The Supreme Court has been busy of late on several fronts of interest to those in the life sciences, and may be busier yet if it accepts a case dealing with preemption. The Court decided a case recently dealing with venue, but there is some disagreement as to how much that decision clarified the questions at hand.
Is Lohr back in play?
Those who find the PMA preemption discussion fascinating will enjoy the potential for a reexamination of preemption for class II devices if the U.S. Supreme Court grants cert for a case addressing surgical meshes. One of the more interesting aspects of this case is that any push for 510(k) preemption might be due to more stringent requirements for these applications imposed by the FDA over the past few years.
J&J subsidiary Ethicon requested cert for Ethicon v. Huskey, which takes up a synthetic surgical mesh applied for stress urinary incontinence. The jury trial returned an award of more than $3 million for the plaintiff, and Ethicon appealed the case on the grounds that the judge in the first trial disallowed evidence as to the company’s adherence to FDA premarket requirements, along with several other bits of regulatory information related to the device.
The appeals court sided with the district court, citing with the Federal Rule of Evidence 403 as justification for omitting the evidence in question, but the appeals court decision also argued that 510(k) filings only “tangentially” deal with safety and efficacy. The court cited Medtronic v. Lohr without comment in this section, which seems likely to provoke a discussion as to whether the FDA’s increasing demands from FDA for 510(k) filings begins to approach the threshold for specificity that is the foundation for PMA preemption. Or at least that’s the argument device makers are inclined to make.
Either way, Lohr dealt with the statute as it existed in 1982, when the FDA cleared the Model 4011 pacemaker, and thus changes imposed by Congress since then, including the Safe Medical Devices Act of 1990, were not considered. This legislation was driven almost entirely by concerns about the tracking of adverse events for class II devices, but the Supreme Court decision in Lohr claimed that a typical 510(k) review takes only 20 hours as opposed to the average of 1,200 hours needed to review a PMA filing.
Whether those times still hold is difficult to know, but the most recent FDA performance report for the soon-to-expire device user fee agreement suggests that overall PMA review times are down to 163 FDA days while the target for 510(k) review times is still 90 FDA days. The question one might ask oneself is: If it takes the FDA 90 days to get through 20 hours of review time for a 510(k), how can it take only 163 days to put 1,200 hours into a PMA?
Venue, vidi, vici
Those who see the question of forum shopping in a negative light might be encouraged by a recent decision in the Supreme Court that seems to put the clamps on this practice. The fact that the decision in Heartland v. Kraft was unanimous would seem to bring the venue question to a thunderous close, but there is some skepticism as to whether the question is fully answered.
Justice Clarence Thomas wrote the 8-0 decision in Heartland – Justice Neil Gorsuch did not take part – and said that §1400 of Title 21 of the U.S. Code was unaffected by congressional modification of Title 21’s §1391. Thomas also pointed to Fourco Glass v. Transmirra Products, the 1957 case in which the Supreme Court declared that the word “resides” means the location of incorporation for a U.S. domestic company.
Former PTO director Todd Dickinson noted that the outcome leaves a few questions unanswered about cases that are already in process, but he also said that stand-alone legislation by Sen. Jeff Flake (R-Ariz.) directed toward venue might be futile. On the other hand, former Senate Judiciary Committee chairman Orrin Hatch said he will draft a bill to take up the vexatious venue problem, so there is clearly some interest on Capitol Hill.
There are those who believe that Heartland might influence whether patent litigants will resort to multidistrict litigation to go after infringers. The America Invents Act disallowed the use of joinder based merely on the charge that each of the named defendants infringed the same patent, and Heartland would seem to suggest that a patent holder will spend a lot more time on the road in pursuit of damages, although a lot of potential targets are located in Delaware thanks to that state’s status as the home of the limited liability corporation.
Multidistrict litigation might seem a handy way to pursue infringers in numerous jurisdictions, but MDLs are infrequently used for patent cases. Would the U.S. Judicial Panel on Multidistrict Litigation (JPML) be persuaded by an application to consolidate patent lawsuits when only half a dozen or so defendants are named? By some accounts, patent MDLs currently account for less than 5 percent of all MDLs, although this might reflect nothing more than underutilization.
Still, it seems plausible that a plaintiff will have to identify a very similar set of allegations for a given number of defendants in order to prod the JPML into action. A lack of sheer numbers presents one problem, but the combination of small numbers and dissimilar allegations could prove fatal to an effort to consolidate patent lawsuits via the JPML.