Confirm favorite deletion?
Torts Keyed to Franklin
Riegel v. Medtronic, Inc.
Citation:552 U.S. 312, 128 S. Ct. 999, 169 L.Ed.2d 892 (2008)
Several thousand tort claims followed the marketing and sale of the Dalkon Shield intrauterine device, which was linked to serious infections, several deaths, and a large number of pregnancies. In response, several states adopted regulatory measures requiring premarket approval of medical devices. Congress swept back state obligations and imposed a regime of detailed federal oversight via the MDA.
The MDA includes an express preemption provision that gave the FDA almost total oversight for medical devices. Once a device receives premarket approval, the MDA subjects the devices to reporting requirements and forbids a manufacturer to make any changes in the product without FDA approval that would affect the safety or effectiveness of the medical device.
Under the MDA, Class III devices receive the most stringent federal oversight. This class includes devices that support or sustain human life and are of substantial importance to prevent impairment of human health, such as replacement heart valves and pacemaker pulse generators.
Medtronic’s Evergreen Balloon Catheter is a Class III device that received FDA premarket approval in 1994.
Riegel went into surgery for a heart attack that was caused by a blocked artery. During the procedure, Riegel’s doctor inserted Medtronic’s catheter, though the labeling of the catheter warned that it should not be used for patients with conditions like Riegel. Additionally, Riegel’s doctor inflated the catheter higher than the maximum pressure recommended by the catheter’s label. The catheter burst, causing Riegel to develop a heart block, be placed on life support, and undergo an emergency coronary bypass surgery.
Riegel and his wife sued Medtronic, alleging that its catheter was designed, labeled, and manufactured in a manner that violated New York common lawand that these defects caused Riegel to suffer severe and permanent injuries.
Only StudyBuddy Pro offers the complete Case Brief Anatomy*
Access the most important case brief elements for optimal case understanding.
*Case Brief Anatomy includes: Brief Prologue, Complete Case Brief, Brief Epilogue
- The Brief Prologue provides necessary case brief introductory information and includes:
Topic:Identifies the topic of law and where this case fits within your course outline.
Parties:Identifies the cast of characters involved in the case.
Procedural Posture & History:Shares the case history with how lower courts have ruled on the matter.
Case Key Terms, Acts, Doctrines, etc.:A case specific Legal Term Dictionary.
Case Doctrines, Acts, Statutes, Amendments and Treatises:Identifies and Defines Legal Authority used in this case.
- The Case Brief is the complete case summarized and authored in the traditional Law School I.R.A.C. format. The Pro case brief includes:
Brief Facts:A Synopsis of the Facts of the case.
Rule of Law:Identifies the Legal Principle the Court used in deciding the case.
Facts:What are the factual circumstances that gave rise to the civil or criminal case? What is the relationship of the Parties that are involved in the case.
Issue(s):Lists the Questions of Law that are raised by the Facts of the case.
Holding:Shares the Court's answer to the legal questions raised in the issue.
Concurring / Dissenting Opinions:Includes valuable concurring or dissenting opinions and their key points.
Reasoning and Analysis:Identifies the chain of argument(s) which led the judges to rule as they did.