| No search history |
Your feedback is extremely important to us and greatly appreciated.
Tell us what went wrong

In the case of Medtronic, Inc. v. Lora Lohr et vir in 1995, the U.S Supreme Court was tasked with determining whether federal law preempted state common-law claims regarding a medical device that had been approved by the Food and Drug Administration (FDA). The plaintiff, Lora Lohr, suffered injuries from an allegedly defective pacemaker manufactured by Medtronic. She filed a lawsuit against Medtronic under Florida's product liability laws claiming negligence and strict liability among other things. However, Medtronic argued that these state-level claims were preempted by federal law - specifically the Medical Device Amendments of 1976 to the Federal Food Drug & Cosmetic Act which prohibits states from establishing any requirement relating to safety or effectiveness that is different from or in addition to FDA requirements for medical devices. The court held in a mixed decision (5-4 on some issues) that while some aspects of Ms. Lohr’s claim might be pre-empted if they sought to impose safety standards different than those required federally; her general state common-law claims were not necessarily precluded as they did not conflict with federal regulations but rather sought damages for violation thereof.
In the dissenting opinion for Medtronic, Inc. v. Lora Lohr et vir, Justice Clarence Thomas argued that federal law preempts state common-law claims challenging the safety or effectiveness of medical devices approved by the Food and Drug Administration (FDA). He contended that Congress intended to create a national, uniform standard for medical device safety under the Medical Device Amendments of 1976 (MDA) to prevent states from imposing their own potentially conflicting requirements. According to him, allowing such lawsuits would undermine this goal by subjecting manufacturers to different liability standards in each state where their products are sold. Furthermore, he disagreed with majority's interpretation of "requirement" in MDA’s preemption clause and stated it should be interpreted broadly enough to include duties imposed through tort litigation.