TITLE

Defending Products Liability Suits Involving Off-Label Use: Does the Learned Intermediary Doctrine Apply?

AUTHOR(S)
Trasatti, Marisa A.; Lanzendorfer, Lindsey N.
PUB. DATE
September 2011
SOURCE
FDCC Quarterly;Fall2011, Vol. 62 Issue 1, p2
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
The article offers discussion on the marketing of drugs and medical devices for off-label use and the role of learned intermediary doctrine in protecting manufacturers against consumer claims. It states difficulties in explaining the risks associated with the off-label use of drugs by physicians who uses it for the treatment of particular condition. It mentions learned intermediary doctrine to be applicable in all cases as physicians use their entire knowledge and training to treat patients.
ACCESSION #
76131401

 

Related Articles

  • Prescription Errors in Psychiatry. Nair, Ashish; Srivastava, Mona // Internet Journal of Medical Update;Jul2013, Vol. 8 Issue 2, p70 

    Prescribing errors are common in mental health settings and a significant number of these errors may result in a serious outcome. In the majority of cases, simple steps such as reduced junior doctor workload, improved training in psychopharmacology and more direct supervision of prescribing may...

  • Back to the Future: Civil RICO in Off-Label Promotion Litigation. Cooney Jr., J. Gordon; Lavelle Jr., John P.; Shariati, Bahar // Defense Counsel Journal;Apr2010, Vol. 77 Issue 2, p168 

    The article discusses several court cases and analyzes the legal principles which have limited attempted expansion of civil Racketeer Influenced and Corrupt Organizations Act (RICO) in the U.S. It states that in the In re Epogen & Aranesp Off-Label Marketing, the plaintiffs allege that Amgen...

  • Biotech Lawsuits: Jan. 1 - Dec. 31, 2012.  // BioWorld Insight;1/21/2013, Vol. 21 Issue 4, p13 

    The article presents details on lawsuits in the pharmaceutical biotechnology industry in the U.S. It mentions that Abbott Laboratories Inc. agreed to pay $1.5 billion to settle issues related to the company's off-label promotion of the medication Depakote after it pled guilty. It notes that...

  • Handle firing with care if employee has complained about alleged corporate wrongdoing.  // HR Specialist: Florida Employment Law;Nov2010, Vol. 5 Issue 11, p2 

    The article focuses on corporate wrongdoing relative to the retaliation case which involves Roche Laboratories' pharmaceutical representative Carolyn Gleason. It states that employees in the private sector are protected from retaliation if they reject to be involved in an illegal behavior that...

  • Is prescribing now lost in translation? Church, David // Pulse;5/9/2012, Vol. 72 Issue 17, p16 

    A letter to the editor is presented in response to the article "GPs face clampdown on off-label prescribing after pharma company challenge" in the www.pulsetoday.co.uk/news.

  • Attorney offers tips to lessen liability when prescribing off label. Mullin, David W.; Nale, Patricia // Primary Care Optometry News;Jul2012, Vol. 17 Issue 7, p8 

    The article reports on the tips offered by Attorney William P. Ramey III on the steps that should be undertaken by physicians to limit their liability when prescribing approved drugs for off-label use in the U.S.

  • Off-Label But On Point? Werthelmer, Albert // Pharmaceutical Executive;Apr2011, Vol. 31 Issue 4, p76 

    The article focuses on the off-label use of drugs in the U.S. It says that physicians have delicate roles on off-label prescription to ensure safety of the patient. It notes that the freedom of physicians to prescribe off-label use of drugs promotes innovation in clinical practice. It mentions...

  • Off-label use of medicine: Perspective of physicians, patients, pharmaceutical companies and regulatoryauthorities. Sandeep Kumar Gupta; Roopa Prasad Nayak // Journal of Pharmacology & Pharmacotherapeutics;Apr-Jun2014, Vol. 5 Issue 2, p88 

    Off-label prescribing of medicines is prevalent worldwide because it gives freedom to physicians to apply new therapeutic options based on the latest evidence. Although physicians may lawfully prescribe approved drugs for any use consistent with available scientific data and proper medical...

  • Off-label use of anti-cancer drugs in India: To be or not to be! Gota, Vikram; Patial, Pankaj // Journal of Cancer Research & Therapeutics;Jan-Mar2011, Vol. 7 Issue 1, p35 

    Background: Administering drugs outside the terms of their official labeling is called off-label use. In the West, oncologists often use drugs off-label, which offers several advantages especially while treating patients with multiple comorbidities or advanced cancer. The practice of off-label...

Share

Read the Article

Courtesy of VIRGINIA BEACH PUBLIC LIBRARY AND SYSTEM

Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics