PLOS: DNA Science

OCTOBER 19, 2023

Last week DNA Science covered a setback in a clinical trial of a gene therapy for Duchenne muscular dystrophy (DMD). The two conditions and the therapeutic approaches differ, but their clinical trials illustrate the importance of selecting patients whose characteristics suggest that they are the most likely to respond.

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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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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

JULY 24, 2023

3d , 2023 WL 4191651 (C.D. PATDC82 II , 2023 WL 4191651, at *3. 2023 WL 4191651, at *8. Thus, “[o]ne supposed ‘nightmare’ trial is preferable to many hundreds of shorter ones.” PATDC82 II , 2023 WL 4191651, at *10. 2023 WL 4191651, at *17 (discussing “excerpts of two depositions” of “prescribing physician[s]”).

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Drug & Device Law

DECEMBER 28, 2022

As we prepare to greet 2023, we find ourselves assuming the Janus-ian posture of simultaneously looking backward and forward. Forward is more fun, as we scan a schedule full of motions, MDL decision-trees, and trials in, er, challenging jurisdictions. But it really is folly to plan the future without learning from the past.

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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

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

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. The FDA had asked the manufacturers to conduct a randomized controlled trial with multiple cardiac endpoints, which they did.

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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 28, 2023

While Frye was seen as a high bar at the start, by the 1980s, a cadre of practitioners of the ancient art of junk science were routinely permitted to offer medical causation opinions at trial despite general causation being anything but generally accepted. 3d _-, 2023 WL 8711617 (S.D.N.Y. 2023 WL 8711617, *2. Litig. , — F.

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Drug & Device Law

OCTOBER 11, 2023

19 2023). Rule 16 : Amend to add privacy and cybersecurity as topics for prompt pre-trial consideration. 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. The court in Bell v.

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Drug & Device Law

MARCH 16, 2023

In two of these cases, our client won summary judgment at the trial court level and an appellate court ended up creating a new cause of action to accommodate the plaintiff’s theory (and lack of helpful testimony from the prescribing physician). 1:22-cv-00141-MR, 2023 WL 2386776 (W.D.N.C. 2023 WL 2386776, *3. In Beaver v.

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Drug & Device Law

FEBRUARY 20, 2023

2023 WL 1192538 (Mag. 27, 2023), which we discussed here , addressed at length the plaintiff’s attempt to rely on “alternatives” that “existed,” but “were not yet cleared by the FDA for the purpose of treating” the plaintiff’s condition. Therefore, Davis excluded as “not relevant” expert testimony about non-FDA-approved alternatives.

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Drug & Device Law

MARCH 23, 2023

22-1737, 2023 WL 2446703 (4th Cir. 10, 2023). Plaintiff also argued that the trial court should have allowed her to offer expert causation testimony from the explanting physician, thus raising an issue of material fact to defeat summary judgment. In an unpublished decision, the Fourth Circuit affirmed. Ethicon, Inc. ,

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Drug & Device Law

DECEMBER 20, 2023

Facteau , 2023 WL 8641918 (1st Cir. So we got this prosecution, a trial, a verdict, and some interesting motions. After a thirty day jury trial, the two executives were found guilty of multiple misdemeanor violations of the Food, Drug, and Cosmetic Act, but were acquitted of the felony accounts.

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Drug & Device Law

OCTOBER 4, 2023

We acquired our trial chops in the Central District of California, where we were an AUSA. 25, 2023), is a not very good decision. We had a great time. We learned a lot. We have warm feelings for C.D. But we do not love all the decisions that come out of that jurisdiction. Abbvie, Inc., LEXIS 170907 (C.D.

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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

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

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 v.

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Drug & Device Law

JUNE 23, 2023

Services , 2023 N.J. June 8, 2023). Adams , 2023 N.J. Plaintiff Adams’ “sworn testimony and plaintiff fact sheet” established that she blew the statute of limitations by some eight years. June 8, 2023); Massey v. June 8, 2023); Linton v. June 8, 2023). Sanofi U.S. Lexis 927, at *2-3 (N.J.

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Drug & Device Law

DECEMBER 12, 2023

As is the situation with most Lone Pine orders, this latest one was entered after the court’s “long-standing effort to bring [the other injury cases] to trial” failed. In re: Zostavax Products Liability Litigation , 2023 WL 8258533, *1 (E.D. A full expert report is not required at this time.

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Drug & Device Law

FEBRUARY 8, 2023

2023 WL 1466607 (11th Cir. 2, 2023), an opinion for which the best aspect is that it is unpublished. She prevailed at trial against one of the manufacturers and lost to the other. Without admitting it, the trial court had allowed the non-physician materials expert to testify about general medical causation.

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Drug & Device Law

MARCH 9, 2023

3:23-cv-00029, 2023 U.S. 24, 2023), drew this response from us. Defense trial lawyers with a lot of, er, gumption have been known to rest at the end of plaintiff’s case without presenting any witnesses. The issue teed up in Campbell v. Depuy Orthopaedics, Inc. , LEXIS 31015 (M.D. LEXIS 31015, *5-6.

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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

MARCH 7, 2023

Just last week we updated our discussion on the 2023 amendments to Rule 702 urging our readers to start using the amendments now before their official implementation in December. The only basis for his “hypothesis” seems to be the expert’s “experience” that the complication occurs “way more” than what the trials reported.

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Drug & Device Law

JUNE 10, 2022

Testimony by expert witnesses. The first amendment provides that the trial judge must exclude expert testimony unless the proponent of the evidence demonstrates, by a preponderance of the evidence, that all of the requirements of Rule 702 are satisfied. Assuming Congress approves it, it will take effect on December 1, 2023.

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Drug & Device Law

AUGUST 8, 2023

But the Federal Rules are also clear that absent compelling circumstances, trial testimony must be given in person: At trial, the witnesses’ testimony must be taken in open court unless a federal statute, the Federal Rules of Evidence, these rules, or other rules adopted by the Supreme Court provide otherwise.

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