Sometimes we hear people say that they know just enough to be dangerous. Homeowners who do their own electrical work fall into this category, as do friends and family who offer to cut our hair. Running wires and cutting hair look so straightforward, and thousands of people do those things every day with nary a problem. So why can’t anyone do them? The answer is that we can, so long as we make the effort to learn the ins and outs, the basic rules, the tricks of the trade. Without taking the time to gain that orientation, the results could be horrific—a house burned down or a hairstyle that causes others to look away suddenly. And, unlike hair, houses do not grow back.
This is how we feel about federal preemption. Courts and lawyers alike know that the Supremacy Clause says that federal law trumps state law. Beyond that, it gets a little fuzzy, and when it comes to drugs and medical devices, a little knowledge can be dangerous. Preemption comes in different types and subtypes, and a shallow understanding of the differences can lead (and has led) to confusing, contradictory, and unfair results. Just the other day, we reported on a case where one party confused express preemption with implied preemption and imported concepts that apply only to one into a controversy dealing exclusively with the other. The court went along with it, and the result was a predictably bad haircut that will not grow back (unless reversed by a higher stylist).
We are not criticizing. We get that preemption can be complicated, and we routinely rely on Bexis and our many scorecards (here, here, and here) to keep it all straight. We also take delight when we read an order where a clear-minded judge understands preemption and applies it correctly. That is what happened in Rodriguez v. American Medical Systems, No. 7:12-CV-330, 2014 U.S. Dist. LEXIS 13803 (S.D. Tex. Feb. 4, 2014). The Rodriguez order involved express medical device preemption and an argument that the plaintiff had alleged a so-called “parallel claim,” but there were a couple of twists that make the case unique. First, the case involved an inflatable prosthesis that received approval through the FDA’s product development protocol (“PDP”) process, a method of premarket approval where a device’s clinical evaluation and the development of information for marketing approval are merged into one process. There are not a lot of reported decisions involving PDP devices, but they typically treat PDP devices as premarket approved for express preemption purposes, and so does the district court in Rodriguez. That is correct and good.
Second, because establishing approval through the less usual PDP process required explanation through a declaration—i.e., evidence outside the pleadings—the court converted the defendant manufacturer’s motion to dismiss under Rule 12(b) into a motion for partial summary judgment under Rule 56. Looking back, this move was a signal that this court is careful and thinks things through before acting.
The court’s discussion and application of express preemption confirmed our impression. The black-letter recitation of express preemption law under the Medical Device Amendments is about as good and clear as we have seen, including its discussion of the MDA’s express preemption provision and the marquee Supreme Court authority, Reigel v. Medtronic. Id. at **7-11. We are even sort of okay with the court’s description of “parallel claims”: “[The MDA’s] protection ends, however, where the state-law claim is premised on the manufacturer’s violation of the applicable federal requirements. . . . In such case, the state-law duties ‘parallel,’ rather than add to, those requirements . . . .” Id. at *11. Fair enough. We generally do not like what has become known as the parallel claim doctrine because it conflicts with 28 U.S.C. § 337(a), which expressly forbids private enforcement of the FDCA. A civil action claiming damages for violating the FDCA therefore should not be allowed, regardless of whether a state law claim “parallels” the federal requirement or not. Separate and apart from this fundamental misgiving, we particularly do not like the inconsistency with which courts have ruled on parallel claims. All that being said, we give the district court in Rodriguez credit for setting forth the rules in a straightforward manner, even if we do not completely agree with them.
The court’s analysis and application of the rules are equally disciplined, particularly in that the court realized that a parallel claim requires two components: A state requirement and a federal requirement that are the same. As the court put it,
[T]he fact that this device has received a declaration of PDP completion means that the FDA considers it to have survived the requisite cost-benefit analysis, and to be reasonably safe and effective. It also means that the device must conform to FDA-approved specifications and applicable federal statutory provisions and regulations. Thus, to identify a “parallel” claim, as Plaintiff is attempting to do, he must articulate how [the manufacturer’s] alleged violation of the duties imposed by the particular claims he asserts equates to a violation of the governing federal requirements.
Id. at *15. We are often dismayed when courts trying to pave plaintiffs’ paths to recovery fail to understand this point. Some courts give plaintiffs a break in identifying exactly what federal requirement the device or manufacturer has allegedly violated, and others are less than vigilant (or altogether forgiving) in forcing plaintiffs to identify a particular state requirement that applies.
The district court in Rodriguez held that the plaintiffs failed to state a parallel claim on both ends. The plaintiff purported to allege a violation of Texas Deceptive Trade Practices Act, but left the court (and the defendant) to make “an educated guess” as to what he was actually claiming under state law. Id. at *16. Assuming that the plaintiff was alleging that the manufacturer’s promotional literature was somehow deceptive, the court found no alleged violation of a federal requirement either, concluding that the plaintiff “fails to articulate how [the manufacturer’s] marketing, through its brochures and literature, deviated from the FDA-approved form.” The plaintiff’s claim for strict liability similarly “fail[ed] to plead or otherwise explain how [the plaintiff] has premised this claim on the violation of an applicable federal requirement.” Id. at **17-18.
That is how medical device express preemption is supposed to work. No articulated violation of a state requirement, no articulated violation of a federal requirement, no parallel claim. No extra leeway from the vague pleading of claims. The court concluded with this beauty of a holding:
Plaintiff essentially asks the Court to assume the violation of a federal requirement because he has alleged that the . . . device implanted into him caused him pain and/or did not work as promised, but governing case law does not recognize a parallel claim premised on such an assumption.
Id. at *18. That statement sums up a lot of cases we see, and in Rodriguez all that remained was the plaintiff’s breach of contract claim, which the court dismissed as “conclusory and devoid of any factual support.” Id. at **15-16. We don’t know this judge, other than from reading this one order, but given the clarity of his analysis on preemption we would be surprised if he does his own electrical work or lets his clerks cut his hair.