Drugs

CA Appeals Court Upholds Federal Preemption

The California Court of Appeal has upheld federal preemption in a case involving the heart drug amiodarone. Attorney Steven Boranian (Reed Smith) writes in a Drug & Device Law Blog post that the plaintiffs in the case alleged that they experienced severe effects after their doctors prescribed amiodarone off-label. The plaintiffs said the drug’s branded and generic manufacturers failed adequately to warn plaintiffs of potential risks because they did not ensure that patients received FDA-approved medication guides with their prescriptions.

A California trial court dismissed the medication guide claims without leave to amend their filing, Boranian says, and the Court of Appeal affirmed in a published opinion.

The appeals court said that federal law preempted the plaintiffs’ failure-to-warn claims because the plaintiffs were trying to enforce the Federal Food, Drug, and Cosmetic Act (FFDCA). “There is no private right of action under the FFDCA,” Boranian writes.

He also says the court rejected the plaintiffs’ argument that they were basing their claims only on state law because the drug manufacturers owed the plaintiffs no duty to warn under California law since the state’s learned intermediary doctrine holds that a drug manufacturer’s duty to warn runs to doctors and not directly to patients.

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

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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