In a landmark liability case the US Supreme Court ruled in favor of the plaintiff in her suit against Wyeth Pharmaceuticals, the makers of Phenergan. Diane Levine was injected with the anti-nausea drug as part of a migraine treatment. The pharmaceuticals company was found negligent in not providing a warning on the package label that would alert doctors or patients as to the dangers of administering Phenergan by injection. The drug’s label was approved by the FDA.
The court’s decision eliminates indemnity for manufacturers in spite of FDA label approvals. "The question we must decide is whether the FDA’s approvals provide Wyeth with a complete defense to Levine’s tort claims, We conclude that they do not," Justice John Paul Stevens concluded in the court’s majority opinion.
The label approval process is lengthy and expensive, so if companies discover a danger after the fact they are not likely to re-submit for approval. (Wyeth attorney’s argued they believed federal law prohibited them from alterning the FDA approved version of the label.)
The Wyeth case sets a precedent of ruling in favor of the consumer instead of big business in liability cases and could pave the way for legal suits involving consumer packaged goods, including house cleaning products. Currently cleaning product manufacturers are protected from divulging their product ingredients on the FDA-approved package label even though more and more research suggests house cleaning chemicals bear ingredients that introduce health risks for humans and pets.
This is a major win for consumers of not just pharmaceuticals but also house cleaning products. David Frederick, Levine’s attorney says the court’s opinion "reaffirms the important role state laws play in promoting consumers safety and providing compensation for injuries."
This is also a major warning to consumers: read the label and pay attention to what it says, but pay attention to what it doesn’t say also. If you think your house cleaning products may not be safe, do some research. We like the Household Products Database as a convenient online reference tool:
Source: (Reuters, Supreme Court rules against Wyeth in liability case, 2009-03-04)