Drug & Device Law

JANUARY 15, 2024

A fourth Justice concurred in the result, treating the issue of standards compliance in Sullivan as a matter of evidence, and holding that the lack of a sufficient trial record supporting the relevance of the specific standards at issue in Sullivan meant that the trial judge’s exclusion was not an abuse of discretion. 2d 521 (Pa.

Compliance 52

Compliance Government FDA Compliance Production 52

Drug & Device Law

JUNE 6, 2022

Thus a confident learned intermediary’s testimony will defeat causation as a matter of law by stating that, notwithstanding a poor result, the treatment provided was standard of care, and even in hindsight they would not do anything different. Confident learned intermediaries stand by their medical decisions. caused anything. 3d 87, 95 (Tex.

Testimonials 59

Testimonials Production Pharmaceuticals Treatment 59

Drug & Device Law

MARCH 16, 2023

In two of these cases, our client won summary judgment at the trial court level and an appellate court ended up creating a new cause of action to accommodate the plaintiff’s theory (and lack of helpful testimony from the prescribing physician). There was a similar endorsement in 2018.

FDA Approval 59

FDA Approval FDA Testimonials Production 59

Drug & Device Law

MARCH 4, 2024

In the middle was In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices. & Plaintiffs will not be heard to argue that they “could have shored up their cases by other means had they known their expert testimony would be found inadmissible.” 49, 55 (2005). Weisgram v. Marley Co. , 440, 455-56 (2000). Fru-Con Inc. ,

Testimonials 52

Testimonials Production Vaccine Pharmaceuticals 52