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
Abbott Laboratories has issued software patches to some of its implantable cardiac devices (manufactured by St. Jude) for cybersecurity flaws and battery issues that have plagued the devices, necessitating the U.S. Food and...more
Late last week, financial services company Raymond James agreed to resolve allegations of conspiring with the owner of several VT ski resorts (and others) in a Ponzi scheme targeting foreign investors through the EB-5...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
Wise v Abbott Laboratories, Limited, 2016 ONSC 7275 was a recent pre-certification summary judgment decision, which was released after the Divisional Court's decision this past summer in Dine v Biomet Inc, 2016 ONSC 4029....more
Class Action Case Update: Justice Perell's recent decision in Wise v Abbott Laboratories, Limited, 2016 ONSC 7275 addressed a number of key areas of interest for the class action bar....more
Class Action Case Update: Justice Perell's recent decision in Wise v Abbott Laboratories, Limited, 2016 ONSC 7275 addressed a number of key areas of interest for the class action bar. ...more
Class Action Case Update: Justice Perell's recent decision in Wise v Abbott Laboratories, Limited, 2016 ONSC 7275 addressed a number of key areas of interest for the class action bar. Justice Perell's recent decision in...more
Earlier this month in Abbott Laboratories v. Adelphia Supply USA et al, the Second Circuit affirmed a district court's grant of a preliminary injunction halting the alleged sale of gray-good diabetes test strips made by...more
The United States Justice Department (DOJ) announced this week that Omnicare, Inc. (Omnicare), the largest nursing home pharmacy in the United States, will pay approximately $28 million dollars to resolve charges that it...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, following a three-week trial and after only three hours of deliberations, a federal jury in Dallas, Texas found that Abbott Laboratories had not violated the False Claims Act (FCA) when it marketed bile duct...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
Upon initiation of a patent infringement action between branded and generic pharmaceutical companies, the Hatch-Waxman Act (21 U.S.C. § 355(j)) provides for an automatic 30-month stay of Food and Drug Administration approval...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
Sleet, J. Defendant’s motion to strike counts 9 and 10 under California’s Anti-SLAPP Stature is granted with prejudice. Defendant’s motion to dismiss counts 9-11 is denied in part and granted in part. Plaintiff’s motion to...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 January 22, 2015, the British Columbia Court of Appeal set aside certification of a class action against Apotex Inc. and Abbott Laboratories Ltd. in Charlton v. Abbott Laboratories Ltd. (Charlton), in which the plaintiffs...more
The Securities and Exchange Commission recently filed suit in the US District Court for the Southern District of New York, alleging that defendants, Juan Cruz Bilbao Hormaeche and Thomas Andres Hurtado Rourke, both Chilean...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
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Alcon Research Ltd. v. Wockhardt Ltd. et al. 1:13-cv-02040; filed December 19, 2013 in the District Court of Delaware. ...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
When is it undue experimentation in practicing the full scope of a claim that contains a genus of chemical compounds and a functional limitation of activity, when the specification provides a method to assess the claimed...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