Healthcare IT News - Telehealth

MARCH 18, 2022

Healthcare IT News sat down with this digital health investor to talk about digital health investment trends during the pandemic and where he sees funding trending in 2022 and beyond. Norden is particularly passionate about funding companies focused on the Medicaid population – a traditionally tricky and often ignored area.

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Medicaid Medicaid COVID-19 Telemedicine 201

Healthcare It News

FEBRUARY 20, 2024

There is also news from federal agencies about deaths attributed to recalled PAP machines, and a new five-year, $4.1 New FDA update on Philips Respironics' 2021 device recalls PAP machines which deliver oxygen through a mask, are one way to treat sleep apnea. in the third quarter. in the third quarter.

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Health Law Advisor

FEBRUARY 1, 2022

The United States Food and Drug Administration (FDA) for many years has been trying to increase the participation of minorities in clinical trials to help ensure that regulated products are tested and labeled in an appropriate cross-section of Americans. National Library of Medicine, with support from FDA.

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Drug & Device Law

DECEMBER 4, 2023

On a host of issues, CPAP II makes a recommendations about state law – but without any basis in existing state law. Undisputedly, the complaint at issue “allege[d] no specific facts about any specific plaintiffs or specific injuries.” Sinclair v. Merck & Co. , 2d 587, 595 (N.J. 28, 2023) (“ CPAP II ”), is entirely Mr. Hyde.

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Fraud FDA Hospitals Doctors 52

Drug & Device Law

OCTOBER 23, 2023

Back in 2008, the United States Supreme Court held, in Riegel v. 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. Medtronic, Inc. , at 356 (emphasis added).

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Drug & Device Law

DECEMBER 21, 2023

FDA , 78 F.4th 2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. The questionable allegations of that single complaint thus effectively trumped many years of the FDA’s science-based decision-making. The FDA, for one, advised patients to keep using these drugs.

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FDA Fraud Informed Consent 52

Drug & Device Law

OCTOBER 10, 2022

The drug at issue was an FDA-recognized breakthrough drug that treats a relatively rare, but invariably fatal, condition – transthyretin amyloid cardiomyopathy (“ATTR-CM”). ATTR-CM only affects about 150,000 Americans, who are mostly elderly. ATTR-CM only affects about 150,000 Americans, who are mostly elderly. Pfizer , 42 F.4th

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Medicare Medicare FDA Prescription Drug Pricing 52

Drug & Device Law

MARCH 25, 2022

Even before the anti-osteoporosis drug Fosamax was FDA approved, its manufacturer was aware of a biologically plausible mechanism for that class of drug (“bisphosphonates”) to cause low-energy – later renamed “atypical” ? The manufacturer informed the FDA, but no evidence then established that risk as anything more than hypothetical.

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FDA Governance 52

Drug & Device Law

JUNE 2, 2022

We are just simple defense hacks writing about product liability law and some other things that matter to medical product manufacturers. Although the male authors here agree wholeheartedly that individual choices about women’s contraception, reproduction, and sexual health are not for us to make.) As we discussed here , McCormack v.

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FDA Licensing 127

Drug & Device Law

APRIL 25, 2022

Fortunately, that 2010 decision has been a pro-plaintiff anomaly, and FDA required label changes, recalls, etc. 2015) (“we will not consider evidence of a subsequent improvement to a drug label as evidence of prior failure to warn, even in cases such as this in which the FDA mandated the change in labeling”) (citing Rule 407).

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FDA Governance 52

Drug & Device Law

FEBRUARY 21, 2022

11, 2022), granted a Rule 702 motion excluding plaintiff’s purported FDA expert Peggy Pence, who “began working as an expert witness for plaintiffs in product liability cases in 2008” and “approximately 100% of her work was as a plaintiff’s expert in product liability litigation.” Coloplast Corp. 2022 WL 425206 (N.D. Coloplast Corp.

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FDA Doctors 59

Drug & Device Law

APRIL 18, 2022

A few years ago we did a couple of posts about the learned intermediary decision that arose from the Zimmer Nexgen Knee Implant MDL, and was subsequently affirmed by the Seventh Circuit Court of appeals. about a risk of clip migration,” to which plaintiff responded “that the learned intermediary doctrine did not apply.” 3d 700 (N.D.

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FDA 59

Drug & Device Law

JUNE 6, 2022

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. . . 2008) (applying Texas law and discussed here ), several times. Bayer HealthCare Pharmaceuticals, Inc. , 3d 1223, 1233 (11th Cir.

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FDA Doctors Malpractice Medical Personnel 59

Drug & Device Law

DECEMBER 14, 2023

Yet, plaintiffs love to pursue evidence of the defendant’s role in shaping the science and, if they get to trial, attack established drugs or devices with often fairly tangential evidence about the defendant’s relationship with authors of studies the plaintiffs do not like. 2008) (cited in Paraquat, 2023 WL 8372819, * 3 n.3).

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FDA 52

Drug & Device Law

MARCH 31, 2022

The Orthopedic Bone Screw would never have occurred – and Bexis might never have found his way to prescription medical product liability litigation – if not for the Kessler-era FDA’s ill-considered salami slicing of the “intended use” of that product. 1396r-8(k)(6). Rather: Using these definitions to construe the phrase “supported by”. . .

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Medicare Medicare FDA Governance 52

Drug & Device Law

AUGUST 7, 2023

312 (2008). 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.

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FDA 52

Drug & Device Law

DECEMBER 19, 2022

We last mentioned the Blackburn litigation, here , where we were not very happy about the Alabama Supreme Court’s loosening of the warning causation standard applicable that state’s learned intermediary rule. Since FDA requires medication guides only for safety reasons, most changes to them can affect safety and effectiveness. (C)

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FDA 59

Drug & Device Law

JANUARY 30, 2023

440 (2008) Buckman was not cited at all in the Merck Sharp & Dohme Corp. 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. Kent , 552 U.S. Lohr , 518 U.S.

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FDA Fraud Governance Medicare 72

Drug & Device Law

MAY 5, 2022

A relatively short post about Greisberg v. 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. We do, however, have reservations about N.J. Boston Scientific Corp.

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Compliance FDA Fraud 52

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. We have written about this excellent Arizona statute several times, including here and here.

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FDA Governance Licensing 69

Drug & Device Law

APRIL 11, 2022

312 (2008), and here’s what the Court said about why the “reasonable assurance of safety and effectiveness” standard is preemptive of personal injury claims: [The FDA] may thus approve devices that present great risks if they nonetheless offer great benefits in light of available alternatives. Medtronic, Inc. ,

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FDA 59

Drug & Device Law

MAY 4, 2023

25, 2023), is one we have been talking about for a long time. 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.

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FDA Fraud Compliance 64

Drug & Device Law

SEPTEMBER 22, 2023

Over the years, this blog has come to serve as an important resource for our drug and defense bar colleagues, and Bexis regularly identifies—if not invents—new legal issues and ideas, then proselytizes about them until they become part of the fabric of our legal lives. 2008), shows how the OTC express preemption provision should work.

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FDA Public Health 105

Drug & Device Law

JULY 18, 2023

As evidenced by our PMA Preemption Score Card , on which today’s case became the 651 st entry, defendant manufacturers of FDA-approved Class III medical devices generally do pretty well with preemption motions. But plaintiffs keep filing PMA medical device complaints, so we’ll keep posting about them. 312 (2008).

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FDA Fraud Governance 52

Drug & Device Law

JANUARY 16, 2023

The claims in Zofran concerned plaintiffs’ demands for warnings about the off-label use of this product for relief of morning sickness during pregnancy. 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.

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FDA Governance 72

Drug & Device Law

MARCH 15, 2024

Plaintiff had the device implanted prior to the recall, and she died about two months after the recall. Plaintiff also included a general claim that the defendant made misrepresentations about the reliability and longevity of the defibrillator. 312, 318 (2008)). at *3 (citing Riegel v. Medtronic, Inc. ,

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FDA Fraud 52

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. Medtronic, Inc.

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FDA Fraud 59

Drug & Device Law

JUNE 28, 2022

June 24, 2022), we fully expect attempts by such states to ban FDA-approved prescription drugs that can be used to bring about abortions by chemical means. But when the FDA has approved a product, states no longer have the power to prohibit their sale or use for FDA-approved indications. Jackson Women’s Health Org. ,

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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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FDA Licensing Hospitals Governance 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 ).

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