Tag Archives: pharmaceuticals

Much of Oklahoma’s $572 Million Opioid Case Likely to Be Replicated Elsewhere, But Unique Cause of Action May Not

On August 26, 2019, Cleveland County, Oklahoma, District Judge Thad Balkman delivered his highly anticipated ruling in the state of Oklahoma’s lawsuit against certain pharmaceutical companies responsible for manufacturing and marketing prescription opioid medications. Because the other pharmaceutical companies named in the state’s case settled with the Attorney General’s Office earlier this year, Johnson & Johnson and its subsidiary Janssen Pharmaceuticals remained the primary subjects of the evidence at trial and the focus of the attention surrounding Judge Balkman’s then-forthcoming ruling.

As Judge Balkman stated in the published judgment, the defendants knowingly and misleadingly marketed their highly addictive prescription opioids, and by doing so caused harm for which the state could seek redress, as their “actions annoyed, injured, or endangered the comfort, repose, health or safety of Oklahomans.”

View the full Alert on the Duane Morris LLP website.

CDER’s New MAPP on Risk-Based Site Selection Model for Routine Inspections

The Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) published a new Manual of Policies and Procedures (MAPP) for the Site Selection Model (SSM) used to prioritize manufacturing sites for routine current good manufacturing practice inspections. As in the past, FDA will use a risk-based approach to inspections of both domestic and foreign drug establishments in order to promote parity in inspectional coverage (i.e., equal frequency for sites with equivalent risk regardless of geography or product type) and effective and efficient use of FDA’s resources.

We invite you to read the full text of this Duane Morris Alert on the firm website.