Drug & Device Law

MARCH 19, 2024

Moreover, the defense prevailed in Hodges : The plaintiffs next argue that the trial justice erred in restricting the jury’s use of the evidence it introduced concerning certain government reports filed by [defendant] that detailed patients’ negative experiences after taking [the drug].

FDA 52

FDA FDA Compliance Trials FDA Approval 52

Drug & Device Law

JANUARY 25, 2024

Put simply, among the morass of Medicare are provisions governing Medicare Advantage programs, which companies can elect to provide and eligible people can elect to receive. In those cases , the question is often whether the claims put FDA compliance at issue or whether the defenses do. Darue Eng’g & Mfg. ,

Production 52

Production Regulations FDA Compliance Compliance 52

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 52

Compliance Government Production FDA Compliance 52

Drug & Device Law

JULY 26, 2023

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. In pre-market approval cases, FDA compliance is controlling − a ground for preemption − so courts and juries never try those cases. at 523-24.

Compliance 52

Compliance FDA Compliance FDA Clinical Trials 52