Agency IQ

SEPTEMBER 29, 2023

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

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The Pharma Data

MAY 14, 2021

testimonials that my happy customers have graciously sent me from. remedies and treatments, and then go through an entire trial and error. Everything in this e-book is presented in. story or testimonial to tell me about the results you’ve achieved – and. Testimonials. | on its own. Or they might.

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The Pharma Data

MAY 13, 2021

I got hot flashes at the most embarrassing times (like when giving a presentation at work)… I would get out of breath just from running up a flight of stairs…. In a major double-blind clinical trial published in the American College of Endocrinology…. Even when they were presented with stressful situations….

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Agency IQ

DECEMBER 1, 2023

Government shutdown: At present, the FDA has appropriated funding through January 19. 12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs.

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The Pharma Data

MAY 13, 2021

Testimonials are not necessarily representative of all of those who will use our products. Some of our testimonials are provided by customers who have received promotional offers in exchange for their participation. The testimonials displayed are given verbatim except for correction of grammatical or typing errors. De Araujo IE.

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The Pharma Data

MAY 13, 2021

scientific trials and regulations, modern medicine by. Just read and watch the testimonials for. the material presented on this Site, E-Book and Program. you were to ask most doctors about ADRs, they would. give you one of the answers I used to give: The. risks of any one person having a problem is pretty. What they say.

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Agency IQ

JULY 28, 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. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

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Drug & Device Law

MARCH 4, 2024

that parties will initially present less than their best expert evidence in the expectation of a second chance should their first try fail. . . . [A]lthough 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.” Weisgram v.

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Drug & Device Law

FEBRUARY 23, 2024

The FDA had asked the manufacturers to conduct a randomized controlled trial with multiple cardiac endpoints, which they did. And the study authors stated that there “are presently no known mechanisms” by which the drug could cause heart failure. As for the one study, it was “no smoking gun.”

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Drug & Device Law

JANUARY 15, 2024

A fourth Justice concurred in the result, treating the issue of standards compliance in Sullivan as a matter of evidence, and holding that the lack of a sufficient trial record supporting the relevance of the specific standards at issue in Sullivan meant that the trial judge’s exclusion was not an abuse of discretion.

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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

DECEMBER 26, 2023

Testimony by expert witnesses. First, the Committee found it necessary to “emphasize” both the court’s role and the burden of proof. “[E]xpert testimony may not be admitted unless the proponent demonstrates to the court that it is more likely than not that the proffered testimony meets the admissibility requirements set forth in the rule.”

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Drug & Device Law

DECEMBER 21, 2023

This reminds us of pleural thickening plaintiffs in asbestos actions, and evidently the MDL court thought so as well, because plaintiffs’ claims had been dismissed for lack of present injury under these plaintiffs’ home states’ laws. Nowhere did Crockett discuss what that “literature” might be. Good riddance.

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Drug & Device Law

DECEMBER 20, 2023

So we got this prosecution, a trial, a verdict, and some interesting motions. After a thirty day jury trial, the two executives were found guilty of multiple misdemeanor violations of the Food, Drug, and Cosmetic Act, but were acquitted of the felony accounts. The trial court refused to give such an instruction.

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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. Evidentiary rulings in the first Bair Hugger bellwether trial that were affirmed by the Eighth Circuit. See Gareis v.

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Drug & Device Law

AUGUST 8, 2023

But the Federal Rules are also clear that absent compelling circumstances, trial testimony must be given in person: At trial, the witnesses’ testimony must be taken in open court unless a federal statute, the Federal Rules of Evidence, these rules, or other rules adopted by the Supreme Court provide otherwise.

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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

Here, all four bellwether plaintiffs presented with essentially the same statute of limitations-related facts. Based on the undisputed and clear record, in 2007, [plaintiff] had knowledge of her injury comprising of permanent and persistent hair loss that, by her own admission, was present for ten years prior to the filing of her lawsuit.

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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 23, 2023

We return to Donalds not only because we realized that we have questioned each of the four experts plaintiff named, but because cases presenting permutations of this same fact pattern are still percolating through the courts. Ethicon, Inc. , 22-1737, 2023 WL 2446703 (4th Cir. 10, 2023). 2d 624, 631 (E.D.N.C.

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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. So, does a defendant have to present witnesses, expert or otherwise, on every issue as to which plaintiff bears the burden of proof? A relative risk of exactly 2.0 LEXIS 31015, *5-6.

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Drug & Device Law

FEBRUARY 20, 2023

That the product had been approved in “other countries” could not create a triable issue of fact because, even for other uses that the FDA eventually allowed, the necessary clinical trials had not been completed in 2010. 7, 2022), which addressed the same question in the context of the admissibility of expert testimony. See Davis v.

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Drug & Device Law

FEBRUARY 8, 2023

She prevailed at trial against one of the manufacturers and lost to the other. The Bayless court finessed this issue, and held that the plaintiff had presented sufficient evidence of both species of causation. 2, 2023), an opinion for which the best aspect is that it is unpublished. The losing manufacturer appealed and lost again.

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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. We’ve also worked up presentations for ACI, DRI, and in-house CLEs. Second, that single study itself did not claim to present evidence of causation. The assault on non-prescription products continues.

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Drug & Device Law

DECEMBER 27, 2022

“When an expert purports to apply principles and methods in accordance with professional standards, and yet reaches a conclusion that other experts in the field would not reach, the trial court may fairly suspect that the principles and methods have not been faithfully applied.” at 83 (citation and quotation marks omitted).

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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. citation and quotation marks omitted).

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Drug & Device Law

NOVEMBER 1, 2022

Starting with the to-be-published Mixson I , this IVC filter case presented rather complex choice of law issues because the plaintiff implantee was in the military when the surgery in question occurred, and the army sent him to Texas for treatment, even though he was a Florida resident. Testimony that the fall was a potential cause ?

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Drug & Device Law

OCTOBER 20, 2022

While that may be true when it comes to trial judges and juries in certain parts of the state, the Texas Products Liability Act and much of the appellate case law applicable to product liability are pretty tight. For some reason, though, plaintiff attempted to rely on the deposition testimony of two of the treating physicians, Drs.

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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. 2002 WL 3696680, *5. at *6 (emphasis added). Corder , 473 F.Supp.3d

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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. As we have noted previously, the presentation of facts can foretell the rigor of the analysis to follow. The procedural history was presented. Atrium Medical Corp. , — F. 3d –, 2022 WL 3357485 (E.D.

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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

When we heard a presentation last week from a Formula 1 executive, we paid it about as much attention as we pay most presentations in a room full of hundreds of lawyers. In our experience, plaintiffs prefer presenting on product or procedure risks without context of how those same risks apply to every other product.

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Drug & Device Law

APRIL 29, 2022

The trial court denied the motion. On appeal, the intermediate appellate court affirmed, holding that “[the geologist’s] testimony about the amount of asbestos released. The defendant moved for JNOV, arguing that the verdict “was not supported by legally sufficient evidence as to causation.”

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Drug & Device Law

APRIL 18, 2022

The trial court granted summary judgment based on evidence that the implanting surgeon “would have used the clips in the surgery even if he had received such a warning” and thus plaintiff “could not prove the cause element of his claims.” Rennick simply made something up to avoid deciding the main issue being presented.

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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 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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