Agency IQ

MARCH 1, 2024

For example, statutorily, the prescription drug user fee program (PDUFA) has a statutory cap of total carryover for operating reserves of 14 weeks, while the biosimilar user fee program (BsUFA) had a goal of bringing the carryover balance down to “no greater than 21 weeks of operating reserves” by the end of the 2022 fiscal year.

Government 40

Government FDA Biosimilars Regulations 40

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.

Regulations 40

Regulations Production Packaging Treatment 40

Agency IQ

JUNE 29, 2023

BY ALEXANDER GAFFNEY, MS, RAC AUG 31, 2022 7:50 PM EDT | UPDATED JUN 26, 2023 12:41 PM EDT Note: This calendar also include some activities scheduled to take the last week of June, after this piece is published. Was supposed to be finalized as of June 24, 2022.

FDA 40

FDA Science Regulations Production 40

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.

FDA 40

FDA Science Regulations Production 40

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.

FDA 40

FDA Science Regulations Production 40

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.

Regulations 40

Regulations FDA Science Production 40

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.

FDA 40

FDA Science Regulations Production 40

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.

FDA 40

FDA Science Biosimilars Regulations 40

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.

FDA Approval 52

FDA Approval FDA Drugs Production 52

Drug & Device Law

JANUARY 11, 2022

In In re: Onglyza and Kombiglyze XR Products Liability Litigation , MDL 2809, 2022 WL 43244 (E.D. 5, 2022), the MDL judge bifurcated discovery into two phases with general causation proceeding first. At the close of expert discovery, plaintiffs move to exclude three defense experts and defendants moved to dismiss one plaintiff expert.

Drugs 40

Drugs Trials Doctors Testimonials 40

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.

Production 59

Production Testimonials Marketing Trials 59

Drug & Device Law

MAY 12, 2022

2:20-cv-02477-AWI-BAK, 2022 U.S. 29, 2022), the judge considered a motion to reconsider in connection with the exclusion of certain opinions from the plaintiff experts in a pelvic mesh remand case. Enborg , 2022 U.S. Their refusal to accept those impacts without a fight can lead to some surprising postures. In Enborg v.

Production 59

Production Testimonials FDA Trials 59

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.

Laboratories 59

Laboratories FDA Production International 59

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.

Testimonials 59

Testimonials Production International Pharmaceuticals 59

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.

FDA 59

FDA Science Testimonials Hospitals 59

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.

Testimonials 59

Testimonials Production International Trials 59

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.

FDA 59

FDA Production FDA Approval Regulations 59

Drug & Device Law

JUNE 3, 2022

B302544, 2022 WL 1679539 (Cal. May 26, 2022). The defendant had a causation expert too, plus testimony from treating physicians on potential alternate causes. The case is Kline v. Zimmer, Inc. ,

Trials 52

Trials Testimonials Production 52

Drug & Device Law

MARCH 23, 2022

Texas March 16, 2022). The plaintiff lawyers had managed to extract some testimony from the prescriber that he would have read with interest any additional information about the mesh product’s complication rates. Back by popular demand, here is the mesh case of the week: Clowe v. Ethicon, Inc. LEXIS 46387 (N.D.

Doctors 59

Doctors Testimonials Production 59

Drug & Device Law

FEBRUARY 9, 2022

Mayo Clinic , 2022 Fla. 27, 2022), and its reasoning is crystalline and straightforward. Against the authority of the Mayo Clinic and other reputable sources, the plaintiffs relied on the testimony of a single doctor. The case is Pisano v. LEXIS 647 (Fla. App 1st Jan.

Doctors 64

Doctors Hospitals Testimonials Treatment 64

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.

Doctors 124

Doctors Hospitals Treatment Testimonials 124

Drug & Device Law

MAY 30, 2022

Somatics, LLC , 2022 WL 989469 (9th Cir. April 1, 2022) (the companion case to this ). The prescriber’s] testimony, however, does not establish that he would have altered his prescribing conduct. Plaintiff] has not identified any testimony from [the prescriber] that. . . at *3 (emphasis original). 3d 1223 (11th Cir.

Testimonials 59

Testimonials Doctors Production Laboratories 59

Drug & Device Law

FEBRUARY 25, 2022

Here’s a snapshot of some of PLAC’s recent activity just from 2021 and early 2022: Drug/Device Issues. The defendant first sought PLAC’s help on en banc rehearing, after suffering a loss on admission of expert testimony that we considered to be the worst decision of 2021. 21, 2022). 5, 2022). Cartee , No. 20-1069 (U.S.

Testimonials 59

Testimonials Production Drugs Pharmaceuticals 59

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?

Testimonials 52

Testimonials Pharmacy FDA Doctors 52

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

Testimonials 59

Testimonials Production Pharmaceuticals Treatment 59

Drug & Device Law

JUNE 16, 2022

May 16, 2022), has nothing to do with prescription medical products. These decisions did that in order to keep holding issues, such as the sufficiency of the factual basis for expert testimony, to be jury questions when the new Rule 702 expressly consigned them to the court’s gatekeeping function. The case, Mata v. Allupick, Inc.

Testimonials 59

Testimonials Production Drugs 59

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.

Testimonials 64

Testimonials Doctors Production Trials 64

Drug & Device Law

FEBRUARY 3, 2022

2775, 1:17-cv-00944, 2022 WL 171503 (D. 18, 2022), interesting not so much for the specific holdings but because of the insight the case provides into one of the more prevalent dynamics of modern MDLs. 2022 WL 171503, *1. First, plaintiffs complained about allegedly undisclosed opinion testimony offered by a defense expert.

Trials 59

Trials Testimonials Doctors Government 59

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. How does such testimony meet the relevance requirement of Fed. The “mesh case of the week” — Robinson v. Ethicon, Inc. LEXIS 36441 (S.D. Evidence 402? It is true that under 21 U.S.C.

Testimonials 64

Testimonials FDA Doctors Regulations 64

Drug & Device Law

APRIL 18, 2022

2022 WL 1016686 (Wis. April 5, 2022) (per curiam). The surgeon’s testimony supported two grounds for non-causation: lack of reliance, and that a warning would not have changed how the prescription product was used. Rennick , 2022 WL 1016686, at *4 (no citations omitted). 2022 WL 1016686, at *4. See Rennick v.

Testimonials 59

Testimonials Production FDA Approval FDA 59

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.,

Testimonials 59

Testimonials FDA Production 59

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.

Testimonials 59

Testimonials Regulations Research International 59

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.,

Testimonials 59

Testimonials FDA Approval FDA Regulations 59

Drug & Device Law

FEBRUARY 23, 2022

2022 WL 468051 (W.D. 15, 2022), a case with a bizarre procedural posture and a mixed bag of rulings. The plaintiff wanted to focus on whether the warning was adequate, but the evidence (via some very good deposition testimony by the implanting physician) showed lack of proximate cause. Consider Terry v. Ethicon, Inc.

Testimonials 59

Testimonials FDA Production Trials 59

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.

Testimonials 59

Testimonials Production Treatment Marketing 59

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. 2022 WL 138630 (C.D. 14, 2022). at *3 (quoting expert’s testimony). Exclusion of expert testimony was affirmed in Ervin v.

Testimonials 64

Testimonials Engineering Doctors Trials 64

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.

Science 52

Science Testimonials Compliance Pharmaceuticals 52