Drug & Device Law

JANUARY 19, 2024

at *2 (we’ve previously posted that such testimony is insufficient to establish causation ). The Court had none of it: Even assuming that the failure to describe the learning curve is not a preempted attack on FDA-approved information., The implanter had attended training with the manufacturer to learn the implant procedure.

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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. They excluded bogus expert testimony under Fed. The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. Bonta , 85 F.4th 4th 1263 (9th Cir. 4th 1030 (9th Cir.

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Drug & Device Law

DECEMBER 21, 2023

Shikada is the first appellate decision creating a state-law warning-based duty (here, via a consumer protection claim, brought by the state rather than anyone actually claiming injury) based solely on pharmacogenomics − racially/ethnically-based genetic variations − allegedly affecting the effectiveness of FDA-approved prescription drugs.

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Drug & Device Law

OCTOBER 4, 2023

Not citing any case where such a distinction had been recognized, the Burton court held the difference between SJS and TEN, and the significance of such difference, to be questions of fact “that will require medical expert testimony to resolve.” Again, the Burton court stood on procedural ceremony so as to dodge the crucial issue.

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Drug & Device Law

JULY 24, 2023

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. It is not clear that [defendants] will − or even can − avail themselves of a TPP-by-TPP causation defense using doctor-by-doctor testimony.

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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). 2023 WL 2386776, *3. citing Gross v. Pfizer, Inc. ,

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Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. to determine whether a proposed alternative drug would have received FDA approval.” at 237-38.

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Drug & Device Law

NOVEMBER 3, 2022

Plaintiff argued the testimony was relevant to a risk/utility analysis but showing that a different medical procedure may be safer, “does not affect whether a product has utility and/or risks.” As long as they don’t, the door to this testimony remains closed. . “It is not an alternative design of any product. Pizzitola I , 2022 U.S.

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Drug & Device Law

NOVEMBER 1, 2022

This is the causation variant that we described here as “ not quite physician failure to read ,” since the pertinent testimony was in the nature of a failure to remember reading the relevant information rather than an absolute “never read it” from the implanter. It is undisputed here that the filter received FDA approval.

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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. at *3 – which means, as we’ve discussed before , a manufacturer cannot include warnings about such off-label uses absent specific FDA approval.

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Drug & Device Law

MARCH 4, 2022

702 – that they were not qualified, their testimony was not based on sufficient facts or data, their methodologies were not reliable, and they did not reliably apply their methodologies to the facts of the case. their testimony does not present a genuine issue of medical fact.” Motion to Exclude Experts. emphasis in original).

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