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No Immunity in Product Liability Suit Because of FDA Warning
In March 2011, the U.S. Supreme Court unanimously affirmed a Ninth Circuit holding that the makers of Zicam Cold Remedy (Matrixx Initiatives, Inc.) were potentially liable for failing to disclose reports of a possible link between their product and anosmia (loss of smell).
The plaintiffs initiated a product liability lawsuit against Matrixx alleging that Zicam had damaged their sense of smell. They alleged that Matrixx made a series of misleading statements to the public, disclaiming any causal linkage between Zicam and anosmia in violation of federal laws prohibiting securities fraud.
The question presented to the High Court was whether the plaintiffs could maintain their claim for damages when the undisclosed reports of adverse effects associated with Zicam usage did not establish a statistically significant risk that Zicam was causing the events. The court reasoned (in part) that because both medical experts and the Food and Drug Administration rely on evidence other than statistically significant data to establish an inference of causation, so too could reasonable investors. See: Matrixx Initiatives, Inc v. Siracusano, 563 U. S. 1309 (2011).
The plaintiffs initiated a product liability lawsuit against Matrixx alleging that Zicam had damaged their sense of smell. They alleged that Matrixx made a series of misleading statements to the public, disclaiming any causal linkage between Zicam and anosmia in violation of federal laws prohibiting securities fraud.
The question presented to the High Court was whether the plaintiffs could maintain their claim for damages when the undisclosed reports of adverse effects associated with Zicam usage did not establish a statistically significant risk that Zicam was causing the events. The court reasoned (in part) that because both medical experts and the Food and Drug Administration rely on evidence other than statistically significant data to establish an inference of causation, so too could reasonable investors. See: Matrixx Initiatives, Inc v. Siracusano, 563 U. S. 1309 (2011).
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Related legal case
Matrixx Initiatives, Inc v. Siracusano
| Year | 2011 |
|---|---|
| Cite | 563 U. S. 1309 (2011) |
| Level | Supreme Court |
| Conclusion | Bench Verdict |
| Injunction Status | N/A |