Product Refinements Can Bring Product Liability: Bayer's Yaz And Yasmin Hit With Wave of Personal Injury Suits
Entering a crowded market with a slight twist on a well-established product is often a successful strategy. But Bayer is learning what Johnson & Johnson learned: modest changes to hormonal birth control products can produce lawsuits as much as they drive sales
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Bayer’s birth control pills Yasmin and Yaz face the most pharmaceutical product liability actions in federal court followed by Pfizer’s Prempro and GlaxoSmithKline’s Avandia. While GSK has settled the bulk of cases before a single trial, Merck and Novartis are winning Fosamax and Aredia jury verdicts.
FDA has oversight over DTC advertising for Bayer’s Yaz contraceptive after the company violated an earlier agreement with state attorneys general.
Stakeholders suggest a variety of USPTO and FDA actions that could help ensure patents do not improperly delay generic and biosimilar competition.