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The Growing Trend of Patient-Led Clinical Research in Rare Disease

Conversations in Drug Development Trends

Increasingly, patients and patient-led organizations are playing a pivotal role in shaping drug development, underscoring the importance of collaboration between patient organizations, CROs, and pharmaceutical and biotechnology companies. Discover more about this industry shift in our blog.

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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.

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Another Reason Why The FDA, Not Litigants, Approves Products

Drug & Device Law

We’ve blogged several times already about the Alliance for Hippocratic Medicine v. Congress created an FDA approval process that is both rigorous and thorough, and pharmaceutical companies invest billions of dollars in research and development to meet FDA’s scientific standards. FDA litigation that is now before the Supreme Court.

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W.D. Wash. Nixes Failure to Warn Claim Under Learned Intermediary Doctrine

Drug & Device Law

I am Susanna Moldoveanu , and I practice with Butler Snow LLP’s Pharmaceutical, Medical Device and Healthcare group. I am excited to join the Drug & Device Law Blogging Team. A more fulsome discussion of the Washington Supreme Court’s answer is on the Blog. Plaintiffs had no evidence to rebut the treater’s clear testimony.

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The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

2023) (remote trial testimony cannot be compelled beyond Rule 45’s 100-mile limit on subpoenas) ( here ); Carson v. 2023) (HHS cannot force pharmaceutical manufacturers to sell unlimited amounts of prescription drugs at a discount) ( here ). They excluded bogus expert testimony under Fed. Bonta , 85 F.4th 4th 1263 (9th Cir.

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New Fed. R. Evid. 702 – Use This Stuff To Update Your Briefs

Drug & Device Law

As readers of the Blog undoubtedly know , the amendments toughening up Fed. Testimony by expert witnesses. But it remains the case that other admissibility requirements in the rule (such as that the expert must be qualified and the expert’s testimony must help the trier of fact) are governed by the Rule 104(a) standard as well.

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Second Circuit Affirms Exclusion of Junk Autism Science

Drug & Device Law

It had filed an amicus brief with the Second Circuit and its post-decision press release headline was “In WLF Success, Second Circuit Affirms Exclusion of an unreliable Causation Evidence in Pharmaceutical Case.” In addition, we blogged about the district court order here. Plus, the case involves some lawyers we know and respect.

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