GlaxoSmithKline – Citizens Report https://citizensreport.org a digital channel commited to health & medical rights. Wed, 17 Jan 2024 09:06:12 +0000 en-US hourly 1 https://wordpress.org/?v=4.9.24 https://citizensreport.org/wp-content/uploads/2016/12/cropped-cr-icon-1-32x32.png GlaxoSmithKline – Citizens Report https://citizensreport.org 32 32 Young Woman Files Against Zofran For Her Own Birth Defects https://citizensreport.org/2016/10/30/young-woman-zofran-birth-defect-lawsuit/ https://citizensreport.org/2016/10/30/young-woman-zofran-birth-defect-lawsuit/#respond Mon, 31 Oct 2016 02:03:12 +0000 http://www.citizensreport.org/?p=10801 An increasing number of women have filed lawsuits against GlaxoSmithKline, the pharmaceutical manufacturer of the anti-nausea drug Zofran. The majority of suits are filed by mothers who used Zofran while pregnant and gave birth to children with defects. In this case, a 20-year-old woman from Texas is suing the company for her own birth defects. The […]

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An increasing number of women have filed lawsuits against GlaxoSmithKline, the pharmaceutical manufacturer of the anti-nausea drug Zofran. The majority of suits are filed by mothers who used Zofran while pregnant and gave birth to children with defects.

In this case, a 20-year-old woman from Texas is suing the company for her own birth defects. The age of the plaintiff shows that Zofran has been prescribed to pregnant women for over two decades.

Using Zofran To Treat A Mother’s Morning Sickness

The plaintiff’s mother took Zofran to treat her severe morning sickness.
Image: The Pregnancy Zone

While pregnant, the woman’s mother dealt with a condition known as hyperemesis gravidarum. It’s a serious form of morning sickness characterized by excessive vomiting and intense nausea. During the first trimester, doctors prescribed Zofran to treat the debilitating symptoms.

Today, the 20-year-old woman suffers from congenital heart defects. She was born with a ventricular septal heart defect and pulmonary stenosis. She also has facial defects, such as cleft lip and cleft palate.

In the complaint, the woman argues that she has no genetic predisposition to cardiac or facial defects. She believes that Zofran exposure caused her defects and forever altered the quality of her life.

Filing A Suit For Compensation

The plaintiff was born with facial defects that require costly medical procedures.
Image: I Am Pregnant

On Nov. 30, 2015, the woman filed a lawsuit with the Northern District of California court system. She’s suing for negligence, fraud, misrepresentation and warranty breach.

The lawsuit alleges that GlaxoSmithKline discovered that Zofran might increase the risk of birth defects in 1992. But according to the complaint, the company didn’t take action and inform doctors of the risk.

GlaxoSmithKline engaged in off-label marketing of the anti-nausea drug, which the FDA approved for cancer patients only. The pharmaceutical company never did clinical studies before pushing the drug but reportedly knew that pre-natal Zofran exposure could injure unborn children.

Throughout her life, the 20-year-old woman had at least three surgeries. Doctors predict that she will need to undergo additional medical procedures for the remainder of her life. She’s suffered from permanent disfigurement, diminished quality of life, low self-esteem and physical and mental pain.

The woman seeks $75, 000 in compensation that would help to cover her medical bills. The award would also reimburse her for the purchase price of Zofran, and general, consequential and punitive damages.

If you or a family member was born with birth defects, then you might be entitled to compensation for this medical side effect.

Complete a free, no-obligation case evaluation now to see if you qualify.

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Mother Seeks Justice For Son’s Heart And Lung Problems Caused By Zofran https://citizensreport.org/2016/01/07/mother-launches-prayers-for-finn-and-takes-on-zofran/ https://citizensreport.org/2016/01/07/mother-launches-prayers-for-finn-and-takes-on-zofran/#respond Thu, 07 Jan 2016 20:01:21 +0000 http://www.citizensreport.org/?p=10149 Health professionals estimate 90 percent of pregnant women experience symptoms of nausea or vomiting. Kelly Blumenthal was no different. During the early stages of her pregnancy, Blumenthal began using a generic version of the off-label morning sickness drug Zofran in 2014. On January 2, 2015, her son was born with multiple heart defects, a lung defect and […]

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Family Sues Zofran Manufacturer in Birth Defects Lawsuit

A Virginia woman named Kelly Blumenthal has filed a lawsuit against Zofran, the morning sickness drug that allegedly caused her son’s severe heart defects.

Health professionals estimate 90 percent of pregnant women experience symptoms of nausea or vomiting. Kelly Blumenthal was no different.

During the early stages of her pregnancy, Blumenthal began using a generic version of the off-label morning sickness drug Zofran in 2014.

On January 2, 2015, her son was born with multiple heart defects, a lung defect and an intestinal issue. In addition to developing a program to support others dealing with similar circumstances, Blumenthal has filed a suit to fight against the drug that changed her family forever.

A Son’s Birth Defects, A Mother’s Broken Heart

Blumenthal’s son suffers from atrioventricular canal defect, which caused holes to develop in the center of his heart.
Image: Hx Benefit

Although doctors believed he wouldn’t make it through the pregnancy, Blumenthal’s son pushed through. However, she knew his life wouldn’t be easy. Originally planning to name him Landon, Blumenthal decided to change his name to Finley, meaning “warrior.”

Blumenthal’s son came into the world with a list of congenital problems, but the most severe is called atrioventricular canal defect. The diagnosis means that Finn has a hole in the center of his heart.

The condition affects the natural regulation blood flow and requires costly open heart surgeries. If untreated, the condition can cause serious complications including enlargement of the heart, heart failure, pulmonary hypertension, and pneumonia. Finn had open heart surgery before his first birthday.

Additionally, Finn has a double outlet right ventricle defect. The condition involves a difference in the structure of the heart, causing the two main arteries to connect to only the right chamber rather than both pumping chambers.

Blumenthal’s 1-year-old boy also suffers from  heterotaxy of the lungs, which is a misalignment of these essential organs in the chest. Finn’s lung has been deteriorating, and his mother needs to constantly monitor his blood oxygen levels. The heterotaxy is likely also linked to Finn’s malrotation of the intestines, in which his small bowel is found on the right side of the abdomen.

Supporting Others And Fighting The Industry

In addition to pursuing legal assistance to get compensation for Finn’s medical expenses, Blumenthal created a support group for families with sick children.
Image: Fredericksburg

There is no doubt that Blumenthal’s heart was broken when she discovered her son suffered from so many medical problems.  Finn’s short life has been filled with expensive surgeries, endless tubes, heavy oxygen tanks and long nights in the hospital.

Through a Facebook page called Prayers for Finn, Blumenthal has created a community of over 26,000 members that offers mutual support and comforting donations to families with sick children. It has been instrumental in helping her get through the surgeries.

On September 28, 2015, Blumenthal took another action. She decided to fight against the drug that allegedly caused her son’s medical issues. She named Glenmark Generics Inc., USA and GlaxoSmithKline LLC in her complaint, taking on both companies that may have had a hand in causing her son’s condition.

But Blumenthal is not alone. Hundreds of lawsuits have been filed against the manufacturer of Zofran, with about 200 cases consolidated in a multi-district litigation in Boston.

If you took Zofran while pregnant and if your child was born with birth defects, then you might be entitled to compensation. Complete a free, no obligation case evaluation now to see if you qualify.

 

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Anti-Nausea Drug Zofran Linked To Birth Defects https://citizensreport.org/2015/08/20/zofran-nausea-birth-defects/ https://citizensreport.org/2015/08/20/zofran-nausea-birth-defects/#respond Thu, 20 Aug 2015 16:00:25 +0000 http://www.citizensreport.org/?p=6730 Zofran has been approved for the most severe cases of nausea, but GlaxoSmithKline has promoted it as a treatment for morning sickness to increase its popularity and profits. The misuse has reportedly caused birth defects in newborns, which led many mothers to file lawsuits against the drug manufacturer. Multiple studies question the safety of Zofran […]

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GlaxoSmithKline's Cancer Drug Zofran Linked To Congenital Disorder

Zofran, also known by its generic form ondansetron, is meant to be used for cancer-related nausea.

Zofran has been approved for the most severe cases of nausea, but GlaxoSmithKline has promoted it as a treatment for morning sickness to increase its popularity and profits.

The misuse has reportedly caused birth defects in newborns, which led many mothers to file lawsuits against the drug manufacturer.

Multiple studies question the safety of Zofran when used by pregnant women. Cleft lips, cleft palates, club feet, craniosynostosis and congenital heart and lung problems are a few of the birth defects that may have stemmed from the use of Zofran while pregnant.

What is Zofran?

Zofran comes in many forms, but the disintegrating oral tablet is the most popular.
Via: Top Class Actions

Manufactured by GlaxoSmithKline, Zofran was approved by the FDA in 1991 to treat cancer patients suffering from nausea. The drug is an 5-HT3 receptor antagonist that acts on serotonin receptors to block negative symptoms. It’s also known by its generic form ondansetron.

Zofran is prescribed for nausea and vomiting caused by cancer medication or surgery, such as chemotherapy or radiation. It has not been designated for any other causes of nausea, including morning sickness. However, the manufacturer GlaxoSmithKline unlawfully encouraged doctors to prescribe it for other uses.

Side Effects of Zofran

 

A few of the side effects of zofran are blurred vision, tiredness and impaired thinking.
Via: Ketogenic Diet Resource

Side effects of zofran include, but are not limited to:

  • blurred vision or temporary vision loss
  • impaired thinking
  • irregular heart rate
  • jaundice
  • difficulty breathing
  • anxiety or agitation
  • shivering
  • unusual urination patterns
  • diarrhea or constipation
  • drowsiness or tiredness

The drug is known for bad reactions with certain medications such as apomorphine (Apokyn). In addition, it should not be taken if the patient has a history of phenylketonuria, liver disease or the heart condition long QT syndrome.

The drug’s active ingredient is ondansetron, which many patients may be allergic to. In addition, researchers believe that Zofran may harm a nursing baby through a woman’s breast milk. It should not be used when breast-feeding.

Research Shows Pregnancy Risk

Many women have taken zofran throughout their pregnancy, which has caused birth defects such as Cleft lips, cleft palates, club feet, craniosynostosis and congenital heart and lung problems.
Via: Top Class Actions

Doctors have been prescribing Zofran to treat morning sickness since 1992, only a year after it was approved for use in cancer patients. The pharmaceutical manufacturer GlaxoSmithKline engaged in unlawful off-label promotion of the drug despite the fact that conflicting scientific studies question the safety of Zofran for other uses.

In December 2014, Dr. Gideon Koren published a study in the American Journal of Obstetrics and Gynecology on the dangers of using Zofran while pregnant. The study included 900,000 Danish women and found that the use of Zofran led to a 30 percent increased risk of major congenital malformations. The popularity of the drug, which is due to the manufacturer’s  advertising techniques, becomes a frightening truth.

“The use of ondansetron for nausea and vomiting in pregnancy has increased from 50,000 monthly prescriptions in 2008 to 110,000 at the end of 2013, despite unresolved issues regarding fetal safety and Food and Drug Administration warnings about serious dysrhythmias,” according to the study.

Dr. Koren encourages the use of doxylamine and pyridoxine to treat nausea, vomiting and other pregnancy-related symptoms.

Lawsuits Filed For Off-Label Promotion 

The pharmaceutical giant has settled a lawsuit with the FDA in addition to various civil suits. However, many are still pending.
Via: Express

In Louisiana, Alexis Alexander had started taking Zofran during her first trimester. She continued to use it for the remainder of her pregnancy. Her son was born in 2006 with congenital heart and lung defects. Alexander is just one of the many mothers who filed a lawsuit against the drug’s manufacturer.

In 2012, the company pleaded to criminal charges for off-label promotion of Zofran in a settlement with the FDA. GlaxoSmithKline paid $3 billion to resolve charges of unlawful promotion and failure to report safety data in the largest health care fraud settlement in U.S history. The company has also paid about $1 billion to settle civil lawsuits, but many are still pending.

As more research confirms that Zofran has a dangerous effect on unborn children, mothers are continuing to come forward to file lawsuits against pharmaceutical company GlaxoSmithKline.

Click here for an evaluation to see if you may be eligible for compensation.

 

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