility of birth defects and that the incentives offered to doctors for writing off-label prescriptions were a way to circumvent gaining FDA approval. It is suggested that the very reason GlaxoSmithKline used this strategy was because it was apparent that such approval would never come based on clinical trials and research.

Complications Linked to Zofran Use During Pregnancy

 Zofran carries a Pregnancy Risk Category B label, which assumes that there isn’t any risk to people taking the medication, but women assuming this means the medication was safe were severely misled. In order to receive approval to market a medication, a manufacturer must first provide enough evidence to prove that it is safe. In the case of pregnant women, GlaxoSmithKline never proved that their children would not be affected by the medication.

There are numerous birth defects and chronic medical conditions that have since been linked to Zofran along with evidence that GlaxoSmithKline was fully aware of these side effects and chose to push the medication on pregnant mothers anyway. Here are some of the effects and conditions that Zofran may cause to unborn children.

  • Physical deformities such as cleft lip, cleft palate, club foot, webbed toes and missing or deformed limbs and digits.
  • Deformity of the brain. In some cases, the brain is severely malformed and the child may suffer from diminished cognitive function for his or her entire life. Other cases result in the premature death of the child soon after birth or during his or her early childhood.
  • Deformed organs, such as the lungs, stomach, kidneys or liver. In some cases, children have needed emergency surgery to repair a hole in the heart or lungs or to repair a deformed liver. These children are often placed on medication for their entire lives to treat the resulting conditions.
  • Hearing or vision loss. Zofran may impact the development of the eyes and ears. In the worst cases, children may be born deaf or blind.

When GlaxoSmithKline was performing clinical trials in the 1980s, prior to the approval of Zofran, researchers reported that the medication showed signs of being toxic to unborn children. Data suggested an increased risk of miscarriage, premature birth, fetal death and incomplete growth of the bones. Animal studies showed that the medication could cross the barrier of the placenta and be passed on through breast milk. Many of the affected animals were born with heart defects or brain damage.

Yet, despite this knowledge, GlaxoSmithKline found a way to market the medication without FDA approval. After gaining approval for unrelated uses, the company offered enticing incentives to doctors who would prescribe the medication to their pregnant patients. Many of these doctors were not informed of the risks their patients would be facing.

Zofran Lawsuits Filed on Behalf of Children With Birth Defects

 There is a mass tort forming against GlaxoSmithKline for marketing a medication it knew would harm unborn children and the Zofran injury attorneys at the Drug Law Center are committed to the pursuit of justice on behalf of the innocent victims of greed and callous disregard for their wellbeing. If your child has been injured or died due to a birth defect caused by the use of Zofran in your first trimester, you may be entitled to compensation.

Contact us today to arrange a free consultation with one of our award winning Zofran injury lawyers so that we can discuss your rights and legal options. If we are unable to secure compensation on your behalf, our services will be completely free of charge.

Despite numerous lawsuits and criminal charges against the developer of Zofran, the infamous nausea medication is still being marketed to pregnant women who suffer from severe morning sickness. GlaxoSmithKline has already received civil and criminal judgements after it deliberately circumvented the required FDA approval to market the medication to pregnant women, but since the patent expired on the medication, Novartis has picked up the torch, and the rights to sell the medication. The Zofran injury attorneys at the Drug Law Center are helping anyone who has a claim against the makers of Zofran and its generics due to the development of birth defects or the loss of their child.

A Medication Marketed Despite Lack of FDA Approval

 The FDA only provided approval to the makers of Zofran to market it for the treatment of nausea following chemotherapy and radiation or after surgical procedures which left patients queasy for long periods of time during their recoveries. Despite knowing that the medicine would harm unborn children and would never receive approval to be marketed to pregnant women, GlaxoSmithKline offered cash incentives to doctors to prescribe it off-label as a morning sickness treatment.

In 2012, GlaxoSmithKline settled with the United States government in what is now considered the largest case of pharmaceutical fraud in our history. The charges the company pled guilty to included fraud and illegal promotion of multiple medications, which included the promotion of Zofran to pregnant mothers. After paying $3 billion in damages, GlaxoSmithKline gave up the rights to its medication to Novartis in 2015 and the cycle is beginning to repeat.

Now that Novartis is marketing Zofran and several generic versions, the drug maker could be pulled into the current legal action that is still being filed against GlaxoSmithKline.

Status of Current Lawsuits Pending Against GSK

 There are currently hundreds of lawsuits being brought against GlaxoSmithKline as of 2015. This litigation is growing rapidly as more mothers begin to learn of the impacts the medication has on unborn fetuses and ask whether their own children were victims. One of the earlier lawsuits was heard in February of 2015 and involved Tomisha LeClair and her daughter.

LeClair was told that Zofran would be safe to take for severe morning sickness and took the drug because she was unable to work or tend to simple tasks due to constant nausea and vomiting. Her daughter was born with multiple heart defects, webbed toes, damage to the ears, facial dysmorphia, vision problems and an inguinal hernia. Over the first twelve years of her daughter’s life, she has needed ten surgeries.

Tomisha has stated that she would have immediately sought an alternative if she knew that there was even the slightest risk that the medication could harm her child and is hoping for punitive damages to set an example on behalf of other mothers who have needed to endure watching their children struggle with multiple deformities.

Another case heard in July of 2015 was filed by Brian and Angela Kutzer. Their son had deformed genitals and a missing kidney at the time of birth. They are seeking damages on the grounds that their son will never be able to reproduce and may not even be able to enjoy sexual function or intimacy at all during the course of his life. In their scathing statement, they alleged that GlaxoSmithKline made completely false representations concerning how safe and effective Zofran was and acted in a criminal manner to circumvent the FDA’s drug approval process.

GlaxoSmithKline Criminal Charges Don’t Bode Well for Civil Cases

 The unprecedented criminal settlement GlaxoSmithKline agreed to followed criminal charges alleging that the drug company marketed Zofran illegally while misbranding two other medications. The practice of encouraging doctors to write off-label prescriptions was used for other drugs as well and GlaxoSmithKline was forced to plead guilty to three different criminal violations. $2 billion of the $3 billion settlement was used to settle civil cases throughout a number of states while the rest was paid to the United States as a penalty for fraud.

This judgement could easily be used to establish precedent in the cases to come and could help the plaintiffs’ cases. Since Novartis entered the market as the new standard bearer for the medication, it too may be pulled into the lawsuits.

Allow Out Zofran Birth Defect Attorneys to Fight on Your Behalf

 The Zofran injury lawyers at the Drug Law Center are working diligently to represent the interests of anyone whose child has suffered needlessly due to the greed and carelessness of GlaxoSmithKline. IF your child was born with birth defects or died due to complications linked to the use of Zofran during pregnancy, we would like to invite you to share your story so that we can determine what recourse you can take.

Contact us today to be connected with one of our award winning Zofran injury attorneys during a free case review so that we can discuss your legal options and strategy. If we are unable to secure damages on your behalf, you will owe us nothing for our time and resources.

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