Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

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Hall Render

MARCH 16, 2022

The measure includes funding for health care-related agencies, such as HHS, CMS, HRSA and the FDA, as well as several health care policy riders and provisions that address issues like 340B and telehealth waivers. Hall Render blog posts and articles are intended for informational purposes only. Your primary Hall Render contact.

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Drug & Device Law

DECEMBER 12, 2022

Some of us on the Blog are veterans of the original vaccine wars – those that preceded the enactment of the Vaccine Act, 42 U.S.C. 223, 231-33 (2011), holding that the Vaccine Act preempted all design defect claims asserted by claimants who rejected Vaccine Act awards and sought to litigate their claims instead. 300aa-10, et seq.

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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”). allegations of failure to report adverse events to the FDA. SC20607 (Conn. 21-241 (U.S.

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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

DECEMBER 19, 2022

b)(2)(v), which lists three types of label changes that absolutely, positively must be made by prior approval supplement – and since those changes require FDA preapproval, the Mensing independence principle preempts tort claims demanding such changes. Even further confirmation is found in the FDA’s regulatory history for §314.70(b),

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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. The first place we went was to the Blog’s own TwIqbal Cheat Sheet , which is relatively narrow, since it: (1) cites only cases where every TwIqbal argument is successful, and (2) is limited to prescription medical product cases.

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Drug & Device Law

FEBRUARY 2, 2022

As the court’s opinion explains in considerable detail, the distinction between “infant” and “children” OTC medications was created with the FDA’s agreement, through a “tentative” final monograph (TFM) published in 1988 to prevent overdosing of infants by restricting the dosage. That was not always the case.

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Drug & Device Law

AUGUST 3, 2023

Way back in September 2012, we—in its Blog-specific veiled singular usage—did our first post. 604 (2011), were still playing out. To the contrary, as one of the panel noted in a concurrence, FDA approval of a drug’s labeling creates a presumption of adequacy. FDA also says so, which the Supreme Court noted in Mensing.

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Drug & Device Law

MARCH 2, 2023

Commentators beyond this Blog have described how this bent affects contraceptive choice and public health. Plaintiffs alleged that they had these contraceptive devices implanted between 2011 and 2013 (presumably in Georgia), and later suffered some combination of a wide range of symptoms that they attributed to “migration” of the device.

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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. Bartlett , 570 U.S.

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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

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. 2011)—reads Buckman Co. 21 U.S.C. § See Spano , 65 F.4th 4th at 264.

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Drug & Device Law

JANUARY 10, 2023

But the same does not generally apply to the DDL blog. Singulair was approved by the FDA in 1998 and its active ingredient is montelukast. But federal law requires “major changes” to a drug product to be submitted to the FDA for approval prior to distribution. 604, 620 (2011). Mensing , 564 U.S.

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Drug & Device Law

JANUARY 13, 2022

. § 360k(a) because those claims were based on an alleged failure to report adverse events to the FDA and the plaintiff had not shown that Massachusetts recognizes a duty to submit such reports. Earlier this week, the First Circuit side-stepped the question of whether Massachusetts recognizes a duty to submit adverse-event reports to the FDA.

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Drug & Device Law

FEBRUARY 19, 2024

This post is only from the non-Butler Snow part of the Blog. 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.

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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

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

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

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. 552 (2011); Thompson v. FDA , 119 F. E.g. , Sorrell v.

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