Over ten years ago, the Food and Drug Administration (FDA) determined that pregnant women who take Depakote (valproate) have a much higher chance of giving birth to a baby who suffers low IQ or a birth defect. In response,...more
Tribunal dismisses Eli Lilly’s NAFTA challenge on promise utility doctrine - As previously reported, Eli Lilly submitted claims to international arbitration under the North American Free Trade Agreement (NAFTA) seeking...more
Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more
On April 7, 2016, after just three hours of deliberations following a three-week trial, a federal jury dismissed False Claims Act (“FCA”) claims against Abbott Laboratories brought by a whistleblowing former employee. The...more
On August 7, 2015, the U.S. District Court for the Southern District of New York released its Amarin opinion addressing whether truthful, non-misleading off-label promotion of U.S. Food and Drug Administration (FDA)-approved...more
Oft-referred to as “quintessential class actions”, the majority of product liability actions that have sought certification as class proceedings in the last 10 years have been granted certification. However, two recent...more
On September 8, 2014, the Federal Trade Commission (FTC) filed a federal antitrust complaint in the United States District Court for the Eastern District of Pennsylvania against defendants AbbVie, Abbott Laboratories, Unimed...more
Last week, the National Institutes of Health denied a petition from a coalition of "public interest" groups who petitioned the agency to exercise so-called "march-in rights" under provisions of the Bayh-Dole Act against...more
In Wyeth v. Abbott Laboratories, the Federal Circuit affirmed the district court’s decision that the claims at issue are invalid for failing to satisfy the enablement requirement of 35 USC § 112....more
Dear Doctor letters were front and center in the just-tried case of Tietz v. Abbott Laboratories, Inc., et al., No. 12-L-002715. On Thursday, May 9, 2013, a Chicago jury returned a $2.2 million verdict in favor of the...more