We keep score here.

We keep the Drug/Vaccine Preemption Scorecard, collecting cases addressing preemption in the context of prescription drugs.

We keep the Device Preemption Scorecard, tracking device preemption cases since Riegel.

We keep the Cross-Jurisdictional Class Action Tolling Scorecard, tracking . . . well, if you understand what those words mean, you know why it matters.

And today we’re keeping score in the District of Utah. We’re calling Lake-Allen v. Johnson & Johnson, No. 2:08CV00930DAK, 2009 U.S. Dist. LEXIS 64860 (D. Utah July 27, 2009), a 1-1-1 decision: One right, one wrong, and one that we don’t much care about.

Lesa Lake-Allen is the widow of Scott Allen, who allegedly died after “a deadly dose of fentanyl [was] introduced into his body via the reservoir system of a Duragesic [pain] patch.” Id. at *3. The complaint pled negligence, strict liability, implied warranty, express warranty, wrongful death, and punitive damage claims against Johnson & Johnson and one of its subsidiaries. J&J moved to dismiss the design defect and punitive damage claims.

Here’s the Lake-Allen motion to dismiss scorecard:

One right — choice of law: The decedent “purchased and used the Duragesic patch in Utah, where he also suffered the injury that allegedly caused his death.” Id. at *5. Thus, even though the patch was designed and manufactured in New Jersey or California, “Utah bears the most significant relationship to the claims at issue,” and Utah law governs the lawsuit. Id.

One that we don’t much care about — design defect claims not based on strict liability survive: “[P]rescription drugs approved for use by the United States Food & Drug Administration (‘FDA’) are ‘unavoidably unsafe’ and, as such, there can be no strict liability claim for a design defect in these products.” Id. at *6 (citation omitted). J&J asserted “that the bar on design defect claims should be extended beyond strict liability.” Id. at *7. The court held otherwise, noting that “Utah courts have consistently limited the application of this [‘unavoidably unsafe’] exception to strict liability claims.” Id. at *7-*8.

A defendant lost an argument! How can we not care about this one?

Although, as defense lawyers, we naturally feel J&J’s pain, this result may easily have been driven by existing Utah law. (We haven’t double-checked, but we’re ready to assume the court was right about this.) If so, this decision hurts J&J in this particular lawsuit, but it doesn’t affect Utah law in a way that will affect later litigants.

Finally, one wrong — failing to dismiss the punitive damages claim under Utah law.

Let’s start with the usual disclaimer: We love the judge who wrote this opinion! We love all judges! We especially love judges before whom we have pending cases! Our disagreement here is simply on an intellectual point, and we’re confident that you’ll understand that when we next appear before you.

Here’s our intellectual difference of opinion:

Utah Code Annotated Sec. 78B-8-203(1) says that plaintiffs cannot recover punitive damages in a case involving a drug that was approved by the FDA. That immunity from punitive damage liability does not apply if “the drug manufacturer knowingly withheld or misrepresented information required to be submitted to the Federal Food and Drug Administration.” Sec. 78B-8-203(2). J&J moved to dismiss the punitive damages claim “[b]ecause Plaintiffs have not alleged that the FDA has determined that it was defrauded.” Id. at *9. Absent an allegation that the FDA itself believed it had been defrauded, J&J thought that it was immune from liability under Sec. 78B-8-203(1). This raises a Buckman preemption issue, and we think the court got that issue wrong at the outset.

The court held that “the federal preemption articulated in Buckman [v. Plaintiff’s Legal Committee, 531 U.S. 341 (2000)] extends only to medical devices and not to prescription drugs,” such as fentanyl. Id. at *10. The court even cited the Levine decision’s language distinguishing medical devices cases as involving “an express preemption provision for medical devices.” Id. at *9. It cited Levine for clarif[ying]” the presumption against preemption. Id.

We beg to differ with this result.

First of all, Buckman turns entirely on implied preemption. How do we know? The Supreme Court said so in Buckman. 531 U.S. at 348 (“In light of this [implied preemption] conclusion, we express no view on whether these claims are subject to express pre-emption”). So the court’s simply incorrect about distinguishing Buckman on the basis of the express preemption clause covering medical devices.

Also Buckman is quite specific about there being no presumption against preemption in fraud on the FDA cases:

[P]etitioner’s dealings with the FDA were prompted by the MDA, and the very subject matter of petitioner’s statements were dictated by that statute’s provisions. Accordingly – and in contrast to situations implicating “federalism concerns and the historic primacy of state regulation of matters of health and safety” –no presumption against pre-emption obtains in this case.

531 U.S. at 347-48 (citation omitted) (emphasis added). So, again, this isn’t just a matter a difference of opinion, the court simply got Buckman wrong.

Under 21 U.S.C. Sec. 337(a), only the United States can enforce the Federal Food, Drug and Cosmetic Act. Permitting private plaintiffs to enforce claims for fraud on the FDA would undermine the federal regulatory scheme.

Buckman held that it is the FDA’s exclusive responsibility to “police fraud consistently with the Administration’s judgment and objectives,” and private plaintiffs should not be allowed to claim that the FDA had been defrauded in situations where the FDA itself does not believe that it has been defrauded. There isn’t a word in Buckman mentioning express preemption or any possible difference in the scope of implied preemption for drugs versus devices.

Buckman applies to drug cases.

We’re not the only ones to differ with the Lake-Allen court on this point.

Federal appellate courts consistently agree with us. Whether or not courts accept the Buckman implied preemption argument, courts consistently recognize that Buckman implied preemption applies fully to drugs. Compare, for example, Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir. 2004), which applied Buckman in the context of the prescription pain reliever Duract, with Desiano v. Warner-Lambert & Co., 326 F.3d 339 (2d Cir. 2006), aff’d by an equally divided court sub nom. Warner-Lambert v. Kent, 128 S. Ct. 1168 (2008), which applied Buckman in the context of the diabetes drug Rezulin. Those courts ultimately disagreed on the merits, creating the circuit split that went to the Supreme Court, but both courts recognized that Buckman applies to drugs as well as devices.

We won’t wade again into the more controversial subject of the precise scope of Buckman preemption. (If you’re curious, Herrmann’s ten-minute rant on that subject was videotaped at a symposium at NYU here.) We’ll simply note that (to our knowledge) no one has ever previously suggested that Buckman applies only to devices and not to drugs. There’s no logic for drawing that distinction, and the suggestion to the contrary in Lake-Allen will only confuse this area of the law.

  • Anonymous

    So correct me if I'm wrong, and since I'm not a lawyer, that very well might be the case… Buckman in combination with Riegel presents a fairly ironclad defense against any medical device lawsuit?

    If that's the case, then why do some congressmen, senators and former FDA chief counsels continue to insist that fraud on the FDA, through a medical device company's negligence in reporting deaths and adverse events, would provide grounds for a lawsuit to proceed? At both the House and the Senate's hearings on the Medical Device Safety Act, this claim has been made several times.

    It leaves one to wonder whether the people making this claim are either horribly misinformed or are being intentionally deceitful in order to make the concept of preemption more palatable.

    I think to the average person, defense lawyers and medical device executives excluded, the idea that absolutely all lawsuits against medical device companies are precluded by preemption, even those that, in any other venue, would proceed without question, is something that they can't civically and morally accept.

    By incorrectly stating that medical device lawsuits can proceed in the event of fraud on the FDA, these people are providing the false assumption that at least some meritorious lawsuits will be allowed.

    If the Buckman Riegel combo does truly preclude ALL medical device lawsuits, the fallacious claim that the proof of fraud on the FDA will provide relief should be dispelled. It is disappointing to me, as a citizen, to think that there are senators and congressmen who are putting out incorrect information in order to further their own political agendas.

  • Not any device case. Only PMA devices, which amount to 1% or less of all devices that the FDA lets on the market (although these are the riskiest, and thus tend to attract more than their share of product liability litigation).

    Beyond that, we've discussed PMA preemption in a lot of other posts. The emerging consensus seems to be that the only claim that isn't preempted is one for an FDA regulatory violation that also parallels some pre-existing tort cause of action. Something like omitting an FDA-mandated warning, which would not only be a violation, but would also state a traditional claim for inadequate warning.

    If they're making that claim, they don't understand how Buckman works. Buckman says it's up to the FDA, not state courts applying state law, to penalize fraud against the FDA.