The Health Law Firm

MAY 14, 2013

On May 8, 2013, the US Food and Drug Administration (FDA) sent a warning to doctors and pharmacists to avoid drugs made by The Compounding Shop, based in St. Click here to read the press release from the FDA. These agencies are trying to prevent another widespread outbreak, like the fungal meningitis outbreak in the fall of 2012.

FDA 40

FDA Doctors 40

Bill of Health

APRIL 7, 2023

Shamnad Basheer, a stalwart Indian IP lawyer, proposed in 2012 an ‘investment protection regime’ for innovation that fits well in the mRNA context. A different regime is needed.

COVID-19 Vaccine 147

COVID-19 Vaccine COVID-19 Governance Public Health 147

HIT Consultant

JULY 11, 2024

Health Sector Cybersecurity Coordination Center and the Office of Information Security, the frequency of healthcare data breaches has trended upward since 2012. Food and Drug Administration (FDA). According to a report from the U.S. Research — and real-world events — demonstrate implantable pacemakers are vulnerable to cyberattacks.

FDA 115

FDA Hospitals Governance Ransomware 115

The Health Law Firm

JUNE 1, 2012

The prescriptions impacted by this recall include all sterile human and veterinary compounded prescriptions distributed by Franck’s Pharmacy from November 21, 2011 to May 21, 2012. Franck's Pharmacy made the announcement on the company's website on May 24, 2012. To see the recall click here.

FDA 40

FDA 40

The Health Law Firm

OCTOBER 9, 2012

The manufacturing center is now closed, and the company has issued a voluntary recall of all products distributed since January 2012. Voluntary Recall Due to Investigation By the US Food and Drug Administration (FDA). Click here to see the recall announcement from NECC.

FDA 40

FDA 40

The Health Law Firm

JUNE 20, 2012

KV) for making false or misleading statements to the US Food and Drug Administration (FDA). The ruling was reached on June 4, 2012. The US Eighth Circuit Court of Appeals ruled that investors can continue to bring claims against KV Pharmaceutical Co. (KV) To view the appeals court ruling in Public Pension Fund Group v.

Fraud 40

Fraud FDA 40

Hall Render

DECEMBER 6, 2024

The Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) has issued its fifth Untitled Letter of the year, matching last years total number of enforcement letters. So far this year, FDA has not issued any Warning Letters.

FDA 40

FDA 40

HIT Consultant

MARCH 15, 2024

Transpara is FDA-approved and widely used by leading medical centers worldwide. Triyam, founded in 2012, is a recognized leader in data conversion, migration, and archiving solutions for hospitals, clinics, and provider networks.

Hospitals 116

Hospitals Medicare Medicare Doctors 116

Hall Render

AUGUST 10, 2023

New Medical Technologies Beginning in 2025, CMS will require add-on payment applicants to have completed an FDA marketing request and provide documentation of such filing and FDA acceptance of the application by May 1 (rather than the current July 1 deadline) of the year prior to the beginning of the FY in which CMS is considering the application.

Hospitals 40

Hospitals Medicare Medicare Medicaid 40

SQA

AUGUST 1, 2024

In addition, the ISPE Guide outlines the authority of State Boards of Pharmacy and their coordination of oversight with the FDA. In the United States, cosmetics are regulated by the FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act. Science and safety are at our core.

FDA 40

FDA Licensing Compliance World Health 40

SQA

AUGUST 2, 2021

Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) and the United States Food and Drug Administration (FDA) released a series of policy recommendations to address the vulnerabilities in United States pharmaceutical supply chains. United States FDA – Guidances for Devices.

FDA 83

FDA COVID-19 Pharmaceutical Industry Hospitals 83

Bill of Health

AUGUST 4, 2024

Food and Drug Administration (FDA) , the D.C. Circuit in 2012 held that a set of FDA-proposed graphic warning labels violated the First Amendment. There is widespread disagreement among the federal courts about the types of disclosures to which Zauderer applies. Take graphic tobacco warning labels as an example. Reynolds v.

Public Health 165

Public Health FDA Governance 165

Bill of Health

JUNE 1, 2023

Food and Drug Administration (FDA) announced that it is lifting its highly contested blood deferral policy for men who have sex with men (MSM, i.e., gay and bisexual men), colloquially known as the blood ban. By Doron Dorfman On May 11, the U.S. Despite this nuance, the new policy categorically excludes PrEP users.

FDA 228

FDA Public Health Licensing 228

Healthcare It News

DECEMBER 30, 2022

FDA authorizes at-home COVID-19 tests from Amazon, Roche, Siemens. Allscripts has seen big changes over the past few years, including the sale of its precision-medicine platform 2bPrecise in 2021 and seeing its CEO since 2012, Paul Black , step down in May. Why does Big Tech often fail in healthcare?

Nurses 355

Nurses COVID-19 Public Health Hospitals 355

Health Populi

MAY 24, 2018

The “innovation” and advances section discusses the 14 therapies for cancer that were launched in 2017, all targeted therapies 11 of which had breakthrough status from the FDA indicating substantial improvement over existing therapies in the market. In the US, spending on oncology doubled from 2012 to 2017, to $50 bn.

FDA 81

FDA 81

Health Populi

JANUARY 6, 2022

That was in 2012, when Tyrone was given the prognosis of six months due to his heart being too weak to pump blood to the rest of his body. FYI, United Airlines was the first to meet CDC requirements with the first FDA-authorized virtually guided COVID-19 test. ” Ford asked, referring to Morris’s diagnosis of heart failure.

COVID-19 71

COVID-19 FDA Hospitals Doctors 71

Kaiser Health News

JANUARY 12, 2023

On one hand, the FDA has relaxed some of the risk evaluation and mitigation strategies (REMS) from the prescribing rules surrounding abortion pills. The FDA puts these extra restrictions or safeguards in place for certain drugs to add additional protection. Some advocates say these pills simply do not bring that level or risk.

US Department of Health and Human Services 52

US Department of Health and Human Services FDA Medicare Medicare 52

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.

FDA 52

FDA Governance 52

Drug & Device Law

FEBRUARY 20, 2024

In 2012, Plaintiff underwent laparoscopic surgery to repair an inguinal hernia that included implanting defendant’s hernia mesh product. The court did not address that the product was cleared by the FDA, but that fact alone should defeat the extreme mental state required of defendants in intentional infliction of emotional distress cases.

FDA 52

FDA Fraud 52

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. 2d 279, 287 (Mich.

FDA 52

FDA Fraud Compliance Hospitals 52

Drug & Device Law

FEBRUARY 8, 2024

29, 2024), would have been pending if filed sooner was opened back in 2012. In Hinton , the plaintiff’s sling was implanted in August 2019, after pretty much all the relevant FDA actions on pelvic mesh devices. The More Things Change Pelvic mesh litigation has been going on for more than a decade. The MDL in which Hinton v. Boston Sci.

COVID-19 Vaccine 52

COVID-19 Vaccine COVID-19 FDA Public Health 52

Drug & Device Law

JANUARY 4, 2024

2012), we hailed it as the best decision of 2012. 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.

COVID-19 Vaccine 59

COVID-19 Vaccine COVID-19 FDA Public Health 59

Drug & Device Law

DECEMBER 4, 2023

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. Plaintiffs Legal Committee , 531 U.S. 341 (2001). 2023 WL 7019287, at *7. Bizarrely, in applying Buckman , CPAP II relies on a “presumption against preemption,” id.

Fraud 52

Fraud FDA Hospitals Doctors 52

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. 2012); Amarin Pharma, Inc. FDA , 119 F. Caronia , 703 F.3d

FDA 64

FDA Health Insurance Nurses Medicare 64

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. Back in 2008, the United States Supreme Court held, in Riegel v. Medtronic, Inc. , After all, PMA “is in no sense an exemption from federal safety review − it is federal safety review.”

FDA 59

FDA Governance Nurses Hospitals 59

Drug & Device Law

AUGUST 7, 2023

By contrast, the Riegel preemption clause for medical devices prohibits only state-law requirements that are “different from or in addition to” FDA medical device requirements. FDA regulations do not mandate that sunscreen manufacturers include claims pertaining to the product’s durational capability. . §379r(a)(1) (emphasis added).

FDA 52

FDA 52

Drug & Device Law

AUGUST 3, 2023

Way back in September 2012, we—in its Blog-specific veiled singular usage—did our first post. For instance, in 2012, the impacts of the decision in PLIVA, Inc. To the contrary, as one of the panel noted in a concurrence, FDA approval of a drug’s labeling creates a presumption of adequacy. Mensing , 564 U.S. Bartlett , 570 U.S.

FDA 52

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

Fraud 52

Fraud FDA Doctors 52

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. A hundred years later, we detailed three rounds of litigation over Massachusetts’ serial efforts to ban, or at least substantially limit, the use of FDA-approved pain medications.

FDA 59

FDA Licensing Doctors Governance 59

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.

FDA 59

FDA COVID-19 Public Health World Health 59

Drug & Device Law

FEBRUARY 2, 2023

2012 WL 956192, at *5 (S.D. March 19, 2012); Holland v. Texas, unlike most states, enforces a strong statutory presumption that prescription medical product warnings complying with FDA requirements imposed by “pre-market approval or licensing of the product” are adequate as a matter of law. 2012) (applying Texas law).

FDA 59

FDA Licensing Fraud 59

Drug & Device Law

JANUARY 30, 2023

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. Mensing , 564 U.S. Mensing , 564 U.S. Lohr , 518 U.S.

FDA 72

FDA Fraud Governance Medicare 72

Drug & Device Law

DECEMBER 5, 2022

at 462-63; FDA §510(k) clearance of the defendants’ instructions for use did not “actually bar” or “clearly permit” the IFU statements so as to create a safe harbor that precluded the Attorney General’s claims, id. 239, 253 (2012) (which the Blog discussed here ). Fox Television Stations, Inc. ,

Doctors 64

Doctors FDA Compliance 64

Drug & Device Law

NOVEMBER 15, 2022

Korlym was approved by the FDA in 2012. During the approval process, the FDA conducted a Medical Review of the drug which included information about endometrial thickening and the related complications experienced by users. The risk plaintiff suffered was discussed in the FDA’s medical review. emphasis in original). .

FDA 104

FDA 104

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.”. 2012) (citing Smith–Haynie v.

FDA 59

FDA Licensing Compliance 59

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

FDA 59

FDA Compliance 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.”

Informed Consent 59

Informed Consent FDA Doctors 59