Bill of Health

MAY 19, 2022

Incremental benefits of novel pharmaceuticals in the UK: a cross-sectional analysis of NICE technology appraisals from 2010 to 2020. Epub ahead of print. Polak TB, Cucchi DGJ, Darrow JJ, Versteegh MM. 2022 Apr 8;12(4):e058279. Rome BN, Sarpatwari A, Kesselheim AS. State Laws and Generic Substitution in the Year After New Generic Competition.

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The Health Law Firm

MARCH 20, 2013

On January 17, 2013, the Food and Drug Administration (FDA) issued an updated public health communication about hip replacement components that have both a metal ball and a metal socket, or metal-on-metal hip devices. Click here to read the FDA communication.

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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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Innovaare Compliance

JANUARY 15, 2024

2] The current Coverage Gap Discount Program (CGDP), pursuant to the Affordable Care Act 2010 , [3] will be sunset on December 31, 2024. 6] A compound drug not approved by the FDA under a New Drug Application or Biological License Application does not meet the definition of an applicable drug and will not be eligible for Part D.

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Health Law Advisor

JANUARY 3, 2023

The regulatory environment at the US Food and Drug Administration (“FDA”) has a tremendous impact on how companies operate, and consequently data on that environment can be quite useful in business planning. Product codes are the language of FDA regulation. Every medical device FDA regulates is placed into a product code.

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HIT Consultant

SEPTEMBER 2, 2022

In December 2021, the company received clearance from Food and Drug Administration (FDA) for its digital contraceptive device and the same is now being rolled out in the U.S. Although most femtech companies started emerging after 2010, the drastic effect they are making on the world is appreciation-worthy.

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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). In making this decision, the appeals court has renewed a securities fraud class action that was dismissed by a trial court in 2010. The ruling was reached on June 4, 2012. To view the appeals court ruling in Public Pension Fund Group v.

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Health Populi

JUNE 11, 2020

adults are thinking about what they eat and drink as part of their overall health context more in 2020 than they did in 2010. In the past ten years, consumers’ emphasis on overall health has grown: 6 in 10 U.S.

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Health Law Advisor

MARCH 1, 2023

1] Originally enacted in 2010, the Online Prescribing Act has allowed health care providers to register with the State to prescribe and dispense certain FDA-approved drugs via online pharmacies and utilization of telehealth visits. Utah Code § 58-83-306.

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HIT Consultant

JUNE 29, 2023

In the report, The Yale Center for Clinical Investigation cited the success of their 2010-initiated ambassador program, reporting, “the proportion of patients in trials from a racial and ethnic group other than non-Hispanic White increased from 3 percent in 2010 to 32 percent in 2021. ”

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HIT Consultant

MAY 31, 2023

The pharmaceutical industry has experienced a wave of accelerated consolidation since 2010. Common industry practice today allows small groups of large, powerful pharmaceutical manufacturers to drive new drugs through regulatory processes, acting as the gatekeepers to achieve FDA approval. million Americans.

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Health Populi

NOVEMBER 13, 2018

Lisa started the Venture Valkyrie blog in 2010. AI will have more health-evidence supporting its adoption, perhaps, she expects, the first AI-developed FDA approved drug, Lisa expects. We’ll also see more and more connected health data in the IoT ecosystem for different applications.

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C&M Health Law

JANUARY 25, 2023

Section 1001 of the Act delays the 4% Statutory Pay-As-You-Go Act of 2010 (PAYGO) sequester for two years, through the end of calendar year 2024. Section 3604 of the Act requires FDA to issue a report on an annual basis, beginning two years after the Act’s enactment, that summarizes its diversity action plans.

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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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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. 2010), which is undoubtedly the worst post- Riegel appellate PMA preemption decision of all. Back in 2008, the United States Supreme Court held, in Riegel v. Medtronic, Inc. ,

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Drug & Device Law

DECEMBER 4, 2023

2010) (citations and quotation marks omitted). “[W]e have exercised restraint” and “opt for the interpretation that restricts liability, rather than expands it, until the Supreme Court of [the affected state] decides differently.” 2010). “[E]ven if we were torn between two competing yet sensible interpretations of [state] law. . .,

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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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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

NOVEMBER 10, 2023

Indeed, the FDA stated, in connection with the same drug recalls that the Valsartan plaintiffs use to define their classes, 2023 WL 1818922, at *20-21: [These] medicines. . . FDA, “ Statement on the agency’s ongoing efforts to resolve safety issue with ARB medications ” (Aug. 18, 2019) (emphasis added). 2023 WL 1818922, at *36.

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Drug & Device Law

FEBRUARY 3, 2022

Redick’s implant, that he was familiar with the Australian registry data, and that he did not recall reading the 2010 label, which was available online and contained the risk information about females and patients needing smaller head sizes. No proof on reliance or proximate cause, no basis for a new trial.

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Drug & Device Law

NOVEMBER 28, 2022

2010) (Matsen); Nelson v. While cosmetic talc is not a drug or medical device, the FDA also regulates it (the “C” in the FDCA). 3d 213, 222-23, 229-32 (S.D.N.Y. 2018) (Etminan); Gerke v. Travelers Casualty Insurance Co. , 316, 328-29 (D. 2013) (Painter); McClellan v. I-Flow Corp. , 2d 1092, 1119-25 (D. Tennessee Gas Pipeline Co.

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Drug & Device Law

AUGUST 8, 2022

Smith, LLC , 2010 WL 11566367, at *7 (N.D. May 14, 2010) (“Defendant [standards institute’s] standards are voluntary, consensus standards, and Defendant. . . 2010); In re Welding Fume Products Liability Litigation , 526 F. Such power rests solely with the FDA.” has no power to enforce compliance”), aff’d , 405 F.

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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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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. . . Bayer HealthCare Pharmaceuticals, Inc. , 3d 1223, 1233 (11th Cir. label, he would still have prescribed [the drug] to [plaintiff]. . . .

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Drug & Device Law

JANUARY 24, 2023

It was not enough for plaintiff to cite to post-2010 studies; she has to plead what information was provided to the FDA and when. To avoid preemption, plaintiff is required to plead what newly acquired information would allow defendant to use the CBE regulations to change its label.

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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.”. 2010 WL 894054 (N.D.

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Drug & Device Law

APRIL 25, 2022

Back in 2010, we examined one restrictive judicial gloss on Rule 407 – a “policy” based exception that the rule somehow doesn’t apply to government-mandated measures. Fortunately, that 2010 decision has been a pro-plaintiff anomaly, and FDA required label changes, recalls, etc. May 20, 2010). See , e.g. , Yates v.

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Drug & Device Law

MARCH 7, 2022

2010) (applying TwIqbal because “[p]unitive damages are never awarded as a matter of right, are disfavored by the law”). These allegations lack any contention or inference that [defendant] withheld or misrepresented information to the FDA. . ., 2010) (other citations and quotation marks omitted). Corrections Corp. , 2, 2020). “In

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Drug & Device Law

MARCH 16, 2023

We have made no secret of our long-held views that “failure to withdraw” or “stop selling” theories of liability for FDA-authorized medical products are unwarranted perversions of state design defect law and preempted anyway. 2010) (Ohio law), and the Pennsylvania Supreme Court in Lance v. Wyeth , 619 F.3d 3d 632 (6th Cir. 3d 434 (Pa.

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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. See Prasol v.

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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. Plaintiff alleged that she consumed Tootsie Rolls from 2010 to 2016 apparently without knowing that they contained artificial trans fats in the form of partially hydrogenated oils (PHOs). Tootsie Roll Indus. LEXIS 982 (Cal.

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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

DECEMBER 7, 2023

In particular, we’re not surprised to learn that AI is being used in the context of FDA-required adverse event reporting, purported problems with which have become one of the other side’s go-to preemption dodges. Yates , 2010 WL 503061, at *1 (E.D. Shinette , 2018 WL 4929736, at *5 (E.D.

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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

MARCH 13, 2023

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. 393, 400 (2010). Coloplast Corp. , 3d 448 (W.D.

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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

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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