Amanda J.
Klingler

Phillips Morris USA v. FDA, 202 F.Supp. 3d (D.D.C. 2016). Represented one of the plaintiffs in a successful legal challenge to an FDA guidance governing the Substantial Equivalence Review process for tobacco products.

Member of a King & Spalding team serving as national coordinating counsel and trial counsel in product liability litigationinvolving GlaxoSmithKline’s antidepressant Paxil®, including in the Philadelphia Court of Common Pleas Mass Tort Program. Experience includes preparing fact and expert witnesses on FDA issues and briefing motions in limine and Daubertchallenges.

Member of a King & Spalding team representing the manufacturer of FDA-cleared surgical gowns in nationwide litigation concerning the design, labeling, advertising and manufacture of the devices, including: a federal class action trial, the verdict from which is on appeal to the Ninth Circuit; a qui tam suit brought under the Federal False Claims Act in which the court granted defendants' motion to dismiss; and a federal Lanham Act lawsuit concerning allegations of false marketing. Experience includes working extensively with the Company's regulatory expert witness on the FDA-related issues in the litigation, leading the development of the Company's expert report and preparing the witness for his trial testimony.

Assisted companies in preparing for FDA inspections, developing responses to FDA investigational observations (FDA-483 forms), and warning letters.

Assisted pharmaceutical and medical device companies under investigation by FDA and the U.S. Department of Justice Office for alleged violations of the FDCA.

Conducted internal investigations of pharmaceutical medical device manufacturers into potential quality systems and advertising and promotion violations to develop a risk profile and recommendation for reducing potential liability and risk exposure.

Conducted FDA regulatory due diligence reviews of target medical device, pharmaceutical manufacturers, and compounding pharmacies.

Counseled companies on radiation-emitting product requirements under the FDCA.

Counseled companies on labeling and promotion requirements for FDA-regulated products.

United States v. Franck’s Lab, 2011 WL 4031102 (M.D. Fla. Sept. 12, 2011). Lead associate for Franck’s Lab in successful defense of FDA enforcement action contending that traditional, state-licensed pharmacy compounding of veterinary medications violates FDA’s statute. Also served as the lead associate for Franck’s Lab in other FDA regulatory and state board of pharmacy matters.

Hill Dermaceuticals, Inc. v. FDA, No. 1:11-cv-01950 (D.D.C.). Lead associate representing innovator drug manufacturer in litigation seeking to require FDA to withdraw its approval of purported generic formulations of manufacturer’s brand name products.