Agency IQ

JULY 13, 2023

That law built upon several other previous laws, including the Public Health Threats and Emergencies Act of 2000, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Project BioShield Act of 2004 ( see a Congressional Research Service report on its legislative history here ).

FDA 40

FDA Packaging Laboratories Testimonials 40

Drug & Device Law

JUNE 1, 2023

We think that they can, and for a state (like Pennsylvania and a number of others) that still follows the “ Frye ” standard looking to the “general acceptance” of expert testimony as the touchstone to admissibility, a Rule 702 state-law equivalent might look something like this: Rule 702. E.g. , Walsh v. BASF Corp. , 3d 446, 461 (Pa.

Testimonials 59

Testimonials Trials Science Government 59

Drug & Device Law

JANUARY 15, 2024

2004) (pre- Tincher product liability case; “assessment of the dangers of unfair prejudice and confusion of the issues are procedural matters that govern in a federal court notwithstanding a state policy to the contrary”); Kelly v. at 354 (citations omitted). Blaw-Knox , 360 F.3d 3d 426, 431 n.3 Janssen Pharmaceuticals, Inc. , 3d 709 (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. Medrano , 28 S.W.3d

Testimonials 59

Testimonials Production Pharmaceuticals Drugs 59

Drug & Device Law

MAY 30, 2022

The prescriber’s] testimony, however, does not establish that he would have altered his prescribing conduct. Given this testimony, the plaintiffs could not “show that stronger manufacturer warnings would have altered the physician’s prescribing conduct.” Plaintiff] has not identified any testimony from [the prescriber] that. . .

Testimonials 59

Testimonials Doctors Production Laboratories 59

Drug & Device Law

SEPTEMBER 9, 2022

For instance, plaintiffs in the vast majority of cases know that they will need evidence from a prescribing physician, testimony or affidavit for summary judgment and testimony for trial. 2004), where the Kentucky Supreme Court adopted the learned intermediary doctrine. The first is Larkin v. Pfizer, Inc. , 3d 758, 769-70 (Ky.

Doctors 59

Doctors Testimonials Production Trials 59

Drug & Device Law

MARCH 4, 2024

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.” His inability to produce admissible expert testimony is due to his own actions, namely the failure of his proposed experts to test their alternatives. Weisgram v.

Testimonials 52

Testimonials Production Vaccine Pharmaceuticals 52

Drug & Device Law

DECEMBER 9, 2022

Here, the court confronted the question directly, turning for guidance to one of our all-time favorite warnings causation decisions, Motus v. Pfizer, Inc ,196 F. 2d 984 (C.D. 2001), aff’d sub nom. Pfizer Inc. Roerig Div.) 3d 659 (9th Cir. at *18 (citations omitted).

Testimonials 64

Testimonials Doctors Production Treatment 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