Failure to Communicate

The Dog Days of summer are here, but no rest for the weary (except Southfllawyers.) Today the Eleventh Circuit issued Guarino v. Wyeth, LLC, Schwarz Pharma, Inc., Teva Pharmaceuticals USA, Inc. For all of you healthcare freaks practitoners, the case has a nice discussion of Preemption, The Learned Intermediary Doctrine and liability of Brand Manufacturers when a consumer ingests only a generic form of the manufacturer's drug.

Guarino sued the generic drug company and the brand manufacturer alleging negligence, strict liability, breach of warranty, misrepresentation and fraud, and negligence per se, essentially for failure to adequately warn. The Eleventh Circuit affirmed the District Court's grant of summary judgment in favor of the Brand Manufacturer because the plaintiff ingested only a generic form of the drug. The Court also affirmed the District Court's grant of the generic manufacturer's motion to dismiss based on the law of Preemption (you remember that whole Supremacy Clause thingy.)

On appeal Guarino attempted to "cloth" her argument to avoid Preemption by asserting not that the generic manufacturer's warning labels were inadequate but that it "failed to communicate" to the prescribing medical providers, the FDA's recent change in labeling requirements. I love creative lawyering as much as the next guy, but Judge Wilson would have none of it.

"No matter the garb in which she attempts to present them, Guarino’s claims are at bottom allegations regarding Teva’s failure to warn her of the dangers of long-term metoclopramide use, and they therefore [fail]."

The decision pretty much forecloses any remedy to those similarly situated as the Plaintiff here (and thus may result in fewer of those annoying late night national lawyer trolling for clients solicitation commercials.) Which is not to say the Court is without compassion for the lack of a remedy to an aggrieved person.

"We are mindful that the disposition of this case may leave Guarino and those similarly situated without a remedy in cases such as these, but as federal judges we are bound merely to interpret and apply the law as promulgated by Congress and the political divisions of government.....Thus, and insofar as Guarino seeks redress for her injuries, such redress lies with Congress or the Florida legislature, not with this Court."

Or as Strother Martin said, "I don't like it any more than you men."