Mothers who were prescribed Zofran, a common “off label” treatment for the symptoms of morning sickness in pregnancy, are now suing the anti-nausea drug’s manufacturer, GlaxoSmithKline.
They say that prenatal exposure to Zofran caused their unborn children to develop major birth defects. In their lawsuits, these families seek damages for medical expenses and pain and suffering, as well as punitive damages in many cases.
Settlements In Zofran Birth Defect Lawsuits
Some estimates place the annual number of “off label” prescriptions written for the drug to pregnant women at more than 1 million.
Thus far, at least seven families have brought individual legal claims against GlaxoSmithKline. But medical experts have noted that prenatal exposure to Zofran has been wide-spread, and the legal community expects many other families to file their own claims for compensation. In fact, any mother who was prescribed Zofran during the first trimester, and then delivered a child with birth defects, may be eligible to file a lawsuit.
Once a number of cases reach trial and verdicts are rendered, many of these lawsuits may result in a settlement. These initial lawsuits are referred to as bellwether trials. They are the “test” cases that get tried first in a mass tort litigation, and their results may lead to serious settlement discussions.
How Legal Settlements Work
After the results of the initial trials, large pharmaceutical companies may decide to enter into settlement agreements, rather than progress to trial proceedings on each and every case, in an effort to minimize court and defense expenses and to limit their exposure to large verdicts. Settlements may offer large defendants the possibility of reducing further scrutiny as well.
In a settlement agreement, plaintiff and defendant come together and negotiate a suitable amount of compensation that both find acceptable. Settlements can be reached either before a trial has commenced, or during its proceedings.
The likelihood of Zofran settlements will only occur after some of the current lawsuits reach trial, and plaintiffs receive a jury verdict in their favor.
As we’ve mentioned, the current Zofran litigation has begun as a series of individually-filed personal injury lawsuits. But if the number of lawsuits grows quickly, it’s possible that many will be consolidated into mass tort claims.
In Federal Court, mass torts are brought as what is known as “Multi-District Litigation,” or MDL. By this mechanism, multiple individual complaints are brought together, but only for the “discovery” phase of pre-trial proceedings. Discovery allows both sides in a legal dispute to obtain evidence from one another. After the facts common to all the claims consolidated in an MDL are gathered, each lawsuit will then proceed individually.
Unlike a “class action,” MDL allows individual plaintiffs to control the result of their lawsuit, including important decisions like whether to proceed to trial or accept a settlement offer.
In Multiple Lawsuits, Plaintiffs Allege Zofran Causes Major Birth Defects
Currently-filed complaints have leveled serious allegations against GlaxoSmithKline, currently the world’s seventh most profitable drug company. Citing a body of epidemiological research that has linked Zofran to increased risks of major birth defects, parents claim that GlaxoSmithKline concealed mounting evidence of the drug’s potential to harm developing babies from doctors, patients and the general public.
Zofran is FDA approved to treat severe nausea and vomiting in:
- cancer patients undergoing chemo- and radiotherapies
- patients undergoing surgical anesthesia
And while the drug is not approved for use in pregnant women, and GlaxoSmithKline has never studied its effects on unborn children, doctors have been prescribing it “off label” to treat morning sickness for more than two decades.
Plaintiffs in a wave of Zofran birth defect lawsuits have alleged that GlaxoSmithKline actually promoted Zofran directly to physicians as a “safe and effective” treatment for the condition, which the majority of pregnant women experience beginning early in pregnancy. In 2012, the federal government charged the company for doing just that. Under federal law, drug manufacturers are not allowed to promote their products for off label use.
Learn More About Zofran Birth Defect Lawsuit Settlements
It is possible that parents and birth defect survivors who bring a lawsuit against GlaxoSmithKline will be eligible to resolve their claim through a settlement in the future.
Monheit Law has joined with a national coalition of plaintiffs’ attorneys to investigate Zofran birth defect claims. You can reach our experienced lawyers for a free consultation by calling 1-877-620-8411 or filling out our contact form. We are available 24 / 7 to answer your questions.