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GlaxoSmithKline Archives - Carey Danis & Lowe

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 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.

Paxil Birth Defects Lawsuit Update: CD&L Case Secure

By | Paxil, Pharmaceutical litigation, Uncategorized

SSRI Antidepressant Paxil Birth Defects LitigationA Paxil birth defects lawsuit was brought under review in a Missouri federal court, and has since been returned to and secured in a Missouri state court. Paxil manufacturer, GlaxoSmithKline, attempted to remove the case.

The plaintiff in the case is being represented by Carey Danis & Lowe attorneys Andrew Cross and Sarah Shoemake Doles. As the plaintiff is a resident of Delaware, like the defendant, GlaxoSmithKline sought to remove this particular case on grounds of non-diversity, meaning that both parties are residents of the same state.

Furthermore, GlaxoSmithKline submitted documents showing that the plaintiff did not fill her Paxil prescription during her pregnancy. However, in response, the plaintiff submitted documents demonstrating that, in fact, she had filled her Paxil prescription during her pregnancy.

GlaxoSmithKline then went on to assert that this particular case was filed outside of the period permitted by the statute of limitations. However, in making this assertion, the pharmaceutical company was similarly outside of the designated period during which they are allowed by the court to amend their original removal request.

Paxil Birth Defects Lawsuit

The case involves a plaintiff who consumed Paxil during her pregnancy, and later, filed a lawsuit targeted at GlaxoSmithKline for failing to properly warn patients and health care providers of the risks associated with Paxil use during pregnancy. The plaintiff also filed her lawsuit claiming that her child developed birth defects through exposure to Paxil in the womb.

Judge’s Ruling

U.S. District Judge Stephen N. Limbaugh ruled that this particular case be sent back to state court, from which it was originally removed by GlaxoSmithKline. Judge Limbaugh also denied requests submitted by GlaxoSmithKline to amend their original removal request, to provide further evidence for their statute of limitations argument, and to remove the case based on diversity.

Therefore, this particular case was remanded to the St. Louis County Circuit Court, and is secure.

Carey Danis & Lowe Represents Victims of Paxil

The defective drug lawyers at Carey Danis & Lowe represent victims of Paxil in Paxil birth defects lawsuits.

If you consumed Paxil during your pregnancy, and your child was born with birth defects, we encourage you to begin exploring your legal options and compensation eligibility today with one of our defective drug lawyers during a free initial case evaluation.

Carey Danis & Lowe is here to listen to your Paxil birth defects story. Contact our law firm by phone at 800.721.2519, or by submitting a confidential personal injury claim form.

Paxil Birth Defects Mass Tort Update, Approaching End

By | Paxil, Pharmaceutical litigation, Uncategorized

SSRI Antidepressant Paxil Birth Defects LitigationThe Paxil birth defects mass tort currently being heard in a Philadelphia court is approaching conclusion. The mass tort once comprised approximately 1,000 lawsuits, and currently includes only two, according to an article recently published by Law.com.

A majority of the lawsuits in the Paxil mass tort were settled without a trial. Even so, a substantial number of these lawsuits were either transferred from the state court in Philadelphia to a federal court, or were sent back to their state of origin.

With legal proceedings wrapping up in Philadelphia, St. Louis is now considered the focal point for Paxil birth defects lawsuits, as a sizable number of cases are currently pending there.

Carey Danis & Lowe, a law firm headquartered in St. Louis, is hoping for a swift conclusion in these cases, as the lives of so many families have been negatively impacted.

Women across the country, along with their families, have filed lawsuits against the manufacturer of Paxil, GlaxoSmithKline, alleging that use of their SSRI antidepressant during pregnancy resulted in their children developing life-altering birth defects. Paxil birth defects range from heart defects, such as a hole in the heart, to persistent pulmonary hypertension of the newborn (PPHN) to Craniosynostosis. A more comprehensive list of birth defects can be reviewed here: Paxil birth defects list.

Carey Danis & Lowe Represents Victims of Paxil

Carey Danis & Lowe specializes in defective drug litigation, and currently represents women and their families in Paxil birth defects lawsuits. If you or a loved one used Paxil during pregnancy, and your child was born with a birth defect, we encourage you to begin reviewing your legal options and compensation eligibility with one of our defective drug lawyers today.

Our lawyers are available to listen to your Paxil story. Contact Carey Danis & Lowe by phone at 800.721.2519, or complete a confidential personal injury claim form.

Wellbutrin Claims and Topamax Claims on the Rise at Carey Danis & Lowe

By | Pharmaceutical litigation, Topamax, Uncategorized, Wellbutrin

Published October 31, 2012 by PR Web

St. Louis, MO (PRWEB) October 31, 2012

Wellbutrin Claims and Topamax Claims on the Rise at Carey Danis & LowePharmaceutical product liability lawyers at Carey Danis & Lowe have announced that they are undertaking an investigation into Wellbutrin claims. Attorneys at Carey Danis & Lowe are asking that individuals and families contact the law firm if they feel their child, or the child of a loved one, was born with a congenital heart defect due to the use of Wellbutrin during pregnancy.

Wellbutrin is a drug manufactured by GlaxoSmithKline, and is used in to treat patients suffering from depression as well as seasonal affective disorder (SAD), attention deficit disorder (ADD), and attention deficit hyperactivity disorder (ADHD). The U.S. Food and Drug Administration (FDA) has classified Wellbutrin as a Pregnancy Category C drug.

Wellbutrin allegedly causes birth defects include oral defects, congenital heart defects, Craniosynostosis, Omphalocele, and Persistent Pulmonary Hypertension of the Newborn (PPHN).

In addition, lawyers at Carey, Danis and Lowe are taking cases related to the use the use of Topamax. Prescribed to patients suffering from epilepsy and migraine headaches, Topamax is a drug manufactured by Ortho-McNeil-Janssen Pharmaceuticals Inc. Allegedly, Topamax can cause congenital oral defects in unborn children. The FDA has categorization Topamax as a Pregnancy Category D drug. Potential oral birth defects caused by Topamax include the development of a cleft lip and cleft palette.

In past pharmaceutical product liability cases, attorneys at Carey Danis & Lowe have aided plaintiffs in winning cases against pharmaceutical giants like GlaxoSmithKline and Ortho-McNeil-Janssen Pharmaceuticals Inc.

If a newborn baby has suffered birth defects allegedly caused by exposure in the womb to either Wellbutrin or Topamax, contact an attorney at Carey Danis & Lowe at 800.721.2519, or submit a claims form about filing a Wellbutrin lawsuit or a Topamax lawsuit.

Antidepressant Wellbutrin Linked to Birth Defects

By | Pharmaceutical litigation, Uncategorized, Wellbutrin

Published October 23, 2012 by LawsuitInformation.org

Antidepressant Wellbutrin Linked to Birth DefectsManufactured by pharmaceutical giant GlaxoSmithKline, Wellbutrin is an antidepressant drug that has been linked to congenital birth defects. The U.S. Food and Drug Administration (FDA) approved the antidepressant medication Wellbutrin (bupropion) in order to treat depression.

Due to the increasing occurrences of life-threatening and life-altering birth defects connected with the use of Wellbutrin in pregnant mothers, the FDA has categorized Wellbutrin as a pregnancy category C drug. Unlike many antidepressants on the market that block serotonin, Wellbutrin is categorized as a norepinephrine and dopamine re-uptake inhibitor (NDRI).

Wellbutrin birth defects include, but are not limited to, the following:

  • Cleft lip
  • Cleft palate
  • Congenital cardiac defects
  • Atrial Septal Defects (ASD)
  • Ventricular Septal Defects (VSD)
  • Persistent Pulmonary Hypertension of the Newborn(PPHN)
  • Craniosynostosis
  • Omphalocele

In 2010, a Wellbutrin study was published in the American Journal of Obstetrics and Gynecology that pointed to data showing a significant link between the use of Wellbutrin by a pregnant woman, especially during the first trimester of pregnancy, and the development of congenital birth defects, in particular cardiac complications and malformations.

Termination of Wellbutrin use during pregnancy will most certainly benefit an unborn child as a result of Wellbutrin’s connection to birth defects. However, discontinued use of an antidepressant drug by a pregnant woman must be discussed with a physician in order to weigh the risks of continued use on the unborn child and terminated use on the expectant mother.

It is also important to note that following pregnancy, if a nursing mother decides to begin use of Wellbutrin, such a decision is important to discuss with a physician. It has been understood that Wellbutrin is a drug that can present itself in breast milk, and therefore, can lead to injurious health effects on a newborn.

If your newborn has suffered from birth defects correlated to exposure to Wellbutrin in the womb, submit your claim to an experienced pharmaceutical litigation lawyer at Carey Danis & Lowe. Also, contact a pharmaceutical product liability attorney at Carey Danis & Lowe at 800.721.2519 for a free legal consultation about filing a Wellbutrin lawsuit. It is important to hold GlaxoSmithKline accountable for their negligence to inform the public about Wellbutrin’s link to the development of life-threatening congenital birth defects.

Our lawyers at Carey Danis & Lowe are committed to providing you the legal support and counsel you need to win a Wellbutrin lawsuit and receive compensation for your pain, suffering, and financial losses.

Carey Danis & Lowe Tackle Paxil Birth Defect Claims

By | Paxil, Pharmaceutical litigation, Uncategorized

Published October 12, 2012 by LawsuitInformation.org

Carey Danis & Lowe Tackle Paxil Birth Defect ClaimsPlaintiff’s litigation firm Carey Danis & Lowe is currently accepting new cases regarding Paxil and its link to birth defects when taken by expectant mothers during pregnancy. Paxil lawsuits have cropped up throughout the United States in response to the life altering, and in some cases life threatening, Paxil caused birth defects in newborn babies.

Paxil is an antidepressant drug classified as a selective serotonin re-uptake inhibitor, or an SSRI. It is known generically as Paroxetine. Paxil was developed by GlaxoSmithKline, a British pharmaceutical company.

In July 2012, GlaxoSmithKline pleaded guilty to federal charges claiming, among many other wrongdoings on part of the pharmaceutical giant, that they failed to properly inform the U.S. Food and Drug Administration (FDA), physicians, and patients about data collected in Paxil’s clinical trials. In fact, it has surfaced that GlaxoSmithKline withheld important information about the drug Paxil, information which could have saved lives. GlaxoSmithKline agreed to pay $3 billion in fines to the federal government – the largest health care fraud settlement in U.S. history.

Recently, GlaxoSmithKline made an announcement about its new effort towards transparency. In the announcement made in early October, the British drug maker stated that it would make public the data collected during clinical trials, which was not the case in regards to Paxil’s clinical trials. However, for many patients who used Paxil, such an effort on the part of GlaxoSmithKline is too late.

Pharmaceutical product liability and personal injury attorneys at Carey Danis & Lowe recognize that there are still families out there whose children have suffered from Paxil related birth defects. The lawyers at Carey Danis & Lowe are currently investigating new claims against drug’s maker, GlaxoSmithKline. If your family has been a victim of Paxil birth defects, contact the experienced attorneys at Carey Danis & Lowe for more information about filing a Paxil lawsuit. Call 800-721-2519 for a free legal consultation.