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This post is from the non-Reed Smith side of the blog.

Today’s case – Bernasek v. Gatz, 2021 WL 2152968 (Fla. Cir. May 20, 2021) – doesn’t exactly break new ground.  But it does support that all of the federal courts to rule on parallel violation claims under Florida law are getting it right.  And “all” in this case is not an insignificant number.  You can check out our 50-state survey on FDA-based failure-to-report claims and our PMA preemption scorecard for a wealth of Florida cases on this issue.

The reason for this wealth of excellent law from the Sunshine State is that Florida simply does not allow parallel claims because they are improper private enforcement of the FDCA without state-law sanction.  Bernasek is a prime example of Florida’s embracing the FDCA’s “no private right of action” provision.  Id. at *2.  Plaintiff’s injuries were allegedly caused by defendant’s implantable spinal cord stimulator.  The claims were strictly for failure to warn of the increased risk of bleeding if the patient is taking anticoagulants.  Id. at *1.  Applying the traditional Riegel analysis, the court first held that any failure to warn claim not based upon a violation of a federal regulation was preempted.  Id. at *3.  In other words, traditional state-law failure to warn was gone.  Defendant’s warnings were dictated by its PMA.

But the complaint also alleged failure to warn claims based on a failure to report adverse events and other scientific information to the FDA, failure to update warnings through FDA procedures, and failure to conduct risk analyses.  Id. at *4.  But none of those things are required by Florida state law.  Rather, “such conduct implicates violations of [defendant’s] obligations to the FDA, enforceable only by the FDA, and is therefore impliedly preempted.”  Id.   Where the allegedly breached duty is one owed to the FDA and the theory of liability is not one traditionally recognized under state law, the claim is preempted. Id.  (citing Mink v. Smith & Nephew, Inc., 860 F.3d 1319 (11th Cir. 2017)).  As noted above, the court could have cited many more cases.  But we too returned to our prior post on Mink and could not help but pause over what we had to say over five years ago:

the parallel claim exception under Riegel is perplexing, and it has led to a plaintiff-run nonsense factory. If courts would shut it down, plaintiffs would stop trying to cobble together specious parallel claims, courts could stop wrestling with the issue, and we could (happily) stop blogging about it.

Unfortunately, Bernasek, therefore, also stands as proof that courts have not shut it down, plaintiffs still cobble together specious parallel claims, courts are still wrestling with the issue, and we are still blogging about it.   At least today we are happily blogging about a state that keeps getting it right.