Drugs

Old Court Case Scores Preemption Win

A 2014 Georgia federal court decision gave Sandoz a win on a variety of preemption defenses in a failure-to-warn case, according to attorney John Sullivan (Cozen O’Connor). Writing in the Drug & Device Law blog, Sullivan says he only recently became aware of the case, which “hits on many of the effective defenses sometimes available to defendants on motions to dismiss.”

The case involved plaintiffs’ state failure-to-warn claim on a generic drug, the post says. Since those claims are preempted under the Supreme Court’s Mensing decision, the plaintiffs argued that their claims were not about label content but instead about the company’s failure to follow federal regulations that would ensure that Medication Guides reach patients.

The court first issued a Buckman preemption, saying that there is no private right of action to enforce federal regulations. It also noted that Georgia follows the learned intermediary doctrine and so any warning needed to go to doctors and the fact that patients did not receive a Medication Guide is irrelevant.

The plaintiffs also claimed that the company engaged in inaccurate off-label promotion and that such an off-label promotion claim is not preempted. But the court saw this allegation as a “failure-to-warn claim in different clothing,” Sullivan says, and dismissed it as preempted.

Finally, Sullivan writes, the court saw the futility of all the claims and denied the plaintiffs’ request to amend the complaint.

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