Terbutaline Sulfate was approved by the FDA for the treatment of bronchospasms associated with asthma, bronchitis and emphysema. However, Terbutaline has been used for preterm labor. This is considered an off-label or unapproved use. Terbutaline was originally marketed under the name Brethine and Bricanyl.
In 2011, the FDA issued a label change for Terbutaline from pregnancy category B to C. The FDA changed the label based on several animal studies showing that Terbutaline was a development neurotoxin. Animal studies are frequently performed on newborn rats, which tend to be at the same neurodevelopment level as human fetal development.
These studies found that Terbutaline adversely affected the medial temporal lobe of the brain and the cerebellum. A pregnancy category C means that there is animal study evidence showing a risk to the fetus. This has led to speculation regarding whether Terbutaline might also cause Autism.
In addition to the animal studies showing that the drug can cause serious fetal injuries, the FDA has reported sixteen maternal deaths since the marketing of the product in 1979 and twelve cases of serious cardiovascular events between 1998 and 2009.
On February 27, 2011, the FDA issued a warning that Terbutaline should not be used in pregnant woman for prevention or prolonged treatment of preterm label because it can cause serious maternal heart problems and sudden death. The FDA placed this warning on the boxed section of the Terbutaline label.
Terbutaline Birth Defect Lawsuits
If your child was born with a birth defect as a result of your use of Terbutaline during pregnancy, you may be entitled to file a lawsuit. Once a preliminary evaluation is done on your case, you will receive a packet. The packet contains a contract, questionnaire and authorization. This information is necessary to further evaluate your claim and to obtain your medical records. Obtaining your medical records can take 3o to 60 days. After the medical records are retrieved, an attorney will review your records and a determination will be made on your case.
If your case is accepted, a lawsuit will be filed. Pharmaceutical and medical device cases are frequently grouped together or “consolidated” in one court before one judge. This helps the discovery process proceed more quickly and efficiently. These consolidations are known as “MDLs” or Multi-District Litigation. An MDL is not a class action. Your case will be evaluated, tried and ultimately settled on the merits of your particular case.
Terbutaline Birth Defect Lawyers
If your child was born with a birth defect, please contact our law firm or call our office toll-free at (855) 400-4714. An experienced attorney will provide a free case evaluation and analyze the facts of your case. We handle all cases on a contingency basis, meaning that we don’t get paid unless we settle or win your case in court.