Drug & Device Law

JULY 24, 2023

at *6 (plaintiff “has documents and formularies reaching back to only 2009”). Second, as for superiority, PATDC82 II admitted that a class trial would face “enormous logistical hurdles,” but nonetheless found a nationwide class action “superior.” First, the class plaintiff got away with destruction of evidence.

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Drug & Device Law

DECEMBER 27, 2022

Documentation for the testing was jumbled and incomprehensible, making reproduction of their results impossible. Reliance on “animal data” – another notorious and frequent error common in unreliable expert testimony. Plaintiffs could not rely on inconclusive language in a single corporate document as some sort of admission.

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Drug & Device Law

FEBRUARY 23, 2024

The FDA had asked the manufacturers to conduct a randomized controlled trial with multiple cardiac endpoints, which they did. Plaintiffs’ response to this was predictable: Leave it to the jury to “evaluate and weigh” the testimony. The Sixth Circuit, however, rejected that approach.

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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.”

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Drug & Device Law

DECEMBER 29, 2023

2023) (remote trial testimony cannot be compelled beyond Rule 45’s 100-mile limit on subpoenas) ( here ); Carson v. They excluded bogus expert testimony under Fed. Plaintiff knew about it, too, since he signed an informed consent document mentioning it. Bonta , 85 F.4th 4th 1263 (9th Cir. 4th 1030 (9th Cir.

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Drug & Device Law

JANUARY 24, 2022

Remote depositions are most often used for relatively brief examinations that do not involve numerous documents, but may also be used to reduce travel costs. . . . The Manual also discusses general issues concerning the presentation of video depositions of any sort at trial. Valsartan Testimony ¶1; accord Blackbaud ¶2; Davol ¶2.

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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.

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Testimonials Production Pharmaceuticals Treatment 59

Drug & Device Law

OCTOBER 11, 2023

Rule 16 : Amend to add privacy and cybersecurity as topics for prompt pre-trial consideration. Rule 1 : Amend to add express reference to protection of reasonable expectations of privacy, particularly as to non-party information. Rule 5 : Amend to discuss role of privacy in the sealing of court filings. The court in Bell v.

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Drug & Device Law

OCTOBER 18, 2023

Thus the Tasigna plaintiffs must submit their devices to “a technical search process to apply search terms in finding the responsive documents.” Nor was the trial court’s order compelling production so overly broad as to be an abuse of discretion. That means plaintiffs would actually have to do the work, which they won’t.

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Drug & Device Law

MARCH 9, 2022

The issue in Robinson was the admissibility of testimony by the plaintiff’s regulatory expert. When we consider the damage a regulatory expert can do, misinterpreting both company documents and FDA regulations to make the company look like Murder, Inc., How does such testimony meet the relevance requirement of Fed. Evidence 402?

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Testimonials FDA Doctors Regulations 64

Drug & Device Law

NOVEMBER 28, 2022

Three years ago we published a lengthy post, “ Stupid Expert Tricks ,” detailing several of the other side’s egregious attempts at passing off junk science “experts” as the real thing, along with our side’s trials and tribulations during the course of unmasking these phonies. 3d 179, 181-87 (D. This effort largely failed.

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Drug & Device Law

DECEMBER 20, 2023

So we got this prosecution, a trial, a verdict, and some interesting motions. After a thirty day jury trial, the two executives were found guilty of multiple misdemeanor violations of the Food, Drug, and Cosmetic Act, but were acquitted of the felony accounts. The trial court refused to give such an instruction.

FDA 52

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Drug & Device Law

FEBRUARY 28, 2022

at 287 (citing transcript of expert’s testimony). [A]t A]t first blush, [the expert’s] testimony. No other witness offered testimony on these unidentified standards. An excellent example is the Sherman case, which involved junk science causation testimony in what we call a “toxic soup” chemical exposure case.

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Testimonials Engineering Doctors Trials 64

Drug & Device Law

FEBRUARY 17, 2022

Earnest involved the appeal of a defense verdict at trial on a single failure to warn count based on the highly questionable proposition that a change to the alopecia warnings for a life-saving cancer drug would have altered the decision of plaintiff’s oncologist to prescribe her the drug that helped save her life. 2022 WL 405298, *1.

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Drug & Device Law

APRIL 6, 2022

The remand court began its opinion with a reference to the court’s gatekeeper role in admitting or excluding expert testimony, so we immediately suspected we were in for a good ride. The issue is whether a trial court has the moxy to draw lines and limit this clever expert’s testimony. Let’s go through the rulings.

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Drug & Device Law

FEBRUARY 21, 2022

702 expert gatekeeping decisions bearing that caption, as Martinez approaches trial (scheduled for March 21, although the plaintiff has sought a continuance). Id. “None” of her “publications has any connection to “conducting clinical trials for medical devices or post marketing surveillance for medical products.” pelvic mesh case.

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