Agency IQ

JUNE 16, 2023

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. To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94

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The Pharma Data

MAY 13, 2021

pharmaceutical model, I truly believed in it, despite. Just read and watch the testimonials for. would even say that thanks to a system of proper. scientific trials and regulations, modern medicine by. and large successfully balances the risks of drugs. against undoubted benefits they offer. since I. What they say.

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Agency IQ

DECEMBER 1, 2023

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. 12/29/2023 FDORA, Section 3305 Medical Device Cybersecurity : GAO will publish a report “identifying challenges in cybersecurity for devices, including legacy devices.”

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Agency IQ

JULY 28, 2023

A big nitrosamine deadline approaches : Unless you’ve been hiding under a rock for the last few years, you’ve probably heard about major issues that the pharmaceutical industry has been having with nitrosamine contamination. But despite the law’s age, it is not yet fully operational.

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Conversations in Drug Development Trends

OCTOBER 29, 2024

Increasingly, patients and patient-led organizations are playing a pivotal role in shaping drug development, underscoring the importance of collaboration between patient organizations, CROs, and pharmaceutical and biotechnology companies.

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The Pharma Data

MAY 13, 2021

Starchy, sugary foods and pharmaceutical drugs have become the modern weapons of terror. Testimonials, case studies, and examples found on this page are results that have been. Hopefully you’re not afraid of the truth like so many people are today. They’re putting us into early graves. It’s not all our fault. results.

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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

Another of our posts quoted similar concerns raised by our clients in the pharmaceutical industry as the matter was being successfully appealed to the United States Supreme Court: The Fifth Circuit’s ruling threatens to stifle pharmaceutical innovation by disrupting industry’s reasonable investment-backed expectations.

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Drug & Device Law

JANUARY 15, 2024

Janssen Pharmaceuticals, Inc. , 2019), analogously held that the standard for admission of expert testimony was “procedural” and therefore Pennsylvania’s Frye rule applied, not Texas’ stricter expert admissibility standard. Sanchez , 716 A.2d 2d 1221, 1223 (Pa. We haven’t seen standards compliance litigated, but T.M. 3d 709 (Pa.

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Drug & Device Law

JANUARY 5, 2024

I am Susanna Moldoveanu , and I practice with Butler Snow LLP’s Pharmaceutical, Medical Device and Healthcare group. Plaintiffs had no evidence to rebut the treater’s clear testimony. For readers noticing the new byline, let me introduce myself. I am excited to join the Drug & Device Law Blogging Team.

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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. 2023) (HHS cannot force pharmaceutical manufacturers to sell unlimited amounts of prescription drugs at a discount) ( here ). They excluded bogus expert testimony under Fed. Bonta , 85 F.4th 4th 1263 (9th Cir.

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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

Takeda Pharmaceutical Co. , Luitpold Pharmaceuticals, Inc. Rather than examine the actual bases of those opinions, as Rule 702(b) required, Crockett waved the testimony through with the single observation that the expert claimed to have “conducted a “detailed review of the literature.” Geri-Care Pharmaceuticals Corp. ,

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Drug & Device Law

AUGUST 2, 2023

It had filed an amicus brief with the Second Circuit and its post-decision press release headline was “In WLF Success, Second Circuit Affirms Exclusion of an unreliable Causation Evidence in Pharmaceutical Case.” Plus, the case involves some lawyers we know and respect. In appellate land, the first issue is standard of review.

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Drug & Device Law

JULY 24, 2023

We’ve discussed recently how a federal statute intended to allow suits against international terrorists has been misapplied as allowing suits against pharmaceutical companies. Takeda Pharmaceuticals Co. , Takeda Pharmaceutical Co. , 3d 1243 (9th Cir. Now, Painters & Allied Trades District Council 82 Health Care Fund v.

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Drug & Device Law

JUNE 23, 2023

Plaintiff Adams’ “sworn testimony and plaintiff fact sheet” established that she blew the statute of limitations by some eight years. This case does not involve an unknown relationship between a pharmaceutical product and an injury,” but rather “a straightforward cause and effect relationship.” This wasn’t a close case. at *34-35.

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Drug & Device Law

JUNE 13, 2023

702 was (at the time – more on this below) identical to the Federal Rule, the Court stated “we believe that Daubert is directed at situations where the scientific or technical basis for the expert testimony cannot be judicially noticed and a hearing must be held to determine its reliability. CSX Transportation, Inc. , 2d 275, 305 (W.

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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 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). That gnaws at us, but the preemption analysis was simple and toothsome. 2023 WL 2386776, *3.

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Drug & Device Law

MARCH 7, 2023

Luitpold Pharmaceuticals, Inc. 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.” Today we add to the discussion a prime example of why you should not wait. In Crockett v. LEXIS 29923 (E.D.PA

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Drug & Device Law

FEBRUARY 20, 2023

The court in Wolfe refused to impose a negligence duty on the defendant pharmaceutical company to develop and obtain FDA approval of the plaintiff’s non-FDA-approved alternative. 7, 2022), which addressed the same question in the context of the admissibility of expert testimony. His testimony is thus irrelevant and inadmissible.

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Drug & Device Law

DECEMBER 27, 2022

Reliance on “animal data” – another notorious and frequent error common in unreliable expert testimony. Novartis Pharmaceuticals Corp. , Relying on the grossly excessive ranitidine exposure lab tests previously excluded for their bizarre results and shoddy methodologies. at *167 (quoting Glastetter v. 3d 986, 991 (8th Cir.

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Drug & Device Law

OCTOBER 14, 2022

Lance held only that comment k did not “readily translate into the negligence arena,” (citation to Lance omitted), and Tincher dealt with steel tubing, not pharmaceutical products. But here’s the problem: neither case supports this [insupportable] proposition.

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Drug & Device Law

JULY 25, 2022

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.” The court concluded, “. [B]ecause So far, so good. citation omitted). What did the court say? Cop-out #3.

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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. Medrano , 28 S.W.3d

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Drug & Device Law

MAY 30, 2022

The prescriber’s] testimony, however, does not establish that he would have altered his prescribing conduct. Given this testimony, the plaintiffs could not “show that stronger manufacturer warnings would have altered the physician’s prescribing conduct.” Plaintiff] has not identified any testimony from [the prescriber] that. . .

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Drug & Device Law

APRIL 18, 2022

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. Wyeth Pharmaceuticals , 471 F. March 30, 2021) (“Where the learned intermediary doctrine applies, the plaintiff must prove that. . . 2d 739, 747 (E.D. 3d 203 (5th Cir.

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Drug & Device Law

MARCH 28, 2022

Ferring Pharmaceuticals, Inc. 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

FEBRUARY 25, 2022

We continue to believe that PLAC membership helps pharmaceutical and medical device defendants litigate stronger (through inter-industry cooperation on shared issues of concern), smarter (through cutting edge CLE and webinars), and more efficiently (utilizing PLAC’s online knowledge base and other resources). Janssen Pharmaceuticals, Inc.

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Drug & Device Law

JANUARY 24, 2022

In re Generic Pharmaceuticals Pricing Antitrust Litigation , MDL No. Valsartan Testimony ¶1; accord Blackbaud ¶2; Davol ¶2. Blackbaud ¶37; Generic Pharmaceuticals Pricing ¶2; Davol ¶1; Zantac at p.1. Valsartan Testimony ¶3. Generic Pharmaceuticals Pricing , ¶1; accord Blackbaud ¶12. “No March 10, 2021).

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