PMID- 19999286
OWN - HSR
STAT- MEDLINE
DCOM- 20091222
LR  - 20100112
IS  - 1064-590X (Print)
IS  - 1064-590X (Linking)
VI  - 64
IP  - 2
DP  - 2009
TI  - Life after Riegel: a fresh look at medical device preemption one year after 
      Riegel v. Medtronic, Inc.
PG  - 291-311
AB  - The United States Supreme Court's landmark decision in Riegel v. Medtronic, Inc. 
      in February 2008 altered the landscape of medical device litigation involving 
      Class III medical devices that have received premarket approval from the Food and 
      Drug Administration (FDA).In Riegel, the Court ruled that the premarket approval 
      process establishes federal requirements and that state law tort claims seeking 
      to impose additional or different requirements on device manufacturers are 
      preempted under the express preemption clause of the Medical Device Amendments 
      (MDA) to the Food, Drug and Cosmetic Act (FDCA). It is only by examining 
      post-Riegel case law that one can develop an appreciation for where medical 
      device litigation and device preemption are likely to head in the future. This 
      article will conduct this evaluation of post-Riegel decisions by dividing the 
      courts' rulings into various types of cases. This classification of claims 
      provides insights into the strategies employed by plaintiffs to distinguish 
      Riegel or side-step the ruling altogether and how courts have received these 
      efforts.
FAU - Wartman, Gregory J
AU  - Wartman GJ
AD  - Saul Ewing LLP, Philadelphia, PA, USA.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Food Drug Law J
JT  - Food and drug law journal
JID - 9215384
MH  - Device Approval/*legislation & jurisprudence
MH  - Duty to Warn/legislation & jurisprudence
MH  - Equipment Failure
MH  - Federal Government
MH  - Fraud/legislation & jurisprudence
MH  - Humans
MH  - *Liability, Legal
MH  - Pacemaker, Artificial/adverse effects
MH  - State Government
MH  - United States
MH  - United States Food and Drug Administration
EDAT- 2009/12/17 06:00
MHDA- 2009/12/23 06:00
CRDT- 2009/12/17 06:00
PHST- 2009/12/17 06:00 [entrez]
PHST- 2009/12/17 06:00 [pubmed]
PHST- 2009/12/23 06:00 [medline]
PST - ppublish
SO  - Food Drug Law J. 2009;64(2):291-311.