2014, FDA Compliance and Marketing - Drug Discovery Digest

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 Trials FDA Approval

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

Drug & Device Law

JANUARY 15, 2024

We have discussed how exclusion of FDA compliance in pelvic mesh cases, based on a false equivalence between preemption and evidentiary admissibility, has hampered the defense in that litigation. A plaintiff’s pursuit of such theories thus should allow admission of standards compliance evidence. Coffing Hoist Division , 528 A.2d

Compliance

Compliance Government Production FDA Compliance

Drug Discovery Digest

A Thorny PMA Preemption Decision from Rhode Island

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

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