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

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. The only basis for that opinion was supposed “extensive research and experience” that the risk occurred “way more” than what the trials stated.

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Drug & Device Law

JULY 24, 2023

2022) (many other cases recognize this problem with class actions). Second, as for superiority, PATDC82 II admitted that a class trial would face “enormous logistical hurdles,” but nonetheless found a nationwide class action “superior.” Thus, “[o]ne supposed ‘nightmare’ trial is preferable to many hundreds of shorter ones.”

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Drug & Device Law

DECEMBER 28, 2022

Forward is more fun, as we scan a schedule full of motions, MDL decision-trees, and trials in, er, challenging jurisdictions. Enterprising plaintiff lawyers are exploiting the many residents of drug and device supply chains to gin up personal jurisdiction by finding local players (raw material suppliers, clinical trials, etc.)

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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

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.

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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. On this record, the trial court decided that the plaintiffs had not made out a case for preliminary injunction.

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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. Ultimately, the thumb that Freeman put on the scale didn’t matter, because the defendant won at trial despite that handicap. 2022), review denied (Cal. July 13, 2022). The Superior Court here “credited testimony from doctors who never implanted mesh, or who did so outside the state of California.”

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Drug & Device Law

APRIL 29, 2022

2022 WL 1217464 (Ct. 26, 2022), New York’s highest court reversed an asbestos jury’s verdict for the plaintiff, holding that the plaintiff’s experts had not adduced sufficient proof that the defendant’s product caused the plaintiff’s decedent’s fatal mesothelioma. Nemeth , 2022 WL 1217464 at *1. We will keep you posted.

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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

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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Testimonials Government Production Pharmaceuticals 52

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.

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Drug & Device Law

AUGUST 26, 2022

After more than a month away at trial, we probably should not have picked a case that hit so close to home, so to speak. 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.

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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. Trials of other drugs in the class also failed to show an association. citation omitted).

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Drug & Device Law

OCTOBER 11, 2023

Rule 16 : Amend to add privacy and cybersecurity as topics for prompt pre-trial consideration. 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.

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Drug & Device Law

MAY 12, 2022

A specific remanded pelvic mesh case is just another case on the judge’s docket that needs a trial date and rulings on motions for summary judgment, to exclude experts, for reconsideration, etc. 2:20-cv-02477-AWI-BAK, 2022 U.S. Enborg , 2022 U.S. From our perspective, the individual focus is the big difference. In Enborg v.

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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. caused anything. 3d 87, 95 (Tex.

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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. How does such testimony meet the relevance requirement of Fed. The “mesh case of the week” — Robinson v. Ethicon, Inc. LEXIS 36441 (S.D. Score one for the good guys. Evidence 402?

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Drug & Device Law

APRIL 18, 2022

2022 WL 1016686 (Wis. April 5, 2022) (per curiam). The trial court granted summary judgment based on evidence that the implanting surgeon “would have used the clips in the surgery even if he had received such a warning” and thus plaintiff “could not prove the cause element of his claims.” 2022 WL 1016686, at *4.

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Drug & Device Law

JUNE 3, 2022

One trial court ruled that way in a hip replacement case in California, and the Court of Appeal reversed in the opinion that prompted today’s post. B302544, 2022 WL 1679539 (Cal. May 26, 2022). The defendant had a causation expert too, plus testimony from treating physicians on potential alternate causes.

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Drug & Device Law

NOVEMBER 28, 2022

Three years ago we published a lengthy post, “ Stupid Expert Tricks ,” detailing several of the other side’s egregious attempts at passing off junk science “experts” as the real thing, along with our side’s trials and tribulations during the course of unmasking these phonies. 3d , 2022 WL 16571057 (M.D.N.C. 3d 179, 181-87 (D.

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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 20, 2023

That the product had been approved in “other countries” could not create a triable issue of fact because, even for other uses that the FDA eventually allowed, the necessary clinical trials had not been completed in 2010. 3d , 2022 WL 6225596 (S.D. 3d , 2022 WL 6225596 (S.D. 2022 WL 6225661, at *5 (S.D. Ethicon, Inc. ,

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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.

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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). appears relevant. But in reality, [the expert never explained what those.

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Testimonials Engineering Doctors Trials 64

Drug & Device Law

FEBRUARY 17, 2022

20-30184, 2022 WL 405298 (5th Cir. 20, 2022) (“ Earnest ”), that is the problem. The district court rejected these arguments before, during, and after trial, but the panel, while purporting to apply an abuse of discretion standard, reversed. 2022 WL 405298, *1.

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Drug & Device Law

OCTOBER 20, 2022

10, 2022), is not one of those. While that may be true when it comes to trial judges and juries in certain parts of the state, the Texas Products Liability Act and much of the appellate case law applicable to product liability are pretty tight. ALN Int’l, Inc. , H-19-3852, 222 WL 6468725 (S.D. C and A, and no retained experts. (It

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Drug & Device Law

JULY 25, 2022

2022 WL 2806390 (D. July 18, 2022), including the ultimate result. Cantrell , 2022 WL 2806390 at *1. B]ecause the opinions in [the expert’s] report pertain only to transvaginal implantation, [the] testimony would be unhelpful to a jury. Accordingly the court grants [the] motion to exclude [the expert’s] testimony.”

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Drug & Device Law

MARCH 9, 2023

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. More generally, a defendant can rely on the jury to reject plaintiff’s expert’s testimony, especially when aided by effective cross-examination. LEXIS 31015, *5-6. The court was having none of it.

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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

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

APRIL 6, 2022

Colorado March 28, 2022), because it hammers some ubiquitous plaintiff mesh experts and because it finds a way to depart from an awful MDL ruling. The remand court began its opinion with a reference to the court’s gatekeeper role in admitting or excluding expert testimony, so we immediately suspected we were in for a good ride.

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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.” 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 21, 2022

Johnson & Johnson, 2022 WL 2115075 (Jun. On defendant’s motion to exclude certain testimony by plaintiff’s expert, most of the court’s rulings were wait and see at trial with some admonitions that plaintiff’s expert should not stray from his reports or attempt to introduce evidence that was excluded by the MDL court.

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Drug & Device Law

FEBRUARY 21, 2022

702 expert gatekeeping decisions bearing that caption, as Martinez approaches trial (scheduled for March 21, although the plaintiff has sought a continuance). 2022 WL 425206 (N.D. Thus, Pence’s proposed testimony didn’t “fit” this case: There is no logical connection between her expertise, the issues in the case, and her opinions.

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Drug & Device Law

APRIL 1, 2022

Usually, the answer will be “no,” because such questioning usually offers no advantages and could well undermine the witness (who may lose focus under friendly questioning) or provide clues as to the client’s trial strategy. 3d , 2022 WL 664719 (Cal. 2022 WL 664719, at *1. For trial – taking the easy/cheaper way ?

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