When we first read Steiden v. Genzyme BioSurgery, 2012 U.S. Dist. LEXIS 99689 (July 18, 2012), we didn’t know which bothered us more: the court’s parallel violation ruling or its TwIqbal ruling. It’s still a close call, but TwIqbal might have won in a photo finish. It’s not all doom and gloom, however. There may be an upside.
There was nothing distinct about the plaintiff’s claim. He alleged that he had a serious adverse reaction to a knee injection of Synvisc-One®, which is regulated as a medical device. Id. at *1-2. He brought product liability claims. The defendant moved to dismiss on the basis of preemption under the Medical Device Amendments to the Food, Drug and Cosmetics Act. The plaintiff then conceded that his product liability claims were preempted. Id. at *4.
Routine enough so far. Here’s where parallel violation claims came into play. Plaintiff asked to amend his complaint to add the following allegations:
(1) Genzyme failed to comply with the FDA’s premarket approval requirements in the continued manufacture, distribution and sale of Synvisc-One®;
(2) Genzyme manufactured, held, sold, and delivered an adulterated dose of Synvisc-One®;
(3) Genzyme did not meet the FDA's Current Good Manufacturing Practices (“cGMPs”) in the manufacture, distribution and sale of Synvisc-One®; and
(4) Genzyme violated KRS 217.175 by manufacturing, holding, selling and delivering an adulterated dose of Synvisc-One®, the violation of which constitutes negligence per se.
Id. at *5. The upshot is that plaintiff wanted to allege that the defendant didn’t follow PMA approval and cGMP requirements and parlay those alleged failures into a parallel violation claim under Kentucky’s negligence per se statute.
The court allowed this claim to go forward. The problem is that there is no private right of action under the FDCA. The FDCA itself says so: “all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.” 21 U.S.C. §337(a). Accordingly, as we’ve discussed before here, the FDCA should not be a proper candidate for private negligence per se enforcement. But there’s no reason to get worked up about it here again.
It’s harder, though, with the TwIqbal ruling. The totality of the plaintiff’s factual allegations in his proposed amended complaint is as follows:
William L. Steiden, a patient of Dr. Edward Tillett, an orthopedic surgeon who practices in Jefferson County, Kentucky, had both of his knees injected with Synvisc-One® (HYLAN G-F 20) on July 22, 2010. The plaintiff suffered an immediate adverse reaction after the injection of Synvisc-One® (HYLAN G-F 20) in his right knee.
Id. at *5-6. That’s it. In fact, the court acknowledged that the allege facts were sparse: “There are indeed precious few facts alleged.” Id. at *12. The rest of the complaint consists of the type of conclusory incantations mentioned above as to unspecified violations of cGMPs and PMA requirements. Yet the court let the complaint stand, a decision that may ultimately serve as an invitation to fill-in-the-blank parallel violation complaints: name the device, allege a reaction, and allege violations of unnamed GMPs and PMA approval requirements. Voilἁ! You’re in federal court, and on to discovery. Frankly, the court all but admitted that that’s all it required:
[W]e find that the allegation of adulteration based on the occurrence of an immediate adverse reaction in one knee to the injection of Synvisc-One® contains sufficient specificity to satisfy Iqbal and Twombly.
(Practitioner’s note: the importance that this court seemed to place on the immediacy of the reaction in the knee may be a basis to distinguish this case, if the argument that this decision was badly decided won’t work.) Nonetheless, to simply allege a reaction to a device (or drug) doesn’t equate to a violation of a cGMP, adulteration or even to a defect. Nor does adding to that the factually devoid allegation that an unnamed FDA requirement was violated in some unnamed way. There’s no substance to the claim, nothing on which to judge its plausibility under Twiqbal: no identification of the supposed manufacturing or design defect; no specific PMA approval or cGMP requirement that was violated; no allegation on how that requirement was violated; and no connection between those things and plaintiff’s injury.
While TwIqbal certainly doesn’t require a plaintiff to prove his claim in a complaint, he must state facts that make it plausible. Other than the general notion (for which plaintiff’s complaint wasn’t necessary) that parallel violation claims are possible, plaintiff’s complaint provided nothing to make his claim plausible. It’s boilerplate pleading, which is precisely what TwIqbal does not allow.
But, again, we’ll try not to get worked up about this.
There may be some good news. All the product liability claims are gone. The court dismissed them (after the plaintiff conceded them). Id. at *14. What’s left – plaintiff’s parallel violation claim – may be difficult for plaintiff to establish.
The plaintiff will have to prove that the defendant violated a PMA approval or cGMP requirement, and that this violation caused his injury. Moreover, we believe that he must also show that the FDA found or would have found such a violation. His claim must truly be “parallel” to the FDA’s position. It cannot be, as the MDA prohibits, “different from” or “in addition to” the FDA’s findings. This further limits the proof that the plaintiff must show to make his claim. So we very well may see the Steiden case back here on a motion for summary judgment, one with a much more favorable holding.