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.

FDA 59

FDA Doctors Malpractice COVID-19 59

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.

FDA 52

FDA Doctors Malpractice COVID-19 52

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.

FDA 59

FDA Governance Nurses Hospitals 59

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.

Fraud 52

Fraud FDA Hospitals Doctors 52

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.

Fraud 52

Fraud FDA Doctors 52

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).

FDA 59

FDA Governance Compliance 59

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.

FDA 59

FDA World Health Governance 59

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”).

FDA 59

FDA Governance Nurses 59

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. ,

Informed Consent 59

Informed Consent Fraud FDA HIPAA 59

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. ,

FDA 59

FDA Doctors Malpractice Medical Personnel 59

Drug & Device Law

MARCH 31, 2022

In other words, the generic manufacturers are not allowed to change the FDA-approved label. The Store Brand Retailer Defendants are removed from any FDA requirements as they are not involved in the approval or labeling process at all. 2001) (“irrespective of the theory of recovery. . . citation omitted). E.g. , Ford Motor Co.

Governance 52

Governance FDA Doctors Hospitals 52

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.

FDA 64

FDA 64

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.

FDA 59

FDA Pharmaceutical Industry Public Health 59

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).

Informed Consent 59

Informed Consent FDA Doctors 59

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.

FDA 52

FDA 52

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.

FDA 59

FDA Fraud 59

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.

FDA 59

FDA Licensing Compliance 59

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.,

FDA 52

FDA Compliance Fraud Hospitals 52

Drug & Device Law

FEBRUARY 24, 2022

341 (2001), stands for the proposition that only the federal government may enforce the Food, Drug, and Cosmetic Act and that any state-law claim that depends on the existence of the FDCA is impliedly preempted by 21 U.S.C. § Plaintiffs’ Legal Committee , 531 U.S. Plaintiffs constantly try to evade Buckman. Medtronic, Inc. , 3d 1026, 1034 n.22

FDA 72

FDA Governance Fraud 72

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.

FDA 105

FDA Public Health 105

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.”

FDA 59

FDA Doctors 59

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.

Fraud 52

Fraud FDA 52

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.”

Compliance 59

Compliance FDA Fraud 59

Drug & Device Law

FEBRUARY 1, 2022

But it was also based in part on allegations that defendant failed to properly investigate reported adverse events, failed to report adverse events to the FDA, and generally failed to comply with the Federal Food, Drug, and Cosmetic Act (“FDCA”). 341 (2001) as impermissible attempts at private enforcement of the FDCA.

Fraud 59

Fraud FDA Doctors 59

Drug & Device Law

MAY 5, 2022

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. Stated differently, the rebuttal provision makes allegations and evidence of fraud on the FDA a prerequisite to state-law liability.

Compliance 52

Compliance FDA Fraud 52

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).

COVID-19 Vaccine 59

COVID-19 Vaccine COVID-19 FDA Public Health 59

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.

FDA 72

FDA Fraud Governance Medicare 72

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.

FDA 105

FDA Doctors 105

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.

FDA 52

FDA Governance 52

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.

FDA 59

FDA Licensing Fraud 59

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 ).

FDA 59

FDA Fraud Governance Compliance 59

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.

FDA 52

FDA Fraud Doctors 52

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,

FDA 52

FDA Compliance Governance 52

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.

FDA 59

FDA 59

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.

FDA 45

FDA Hospitals 45

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.

FDA 59

FDA 59

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.

FDA 64

FDA Telemedicine 64