One way that some plaintiffs seem to be responding to TwIqbal is simply to make up the facts needed to plead a plausible claim.  That happened in Cornwell v. Stryker Corp., 2010 U.S. Dist. Lexis 116824 (D. Idaho Nov. 1, 2010).  Cornwell involved a PMA medical device (a total hip implant), so obviously preemption was going to be a big deal.  The only way to get around preemption is to allege a “parallel” state-law claim based upon an FDCA violation.  Some of these devices were made at a particular overseas plant and were subject to an FDA recall.  Others were not.

The plaintiff in Cornwell had no factual basis to believe that his implant was one of those recalled – but went ahead and pleaded it anyway.  That led to something that has us scratching our heads a bit as to how it happened – discovery in the context of a Rule 12 motion to dismiss.  We didn’t know you could do that.

Anyway, according to the opinion, “[d]iscovery completed in this matter has now established the [device] in Plaintiff was not manufactured in [the overseas plant] and was not the subject of any recall or other regulatory action.”  2010 U.S. Dist. Lexis 116824, at *1-3.

Because of that, the plaintiff’s case was held preempted.  We’ve put the case on our device preemption scorecard, but it’s hardly the first to address this device or this recall.  That would have been it, but for this footnote:

Defendants argue Plaintiff’s counsel should be subject to Fed. R. Civ. P. 11 sanctions for failing to dismiss this claim once documentation was provided the medical device at issue had not been manufactured at the [overseas] facility.  The Court agrees counsel for the Plaintiff should have acknowledged the undisputed facts and provided notice to the Court regarding Plaintiff’s position due to changes to the factual basis for the parallel claim argument, but the Court declines to award Rule 11 sanctions in this matter.

2010 U.S. Dist. Lexis 116824, at *10-11 n.1.

We say good for the defendants for seeking Rule 11 sanctions – and phooey on the court for not awarding at least a symbolic $1.  The plaintiff plainly had violated the rule by not investigating the allegations he made, and they were conclusively proven to have no basis in fact.  Still the plaintiff didn’t withdraw them – forcing the defendant to go through with its motion and the court to write an opinion dismissing the case.  TwIqbal won’t mean anything if plaintiffs are simply allowed to make stuff up without suffering any consequences.