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. Finally, on October 3, 2023, DEA published an increase to the methylphenidate APQ.

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Perficient: Drug Development

JANUARY 23, 2024

I mean, it was Merriam Webster’s word of the year in 2023.) One way is to lean into consumer quotes and testimonials, whether patients or clinical profiles. However, consumers have made it clear that authenticity is exactly what they are after. (I So how can you strike the balance?

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Agency IQ

DECEMBER 11, 2023

BY WALKER LIVINGSTON, ESQ | NOV 29, 2023 6:48 PM EST AFFF suit and proposed settlements Beginning in 2019, the U.S. The case proceeded, and reached its first major settlement in early June 2023, when DuPont, Corteva, and Chemours reached an agreement to settle all claims for a combined $1.185 billion settlement.

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Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The latest update, announced this week, is known as the Spring 2023 Unified Agenda.

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Agency IQ

MAY 28, 2024

The new draft document comes as FDA leadership has been flagging concerns about misinformation, including in public testimony and reports. For example, recent guidance from the National Institute of Standards and Technology (NIST) offered insights into how Generative AI could contribute to health care misinformation.

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Agency IQ

MARCH 1, 2024

In September 2023’s version of the FY 2024 contingency plan , the agency stated that 81% of staff would be retained: “15,602 (81%) of FDA staff will be retained including 12,300 (64%) who are exempt (their activities or position are already funded or otherwise exempted) and 3,302 (17%) who are excepted.” What happens to inspections?

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 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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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. A highly-tauted quality of Lume is that the effect lasts 72 hours, although a class action lawsuit filed May 2023 challenges that claim, key to the advertising.

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Agency IQ

OCTOBER 20, 2023

OCT 11, 2023 7:05 PM CDT What are PFAS? The EPA updated and widened the definition of a PFAS in the final TSCA recordkeeping and reporting rule for PFAS published on October 11, 2023. On June 28, 2023, the EPA published a TSCA framework for how it planned to address new PFAS and new uses of PFAS. BY PATRICIA ISCARO, ESQ. |

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FDA Law Blog: Biosimilars

MARCH 14, 2023

Merrick Garland, Testimony Before the Senate Judiciary Committee, Mar. 1, 2023 ( 02:38:46 ). AG Garland concluded that he anticipates DOJ’s cannabis policy will be consistent with what he said during his confirmation in that “it will be very close” to the Cole Memorandum.

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Agency IQ

JULY 28, 2023

Everything the FDA is planning to do in Q3 2023 The third quarter of the 2023 calendar year is shaping up to be one of the busiest periods of regulatory policymaking at the FDA in at least the last decade. Notably, one aspect of its transition plan will come into effect on August 9, 2023.

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Agency IQ

JULY 13, 2023

BY LAURA DIANGELO, MPH JUL 12, 2023 7:14 PM CDT Quick background: the Pandemic and All-Hazards Preparedness Act The Pandemic and All-Hazards Preparedness Act (PAHPA) was originally passed in 2006. PAHPA must be reauthorized by the end of federal fiscal year 2023, or by September 30, 2023. Pallone (D-NJ)

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Drug & Device Law

MARCH 4, 2024

3d , 2023 WL 8711617 (S.D.N.Y. 18, 2023), some late-arrival plaintiffs in that litigation sought a do-over, which is now being litigated. 2023) (denying do-over not an abuse of discretion; “allowing plaintiffs to designate a new expert would prejudice defendants”). 2023 WL 5322213, at *6 (6th Cir. 3d 480, 495 (Cal.

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Drug & Device Law

FEBRUARY 23, 2024

We gave you our take on the MDL judge’s order excluding the plaintiff’s expert here , and the California appellate opinion affirming a similar order came in as our fifth best drug/device case of 2023. Plaintiffs’ response to this was predictable: Leave it to the jury to “evaluate and weigh” the testimony.

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Drug & Device Law

FEBRUARY 11, 2024

3d , 2023 WL 2825871 (N.D. April 7, 2023) (“ AHM I ”). 2023) (“ AHM II ”). See AHM I , 2023 WL 2825871, at *4 n.9 19, 2021) (admitting and excluding Studnicki testimony); Whole Woman’s Health Alliance v. See Alliance for Hippocratic Medicine v. See Alliance for Hippocratic Medicine v. FDA , 78 F.4th Studnicki J.,

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Drug & Device Law

JANUARY 16, 2024

But that “purely fact testimony” was inadmissible for several reasons. Second, the testimony plaintiff wants to offer is still expert testimony—it involves the witness’ “specialized knowledge” beyond what a lay person would know. And if he’s a turncoat expert, his testimony is inadmissible. Depuy Orthopaedics Inc.

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Drug & Device Law

JANUARY 15, 2024

2021), aff’d by an equally divided court , 2023 WL 8859656 (Pa. 22, 2023) (“ Sullivan I ”), another decision not involving prescription medical products. 2023 WL 8859656, at *9 (Pa. 22, 2023) (Opinion Announcing the Judgment of the Court (“OAJC”)). OAJC, 2023 WL 8859656, at *11. Werner Co. , 3d 730 (Pa. Sullivan v.

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Drug & Device Law

JANUARY 9, 2024

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. 9, 2023). Plaintiff had an IVC filter implanted in 2013 and filed suit in 2021. And the court in Stanford v. That’s a no-no.

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Drug & Device Law

JANUARY 5, 2024

2023 WL 8717570 (W.D. 18, 2023). 2023 WL 8717570, *3. Plaintiffs had no evidence to rebut the treater’s clear testimony. The best group of legal wonks there is. Today we discuss the Western District of Washington’s recent summary judgment order in Dearinger v. Eli Lilly & Co.,

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Drug & Device Law

DECEMBER 29, 2023

In 2023 there seemed to be an unusually large number of other decisions that are likely to have a substantial impact on what we or our clients do, but involve either different products, non-product claims, or both. In 2023, these include United States ex rel. 2023) (no medical monitoring in Delaware) ( here ); Brown v.

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Drug & Device Law

DECEMBER 28, 2023

3d _-, 2023 WL 8711617 (S.D.N.Y. 18, 2023), is a worthy heir to the history above. 2023 WL 8711617, *2. In a paraphrase of the testimony of a difficult opposing epidemiology expert who passed away recently, “you have to say what you will do and then do what you say.” Litig. , — F.

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Drug & Device Law

DECEMBER 26, 2023

702 became effective on December 1, 2023. Testimony by expert witnesses. We say “bluntly” because that’s what the 2023 Committee Note to the newly amended rule states. Committee Note to 2023 Amendments at (1). As readers of the Blog undoubtedly know , the amendments toughening up Fed. emphasis added).

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Drug & Device Law

DECEMBER 21, 2023

Speaking of cold and darkness, it is now time for us to look back upon the results of drug and medical device litigation during 2023 and to select the ten worst decisions of the year. 122 (2023) ( here ). 2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. FDA , 78 F.4th

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Drug & Device Law

DECEMBER 20, 2023

Facteau , 2023 WL 8641918 (1st Cir. Despite the chorus of criticism of recent Congressional testimony by a trio of tone-deaf college presidents, there really is a valid, if sometimes difficult, distinction between speech and conduct.) Such is the case with United States v.

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Drug & Device Law

DECEMBER 12, 2023

In re: Zostavax Products Liability Litigation , 2023 WL 8258533, *1 (E.D. Ten cases alleging miscellaneous injuries were selected for trial by plaintiffs and defendants, and all were dismissed either because plaintiff conceded they could not get expert testimony or because the court excluded what expert evidence was offered.

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Drug & Device Law

DECEMBER 6, 2023

2023 WL 4778447 (E.D. July 26, 2023), falls into none of those categories. Tennessee, like most states, requires expert testimony to establish liability in cases alleging manufacturing and design defects. But Kiser v. Terumo Medical Corp., It is reasonably interesting and reasonably concise. Adios, expert.

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Drug & Device Law

NOVEMBER 27, 2023

Thus, when the other side inveigles one of ours to switch sides – usually with the promise of a lot more money for a lot more testimony – the result can be a lot of collateral litigation. 2023 WL 7292164 (D.D.C. 6, 2023), attracted our interest. 2023 WL 5624710 (D. 31, 2023); Cannon v. 2023 WL 7477903 (N.D.

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Drug & Device Law

NOVEMBER 7, 2023

Abott Labs , 2023 U.S. The prescriber’s testimony in this case is key. A woman who suffered from bipolar disorder and who was not trying to get pregnant did in fact become pregnant two months after being prescribed a mood stabilizer that carried a black box warning regarding birth defects. LEXIS 194594 (C.D.

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Drug & Device Law

OCTOBER 31, 2023

Howmedica Osteonics Corporation, 2023 WL 6850144 (D. 17, 2023) told plaintiff when it dismissed his case. Clinical experience can be a basis for reliable expert testimony, but only where the clinician has “extensive experience” with the issue on which he is opining. As the court in Hobus v.

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Drug & Device Law

OCTOBER 30, 2023

3d , 2023 WL 5807340 (D. G/N , 2023 WL 5807340, at *1. G/N , 2023 WL 5807340, at *9 (plaintiffs’ experts “conducted no independent studies” and “explicitly relied on” the memo as the basis of their opinions). Chiefly, this victory was because the plaintiff’s expert testimony was blatantly contradictory.

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Drug & Device Law

OCTOBER 24, 2023

30, 2023), where the court found that “the mere fact that the sale representatives were present for the implant surgeries” did not make their testimony relevant. The surgeons’ testimony also made it clear that they were better positioned to testify about plaintiff’s condition or the condition of the implants—not the sales reps.

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Drug & Device Law

OCTOBER 18, 2023

In our recent ediscovery for defendants update , we highlighted two of the twenty-eight cases we included as the most important: In re Tasigna (Nilotinib) Products Liability Litigation , 2023 WL 6064308 (Mag. 18, 2023), and Davis v. March 16, 2023). 2023 WL 6064308, at *1. Disability Rights New Jersey , 291 A.3d

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Drug & Device Law

OCTOBER 11, 2023

19 2023). See LCJ, “ FRCP Amendments Are Needed To Guide Courts and Litigants in Proactively Managing Their Shared Obligations To Protect Privacy Rights and Avoid Attendant Cyber Security Risks ” (LCJ Sept. We think that’s an important initiative that our audience should know about, and consider. The court in Bell v. 3d 520 (M.D.N.C.

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Drug & Device Law

OCTOBER 9, 2023

LEXIS 138412, 2023 WL 5044944 (E.D. Aug 8, 2023). In re Zostavax (Zoster Vaccine Live) Products Liability Litigation , 2023 U.S. LEXIS 45440, 2023 WL 2562981 (E.D. March 16, 2023). 4, 2023), and it’s another good one. See In re Zostavax (Zoster Vaccine Live) Prods.

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Drug & Device Law

OCTOBER 4, 2023

25, 2023), is a not very good decision. Not citing any case where such a distinction had been recognized, the Burton court held the difference between SJS and TEN, and the significance of such difference, to be questions of fact “that will require medical expert testimony to resolve.” We learned a lot. We have warm feelings for C.D.

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Drug & Device Law

SEPTEMBER 25, 2023

Assuming the expert testimony doesn’t change, the defendant essentially gets a do-over. 3d , 2023 WL 5541638 (D. July 10, 2023). Not surprisingly the once and future exclusion of the plaintiffs’ expert testimony loomed large in this ginned-up dispute. 2023 WL 5541638, at *2 (quoting 28 U.S.C. See Gareis , supra.

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Drug & Device Law

SEPTEMBER 12, 2023

Opting instead for expert testimony based on a consumer’s perspective is risky and likely problematic. If a court tells you your only non-preempted claim is one based on a theory that your labeling does not comply with the Federal Food, Drug & Cosmetic Act (“FDCA”), it’s probably a good idea for your expert so opine.

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