Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. November is packed with regulatory and industry meetings.

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Agency IQ

JULY 28, 2023

And following the reauthorizations of several of the FDA’s user fee programs in late 2022 – PDUFA, GDUFA, MDUFA and BsUFA – the FDA has an enormous amount of things it has committed to doing as of October 1, 2023. Therefore many of the FDA’s deadlines are tied to the start or end of the fiscal year.

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Drug & Device Law

DECEMBER 21, 2023

2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. There’s no science to back any of the allegations up – as demonstrated by the masterful (and even longer) take down of nearly identical substantive allegations in the Zantac ( 2022+4 ) MDL. FDA , 78 F.4th 4th 210 (5th Cir.

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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.

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Drug & Device Law

DECEMBER 5, 2022

2022 WL 3147194 (C.D. 2022), review denied (Cal. July 13, 2022). The final bullet point, concerning due process is the focus of the defendants’ petition for certiorari with the United States Supreme Court, filed on November 10, 2022, and currently pending at Johnson & Johnson v State of California , No. Ethicon, Inc.

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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. As a matter of science, the purported link was imaginary, as discussed at great length in one of the many excellent Zantac ( 2022+4 ) MDL opinions. Bonta , 85 F.4th

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Drug & Device Law

JUNE 1, 2022

Aurora Healthcare , 2022 WL 1657559 (Wisc. May 25, 2022), the Wisconsin Court of Appeals reversed a lower court’s granting of an injunction compelling treatment with ivermectin. The case was brought by a Covid-19 patient’s nephew, who was acting as the patient’s health care representative. None of those concerns were implicated here.

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Drug & Device Law

FEBRUARY 11, 2024

22 (both articles for the proposition that there are “‘many intense side effects’ and ‘significant complications requiring medical attention’” resulting” from FDA’s regulation of mifepristone), at *22 n.37 19, 2021) (admitting and excluding Studnicki testimony); Whole Woman’s Health Alliance v. We were hardly alone. Longbons T.,

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Drug & Device Law

FEBRUARY 20, 2023

3d , 2022 WL 6225596 (S.D. 7, 2022), which addressed the same question in the context of the admissibility of expert testimony. Another decision in the same case reached the same result: In the United States, the FDA regulates the sale of medical devices. 2022 WL 6225661, at *5 (S.D. Baksic relied on Pizzitola v.

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Drug & Device Law

MARCH 9, 2022

Texas March 2, 2022)— is a veritable mixed bag. 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., Ethicon, Inc. Evidence 402?

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Drug & Device Law

NOVEMBER 28, 2022

3d , 2022 WL 16571057 (M.D.N.C. 13, 2022), involved Dr. Jaqueline Moline, and her increasingly questionable paper “Mesothelioma Associated with the Use of Cosmetic Talc,” 62 J. While cosmetic talc is not a drug or medical device, the FDA also regulates it (the “C” in the FDCA). Bell , 2022 WL 16571057, at *2 (citations omitted).

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Drug & Device Law

MARCH 4, 2022

2022 WL 326781 (D. 3, 2022), the plaintiff alleged that he was injured when the defendants’ modular hip implant fractured seven years after it was implanted in him. Vollrath , 2022 WL 326781 at *3-4. their testimony does not present a genuine issue of medical fact.” In Vollrath v. Depuy Synthes Business Entities, et al.,

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Drug & Device Law

FEBRUARY 21, 2022

2022 WL 425206 (N.D. 11, 2022), granted a Rule 702 motion excluding plaintiff’s purported FDA expert Peggy Pence, who “began working as an expert witness for plaintiffs in product liability cases in 2008” and “approximately 100% of her work was as a plaintiff’s expert in product liability litigation.” Feb. 2022 WL 409638 (N.D.

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Drug & Device Law

MARCH 28, 2022

2022 WL 614919 (S.D. 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.

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Drug & Device Law

JUNE 13, 2022

The FDA’s regulations for medical device labeling generally require that such labeling include “any relevant hazards, contraindications, side effects, and precautions.” 2022 WL 970681 (N.D. March 31, 2022); Robinson v. 3d , 2022 WL 614919 (S.D. March 2, 2022). Robinson , 2022 WL 614919, at *4 (citations omitted).

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Drug & Device Law

MARCH 30, 2022

March 21, 2022), is the pelvic mesh case of the week, and it involves a variety of plaintiff challenges to the defendant’s experts. There is also a more detailed and nuanced discussion of challenges to a defense regulatory expert, particularly regarding testimony about testing, than is normally the case in mesh decisions. Ethicon, Inc.

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