2014, Compliance, FDA Compliance and Marketing

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2014

Compliance

FDA Compliance

Marketing

Dealing with the Pennsylvania Supreme Court’s Non-Decision on Standards Compliance Evidence

Drug & Device Law

JANUARY 15, 2024

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.

Compliance

Compliance Government FDA Compliance Production

A Thorny PMA Preemption Decision from Rhode Island

Drug & Device Law

MARCH 19, 2024

It involves allegations against the manufacturer and distributor of surgical clips used in tubal ligation surgery—Class III Pre-Market Approved (“PMA”) medical devices. Plaintiff had surgery in 2014 in which the clips were used. 14, 2024). Shortly thereafter she began experiencing several adverse symptoms, including pain.

FDA

FDA FDA Compliance FDA Approval Production

Drug Discovery Digest

Dealing with the Pennsylvania Supreme Court’s Non-Decision on Standards Compliance Evidence

A Thorny PMA Preemption Decision from Rhode Island

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