Recently by Vincent Lodato
Appellate Law
Poking Holes in Pliva v. Mensing: Are Failure to Timely Update Label Claims Cognizable?
In Pliva, Inc. v. Mensing, 131 S. Ct. 2567 (2011), the United States Supreme Court held that state law failure to warn claims against manufacturers of generic pharmaceutical products were impliedly pre-empted by federal law because FDA regulations preclude generic manufacturers from including...
Read MoreEffective Use Of A Regulatory Expert In Product Liability Litigation
Regulatory issues are often front and center in complex pharmaceutical and medical device product liability litigation. Plaintiffs' complaints routinely focus on product labels and claim that they do not adequately reflect risks which were known or learned during pre-clinical testing, clinical...
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