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Product
Liability refers to the legal liability of manufacturers and
sellers to compensate for an injury or a damage resulting
from a defective medication or goods purchased by the patient.
EpiConsults,
Inc. had the privilege to work in different product liability
cases. Product Liabiblity includes pharmaceutical products
and defective products, most of which have been taken off the U.S.
and the Canadian
market by the FDA after serious adverse drug or device reactions
were reported to the FDA. Law suits are being filed constantly
in various U.S. and Canadian courts of justice allegedly claiming that pharmaceutical
companies outweighed benefits over risks. Financial gains
were substantial in the amount of billions of dollars forcing
the manufacturers to increase their advertising campaigns
and to ignore various health risks.
Health risks include Valvular Heart Disease, Pulmunary Hypertension
as in the case with Fenfluramine and Phentermine also known
as the combination cocktail of Fen-Phen.
Arrythmias and Torsade de Points in the case of Propulsid,
Liver Failure with Rezulin, Lamisil and Sporanox, Stroke and
increased blood pressure with PPA and Ephedra, Rhabdomyolysis
with Baycol among others.
Fen-Phen is probably the most popular example of product liability
ever brought to justice in the U.S.and Canada. The Food and Drug Administration,
acted on evidence about significant side-effects associated
with Fenfluramine and Dexfenfluramine, has asked the manufacturers
to voluntarily withdraw both treatments for obesity from the
market in Sept of 1997. Dexfenfluramine is manufactured for
Interneuron Pharmaceuticals and marketed under the name of Redux by Wyeth-Ayerst Laboratories, a subsidiary of American
Home Products Corp. of Madison, N.J., which also manufactures
and markets fenfluramine under the brand name Pondimin. Both
companies have agreed to voluntarily withdraw their drugs.
The FDA is not requesting the withdrawal of phentermine, the
third widely used medication for obesity.
The list of products includes but not limited to Fen-Phen, Propulsid, Rezulin, PPA, Lamisil,
Sporanox, Baycol, Celebrex, Vioxx, and Oxycontin, Sulzer hip
and knee replacements, etc.
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