Margaret represents and counsels pharmaceutical and medical device clients in a variety of areas. She is involved in all stages of mass tort product liability litigation, from case filing to trial. She also represents clients under investigation by state and federal governments and defends clients subject to civil enforcement proceedings. Margaret counsels clients on regulatory matters in the areas of prescription drug labeling, medical device labeling, adverse event reporting and product recalls. In addition, Margaret has counseled food, drug and cosmetic clients on regulatory issues such as labeling, marketing and advertising.
Representative experiences include:
- Representing a medical device manufacturer in high-profile mass tort litigation in federal multidistrict litigation and state consolidated cases;
- Representing a pharmaceutical company during the preparation and transfer of a case to the U.S. Judicial Panel on Multidistrict Litigation;
- Representing a pharmaceutical company under investigation by the federal government and state attorneys general for allegations under the False Claims Act and state consumer protection laws;
- Serving as counsel for a medical device manufacturer in connection with the defense against and eventual settlement of False Claims Act allegations;
- Serving as counsel for a government contractor in connection with the defense of a qui tam matter and investigation by the federal government;
- Counseling a pharmaceutical company on compliance with regulatory requirements for proposed marketing materials; and
- Conducting early case assessments for a pharmaceutical company in product liability litigation.
Prior to becoming an attorney, Margaret served as a legislative aid for Senator Herb Kohl and the Senate Judiciary Committee’s Subcommittee on Antitrust, Competition Policy and Consumer Rights. Margaret also served as an honors paralegal at the Federal Trade Commission’s Bureau of Consumer Protection where she worked on complex litigation in the agency’s Enforcement Division.
Publications and Presentations
Margaret Horn and Kelly Dawson, Product Liability in the U.S., Getting the Deal Through: Product Liability, August 2019.
Sonali P. Gunawardhana and Margaret Horn, Medical Device Cybersecurity: How the US Food and Drug Administration and Other Stakeholders Are Collaborating to Increase Patient Safety, FDLI Update, April/May 2019; reprinted with the permission of FDLI.
Patrick Oot, ed. in chief, Spoliation: A 50 State Guide, The Electronic Discovery Institute (contributing author, editorial board) (Oct. 2015).
Mark A. Behrens & Margaret Horn, Liability for Asbestos-Containing Connected or Replacement Parts Made by Third Parties: Courts Are Properly Rejecting this Form of Guilt by Association, 37 Am. J. Trial Advoc. 489 (2014).
Carol A. Poindexter & Margaret Horn, Corporate Criminal and Civil Liability, Understanding and Minimizing Risk, Practical Law The Journal: Litigation, Sept. 2013, at 40.
David L. Douglass and Margaret Horn, The Affordable Care Act and Health Care Fraud: What Providers and the Public Need to Know, ABA CLE Webinar (August 2012).