Tuesday, August 04, 2009

Read The Blog, Luke!

C'mon, guys. We publish this blog for a reason. Pay attention.

We've explained over and over again that plaintiffs often cannot pursue alleged violations of the Food, Drug, and Cosmetic Act under the rubric of negligence per se where "the legislature does not intend for a statute to be privately enforced."

In Pantages v. Cardinal Health, No. 5:08-cv-116-Oc-10GRJ, 2009 U.S. Dist. LEXIS 64238 (M.D. Fla. July 27, 2009), plaintiff sued the manufacturer of a catheter that broke during surgery. Count VI of the Complaint pleaded negligence per se.

Plaintiff moved for partial summary judgment on that count, asserting that exposure to ultraviolet light had caused the catheter to become brittle and break, and defendant had failed to use foil packaging that allegedly would have protected the catheter from that light. Id. at *4.

The defendant moved to dismiss Count VI because the FDA "Device Packaging" regulation that defendant had allegedly violated did not apply to Class I medical devices, such as the catheter. Moreover, the defendant said, plaintiff wasn't entitled to summary judgment because the Device Packaging regulation did not specifically require the use of foil packaging, but rather only packaging that would protect the product from damage during storage.

Defendant did not raise the issue that we always harp on -- that plaintiff could not use an alleged violation of the FDCA as a predicate for a negligence per se claim.

Happily for the defendant, Magistrate Judge Gary Jones saw the issue.

Maybe he reads the blog.

Or maybe he just reads a lot of Florida law.

In any event, Judge Jones addressed the "more fundamental problem with Plaintiff's claim for negligence per se" that the parties had overlooked. Id. at *6. "Under Florida law, the violation of a federal regulation does not create civil liability based upon a theory of negligence per se in the absence 'of a legislative intent to create a private right of action.'" Id. Because there is no legislative intent to create a private right of action under the Device Packaging regulation, "Plaintiff's claim fails to state a cause of action for which relief can be granted because Florida law does not recognize a claim based upon a theory of negligence per se for an alleged violation of this particular federal regulation." Id. at *8.

The court thus dismissed Count VI with prejudice.

The court went on to note that, even if Florida law reognized a claim for negligence per se for violation of this regulation, there were nonetheless "genuine issues of material fact with regard to whether the packaging was compliant with federal regulation." Id. at *9. Thus, plaintiff was not entitled to summary judgment on that issue.

The court chose not to resolve the question whether the catheter was in fact a Class I device to which the Device Packaging regulation did not apply. Id.

We leave you with these words of wisdom for defense counsel:

"Do or do not. There is no try."

Okay, okay. We meant:

Mmm. Lost a planet, Master Obi-Wan has. How embarrassing. How embarrassing."

1 comment:

health-gene said...

nice article...