HIPAA Journal

JANUARY 23, 2024

Carreyrou published the story in 2015 that revealed the company was using third-party technology rather than its own, as its own technology was inefficient. The FDA launched an investigation into Theranos that found that the allegations in Carreyrou’s article were correct. Holmes was also ordered to pay $452,047,200 in restitution.

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Fraud FDA Medicaid Medicaid 73

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. Justin Norden is a partner at GSR Ventures. What has been one digital health investment trend during the COVID-19 pandemic, and why is it important?

Medicaid 211

Medicaid Medicaid COVID-19 Telemedicine 211

Health Populi

JANUARY 4, 2023

Withings has received similar kudos at previous CES shows: last year, for the Body Scan weight scale ( recognized by TIME magazine as one of the best inventions of the year), and back in 2015 for the Activité watch and the Home HD camera embedded with environmental sensors. In 2022, Withings had seen over 1 million new devices installed.

COVID-19 62

COVID-19 FDA Doctors Hospitals 62

Bill of Health

AUGUST 29, 2022

Victoria Kalumbi received her JD from Harvard Law School in 2022. 5] Stephanie Anne Deutsch & Kristine Fortin, Physical Health Problems and Barriers to Optimal Health Care Among Children in Foster Care , 45 Current Problems in Pediatric and Adolescent Health Care 286, 286 (2015); Council on Foster Care et al.,

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COVID-19 Vaccine COVID-19 Informed Consent Governance 130

Hall Render

DECEMBER 22, 2023

health care spending hits $4.5 Million in Retaliation Suit John Muir, Tenet scrap hospital deal after FTC challenge Kaiser to lay off 79 administrative employees Leaning toward big wins in schizophrenia and vaccines, venture group raises new fund of $389 million Madera hospital creditors want to be paid, including CEO. health care spending hits $4.5

Nursing Homes 40

Nursing Homes Nurses Hospitals COVID-19 40

Health Populi

MAY 24, 2018

The report covers these three themes across four sections: advances in therapies, spending, pipeline and new product innovations, and an outlook through 2022. The outlook to 2022 forecasts the global spending on oncology therapies will reach $200 bn globally. That calculates to 10 to 13% growth annually over the five-year period.

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FDA 81

Hall Render

DECEMBER 29, 2023

NATIONAL 4 largest healthcare data breaches of 2023 Anesthesia practices sue CMS over reimbursement method Antitrust enforcements hit a high in 2022, with health deals impacted ASCs face leadership exodus CMS floats appeals process over observational stays CMS proposes additional Medicare appeals processes FTC eyes healthcare mergers, report shows (..)

Nursing Homes 40

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

Hall Render

APRIL 21, 2023

ranked healthiest in West Virginia Women’s Health Center of West Virginia drops lawsuit challenging abortion law WISCONSIN A giant in UW Hospital’s transplant program retires Advocate Aurora is latest nonprofit in the red, posts $751M net loss in 2022 Common Council urges Ascension St.

US Department of Health and Human Services 40

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

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. 2022) (“[i]n making that prediction, the decisions of intermediate Pennsylvania appellate courts receive significant weight”) (citations and quotation marks omitted).

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Fraud FDA Hospitals Doctors 52

Drug & Device Law

APRIL 28, 2022

155 (2015), spelled out what makes a restriction on speech content-based and, thus, presumptively invalid. As we noted soon after Reed and since , these standards flow directly into whether and how FDA can restrict what drug and device manufacturers say about off-label use, the main recurring issue for these companies.

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FDA Governance 59

Drug & Device Law

AUGUST 8, 2022

3d , 2022 WL 1592444, at *4 (E.D. May 19, 2022). 2015 WL 6393869 (S.D. 21, 2015): Mississippi does not recognize any cause of action against a voluntary non-profit trade association like TMA. . . . [T]he Such power rests solely with the FDA.” Educational Commission for Foreign Medical Graduates , F.

Doctors 52

Doctors Fraud Licensing Compliance 52

Drug & Device Law

DECEMBER 29, 2023

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

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FDA US Department of Health and Human Services COVID-19 COVID-19 Vaccine 105

Drug & Device Law

MAY 16, 2022

2015), took one on the chin recently in the Ninth Circuit at the hands of free speech under the First Amendment. 2022) (“CCoC”), a number of business groups originally sued the State of California seeking a preliminary injunction “to halt acrylamide litigation brought under. . . as the FDA acknowledged the warning might be. . . . [W]hen

Governance 59

Governance FDA 59

Drug & Device Law

JANUARY 9, 2023

The flimsy decision in In re Acetaminophen − ASH-ADHD Products Liability Litigation , 2022 WL 17348351 (S.D.N.Y. 14, 2022), leaves us scratching our heads. 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.

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FDA Governance Nurses 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. . . 2022 WL 800879, at *21 (E.D. March 29, 2019); Byetta Cases , 2015 WL 883211, at *1 (Cal. 3d 1223, 1233 (11th Cir.

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FDA Doctors Malpractice Medical Personnel 59

Drug & Device Law

MAY 13, 2022

2022 WL 1415031 (W.D.N.Y. May 4, 2022), the plaintiff alleged that the defendant’s osteoporosis drug, Fosamax, caused her to suffer serious injuries, including osteonecrosis of the jaw and atrial fibrillation. MacSwain , 2022 WL 1415031 at *4 (citations to Complaint omitted). 2015), leading the charge in the “yes” column.

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Fraud FDA Nurses Hospitals 59

Drug & Device Law

MARCH 7, 2022

2022 WL 610276 (C.D. 31, 2022), fell into our laps. These allegations lack any contention or inference that [defendant] withheld or misrepresented information to the FDA. . ., 2015 WL 3466517 (D. 2015); Tapia v. 2015 WL 6828660, at *8 (S.D. 6, 2015); Rhoton v. 2015 WL 7770234, at *4 (N.D.

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Fraud FDA Licensing Pharmaceutical Industry 59

Drug & Device Law

MARCH 30, 2022

March 21, 2022), is the pelvic mesh case of the week, and it involves a variety of plaintiff challenges to the defendant’s experts. Another defense expert was an ob-gyn who had been retired since 2015. Ethicon, Inc. LEXIS 51601 (E.D. That fact in itself is interesting. Usually it is the defense side that challenges expert opinions.

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FDA 59

Drug & Device Law

AUGUST 22, 2022

2022), is a very peculiar case and will probably leave some plaintiffs wondering if, maybe, they would be better off without their lawyers. The plaintiff in Jacob sued the manufacturer of a Class III, FDA premarket-approved medical device. She also tried to sue three new defendants – a doctor, a medical society and the FDA itself.

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Informed Consent FDA Doctors 59

Drug & Device Law

FEBRUARY 2, 2023

2022 WL 17443711, at *2 (5th Cir. 6, 2022) (applying Texas law), applying this standard in a Texas medical device decision. Atkinson pointed out that the main exception – fraud on the FDA − to this otherwise not easily rebutted presumption of warning adequacy is preempted. See Harrison v. Medtronic, Inc. manufacturer, . .

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FDA Licensing Fraud 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. Doyle , 2015 WL 4528759, at *21 (Mag. 8, 2019); Konrick v. Exxon Mobil Corp.

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FDA 52

Drug & Device Law

JANUARY 13, 2023

Adams) , 2022 WL 16923721 (E.D. 2, 2022), concerned the summary judgment motions of three defendants who manufactured generic versions of the prescription cancer medication at issue in the litigation. If the generic drug’s label was as approved by FDA and matched the branded drug’s label, then any warning claim would be preempted.

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FDA 59

Drug & Device Law

SEPTEMBER 12, 2022

9, 2022), and the decision has a number of useful – for our side – rulings concerning branded drug preemption post- Merck Sharp & Dohme Corp. The plaintiffs in Pfaff , who opted out of the settlement, had originally brought suit in California federal court back in 2015. T]he FDA responded. Merck & Co. , Albrecht , 139 S.

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FDA Compliance 59

Drug & Device Law

MARCH 16, 2022

2022 WL 604889 (D. Arizona March 1, 2022) – focuses on the regulatory status of the device. 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 pelvic mesh case of the week – McBroom v.

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FDA Governance Licensing 69

Drug & Device Law

FEBRUARY 24, 2022

One tack they take is to argue that Buckman is limited to its facts and thus applies only to state-law fraud-on-the-FDA claims. 3d —-, 2022 WL 464149 (N.D. 2022), rejected that sophistry. 2022 WL 464149, at *1. 2022 WL 464149, at *4. 2022 WL 464149, at *4. 2015) (Gorsuch, J.). Medtronic, Inc. ,

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FDA Governance Fraud 72

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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FDA 52

Drug & Device Law

JULY 26, 2023

2015 WL 5567578, at *6-7 (W.D.N.C. 22, 2015) (admitting §510(k) compliance in pelvic mesh case under North Carolina law). So plaintiffs will not be able to hide the truth of FDA regulation from the jury on retrial, while misleading the jury, nor try the same trick in any other pelvic mesh case in New Jersey going forward.

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Compliance FDA Licensing Governance 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. 2022 WL 5265300 (D.N.J. 20, 2022) (dismissing 197 cases)) and discouraged countless others from being filed. 2021 WL 1285087 (E.D.

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FDA Compliance Fraud Hospitals 52

Drug & Device Law

DECEMBER 6, 2022

According to the FDA, nothing, and that’s why the court dismissed the putative class action in Beasley v. 30, 2022). . As it turns out, thanks to very specific language from both the FDA and Congress, neither could the presence of PHOs before 2018. Like with drugs, foods regulated by the FDA cannot be “adulterated.”

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FDA Compliance Governance 59

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. 3d , 2022 WL 827235 (D. 2015); Wilhite v.

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FDA 59

Drug & Device Law

JANUARY 16, 2023

One of the decisions we were looking forward to at the end of 2022 has occurred. 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. 4th , 2023 WL 128570 (1st Cir. quoting 73 Fed. 22, 2008)).

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FDA Governance 72

Drug & Device Law

OCTOBER 27, 2022

2022 WL 4329094 (N.D. 2022), is neither a medical-device nor a pharmaceutical case. 2022 WL 4329094, at *4 (quoting Benson v. 2022 WL 715494 (5th Cir. 2022); Caplinger v. 2015); Otis-Wisher v. 2015); Bledsoe v. Drake Oak Brook Resort LLC , 2022 WL 2715854, at *4 (N.D. Biomat USA, Inc.

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FDA Licensing Compliance 59

Drug & Device Law

MARCH 28, 2022

In a recent post , we discussed a decision that, among other things, excluded an FDA expert’s “opinion” that the defendant’s medical device was “adulterated” and/or “misbranded.” 2022 WL 614919 (S.D. Here, we’re focusing on expert opinions misusing these FDA terms of art. In Robinson v. Ethicon, Inc. of Bexis’ book.

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FDA 59

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

FEBRUARY 11, 2024

FDA litigation that is now before the Supreme Court. FDA , 78 F.4th quoting FDA appellate brief ). Congress created an FDA approval process that is both rigorous and thorough, and pharmaceutical companies invest billions of dollars in research and development to meet FDA’s scientific standards. 4th 210 (5th Cir.

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Drug & Device Law

JUNE 28, 2022

2022 WL 2276808 (U.S. 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.

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FDA Public Health Federal Policy Doctors 116