Agency IQ

JUNE 16, 2023

An update on the Medical Device Quality Management System Regulation : In February 2022, the FDA proposed a new rule which would effectively transition the agency away from its longstanding Quality System Regulation (QSR) in favor of the ISO 13485:2016 standard. Read our analysis of that rule here and here. ]

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The Pharma Data

MAY 15, 2021

2016 Apr;46(4):605-10]. Davies T, Orr R, Halaki M, Hackett D. Effect of Training Leading to Repetition Failure on Muscular Strength: A Systematic Review and Meta-Analysis [published correction appears in Sports Med. Sports Med. 2016;46(4):487?502. doi:10.1007/s40279-015-0451-3. Schoenfeld BJ, Peterson MD, Ogborn D, Contreras B, Sonmez GT.

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Agency IQ

DECEMBER 1, 2023

The revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufacturers, ISO 13485:2016. 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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Agency IQ

OCTOBER 27, 2023

The revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufacturers, ISO 13485:2016. 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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The Pharma Data

MAY 13, 2021

For example, a 2016 study in the Journal of Environmental Health found that supplementing with these minerals led to higher levels of T3 and T4 in the bloodstream…iv. Wood also recommends adding more Copper, Iron, Zinc, Magnesium, and Selenium to your diet as well…. Where they power your metabolism and your cells.

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Drug & Device Law

FEBRUARY 11, 2024

On appeal, the Fifth Circuit overturned the District Court’s nullification of the FDA’s approvals of both branded and generic versions of mifepristone but affirmed that court’s voiding of both the 2016 risk evaluation and mitigation strategy (“REMS”) and 2021 non-enforcement decision that allowed telemedicine prescription of mifepristone.

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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). 2016), and In re Zantac (Ranitidine) Prods. Wyeth , 85 A.3d 3d 434 (Pa. 3d 281 (6thCir.

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Drug & Device Law

APRIL 18, 2022

2016), “ Probably the Best Wisconsin Law Decision We’ve Ever Seen.” make clear that Wisconsin adopts the doctrine, as consistently predicted by Wisconsin federal courts since 2016. We designated the opinion In re Zimmer Nexgen Knee Implant Products Liability Litigation , 218 F. 3d 700 (N.D. 3d 746 (7th Cir. and finally ?

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Drug & Device Law

FEBRUARY 14, 2023

In 2016, a year before plaintiff’s revision surgery, the defendant manufacturer published a surgical technique brochure that warned “against the use of a metal. Also in 2016, defendant issued an Advisory Notice “which advised against the use of metal.

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Drug & Device Law

JUNE 16, 2022

1938 (2016), and its effect on preemption cases in our drug/device sandbox. These decisions did that in order to keep holding issues, such as the sufficiency of the factual basis for expert testimony, to be jury questions when the new Rule 702 expressly consigned them to the court’s gatekeeping function.

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Drug & Device Law

JANUARY 28, 2022

2016)): Bifolk 1 – “A reasonable alternative design was available that would have avoided or reduced the risk of harm and the absence of that alternative design renders the product unreasonably dangerous. Third, the majority did not buy the dissent’s reliance on the implanting surgeon’s testimony. newsflash! ) Philip Morris, Inc. ,

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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. 17, 2023) told plaintiff when it dismissed his case.

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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

JUNE 14, 2023

Sometimes expert testimony bolsters the warnings story for one or both sides, but not always. The defendant has the option of offering “responsive expert testimony that physicians are free to ignore such a directive.” Real life practice taught us that failure to warn is far and away the most common and dangerous claim we face.

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Drug & Device Law

OCTOBER 30, 2023

Notwithstanding a settlement in 2016, it’s still up and running, it appears. W]ith considerable testimony from their own experts that all of the plaintiffs fell within an acceptable range, they have failed to adduce competent evidence in support of their claims. The Granuflo/Naturalyte MDL (“ G/N ”) was created a decade ago, in 2013.

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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

MARCH 4, 2024

2016) (citation omitted). 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.” 2001), recognized that “fairness does not require that a plaintiff, whose expert witness testimony has been 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

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

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

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

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

FEBRUARY 16, 2024

Plaintiffs included in their motion for reconsideration a lengthy affidavit contending that the court’s decision dismissing their failure to warn claim was based on the wrong physician’s testimony. If accepted, the testimony may have altered the court’s analysis in the second motion for summary judgment. Allied Mut.

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