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When is a warning not a warning?  Apparently when it’s given in Wisconsin.  Here are the facts which led to the denial of summary judgment in Platten v. Dean Health Plan, 2023 WL 1820994 (E.D. Wis. Feb. 8, 2023).  Plaintiff had hip replacement surgery in 2011 with a ceramic-on-ceramic hip replacement system. In 2017 she had to have revision surgery due to a fracture of one of the ceramic components.  Plaintiff’s surgeon opted not to remove the whole system but to replace the fractured components with metal components.  Following that surgery, plaintiff suffered from metal poisoning and which caused additional complications and necessitated further surgery.  Id. at *1.

In 2016, a year before plaintiff’s revision surgery, the defendant manufacturer published a surgical technique brochure that warned “against the use of a metal . . . component for a revision surgery that was necessitated by the fracture of a ceramic component” due to the risk of “accelerated wear and reduced implant life.”  Id. at *2.  Also in 2016, defendant issued an Advisory Notice “which advised against the use of metal . . . components during a revision surgery for a fractured ceramic component.”  Id. at *3.  Plaintiff’s implanting surgeon testified that he did not review either of those documents, nor did he read or rely on the Instructions for Use (IFUs) that accompanied the device.  Id.  Plaintiff’s sales representative testified that he spoke to plaintiff’s surgery before the operation and he also advised against a partial revision in this situation.  Plaintiff’s surgeon denied the sales rep told him that.  Id. Plaintiff’s surgeon also testified that he took the risk of metal toxicity into account when deciding what components to use in the revision surgery.  Id.

So, the manufacturer issued multiple warnings advising surgeons not to perform the type of revision surgery plaintiff’s surgeon performed.  Plaintiff’s surgeon did not rely on any manufacturer warnings in reaching his medical decision and even if a different warning was provided, the surgeon would not have seen it because he does not read the IFUs.  And, plaintiff’s surgeon was aware of and considered the risk of metal toxicity in reaching his independent medical decision to proceed with using the metal components.

This should have been a textbook fact pattern for summary judgment on learned intermediary causation.  Instead, after summary judgment plaintiff ended up with her case moving forward on causes of action she didn’t even plead.

Plaintiff brought breach of express and implied warranty claims.  Wisconsin law requires privity for warranty claims.  Since plaintiff did not purchase the medical device from defendant, there was no privity and therefore, no breach of warranty claims.  Id. at *5.  But that was not the end of analysis.  Plaintiff argued that her breach of implied warranty claim should be recognized as a product liability claim.  She did not ask to amend her complaint.  Just that the court should read into her existing complaint a non-pleaded strict liability failure to warn claim.  The court agreed.  “Having specified the harm done to him, a plaintiff may substitute one legal theory for another without altering the complaint.”  Id. (citations omitted).  I can’t substitute mushrooms for peppers on a western omelet at my favorite diner, but plaintiffs can swap out causes of action as they choose to avoid summary judgment?  The court allowed the substitution because the allegations in the complaint “narrate a claim” that defendant failed to warn.  While plaintiff’s allegations may include failure to warn, the time for them to bring a failure to warn claim has likely long passed given we are at the summary judgment stage.  That is not the first time for a defendant to learn that plaintiff is proceeding under a completely different legal theory.

Based on the above facts, swapping failure to warn for breach of warranty should have been a matter of form over substance.  The warning was given, it was not relied on by the surgeon, and he had independent knowledge of the very risk plaintiff suffered.  The court saw it differently accepting plaintiff’s challenge to both the adequacy of the warning and the adequacy of its distribution.  Id. at *7-8.  Adequacy should not have mattered in a case where the surgeon did not read the warning and in fact never read IFUs. 

Presumably because of the uncertainty over the learned intermediary rule in Wisconsin, it has not yet been considered by the state’s highest court, defendant also raised the sophisticated user doctrine – no duty to warn members of a profession about a danger known generally in the profession.  Id. at *8.  Again, plaintiff’s surgeon testified he considered metal toxicity among the risks of the revision surgery.  But the court found there was a question as to whether he was aware of the “increased risk” when metal was used following ceramic failure. 

Defendant, of course, argued a lack of causation based on plaintiff’s surgeon lack of reliance on or even reading of any of defendant’s warnings or labeling and his testimony that he performed the surgery based on his own experience and training.  In other words, nothing defendant did or did not do would have changed the outcome.  

As for the surgeon’s conversation with defendant’s sales representative, he testified both that he did not recall having the conversation and that the sales representative never conveyed the warning.  Well, which is it?  Generally, if I don’t recall a conversation I find it difficult to refute what was or was not conveyed in that conversation.  However, the judge here has given us all a new precedent to cite the next time someone (perhaps a spouse) claims he both does not recall you telling him what time the appointment was and is simultaneously 100% sure the actual time of the appointment was never provided because otherwise he would have shown up on time:

Lacking a recollection of a conversation is not inconsistent with being certain specific information was not conveyed if the information allegedly conveyed is such that it would have spurred a reaction.

Id. at *10.

That is both self-serving and circular reasoning and should not have been sufficient to get over the hurdle on summary judgment.  The court seemed swayed by plaintiff’s allegations that defendant could have done more to warn surgeons generally.  But what information is or was provided “generally” has no bearing on specific warning causation.  The totality of the evidence in this case is that plaintiff’s surgeon was provided with multiple warnings that he either failed to read or simply ignored and therefore, the newly created failure to warn claim should have been dismissed for lack of causation.  Here the court was only willing to concede that the surgeon’s possible negligence was a contributing but not a superseding cause. 

A duplicative negligent misrepresentation also was allowed based on the surgeon’s rather than the plaintiff’s reliance.  Id. at *11-12.  But we think you get the idea that we think this claim should also have been dismissed for lack of causation, so we won’t belabor the point or our discussion of this woefully disappointing case any longer.