Drug & Device Law

OCTOBER 23, 2023

312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted. 544, 559 (2007). [T]he That rationale is about as far from the Supreme Court’s holdings in TwIqbal , quoted above, as it is possible to be. [T]he Medtronic, Inc. , Twombly , 550 U.S.

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Drug & Device Law

MAY 19, 2023

The core premise of Bexis’ article is very simple: Once the FDA has said “yes” and approved a particular drug for a particular indication (“intended use”) for sale in the United States, federal preemption precludes any state from saying say “no” and trying to ban that same FDA-approved drug. T]he growing market for mifepristone. . .

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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

NOVEMBER 10, 2023

Two of your intrepid bloggers took shots at writing blogposts about Valsartan shortly after it was decided – but found the opinion simply too complicated, verbose, and depressingly wrong for us to wrap our hands, or our brains, around. FDA, “ Statement on the agency’s ongoing efforts to resolve safety issue with ARB medications ” (Aug.

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Drug & Device Law

AUGUST 8, 2022

Recently, we have become concerned about personal injury plaintiffs deciding to sue these kinds of organizations because they don’t like some standard that stands between them and the pot of gold at the end of the litigation rainbow. Such power rests solely with the FDA.” Heck, even lawyers get rated. May 19, 2022). 471 (11th Cir.

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Drug & Device Law

MARCH 7, 2022

544 (2007), and Ashcroft v. These allegations lack any contention or inference that [defendant] withheld or misrepresented information to the FDA. . ., That’s a start, but what about the federal courts of appeals? The ruling in question was that the TwIqbal ( Bell Atlantic Corp. Twombly , 550 U.S. Iqbal , 556 U.S. 2, 2020). “In

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Drug & Device Law

JUNE 2, 2022

We are just simple defense hacks writing about product liability law and some other things that matter to medical product manufacturers. Although the male authors here agree wholeheartedly that individual choices about women’s contraception, reproduction, and sexual health are not for us to make.) As we discussed here , McCormack v.

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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 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. . . 2007 WL 2526402, at *3 (D. 2007 WL 5861354, at *4 (C.D. Bayer HealthCare Pharmaceuticals, Inc. , 3d 1223, 1233 (11th Cir.

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Drug & Device Law

APRIL 21, 2022

544 (2007), and Ashcroft v. Plaintiffs alleged that manufactured had failed to investigate and report the event to the FDA as purportedly required. For example, the court took judicial notice of an FDA recall notice. Defendants love and plaintiffs hate Bell Atlantic Corp. Twombly , 550 U.S. Iqbal , 556 U.S. Medtronic Inc.

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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. April 6, 2022), was being prosecuted for “conspiracy to steal trade secrets.” E.g. , Dalgic v.

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Drug & Device Law

FEBRUARY 2, 2023

2007 WL 4042757, at *3 (N.D. 15, 2007); McNeil v. 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. Novartis Pharmaceuticals Corp. , 2d 898, 909-10 (W.D.

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Drug & Device Law

JANUARY 25, 2024

142 (2007), mere regulation of the product or conduct at issue—the medical walker is a non-prescription, Class I medical device with general controls only—is not a basis for removal under this statute. That is how plaintiff bought his medical walker and why we are talking about federal officer removal. Philip Morris Cos. ,

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Drug & Device Law

MAY 26, 2022

After attending a patient education class, seeking a second opinion, being warned that she was at increased risk for revision as a woman, and being warned of a risk of metal ions accumulating in her blood, she went forward with the BHR implant in her left hip on June 25, 2007. no re-operation] of 98.4 at *7 (citing the case discussed here ).

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Drug & Device Law

OCTOBER 3, 2022

That’s because most of the decision was about evidentiary rulings that the court found to be “harmless” error, and one might even have some benefit for our clients in the long run. The most blatant problem with Nicholson has to do with the treatment of certain data from the FDA’s medical device adverse reporting system (called “MAUDE”).

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Drug & Device Law

MARCH 16, 2022

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. We have written about this excellent Arizona statute several times, including here and here.

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Drug & Device Law

FEBRUARY 22, 2024

This “keep selling” theory found some traction in two 2007 decisions, Abigail Alliance for Better Access to Developmental Drugs v. 2007) (en banc), and CareToLive v. Ohio 2007), but has generally failed to expand that foothold since. This is not the first time we have written about litigation related to this shortage.

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Drug & Device Law

MAY 26, 2023

We are not looking do either of those, but we will weigh in on what NPP means for non-product liability cases involving FDA-regulated medical products. Are we down to talk about NPP and its impact on reproductive rights litigation? Both talk a fair amount about “commerce” and the respective roles of the states and federal government.

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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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