Photo of Michelle Yeary

This post is not from the Reed Smith or Holland & Knight sides of the blog. 

Sometimes the intersection of the law and the facts are simply undeniable. Such was true of the fourth bellwether case selected in the Bard hernia mesh MDL–Bryan v. C.R. Bard, Inc., 2024 WL 385108 (S.D. Ohio Feb. 1, 2024). It was undeniable that the implanting surgeon did not rely read any warning from the manufacturer or rely on any representation from the manufacturer. It was undeniable that Florida law embraces the learned intermediary doctrine. It was undeniable that Florida requires privity for breach of warranty claims. It was undeniable that Florida does not allow products liability claims for intentional infliction of emotional distress. So, it was undeniable that the court should grant summary judgment on all these claims.

In 2012, Plaintiff underwent laparoscopic surgery to repair an inguinal hernia that included implanting defendant’s hernia mesh product. The mesh remained in place until plaintiff underwent a partial explant in 2017, where the explanting surgeon noted “no obvious signs of an abnormality.”  Id. at *3. Plaintiff alleges he continued to suffer pain and so filed suit seeking damages based on a myriad of causes of action. The court deferred ruling on certain claims, but on those it did entertain it granted summary judgment.

On failure to warn, the court determined it did not have to decide the adequacy of the warning because plaintiff failed to establish warning causation which required plaintiff show that his physician would have chosen not to use the product if he had received different warnings. Here, plaintiff’s implanting surgeon testified he did not rely on the product’s Instructions for Use (IFU) in deciding to use the mesh. In fact, he had never even seen it. Id. at *6. While plaintiff tried to rely on out of state cases to suggest that failure to review the IFU was not dispositive, the court deferred to the numerous Florida federal courts that ruled just the opposite. Id. Nor did the court find persuasive cases in which other courts left open the possibility that the treating physician may have at some time reviewed the IFU because here the surgeon’s testimony left no room for doubt.  He’d never read the IFU; never seen it.  He didn’t rely on it and if it contained different information, it would have made no difference to him.  Id. at *7. 

Plaintiff’s negligent and fraudulent misrepresentation claims suffered from a similar fatal deficiency.  Florida law requires not only a misrepresentation, but reliance on the misrepresentation resulting in injury.  Once again, plaintiff’s implanting surgeon was clear.  Not only did he not rely on the IFU, he did not rely on anything said to him by defendant’s sales representatives.  His decision to use defendant’s mesh was “absolutely” his own clinical judgment. Id. at *8. Sales representatives have “zero influence” in his clinical decisions. Id.

To bring a breach of warranty claim under Florida law, the plaintiff must be in privity of contract with the defendant. Id. at *9. Plaintiff, relying on one federal case from 2021, tried to argue that as the third-party beneficiary of defendant’s warranties, he had a valid claim. The court quickly pointed out that plaintiff’s lone precedent was an outlier and that the majority of Florida federal courts since have ruled differently.  Absent privity, plaintiff could not maintain his warranty claims.

Finally, plaintiff tried to argue that defendant’s failure to warn of known risks was so “extreme and outrageous” to justify a claim for intentional infliction of emotional distress. Not only did plaintiff have no case law to support his failure to warn turned intentional infliction claim, but the court also found plaintiff offered no evidence that defendant’s conduct rose to the level of outrageousness required by Florida law.  The court did not address that the product was cleared by the FDA, but that fact alone should defeat the extreme mental state required of defendants in intentional infliction of emotional distress cases.

No reliance, no privity, and no outrageous conduct—a trifecta we’ll laud any day.