Maslon Litigation attorneys David Schultz and Scott Aberson have authored an article in the William Mitchell Law Review titled, "Be Careful What You Ask For: The FDA's Denials of Petitions Confirms There Is No Such Thing as a Limited Premarket Approval." In the article—from Volume 39, Issue 4, which is focused on medical device law—David and Scott discuss the statutory and regulatory background related to the regulation of medical devices, as well as the FDA's approval processes for selling Class III medical devices. They provide a brief history of preemption under the Medical Device Act and examine recent court decisions holding that premarket approval of medical devices applies to all aspects and components of the medical device system. David and Scott also address the FDA's denial of plaintiffs' citizen petitions in medical device cases as evidence that the FDA intends premarket approval to apply to an entire medical device.
David Schultz is a partner in Maslon's Litigation Practice Group and focuses his practice on trial and appellate work in healthcare/medical malpractice and medical devices, intellectual property, commercial litigation, and civil and criminal fraud. David served on the Board of the Innocence Project of Minnesota for six years. David's work on the Innocence Project reflects his long-standing passion for fairness in our justice system. He has been recognized on the Minnesota Super Lawyers® list from 2003 - 2012.
Scott Aberson practices in Maslon's Litigation Group. He represents business entities, major manufacturers, and individuals in complex commercial litigation in the areas of tort and product liability, intellectual property litigation, and general business litigation. Scott has successfully represented both plaintiffs and defendants in multiple state and federal jurisdictions, including courts in Minnesota, Delaware, Pennsylvania and Arizona.