About | HeinOnline Law Journal Library | HeinOnline Law Journal Library | HeinOnline
LOG IN
LOG IN

59 Food & Drug L.J. 245 (2004)
Express Preemption and Premarket Approval under the Medical Device Amendments

handle is hein.journals/foodlj59 and id is 273 raw text is: Express Preemption and Premarket Approval Under the Medical Device Amendments GREGORY J. SCANDAGL1A* THERESE L. TULLY* I. INTRODUCTION Millions of dollars are spent each year in an effort to develop new medical devices designed to help individuals facing serious medical conditions. Before these devices can reach consumers, however, they must be reviewed and cleared by the Food and Drug Administration (FDA). Innovative medical devices, which pose the greatest risks and are aimed at helping the most critically ill consumers, are subjected to intense FDA scrutiny under a process known as premarket approval (PMA). Having undergone an extensive, time-consuming, and expensive premarket review by FDA, those devices that meet FDA's strict requirements may then be offered for sale in the United States. Despite the emphasis placed on safety by FDA and the manufacturer, FDA-approved devices have injured consumers. When the device at issue has been reviewed and approved by FDA under its rigorous PMA process, courts are divided as to whether injured consumers can bring state law tort claims against device manufacturers, or whether such claims are expressly preempted by the Medical Device Amendments of 1976 (MDA), one of the statutes that guides and empowers FDA in its review of medical devices. The resolution of this question has wide-reaching implications for consumers and manufacturers alike. Consider the following hypothetical scenario: MediX is a medical device manufac- turer located in Illinois. After years of heavily-funded research and development, MediX has designed a revolutionary microchip pacemaker called the Pacer2004. It also has plans to develop a second device, an implantable device that will constantly monitor the body for early warning signs of cancer. Anticipating that its Pacer2004 will need to be reviewed and approved by FDA under the PMA process prior to being offered for sale, MediX submits an investigational device exemption (IDE) to FDA. After FDA approves the IDE, MediX conducts numer- ous studies examining the safety and efficacy of its pacemaker. When it is satisfied with the safety and performance of its Pacer2004, MediX submits an application seeking FDA approval. As part of the application, MediX submits the results of clinical investi- gations; a sample of its pacemaker; samples of the proposed labeling; a full statement of its pacemaker's components, properties, and principles of operation; and a full descrip- tion of the methods used in (and the facilities and controls used for) the manufacture, processing, packing, and installation of its pacemaker. After an extensive six-month review of the Pacer2004, FDA informs MediX that additional information regarding the components must be submitted and certain changes must be made to the Pacer2004's * Mr. Scandaglia is a Partner and founding member of the law firm of Scandaglia & Ryan, Chicago, IL, a litigation boutique specializing in complex commercial litigation. From 1986 to 1992, Mr. Scandaglia was a federal prosecutor with the Chicago office of the U.S. Department of Justice, Antitrust Division. °* Ms. Tully is an Associate in the law firm of Scandaglia & Ryan, Chicago, IL. Prior to private practice, Ms. Tully was an attorney with the Federal Trade Commission and, before then, clerked for the Hon. Martin C. Ashman, magistrate judge in the U.S. District Court for the Northern District of Illinois. 245

What Is HeinOnline?

HeinOnline is a subscription-based resource containing thousands of academic and legal journals from inception; complete coverage of government documents such as U.S. Statutes at Large, U.S. Code, Federal Register, Code of Federal Regulations, U.S. Reports, and much more. Documents are image-based, fully searchable PDFs with the authority of print combined with the accessibility of a user-friendly and powerful database. For more information, request a quote or trial for your organization below.



Short-term subscription options include 24 hours, 48 hours, or 1 week to HeinOnline.

Purchase Access

Contact us for annual subscription options:

Contact Us

Already a HeinOnline Subscriber?

Log In

profiles profiles most