Women Harmed By Yaz, Yasmin, or Ocella May Have Products Liability Claims

Lawsuits are mounting against the drug manufacturer Bayer International, Inc., for injuries allegedly caused by the oral contraceptives Yaz, Yasmin, and Ocella. In Indiana, more than 50 women have sued Bayer, according to 6News, an Indiana news outlet. The plaintiffs claim that these drugs are dangerous and defective, causing heart attacks and strokes in women who take them.

In the Indiana class action lawsuit, plaintiffs argue that the warning label on the drug packaging is not enough to sufficiently caution women about the risks of taking Yaz, Yasmin, and Ocella. If a product manufacturer fails to warn consumers about safety risks inherent in the use of its product, the manufacturer may be held liable in a defective products lawsuit for injuries caused as a result of the failure to warn.

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 Indiana plaintiffs, Bayer has also been reprimanded by the FDA for having engaged in a misleading advertising campaign, including failing to adequately communicate the risks associated with taking these drugs. That campaign, despite its disingenuous marketing approach, helped to make Yaz the most popular oral contraceptive in the United States. In fact, more than 30 percent of women who use hormonal oral contraceptives take Yaz or Yasmin, according to 6News.