Depakote Birth Defect Suit Moves Forward in Court

The Depakote lawyers at Pintas & Mullins Law Firm are currently accepting cases involving spina bifida in children born to mothers who took the anti-seizure drug Depakote during pregnancy. Here, we report on a Depakote injury lawsuit filed by an Ohio woman and her daughter, who was born in 2004 with numerous birth defects.

The mother, Pamela Rheinfrank, filed suit against Depakote's manufacturers, Abbott Laboratories and AbbVie Inc, under claims of: defective design, negligent misrepresentation, failure to warn, fraud, breach of warranty, and unjust enrichment. The federal judge assigned to her case, U.S. District Judge Susan Dlott, preserved only her warranty and failure to warn claims.

Rheinfrank suffers from epileptic seizures stemming from childhood and began taking Depakote at age 14. She took two medications throughout the pregnancies of her five children. Her youngest child, born in 2004, suffers from birth defects such as cognitive impairment, abnormal facial features, and developmental delays.

Let's unpack each claim against Abbott one by one.

  • Design defects - This claim was rejected because Rheinfrank did not prove that there was another, safer medication available for her to take during pregnancy that would have properly controlled her seizures.
  • Negligent misrepresentation - This claim was rejected because Rheinfrank did not prove that her doctor relied on Abbott's misrepresentations when prescribing Depakote. Her doctor stated she did not remember prescribing the drug.
  • Failure to warn - The judge stated this claim was preempted, because the FDA rejected Abbott's attempts to add warnings about the risk of developmental delays on Depakote's labels. The judge did state that Depakote's labels were inadequate, allowing the claim to move forward.
  • Fraud - This claim was denied, again because she cited no evidence that her prescribing doctor relied on Abbott's misrepresentations to prescribe Depakote.
  • Breach of express and implied warranty - The judge stated this claim was interconnected with the failure to warn claims.
  • Unjust enrichment - This claim was denied because it did not meet Ohio's legal requirements.

The two preserved claims, failure to warn and breach of warranty, are now the basis of Rheinfrank's suit. She is also allowed to pursue punitive damages under common law negligence claims.

Her failure to warn claim rests on the appropriateness of comparing Depakote to other drugs on its labels, evidence that Abbott failed to warn about the severe risks of birth defects, and whether or not these risks were common knowledge. The FDA did not release a warning on the increased risk of Depakote-caused cognitive impairments until 2011, more than seven years after Rheinfrank's delivery. The FDA warned that by age three, children whose mothers took Depakote during pregnancy scored lower on IQ tests than children born to mothers who took other anti-seizure medications.

Two years earlier, in 2009, the FDA warned that Depakote could cause defects of the neural tube, heart and skull. The primary ingredient in Depakote has been found to cause severe defects if taken during the first trimester of pregnancy, including heart conditions, spina bifida, deformities of the limbs and fingers, and cleft lip and palate.

Abbott was also sued for promoting Depakote for off-label uses, ultimately settling for $1.3 billion. This was the third-largest illegal pharmaceutical marketing settlement in U.S. history. Abbott was accused of exerting significant pressure on sales reps to increase off-label uses of Depakote.

Mothers and children filing suit against Abbott seek compensation for physical pain, permanent injury, mental suffering, embarrassment, lost profit and salary, medical expenses, and future economic damages. We are currently handling cases of spina bifida from Depakote use during pregnancy. Spina bifida is a group of neural tube defects causing injury to the spinal cord and bones. The severity of spina bifida ranges, though treatment typically involves surgery and ongoing care.

Our team of Depakote lawyers offers free case reviews to anyone with questions or concerns about this drug. We accept clients nationwide, and we can travel to you to help guide you through the legal process.

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