About Matthew Smith

Matthew P. Smith is a partner in the Products Liability Group in the San Francisco office. He is an experienced litigator who concentrates his practice on complex products liability cases, primarily involving pharmaceutical products and medical devices. Read Matthew's full bio

§ 510(k) Safety and Effectiveness – A Changing Landscape for Punitive Damages?

The Central District of California recently issued an opinion that breathes new life into the argument that the § 510(k) substantial equivalence process for Class II medical devices involves an FDA finding of safety and effectiveness. It is part of a trend of recent federal cases giving credence to the § 510(k) process, which could have significant implications for punitive damages claims brought against manufacturers of Class II devices.

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