Terbutaline Lawsuit: Autism Claims After Brethine Use in Pregnancy

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What families should know about terbutaline exposure during pregnancy, the Novartis lawsuits, and the 2017 California Supreme Court decision

Were you prescribed terbutaline or Brethine during pregnancy to stop or delay premature labor? Was your child later diagnosed with autism, a learning disability, or another developmental condition? Terbutaline is an asthma medication that was frequently prescribed off-label to pregnant women between 2002 and 2011, and lawsuits allege that the manufacturer did not adequately warn about the risks of using it this way.

Singleton Schreiber represents families in pharmaceutical claims as part of our Mass Tort Practice. Our attorneys can review your prescription history and your child's diagnosis to help you understand whether a terbutaline claim may be available.

These cases often involve an important legal question: who is responsible when a mother took a generic version of the drug? In 2017, the California Supreme Court held in T.H. v. Novartis Pharmaceuticals Corp. that a brand-name manufacturer may be held liable for inadequate warnings that also appeared on generic versions. Whether that ruling applies to a particular family depends on the facts and governing law.

If you believe terbutaline may be connected to your child's condition, preserve your prenatal and obstetric records, pharmacy and prescription records, hospital records from any preterm labor treatment, your child's diagnosis and developmental evaluations, therapy records, and any school or special education records.

What Is Terbutaline and Why Was It Prescribed During Pregnancy?

Terbutaline is an asthma medication that was also sold under the brand name Brethine. It was never approved by the FDA to treat preterm labor, but obstetricians and gynecologists prescribed it off-label to help keep pregnant women from going into labor too early. The number of women who took the drug without knowing its potential risks is believed to be in the thousands.

What the Terbutaline Lawsuits Allege

Plaintiffs argue that Novartis, a manufacturer of terbutaline, knew about the risk of autism associated with exposure in the womb but did not warn doctors or patients. According to the lawsuits, it took nearly a decade for the label to be updated with the necessary warning, and the change came only after the FDA mandated stronger warnings against using terbutaline in pregnant women.

The key case, T.H. v. Novartis Pharmaceuticals Corp., involved fraternal twins who both developed autism. Experts in that case said the likelihood of both twins being born with autism would have been very low without a harmful chemical exposure.

Injuries Alleged in Terbutaline Lawsuits

Terbutaline use during pregnancy has been linked in lawsuits to serious conditions in children, including:

• Autism
• Brain damage
• Learning disabilities
• Cognitive impairments
• Motor dysfunction

Whether exposure contributed to a specific child's condition depends on medical evidence and expert analysis.

Common Situations Behind Terbutaline Claims

1. Brand-Name Brethine Prescribed to Delay Labor.

A mother was given Brethine during pregnancy to stop contractions or prevent premature delivery, and her child was later diagnosed with autism or another developmental condition.

2. Generic Terbutaline Dispensed by the Pharmacy.

The prescription was filled with a generic version. Under the 2017 California Supreme Court ruling, the brand-name manufacturer may still be responsible for the warning label, depending on the facts and governing law.

3. More Than One Child Affected.

As in the T.H. case, twins or multiple children exposed during the same pregnancy were later diagnosed with autism. Records for each child can be important.

4. Terbutaline Taken After Novartis Sold the Brand.

Novartis sold Brethine to another manufacturer in 2001. A mother who took terbutaline after that date may still have questions about Novartis's responsibility, which the courts have addressed.

The 2017 California Supreme Court Decision

The U.S. Supreme Court has ruled that generic drug manufacturers generally cannot be held liable for inadequate warning labels, because federal law requires their labels to match the brand-name version. Families harmed by improperly labeled generic drugs argued that they should instead be able to sue the brand-name manufacturer, since it was ultimately responsible for the label content.

The 2017 California Supreme Court ruling gave them that path, holding that brand-name manufacturers like Novartis can be held responsible for injuries caused by inadequate warnings on generic drugs. In the twins' case, Novartis argued that it stopped selling terbutaline six years before the mother took it. The court rejected that argument based on evidence that Novartis was aware of the potential dangers before it sold the brand in 2001.

FDA Warnings About Terbutaline for Preterm Labor

In 2011, the FDA began warning doctors against using terbutaline to treat preterm labor because of known risks, including heart problems the agency connected to at least a dozen deaths since 1998 and as many as 16 since 1976. The FDA also required a boxed warning on the label and a contraindication against use for preterm labor. That 2011 warning was the first time the agency spoke out against this off-label use.

Barbara and Jack's Story

After her son Jack was diagnosed with nonverbal autism, Barbara Higgins spent years advocating for him and supporting other families facing similar challenges. In this video, she shares her family's experience and her reaction after learning more about terbutaline use during pregnancy.

Barbara began noticing developmental differences in Jack before his second birthday. Today, she shares the challenges her family faced, the milestones they celebrated, and the questions she asked after learning she had been prescribed terbutaline during pregnancy.

Is There a Deadline to File a Terbutaline Lawsuit?

Yes. Deadlines called statutes of limitations apply to these claims, but they vary by state, by the type of claim, and by facts such as the child's age and when the injury was discovered or connected to the medication. Because these rules can be complex, families may want to speak with an attorney before a deadline passes.

Records and Documents to Keep

• Prenatal and obstetric records from the pregnancy
• Pharmacy and prescription records showing terbutaline or Brethine, including whether it was brand-name or generic
• Hospital records from any preterm labor treatment
• Your child's autism or developmental diagnosis records
• Developmental, neurological, and psychological evaluations
• Therapy and treatment records
• School, special education, or IEP records
• A written timeline of when you first noticed developmental differences

When to Contact a Terbutaline Lawyer

Consider speaking with an attorney if you were prescribed terbutaline or Brethine during pregnancy and your child was later diagnosed with autism, brain damage, a learning disability, a cognitive impairment, or motor dysfunction. An attorney can review your records, help determine which manufacturer may be responsible, and explain how deadlines may apply in your state.

How Singleton Schreiber Helps

Our Mass Tort Attorneys have brought lawsuits against pharmaceutical companies, including Novartis. We can help gather prescription and medical records, work with medical experts, and pursue compensation for the harm to your child and your family. We take on large corporations and insurance companies on behalf of everyday people.

Example of a Filed Terbutaline Complaint

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