Tag Archives: Dana Ash

Spate of FDA and FTC Warning Letters Sets Stage for Wave of False Advertising Consumer Class Action Lawsuits

Since the 2018 Farm Bill passed in December 2018, removing hemp from the Controlled Substances Act and thus legalizing it under federal law, consumer goods containing the hemp-derivative cannabidiol (CBD) have become exceptionally popular. With that growing popularity among consumers has come increased scrutiny by federal regulators whose mission is consumer safety and protection, such as the Food and Drug Administration and Federal Trade Commission, and now by the plaintiffs’ bar, which files consumer class actions based on advertising. As the recent spate of warning letters and consumer class actions demonstrate, hemp-derived CBD product manufacturers and others in the supply chain for those products have to be mindful of the claims they make to consumers about their products.

View the full Alert on the Duane Morris LLP website.

FDA Proposes Labeling Recommendations for Complications Linked to Breast Implants

On October 24, 2019, the Food and Drug Administration (FDA) announced new draft guidance entitled “Breast Implants—Certain Labeling Recommendations to Improve Patient Communication.” The draft guidance “contains recommendations concerning the content and format for certain labeling information for saline and silicone gel-filled breast implants.”

In its announcement, FDA noted that it has received “new information pertaining to risks associated with breast implants, including breast implant-associated anaplastic large cell lymphoma” and additional illnesses attributed to breast implants. Complications related to breast implants have been widely reported over the last year, with other symptoms, including increased presence of autoimmune disease in women who have received breast implants, as well as muscle and joint pain, fatigue and weakness, and certain cognitive difficulties. These proposed labeling requirements also follow FDA warnings issued to two implant manufacturers who had failed to carry out adequate postmarket surveillance of the implants as a condition of their approval, as well as an FDA request that another manufacturer recall certain textured breast implant products.

View the full Alert on the Duane Morris LLP website.

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.