Pharmaceutical Companies May Be Held Liable for Failure to Warn Mothers of Potential Birth Defects

Court Upholds $3 Million Verdict for Failing to Warn of Birth Defects

According to one news source, a court of appeals recently upheld a $3 million verdict against a subsidiary of Johnson & Johnson after a baby was born with severe birth injuries as a result of medication taken during the mother’s pregnancy. The baby’s parents brought a claim against the company, and the jury found the company liable for failing to warn the mother’s doctors of the risk of birth injuries if she took Topamax during her first trimester.

The mother took Topamax, a drug prescribed to help prevent seizures and migraine headaches. While she was pregnant, she took the drug to treat migraines—but she did not know of the dangerous effects it could have on her baby. Research has shown that 3.8 percent of children exposed to Topamax in utero during the first trimester have oral birth defects. In particular, cleft lip and cleft palate are known risks.

The couple’s daughter was born with a bilateral cleft palate and lip. The girl has had to undergo over 14 procedures, including surgeries, to treat the birth defects. She has also suffered hearing loss, speech difficulties, and bullying because of her speech and appearance. The parents were awarded $1.5 million for future health care expenses, and their daughter was awarded $1.5 million in non-economic damages.

The company argued that it should not be found liable because it could not have changed the warning on the drug without permission from the U.S. Food & Drug Administration. However, an appellate court found that the labeling was a separate issue and that it still had a duty to warn consumers of the risks. The court found that the label implied that there were general risks, but it failed to state the established risk that it caused particular birth defects. Accordingly, the court found that the company knew about the risks of specific birth defects but failed to adequately warn physicians and consumers. Three years after the couple’s daughter was born, the FDA required the company to update its label.

The attorney for the plaintiffs stated that the decision “proves that big pharmaceutical companies consistently hide dangerous side effects from the American public, but that our legal system allows consumers and families to level the playing field and hold them accountable.”

Failure-to-warn cases allege that a defendant is liable for failing to warn consumers of dangerous conditions or risks found in a product. Under Illinois law, a product must adequately warn of dangers, but when a danger is obvious, there is no duty to warn. Generally, a plaintiff must prove that the defendant did not disclose an unreasonably dangerous condition, or did not instruct on the correct use of the product, and that the average consumer would not have been aware of the condition or correct use.

Instructions may also be inadequate if they are ambiguous or do not contain sufficient information about how to use the product. These types of cases often require substantial investigation into available research and what the defendant was aware of at the time. If a claim is successful, an individual could potentially recover a wide range of compensatory damages, including medical bills, out-of-pocket expenses, the costs of future treatment, loss of income, mental anguish, and pain and suffering.

Have You Suffered Injuries as a Result of a Medication?

If you suffered injuries after taking a medication, you may be able to file a claim against the drug manufacturer. If you were unaware of the risks due to an inadequate warning on the label or from your doctor, the warnings may be legally inadequate. The pharmaceutical injury attorneys at Moll Law Group are available to advise people throughout the United States who have been hurt by defective products. We provide aggressive representation so that you can receive what you deserve and so that other consumers are protected. Call us at 312-462-1700 or use our online form to set up a free consultation.

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