We defense lawyers enjoy reading lengthy opinions that analyze key defense issues and rule in our favor. But it can be more satisfying to read a short opinion in favor of the defense on an issue we care about. Short opinions usually show that the law on a particular point is settled. Rounds v. Genzyme Corp., 2010 U.S. Dist. LEXIS 137491 (M.D. Fla. Dec. 20, 2010), is a good example.
The plaintiff’s doctor implanted Carticel, a biological product manufactured by Genzyme, into her knees in 2006 and 2007. Evidently it did not go well, and she and her husband sued Genzyme alleging that the company was negligent and failed to adequately train her doctor about implanting Carticel.
The opinion does not say why she didn’t sue the doctor as well. Maybe she had already sued him, or maybe state tort reform made it more difficult or less lucrative to sue the doctor. But if he really did screw up the implantation, he should be sued, not Genzyme.
The plaintiffs tried to support their claim with a mishmash of conflicting allegations. Those allegations include a claim that Genzyme “failed to comply with an FDA-approved safeguard.” Id. at *8. In support of that claim, plaintiffs offered a letter from the FDA stating that certain materials submitted to the FDA for approval in 2009 violated the FDCA. Id. at *8 & n.5.
The court made hash of their mishmash. The court held, citing Florida law, that a violation of a statute does not create civil liability absent legislative intent to create a private right of action, and the FDCA unambiguously prohibits “a private right of action for a violation of either the FDCA or the FDA’s implementing regulations. Accordingly, a plaintiff cannot use a negligence per se claim to create a private cause of action for a defendant’s alleged violation of the FDCA.” Id. at *10 (citations, quotation marks, and similar stuff omitted). Hear, hear! The court dismissed plaintiffs’ claim because it “amount[ed] to no more than a per se negligence claim based on the defendant’s violation of the FDCA and FDA regulations, which claim the law prohibits.” Id. at *11.
The court also rejected the complaint on TwIqbal grounds because it failed to allege facts showing a defect in the product or the training program or supporting a causal connection between either the supposed failure to train or the FDA violations and the alleged injuries. Id. at *6-7, 11. And the court took judicial notice of certain FDA records and statements about Carticel, which enabled the court to consider those documents in resolving the motion to dismiss. Id. at * 3-4.
Rounds does not break new ground, but it confirms what the law is in Florida and should be everywhere: no negligence per se claims for violating the FDCA and FDA regulations.