Zofran Birth Defects Lawsuits: Profit Maximization, Not Health

By | Pharmaceutical litigation, Uncategorized, Zofran

Zofran birth defects lawsuitsProfit maximization—that was the driving force of a pharmaceutical company’s marketing campaign. Not patient health maximization. The primary concern of GlaxoSmithKline (GSK) in one of their sales campaigns rested in money, not healing.

Zofran (ondansetron)

GSK developed Zofran to treat nausea and vomiting in chemotherapy patients. The US Food and Drug Administration (FDA) approved the drug for these purposes. And with approval in hand, GSK moved forward with their marketing efforts.

Making physicians think of money, not health

The pharmaceutical company ran a sales campaign with the tagline “Profit Maximization—It’s in the Bag”, according to Courthouse News in an article from November 2015.

The tagline’s target audience—doctors. With such a tagline, GSK sought to direct physician focus to finances, not health.

Marketing to make Zofran look good

GSK promoted Zofran to the medical community and to consumers as safe for pregnant mothers. This way, doctors could feel good about writing off-label prescriptions for mothers-to-be, while also taking advantage of kickbacks from GSK.

GSK’s marketing efforts made Zofran appear safe and effective for morning sickness, even though the FDA never approved Zofran to treat this pregnancy symptom.

Having constructed a positive, strong reputation for Zofran, GSK could conceal what they knew about Zofran birth defects.

The Brown family’s Zofran birth defect lawsuit

In a Zofran birth defect lawsuit filed on October 29, 2015, the plaintiff alleged that Zofran caused her child to be born with congenital band syndrome and teratological clubfoot.

Congenital band syndrome can cut off circulation, hinder development, and result in amputation.

Teratological clubfoot, a condition where a child is born with feet pointing inward, can be caused by exposure to “toxic substances” in the womb, according to Courthouse News, who cited the National Center for Biotechnology Information.

Zofran lawsuits consolidated

A judicial panel consolidated Zofran lawsuits in a federal court in Boston in October 2015. In early March 2016, there were almost 250 lawsuits pending in that court.

The multidistrict litigation is In re: Zofran (Ondansetron) Products Liability Litigation MDL No. 2657 in the US District Court for the District of Massachusetts.

You aren’t alone

You aren’t alone in your experience with Zofran birth defects. And, you can hold GlaxoSmithKline accountable for their misleading practices.

We can help you

Carey Danis & Lowe currently represents families whose lives have been turned upside down by Zofran. We understand the pain and suffering caused by this drug, and that’s why we want to help you. We offer free, no obligation case evaluations.

Call one of our Zofran lawyers today at 800.721.2519.

You can also reach us online. Please complete a confidential personal injury claim form.

We look forward to offering you any help that we can.

You may also be interested in reading:

Feeling the Heat: At COP 21 & in GSK Zofran Lawsuits

By | Pharmaceutical litigation, Uncategorized, Zofran

zofran-birth-defectsThings are heating up this week. World leaders are talking about climate change in Paris. And on the pharmaceutical litigation front, GlaxoSmithKline is feeling the heat from hundreds of Zofran birth defect lawsuits.

The Daily Beast took on Zofran birth defects in a November 2015 article. They focused on Deana Brown, a mother who took Zofran, a drug manufactured by GlaxoSmithKline (GSK), during her pregnancy. Now, Brown is the plaintiff in a lawsuit targeting GSK over her child’s Zofran birth defects.

Brown’s child was born with “amniotic band constriction and a teratologic clubfoot deformity”.

Illegal off-label advertising

Zofran isn’t FDA-approved to treat morning sickness. However, doctors write off-label prescriptions for pregnant women.

Doctors can recommend the off-label use of a drug, but the drug’s manufacturer isn’t allowed to promote that drug for any use other than those with FDA approval. Still, GSK launched a marketing campaign to promote Zofran as safe for pregnant mothers.

This move resulted in civil and criminal charges.

As a result of their illegal promotion, GSK paid $3 billion to settle charges brought by the US Department of Justice.

More studies needed

In August 2015, the American College of Obstetricians and Gynecologists (ACOG) released new information on morning sickness treatments. According to The Daily Beast, the organization noted that more research is needed to determine the safety of Zofran use during pregnancy.

GSK calls Zofran lawsuits groundless

The Daily Beast reached out to GSK for comment. They responded, and stated that the Zofran lawsuits are “unfounded”.

GSK’s decision-making

The Daily Beast also reached out to Brown’s legal representative, who said that GSK could’ve conducted Zofran clinical trials, but they “just chose not to”.

Do you have a Zofran lawsuit?

Was your child born with Zofran birth defects?

We encourage you to explore your legal options and compensation eligibility. Our law firm offers free case consultations. Share your Zofran story with one of our Zofran lawyers today.

Call Carey Danis & Lowe toll free at 1-800-721-2519. You can also reach us online by completing a confidential personal injury form.

You may be interested in reading:

  1. Zofran Multidistrict Litigation (MDL) Formed in Massachusetts
  2. Zofran Birth Defect Lawsuit Filed in Ohio
  3. Zofran Birth Defect Lawsuits: Carey Danis & Lowe Investigating Cases

Meet our St. Louis class action attorneys.

  1. John Carey — Partner
  2. Joseph Danis — Partner
  3. Jeffrey Lowe — Partner
  4. Andrew Cross — Attorney

Zofran Multidistrict Litigation (MDL) Formed in Massachusetts

By | Pharmaceutical litigation, Uncategorized, Zofran

zofran-birth-defectsThe Judicial Panel on Multidistrict Litigation (JPML) ordered to consolidate Zofran birth defect lawsuits in Massachusetts.

Why did the JPML consolidate Zofran cases?

An increasing number of families across the US are coming forward, seeking to hold Zofran’s manufacturer, GlaxoSmithKline (GSK), accountable.

And accounting for the current number of pending Zofran lawsuits, in addition to estimates of future lawsuits, the move to consolidate is wise.

What is an MDL?

Think of a multidistrict litigation like this.

Say you ask 10 small grocers across the US for 10 red apples. And the small grocers hop to it, and each of them meets your request.

In doing so, they’re duplicating the same action, over and over again.

This duplicative process is what MDLs seek to avoid. When similar lawsuits are consolidated, there’s no replicating the same legal process over and over; put another way, grocers don’t have to pick out those 10 red apples over and over again.

Another benefit of MDLs is they avoid the confusion of conflicting rulings that can happen when cases are tried separately in courts all over the US.

Zofran MDL

On October 13, 2015, the JPML consolidated Zofran lawsuits into MDL No. 2657 before Judge Dennis F. Saylor IV.

GlaxoSmithKline has been here before

In 2012, GSK pled guilty to criminal charges brought by the US Department of Justice (DOJ). The charges alleged that GSK “promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women”.

GSK and the DOJ agreed to a civil settlement in excess of $1 billion.

GSK also pled guilty to “promoting…Zofran for off-label, non-covered use and paying kickbacks to physicians”.

Do you want to hold GSK accountable?

If so, we can help you.

The team of experienced Zofran lawyers at Carey Danis & Lowe are available to discuss your case with you during a free case evaluation.

We can walk you through your legal options and compensation eligibility.

Call Carey Danis & Lowe today at 800.721.219. You can also reach us by completing a confidential personal injury claim form.

Zofran Birth Defect Lawsuit Filed in Ohio

By | Pharmaceutical litigation, Uncategorized, Zofran

zofran-birth-defectsA mother suffered severe nausea during her pregnancy. She listened to her doctor’s recommendation to take Zofran, an anti-nausea drug that doctors sometimes prescribe off-label to treat morning sickness.

The mother took Zofran during her pregnancy, and she delivered a child with birth defects.

The suffering and emotional strain resulting from the child’s birth defects led the mother to file a Zofran birth defect lawsuit targeting the drug’s manufacturer, GlaxoSmithKline (GSK).

The family filed the lawsuit in July 2015 in the US District Court for the Northern District of Ohio, Eastern Division.

The child suffered from a cleft lip, cleft palate, speech impediments, and ear problems. As a result of these birth defects, the child underwent 8 reparative surgeries. According to the child’s doctors, they expect to perform future surgical operations.

This is no way for a child to grow up.

GSK must be held accountable for pushing Zofran on physicians and pregnant mothers.

According to this lawsuit’s court filing, GSK didn’t conduct studies on Zofran use during pregnancy. Instead, the pharmaceutical giant went straight to promoting the drug as safe for pregnancy. The court document states that “GSK’s conduct was tantamount to using expectant mothers and their unborn children as human guinea pigs.”

In pushing the off-label prescription of Zofran for morning sickness, GSK thought only of sales, and not at all of consumer safety.

We are here for you.

The Zofran lawyers at Carey Danis & Lowe can help you and your family. If you used Zofran during your pregnancy, and your child developed birth defects in the womb, we encourage you to explore your legal options today.

Our Zofran lawyers are currently investigating birth defect cases, and are offering free case evaluations. We can help you decide if filing a lawsuit is the right decision for you and your family.

Contact Carey Danis & Lowe today.

You can reach us by phone at 800.721.2519, or by completing a confidential personal injury claim form.

Zofran Litigation: Drug Caused Cleft Palate say Mississippi Parents

By | Pharmaceutical litigation, Uncategorized, Zofran

zofran-birth-defectsNew lawsuits allege that the anti-nausea drug, Zofran is to blame for cleft palate in infants whose mothers took the drug at the beginning of pregnancies.

One Mississippi family claims that exposure to Zofran during the first trimester caused their daughter’s soft cleft palate. The lawsuits, filed against drug behemoth GlaxoSmithKline, were issued in the US District Court for the Southern District of Mississippi on July 17, 2015. It’s believed that they are the first parents to file in the Mississippi Federal Court.

In January 2015, the Mississippi mother gave birth to a child diagnosed with soft cleft palate. With this disability, the roof of the mouth is split, which affects feeding, speech, breathing and language development. There’s no history of birth defects in this family and a previous child was born healthy and without congenital problems.

Are there links between Zofran and Cleft Palate?

While the drug is prescribed as an “off label” treatment for morning sickness, its efficacy hasn’t been proven and recent research has found a link between the drug and birth defects.

A paper published by researchers at Harvard and Boston University, discovered a 2.37 times increase in the chance for cleft palate after prenatal exposure to Zofran.

While 34 families have filed Zofran lawsuits in Federal Court, that number hardly compares to the amount of women who have been exposed to the pharmaceutical during pregnancy. Zofran use has soared to over 1 million prescriptions every year.

Carey Danis & Lowe can help with Zofran Birth Defect Lawsuits

If you or someone you love used Zofran during the first trimester of pregnancy, and a child was born with birth defects, then you or your loved one may be eligible to receive compensation.

Contact Carey Danis & Lowe for a free legal consultation. One of our Zofran lawyers will walk you through your litigation options, and whether filing a Zofran birth defect lawsuit is the right path for you.

Call Carey Danis & Lowe at 800.721.2519, or complete a confidential personal injury claim form.

Zofran Birth Defect Lawsuits: Carey Danis & Lowe Investigating Cases

By | Pharmaceutical litigation, Uncategorized, Zofran

zofranCarey Danis & Lowe is currently investigating Zofran birth defect cases, and is assisting families with filing Zofran birth defect lawsuits.

Zofran is an anti-nausea drug manufactured by GlaxoSmithKline, and was originally intended to prevent nausea and vomiting in patients undergoing chemotherapy.

Ondansetron, the active ingredient in Zofran, has been linked to birth defects in children.

Swedish Study

A Swedish study, published in Reproductive Toxicology in December 2014, found that children exposed to Zofran in the womb had double the risk of developing a heart defect. The researchers also discovered that the most common heart defect was a hole in the heart, also known as an atrial or ventricular septal defect.

BioMed Study

Another study published in 2013 by BioMed Research International found a 20% increased risk of children developing major birth defects if exposed to Zofran in the first trimester of pregnancy. Still, the researchers noted that they could not make a firm determination on the safety of Zofran for pregnant women based on their results.

LeClair Zofran Birth Defect Lawsuit

Tomisha LeClair filed a Zofran birth defect lawsuit after her child was born with an atrial septal defect, among many other birth defects that included facial dysmorphia and hearing loss.

LeClair claimed that her child’s birth defects resulted from exposure to Zofran in the womb.

Many women like LeClair, along with their families, have filed lawsuits against GlaxoSmithKline. These lawsuits assert that the pharmaceutical giant marketed Zofran to pregnant women, and made the anti-nausea drug appear to be safe to use.

However, as these women discovered, Zofran is not safe for pregnant mothers and their unborn children.

You are not alone. You don’t have to suffer in silence.

The team of experienced Zofran lawyers at Carey Danis & Lowe work to recover losses for people like you. Contact our law firm for a free case evaluation. One of our Zofran lawyers can guide you through your legal options, and whether filing a Zofran birth defect lawsuit is right for you.

You can reach our law firm by phone at 800.721.2519, or by completing a confidential personal injury claim form.