Agency IQ

SEPTEMBER 29, 2023

An avalanche of new legislation: Speaking of Congress, the House and Senate are back in session as of mid-September and we have already noticed a lot of legislative interest in the FDA – probably about two dozen bills related to drug shortages, generic drug competition, supply chain security, opioids, medical device recalls and orphan drug products.

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Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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Agency IQ

DECEMBER 1, 2023

This is what OIRA is currently reviewing. Note: If a link no longer works, it is likely because OIRA has since cleared the document.)

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The Pharma Data

MAY 13, 2021

Product Name: The TMJ Solution vsl cb | Blue Heron Health News. If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked.

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Agency IQ

JUNE 29, 2023

As a result, our statutory authority under section 704(a)(4) of the FD&C Act to request records or other information in advance of or in lieu of a drug establishment inspection does not apply to these products. The final rule will amend the administrative destruction provisions in 21 CFR 1.94

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Agency IQ

DECEMBER 11, 2023

This was corroborated by testimony from Boulder City attorney Brittany Walker at a November 28, 2023 Boulder City Council meeting. There is no end in sight to PFAS litigation in the United States that stems from water pollution, consumer products, or personal injury.

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The Pharma Data

MAY 13, 2021

Product Name: Let's Quit Sugar With Audiobook – Let's Quit Sugar. If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked.

Disease 52

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The Pharma Data

MAY 14, 2021

Product Name: CarboFix. If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked. That stops the production of “new fat”….

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The Pharma Data

MAY 13, 2021

Product Name: Multiple Sclerosis MS Treatment eBook Cure By Dr. Gary M. If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked. Payment can be.

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The Pharma Data

MAY 13, 2021

Product Name: Unblock My Hormones And Start Burning Fat TODAY With HB5. If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked.

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The Pharma Data

MAY 13, 2021

Product Name: Eat The Fat Off. If within the first 60 days of receipt you are not satisfied with Wake Up Lean , you can request a refund by sending an email to the address given inside the product and we will immediately refund your entire purchase price, with no questions asked. Spend a few years in trial and error testing.

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Agency IQ

JULY 28, 2023

On March 27, the FDA finalized a transition guidance document covering products that had been marketed under enforcement discretion policies during the PHE. Those concerns have proven serious enough that in September 2020 the FDA published a final guidance document calling on manufacturers of drug products to take two steps.

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Codon

JUNE 2, 2024

This discordance, or lack of “ predictive validity ” when translating results across organismal boundaries, is perhaps most harmful in the biomedical field; despite extensive testing in mouse models, only 10 percent of drugs that make it to clinical trials ever make it to market. In a testimony in front of the U.S.

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Drug & Device Law

MARCH 6, 2024

It’s getting harder and harder to get civil jury trial experience. Still, wouldn’t it be better if your trial judge had some sense of how these things really work?) For example, if the expert opines that our client’s product has a defective design, we will ask specific questions about the design process. But at least he got it.

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Drug & Device Law

DECEMBER 21, 2023

But this year, as bad as the bottom ten opinions we discuss below are, our sense is that they are somewhat overshadowed by even worse non-prescription medical product judicial malarkey. But even putting those goliaths aside, it’s an unpleasant enough job to chronicle the ten worst prescription medical product liability decisions of the year.

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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.” Prescription medical product liability litigation has existed for decades.

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Drug & Device Law

DECEMBER 27, 2022

In the Zantac MDL, the plaintiffs’ causation problems were plainly visible on the horizon, as we mentioned in our post last year about the Zantac ruling on medical monitoring, In re Zantac (Ranitidine) Products Liability Litigation , 546 F. In re Zantac (Ranitidine) Products Liability Litigation , F. 3d 1152 (S.D. A Numbers Racket.

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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

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

FEBRUARY 25, 2022

We return to a theme we’ve repeated twice before, in 2011 and in 2014 – that in addition to industry-specific groups, manufacturers of prescription medical products should definitely consider joining the Product Liability Advisory Council (“PLAC”). In re Bair Hugger Forced Air Warming Devices Products Liability Litigation , No.

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Drug & Device Law

FEBRUARY 23, 2024

In In re Onglyza & Kombiglyze Products Liability Litigation , No. The FDA had asked the manufacturers to conduct a randomized controlled trial with multiple cardiac endpoints, which they did. Plaintiffs’ response to this was predictable: Leave it to the jury to “evaluate and weigh” the testimony.

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Drug & Device Law

JANUARY 24, 2022

The Manual also discusses general issues concerning the presentation of video depositions of any sort at trial. In re Valsartan, Losartan, & Irbesartan Products Liability Litigation , MDL No. In re Onglyza (Saxagliptin) & Kombiglyze XR (Saxagliptin & Metformin) Products Liability Litigation , MDL No. 2775, CMO 17 (D.

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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 ? the defendants won 12½.

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Drug & Device Law

DECEMBER 5, 2022

Ultimately, the thumb that Freeman put on the scale didn’t matter, because the defendant won at trial despite that handicap. Before the advent of this sort of aggregated enforcement actions, businesses defending against product related inadequate warning claims could assert basic, well-understood common-law defenses. and actual injury.

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Drug & Device Law

JANUARY 15, 2024

As we discussed at length in this post, since the 1940s, the Pennsylvania Supreme Court and other courts applying Pennsylvania law have refused to subject prescription medical products to strict liability. Neither Lewis nor Tincher involved prescription medical products, but rather what we describe as “things that go clank.”

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Drug & Device Law

APRIL 29, 2022

26, 2022), New York’s highest court reversed an asbestos jury’s verdict for the plaintiff, holding that the plaintiff’s experts had not adduced sufficient proof that the defendant’s product caused the plaintiff’s decedent’s fatal mesothelioma. The trial court denied the motion.

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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 29, 2023

In 2023 there seemed to be an unusually large number of other decisions that are likely to have a substantial impact on what we or our clients do, but involve either different products, non-product claims, or both. 2023) (remote trial testimony cannot be compelled beyond Rule 45’s 100-mile limit on subpoenas) ( here ); Carson v.

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Drug & Device Law

DECEMBER 28, 2023

Many lawyers who at least dabble in product liability litigation have heard the term “Bradford Hill criteria.” In a paraphrase of the testimony of a difficult opposing epidemiology expert who passed away recently, “you have to say what you will do and then do what you say.” We offer two examples.

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Drug & Device Law

JANUARY 11, 2022

In In re: Onglyza and Kombiglyze XR Products Liability Litigation , MDL 2809, 2022 WL 43244 (E.D. At the request of the FDA, manufacturers conducted a cardiovascular outcomes study, a randomized controlled trial with multiple cardiac endpoints. Trials of other drugs in the class also failed to show an association.

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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. We will not attempt to do a full recap of all the posts and decisions on the issue of whether Pennsylvania recognizes such a claim for prescription medical products. Atrium Medical Corp. , — F. Richter , 673 A.2d

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Drug & Device Law

MARCH 23, 2023

were proximately caused by the erosion of the mesh product.” Plaintiff also argued that the trial court should have allowed her to offer expert causation testimony from the explanting physician, thus raising an issue of material fact to defeat summary judgment. 2d 624, 631 (E.D.N.C.

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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. 2d 16, 19 (Minn. 2d 16, 19 (Minn. II) , 341 F.

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Drug & Device Law

MARCH 16, 2023

We have made no secret of our long-held views that “failure to withdraw” or “stop selling” theories of liability for FDA-authorized medical products are unwarranted perversions of state design defect law and preempted anyway. Some discussion of preemption of state “stop selling” actions outside of product liability are here , here , and here.]

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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. 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 18, 2022

We designated the opinion In re Zimmer Nexgen Knee Implant Products Liability Litigation , 218 F. Then we described In re Zimmer, NexGen Knee Implant Products Liability Litigation , 884 F.3d Apparently, the “no warnings” issue arose because physician in Rennick put the product to an off-label use, id. 3d 700 (N.D. 3d] at 751.

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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. The adequacy of any warnings provided to the patient are not at issue in this product liability case and are not relevant. How does such testimony meet the relevance requirement of Fed. Texas March 2, 2022)— is a veritable mixed bag.

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