Maddison Schmidt, 12, has spina bifida and numerous other birth defects. This week, a St. Louis, Missouri, jury agreed with her family that the drug Depakote, which Schmidt’s mother took while she was pregnant, caused her health problems and awarded the girl $15 million.
The unanimous verdict arrived Tuesday. The jurors, who began deliberations on Friday, are now determining whether to award Schmidt punitive damages. The girl’s family claimed in the lawsuit that Abbott, the maker of Depakote, downplayed the dangers of the drug, and that the medication was defectively designed and inadequately tested, according to St. Louis Post-Dispatch (Post-Dispatch).
“Abbott steadfastly refused to communicate the true nature and extent of the risk in its product labeling and warnings to physicians and consumers,” the suit, obtained by Post-Dispatch, states.
Maddison Schmidt is only one of two dozen plaintiffs listed in the suit. Though Abbott is named in the suit, AbbVie Inc. is the financially responsible party in the verdict, as Abbott spun off its branded drug business to the company in 2013, regulatory filings viewed by Post-Dispatch indicate. At the time of the spinoff, Abbott required AbbVie to assume business-related liabilities that occurred before the spinoff, according to the company’s annual report filed with the U.S. Securities and Exchange Commission, which Post-Dispatch obtained.
“With the separation the commercial rights and associated responsibilities for Depakote passed to AbbVie,” a statement provided by Illinois-based Abbott reads.
A safety announcement was issued by the U.S. Food and Drug Administration in 2013 warning that pregnant women should not use sodium valproate drugs, including Depakote. The agency said would-be mothers should avoid using the class of drugs to prevent migraines, in particular. The announcement was spurred by a then-recent FDA study that found sodium valproate drugs can decrease children’s IQ scores, Post-Dispatch reported.
The agency also said at the time that Depakote and other sodium valproate drugs should only be used by pregnant women suffering with epilepsy or bipolar disorder if other medications were not effective or deemed inappropriate, according to Post-Dispatch.
Abbott agreed in 2012 to pay the federal government $1.5 to settle allegations that the drugmaker had unlawfully promoted Depakote for “off-label” purposes not approved by the FDA. The company allegedly marketed the drug to elderly patients with dementia and patients with schizophrenia. In a 2012 U.S. Department of Justice statement obtained by Post-Dispatch, the agency said that Depakote was approved only for the treatment of epilepsy, bipolar disorder and migraines.
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from Parker Waichman http://www.yourlawyer.com/blog/12-year-old-girl-awarded-15-million-for-birth-defects-caused-by-depakote-which-her-mother-took-during-pregnancy/
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