1. What exactly is Zofran?
Zofran (generic name “Ondanestron”) is approved to treat nausea and vomiting in patients following chemotherapy and surgery. However, it was prescribed off-label to treat pregnant women for morning sickness. It works by blocking serotonin’s function, which can cause vomiting and nausea.
2. Why were pregnant women prescribed Zofran?
Zofran was first approved to treat nausea & vomiting after chemotherapy. When chemotherapy is administered, it can release serotonin into the stomach, intestines or brain. During pregnancy, the serotonin levels in women also rise, which can cause the nausea & vomiting associated with morning sickness. As the medication had been successful with cancer patients, doctors started prescribing it off label to pregnant women.
3. How long has Zofran been around?
Zofran was originally approved in January 1991 for postoperative nausea and vomiting in adults with cancer. GSK lost its patent in 2006 and generic Ondanestron became available. Novartis, through a subsidiary, Sandoz Pharmaceuticals, began releasing a generic Ondanestron of their own.
4. How common is the use of Zofran?
Zofran is one of the most commonly prescribed medications by GlaxoSmithKline (GSK). It has been estimated that almost 1 million pregnant women are prescribed Zofran each year for morning sickness.
5. What types of birth defects in children have been associated with Zofran usage?
Heart defects, primarily septal defects (holes in the heart) and cleft palate.
6. Has the FDA issued any warnings concerning the use of Zofran during pregnancy?
In March 1999, the FDA issued a warning letter to GSK regarding its marketing of anti-nausea medication Zofran, saying that it failed to warn consumers about potential adverse side effects. In September 2011, the FDA released a warning that Ondanestron may increase the risk for abnormal changes in the electrical activity of the heart. After which, GSK revised its label to include a risk to patients with specific cardiac (Q-T) issues. In June 2012, the FDA issued a warning that the 32mg dose may affect the electrical activity of the heart and that no dosage should be over 16mg. In December 2012, the FDA recalled all brand and generic versions of Zofran in the 32mg dose.
7. When did the problems with Zofran first become known? (or how soon did people start filing lawsuits)
In the fall of 2015, the U.S. Judicial Panel on MultiDistrict Litigation (JPML) centralized all Zofran lawsuits into MDL 2657 before Judge Dennis Saylor in the District of Massachusetts. There are currently about 200 lawsuits pending in this federal MDL over birth defects caused by Zofran. These MDL proceedings remain in the early stages, with discovery into common issues that pertain to all claims currently underway. By the end of 2016, it is anticipated that there will be about 1,000 cases pending in the federal MDL.
Filed lawsuits indicate that studies as early as 2006 show an increase in potential pregnancy risks with Zofran. Multiple studies have shown a two-fold increase in the risk of cardiac defects and almost a 30% risk of major malformations, including a study in Denmark in 2013 reported in the New England Journal of Medicine, as well as 2014 studies by Sweden and the CDC in the U.S. A 2012 study by Birth Defects Research showed a doubling of risk for cleft palate. However, there were other studies that did not indicate the same risk that these studies showed, so there is some conflicting scientific data.
8. What has been the response from Zofran manufacturers?
In June 2012, GlaxoSmithKline pleaded guilty to illegally promoting the off-label use of Zofran to prevent morning sickness (among other charges), and paid a $3 billion fine. However, they are fighting these growing lawsuits. In December 2015, GSK requested that all Zofran lawsuits in the MDL be dismissed because there is sufficient evidence in the public record to establish that the FDA wouldn’t have allowed the creation of a warning label that the plaintiffs claim would have informed the public of the certain risks of the drug. The plaintiffs filed an appeal earlier this month. There was a status conference on January 14th but the determination has yet to be announced.
9. What are the primary allegations in Zofran lawsuits?
No version of Zofran has ever been approved for pregnant women, so we are alleging off-label usage, as well as heart defects and cleft palates in newborn babies, both of which require extensive and usually multiple surgeries to correct. Most of the affected children will require lifelong medical care as a result of their injuries, including multiple surgical interventions.
10. Has there been a recall of Zofran from the market?
In December 2012, the FDA stated that the brand & generic versions of Zofran were being recalled in the 32mg dose after the June 2012 FDA warning that no dose should exceed 16mg. However, in lower dosages, it remains on the market.
11. Who can make a Zofran claim or file a Zofran lawsuit?
Any women who took Zofran for morning sickness during their first trimester of pregnancy and the resultant child developed a heart defect or cleft palate.
12. How will I know if I have a case?
You may not know yet. If your doctor has informed you that he/she feels your child’s defects were caused by Zofran, please contact us immediately. Our law firm will review records to determine causation and that responsibility is not placed on you.
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13. Do I still have a lawsuit if I took the generic version of Zofran and my child was born with a birth defect?
In most cases, yes. However, we would need to review the specifics of the case to determine its viability.
14. I used Zofran several years ago. Is there still time to bring a lawsuit?
The statute of limitations is different for each claim; based mainly on state of residence, state where you saw your doctor or received the medication (if different) and when the injury occurred. Therefore, we urge you to contact us immediately so we can ensure to bring your claim in a timely fashion. We would need to review the specifics of the case to determine its viability.
15. How soon should I consult a Zofran lawyer if I want to pursue a lawsuit?
The statute of limitations is different for each claim, so, we urge you to contact us immediately so we can ensure to bring your claim in a timely fashion.
16. Is there a statute of limitations on Zofran lawsuits?
The statute of limitations is different for each claim based mainly on state of residence; state where you saw your doctor or received the medication (if different) and when the injury occurred.
17. Does it cost anything for you to review my case?
No, there is no cost to review your case. Our firm strictly works on a contingency basis. That means that the firm only gets paid if you receive an award/settlement and would be paid out of that award. The law firm would front any of the litigation costs and fees.
18. We’re not the type of people who sue; do we really need to file a lawsuit?
No, there is no formal claims office for Zofran. The manufacturers are not admitting liability as of now and we will have to sue them for defective pharmaceuticals. An attorney is needed to file a lawsuit and prove causation between Zofran and any injuries your child may have incurred.
19. Are these class action cases?
No, these are not class action cases, they are multi-district litigation (MDL) claims. Class-action lawsuits form when individuals harmed by a drug or device combine cases into a single lawsuit. Multidistrict litigation cases occur when a panel transfers individual cases to a single court, but the cases are not combined into a single lawsuit. With a MDL court, you get many of the benefits of the class action (saving time, money) but you still retain the rights of an individual lawsuit.
20. What is the difference between filing a Zofran class action or individual claim?
Generally, with a class action, it is an all or nothing situation. All claimants either win or lose. In addition, most of the time the claimants will receive the same monetary award. In an individual lawsuit, the claimant will get to argue the merits of their specific injuries and obtain an award tailored to the details of their case.
21. Who will be sued? My doctor or the manufacturer?
This is strictly a product liability and NOT a medical malpractice claim, so we will not be suing any of the medical providers who provided/prescribed the medication or were involved with resultant injuries. We will solely be going after the manufacturers of this medication – GlaxoSmithKline (GSK), Novartis and Sandoz, as well as any of the generic manufacturers.
22. I am ready to move forward with my Zofran case. What is the process?
You will need to hire a product liability law firm to represent you in this matter. As this is federal litigation, you do not need a law firm in the same state as which you live. Time is of the essence, so you will need to contact them to sign the necessary paperwork. They will need the information regarding your medication, as well as any associated complications or procedures you may have had. If you have any of your medical records, it will expedite the process. However, the law firm can order any necessary records on your behalf.
23. What damages are available for myself and my child in a Zofran birth defect lawsuit?
There have not been any bellwether trials as of yet in this litigation, so we cannot give any estimation of valuation for these cases. In addition, each claim will be different based upon the patient, the severity of their injuries and the state in which they live.
24. Is this going to be a big fight against the company?
Yes, this will be a big fight against GSK – they are fighting liability and there is an issue with the generic medication based upon a previous US Supreme Court case. In addition, conflicting medical studies complicate the issue further. However, it will take up a great amount of time on the law firm’s part, but not of yours. In general, most of what is required of you for the litigation claim is filling out some paperwork and telephone conferences. We will walk you through the process and advise what is needed of you.
25. How long will a Zofran lawsuit take?
The timeline for this type of litigation varies greatly. Some cases can resolve in a year, while others can last for over ten years. In general, these cases usually take about two to three years to resolve. However, as there are issues with the generics for these claims, it is highly possible that these cases will take longer to resolve.
26. I don’t live in your state. Can I still retain your law firm?
As this is federal litigation, you do not need a law firm in the same state as which you live. In addition, should we need local counsel for any aspect of your claim, we will take care of retaining one as a partner.
27. Tell me what sets your firm apart in handling my claim?
The Fenstersheib Law Group, P.A. fit all the necessary requirements for the type of law firm that you want handling your claim. In addition, we are particular about the types of litigation that we handle and only take on cases that we believe have a strong foundation. We do not treat our clients like they are just a number and limit the amount of clients that we take so we can retain a personal one-on-one relationship. We value our clients and aim to always make sure to walk them through the process and hold their hands every step of the way. In addition, we have had years of experience with federal MDL mass tort litigation, with a number of large, successful verdicts.
Get your questions answered - call us for your FREE consultation at 800-835-5762 & 954-456-2488