Hall Render

JULY 17, 2024

Part 255 , had not been updated since 2009, well before the advent of popular social media platforms like TikTok and Instagram and the rise of social media influencers. Could FDA Action Be Next? The FDA has not updated its guidance since 2014. As of July 2024, the FDA has not publicly responded to the letter.

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Bill of Health

OCTOBER 31, 2024

Since 2009, the U.S. Food and Drug Administration (FDA) is expected to propose new rulemaking on front-of-package labeling in 2024. On the other hand, in 2016, the FDA proposed a new rule requiring food manufacturers to disclose added sugar content on packaging. No standardized system exists but the U.S. While the U.S.

Public Health 100

Public Health FDA Governance Licensing 100

Healthcare IT Today

FEBRUARY 28, 2023

He reported poor standardization of data coming out ot at test centers, despite the standards for interoperability delineated in the Health Information Technology for Economic and Clinical (HITECH) Act of 2009. Pinho called for real-time decision making as well.

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Health Populi

JANUARY 6, 2023

. “Despite breathtaking medical advancements since President Harry Truman declared war on heart disease 75 years ago, researchers have observed a disturbing trend that started in 2009: America’s death rate from heart-related conditions is climbing again,” the detailed essay explains.

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Hall Render

JULY 26, 2024

Murphy signs new medical debt protections into law Some N.J. in workforce training NORTH CAROLINA Atrium Health Pineville earns spinal surgery certification by The Joint Commission Atrium Health Wake Forest Baptist opens 20,000 SF, $3.5M

US Department of Health and Human Services 40

US Department of Health and Human Services Nursing Homes Nurses COVID-19 40

Hall Render

JULY 26, 2024

Murphy signs new medical debt protections into law Some N.J. in workforce training NORTH CAROLINA Atrium Health Pineville earns spinal surgery certification by The Joint Commission Atrium Health Wake Forest Baptist opens 20,000 SF, $3.5M

US Department of Health and Human Services 40

US Department of Health and Human Services Nursing Homes Nurses COVID-19 40

Hall Render

APRIL 26, 2024

MASSACHUSETTS High demand is pushing hospitals past their limits, say Southeastern Mass. Texas North Runnels County Health District faces financial issues, at risk of closure Larry Ellison: Oracle moving world HQ to Nashville Patients in limbo amid Memorial Hermann transplant probe Texas Medicaid shake-up could force 1.8

Nursing Homes 40

Nursing Homes US Department of Health and Human Services Nurses Medicaid 40

Bill of Health

MAY 28, 2024

From 2009-2018, several U.S. Schedule 3 drugs must be approved by the Food and Drug Administration (FDA,) prescribed by a doctor, and distributed by a pharmacy. Congress must specify that FDA’s jurisdiction over cannabis should be no more than that over alcohol and designate cannabis in food as “generally recognized as safe.”

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Hall Render

MARCH 29, 2024

Ron DeSantis signs bills to train, retain healthcare workers Tampa health care REIT pays $86M for Texas, Arizona portfolio GEORGIA 9 Georgia hospitals earn awards for patient safety Another inmate escapes Grady Memorial Hospital CHI Memorial breaks ground on new North Georgia hospital CON overhaul gains final passage in General Assembly Ga.

Nursing Homes 40

Nursing Homes US Department of Health and Human Services Nurses Hospitals 40

Health Law Advisor

MAY 3, 2022

We have just gone through an extraordinary two years where, in unprecedented fashion, FDA’s inspection process was essentially shut down. Further, from a warning letter standpoint, without inspection data, FDA focused in other compliance realms than it typically might. Just a short while ago FDA recommenced inspections.

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Hall Render

FEBRUARY 14, 2025

Meet its new president No Room: Washington hospitals overwhelmed by worst flu season since 2009 WA, UW join lawsuit over Trump order cutting funding for medical research Wash. Opposes Bankrupt Prospect Medical’s ‘Plunder’ CT medical device company raises $9.3M

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Nursing Homes Nurses Hospitals Doctors 40

Drug & Device Law

FEBRUARY 26, 2024

Since the FDCA didn’t “impose any obligations” on anybody but the FDA, “it cannot conflict” with anything these defendants did or didn’t do. 555, 573 (2009), and these antivaxxers didn’t come close. Rather, it “obligate[d] only the Secretary of Health and Human Services” to create “‘conditions designed to ensure’ informed consent.”

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Drug & Device Law

FEBRUARY 22, 2024

The history of litigation over a June 2009 to March 2012 shortage of a drug called Fabrazyme, which was at the time the only FDA-approved drug to treat a nasty thing called Fabry’s disease, helps to explain our view. We do not even need to call out the emphasis that plaintiff lawyers place on FDA approval when it suits them.

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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. 2009) (citations omitted).

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Drug & Device Law

JANUARY 15, 2024

We have discussed how exclusion of FDA compliance in pelvic mesh cases, based on a false equivalence between preemption and evidentiary admissibility, has hampered the defense in that litigation. 2009) (en banc), decided before Tincher adopted consumer expectations as a Pennsylvania design defect test. 3d 1245 (N.J. Ford Motor Co. ,

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Drug & Device Law

DECEMBER 4, 2023

662, 679 (2009). 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. 2009), rev’d in part on other grounds, 393 F. But Supreme Court precedent is clear, “pleadings that. . . Ashcroft v. Iqbal , 556 U.S.

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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. 2009); accord, e.g. , Blankenship v. 21 U.S.C. §

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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. 662, 684-85, 686 (2009) (citations, including to Twombly , omitted). Back in 2008, the United States Supreme Court held, in Riegel v. Medtronic, Inc. , Ashcroft v. Iqbal , 556 U.S.

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Drug & Device Law

AUGUST 31, 2023

The Ganz plaintiff alleges that her husband died after experiencing hypersensitivity to a biologic approved by the FDA. b)(2) not to make such a change without first obtaining FDA approval.” As construed by the court, the complaint alleged that the biologic approved by the FDA is defective as a matter of state law.

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Drug & Device Law

AUGUST 25, 2023

As it became widely used off-label for morning sickness, the FDA considered, but did not require, pregnancy-related labeling. Then, over the next several years, both sides brought the plaintiffs’ allegations/evidence to the FDA’s attention, and the FDA rejected multiple proposed labeling changes regarding birth defects.

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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. But the FDA has concluded just the opposite. 3d 1243 (9th Cir.

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Drug & Device Law

MAY 11, 2023

A perusal of amicus briefs drew more than a few “they should know what they are talking about here” responses to groups of food and drug law scholars (as opposed to DDL bloggers), former FDA commissioners, former FDA officials, and former DOJ officials, among others. The appellate brief from FDA bears that out well.

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Drug & Device Law

MAY 4, 2023

2015), finally gave appellate recognition to the preemption of design defect claims for FDA-approved branded prescription drugs. FDA approved the drug with its particular formulation and the manufacturer could not have changed the formulation on its own. As detailed here , the decision in Yates v. Ortho-McNeil-Janssen Pharms.,

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Drug & Device Law

APRIL 14, 2023

The device in question was a Class II medical device, subject to the FDA’s 510(k) clearance standard, not to the full premarket approval (“PMA”) process. As readers know, FDA reviews Class II devices for “substantial equivalence” to devices that are on the market. internal punctuation and citation omitted). citations omitted).

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Drug & Device Law

MARCH 13, 2023

2009) (automotive seatbelts). If “strict liability” design defect claims are allowed under Pennsylvania law, the other side hopes to use Lewis and its Pennsylvania progeny to argue that all evidence of a prescription medical product’s compliance with the FDCA and FDA regulations is completely inadmissible. Coloplast 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

FEBRUARY 16, 2023

Back in the antediluvian era of the Bone Screw Litigation some 25 years ago, Bexis was responsible for crafting (and sometimes outright inventing, see fraud on the FDA) defenses for that then-unusual medical device-related mass tort. However, those claimed alternatives “were not yet cleared by the FDA” for the use at issue in Baksic.

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Drug & Device Law

FEBRUARY 3, 2023

In 2009, a detailed warning was added to the “Precautions” section of the label. The defendants warned of these adverse events over the years, progressively strengthening the warnings and increasing their prominence. Again – need we say it? that’s not the law.

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Drug & Device Law

JANUARY 30, 2023

555 (2009), and rated only a “ cf. 470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. 2019), or Mutual Pharmaceutical Co. Bartlett , 570 U.S. Levine , 555 U.S.

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Drug & Device Law

JANUARY 16, 2023

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. at *4 (“plaintiffs focus their appeal on the three Japanese studies not originally submitted to the FDA”). quoting 73 Fed. 22, 2008)).

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Drug & Device Law

JANUARY 10, 2023

Singulair was approved by the FDA in 1998 and its active ingredient is montelukast. Plaintiff was prescribed and took Singulair to treat his asthma from 2000 to 2009 and alleges he now suffers from depression and social anxiety as a result. Plaintiff’s lawsuit makes two design defect claims – strict liability and negligence.

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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. 14, 2022), leaves us scratching our heads. First, it claims to find “helpful guidance,” id. at *7, in Wyeth v. Levine , 555 U.S. 2022 WL 17348351, at *4.

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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 19, 2022

b)(2)(v), which lists three types of label changes that absolutely, positively must be made by prior approval supplement – and since those changes require FDA preapproval, the Mensing independence principle preempts tort claims demanding such changes. 555 (2009), relied upon to limit impossibility preemption. (B) 4 (FDA Jan.

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Drug & Device Law

NOVEMBER 7, 2022

We’ve written several posts about ridiculous absolute liability theories seeking to hold drug manufacturers liable simply for making an FDA approved prescription drug. The defendant’s drug in Wilkins was the only FDA-approved medication for the treatment of a rare disease ( Fabry Disease ). Genzyme Corp. 2022 WL 4237528 (D.

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Drug & Device Law

SEPTEMBER 19, 2022

555 (2009) , and PLIVA, Inc. 604 (2011) , failure-to-warn claims targeting a pharmaceutical are preempted unless the manufacturer could have provisionally changed its warning label without prior FDA approval under the “changes being effected” (“CBE”) provision codified at 21 C.F.R. Under Wyeth v. Levine, 555 U.S. Mensing, 564 U.S.

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Drug & Device Law

SEPTEMBER 12, 2022

The case alleged on-label drug use between 2009 and early 2012, purportedly leading to plaintiffs’ decedent’s suicide in 2013 – more than a year after use of the drug had ceased. This internal FDA decision was one of the reasons that preemption prevailed in Pfaff. T]he FDA responded. However, the FDA concluded that. . . [it

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