They could have taken a middle ground, given the unique facts of FTC v. Shire ViroPharma — but instead the Third Circuit went whole hog with a decision that, if it stands, could set the FTC’s litigation authority back decades. In this case, bad facts …
On December 11, 2018, the authors of this blog post attended the oral argument in Federal Trade Commission v. Shire ViroPharma, Inc., No. 18-1807 (3d Cir. filed Apr. 12, 2018). We have previously blogged about the case here, here, and here. In a nutshell, Shire …
Hard to believe that just two years ago, ev3, Inc. scored a resounding victory after the First Circuit affirmed the dismissal of a qui tam action against it (we reported it here). This week, DOJ announced that the same company has agreed to a criminal …
Once in a while a consumer class action catches our particular attention. Most recently, Kind LLC was sued in the U.S. District Court for the Eastern District of New York over its advertising, labels, and ingredient statements for its “Pressed by KIND” and “KIND Fruit …
Last week, the President signed into law a bill that gives the FTC greater authority to police agreements between biologic license holders and biosimilar applicants – so-called “pay-for-delay” settlements. The FTC has been focused on these settlements in the pharmaceutical space for years, but until now …
Earlier this year, we blogged on an interesting case out of the District of Delaware, FTC v. Shire ViroPharma, No. 17-cv-00131 (D. Del. Feb. 7, 2017), which called into question the FTC’s authority to litigate pursuant to section 13(b) of the FTC Act (15 U.S.C. …
Last month, FDA announced the creation of a new Drug Shortage Task Force, intended to address continuing shortages of medically necessary drug products. The Task Force expands FDA’s existing group focused on drug shortages and, according to Commissioner Scott Gottlieb, will “delve more deeply into …
Following our blog post on the topic, in which we urged others to comment in response to FDA’s Proposed Product Jurisdiction rule changes, we decided to take our own advice. On July 15, 2018, Hyman, Phelps & McNamara, P.C. filed comments to Docket No. FDA-2004-N-0191. Our …
On June 19, the D.C. Circuit issued a decision setting forth the Court’s views on attorney-client privilege in Federal Trade Commission v. Boehringer Ingelheim Pharms., Inc. The D.C. Circuit previously ruled on attorney work-product protection issues in the same matter. See 778 F.3d 142 (D.C. …
On June 6, the Eleventh Circuit vacated the Federal Trade Commission’s (“FTC’s”) data security-related cease and desist order against LabMD, Inc. (“LabMD”), a diagnostic testing company. The decision was less than satisfactory for many amici who had called on the Court to opine – one …
Last September, we posted on the Fifth Circuit’s decision to uphold summary judgment and award of costs in favor of Solvay Pharmaceuticals, Inc. in a False Claims Act (FCA) case (see post here). The relators pursued an FCA theory against Solvay based on allegations of …
On May 15th, FDA published in the Federal Register a proposal to amend the product jurisdiction regulation (21 C.F.R. Part 3). This proposal seeks to update, clarify, and streamline the product classification and designation process. However, the proposal fails to address some significant flaws in …
Last week United States ex rel. Campie v. Gilead Sciences Inc. took one step closer to being the first FCA materiality case to be taken up by the Supreme Court since the Court’s seminal decision in Universal Health Services, Inc. v. United States ex rel. …
Declaring its intent to stand on the original complaint in FTC v. Shire ViroPharma, the FTC has appealed the District Court for the District of Delaware’s decision to dismiss the Commission’s unfair competition case against Shire without prejudice. We previously blogged about this case here, …
Last February we reported on FTC v. Shire ViroPharma, in which the Federal Trade Commission (FTC) took the relatively unusual (although not unprecedented) step of suing a brand drug company for anti-competitive use of the Food and Drug Administration’s (FDA’s) citizen petition process to delay …
