Drugs

Another Failure-to-Update Case Preempted

An Alabama federal court has dismissed a case charging that Wyeth failed to update labeling for its generic metoclopramide. Writing in an online blog post, attorney James Beck says that the plaintiff alleged that for a period of several months in 2004-05, the company did not include the latest in a number of FDA-approved labeling revisions. The period overlapped briefly with the allegedly injured plaintiff’s use of the drug. “So there is a short period,” Beck says, “where it is temporally possible that a prescribing physician could have acted on the basis of un-updated labels.”

But he notes that temporality of use is not enough to establish causation, particularly in a case such as this that turns on information. “Plaintiff’s own allegations were incompatible with causation, because the doctor in question didn’t even prescribe generic metoclopramide,” Beck writes. “Instead, the doctor’s prescription was for the branded drug, and generic substitution came later.”

The court noted that the labeling for the branded product contained the updates that the plaintiff said were missing from the generic label. “Thus,” the court ruled, “[plaintiff’s] doctors had already gleaned ‘substantially the same’ knowledge about the effects of using [the drug] from the 2004 updates to the [branded] label that they would have gained from an identical update to the labels of the generic version of the drug.”

Plaintiff’s claims for failure to add warnings and failure to send reminder Dear Doctor letters were also preempted, Beck says. And a fraud claim wasn’t pleaded with specificity. He says the decision “is further confirmation that the other side’s duty-to-update ruse to avoid preemption is hardly worth the candle. Even if they beat preemption, the claim itself is worthless. Most doctors never see generic labeling at all, particularly those who prescribe the branded product subject to pharmacy substitution. As we’ve discussed at great length, failure to read the allegedly inadequate label is fatal to causation in a warning case.”

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