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. 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 to include devices.

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Drug & Device Law

MARCH 4, 2024

2014), the MDL court let plaintiffs try again. 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.” 2d 449 (E.D. In re Zoloft Products Liability Litigation , 2015 WL 115486 (E.D. Weisgram v. Marley Co. , 440, 455-56 (2000).

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Drug & Device Law

JANUARY 15, 2024

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. Coffing Hoist Division , 528 A.2d 2d 590 (Pa. Omega Flex, Inc. , 3d 328 (Pa. We haven’t seen standards compliance litigated, but T.M. 3d 709 (Pa.

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Drug & Device Law

DECEMBER 28, 2023

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.” including all neurodevelopmental issues to get an increased risk in a study that was only designed to look at ASD).)

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Drug & Device Law

OCTOBER 31, 2023

Plaintiff suffered from back problems nearly his whole life that were exacerbated by a car accident in 2014 that led to spinal fusion surgery in 2016 during which his surgeon chose to implant an expandable interbody fusion cage device manufactured by the defendant. Howmedica Osteonics Corporation, 2023 WL 6850144 (D.

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Drug & Device Law

JULY 24, 2023

2014) (both complete with diagrams). 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. See , e.g. , In re Thalomid & Revlimid Antitrust Litigation , 2018 WL 6573118, at *4 (D.N.J. 555, 565 (E.D.

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Drug & Device Law

JUNE 13, 2023

Then, in 2014 the Court amended Rule 702 from mirroring its federal counterpart to expressly limiting the Daubert admissibility analysis to “novel scientific theory, principle, methodology, or procedure.” Evid. methodology underlying proffered expert testimony is scientifically valid and whether that. CSX Transportation, Inc. ,

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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). 2014) (Pennsylvania law), mucked things up and cases like Yates v. Wyeth , 619 F.3d

FDA Approval 59

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Drug & Device Law

FEBRUARY 20, 2023

7, 2022), which addressed the same question in the context of the admissibility of expert testimony. Therefore, Davis excluded as “not relevant” expert testimony about non-FDA-approved alternatives. His testimony is thus irrelevant and inadmissible. 2014 WL 12685965, at *6 (S.D.W. Baksic relied on Pizzitola v.

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Drug & Device Law

AUGUST 26, 2022

2014), a prescription drug case. 2014), a case about steel tubing used as a gas line. Instead, it looked to Pennsylvania’s ultimate requirement of proof of expert testimony to prove a prescription drug (!!!) The Swedish company was surely not at home in Pennsylvania for purposes of general jurisdiction. Wyeth , 85 A.3d

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Drug & Device Law

JUNE 20, 2022

The pre-litigation facts of Donaldson are fairly simple: Implant in 2010 of the two devices and treatment in 2014 for “injuries resulting from erosion of the mesh into her bladder, vagina and adjacent tissues, causing scarring, bladder stones and abdominal pain, among other problems.” That meant summary judgment.

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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

MAY 12, 2022

We actually wrote previously about rulings in this case , including the rejection of the plaintiff’s argument that defense experts could not dispute the theory that polypropylene degrades in the human body because of the testimony of a corporate representative. 2:12-CV-4301, 2014 WL 457544, at *5 (S.D.W.

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Drug & Device Law

MARCH 28, 2022

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. 2014 WL 4851989, at *36 (S.D.W.

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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. An excellent example is the Sherman case, which involved junk science causation testimony in what we call a “toxic soup” chemical exposure case. Boulle, Ltd.

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Drug & Device Law

FEBRUARY 25, 2022

We return to a theme we’ve repeated twice before, in 2011 and in 2014 – that in addition to industry-specific groups, manufacturers of prescription medical products should definitely consider joining the Product Liability Advisory Council (“PLAC”). Notice how admissibility of expert testimony under Fed. 19-2899 (8th Cir. filed Sept.

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Drug & Device Law

JANUARY 28, 2022

Clearly, given Dr. Rosenzweig’s meat-axe testimony that all mesh products made from polypropylene are unsafe and unsuitable for implantation in the human body, Plaintiffs’ proposed alternative design (TVTs in general) was dead on arrival, which the opinion recognized. newsflash! ) The legal framework for Fajardo was straightforward.

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