As we write this, it is a glorious Labor Day Monday in the suburbs of Philadelphia. We are pleased to confirm that the Drug and Device Law Rock Climber retrieved her dogs last week, though not before we rushed to the vet one last time, this time to address the Pom's allergic skin reaction to something the groomer had used the day before. We are delighted to be back to our original "pack."
We are also delighted with today's decision, in the same remanded inferior vena cava ("IVC") filter case that produced the excellent comment k decision on which we reported last week. Today's decision, Keen v. C.R. Bard, Inc., et al., 2020 WL 4818801 (E.D. Pa. Aug 19, 2020), deals with the admissibility and probative value of evidence that a medical device was "cleared" for marketing through the FDA's 510(k) process, a question we face every time one of our medical device cases approaches trial.
Let us step back and provide some background for those who do not deal with this issue in their practices. The FDA uses a three-tier classification system for implanted medical devices. Devices are "Class I," "Class II," or "Class III," depending on the level of risk the agency associates with the device, and the classification determines the process required to bring the device to market. Class III devices are required to undergo a full premarket approval ("PMA") process. Class I and Class II devices may be "cleared" for marketing through the agency's 510(k) process, which determines whether a device is "substantially equivalent" to a predicate device that was subject to PMA.
In Keen, the plaintiff alleged that he was injured by the defendant's IVC filter, a Class II device cleared for marketing through the 510(k) process. He moved in limine to exclude references to the FDA's clearance of the IVC filter and to the dearth of FDA enforcement actions related to the device. With respect to the former, the plaintiff argued that the 510(k) clearance process is "irrelevant, because it is a comparative, rather than definitive, finding by the FDA that a device is safe and effective." Keen, 2020 WL 4818801 at *2. Following the lead of an earlier decision by the MDL judge, the Court rejected the plaintiff's argument, holding that, "even if the standard for [safety and effectiveness] considerations [in a 510(k) review is only comparative, ... [a] factfinder, after taking into consideration the history of the FDA's 510(k) clearance of [the IVC filter], could determine that [the defendant] took reasonable and appropriate steps in its effort to bring [the] filter to market." Id. Of course it could, and of course a defendant should be entitled to inform the jury that its device was "cleared" by the FDA.
The plaintiff also cited Medtronic v. Lohr "for the proposition that the 510(k) process focuses on device equivalence rather than device safety." Id. at *3. Holding that this argument was "meritless," the Court emphasized that Lohr "inquired into whether FDA's clearance of a 510(k) device preempted state law product liability claims . . . ." not "whether evidence concerning FDA clearance [was] admissible or relevant to the reasonableness of a manufacturer's conduct." Id. In sum, the Court concluded, "the fact that the 510(k) process focuses on device equivalence does not render evidence of the 510(k) process irrelevant to the reasonableness of [the defendant's] conduct. Id. (citation omitted).
The Court also denied the plaintiff's request to exclude references to the lack of FDA enforcement actions related to the line of filters that included the plaintiff's filter. The Court held, "The fact that the FDA did not bring an enforcement action . . . during the nearly five years that the [line of filters] was on the market before the [filter] was implanted in the [the plaintiff] could be relevant to whether it was reasonable for [the defendant] to design and manufacture the [filter] and to continue marketing it . . . ." Id. The Court concluded, "[The defendant may . . . be prejudiced if it is not permitted an opportunity to present to the jury a full picture concerning its decisions to market [the filter initially] and to continue marketing it . . . ."
Keen will be a boon to anyone facing a plaintiff's (illogical) argument that evidence of 510(k) clearance is not relevant to the care a manufacturer exercised in developing and marketing a Class II medical device. We again applaud Judge Gene Pratter, whose stewardship of this case is spawning a body of singularly well-reasoned decisions on issues faced over and over again by lawyers representing medical device manufacturers. We will keep you posted on any new decisions. In the meantime, stay safe out there.
This article is presented for informational purposes only and is not intended to constitute legal advice.