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.

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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.

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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.

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Health Populi

NOVEMBER 8, 2018

substantially grew between 2012 and 2017, many more women than men use these holistic medicine approaches. Headspace is a well-adopted app for meditation, getting traction in healthcare with research partners at Carnegie Mellon, Harvard, and Kaiser Permanente who are studying the app to collect data for FDA scrutiny. In 2017, 14.3%

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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Drug & Device Law

AUGUST 8, 2022

2012 WL 3265002, at *5 (N.D. 8, 2012) (“For claims against trade associations in particular, public policy is ‘part of the legal mix’ and favors not imposing a duty.”); Lockman v. Such power rests solely with the FDA.” 3d 732, 745 (M.D.N.C. 2016) (association’s “adoption of rules, policies, and procedures. . .

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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. ,

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Drug & Device Law

JUNE 6, 2022

2012), it had to apply the rule. The prescriber] provided explicit, uncontroverted testimony that, even when provided with the most current research and FDA mandated warnings, as well as the information found in [defendant’s] updated. . . 2012 WL 12848432, at *4 (E.D. Hamilton , 372 S.W.3d 3d 140 (Tex. 3d 1223, 1233 (11th Cir.

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Drug & Device Law

APRIL 19, 2022

Not too long ago we researched precedent that forbade persons claiming to be “FDA experts” from opining that products are “adulterated” or “misbranded.” 2012), prohibited an expert from opining on what constituted “exclusive control,” “dangerous condition,” “substantial cause,” and “negligence.” at *10 (citation omitted).

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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. 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.”

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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.”

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Drug & Device Law

APRIL 21, 2022

Plaintiffs alleged that manufactured had failed to investigate and report the event to the FDA as purportedly required. 452, 460 (2012). For example, the court took judicial notice of an FDA recall notice. In support of that allegation, plaintiffs pointed to a particular adverse event that was noted in a recall notice.

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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

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

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.

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Drug & Device Law

MARCH 7, 2022

These allegations lack any contention or inference that [defendant] withheld or misrepresented information to the FDA. . ., 2012): But the cases do not suggest that claims for punitive damages are exempt from [ TwIqbal ] pleading requirements. 2012); Sieloff v. 2012 WL 5835396, at *1 (D. 16, 2012); Salvio v.

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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. 2d 279, 287 (Mich.

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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.

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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).

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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.

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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).

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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.

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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.

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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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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

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.

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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. 2012), abrogated on other grounds by McCarrell v. 2012), and Garcia v. Boston Scientific Corp. 2022 WL 1261318 (3d Cir.

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Drug & Device Law

JUNE 2, 2022

2012), addressed a challenge to the application of Idaho’s Pain-Capable Unborn Child Protection Act to criminalize the use of an FDA-approved abortifacient medication obtained through an internet prescription and mailed to the plaintiff from out of state. As we discussed here , McCormack v. Hiedeman, 694 F.3d 3d 1004 (9th Cir.

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Drug & Device Law

MARCH 16, 2022

As you must know by now, the pelvic mesh MDL court ruled that the FDA 510(k) regulatory clearance of pelvic mesh devices was irrelevant because such clearance was not probative of safety. The Arizona legislature passed the punitive damages exemption statute in August of 2012.

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