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TBI was the first nationwide (or close to it) analysis of whether a given jurisdiction permitted, under state law, a “warning”-based cause of action against a manufacturer of an FDA-regulated prescription drug or medical device for allegedly failing to report adverse events to the FDA.
142 (2007), mere regulation of the product or conduct at issue—the medical walker is a non-prescription, Class I medical device with general controls only—is not a basis for removal under this statute. In those cases , the question is often whether the claims put FDAcompliance at issue or whether the defenses do.
That is significant because, unlike (now) every other state in the country, since 1987 Pennsylvania precedent prohibited defendants from introducing evidence of their compliance with government and/or industry standards (“standards compliance” or “compliance” evidence, for short) in strict liability design defect cases – generally.
2018), holding (as discussed here ) that New Jersey multi-county mass-tort litigation will henceforth be governed exclusively by New Jersey law, no matter where the plaintiff resided. pursuant to conditions established by the federal Food and Drug Administration and applicable regulations, including. . . labeling regulations.
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