Wyeth v. Levine: Challenging Implied Pre-emption for drugs

2009 ◽  
Vol 37 (3) ◽  
pp. 527-530
Author(s):  
Pooja Nair
Keyword(s):  
Supreme Court ◽  
Drug Administration ◽  
Medical Devices ◽  
Food And Drug Administration ◽  
State Law ◽  
Drug Labeling ◽  
The Supreme Court ◽  
Premarket Approval ◽  
Tort Claims

In March 2009, the Supreme Court held in Wyeth v. Levine that federal drug labeling laws do not pre-empt state tort claims against drug manufacturers. The decision surprised many Court watchers, coming on the heels of a 2008 decision, Riegel v. Medtronic, in which the Court found that the Food, Drug, and Cosmetic Act (FDCA) does pre-empt state-law claims for injuries caused by medical devices that received premarket approval from the Food and Drug Administration. Wyeth dealt an immediate and surprising blow to the pharmaceutical industry’s principal strategy for avoiding tort lawsuits, but failed to clarify the Court’s overall pre-emption jurisprudence.

Drug Preemption and the Need to Reform the FDA Consultation Process

2008 ◽  
Vol 34 (4) ◽  
pp. 539-561 ◽  
Author(s):  
Margaret Gilhooley
Keyword(s):  
Supreme Court ◽  
Prescription Drug ◽  
Drug Administration ◽  
Medical Devices ◽  
Food And Drug Administration ◽  
Product Liability ◽  
Drug Manufacturer ◽  
Tort Liability ◽  
Consultation Process ◽  
The Supreme Court

The scope of product liability for prescription drug injuries is a highstakes matter. As the recent Vioxx litigation illustrates, drug manufacturers can face numerous lawsuits when users are injured by risks discovered only after the drug reaches the market. The extent to which Food and Drug Administration (FDA) decisions preempt tort liability has emerged as a major issue. The agency itself has issued a policy that favors preemption when a drug manufacturer consults with the agency about a new risk. The Supreme Court has found liability preempted for medical devices based on an express preemption provisions and is expected to make an important ruling on drug preemption this term in Wyeth v. Levine. Some believe that the Court will rule in favor of preemption even though there is no express statutory provision for drugs.

scholarly journals Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008-2017

2021 ◽  
Vol 4 (5) ◽  
pp. e217274
Author(s):  
Jonathan R. Dubin ◽  
Stephen D. Simon ◽  
Kirsten Norrell ◽  
Jacob Perera ◽  
Jacob Gowen ◽  
...  
Keyword(s):  
Drug Administration ◽  
Medical Devices ◽  
Food And Drug Administration ◽  
Premarket Approval

Characterization of Pharmacogenetic Information in Food and Drug Administration Drug Labeling and the Table of Pharmacogenetic Associations

2020 ◽  
pp. 106002802098304
Author(s):  
Christine M. Cheng ◽  
Thomas W. So ◽  
Jeff L. Bubp
Keyword(s):  
Clinical Outcome ◽  
Drug Administration ◽  
Gene Pair ◽  
Drug Disposition ◽  
Food And Drug Administration ◽  
Cross Sectional ◽  
Drug Labeling ◽  
Gene Pairs ◽  
Genetic Test Results ◽  
Sectional Analysis

Background: The US Food and Drug Administration (FDA) recommends using only FDA-reviewed pharmacogenetic information to make prescribing decisions based on genetic test results. Such information is available in drug labeling and in the Table of Pharmacogenetic Associations (“Associations table”). Objective: To compile a list of drug-gene pairs from drug labeling and the Associations table and categorize the pharmacogenetic information and clinical outcome associated with each drug-gene pair. Methods: This was a cross-sectional analysis of pharmacogenetic information in the Associations table and individual drug labeling in March 2020. We used the Table of Pharmacogenomic Biomarkers in Drug Labeling to identify drug labels to review. We categorized the pharmacogenetic information for each drug-gene pair according to whether the purpose was to describe (1) polymorphisms affecting drug disposition (metabolism or transport), (2) polymorphisms affecting a direct drug target, (3) variants associated with adverse drug reaction (ADR) susceptibility, (4) variants associated with therapeutic failure, (5) a biomarker-defined indication, or (6) a biomarker-defined ADR. We also categorized the clinical outcome—efficacy, safety, or unknown—associated with each drug-gene pair. We reported counts and proportions of drug-gene pairs in each pharmacogenetic information and clinical outcome category. Results: We identified 308 drug-gene pairs, of which 36% were associated with a biomarker-defined drug indication, 33% with polymorphic drug metabolism, and 28% with ADR susceptibility. Most drug-gene pairs (n = 267, 87%) were associated with an efficacy or safety-related outcome. Conclusion and Relevance: FDA-reviewed pharmacogenetic information is available for more than 300 drug-gene pairs and can help guide prescribing decisions.

SUIT CLAIMS RESEARCH-HOSPITAL DOCTORS SUBMITTED PHONY BILLS TO GET U.S. FUNDS

PEDIATRICS ◽  
1995 ◽  
Vol 96 (5) ◽  
pp. A41-A41
Author(s):  
J. F. L.
Keyword(s):  
Drug Administration ◽  
Medical Devices ◽  
Food And Drug Administration ◽  
Controversial Issue ◽  
Criminal Investigation ◽  
Research Hospital ◽  
Medical Centers ◽  
Cardiac Procedures ◽  
Hospital Doctors ◽  
The Government

Physicians at dozens of prominent research hospitals nationwide allegedly submitted phony bills and sometimes even falsified patients' records to obtain as much as $1 billion in federal payments for sophisticated, but still experimental, cardiac procedures, a newly unsealed whistleblower suit claims. The allegations of years of systematic fraud involving as many as 130 major medical centers nationwide, accusations that already have prompted a previously reported criminal investigation, are likely to shine a spotlight on the controversial issue of which cutting-edge devices and procedures currently are, or should be, eligible for Medicare or Medicaid claims. Existing regulations say that the government generally won't pay for treatment considered to be "experimental" or for the use of medical devices that haven't been formally approved by the Food and Drug Administration...

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