We’ve read Phelps v. Wyeth Inc., No. 09-6168, slip op. (D.Or. April 2, 2013) (also at 2013 WL 1403060). In general, Phelps is another rather dismal Fulgenzi-type decision holding involving metoclopramide and holding both that failure-to-update claims are not preempted (expressly or impliedly) and state a state-law cause of action. It’s not good news for generic manufacturers who don’t keep up with their FDCA “sameness” requirements, but in the larger scheme of things it’s not a claim that should recur (now that generic manufacturers fully grasp the post-Mensing litigation importance of carefully maintaining their “sameness”), nor is it one that is likely to spread (since “sameness” is not an attribute of branded drugs or PMA devices – or products generally). But there is another aspect of Phelps that we found interesting, the discussion of off-label use. The narrow view that Phelps takes of off-label use could be instructive, certainly in Pain Pump litigation and perhaps elsewhere. Phelps holds that, if the FDA-approved label does not specifically exclude a use in its description of the product’s indications/“intended uses,” then that use isn’t off-label use at all. Here’s what brought that about.
In Oregon, apparently (we’re going solely on the description of general Oregon law in Phelps) a plaintiff has to offer affirmative evidence that the product is “unreasonably dangerous for its intended use” in order to overcome a state-specific statutory presumption. Phelps, slip op. at 27 (quoting statute). Something more than the mere presence of a defect is required. Id. The generic defendant in Phelps claimed that the plaintiff couldn’t overcome the presumption because the product was being used off-label, rather than as “intended.”
What? You didn’t think that Phelps would be doing defendants any favors (at least intentionally), did you?
Phelps rejected the off-label use argument because the product’s labeling – which hadn’t been updated to include the FDA’s specific new language about “12 weeks” as the limit for using the product – wasn’t specific enough to make the off-label nature of longer term use evident to the reader:
In 2004, the warning labels on the name-brand version of [drug], were changed to include a specific warning against using the drug for more than 12 weeks. . . . Plaintiffs present evidence, however, that [defendant] failed to update its label to match the new warning. Thus, [plaintiff’s] use of [defendant’s] product for more than 12 weeks during the time that [defendant’s] label was not updated cannot be considered an “off-label” use, as the label provided on [defendant’s] product did not describe such a limitation on use.
Phelps, slip op. at 27-28 (quotation of 2004 label omitted) (emphasis added). Rather, the label’s actual (unupdated) language was too vague to create an off-label use:
The record indicates that the [prior] name-brand label included only an indication that the drug was a short-term therapy, but did not include any express time limitation. Thus, the label was strengthened [subsequently] to include a limitation on use that was not previously there.
Id. at 28-29.
So if the product’s previously approved label isn’t specific enough to alert the reader that a particular use is off-label, then there’s no off-label use at all. Indeed, in Phelps even the prescriber’s admission at his deposition that his prescription was “off-label” wasn’t sufficient evidence of “intended use,” since the prescriber only gave this testimony after being shown the updated labeling. Id. at 28.
Back in our Bone Screw days some of defendants’ screws had labeling that described them as being “for fractures,” because that’s how the FDA had cleared them for labeling and marketing. Under the reasoning in Phelps, because “fractures” literally encompasses all fractures, including those of the spine, then spinal use wouldn’t be considered “off-label,” even though the FDA initially (it later reversed itself) refused to clear marketing with a specific spinal indication. Pain Pump litigation sounds similar – the indicated use for these products was “joints” generally, but plaintiffs allege use in the shoulder joint is off-label because the FDA didn’t clear the product specifically for that use.
Not so under Phelps. Even more than “short term” doesn’t necessarily exclude more than 12 weeks, “joint” includes all joints.
What’s sauce for the goose should be sauce for the gander. If defendants are held to the literal scope of labeled indications, then so should plaintiffs.
The way the plaintiffs threw around “off-label” allegations in Bone Screw always bothered us. Some defendants sold screws that were labeled for “long bone” use – which clearly made spinal implantation an off-label use. But for other defendants’ screws cleared for “fractures,” we never did think that the off-label use allegations were valid as applied to spinal fractures.
But back then, we didn’t have anything to cite for the proposition that anything that can reasonably be read as coming within the indications on the product label can’t be “off-label” use – or, conversely, that “intended use” encompasses a fair reading of the labeled indications.
Now we do.