SQA

FEBRUARY 26, 2024

During the operation, food supplements, cannabidiol in various presentations, testosterone, perfumes, and sibutramine tablets were identified, including about 6,000 units of electronic cigarettes and 35,500 packs of cigarettes. The products found, subject to retention and seizure, were retained by the Federal Revenue Service.

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FDA Compliance COVID-19 Public Health 52

Drug & Device Law

SEPTEMBER 11, 2023

FDA litigation, back in April, the United States Supreme Court had just stayed what we described as “a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.” FDA , 727 F. That’s why Buckman Co.

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FDA Doctors Malpractice COVID-19 59

Drug & Device Law

AUGUST 28, 2023

FDA litigation, back in April, the United States Supreme Court had just stayed what we described as “a truly ridiculous decision purporting to invalidate a number of actions taken by FDA with regard to mifepristone, the only currently marketed approved medication for medical abortion.” FDA , 727 F. That’s why Buckman Co.

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FDA Doctors Malpractice COVID-19 52

Drug & Device Law

DECEMBER 4, 2023

2002). “[I]t is not the role of a federal court to expand state law in ways not foreshadowed by state precedent.” On a host of issues, CPAP II makes a recommendations about state law – but without any basis in existing state law. “[E]ven if we were torn between two competing yet sensible interpretations of [state] law. . .,

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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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FDA Governance Nurses 59

Drug & Device Law

JUNE 6, 2022

The prescriber] provided explicit, uncontroverted testimony that, even when provided with the most current research and FDA mandated warnings, as well as the information found in [defendant’s] updated. . . Bayer HealthCare Pharmaceuticals, Inc. , 3d 1223, 1233 (11th Cir. label, he would still have prescribed [the drug] to [plaintiff]. . . .

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FDA Doctors Malpractice Medical Personnel 59

Drug & Device Law

FEBRUARY 2, 2023

What’s really interesting about Atkinson is its holding that the other prerequisite to case-by-case application of comment k – that the product have “proper directions and warning” – was also satisfied as a matter of law. March 4, 2005), rev’d on other grounds , 462 F.3d 3d 364 (5th Cir. 2006) (reversal concerned warning issues); Blackmon v.

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FDA Licensing Fraud 59

Drug & Device Law

APRIL 19, 2022

Not too long ago we researched precedent that forbade persons claiming to be “FDA experts” from opining that products are “adulterated” or “misbranded.” July 3, 2019) (expert may not opine about “proximate cause”); Perez v. 2002) (prohibiting expert testimony on FDCA term “materially misleading”); Torres v. E.g. , Dalgic v.

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FDA Governance 72

Drug & Device Law

NOVEMBER 10, 2022

3, 2002) (to be published), the California Court of Appeal held that federal law preempts state law failure-to-warn claims alleging that branded and generic drug manufacturers did not ensure that patients received FDA-approved Medication Guides for amiodarone, a heart medicine. In Amiodarone Cases , No. A161023, 2022 WL 16646728 (Cal.

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FDA Doctors Fraud Governance 52

Drug & Device Law

AUGUST 7, 2023

By contrast, the Riegel preemption clause for medical devices prohibits only state-law requirements that are “different from or in addition to” FDA medical device requirements. 2002) (“Under the product liability law of California, injury to the plaintiff from a defective product is an essential element. . ., E.g. , Kanter v.

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Drug & Device Law

FEBRUARY 13, 2023

Those allegations, Pietrantoni held, sufficed to state an unpreempted (because the PAC program was apparently not FDA required) claim for negligent performance of a voluntarily assumed duty. Under Massachusetts law – and in similar cases just about anywhere in the country – undertaking-related allegations are necessary, but not sufficient.

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Drug & Device Law

JUNE 13, 2022

But in the device area – we looked, but did not find an analogous FDA regulatory exception for drugs – the FDA has itself recognized this common-sense, and common-law, exception to the duty to warn. Somewhat surprisingly, at least until recently, there hasn’t been much case law addressing the FDA’s “commonly known” hazard exception.

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Drug & Device Law

JANUARY 30, 2023

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. Mensing , 564 U.S. Lohr , 518 U.S.

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Drug & Device Law

JANUARY 4, 2024

That Complaint alleges various antivax conspiracy theories concerning COVID-19 vaccines, the FDA, emergency use authorizations, and the media that have circulated since these vaccines first became available. The FDA, however, did not and does not share that belief. FDA (8/23/21) press release (emphasis original).

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COVID-19 Vaccine COVID-19 FDA Public Health 59

Drug & Device Law

FEBRUARY 19, 2024

For both prescription drugs and medical devices, FDA regulations provide that direct-to-patient warnings – called “adequate directions for use” – are not necessary for drugs or devices that are available only with a physician’s prescription. . 6551, 6553 (FDA Feb. Ortho Pharmaceutical Corp., 2d 522, 528 (Or. Griffith v. Blatt , 51 P.3d

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FDA Licensing 52

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. 357 (2002); United States v. FDA , 119 F. IMS Health Inc. ,

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