Agency IQ

SEPTEMBER 29, 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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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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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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Agency IQ

OCTOBER 27, 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

DECEMBER 5, 2022

239, 253 (2012) (which the Blog discussed here ). The Superior Court here “credited testimony from doctors who never implanted mesh, or who did so outside the state of California.” at 27 (testimony that “large” amount of material had to be “recycl[ed]”). Fox Television Stations, Inc. , Petition at 13.

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Drug & Device Law

JULY 24, 2023

Apparently, plaintiff’s statistician, in considering the post-2011 decline in Actos sales, did not deem it important that generic versions became available in August 2012. 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.

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Drug & Device Law

APRIL 29, 2022

The decedent was diagnosed with peritoneal mesothelioma in 2012 and died in 2016. On appeal, the intermediate appellate court affirmed, holding that “[the geologist’s] testimony about the amount of asbestos released. The trial court denied the motion.

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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.

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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

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. 2012), it had to apply the rule. Hamilton , 372 S.W.3d 3d 140 (Tex. Medrano , 28 S.W.3d

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Drug & Device Law

APRIL 19, 2022

The defendant opposed admission of that testimony on the ground that “trade secret” – like “adulterated”/”misbranded” in our prior post – was a legal term of art, and thus improper as a basis for an expert opinion. The court agreed with the defendant, and wrote an unusually thorough explanation of why this testimony was being excluded. “One

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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

FEBRUARY 20, 2024

In 2012, Plaintiff underwent laparoscopic surgery to repair an inguinal hernia that included implanting defendant’s hernia mesh product. It was undeniable that Florida does not allow products liability claims for intentional infliction of emotional distress. He’d never read the IFU; never seen it.

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