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

In this month’s post, in the medical device realm I explore what kinds of inspection citations most often precede a warning letter. We have just gone through an extraordinary two years where, in unprecedented fashion, FDA’s inspection process was essentially shut down. Just a short while ago FDA recommenced inspections.

FDA 52

FDA Compliance 52

Drug & Device Law

JANUARY 15, 2024

As we discussed at length in this post, since the 1940s, the Pennsylvania Supreme Court and other courts applying Pennsylvania law have refused to subject prescription medical products to strict liability. Neither Lewis nor Tincher involved prescription medical products, but rather what we describe as “things that go clank.”

Compliance 52

Compliance FDA Governance State Policy 52

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

The availability of this type of cutting-edge presentations is yet another reason why drug and medical device manufactures would be well served by joining PLAC. For those of you accessing the Blog on mobile devices, this post may be hard to read. 555 (2009), and rated only a “ cf. Plaintiffs Legal Committee , 531 U.S.

FDA 72

FDA Fraud Governance Medicare 72