Labels, Lawyers, & Logic
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Keywords

Tort reform
Product Labeling
FDA
Federal Preemption
Vaccines
Access
Cost

Abstract

America deserves access to high-quality health care without avoidable medical errors and complications. This achievable goal begins with harnessing and using the power of information. And that begins with clear, accurate, and usable labeling.

The American health care system is undermined, underserved, and undervalued when labeling is written more for corporate liability protection than as a valuable tool for health care providers.

Today, labeling includes excessive risk information and exaggerated warnings. And this has set into motion a dangerous dynamic: labeling that does not accurately communicate to either the health care professional or the patient the conditions in which any given product can be used safely and effectively. This is nothing less than a grave menace to the public health. America is suffering from a legal system that is dangerous to its health. Why has this happened? There is, unfortunately, a simple answer - fear of liability. Manufacturers have significant monetary incentives to add dense and confusing legalese because, under current law in most states, they can be found liable for failing to provide "adequate" warnings about therapeutic products. Money, not medicine, is driving this dangerous practice. When it comes to labeling written for lawyers rather than doctors, more is less.

https://doi.org/10.5912/jcb699
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References

United States District Court for the Northern District of Illinois, Eastern Division, Case No. 14-cv-04361

http://paindr.com/wp-content/uploads/2013/09

/FDA_CDER_Response_to_Physicians_for_Responsible_Opioid_Prescribing_Partial_Petition_Approval_and_Denial.pdf

Ibid

http://www.citizen.org/documents/2048.pdf

www.phrma.org

http://www.manhattan-institute.org/pdf/triallawyersinc.pdf

http://www.triallawyersinc.com/html/print02.html

“The Litigation Machine,†Business Week, January 29, 2001

Ibid

Ibid

http://www.rand.org/pubs/technical_reports/TR562z17/analysis-of-medical-malpractice.html

http://www.fda.gov/NewsEvents/Speeches/ucm053699.htm

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