Zofran Lawsuits – Pregnancy Claims & Birth Defect Litigation

Zofran Birth Defecs

Doctors prescribe Zofran (ondansetron) to pregnant women as a treatment for nausea and vomiting during pregnancy. Unfortunately, studies link the medication to birth defects, and families are taking drugmaker GlaxoSmithKline to court, saying it marketed the drug to pregnant women without FDA approval.

Unapproved Zofran Use

The U.S. Food and Drug Administration approved Zofran to help cancer patients with nausea after treatments or after surgery. It helped people who vomited as a side effect from chemotherapy or who grew sick after taking post-op meds to help with pain or other complications.

But drugmaker GlaxoSmithKline soon found other patients to take the drug – pregnant women suffering from morning sickness. There was just one problem. The FDA never approved Zofran for use by pregnant women.

In 2012, Glaxo pleaded guilty to federal charges of fraud and illegal promotion of several drugs, including Zofran, and paid $3 billion as part of the legal settlement. Now the company is going back to court to defend more specific allegations about Zofran (ondansetron).

Why Are Former Zofran Users Filing Lawsuits?

Court documents show Glaxo knew as early as 1992 that Zofran presented “unreasonable risk of harm” to developing babies because the drug passes through the human placenta. Despite this knowledge, the drugmaker continued to market the drug to pregnant women.

    • Lawsuits assert a number of claims against Glaxo. Among them:
    • failure to ensure its drug was safe before offering it to the public and failed to determine safety risks before selling it.
    • failure to warn the public about dangerous side effects.
    • advertising the drug (Zofran) as a safe treatment for morning sickness and nauseua
    • misrepresenting results of clinical animal studies and research
    • failing to use all data and safety information on Zofran for use in pregnant women.
    • producing a defective drug and
    • claiming that Zofran was safe for pregnant women.

Zofran is not approved for use in pregnant women, and publicly-available lawsuits allege GlaxoSmithKline marketed the drug to expectant mothers and paid doctors to prescribe it. The drug brought in millions of dollars for Glaxo, and roughly 1 million women take the medication or its generic counterpart each year.

Over $500 Million
Recovered Since 1993

We've Helped Thousands of People Just Like You

We are known for getting life-changing results and fighting to make our communities safer.

Why Choose Us As Your  Attorneys?

With us on your side, you can focus on what’s most important – your recovery.

Decades Of Experience

Decades Of Experience

Our Nashville attorneys have over 75 years of combined practice handling cases involving personal injury, medical malpractice, civil rights, medical device lawsuits, wrongful death, and much more.

Excellent Reputation

Excellent Reputation

DRS Law is a well-respected law firm in Nashville and throughout the U.S. Founder, David Randolph Smith, has been selected as a Mid-South Super Lawyer, named one of the Top 100 attorneys in Tennessee in all fields of practice, and is included in the Best Lawyers in America guidebook.

Small Case Volume

Small Case Volume

Unlike many Nashville firms or lawyers that handle a large volume of cases, we concentrate our expertise on a select few cases. With this, our attorneys ensure that every step is taken to obtain the most favorable outcomes for our clients.

We Prepare For Trial

We Prepare For Trial

Every case is meticulously prepared for trial by our trial team and support staff in order to maximize the recovery for our client, whether by settlement or trial verdict. Our proven track record of success has resulted in multi-million-dollar settlements and judgments in a wide variety of individual and group cases.

What to Expect

Our Legal Services Are Completely Personalized To You And Your Unique Needs

01  Free Consultation

Our top-rated Tennessee personal injury lawyers provide free, no-pressure case evaluations. We will help you determine if you have a case and will answer all your questions in plain English. We never charge any fees until we win your case.

02  Personalized Service

If we take your case, it’s because we believe we can help you. We will get to work outlining a strategic plan of action. We want you to feel taken care of during this difficult time — whatever questions you have, we’re here with answers. Frequent check-ins ensure you are comfortable with the progress of your case.

03  You Get Paid

We are passionate about the success of your case and will give it the close attention and focus it deserves. We find solutions that other lawyers miss, discovering key facts that help you win. We call upon our gifts in storytelling to argue your case with passion and conviction so you get the compensation and justice you deserve.

What Our Clients Say

Get Started Today

Request Your Free Consultation

    The Nashville personal injury and medical malpractice law firm of David Randolph Smith & Associates serves clients throughout Tennessee in communities such as Memphis, Knoxville, Chattanooga, Clarksville, Murfreesboro, Jackson, Johnson City, Franklin, Hendersonville, Bartlett, Cleveland, Columbia, Cookeville, Gallatin, Lebanon, Brentwood, Springfield, Dickson, Davidson County, Shelby County, Knox County, Hamilton County, Rutherford County, Williamson County, Robertson County, Cheatham County, Maury County and Montgomery County. We also serve clients in Alabama, Kentucky, Indiana, Mississippi and Illinois. AL, KY, IN, MS, IL.

    If you are seeking a:
    Davidson County Medical Malpractice Lawyer
    Tennessee Personal Injury Attorney
    Tennessee Medical Malpractice Attorney
    Tennessee Wrongful Death Attorney
    Tennessee Product Liability Attorney
    Tennessee Trucking Accident Attorney
    Tennessee Auto Accident Attorney
    Tennessee Civil Rights Attorney
    Tennessee Birth Injury Attorney or
    Tennessee Fire Attorney

    We would welcome the opportunity to discuss your case confidentially and free of charge.