Download Toxic Shock Syndrome Litigation

Toxic Shock Syndrome Litigation
Toxic Shock Syndrome (TSS) is a serious, sometimes fatal disease, caused by a toxin produced by certain
types of bacteria. TSS first emerged in the late 1970s and early 1980s. It showed up in women using
highly absorbent menstrual tampons. The symptoms of the disease include high fever, a red rash,
muscle ache, nausea, vomiting and/or diarrhea, seizures, headache, and organ failure. Studies by the
Centers for Disease Control and by several state health departments show that a statistically significant
link exists between tampon use and TSS. Certain brands of super-absorbent tampons were withdrawn
from the market in the 1980s.
Menstrual tampons are a Class II medical device. The U.S. Food and Drug Administration (FDA) regulate
tampons. The FDA has enacted regulations that require manufacturers to label tampons and to warn
consumers of the risks associated with their use. Consumers have generally lost lawsuits against tampon
manufactures in which the consumers claimed the manufacturers failed to warn of the dangers of
tampon use or gave inadequate warnings. In one federal case by a consumer, the court found in favor of
the tampon manufacturer because the tampon package included a warning in the exact language of the
FDA regulation. The package insert also provided information about TSS, as required by the federal
regulation. The courts have held that the federal regulations on tampon preempt or block any state
claims against the manufacturers for failure to warn about the risks of tampon use.
Consumers have claimed design defect in suits against tampon manufacturers. Studies have shown that
tampons made from pure cotton are safer than tampons made of a rayon-cotton blend. Consumers
have also argued that the tampon is defectively designed because it is more absorbent than it should be
in order to be a safe product. In 1996, the United States Supreme Court held that federal law did not
preempt a consumer's claims based on design defect, defective manufacture and failure to warn.
In a 2003 decision, a federal court of appeals held that the district court properly found that a
consumer's state law failure to warn claims were preempted by federal regulation. The consumer's
design defect claims were properly dismissed, the appeals court said, because the consumer failed to
show that the risks inherent in marketing rayon tampons outweighed the benefit to consumers. Finally,
the consumer did not prevail because she had read the TSS alert statement on the outside of the
tampon package prior to her illness and she was aware of the risk of TSS from tampon use.