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. That rationale is about as far from the Supreme Court’s holdings in TwIqbal , quoted above, as it is possible to be. [T]he Back in 2008, the United States Supreme Court held, in Riegel v.

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Drug & Device Law

DECEMBER 4, 2023

2001). “[A] federal court in a diversity case should be reluctant to expand state common law.” On a host of issues, CPAP II makes a recommendations about state law – but without any basis in existing state law. Undisputedly, the complaint at issue “allege[d] no specific facts about any specific plaintiffs or specific injuries.”

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Drug & Device Law

JULY 24, 2023

Nonetheless, the Ninth Circuit’s PATDC82 I allowed a RICO claim alleging that, between 1999 and 2011, defendants concealed that risk from the FDA and that, as a result, every TPP in the country paid for Actos prescriptions that it otherwise would not have reimbursed. 341 (2001). But the FDA has concluded just the opposite.

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Drug & Device Law

DECEMBER 27, 2022

In the Zantac MDL, the plaintiffs’ causation problems were plainly visible on the horizon, as we mentioned in our post last year about the Zantac ruling on medical monitoring, In re Zantac (Ranitidine) Products Liability Litigation , 546 F. The FDA recognized these results as bogus, “conclud[ing] that. . . 3d 1152 (S.D.

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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

OCTOBER 20, 2023

We have posted a few times ( here , here , and here ) about the Alliance for Hippocratic Medicine v. FDA/Alliance for Hippocratic Medicine v. As Bexis put it: In our line of work, much of what we do depends on the continuing validity of what the FDA does with respect to prescription medical products. FDA , 727 F.

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Drug & Device Law

NOVEMBER 28, 2022

2001) (Kilburn); and Wade-Greaux v. While cosmetic talc is not a drug or medical device, the FDA also regulates it (the “C” in the FDCA). On the “strength” of this article, Dr. Moline not only set out to become a repeat P-side asbestos expert, but also “testified to Congress about her findings” using “a pseudonym. . .

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Drug & Device Law

SEPTEMBER 1, 2023

The FDA approved the defendant’s first TDF drug in 2001, and the company started its first clinical trial on a different compound—tenofovir alafenamide (“TAF”)— about a year later. So the plaintiffs pivoted.

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Drug & Device Law

JUNE 6, 2022

Because we encountered many stand up learned intermediary surgeons in the Bone Screw litigation, several of the relatively early decisions from the 1999-2001 timeframe are Bone Screw cases. 2001) (no causation where medical personnel “had no alternative other than to use the. . . Bayer HealthCare Pharmaceuticals, Inc. ,

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Drug & Device Law

AUGUST 22, 2022

The plaintiff in Jacob sued the manufacturer of a Class III, FDA premarket-approved medical device. First, the plaintiff’s non-parallel claims were “preempted to the extent” that they would have imposed “alleged labeling or manufacturing requirements that are different from, or in addition to, those imposed by the FDA.” 341 (2001).

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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. The two of us recently wrote about the issue of retroactivity of Michigan S.B. Nothing about retroactivity. 410 repeal in Law360 (i.e.,

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Drug & Device Law

JUNE 9, 2022

In our initial post, we focused on the exception to the presumption, which allows liability to be imposed if a plaintiff alleges and ultimately proves that the defendant manufacturer committed fraud on the FDA. The court held that the presumption applied because it was “undisputed that the [device] is subject to FDA oversight.”

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Drug & Device Law

SEPTEMBER 22, 2023

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. Federal preemption is based in the U.S. at 1276.

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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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Drug & Device Law

MAY 5, 2022

A relatively short post about Greisberg v. 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. We do, however, have reservations about N.J. Boston Scientific Corp.

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Drug & Device Law

SEPTEMBER 29, 2022

Before a biologic may be marketed, the manufacturer must obtain a license from the FDA. Approval of an application “constitute[s] a determination” by the FDA “that … the product meet[s] applicable requirements to ensure the continued safety … of such products.” See 42 U.S.C. § See 21 C.F.R. 2022 WL 4305656, at *8.

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Drug & Device Law

JANUARY 30, 2023

341 (2001), with the rejection of the so-called “purposes and objectives” prong of implied preemption by the most conservative justices (at least in terms of federalism) on the Court. Plaintiffs Legal Committee , 531 U.S. Plaintiffs Legal Committee , 531 U.S. Plaintiffs Legal Committee , 531 U.S. Mensing , 564 U.S. Mensing , 564 U.S.

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Drug & Device Law

JANUARY 12, 2024

Superior Court , where the parties argued about whether California law recognizes a broad “duty to innovate.” The FDA approved the defendant’s first TDF drug in 2001, and the company started its first clinical trial on a different compound—tenofovir alafenamide (“TAF”)—about a year later. at *48-*50. at *31, *32.

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Drug & Device Law

JANUARY 11, 2024

Anybody who might attempt to obtain similar discovery from the FDA in a prescription medical product case, take note. Basically, the Camp Lejeune litigation is about allegations (often overblown) of exposure to carcinogenic substances. 1, 8-9 (2001)) (internal quotations omitted). Instead, they received a judicial Alpha Charlie.

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Drug & Device Law

JANUARY 23, 2024

Today’s case is a counterpart to our post a few months ago about a case applying Buckman preemption to a contract dispute where adjudicating the alleged breach would have forced the court to decide FDA regulatory issues. 4, 353 (2001). In that case ( Thogus Products Co. Bleep, LLC , 2023 WL 5607458 (N.D. 341, 349 n.4,

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Drug & Device Law

AUGUST 11, 2023

Like having a first child, when you assume new responsibilities in caring for elderly parents, you get a crash-course education in topics you otherwise never would have thought about. Which is how we came to know a little bit about hydrogen peroxide. Moreover, the FDA established federal labeling for 3% hydrogen peroxide.

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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

OCTOBER 6, 2023

He proposed writing his own law review article on this subject – about which he knows as much as anyone – to the Food & Drug Law Institute. 341 (2001), (2) impossibility preemption barring “stop selling” claims under Mutual Pharmaceutical Co. 109 (2023). Plaintiffs Legal Committee , 531 U.S. Bartlett , 570 U.S.

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Drug & Device Law

JANUARY 16, 2024

Not long ago we posted about how a turncoat expert witness who switched to the dark side had been precluded from testifying in several cases. Specifically, plaintiff claimed to want the expert to testify regarding comments he made to an FDA advisory panel in 2001, his discussions with other panel members, and the panel’s decisions.

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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. An unfortunate fiction developed post- Buckman —particularly after Riegel v. Stryker Corp. ,

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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

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.” without adversely affecting FDA’s ability to monitor and react to such events. 18, 2022) ( available here ).

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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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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. 3d 196 (S.D.N.Y.

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