title: Bad medicine: prescription drugs, preemption, and the potential for a no-fault fix.
abstract: For decades, federal regulation of pharmaceutical drugs and medical devices has worked hand in hand with state tort claims to protect the health and safety of the American public. Now, a new trend toward preemption endangers this scheme. In recent years, the Supreme Court has given increasing deference to agency assertions about their preemptive authority and has found preemption in an increasing number of cases. In the process, the Supreme Court has preempted claims for medical device injuries and left claims for pharmaceutical harms in a precarious position. The elimination of common law claims for drug and device harms will leave holes in the FDA's regulatory scheme, endangering the health and safety of Americans. It will also prevent ordinary Americans from seeking compensation for their injuries--even those injuries caused by manufacturer malfeasance. This Article proposes that Congress create a no-fault compensation scheme for drugs and medical devices to close these gaps. Such a scheme could be both practical and politically possible, satisfying manufacturers, tort reformers, patients, and plaintiffs' lawyers alike.
authors.forename: Amalea
authors.initials: A
authors.lastname: Smirniotopoulos
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration*; D001720:Birth Injuries; D002648:Child; D035881:Compensation and Redress / Q000331:legislation & jurisprudence; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence*; D003625:Data Collection; D018795:Device Approval / Q000331:legislation & jurisprudence; D017277:Drug Approval / Q000331:legislation & jurisprudence; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D064420:Drug-Related Side Effects and Adverse Reactions; D035082:Federal Government; D005260:Female; D033161:Government Regulation; D006801:Humans; D007231:Infant, Newborn; D007344:Insurance Claim Reporting / Q000331:legislation & jurisprudence; D007345:Insurance Claim Review / Q000331:legislation & jurisprudence; D007880:Legislation, Drug; D016365:Liability, Legal; D008318:Malpractice; D032541:Mass Vaccination / Q000009:adverse effects / Q000331:legislation & jurisprudence; D009313:National Health Programs / Q000458:organization & administration; D061214:Patient Safety / Q000331:legislation & jurisprudence*; D011247:Pregnancy; D055553:Prescription Drugs; D011358:Product Surveillance, Postmarketing; D013219:State Government; D035521:Supreme Court Decisions; D020196:Trauma, Nervous System; D014481:United States; D014486:United States Food and Drug Administration; D014611:Vaccination / Q000009:adverse effects / Q000331:legislation & jurisprudence
chemical_list: D055553:Prescription Drugs