Verisys

JULY 13, 2023

Verisys’ former VP of Pharma and Pharmacy Solutions, Joe Thompson, shared a prime example of how speaker programs introduce risk to the pharmaceutical company: “In 2011, one of the most prominent endocrinologists in my sales region was an active speaker for my previous company. He led multiple programs for us each year.

Compliance 52

Compliance Due Diligence Pharmaceutical Industry Fraud 52

CMS.gov

NOVEMBER 2, 2018

Just another name for a government-run, single payer system. Just another name for a government-run, single payer system. As head of the agency that serves over 58 million Medicare beneficiaries, I deal first-hand with the challenges of government run healthcare. percent from 2011-2016, from $17.6 keya.joy-bush@….

Governance 55

Governance Medicare Medicare ACA 55

C&M Health Law

JANUARY 25, 2023

trillion spending package, which consists of all 12 fiscal year (FY) 2023 appropriations bills and funds the federal government through September 30, 2023, provides additional assistance to Ukraine, and makes numerous health care policy changes. 117-164 ) (the “Act”)—an approximately $1.7

Medicaid 104

Medicaid Medicaid Medicare Medicare 104

Drug & Device Law

DECEMBER 29, 2023

2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. 2023) ( Buckman preemption barred MDL asserting fraud on EPA), cert. In 2023, these include United States ex rel. Polansky v. 3d 239 (Cal.

FDA 105

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

Drug & Device Law

NOVEMBER 10, 2023

These class certifications combined 428 different pharmaceutical products, produced and marketed by 28 separate defendants, with claims governed by the laws of 52 separate jurisdictions. A procedural rule, such as Rule 23 governing class actions, should not, and legally cannot , change that result. Valsartan , 2023 WL 1818922, at *24.

FDA 59

FDA Governance Fraud 59

Drug & Device Law

MARCH 31, 2023

Criticizing attempts to sue publishers of scientific content, here in 2011, and again, here in 2013. Scientific literature about the risks and benefits of prescription medical products does not – at least in the absence of academic fraud such as the actual falsification of data (see, here ) – subject the speaker to tort liability.

Medical Personnel 59

Medical Personnel COVID-19 Fraud Doctors 59

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. Bartlett , 570 U.S. 472 (2013), implied preemption decisions, cited only by the dissent in Wyeth v. Levine , 555 U.S. 555 (2009), and rated only a “ cf.

FDA 72

FDA Fraud Governance Medicare 72