Drug & Device Law

DECEMBER 21, 2023

Moreover (as we suspected at the time ), the unprecedented “express warranty” claim based on these drugs simply appearing in the FDA’s “Orange Book” that a previous Valsartan decision ( 2021-4 ) claimed to be the law in all fifty states, now appears as the linchpin for why that cause of action can be certified.

FDA Approval 52

FDA Approval FDA Drugs Production 52

Drug & Device Law

MARCH 6, 2024

It’s getting harder and harder to get civil jury trial experience. Still, wouldn’t it be better if your trial judge had some sense of how these things really work?) Moreover, not all of legal practice is open book. How should the court approach a Rule 702 issue as to whether an expert’s testimony is admissible?

Testimonials 98

Testimonials Compliance Trials Production 98

Drug & Device Law

DECEMBER 27, 2022

Both the “independent” laboratory whose questionable product testing sparked this litigation, and the plaintiffs’ experts, used every trick in the book to inflate the amount of NDMA supposedly generated by the purported “normal” breakdown of ranitidine. Lab Rats – Or at Least A Ratty Lab. at 83 (citation and quotation marks omitted).

Laboratories 59

Laboratories FDA Production International 59

Drug & Device Law

DECEMBER 5, 2022

Ultimately, the thumb that Freeman put on the scale didn’t matter, because the defendant won at trial despite that handicap. The Superior Court here “credited testimony from doctors who never implanted mesh, or who did so outside the state of California.” In our books, that’s not a fine, but rather a judicially imposed tax.

Testimonials 64

Testimonials Doctors Production Trials 64

Drug & Device Law

DECEMBER 26, 2023

Testimony by expert witnesses. First, the Committee found it necessary to “emphasize” both the court’s role and the burden of proof. “[E]xpert testimony may not be admitted unless the proponent demonstrates to the court that it is more likely than not that the proffered testimony meets the admissibility requirements set forth in the rule.”

Testimonials 52

Testimonials Government Production Pharmaceuticals 52

Drug & Device Law

FEBRUARY 20, 2023

In updating chapter three of his book , on non-informational causes of action, Bexis had the opportunity to add the last several years of “alternative design” opinions. 7, 2022), which addressed the same question in the context of the admissibility of expert testimony. His testimony is thus irrelevant and inadmissible.

FDA 59

FDA FDA Approval Testimonials Vaccine 59

Drug & Device Law

APRIL 18, 2022

The trial court granted summary judgment based on evidence that the implanting surgeon “would have used the clips in the surgery even if he had received such a warning” and thus plaintiff “could not prove the cause element of his claims.” Even then Rennick ’s rationale didn’t do a very good job.

Testimonials 59

Testimonials Production FDA Approval FDA 59

Drug & Device Law

MARCH 28, 2022

of Bexis’ book. The Federal Rules of Evidence do not permit an expert to render conclusions of law, because such testimony cannot properly assist the jury in understanding the evidence or determining a fact in issue. Rather, expert testimony couched as legal conclusion merely tells the jury which result to reach. See Tyree v.

Testimonials 59

Testimonials FDA Regulations Production 59