Port Huron, MINot many weeks after being hit with a $1.6 billion settlement bill over accusations of illegal off-label marketing of Depakote for unapproved uses, manufacturer Abbott Laboratories has been hit with more litigation alleging Depakote birth defects.
The Madison County Record (6/28/12) reports that plaintiff Nicolas Battle has filed a lawsuit, both individually and on behalf of more than a dozen other plaintiffs, claiming the use of Depakote by his mother caused spina bifida and neural tube defects.
In his Depakote lawsuit, Battle et al v. Abbott Laboratories Inc. (St. Clair County Circuit Court Case No. 12-L-294), filed June 7 in St. Clair County Circuit Court, Battle asserts that his mother was one of many women who were prescribed the anti-seizure medication without being apprised of the potential risks. Specifically, Depakote (valproic acid) is known to have the potential for severe birth defects if ingested during the first trimester of a pregnancy.
Plaintiff Battle alleges Abbott misled doctors as to the dangers of Depakote. He and his fellow plaintiffs accuse Abbott of negligence for manufacturing and marketing a defective drug. In their Depakote lawsuit they ask for undetermined compensation for medical expenses, future loss of income and court costs.
Meanwhile, the recent $1.6 billion settlement over alleged off-label marketing of Depakote for unapproved uses was put into perspective by Dr. Kate Scannell, writing in a recent edition of the Contra Costa Times (5/26/12). While doctors have the moral, legal and medical authority to prescribe drugs off-label (for uses not formally approved by the US Food and Drug Administration, FDA) manufacturers do not have that authority. Knowing, however, the capacity of doctors to circumvent FDA parameters, a manufacturer looking to increase profits while unconcerned over legal boundaries may attempt to persuade doctors to prescribe their medications with regard to indications for which they do not carry formal FDA approval.
Even for drugs that are properly approved, writes Scannell, there are questions. Negative studies are buried, while positive outcomes are spun and over weighted by the sponsoring manufacturers.
"That is precisely why it should seriously matter when yet another corporate behemoth shoves us down a risky path it has knowingly forged with falsehoods, distorting medical evidence and corrupting our ability to make realistic health care choices," Scannell writes. "That is precisely why we should be outraged when yet another profit-seeking pharmaceutical company lures us to jump into an unsound health care decision at our own peril."
She notes the $1.6 billion settlement is but "a mere year's worth of Depakote sales for Abbott," Scannell writes of the drug that has been linked to various Depakote side effects. But rather than focus on the monetary fine, "This story needs to be told in profoundly human terms.
"It needs to be narrated as a cautionary tale about modern medical practice and the corrupting influences that undermine evidence-based care."
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