[Drug and Device Law] How Easy Is It to Allege Proximate Causation in a Medical Device Case
This post comes from the Cozen O’Connor side of the blog, not the Reed Smith side.
Last July, in the Tapia v. Davol, Inc. hernia patch case, Davol won its motion to dismiss the plaintiff’s failure to warn claim. 2015 U.S. Dist. LEXIS 98521 at *16-17 (S.D. Cal. July 28, 2015). The court was clear on why. While plaintiff alleged facts on what was supposedly missing from the warnings, he alleged no facts suggesting that his own doctor didn’t receive a warning or that, if he had, he would not have prescribed the patch to plaintiff. In other words, plaintiff did not allege facts to suggest proximate causation. The court was explicit:
As to Defendant's second argument regarding causation, while Plaintiff alleges the specific defect in Defendants' product and specific warnings they failed to provide, he does not allege that Defendants failed to warn his own prescribing physician and that his own physician would not have used the Patch if warnings had been given.
Id. at *16-17. Allegations about “‘physicians’ in general and the ‘healthcare community’” didn’t provide facts to suggest the existence of proximate causation. Plaintiff needed to allege “facts as to his own prescribing physician.” Id. at *17.
Little did Davol know how specific the court was being. In particular, when the court wrote that plaintiff must allege a failure to warn “his own prescribing physician and that his own physician would not have used the Patch,” it meant just that. Literally. Invoke those words. And no more.
So, next time around, plaintiff’s failure to warn allegations did just that. Plaintiff replaced “physicians” and “healthcare community” with “his prescribing physicians” and “his healthcare providers.” Tapia v. Davol, Inc., 2015 U.S. Dist. LEXIS 151168, at *15 (S.D. Cal. November 6, 2015). That’s it. Voila! Somehow those stock words made the existence of proximate causation more plausible—the TwIqbal standard—than it had been in his first complaint:
Here, the FAC has changed the references of "physicians" and "healthcare community" to "his healthcare providers” . . . and "his prescribing physicians.” As to a failure to warn, the FAC alleges that Defendants failed to warn his own prescribing physician and that his own prescribing physician would not have used the Patch if warnings had been given. . . . These allegations have been deemed sufficient on a motion to dismiss. See Baker v. Bayer Healthcare Pharms., Inc., No. C13-490 TEH, 2013 U.S. Dist. LEXIS 179131, 2013 WL 6698653, at *5 (N.D. Cal. Dec. 19, 2013).
Id. at *15-16.
The court allowed a number of other claims to go forward (expect fraudulent misrepresentation), but our focus is the court’s treatment of these two sets of failure to warn allegations. Had the court allowed the failure to warn claim in the first complaint go forward, we might not have loved it, but we wouldn’t have blinked.
Together, however, these two decisions signal something different. They suggest the days in which a plaintiff need only invoke magic words to plead key elements of a claim. That’s something that TwIqbal eliminated. There must be actual facts alleged that make elements of the claim plausible. In a medical-device product-liability complaint, pleading “my physician wasn’t warned and if he had been he wouldn’t have prescribed the device” is no different from pleading the words “proximate causation exists.” The latter phrase is deficient, and so too should be the first.
So we’d like to think that there was more to the court’s decision than meets the eye. Maybe the court believed that the balance of the factual allegations in the complaint made it plausible that the treating doctor was not warned and would have acted differently if he had been. While we might disagree with that reasoning, at least its reasoning based on factual allegations, not stock phrases. Of course, if the court had believed that, it should have upheld the failure to warn claim in the first complaint.
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Posted By John J. Sullivan to Drug and Device Law at 11/16/2015 12:27:00 PM --
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