Tag Archives: justin stern

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.

OTC Personal Products Manufacturer Cited by FDA for Various Regulatory Violations

On August 20, 2019, the U.S. Food and Drug Administration announced that it had sent and posted a warning letter to an over-the-counter drug manufacturer citing “significant” violations of current good manufacturing practice (CGMP) and also issued a news release in connection with this letter. The letter was sent to NingBo Huize Commodity Co., Ltd., a China-based manufacturer of health and beauty products such as sunscreen lotion, shampoo, hand sanitizer and lip balm, following FDA’s inspection of the facility in March 2019. In particular, the warning letter, and concurrent press release and import alert, show that FDA continues to have significant concerns related to data integrity and will harshly sanction companies that falsify data.

View the full Alert on the Duane Morris LLP website.