Drugs

Oklahoma Court Overturns J&J Opioid Case Ruling

The Oklahoma Supreme Court has overturned a lower court’s $465 million opioid ruling against Johnson & Johnson, saying the lower court wrongly interpreted the state’s public nuisance law. The Associated Press reports that public nuisance claims are at the heart of about 3,000 suits brought by state and local governments against drug manufacturers, distributors, and pharmacies. The wire service says it is unclear whether the legal theory is in trouble since this was only the first case of its kind to go to trial.

In a 5-1 decision, the high court said the lower court “has allowed public nuisance claims to address discrete, localized problems, not policy problems. J&J had no control of its products through multiple levels of distribution, including after it sold the opioids to distributors and wholesalers, which were then disbursed to pharmacies, hospitals, and physicians’ offices, and then prescribed by doctors to patients.” The ruling also found that the company had no control over how patients used its products.

The court acknowledged the suffering faced by thousands of Oklahomans due to opioids but said the question before it was whether the company’s marketing and sale of opioids created a public nuisance.

“J&J no longer promotes any prescription opioids and has not done so for several years,” Justice James Winchester wrote for the majority. “Even with J&J’s marketing practices these … medications amounted to less than 1% of all Oklahoma opioid prescriptions.”

The state government, which wanted to use the lower court’s financial award to fight the opioid crisis, had asked that the $465 million in damages be increased to $9.3 billion. The court also rejected that request. The dissenting justice on the panel said he would uphold the verdict but send the case back to the district court to recalculate the damages award.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome