Summary Judgment for Drug Manufacturer Reversed

Hmm.  Summary judgment for a drug manufacturer is reversed?  In the 21st Century?  In Federal Court?   Now, that is something worth writing about.

In McNeil v. Wyeth, No. 05-10509 (August 22, 2006) the Fifth Circuit Court of Appeals faced an appeal after summary judgment was granted in favor of the manufacturer of Reglan, a drug used to treat gastroesophageal reflux disease (GERD).  The plaintiff had taken the prescription drug for multiple months over the 12 weeks approved by the FDA; each time the drug was ordered by a physician.  McNeil developed  Reglan-induced  tardive dyskinesia in addition to Reglan-induced extrapyramidal symptoms (EPS). 

She sued, alleging that "Wyeth had failed adequately to warn physicians and consumers of the increased risk of tardive dyskinesia that  accompanies long-term use of Reglan. McNeil  argued that Wyeth’s failure to warn rendered the inherently unsafe product unreasonably dangerous. Further, McNeil alleged that the Reglan label was misleading as to the risk of tardive dyskinesia and failed adequately to warn about the increase in risk associated with exposure to the drug for more than twelve weeks."  The lower court found the label adequate and dismissed the case.

The appellate court reversed; its opinion included the following:

(a)  "Warning the learned intermediary of a much lower risk than the actual risk could render the warning not just misleading, but ineffective.  When the risk described on the label is so low as to induce a doctor to undertake the risk, had he not done so if he were warned of the real risk, we cannot say that no reasonable jury could conclude that a warning was inadequate. Thus, if the manufacturer decides to label a risk as “comparatively rare” and also to provide a numerical quantification of that risk, that number must be within a certain degree of accuracy."

(b) "Wyeth argues that it does not have a duty to warn about risks of use longer than twelve  weeks because the label clearly states that the drug is indicated for treatment for no more than that duration. Thus, not only would such a warning be superfluous, but it would also be improper, because Wyeth allegedly cannot tell a medical professional how to exercise professional judgment on whether a drug should be  used longer than the period approved by the FDA. We disagree.  … Because the widespread long-term use of Reglan suggests that Wyeth’s indication for use for no more than twelve weeks was widely disregarded, a jury could infer that Wyeth’s warning was ineffective and thus inadequate. Therefore, McNeil’s suggested additional warning about long-term use would not be superfluous. Moreover, the FDA regulations require a manufacturer to inform a medical professional
precisely how to exercise his professional judgment in certain circumstances."

(c) "Wyeth argues, however, that it was not required to update its label, because the studies indicating that the risk for long-term use could be a hundred times higher showed mere association
with a disease, not necessarily causation. Thus, Wyeth argues, because there could be a variety of other factors responsible for the “association” found in these studies, that association does not necessarily require a warning to physicians. This argument, however, is contradicted by the FDA regulations that require that the labeling “be revised to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved.” 21 C.F.R. § 201.57(e) (emphasis added by the court).

And there’s more – but you get the general idea.

If you try to take on a drug company on a failure to adequately warn of the risk of injury you need to read this opinion.

The folks with Vioxx cases will love this one.

Read it here.