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Johnson v. Hologic, Inc., 2015 U.S. Dist. LEXIS 1105 (E.D. Cal. Jan. 5, 2015) is a case brought by a pro se plaintiff alleging she was injured by a mammography machine which happens to be a Pre-Market Approved, Class III medical device.  Given that even the best of plaintiffs’ counsel have difficulty putting together a claim that fits through the “narrow gap” of express and implied preemption in a PMA medical device case, pro se plaintiff Johnson certainly had her work cut out for her.  For a pro se case, the opinion is actually fairly detailed, including a nice description of the MDA regulatory scheme that governs PMA devices and the preemption of state law claims that flows from it.  Id. at *7-9.

It also seems that plaintiff did do some homework before she filed her complaint because she attempted to plead a Stengel failure to report adverse events claim.  Id. at *9.  Where plaintiff’s claim fell apart, however, was her failure to plead sufficient facts to support a causal nexus between the alleged failure to report and her alleged injuries.  That’s because the adverse event plaintiff alleged defendant failed to report was the incident involving plaintiff.  And, as the court correctly noted:

Any failure to report this particular adverse event to the FDA could not have caused the injuries alleged in the first amended complaint because it was necessary for plaintiff’s injuries to have occurred before defendant’s duty to report that event could arise.

Id. at *10.

We don’t expect to see this argument that often (or ever again).  But, it is a good reminder that if you are in a jurisdiction that recognizes a Stengel-claim, causal nexus shouldn’t be overlooked.  What is plaintiff alleging defendant failed to report to the FDA?  Did the events take place before the incident involving plaintiff?  Did they occur substantially enough before plaintiff’s incident to have possibly effected a change to the device before plaintiff used it?  If not, can the failure to report really be a cause of injury?  Did the incident involve the same medical device?  And when we say “same” we mean “same.”  Not substantially similar, not a similar model, not another generation of the device – the same device.  Allegations about adverse events involving a different device should not meet the causal nexus requirement.  Was the injury the same?  “Same” here might not be quite as strict as when talking about the device, but it should have to be in the ballpark to count for causation.

In Johnson, the court found no allegations “that the defendant failed to report to the FDA the occurrence of similar adverse incidents that occurred prior to her use of the machine.”  Id. at *12.  As that was the only possible parallel violation claim that plaintiff pleaded, her case was dismissed.  We give plaintiff a nod for getting even this far on her own and a nod to the court for authoring a solid decision.