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Abbott Laboratories must turn over medical literature and documents related to the potential side effects of Depakote as soon as possible, a federal magistrate has ordered.
On December 16, U.S. Magistrate Judge Stephen C. Williams, of the Southern District of Illinois, issued an order (PDF) that requires Abbott to produce Depakote birth defect information that is “long overdue.” He also ordered the company to release custodial files that are also late.
The documents are required as part of the discovery process in two Depakote lawsuits filed by parents who claim their children were born with defects or malformations caused by exposure to the epilepsy drug while in the womb. The parents accuse Abbott of failing to adequately warn pregnant women or their doctors that the antiseizure medication carried a risk of causing birth defects if taken during pregnancy.
The order notes that Abbott was asked to produce the documents months ago, but has apparently failed to meet the order’s requirements. The company says there is no centralized database to pull all the information from and that it will begin going through about 215 boxes of medical literature in a warehouse this week.
“The Court notes that the documents are long overdue, as this issue was originally discussed with the Court, and the documents ordered produced, back in April. However, the Court will not impose another deadline for the production of these documents as several deadlines have not been met by Abbott and the Court will not set another arbitrary deadline,” the order reads. “Instead, the court ORDERS Abbott to turn over the documents as soon as possible and to exercise all avenues available to them to make this production as quickly as possible.”
The Magistrate notes that it appears that Abbott is now taking the order seriously given recent moves the company has made, but warns that they could face other relief judgments if they continue to fail to produce the documents necessary to move the case forward. The parties will discuss the matter further in a telephone conference scheduled for Friday.
Depakote Birth Defect Lawsuits
Abbott currently faces a number of similar Depakote birth defect lawsuits filed by families throughout the country, which allege that the drug maker failed to adequately research the medication or warn consumers and the medical community about the risks associated with using the popular medication during pregnancy.
Depakote (valproic acid) was approved in the United States in 1978 for treatment of certain forms of epilepsy. However, Depakote pregnancy risks have been associated with the development of severe birth defects and malformations, including spina bifida, cleft palate, abnormal skull development, malformed limbs, holes in the heart and urinary tract problems; especially when the drug is taken during the first 28 days, when neural tube closure and other critical formations are taking place.
In 2006, the FDA added a “black box” warning about the potential risk of Depakote birth defects after a study found that 20% of pregnant mothers who gave birth while on Depakote had a child with malformations or a birth defect.
Earlier this year, the FDA put new restrictions on Depakote pregnancy use, contraindicating it for pregnant women, but only when it was used for the treatment of migraines. The agency did not contraindicate it for pregnant women.
The FDA changed all valproate-based drugs from a class “D” to a class “X” pregnancy drug, but only as they pertain to migraines. In addition to Depakote and Depacon, other drugs that are affected by the warning include Depakene, Stavzor and generic equivalents.
A Class D classification means that a drug’s benefits may be acceptable despite known potential risks to pregnant women. A Class X designation means that the risks of a drug outweigh the benefits for pregnant women. However, the FDA still considers the side effects to be an acceptable risk for the treatment of epilepsy and manic episodes associated with bipolar disorder, but not migraines.