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# Another Failure-to-Update Case Preempted
- URL: https://www.fdaweb.com/another-failure-to-update-case-preempted/
- Published: 2016-05-17T12:00:00.000Z
- Updated: 2026-09-14T21:03:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135690

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](http://www.lexology.com/library/detail.aspx?g=1dc71818-84e5-4ae0-903c-deb057773628&ref=fdaweb.com), 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.”