SQA

JUNE 10, 2021

Commission in March 2015 after the publication, in December 2014, of the Q3D Guideline on Elemental Impurities (EI) by the International Council for Harmonization (ICH). FDA plant inspection and pay $50 million in fines and forfeiture. Unique Device Identification (UDI) for medical devices. Reprocessing of Reusable Medical Devices.

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SQA

FEBRUARY 15, 2023

Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.

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Health Populi

JANUARY 2, 2020

Healthcare is getting serious at #CES2020, blurring into the medical and FDA regulated turf which Omron pioneered last year launching its 80+-patented blood pressure watch, the HeartGuide. A recent blog from Valencell, a long-time digital health exhibitor at CES, pointed out “ why this time is different for wearables.”

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Health Populi

NOVEMBER 13, 2018

Lisa started the Venture Valkyrie blog in 2010. The Tech-Tonics podcast , co-hosted with David Shaywitz, was an early entrant into that medium, launching in 2015 (today, podcasts in healthcare are multiplying like rabbits). You would get smarter by mining the archive of TechTonics: so many hours of insightful (and funny!)

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Drug & Device Law

DECEMBER 4, 2023

CPAP II shrugs off plaintiffs’ repeated allegations that defendants “failed to apprise the FDA” of this or that, with the excuse that plaintiffs don’t really “rely” on them. In 15 years of blogging we’ve mentioned battery claims exactly once , in passing in a case where the claim was dismissed. Plaintiffs Legal Committee , 531 U.S.

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Drug & Device Law

APRIL 28, 2022

This past weekend, there was an NCAA Division I clash of athletic teams ranked #5 and #7, respectively, that included two children of two different authors of this Blog. 155 (2015), spelled out what makes a restriction on speech content-based and, thus, presumptively invalid. The Supreme Court decision in Reed v.

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Drug & Device Law

DECEMBER 29, 2023

This year’s Drug & Device Law Blog top ten decisions of the year reinforced preemption – the most powerful defense we can assert. Further, the plaintiffs’ arguments were based on scientific standards “not utilized by the FDA,” and thus preempted. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

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Drug & Device Law

JANUARY 9, 2023

555 (2009), a prescription drug preemption case, despite the relevant drug(s) being over-the-counter (“OTC”), and thus approved under an entirely different FDA regulatory process. 15, 2022), that we blogged about not too long ago , with the monstrosity that follows here. Levine , 555 U.S. Just compare the felicitous result in Truss v.

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Drug & Device Law

JUNE 2, 2022

For this post, however, all seven authors of the Blog are joining together. From its founding, the Blog has been addressing plaintiff attacks on medications and devices for contraception, state attempts to limit medical options for abortion, and other legal disputes affecting women’s health issues. As we discussed here , McCormack v.

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Drug & Device Law

MAY 13, 2022

472 (2013), as readers of this blog are aware, the United States Supreme Court held that a state law design defect claim against a generic drug manufacturer was pre-empted because the manufacturer could not “redesign” a drug to comply with state law tort duties without first obtaining FDA approval. Bartlett , 570 U.S.

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Drug & Device Law

MARCH 7, 2022

Thus, Bexis made a note to blog on it – but only after he finished his chapter update due at the end of February. These allegations lack any contention or inference that [defendant] withheld or misrepresented information to the FDA. . ., 2015 WL 3466517 (D. 2015); Tapia v. 2015 WL 6828660, at *8 (S.D. 2, 2020). “In

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Drug & Device Law

JUNE 2, 2023

318, 328 (2015)). So, why does the Drug and Device Law Blog care? We’ve often said that we like preemption being a question of law because, on the whole, we expect that our FDA-related facts will more persuasive than the other side’s, so we want courts to decide these issues as soon as possible. Sandoz, Inc. ,

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Drug & Device Law

JANUARY 30, 2023

For those of you accessing the Blog on mobile devices, this post may be hard to read. 470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. Mensing , 564 U.S.

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Drug & Device Law

FEBRUARY 24, 2022

One tack they take is to argue that Buckman is limited to its facts and thus applies only to state-law fraud-on-the-FDA claims. Still, the Chong court should be commended for taking “a fresh look at the governing FDA regulations” and acknowledging that it had previously “incorrectly decided” a “nearly identical” case. 3d 1026, 1034 n.22

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Drug & Device Law

SEPTEMBER 22, 2023

It is fair to say that Bexis co-founded this blog (in 2006!) Over the years, this blog has come to serve as an important resource for our drug and defense bar colleagues, and Bexis regularly identifies—if not invents—new legal issues and ideas, then proselytizes about them until they become part of the fabric of our legal lives.

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Drug & Device Law

OCTOBER 13, 2023

We blogged on similar cases here , here , and here. 2015), and the Supreme Court’s opinion in Mutual Pharmaceutical Co. It makes no difference in our view that the FDA ultimately approved TAF-based drugs. It is just a claim that the defendant should have proposed to the FDA a different warning than what the FDA approved.

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Drug & Device Law

FEBRUARY 15, 2024

As the DDL blog has previously reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As both the blog and many of us defense practitioners can attest, the statute before repeal, Mich. 15-cv-10133, 2015 WL 8175256, at *3 (E.D.

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Drug & Device Law

NOVEMBER 2, 2023

This post is solely from the non-Reed Smith side of the Blog. 2023), because it rejects the use of state law to impose requirements beyond those imposed by the FDA. In general, a prescription drug must be approved by the FDA before it may be sold. 2015) (Gorsuch, J.). Wells Pharma of Houston, LLC , 2023 WL 6301651 (S.D.

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Drug & Device Law

SEPTEMBER 9, 2022

470 (1996), has nothing useful to say about the FDA’s current system for clearing medical devices. FDA: A Lesson from Pelvic Mesh Litigation on Relative Competence to Decide a Legal Question,” 76 Food & Drug L.J. The FDA reviewed the notices but did not then have to grant permission before the device could be sold.

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Drug & Device Law

APRIL 25, 2022

Fortunately, that 2010 decision has been a pro-plaintiff anomaly, and FDA required label changes, recalls, etc. 2015) (“we will not consider evidence of a subsequent improvement to a drug label as evidence of prior failure to warn, even in cases such as this in which the FDA mandated the change in labeling”) (citing Rule 407).

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Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. Are manufacturers liable only for failing to employ an alternative design that the FDA has approved for distribution. . .

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Drug & Device Law

JUNE 28, 2022

June 24, 2022), we fully expect attempts by such states to ban FDA-approved prescription drugs that can be used to bring about abortions by chemical means. But when the FDA has approved a product, states no longer have the power to prohibit their sale or use for FDA-approved indications. Jackson Women’s Health Org. ,

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Drug & Device Law

NOVEMBER 9, 2023

In addition to its recent revamp of its “§510(k)” substantial equivalence clearance process for medical devices, (see our post here ), the FDA has also been active with respect to off-label communications – another regulatory area of continuing interest to this Blog. FDA , 119 F. Caronia , 703 F.3d 3d 149 (2d Cir.

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Drug & Device Law

FEBRUARY 11, 2024

We’ve blogged several times already about the Alliance for Hippocratic Medicine v. FDA litigation that is now before the Supreme Court. FDA , 78 F.4th quoting FDA appellate brief ). See Alliance for Hippocratic Medicine v. 3d , 2023 WL 2825871 (N.D. April 7, 2023) (“ AHM I ”). See Alliance for Hippocratic Medicine v.

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