Agency IQ

JULY 28, 2023

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 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.

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Drug & Device Law

MARCH 4, 2024

In re Zoloft Products Liability Litigation , 2015 WL 115486 (E.D. In re Zoloft (Sertraline Hydrochloride) Products Liability Litigation , 2015 WL 7776911 (E.D. 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.”

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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. Further, “adequacy” is an objective standard, that neither a plaintiff’s self-interested testimony nor equivocal health care provider testimony can touch.

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Drug & Device Law

JUNE 23, 2023

All of them had very stale claims – with that injury occurring before 2008, which was seven years before the critical 2015 label change that added “reports of permanent hair loss” to the drug’s label. Plaintiff Adams’ “sworn testimony and plaintiff fact sheet” established that she blew the statute of limitations by some eight years.

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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). 2015), Tersigni v. Wyeth , 619 F.3d 3d 632 (6th Cir. Wyeth , 85 A.3d 3d 434 (Pa.

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Drug & Device Law

FEBRUARY 20, 2023

0295, 2015 WL 5022618, at *12 (N.J. 14, 2015) (claimed alternative could not be considered for plaintiffs who “had their surgeries prior to the commercial availability of” the claimed alternative because it “was not approved by the Food and Drug Administration until June 2007 and was not commercially available until late” that year).

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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 30, 2022

Several of the rulings in Enborg are common to numerous mesh decisions out there, but there is a favorable decision about Rule 30(b)(6) deposition testimony not being a judicial admission that we have not seen addressed before in any detail. Consequently, the court denied the plaintiffs’ motion to exclude the expert testimony.

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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. 2015 WL 868907, at *29 (S.D.W.

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