Two recent cases, one good and the other not, have us thinking about the presumption against preemption in the context of “parallel” claims – that would be medical device preemption – and allegations of fraud on the FDA, which could be either. We think it would be a good idea for defense counsel to review
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.Continue Reading Barbecued Buckman
It’s been said that the third time’s the charm. Maybe that means that we’ll get it right this time.
Anyway, as regular readers of this blog know, Wyeth filed its principal merits brief in Wyeth v. Levine early last week. As night follows day, that means that all defense amicus briefs are due a
We promised you that we would be “mining the depths” of Third Circuit’s opinion in Colacicco v. Apotex Inc., 521 F.3d 253, 2008 WL 927848 (3d Cir. Apr. 8, 2008), affirming implied prescription drug preemption. That, of course, assumes that our doing so is a good thing. But we have to believe that most
The Third Circuit has affirmed the finding of extensive preemption in the Colacicco/McNellis suicidality litigation. Here’s a copy of the opinion. Judge Sloviter wrote the opinion. There is a dissent, by Judge Ambro. This is the first federal court of appeals decision to address preemption following the FDA’s 2006 Preemption Preamble.
The
As regular watchers of our Drug Preemption Scorecard know, the good guys had been on a bit of a roll with preemption in prescription drug cases in 2008. We’d gone 5 for five, with courts in Dobbs v. Wyeth Pharmaceuticals, 530 F. Supp.2d 1275 (W.D. Okla. 2008); O’Neal v. SmithKline Beecham Corp., 551
Now we’ve read it, and before we go off to celebrate (and maybe to look for new jobs as IP lawyers – that’s a joke, folks), we thought we’d tell our readers why that’s exactly what we’re doing.
The 7-1 Riegel decision definitively demolishes a lot of the arguments we’ve been seeing for years (if
Ever since the Supreme Court granted certiorari in Warner Lambert v. Kent the other day, we’ve been thinking about what’s at stake. We’ve seen the case described by Bloomberg as a “chance to extend a victory [defendants] won in 2001, when the Supreme Court said patients can’t sue companies for defrauding the U.S. Food and
How many times have we heard that, in deciding preemption issues the “purpose” or “intent” of congress is the “ultimate touchstone” that the courts must respect? Lots. We can start with Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), the express preemption case involving medical devices and the Medical Device Amendments to the FDCA:
Preemption, of course, can be a valuable defense in pharmaceutical and medical device product liability cases. The presumption against preemption originated in “field” preemption cases. In a sentence, field preemption is the total exclusion of state regulation from a particular “field” by the nature or comprehensiveness of the federal assertion of responsibility. From there, it’s