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 litigation involving 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 Daubert challenges.
• 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.

Amanda Klingler is a partner in the firm’s Washington, D.C. and Chicago offices with more than 10 years of experience advising life science clients.  As a partner in the firm's FDA and Life Sciences practice, Amanda advises pharmaceutical, medical device and biotech companies and pharmacies, on a wide range of regulatory matters, enforcement actions, civil litigation, investigations, product liability litigation, and compliance counseling.

Amanda counsels clients on pre- and post-marketing regulatory activities and strategies, including obtaining FDA approval and clearance for medical products.  Amanda also regularly advises clients on product labeling, adverse event reporting, product safety issues, recalls/field corrections, import detention, and advertising and promotion issues.  She counsels clients on quality system and manufacturing practices for drugs and medical devices and factory inspections, including conducting mock inspections and working closely with and providing advice to clients during the inspection, and provide guidance in responding to FDA investigational observations (FDA-483 forms), and warning letters.  Amanda, as a co-leader of the firm’s AI/ML Tactical Operations team, also frequently advises clients on the use of AI/ML during the life cycle of drugs and medical devices, including digital health products. 

Amanda advises clients during internal and government investigations.  She also assists in the negotiation and management of several consent decrees of injunction for pharmaceutical, medical device, food companies and compounding pharmacies.

Amanda works closely with the firm's product liability team and is experienced in handling FDA issues in product liability litigation, including the development of supporting evidence, writing briefs, and preparing expert witnesses to testify.

Amanda also has significant experience and expertise in FDA's regulation of tobacco products.