Drugs

Appeals Court Remands Elements of Clomid Case

The 10^th Circuit Court of Appeals has remanded to a Utah federal court portions of a failure-to-warn case brought against Aventis over its fertility drug Clomid (clomiphene citrate). The Utah court had granted summary judgment to Aventis on the failure-to-warn, breach of implied warranty, negligent misrepresentation, and fraud claims brought by a couple who said their son was born with birth defects associated with the woman’s use of the drug before she became pregnant.

In granting summary judgment to Aventis, the district court reasoned that FDA would not have approved the type of warning labels the plaintiff couple sought. The appeals court agreed with the district court about a warning about risks associated with Clomid before pregnancy, noting that the agency had rejected a citizen petition making virtually identical claims about pre-pregnancy risks to a fetus.

But it said the district court erred in ruling that federal preemption applied to the claim about a warning for drug use during pregnancy. The claim addressed Utah law, while Aventis made its motion for summary judgment based on federal law.

“The district court did not consider whether it could rest on Utah law when deciding a summary judgment motion that had relied on federal preemption,” the appeals court decision said. “Because the district court did not consider the question and it has not been fully briefed on appeal, we leave this question for the district court to address on remand.”

The court also said that the district court should consider on remand the plaintiffs’ implied warranty, negligent misrepresentation, and fraud claims since they are all distinguishable from the failure-to-warn claims because they are based on “affirmative misrepresentations rather than on a failure to provide a warning.”

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