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Only 37 days until this blogger heads back to her home away from home—Key West.  My last trip to the island having ended exactly 105 days ago.  So, as we were divvying up this week’s cases, it was a no brainer that I chose the case regarding whether the Lower Keys Medical Center in Key West could be held strictly liable as a seller of medical devices.  Of course, the answer is no.  We even have a 50-state survey on the issue.  But before turning to the case, I feel uniquely qualified to offer some Key West knowledge.  Definitely go to Hemingway’s house and see the 6-toed cats.  They do a nice tour.  Everyone will tell you the best snorkeling is out at the Dry Tortugas, but there are lots of sandbars around the main island with some really beautiful scenery.  Don’t forget aqua shoes!  The Key West Butterfly Conservatory is an oasis right downtown.  Kermit’s for key lime.  El Mason de Pepe for Cuban food.  B.O.’s Fish Wagon for conch fritters (don’t let it’s funky style scare you away).  Willie T’s for mojitos.  Cuban Coffee Queen for coffee. And just about anywhere for live music (some of my favorites play at Irish Kevin’s, including Irish Kevin himself)! 

Now, back to In re Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation, 2022 WL 4781952 (S.D. Ohio Oct. 3, 2022) and the Lower Keys Medical Center.  The allegations are simple.  Plaintiff underwent surgery to repair a hernia.  His surgeon implanted surgical mesh to make the repair.  Plaintiff suffered complications and had to have a second surgery to remove the device.  And then plaintiff sued the hospital where his surgery occurred not for medical malpractice but for strict products liability.  The law is pretty clear that a hospital cannot be strictly liable for claimed defects in drugs and medical devices that are used in medical procedures within its walls.  And plaintiff here did not do a particularly good job of distinguishing his claims from the precedent.  But the court’s explanation is spot on. 

The court’s analysis starts with a lengthy list of cases that stand for the proposition that hospitals are not sellers engaged in the business of selling medical devices “used in the course of their primary function of providing medical services.”  Id. at *2.  Therefore, plaintiffs cannot invoke strict products liability against hospitals.  The appropriate cause of action against a hospital is medical malpractice. 

In the face of overwhelmingly pro-defense precedent, plaintiff tried to distinguish his case from cases where the device at issue was used in the surgery but not transferred to the plaintiff (like a grounding pad or cauterizing tool).  Or, from cases where the surgery could not have been done without the device.  Plaintiff argued his surgeon could have repaired his hernia without using mesh at all.  Id. at *3.  However, the court could not ignore that regardless of the precise situation or product at issue, “a physician is exercising his or her professional judgment in determining what medical procedure to perform and then in selecting the appropriate product to utilize in connection with the procedure.”  Id.  Therefore, any “sale” of the device is secondary to the exercise of the physician’s professional medical judgment.  That was certainly true in this case where the “predominant purpose” of the surgery was to repair plaintiff’s hernia.  In the course of which, plaintiff’s surgeon exercised his professional medical judgment to determine how best to achieve that purpose.  Therefore, the selection of the mesh was “integrally related t the professional services and skills of providing and facilitating the surgery offered by [Lower Keys Medical Center].”  Id. at *4. 

Plaintiff’s only other argument in response was that his complaint could not be dismissed under Rule 12(b)(6) because it alleges that the hospital was a seller and the court it required to accepted as true all well-pleaded allegations.  Plaintiff, however, forgot that that rule only applies to well-pleaded factual allegations—not legal conclusions.  Id. Plaintiff made the same argument trying to save his breach of implied warranty claim; that the court had to accept his legal conclusion that he was in contractual privity with the hospital.  Id. at *5.  That argument failed for the same reason.  Plaintiff also tried to argue that under Florida law breach of implied warranty claims are not limited to sellers but have been extended to lessors.  But just as plaintiff did not buy the mesh from the hospital, nor did he rent or lease it.  Id. 

Plaintiff’s final claim was for negligent misrepresentation.  Plaintiff failed to include in his complaint a single specific misrepresentation made by the hospital and relied upon by plaintiff to his detriment.  The entirety of his claim was “a conclusory recitation of the elements of negligent misrepresentation without any supporting facts.”  Id. at *6.  And like his other legal conclusions, the court was not obligated to accept them as true.

Also pending was plaintiff’s motion to remand based on lack of diversity between himself and the medical center.  Really, that’s the beating heart of these types of claims.  Plaintiffs looking for a wait to beat diversity and stay in state court.  So, with the state law restrictions on medical malpractice claims, it is important that courts continue to keep the door closed and locked against hospital products liability claims. 

And if you happen to find yourself in Key West and looking for some other offbeat things to do – the Key West Cemetery is equally creepy and quirky.  Books & Books is a cool indy bookstore co-founded by author Judy Blume, who has been known to drop in.  Or have lunch at the spot where Pan Am was founded before checking out the local art scene.