Warning defect

Defect. A plaintiff must estabUsh that the product which iajured him was defective. A product can be defective ia three ways it may be defectively manufactured, defectively designed, or sold with iaadequate warnings. 

A product may also be defective because it was sold with iaadequate wamiags. Burch vs Amsterdam Corporatioa (11) is an early example of a failure-to-wam case. A plaintiff was badly burned ia an explosion and flash fire that occurred while he was applyiag a floor tile adhesive sold by the defendant. The label on the can of mastic adhesive warned that the product was extremely flammable and should not be used near a fire or flame. 

In June 1992, the American Law Institute undertook the task of drafting the Restatement (Third) of Torts "Products LiabiUty." Tentative Draft No. 2 takes the position that different HabiUty rules must apply for manufacturing defects and defects based on inadequate design or failure to warn ... 

Most manufacturers perform periodie tests on their products for total microbial bioburden and for the presence of known problem mieroorganisms, to be used for in-house eonfirmahon of the eonhnuing efFieiency of their GPMP systems, rather than as conventional end-produet eonformance tests. Fluetuation in values, or the appearanee of speeific and unusual species, can warn of defects in procedure and impending problems. 

Most warn of the increased risk of deformities of limb development and defects like cleft palate. A few drugs carry the risk of distinct organ defects. For example, chlorambucil may cause agenesis of the fetal kidneys Penicillamine seems to affect fetal connective tissue, causing relaxation of the skin, hypotonia, and hyper flexion of the hips and shoulders... 

Hematologic effects Aspirin interferes with hemostasis. Avoid use if patients have severe anemia, history of blood coagulation defects, or take anticoagulants. Long-term therapy To avoid potentially toxic concentrations, warn patients on long-term therapy not to take other salicylates (nonprescription analgesics, etc). Salicylism Salicylism may require dosage adjustment. 

Tablets/Capsules/Oral solution Ribavirin may cause birth defects or death of the exposed fetus. Ribavirin is contraindicated in women who are pregnant or in men whose female partners are pregnant (see Warnings), in patients with a history of hypersensitivity to ribavirin or any component of the drug, and in patients with hemoglobinopathies (eg, thalassemia major, sickle-cell anemia).

Ribavirin use Ribavirin may cause birth defects and/or death of the unborn child. Take extreme care to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with ribavirin therapy may result in a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic consider it a potential carcinogen (see Ribavirin monograph for additional information and warnings). 

Must have signed a patient information/consent form that contains warnings about the risk of potential birth defects if the fetus is exposed to isotretinoin. 

A federal law requires warning labels on alcoholic beverage containers. They state that women should not drink during pregnancy due to the risk of birth defects, and that alcoholic beverages impair your ability to drive a car or operate machinery and may cause other health problems. Lower costs and the availability of a smokable version leads to a resurgence in heroin use. 

Phenylketonuria was among the first inheritable metabolic defects discovered in humans. When this condition is recognized early in infancy, mental retardation can largely be prevented by rigid dietary control. The diet must supply only enough phenylalanine and tyrosine to meet the needs for protein synthesis. Consumption of protein-rich foods must be curtailed. Natural proteins, such as casein of milk, must first be hydrolyzed and much of the phenylalanine removed to provide an appropriate diet, at least through childhood. Because the artificial sweetener aspartame is a dipeptide of aspartate and the methyl ester of phenylalanine (see Fig. l-23b), foods sweetened with aspartame bear warnings addressed to individuals on phenylalanine-controlled diets. 

Mr. Kirwan, in the defects that he takes exception to in my table of the affinities of the oxygen principle with various substances, does not judge me more severely than I have judged myself, but he should be warned that all the objections he makes against this table I have made before he did, and perhaps in a stronger manner. ... 

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