Products Intended to Fight COVID-19 Protected by Broad – but Not Unlimited – Immunity From Suit

2020-05-22T14:40:22+00:00 May 22nd, 2020|Categories: Epidemiology, Johanna L. Matloff, Julie L. Martin, Manufacturing Processes, Warnings and Code Compliance|Tags: , , , |

On January 31, 2020, the Secretary of the United States Department of Health and Human Services declared a public health emergency under the Public Health Service Act to aid the health care community’s response to the spread of the COVID-19 virus.  As global efforts to treat, prevent, and slow the

Defining the Boundaries for Pre-emption of Drug Labeling Claims

2020-02-18T21:00:25+00:00 February 18th, 2020|Categories: Johanna L. Matloff, Julie L. Martin, Manufacturing Processes, Warnings and Code Compliance|Tags: , , |

Drug warning labels must comply with federal regulations and receive approval from the Food and Drug Administration (“FDA”) before going to market. Therefore, manufacturers may argue that state law actions related to the information contained in – or missing from – the labels should be preempted if it would be