Zofran For Morning Sickness Linked To Birth Defects
There are so many useful medicines available to those in need. Unless the condition you're suffering from has never been heard of, there's likely to be some form of treatment for it. Whether it works as intended or not is a different story. Nowadays, it seems as though Big Pharma companies try their best to give potential consumers half-truths about their medicines in an effort to increase sales. It's obvious that something has gone wrong when the health industry is more interested in profit than the health and well-being of consumers. Many pharmaceutical companies have an allegedly poor reputation for putting consumers second, including (but not limited to):
- Johnson & Johnson/Janssen Pharmaceutical
(GSK) is the maker of Ondansetron Hydrochloride, better known by its trade name Zofran. GSK has a long history, going back to the late 1800s, and is actually a merger of 2 pharmaceutical companies that were both very successful on their own: Glaxo Wellcome and SmithKline Beecham. Zofran was developed by the Glaxo divison (before the merger) around 1984 and has only grown since then. GSK makes an estimated $35 billion per year from their countless medications and other health products and/or services. In fact, Zofran was pulling in a great amount of money ($1.3 billion in only 9 months) for the company until late 2006, when the patent for Ondansetron Hydrochloride expired and a ton of generic versions
flooded the market and were approved by the FDA. One notable company that has made a name for itself selling a generic version of Zofran is Teva Pharmaceuticals
What is Zofran used for?
Zofran was approved by the FDA in January of 1991 for two very specific uses. The first was for those undergoing chemotherapy and suffering from nausea and vomiting; the second being patients that just recently underwent surgery involving anesthesia
—also to combat the nausea and vomiting. The people taking Zofran for its FDA-approved use felt (and still do feel) significantly better. The side effects are minimal, leaving those who were once feeling nauseous and vomit-prone, now feeling relieved and comfortable. The medication was extremely successful in its prime, once ranking as the 20th
most used prescription in the United States alone. However, the Zofran industry took a turn for the worst when GSK began making some questionable marketing choices.
One overwhelmingly common aspect of pregnancy is morning sickness. Morning sickness is completely normal and is usually experienced during the first trimester of pregnancy. Coincidentally, morning sickness puts sufferers in the same position as those chemo and postoperative patients are in; bed-ridden with nausea and vomiting. Because of this convenient correlation, GSK took advantage of the potentially profitable target audience and sneakily shifted its focus towards grabbing the attention of pregnant women suffering from morning sickness. Through deceptive marketing, half-truths, and other techniques (all of which they nearly got away with), Zofran became a popular product prescribed to pregnant women by obstetricians and gynecologists alike. These expecting consumers were once happy with the results, but things changed. Now the consequences of the not only illegal, but highly unethical practices of GlaxoSmithKline are catching up to them. Here's why.
Why is Zofran bad?
Once again, keep in mind that when the FDA approved Zofran for prescribed use in 1991, it wasn't approved for morning sickness. The medication (which comes in a few forms: pill, injection, and dissolvable tablet) had never been tested on pregnant women and therefore was not approved for said use. However, GSK did make a half-hearted attempt at getting it approved for such use by providing to the FDA the results of some experiments conducted over 30 years ago on animals. These results aimed to “prove” that the medicine posed no contribution to birth defects. The studies were too bland; the results were too vague; the FDA never approved Zofran
for the purpose of combating morning sickness. Instead, Diclegis has secured its spot
as the “morning sickness drug”.
However, the mere fact that the FDA never approved Zofran for that use apparently meant nothing to GlaxoSmithKline. Instead, they kept everything under the table; the company found ways to successfully market and sell the pill to women interested in fighting off their morning sickness—and it sold in the masses specifically for this use. One way that the company pulled it off was by offering “kickbacks
” to prescribing physicians in return for pressuring patients into using Zofran for morning sickness. These kickbacks resembled bribes. GSK would pay these physicians a portion of the final sale price(s) as a “thanks” for the favor. When it comes down to the health and well-being of others, and is being headed by a monstrous pharmaceutical company, kickbacks are usually considered unmoral, unfair, and illegal.
So what's the big deal? If Zofran is seemingly working for women suffering from morning sickness, why won't the FDA finally approve it for that use? Well, pregnancy is a 40 week process
. Most women only experience morning sickness during the first trimester, or weeks 1 through 12. That means they are likely to stop taking the medication at some point well before their baby is born. When the baby finally is born about 6 months later, Zofran is probably the last thing on the mind of the parents. However, it should be the first, because more and more information is being gathered and continually proving a correlation between birth defects and Zofran use. Now, GlaxoSmithKline is being considered blatantly responsible for those birth defects with a storm of lawsuits headed their way.
What are these lawsuits regarding?
If you weren't aware, companies have a certain amount of responsibility over consumers and the safety of their product(s). If there was no duty of care, companies would rarely conduct safety tests or create cushions to fall back on in the event of a lawsuit. So when it's discovered that a company has failed to meet the minimum care expectation, harsh repercussions often linger behind their trail. In the world of personal injury, product liability law
focuses on injuries caused by faulty, defective, negligently manufactured, falsely advertised, misleading, and altogether harmful products. Zofran is recently being considered all of the above.
By this point, there's plenty of evidence to back up the allegations that a pregnant women taking Zofran to fight morning sickness increases the chance for a birth defect(s). More specifically, these birth defects have been narrowed down to a select few, and the chances of your baby obtaining one of them is said to be doubled.
Some abnormalities commonly seen in newborns whose mother took Zofran during pregnancy are:
- Congenital heart malformations – Including both atrial and ventricular septal defects, this birth defect takes the form of a “hole in the heart” and usually requires surgery to fix. Even after the surgery, however, your baby can experience difficulties later in life performing heart-strenuous activities.
- Orofacial clefts – Lip and palate clefts are physical defects in the formation of the baby's lip or roof of his/her mouth. These defects not only require surgery, but often times lead to difficulty breathing and permanent facial deformations which can lead to social uneasiness for your child in the future.
- Heart murmurs – These are usually the less damaging of the possible birth defects, but can pose a real health problem if the murmurs are anything more than mild.
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- Others – Club foot and minor skeletal deformities have also been mentioned in Zofran lawsuits.
When the benefits of Zofran are being pounded into the heads of pregnant women who are suffering from morning sickness, it can seem like an easy way out. However, when a risk like your baby having birth defects arises, is it worth taking the medication for any length of time while pregnant? The short answer is no, but for many, it's too late; perhaps you're wishing you'd known sooner. Luckily for the parents of any child born with malformations related to Zofran, most of them are treatable. However, they cost a pretty penny and can leave a family wrongfully overwhelmed with pain and suffering, lost wages, and medical expenses. If this has happened to you or your family, you have every reason to be stressed, but are you going to let GlaxoSmithKline get away with their deceitful marketing techniques and harmful practices?
If your child suffers from birth defects after taking Zofran during pregnancy, you may be eligible for significant financial compensation. Aside from the compensation for actual damages that you could receive, you may also be awarded a generous amount of punitive damages; a sort of “fee” imposed on the wrongdoer (GSK) to “punish” them financially in hopes that they'll learn their lesson. If you'd like to figure out whether or not you're eligible to recover for your physical, mental, emotional, or financial losses related to Zofran and birth defects, feel free to call Dolman Law Group Accident Injury Lawyers, PA. We have knowledgeable product liability attorneys ready to help. Contact us now for a free consultation and case evaluation through our website, or give us a call as soon as possible at (833) 606-DRUG .
Dolman Law Group Accident Injury Lawyers, PA
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This article was written and reviewed by Matthew Dolman. Matt has been a practicing civil trial, personal injury, products liability, and mass tort lawyer since 2004. He has represented over 11,000 injury victims and has served as lead counsel in over 1000 lawsuits. Matt is a lifetime member of the Million Dollar Advocates Forum and Multi-Million Dollar Advocates Forum for resolving individual cases in excess of $1 million and $2 million, respectively. He has also been selected by his colleagues as a Florida Superlawyer and as a member of Florida’s Legal Elite on multiple occasions. Further, Matt has been quoted in the media numerous times and is a sought-after speaker on a variety of legal issues and topics.