2008, FDA and Fraud - Health Care Compliance Brief

States and Feds Signal Big Changes to Telehealth Prescribing

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1] Originally enacted in 2010, the Online Prescribing Act has allowed health care providers to register with the State to prescribe and dispense certain FDA-approved drugs via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.

Telemedicine

Telemedicine COVID-19 Fraud Licensing

The Wait is Over. Or Is It? DEA’s Proposed Rules Around Telemedicine Prescribing: Initial Impressions and Key Takeaways

Health Law Advisor

MARCH 7, 2023

Background on the Ryan Haight Act The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Ryan Haight Act”) made certain amendments to the CSA which established controls on the remote prescribing of controlled substances. 18 U.S.C. § Are the proposed record-keeping obligations reasonable and/or sufficient? 1301.28.

Telemedicine

Telemedicine COVID-19 FDA Compliance

CPAP MDL Overinflates Plaintiffs’ Claims

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. 2008) (applying the rule; rejecting distinction that “this is a ‘no warning’ case as opposed to an inadequate warning case”), aff’d , 321 F. Sinclair v.

Fraud

Fraud FDA Hospitals Doctors

Malarkey ? The Ten Worst Prescription Drug/Medical Device Decisions of 2023

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.

FDA

FDA Fraud Informed Consent

Guest Post – Second Circuit Rejects Manufacturer’s Plan to Share Cost of Expensive Drug with Medicare Part D Beneficiaries

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”). 3 (2008), the court explained that “the word ‘includes,’ when used in a statute, ‘is usually a term of enlargement, and not of limitation.’” Pfizer, Inc. ,

Medicare

Medicare Medicare FDA Prescription Drug Pricing

Pretty Potent Mix In A Prescription Painkiller Preemption Decision

Drug & Device Law

MAY 4, 2023

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. 440 (2008), in the face of a contrary ruling from the Sixth Circuit in Garcia v.

FDA

FDA Fraud Compliance

Thinking About the FDA’s Alternative Summary Reporting Program

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 ).

FDA

FDA Fraud Governance Compliance

PMA Preemption Guts Ohio Case Down to Narrow Failure to Warn Claim

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. The device was pre-market approved by the FDA in 1996 and has been sold throughout the United States ever since. 312 (2008).

FDA

FDA Fraud Governance

Logical Contradiction Doctrine: Buckman for Textualists

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.

FDA

FDA Fraud Governance Medicare

Applying the Helpful but Problematic New Jersey Statute Creating a Rebuttable Compliance Presumption, the Third Circuit Affirms Dismissal of a Failure-to-Warn Claim

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. Stated differently, the rebuttal provision makes allegations and evidence of fraud on the FDA a prerequisite to state-law liability.

Compliance

Compliance FDA Fraud

Getting it Right on PMA Preemption

Drug & Device Law

MARCH 15, 2024

The Court noted the rigorous process for PMA approval, emphasizing that the FDA spends an average of 1,200 hours reviewing an application for PMA. Describing the role of the FDA, the Court recognized that the FDA may “approve devices that present great risks if they nonetheless offer great benefits in light of available alternatives.”

FDA

FDA Fraud

Fallacious FDA Reporting Claim Finally Falls

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.

FDA

FDA Fraud

Health Care Compliance Brief

States and Feds Signal Big Changes to Telehealth Prescribing

The Wait is Over. Or Is It? DEA’s Proposed Rules Around Telemedicine Prescribing: Initial Impressions and Key Takeaways

Trending Sources

CPAP MDL Overinflates Plaintiffs’ Claims

Malarkey ? The Ten Worst Prescription Drug/Medical Device Decisions of 2023

Guest Post – Second Circuit Rejects Manufacturer’s Plan to Share Cost of Expensive Drug with Medicare Part D Beneficiaries

Pretty Potent Mix In A Prescription Painkiller Preemption Decision

Thinking About the FDA’s Alternative Summary Reporting Program

PMA Preemption Guts Ohio Case Down to Narrow Failure to Warn Claim

Logical Contradiction Doctrine: Buckman for Textualists

Applying the Helpful but Problematic New Jersey Statute Creating a Rebuttable Compliance Presumption, the Third Circuit Affirms Dismissal of a Failure-to-Warn Claim

Getting it Right on PMA Preemption

Fallacious FDA Reporting Claim Finally Falls

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