Health Populi

JANUARY 6, 2023

. “Despite breathtaking medical advancements since President Harry Truman declared war on heart disease 75 years ago, researchers have observed a disturbing trend that started in 2009: America’s death rate from heart-related conditions is climbing again,” the detailed essay explains. In the U.S.

FDA 104

FDA Doctors COVID-19 Hospitals 104

Health Law Advisor

MAY 3, 2022

We have just gone through an extraordinary two years where, in unprecedented fashion, FDA’s inspection process was essentially shut down. Further, from a warning letter standpoint, without inspection data, FDA focused in other compliance realms than it typically might. Just a short while ago FDA recommenced inspections.

FDA 52

FDA Compliance 52

Drug & Device Law

FEBRUARY 3, 2023

In 2009, a detailed warning was added to the “Precautions” section of the label. The defendants warned of these adverse events over the years, progressively strengthening the warnings and increasing their prominence. Again – need we say it? that’s not the law.

COVID-19 52

COVID-19 Doctors FDA 52

Drug & Device Law

JANUARY 15, 2024

We have discussed how exclusion of FDA compliance in pelvic mesh cases, based on a false equivalence between preemption and evidentiary admissibility, has hampered the defense in that litigation. 2009) (en banc), decided before Tincher adopted consumer expectations as a Pennsylvania design defect test. 3d 1245 (N.J. Ford Motor Co. ,

Compliance 52

Compliance FDA Governance State Policy 52

Drug & Device Law

JANUARY 9, 2023

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. 14, 2022), leaves us scratching our heads. First, it claims to find “helpful guidance,” id. at *7, in Wyeth v. Levine , 555 U.S. 2022 WL 17348351, at *4.

FDA 59

FDA Governance Nurses 59

Drug & Device Law

AUGUST 22, 2022

The plaintiff in Jacob sued the manufacturer of a Class III, FDA premarket-approved medical device. First, the plaintiff’s non-parallel claims were “preempted to the extent” that they would have imposed “alleged labeling or manufacturing requirements that are different from, or in addition to, those imposed by the FDA.”

Informed Consent 59

Informed Consent FDA Doctors 59

Drug & Device Law

JANUARY 30, 2023

555 (2009), and rated only a “ cf. 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. 2019), or Mutual Pharmaceutical Co. Bartlett , 570 U.S. Levine , 555 U.S.

FDA 72

FDA Fraud Governance Medicare 72