Agency IQ

SEPTEMBER 29, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED SEP 25, 2023 10:39 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events. the drug and device) of the combination product.

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The Pharma Data

MAY 14, 2021

It’s so powerful that in a 4 month trial… A group of patients lowered insulin levels without changing their diets [21]. Along with information on how to get in contact with our support team…. You’ll also receive an email with our customer service contact information. Think of it like an air traffic controller….

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The Pharma Data

MAY 13, 2021

I have to admit that when I discovered this information, I was extremely skeptical. In a major double-blind clinical trial published in the American College of Endocrinology…. Numerous double-blind, randomized, and placebo-controlled trials have also found Rhodiola to…. But that’s a small price to pay I love it!”.

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The Pharma Data

MAY 13, 2021

The information provided on this site is for informational purposes only and is not intended as a substitute for advice from your physician or other healthcare professional. You should not use the information on this site for diagnosis or treatment of any health problem or for prescription of any medication or other treatment.

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Agency IQ

DECEMBER 1, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED NOV 27, 2023 10:59 PM CST Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

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The Pharma Data

MAY 13, 2021

scientific trials and regulations, modern medicine by. Just read and watch the testimonials for. treatms.org and its officers, directors, employees, agents, licensors, suppliers, and any third party information providers. of this information contained on this Site, E-Book and Program. As I said above, since I don’t feel.

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Conversations in Drug Development Trends

OCTOBER 29, 2024

By: Juliane Mills, Senior Director, Therapeutic Strategy Lead, Rare Disease The rise of patient-led clinical research, particularly in rare disease, represents a significant shift in the clinical trial landscape. Why Is There an Increase in Patient-Led Rare Disease Research?

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Conversations in Drug Development Trends

MARCH 11, 2025

As these innovative therapies begin clinical trials in new patient communities, its essential to understand how to successfully adapt lessons and processes from oncology CAR T therapies into these studies. Moreover, these factors continue to be limiting even after marketing authorization is achieved.

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Agency IQ

JULY 28, 2023

That’s because significant guidance documents typically require review and approval by the White House’s Office of Information and Regulatory Affairs (OIRA) prior to publication. It’s also possible that some of FDA’s commitments – and especially things like new guidance documents – might get delayed later into October.

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Drug & Device Law

MARCH 4, 2024

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.” His inability to produce admissible expert testimony is due to his own actions, namely the failure of his proposed experts to test their alternatives. Weisgram v.

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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. Instead, Zofran turned mainly on animal studies – three Japanese studies that were not “newly acquired information” that could avoid preemption. Bonta , 85 F.4th

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Drug & Device Law

DECEMBER 28, 2023

While Frye was seen as a high bar at the start, by the 1980s, a cadre of practitioners of the ancient art of junk science were routinely permitted to offer medical causation opinions at trial despite general causation being anything but generally accepted. The only thing missing was accusing the defendants of buying the science.

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Drug & Device Law

DECEMBER 21, 2023

That’s significant because the labels for over 500 drugs already have such information, under a voluntary FDA program. The safe harbor did not include a defendant’s decision to add information that the FDA encouraged but did not mandate. In Shikada , the ultimate result was a nuclear penalty of over $800 million.

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Drug & Device Law

OCTOBER 18, 2023

First, civil discovery in New Jersey (as elsewhere) extends to “all relevant, non-privileged information.” Id. “The rules do not extend a privilege to private social media account information.” Nor was the trial court’s order compelling production so overly broad as to be an abuse of discretion.

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Drug & Device Law

OCTOBER 11, 2023

Rule 1 : Amend to add express reference to protection of reasonable expectations of privacy, particularly as to non-party information. Rule 16 : Amend to add privacy and cybersecurity as topics for prompt pre-trial consideration. Rule 5 : Amend to discuss role of privacy in the sealing of court filings. in the heading of Rule 5.2,

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Drug & Device Law

OCTOBER 4, 2023

We acquired our trial chops in the Central District of California, where we were an AUSA. 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.”

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Drug & Device Law

SEPTEMBER 25, 2023

Assuming the expert testimony doesn’t change, the defendant essentially gets a do-over. Not surprisingly the once and future exclusion of the plaintiffs’ expert testimony loomed large in this ginned-up dispute. and they should never disclose any confidential information received in the course of official duties. See Gareis v.

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Drug & Device Law

JULY 24, 2023

Second, as for superiority, PATDC82 II admitted that a class trial would face “enormous logistical hurdles,” but nonetheless found a nationwide class action “superior.” Thus, “[o]ne supposed ‘nightmare’ trial is preferable to many hundreds of shorter ones.” 2023 WL 4191651, at *8. But that conclusion is premature.

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Drug & Device Law

JUNE 23, 2023

That’s not just true in the Taxotere MDL Shook Hardy’s Harley Ratliff , who keeps informed of Taxotere goings on, recently let us know of the recent dismissal of all four of the bellwether plaintiffs selected in the New Jersey Taxotere “multi-county litigation (that jurisdiction’s MDL equivalent). This wasn’t a close case. at *34-35.

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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. 2013) (citation and quotation marks omitted). “We.

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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 9, 2023

Defense trial lawyers with a lot of, er, gumption have been known to rest at the end of plaintiff’s case without presenting any witnesses. We perused the docket for some more information, which we will discuss later. Pattern jury instructions often include some version of the phrase “the defendant does not have to prove anything.”

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Drug & Device Law

FEBRUARY 20, 2023

In updating chapter three of his book , on non-informational causes of action, Bexis had the opportunity to add the last several years of “alternative design” opinions. 7, 2022), which addressed the same question in the context of the admissibility of expert testimony. His testimony is thus irrelevant and inadmissible.

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Drug & Device Law

DECEMBER 28, 2022

Forward is more fun, as we scan a schedule full of motions, MDL decision-trees, and trials in, er, challenging jurisdictions. Enterprising plaintiff lawyers are exploiting the many residents of drug and device supply chains to gin up personal jurisdiction by finding local players (raw material suppliers, clinical trials, etc.)

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Drug & Device Law

DECEMBER 27, 2022

The chemist did none of the testing himself, and “left operational decisions to the professional judgment of his employees” with “no written procedures, instructions, or guidance that would inform analysts of how to perform manual integrations.” Due to supposed litigation “confidentiality,” none of his testing was peer reviewed.

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Drug & Device Law

NOVEMBER 28, 2022

Three years ago we published a lengthy post, “ Stupid Expert Tricks ,” detailing several of the other side’s egregious attempts at passing off junk science “experts” as the real thing, along with our side’s trials and tribulations during the course of unmasking these phonies. 3d 179, 181-87 (D. This effort largely failed.

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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. Testimony that the fall was a potential cause ? is not irrelevant.

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Drug & Device Law

SEPTEMBER 9, 2022

317, 322 (1986), that summary judgment was mandated “against a party who fails to make a showing sufficient to establish the existence of an element essential to that party’s case, and on which that party will bear the burden of proof at trial.” Catrett , 477 U.S. Pfizer, Inc. , 3d 758, 769-70 (Ky. The second was the decision below.

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Drug & Device Law

AUGUST 26, 2022

After more than a month away at trial, we probably should not have picked a case that hit so close to home, so to speak. Instead, it looked to Pennsylvania’s ultimate requirement of proof of expert testimony to prove a prescription drug (!!!) Atrium Medical Corp. , — F. 3d –, 2022 WL 3357485 (E.D. Wyeth , 85 A.3d 3d 434 (Pa.

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Drug & Device Law

JULY 25, 2022

B]ecause the opinions in [the expert’s] report pertain only to transvaginal implantation, [the] testimony would be unhelpful to a jury. Accordingly the court grants [the] motion to exclude [the expert’s] testimony.” The court concluded, “. [B]ecause So far, so good. citation omitted). citation omitted). (citation omitted).

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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

MAY 12, 2022

A specific remanded pelvic mesh case is just another case on the judge’s docket that needs a trial date and rulings on motions for summary judgment, to exclude experts, for reconsideration, etc. We have offered praise for a number of decisions in remand cases where the defendants won issues they were not winning in the MDL. Sunnyside Prods.,

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Drug & Device Law

APRIL 18, 2022

That was precisely the kind of on-the-ground information we had hoped for from this kind of guest post from local practitioners familiar with the lay of a particular state’s legal landscape. Nothing about what does or does not “inform” prescribers. and finally ? See [ Zimmer Nexgen , 884 F.3d] 3d] at 751. 2022 WL 1016686, at *4.

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Drug & Device Law

APRIL 1, 2022

Usually, the answer will be “no,” because such questioning usually offers no advantages and could well undermine the witness (who may lose focus under friendly questioning) or provide clues as to the client’s trial strategy. For trial – taking the easy/cheaper way ? In Berroteran v. Superior Court , P.3d 3d , 2022 WL 664719 (Cal.

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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. See Tyree v. 3d 501, 543 (S.D.W.

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Drug & Device Law

MARCH 9, 2022

The issue in Robinson was the admissibility of testimony by the plaintiff’s regulatory expert. But the defendant pointed to 21 CFR section 801.109(c), which says that labels may omit information “commonly known” to licensed medical practitioners. No Informed Consent. Texas March 2, 2022)— is a veritable mixed bag.

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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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