Healthcare Law Blog

JUNE 15, 2023

Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, was curtailed. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. May 17, 2023 : The Fifth Circuit heard oral arguments from the FDA, Danco, and the Plaintiffs. Had the U.S.

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Healthcare IT News - Telehealth

MARCH 18, 2022

Healthcare IT News sat down with this digital health investor to talk about digital health investment trends during the pandemic and where he sees funding trending in 2022 and beyond. Justin Norden is a partner at GSR Ventures. What has been one digital health investment trend during the COVID-19 pandemic, and why is it important?

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Innovaare Compliance

MARCH 1, 2022

in 2022, which is partly offset by a cost-of-living increase of 5.9% The premium increase in 2022 was widely known to be attributable to the potential use of the Alzheimer drug, Aduhelm™ (aducanumab) by Medicare beneficiaries. [2] The monthly premium for Medicare Part B rose 14.5%, from $148.50 in 2021 to $170.00

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Healthcare Law Blog

OCTOBER 25, 2023

Effective January 1, 2022, an individual in Oregon who acts as a pharmaceutical representative for more than 15 days during the calendar year must have, and renew annually, a license from the Department of Consumer and Business Services (“DCBS”). xii] SafeRx Amendment Act of 2008. xi] Washington D.C. 2017 Nevada Laws Ch.

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Health Law Advisor

MARCH 7, 2023

Background on the Ryan Haight Act The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Ryan Haight Act”) made certain amendments to the CSA which established controls on the remote prescribing of controlled substances. 15, 2022), [link] 18 U.S.C. § Impact On Off-label Prescribing of Controlled Substances.

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Drug & Device Law

MAY 16, 2022

2022) (“CCoC”), a number of business groups originally sued the State of California seeking a preliminary injunction “to halt acrylamide litigation brought under. . . as the FDA acknowledged the warning might be. . . . [W]hen 2008) (see our post here ), that broadly authorize private litigants to enforce state statutory requirements.

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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. 2008) (applying the rule; rejecting distinction that “this is a ‘no warning’ case as opposed to an inadequate warning case”), aff’d , 321 F. Sinclair v.

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Drug & Device Law

DECEMBER 14, 2023

It has also been the case for a long time that the use of citizen’s petitions to FDA has been a tool by the plaintiff bar to shape, and sometimes sidestep, the science. ( In December 2022, the court set a schedule for expert discovery and Rule 702 motions, which were then due on April 17, 2023. See, e.g. , here.) See, e.g. , here.)

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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. . . 2008) (applying Texas law and discussed here ), several times. 2022 WL 800879, at *21 (E.D. 3d 1223, 1233 (11th Cir.

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Drug & Device Law

OCTOBER 10, 2022

The drug at issue was an FDA-recognized breakthrough drug that treats a relatively rare, but invariably fatal, condition – transthyretin amyloid cardiomyopathy (“ATTR-CM”). 3 (2008), the court explained that “the word ‘includes,’ when used in a statute, ‘is usually a term of enlargement, and not of limitation.’” Pfizer, Inc. ,

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Drug & Device Law

APRIL 18, 2022

2022 WL 1016686 (Wis. April 5, 2022) (per curiam). Rennick , 2022 WL 1016686, at *4 (no citations omitted). at *3 – which means, as we’ve discussed before , a manufacturer cannot include warnings about such off-label uses absent specific FDA approval. 2022 WL 1016686, at *4. 2008); Herzog v. See Rennick v.

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Drug & Device Law

FEBRUARY 21, 2022

2022 WL 425206 (N.D. 2022 WL 409638 (N.D. 2022 WL 336811 (N.D. 4, 2022), similarly excluded large parts of the opinions of Michael Margolis, M.D., 2022 WL 336810 (N.D. 4, 2022), in which a fourth repeat-player, plaintiff-side purported expert bit the dust ? Coloplast Corp. Decision #2: Martinez v.

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Drug & Device Law

MARCH 31, 2022

The Orthopedic Bone Screw would never have occurred – and Bexis might never have found his way to prescription medical product liability litigation – if not for the Kessler-era FDA’s ill-considered salami slicing of the “intended use” of that product. Secretary of HHS , 2022 WL 424813 (11th Cir. 2022 WL 424813, at *3.

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Drug & Device Law

DECEMBER 21, 2023

FDA , 78 F.4th 2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. The questionable allegations of that single complaint thus effectively trumped many years of the FDA’s science-based decision-making. The FDA, for one, advised patients to keep using these drugs.

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Drug & Device Law

FEBRUARY 18, 2022

2022 WL 378143 (D.S.C. 8, 2022), the plaintiff was implanted with the defendant’s pacemaker. The pacemaker was a Class III medical device, subject to the FDA’s full premarket approval (“PMA”) process. Feeser, 2022 WL 378143 at *2 (citation to Riegel omitted). It’s all a bit of a mixed bag, as is today’s case. In Feeser v.

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Drug & Device Law

AUGUST 7, 2023

312 (2008). 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. FDA regulations do not mandate that sunscreen manufacturers include claims pertaining to the product’s durational capability.

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Drug & Device Law

DECEMBER 19, 2022

2022 WL 16729466 (11th Cir. 7, 2022) (thankfully unpublished), is such a decision. 2022 WL 16729466, at *3. 2022 WL 16729466, at *3. Sub-Subsection (v) doesn’t list exceptions to what the FDA considers “major changes” (requiring FDA preapproval) – but rather, lists examples of such “major changes.”.

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Drug & Device Law

MARCH 16, 2022

2022 WL 604889 (D. Arizona March 1, 2022) – focuses on the regulatory status of the device. As you must know by now, the pelvic mesh MDL court ruled that the FDA 510(k) regulatory clearance of pelvic mesh devices was irrelevant because such clearance was not probative of safety. The pelvic mesh case of the week – McBroom v.

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Drug & Device Law

MARCH 25, 2022

3d , 2022 WL 855853 (D.N.J. March 23, 2022), is further confirmation that our initial analysis of Albrecht was spot on. The manufacturer informed the FDA, but no evidence then established that risk as anything more than hypothetical. 2022 WL 855853, at *4-7. Fosamax , 2022 WL 855853, at *10. femur fractures.

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Drug & Device Law

MAY 5, 2022

2022 WL 1261318 (3d Cir. 2022), a short decision that came out the right way, but did so based on a problematic statute that creates a rebuttal presumption that warning labels approved by the FDA are adequate as a matter of state law. 2022 WL 1261318, at *1 (quoting N.J. 2022 WL 1261318, at *2. 440 (2008)).

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Drug & Device Law

APRIL 11, 2022

312 (2008), and here’s what the Court said about why the “reasonable assurance of safety and effectiveness” standard is preemptive of personal injury claims: [The FDA] may thus approve devices that present great risks if they nonetheless offer great benefits in light of available alternatives. 3d , 2022 WL 827235 (D.

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Drug & Device Law

JANUARY 16, 2023

One of the decisions we were looking forward to at the end of 2022 has occurred. As we’ve also discussed previously , the FDA imposes tight restrictions about anything that a regulated entity proposes to say about off-label uses in the label. 49603, 49605-06 (FDA Aug. 22, 2008)). 4th , 2023 WL 128570 (1st Cir.

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Drug & Device Law

SEPTEMBER 18, 2023

He came across several preemption decisions involving defendants who employed the FDA’s “alternative summary reporting” (“ASR”) system that the agency operated for about 20 years, “from 1997 through June 2019.” 3d , 2022 WL 17668486, at *3 (N.D. 14, 2022); D’Addario v. FDA, MDR Data Files, Alternative Summary Reports (Feb.

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Drug & Device Law

JUNE 28, 2022

2022 WL 2276808 (U.S. 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.

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Drug & Device Law

DECEMBER 30, 2022

When you hear Class III medical device product liability case, you should look for all claims to be dismissed unless there is something as unusual as a basis to claiming the plaintiff’s particular device deviated from its FDA-approved specifications. 3d __, 2022 WL 17668486 (N.D. 2022 WL 17668486, *2. Medtronic, Inc.

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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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