Hall Render

JULY 14, 2023

How did we get here? Nonprofit hospitals under growing scrutiny over how they justify billions in tax breaks States increase pressure on nonprofit hospitals as charity care scrutinized Senate proposal would give hospitals $385M for emergency preparedness. to 18 central Mass. nonprofits MICHIGAN Ascension St. Not everyone is happy.

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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reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue. Lynch & Co. Flex Techs.,

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Drug & Device Law

FEBRUARY 11, 2024

FDA litigation that is now before the Supreme Court. FDA , 78 F.4th quoting FDA appellate brief ). Congress created an FDA approval process that is both rigorous and thorough, and pharmaceutical companies invest billions of dollars in research and development to meet FDA’s scientific standards. 4th 210 (5th Cir.

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Drug & Device Law

JANUARY 31, 2024

341 (2001). The Ninth Circuit held that false advertising claims that “would require litigation of the alleged underlying FDCA violation in a circumstance where the FDA had not itself concluded there was a violation” are preempted. But claims based on violations of the FDCA are preempted by Buckman Co. That’s where Nexus comes in.

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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

JANUARY 16, 2024

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. First, his discussions with FDA panelists are hearsay. But that “purely fact testimony” was inadmissible for several reasons.

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Drug & Device Law

JANUARY 12, 2024

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. The court also assumed that physicians naturally would prescribe the “newer” TAF once the FDA approved it. 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. 1, 8-9 (2001)) (internal quotations omitted). The same privilege should protect the FDA from similar impositions. In In Re: Camp Lejeune Water Litigation , 2023 WL 8791671 (E.D.N.C.

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Drug & Device Law

JANUARY 8, 2024

The Acetaminophen MDL was a classic example, where the FDA had independently looked at the science no fewer than six times (in 2014, 2015, 2016, 2017, and 2022, and 2023) and each time concluded that the science did not justify any warning. 2001), aff’d , 303 F.3d Amorgianos v. National Railroad Passenger Corp. , 2d 147, 165 (E.D.N.Y.

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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

DECEMBER 4, 2023

2001). “[A] federal court in a diversity case should be reluctant to expand state common law.” 341 (2001). 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. 2001), aff’d , 358 F.3d Beretta, U.S.A.

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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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Drug & Device Law

NOVEMBER 2, 2023

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. Qualifying compounding pharmacies do not require FDA approval to sell compounded drugs. Wells Pharma of Houston, LLC , 2023 WL 6301651 (S.D.

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Drug & Device Law

OCTOBER 26, 2023

341 (2001) (a Bone Screw case). Plaintiffs constantly seek to create FDCA violations that do not exist, often through bizarre interpretations of FDA regulations that the FDA has never followed. Alcozar , like Disarro , involved claims relating to drug impurities, what the FDA calls “adulteration.”

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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. 341 (2001), which put an end to any doubt about this proposition. Back in 2008, the United States Supreme Court held, in Riegel v. Medtronic, Inc. , at 356 (emphasis added). at 1206.

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Drug & Device Law

OCTOBER 20, 2023

FDA/Alliance for Hippocratic Medicine v. LLC litigation, in which an anti-abortion group is seeking to invalidate regulatory actions taken by the FDA with regard to mifepristone , a pharmaceutical FDA-approved for use in the termination of pregnancy to ten weeks, in combination with misoprostol. 341 (2001), is so important.

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Drug & Device Law

OCTOBER 10, 2023

Luminas Int’l LLC , like this—hey court, it’s not fair that I’m following the FDA’s rules and my competitors are not, so you should force them to do so to even the playing field. To which the court appropriately said—you’ve come to the wrong place; FDA rules are the FDA’s to enforce. That’s the FDA’s job, not the court’s.

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Drug & Device Law

OCTOBER 6, 2023

341 (2001), (2) impossibility preemption barring “stop selling” claims under Mutual Pharmaceutical Co. 379r, should preclude some (but hardly all) state abortion-related bans – particularly when states purport to target the availability of FDA-approved drugs for their FDA-approved indications. . Bartlett , 570 U.S.

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Drug & Device Law

SEPTEMBER 22, 2023

As Carter recounts, starting in 1976, FDA developed the OTC Cough and Cold Monograph, 21 C.F.R. 341 (2001), recognized that any state-law claim that depends on the existence of the FDCA is impliedly preempted by 21 U.S.C. § at 1276. part 341 , which provides “approved indications for use and age-dependent dosage instructions.” Id.

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Drug & Device Law

SEPTEMBER 21, 2023

The parties’ contract required the supplier to deliver components that “meet FDA standards for medical devices.” The manufacturer claimed that the supplier breached the contract when it delivered components that, according to the manufacturer, violated the FDA’s Current Good Manufacturing Practices (CGMP) regulations. 4, 353 (2001).

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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

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.” 341 (2001), is so important. FDA , 727 F.

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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

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.” 341 (2001), is so important. FDA , 727 F.

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Drug & Device Law

AUGUST 11, 2023

Hydrogen peroxide is an FDA-regulated over-the-counter (OTC) drug, so Novotney addressed whether plaintiff’s claims were barred by federal preemption. Moreover, the FDA established federal labeling for 3% hydrogen peroxide. That means express preemption. Plaintiffs Legal Committee , 531 U.S.

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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

JUNE 19, 2023

As discussed here , the primary allegations asserted the same sort of “fraud on the FDA” claim that, when brought as a common-law tort claim, were held preempted in Buckman Co. As the earlier post discussed, the First Circuit rightly put an end to that attack on FDA authority in United States ex rel. No other causation needed.

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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

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 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. 341, 352 (2001) (“neither an express pre-emption provision nor a saving clause bars the ordinary working of conflict pre-emption principles”).

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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

DECEMBER 27, 2022

Filing a citizen’s petition, Valisure shocked the FDA into an ill-advised recall by reporting that “tests found NDMA in ranitidine in excess of 3,000,000 ng [nanograms] per pill” – far above FDA’s 96 ng/day “daily limit.” The FDA recognized these results as bogus, “conclud[ing] that. . . 2022 WL 17480906, at *1.

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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). I-Flow Corp. , 2d 1092, 1119-25 (D. 2010) (Matsen); Nelson v. Tennessee Gas Pipeline Co. 1998 WL 1297690, at *4, 7-8 (W.D. 31, 1998), aff’d , 243 F.3d 3d 244 (6th Cir. Whitehall Laboratories, Inc. ,

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Drug & Device Law

OCTOBER 27, 2022

640.65, an FDA biologics regulation that requires entities that collect blood via a particular method to establish “donor identification system[s]” that “positively identifies each donor and relates such donor directly to his blood and its components as well as to his accumulated records and laboratory data.”. 341 (2001), the U.S.

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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

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

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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