Agency IQ

SEPTEMBER 29, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED SEP 25, 2023 10:39 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events. to include devices.

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Agency IQ

JUNE 16, 2023

The latest Fall 2022 Unified Agenda contains 51 regulations that FDA plans to publish related to human medical product regulation. to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug.

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Agency IQ

OCTOBER 27, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED OCT 25, 2023 10:59 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events. November is packed with regulatory and industry meetings.

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PLOS: DNA Science

APRIL 4, 2024

” The Patent Trail Rather than relying on social media, company websites, and testimonials, I consulted the Patent and Trademark database to reconstruct the story of invention. Lume commercially debuted in August 2022. ” Lady parts. .” ” Lady parts. An objective assessment of odor would be nice.

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Agency IQ

OCTOBER 20, 2023

The first PFAS test order was issued in June 2022 for 6:2 fluorotelomer sulfonamide betaine (6:2FTSB) (CAS RN 34455-29-3), which is used in aqueous film-forming foams (AFFFs), which are often used to put out high-temperature liquid fuel fires. For the 2022 reporting year, the deadline was July 1, 2023.

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FDA Law Blog: Biosimilars

APRIL 8, 2024

In 2022, the Government Accountability Office (GAO) reported that FDA needed to improve its foreign inspection program and that report prompted a hearing on Capitol Hill in February of this year where HPM Counsel John Claud offered testimony.

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Agency IQ

DECEMBER 1, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED NOV 27, 2023 10:59 PM CST Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events. to include devices.

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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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FDA Law Blog: Biosimilars

DECEMBER 11, 2024

Based on what weve heard from the talk on Capitol Hill, the latest version of the BLOCKING Act that is poised for introduction in Congress within the next few days is the same language proposed for inclusion in the never-passed Food and Drug Administration Safety and Landmark Advancements Act of 2022.

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Drug & Device Law

MARCH 4, 2024

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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Drug & Device Law

FEBRUARY 11, 2024

19, 2021) (admitting and excluding Studnicki testimony); Whole Woman’s Health Alliance v. The journal retracted the following three articles: Studnicki J., Longbons T., Harrison D.J., et al. , “A Post Hoc Exploratory Analysis: Induced Complications Mistaken for Miscarriage in the Emergency Room Are a Risk Factor for Hospitalization,” 9 H.

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Drug & Device Law

JANUARY 5, 2024

A prior opinion in this case earned the top spot on the Blog’s Ten Best Prescription Drug/Medical Device Decisions of 2022. Plaintiffs had no evidence to rebut the treater’s clear testimony. Eli Lilly & Co., 2023 WL 8717570 (W.D. 18, 2023). This opinion is short and sweet, but a good one too. Eli Lilly & Co. ,

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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

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 21, 2023

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. Also, given other recent rulings in Zostavax ( 2022+10 ; 2021+19 ), the remaining plaintiffs in Zostavax aren’t likely to profit from that mistake.

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Drug & Device Law

OCTOBER 11, 2023

Jacqueline Moline being sued for product disparagement, fraud and Lanham Act violations for allegedly ginning up a false medical study upon which she based expert testimony against the defendant-turned-plaintiff in product liability litigation. The court in Bell v. American International Industries , 627 F. 3d 520 (M.D.N.C.

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Drug & Device Law

OCTOBER 9, 2023

See In re Zostavax (Zoster Vaccine Live) Products Liability Litigation , 2022 U.S. LEXIS 143883, 2022 WL 3309471 (E.D. In fact, Zostavax has made our year-end “best of” lists twice, in 2022 (#10) and 2021 (honorable mention). LEXIS 57935, 2022 WL 952179 (E.D. LEXIS 57935, 2022 WL 952179 (E.D.

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Drug & Device Law

AUGUST 2, 2023

And in our Best of 2022 wrap-up, we said we were eagerly awaiting the outcome of the Daniels-Feasel decision. The district court ruled that the three plaintiffs experts flunked the Rule 702 analysis and then granted summary judgment to the defendant because the absence of admissible expert testimony on general causation sunk the case.

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Drug & Device Law

JULY 24, 2023

2022) (many other cases recognize this problem with class actions). This time-tested type of evidence is mostly absent from the analysis in PATDC82 II – as in Neurontin , the only actual prescriber testimony belied plaintiffs’ position. E.g. , Laudato v. EQT Corp. , 4th 256, 260 (3d Cir. How could this happen?

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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

MARCH 9, 2023

Citing a range of Tennessee cases, the Campbell court rejected plaintiff’s argument with “it is only the Plaintiffs who are required to present expert testimony to establish causation in cases where the plaintiff has suffered a complex medical injury.” LEXIS 31015, *5-6. The court was having none of it.

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Drug & Device Law

MARCH 7, 2023

Specifically, the court’s analysis started with the false premise that “[w]hen reliability questions go to the weight of an expert’s proposed testimony rather than admissibility.” of Pennsylvania , 2022 WL 2467080, at *1 (E.D. LEXIS 29923 (E.D.PA at *11 (citing another case that does not survive the Rule change, Durando v.

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Drug & Device Law

FEBRUARY 27, 2023

As we’ve discussed, those amendments reiterate what had always been (at least since 2000) the Rule’s requirements for analyzing the admissibility of expert witness testimony. The Committee concluded that in a fair number of cases, the courts have found expert testimony admissible even though the proponent has not satisfied the Rule[‘s]. . .

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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. 2022 WL 6225661, at *5 (S.D. 4:20-CV-02256, 2022 WL 6225573, at *3 (S.D. 4:20-CV-02256, 2022 WL 6225573, at *3 (S.D. Johnson & Johnson , 2022 WL 2115075 (D. Ethicon, Inc.

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Drug & Device Law

JANUARY 6, 2023

2022 WL 17903708 (E.D. 23, 2022), the plaintiff sued, in the Eastern District of Louisiana, for injuries allegedly caused by the defendant’s implantable cardiac defibrillator, asserting claims under Louisiana’s Product Liability Act. Reddick , 2022 WL 17903708 at *3. . In Reddick v. Medtronic, Inc.,

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Drug & Device Law

DECEMBER 28, 2022

It is hard to beat Bexis’s lists of the best and worst DDL cases, the latter of which graced us last week , and the former of which will adorn this blog tomorrow, for inventorying what happened and what mattered in our area of the law in 2022. Litigation , 2022 WL 3050665 (E.D. In re Onglyza and Kombiglyze Prods Liab.

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Drug & Device Law

DECEMBER 27, 2022

3d , 2022 WL 17480906 (S.D. 2022 WL 17480906, at *1. 2022 WL 17480906, at *2 (emphasis added). 2022 WL 17480906, at *7. Zantac , 2022 WL 17480906, at *14 (citation omitted). “The Zantac , 2022 WL 17480906, at *3 (footnote omitted). 702, and summary judgment entered. Lab Rats – Or at Least A Ratty Lab.

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Drug & Device Law

DECEMBER 9, 2022

2022 WL 17219513 (C.D. 18, 2022), the plaintiff alleged that the warnings provided with her pelvic mesh devices were inadequate. Brennan , 2022 WL 17219513 at *12. In Brennan v. Johnson & Johnson, et al., at *18 (citations omitted).

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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

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. Bell , 2022 WL 16571057, at *1 (citations omitted) (emphasis added). Bell , 2022 WL 16571057, at *2 (citations omitted). 1441, 1559-62 (D.V.I.

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Drug & Device Law

NOVEMBER 25, 2022

2022 WL 16753646 (11th Cir. 8, 2022), is a decision on the appeal of a Northern District of Florida decision we liked very much. Arevalo , 2022 WL 1673646 at *4. The court then granted summary judgment for the defendant because the plaintiff could not reach the jury without expert specific causation testimony. at *8. .

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Drug & Device Law

NOVEMBER 3, 2022

Pizzitola I , 2022 U.S. Plaintiff argued the testimony was relevant to a risk/utility analysis but showing that a different medical procedure may be safer, “does not affect whether a product has utility and/or risks.” Further, the choice between two classes of products is a matter of medical judgment, not alternative design.

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Drug & Device Law

NOVEMBER 1, 2022

16, 2022) (“ Mixson I ”), and Mixson v. 2022 WL 7581737 (N.D. 23, 2022) (“ Mixson II ”), by no means won everything, but what they won was more important than what they didn’t, so we’re OK with the results. 2022 WL 4364153, at *2. 2022 WL 4364153, at *2. Mixson I , 2022 WL 4364153, at *5. Bard, Inc. ,

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Drug & Device Law

OCTOBER 20, 2022

10, 2022), is not one of those. For instance, a plaintiff has to prove both “substantial factor” and “but for” causation and that has to come from expert testimony for a prescription medical device. For some reason, though, plaintiff attempted to rely on the deposition testimony of two of the treating physicians, Drs.

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Drug & Device Law

OCTOBER 14, 2022

Johnson & Johnson , 2022 WL 5109167 (W.D. 15, 2022) is a pelvic mesh case, remanded to the Western District of Pennsylvania from the mesh MDL. Cohen , 2022 WL 5109167 at *15 (internal punctuation and citation omitted.) In this case, the plaintiffs did not depose the surgeon who implanted the plaintiff’s mesh device.

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Drug & Device Law

OCTOBER 4, 2022

26, 2022). Plaintiff offered no expert testimony regarding the expectations of an implanting surgeon. Plaintiff offered no testimony from her surgeon and admitted that she relied on her doctor’s advice rather than any statement by defendant in deciding to undergo surgery. Then short equals easy to dismiss. Coloplast Corp.

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Drug & Device Law

AUGUST 26, 2022

3d –, 2022 WL 3357485 (E.D. 12, 2022), is a hernia mesh case brought by a frequent flyer lawyer via a cookie-cutter complaint not tailored to the law or facts of the case. 2022 WL 3357485, *1. 2022 WL 3357485, *1. 2022 WL 3357485, *2. Atrium Medical Corp. , — F. Fast forward to Spear.

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