Drug & Device Law

FEBRUARY 11, 2024

Considering the rigorousness of this process and the due process interests of drug sponsors, Congress also mandated by statute a process for withdrawal or suspension of an FDA approval decision − a process the Fifth Circuit circumvented. 19, 2021) (admitting and excluding Studnicki testimony); Whole Woman’s Health Alliance v.

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Drug & Device Law

NOVEMBER 28, 2022

2013) (Painter); McClellan v. While cosmetic talc is not a drug or medical device, the FDA also regulates it (the “C” in the FDCA). Moline has given testimony in many other cosmetic talc cases” while keeping the (at least potentially) false premise of her article secret supported disclosure of the contrary evidence. 11-17 (Jan.

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Drug & Device Law

OCTOBER 30, 2023

The Granuflo/Naturalyte MDL (“ G/N ”) was created a decade ago, in 2013. W]ith considerable testimony from their own experts that all of the plaintiffs fell within an acceptable range, they have failed to adduce competent evidence in support of their claims. 2d 1362 (J.P.M.L G/N , 2023 WL 5807340, at *16 (citations omitted).

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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. 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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Drug & Device Law

JUNE 13, 2023

In the “ 50-State Survey of State Court Decisions Supporting Expert-Related Judicial Gatekeeping ,” the Drug & Device Law Blog (the Best Blog on the Planet) describes West Virginia as a “gatekeeper” state because of cases reflecting adoption of the Daubert analysis of W. 2013) (citation and quotation marks omitted). “We.

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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. Medrano , 28 S.W.3d 3d 75 (Fla.

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Drug & Device Law

MARCH 16, 2023

Back during the diet drug litigation, we had cases with very significant alleged injuries and a colorable argument that the label was inaccurate as to the risk of the plaintiffs’ injuries. If the drug had not been sold at the time, then it did not matter what the prescribers thought. 472 (2013). Bartlett , 570 U.S.

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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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Drug & Device Law

MARCH 28, 2022

A lot of the discussion in Tsao was case specific because the purported expert opinions at issue were among the most ridiculous we’ve ever seen – directly contrary to the controlling FDA regulations applicable to the particular drug. Rather, expert testimony couched as legal conclusion merely tells the jury which result to reach.

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Drug & Device Law

JANUARY 9, 2024

As drug and device defense lawyers today, we use that skill to find the one version of plaintiff’s story that just doesn’t line up. Like when written discovery responses say one thing, medical records say the same thing, plaintiff’s deposition testimony is also the same, but a post deposition affidavit says something completely different.

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FDA Law Blog: Biosimilars

OCTOBER 24, 2024

Gibbs — A recent blog post focused on the potentially negative implications of the proposed Patent Eligibility Restoration Act (PERA) for manufacturers of generic drugs and biosimilar products. Javitt & Jeffrey N. The concerns raised by PERA are not limited to these industries, however.

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