article thumbnail

50-State Survey of State Court Decisions Supporting Expert-Related Judicial Gatekeeping

Drug & Device Law

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.

article thumbnail

The FDA and Feasible Alternative Designs

Drug & Device Law

2003), aff’d , 810 N.Y.S.2d The court in Wolfe refused to impose a negligence duty on the defendant pharmaceutical company to develop and obtain FDA approval of the plaintiff’s non-FDA-approved alternative. 7, 2022), which addressed the same question in the context of the admissibility of expert testimony. 2d 839, 851 (N.Y.

FDA 59
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Unimpressed Learned Intermediaries Defeat Warning Causation

Drug & Device Law

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. . .

article thumbnail

Not the Best Wisconsin Law Decision We’ve Ever Seen

Drug & Device Law

The surgeon’s testimony supported two grounds for non-causation: lack of reliance, and that a warning would not have changed how the prescription product was used. Wyeth Pharmaceuticals , 471 F. 2003 WL 1785795, at *13 (D. March 30, 2021) (“Where the learned intermediary doctrine applies, the plaintiff must prove that. . .

article thumbnail

No Expert Do-Overs

Drug & Device Law

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.

article thumbnail

On Expert “Adulteration” and “Misbranding” Opinions

Drug & Device Law

Ferring Pharmaceuticals, Inc. 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.

article thumbnail

Guest Post – More on Expert Gatekeeping in West Virginia

Drug & Device Law

702 was (at the time – more on this below) identical to the Federal Rule, the Court stated “we believe that Daubert is directed at situations where the scientific or technical basis for the expert testimony cannot be judicially noticed and a hearing must be held to determine its reliability. CSX Transportation, Inc. , 2d 275, 305 (W.