About | HeinOnline Law Journal Library | HeinOnline Law Journal Library | HeinOnline

12 Cardozo Pub. L. Pol'y & Ethics J. 423 (2013-2014)
Failing to Warn in the Context of Rare Side Effects

handle is hein.journals/cardplp12 and id is 457 raw text is: FAILING TO WARN IN THE CONTEXT OF
RARE SIDE EFFECTS
Morris Dweck*
The act of Choice that can be determined by pure Reason, consti-
tutes the act of Free-will. That act which is determinable only by
Inclination as a sensuous impulse or stimulus would be irrational
brute Choice (arbitrium brutum).... The Freedom of the act of voli-
tional Choice, is its independence of being determined by sensuous
impulses or stimuli. This forms the negative conception of the Free-
will. The positive Conception of Freedom is given by the fact that the
Will is the capability of Pure Reason to be practical of itself.'
INTRODUCTION    ..............................................  424
I. THE DUTY OF A DRUG MANUFACTURER .............. 426
A. Balancing the Risks and the Benefits .............. 426
B. The General Duty to Warn .....................      429
i.  Rarity of Occurrence and the Duty to Warn... 430
ii. Adverse Reaction Reports ..................... 433
II. THE LEARNED INTERMEDIARY DOCTRINE ............. 436
A. Exceptions to the Learned Intermediary Doctrine ..... 438
III. A DOCTOR'S DUTY TO WARN ........................ 439
A. The Standard of Review in the Medical Profession.... 440
i.  The New York Standard ................... 441
B. Plaintiffs Burden of Proof in an Informed Consent
Claim...      ........................    ...... 442
IV. CURRENT CASE LAW IN NEW YORK DEALING WITH
RARE SIDE EFFECTS .................................. 443
V. INTERPRETING STATISTICS AND CREATING A LIABILITY
SCALE................................................ 449
A.   The Affect Heuristic ...............................  450
B. The Statistical Liability Scale....................... 453
CONCLUSION   .................................................  456
* J.D. Candidate, 2014, Benjamin N. Cardozo School of Law; Notes Editor, Cardozo Pub-
lic Law, Policy & Ethics journal; B.A., 2010, Macaulay Honors College, Brooklyn College.
Thank you to Professor Ekow Yankah for his guidance in writing this Note.
1 IMMANUEL KANT, THE PHILOSOPHY OF LAW: AN EXPOSITION OF THE FUNDAMENTAL
PRINCIPLES OF JURISPRUDENCE AS THE SCIENCE OF RIGHT 13, (William Hastie trans., Edin-
burgh, T. & T. Clark 1887), available at http://books.google.com/books?id= FakeAQAAMAAJ
&printsec=frontcover&source=gbsge-summary-r&cad=0#v=onepage&q&f=false.

423

What Is HeinOnline?

HeinOnline is a subscription-based resource containing thousands of academic and legal journals from inception; complete coverage of government documents such as U.S. Statutes at Large, U.S. Code, Federal Register, Code of Federal Regulations, U.S. Reports, and much more. Documents are image-based, fully searchable PDFs with the authority of print combined with the accessibility of a user-friendly and powerful database. For more information, request a quote or trial for your organization below.



Short-term subscription options include 24 hours, 48 hours, or 1 week to HeinOnline.

Contact us for annual subscription options:

Already a HeinOnline Subscriber?

profiles profiles most