Update: December 22, 2017
California Supreme Court Exposes Drug Makers to Additional Liabilities
Summary: The California Supreme Court ruling came in a lawsuit against drug company Novartis by the children of a woman who while pregnant in 2007 was prescribed a generic version of the drug terbutaline — an asthma medication that Novartis once sold under the brand name Brethine. The drug was used to stop the mother’s premature labor, but the children claim it caused them to suffer brain injuries.
More Information on Terbutaline
Terbutaline Sulfate, sold under the brand names Brethine and Bricanyl, is an asthma medication that has come to be used on an “off-label” basis to treat preterm labor. Premature labor occurs in nearly 20 percent of all pregnancies in the United States and an estimated 1 million women annually are treated with Terbutaline or similar drugs to halt early contractions.
What is Off-Label Use?
The use of Terbutaline for this purpose is not an approved use by the Food and Drug Administration (“FDA”) and is considered “off-label” since it was not used as intended for asthma. As early as 1997 the FDA issued its first warning concerning the potential dangers associated with the use of this drug for the treatment and prevention of preterm labor. As noted by the FDA, “The approved labeling for terbutaline…states that the drug should not be used for management of preterm labor.”
Evidence and Studies Against the Use of Terbutaline
Supporting the reasons for not using Terbutaline to manage preterm labor, studies have revealed a link between the use of terbutaline during pregnancy and an increased risk of brain damage and cognitive deficits. These conditions manifest themselves at infancy, continue through adolescence and cause permanent disabilities. A study conducted at Duke University showed that the use of terbutaline may leave the brains of children susceptible to other chemicals present in the environment. The researchers suggest that such an exposure predispose newborns and infants to fall victim to particular ailments and medical conditions in the future.
Consistent with the findings of the Duke University study, the National Asthma Education and Prevention Program has recommended that Terbutaline no longer be given to women with mild intermittent asthma while they are pregnant. The reason for this recommendation was that drugs such as Terbutaline, when administered to pregnant women, also penetrate to the fetus where they affect brain development.
Even the American College of Obstetrics and Gynecology (“ACOG”) warns against the use of terbutaline to prevent preterm labor, when they stated in a Technical Bulletin to its members that “no studies have convincingly demonstrated an improvement in survival or any index of long-term neonatal outcome with the use of tocolytic (Terbutaline) therapy. On the other hand, the potential damages of tocolytic therapy to the mother and the neonate are well documented.”
In spite of these facts, it is believed that many physicians continued to treat their pregnant patients with Terbutaline.
Have You or a Child Been Affected?
Due to previous national laws which protected drug companies from the liability of the side effects of their generic drugs, our firm is encouraging those affected to seek a legal consultation. We understand you may have several questions, and the best way to ensure you receive the most reliable information is to speak with a lawyer as each individual carries a unique case with varying details yet common fundamentals.
To contact us, you may use the email form on this webpage or call, 212-233-2100.
Note: During the 2017 holidays it is best recommended to make initial contact by email form and we will return your call typically in one business day or as soon as possible. Please include details that you believe Terbutaline was used during pregnancy and what affects it may have had on you or your child.