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Liability for injuries caused by defective products may be based on either failure to warn, design defect, or manufacturing defect. In theory, Bayer could be vulnerable to all three types of products liability claims with respect to Yaz, Yasmin, and Ocella.
Design Defect?
If a product has a design defect, all of the products manufactured according to the design specifications will pose the same danger.
Yaz, Yasmin, and Ocella use a new synthetic progestin called drospirenone which, according to an August 2009 British Medical Journal study, may be the reason the pills carry a 6.3 times increased risk of deep vein thrombosis or pulmonary embolism (blood clots).
Manufacturing Defect?
With a manufacturing defect, something occurs during the manufacturing process that makes the product defective. This may be due to use of substandard materials, failure to inspect the product, or a problem on the assembly line.
Bayer has come under fire with the FDA for using a German manufacturing facility that does not adhere to minimum health and safety standards. Specifically, the way in which the facility calculates variability in ingredients does not meet American standards. If these sub-standard conditions lead to a manufacturing error and a woman is harmed as a result, she may be able to recover damages under a manufacturing defect theory.
Failure to Warn?
Products must have clear and complete warnings of any reasonably foreseeable hazards. Even if a product is safe in its design and manufacture, if the warnings and instructions fail to disclose a known risk associated with a product, or are vague or incomplete, the manufacturer can be held liable.
In addition to the claims brought by the