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14 UCLA J.L. & Tech. 31 (2010)

handle is hein.journals/ujlt14 and id is 1 raw text is: Spring 2010 www.lawtechjournal.com Volume 14, Issue 1 UCLA Journal of Law & Technology LEGAL ISSUES STEMMING FROM THE ADVANCEMENT OF PHARMACOGENOMICS Michael J. Donovan I. Pharmacogenomics Background ............................................................................................. 35 A. Pharmacogenomics: A Historical Perspective ......................................................................35 1. Pharmacogenomics in the Pre-Biotechnology Era.............................................................35 2. Pharmacogenomics in the Biotechnology Era and the Modern Science Behind It............36 B. The Pharmaceutical Industry's Cry for Pharmacogenomic Help ...................................... 39 1. T h e F D A P ro cess ...............................................................................................................3 9 2 . Pharm aceutical F ailures .....................................................................................................4 1 3. Pharmacogenomics to the Rescue?............................................................................... 43 II. Legal Issues ..................................................................................................................................45 A. Pharmaceutical Manufacturer's Potential Liability ...........................................................46 1. D e sig n D efects ...................................................................................................................4 6 2 . F ailure to W arn ..................................................................................................................4 8 3. C assidy v. Sm ithK line B eecham ........................................................................................52 B . Physician's Possible L iability ................................................................................................53 1. M edical M alpractice ...........................................................................................................54 2. Lack of Inform ed C onsent ............................................................................................. 58 C . P h arm acists ............................................................................................................................6 0 1. Common Law Changes in Pharmacists' Immunity from Duty to Warn Suits...................61 2. Omnibus Budget Reconciliation Act of 1990 (OBRA) ................................................. 62 III. C o n clu sio n .................................................................................................................................6 5 -31 -

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