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It’s Labor Day, the unofficial end to what has been a long, hot Summer. (Shakespeare wrote that “thy eternal summer shall not fade,” but this sweltering season has us saying, ‘please, please, fade away.’) We’re getting ready for the family BBQ and suspect that, as is often the case, the appetizers (salmon pinwheels, buffalo mozzarella) will outshine the more pedestrian main course.
The same thing happened in the case of Yocham v. Novartis Pharmaceuticals Corp., 2010 U.S. Dist. LEXIS 90005 (D. N.J. August 31, 2010). We like the minor rulings. But the main ruling on preemption makes us gag.
The plaintiff was a Texas resident who alleged that she developed Stevens-Johnson Syndrome from Lamisil. Her complaint asserted claims of negligence, strict liability, express and implied warranty, misrepresentation, unjust enrichment, and violations of the New Jersey Product Liability Act and the New Jersey Consumer Fraud Act.
Let’s start with the good bits. Plaintiff sought application of the law of New Jersey, where Defendant was located. Plaintiff lived in Texas, took the Lamisil in Texas, and sustained the injury in Texas. But Texas “does not permit design defect claims for prescription drugs with otherwise adequate warnings.” Yocham, 2010 U.S. Dist. LEXIS 90005 at * 13. So it’s no surprise that the Texas plaintiff shunned Texas law. Following the “most significant relationship” test, the Court didn’t have much difficulty choosing Texas law. Plaintiff put up a struggle, contending that the location of the injury was “fortuitous.” Id. at * 13-14. That’s sort of silly. It reminds us of people who misuse certain words, “fortuitous” often one of them. It’s almost as irritating as the misplaced “hopefully,” lodging “only” next to the wrong adjective or verb, or writing “alot” as one word.
One’s choice of residence is not “fortuitous.” The late, great comedian Bob Schimmel said it would be weird to show up at somebody’s house and claim it was “fortuitous” to find them there. The Restatement’s “example of fortuitous place of injury involves the purchase of an airline ticket to fly from one state to another part, which route happens to overfly a second state, that state has no relationship to the parties, and the only relationship to the occurrence is mere chance.” Id. at * 14. Bottom line: “It was not fortuitous that Plaintiff was injured in Texas, her state of residence.” Id.
We also like the way the Court dealt with the express warranty claim. The Court pushed the eject button because Plaintiff “has not adduced evidence of reliance.” Id. at * 39. Rather, Plaintiff “relied exclusively on the advice of her physician in deciding to use Lamisil.” Id. at * 40.
Now for the main course, which gave us indigestion. Under Texas law, there is a statutory defense to failure-to-warn claims aimed at FDA-approved warnings. The only exception to the defense requires a showing that the defendant misled the FDA. Is that exception preempted by federal law? Do you really need to ask?
In Buckman Co. v. Plaintiff’s Legal Committee, 531 U.S. 341 (2001), the Supreme Court “held that a state cause of action for injuries caused by misrepresentations made to the FDA was impliedly preempted by the [FDCA].” Yocham, 2010 U.S. Dist. LEXIS 90005 at * 22. Since Buckman was decided, the battleground has been state statutes, like that in Texas, providing a defense that is called off only if there was fraud on the FDA. That battle has largely turned out to be a debate between the pro-preemption position set forth by the Sixth Circuit in Garcia v. Wyeth-Ayerst Laboratories, 385 F.3d 961 (6th Cir. 2004), and the anti-preemption position set forth by the Second Circuit in Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006), aff’d by equally divided court, 552 U.S. 440 (2008). We’ve written at length on this debate before and before and before that, so we won’t repeat ourselves here (at least not too much). Let’s leave it at this: the Garcia line of cases (which, thankfully, seems to be winning) is a straightforward application of Buckman, while the Desiano line tortures logic and policy.
Sadly, the Judge in Yocham (who had authored a bad preemption opinion that became part of the Colacicco appeal) adopts Desiano, reasoning that because fraud-on-the-FDA is only an exception to the Texas product liability law, the state’s police powers are at work and the presumption against preemption is fully operative: “the distinction between a fraud-on-the-FDA tort and a traditional common law tort that must prove fraud to overcome an affirmative defense means that, unlike in Buckman, the presumption against preemption applies.” Yocham, 2010 U.S. Dist. LEXIS at * 29. As in Desiano, the Yocham court distinguishes Buckman by pointing to the oral argument in Buckman — as opposed to the actual opinion — and speculates that company incentives to submit complete and accurate information to the FDA would not be skewed by a state’s fraud-on-the-FDA exception.
We mentioned before there are certain words people misuse that drive us nuts. There are phrases like that, too. What exactly is “the exception that proves the rule?” And we’ve never been completely certain what it means to say that something is “too clever by half.” But that phrase does, indeed, seem to be apt for the reasoning in Desiano and Yocham. The basic teaching of Buckman is that states (whether via statute or jury verdicts) have no business meddling with the FDA’s policing of its own regulatory processes. What if the state disagrees with the FDA? What if different states disagree? That’s why the Texas statute and other, similar statutes (as in Michigan) are preempted, and that’s why Desiano and Yocham are wrongly decided.
It’s hard work trying to make sense of Yocham, and it was probably hard work writing it. Today is set aside as a day to honor work. So we’ll cease carping about the case and are content to leave it to the tender mercies of the Third Circuit. Instead, we’ll return to the grill. It’s time for the course that most reminds us of the Yocham preemption analysis: the wurst.