In our day job, we generally rely on final decisions of FDA about things like drug approvals, device clearances, and rules and guidances. We also rely on the general integrity of the FDA’s processes. Even when there are things we do not like on the merits, like observations in form 483s or warnings letters—each is not a final determination of anything according to FDA—we often look to the process itself, which can include a number of steps after the offending statement or action is final.
We also find ourselves calling to the Congressional charge of FDA to protect public health and its various powers of enforcement as counters to the plaintiff charges that FDA’s actions or actions do not amount to condoning our client’s conduct. Even when we read reports like IOM’s panning aspects of FDA, we still find ourselves looking at the process for the product in our case, with (we hope) thorough evaluation of evidence, layers of review, and consistency in reasoning.
The underlying facts in Ivy Sports Medicine, LLC v. Sebelius, No. 11-cv-1006 (RLW), 2013 U.S. Dist. LEXIS 51763 (D.D.C. April 10, 2013), test even our somewhat slanted view of things. The case came up on dueling summary judgment motions on an Administrative Procedures Act (APA) review of an FDA decision on a medical device. We have posted on cases in a similar posture before and noted the tension we, as a drug and device products defense lawyers, feel when FDA screws up. In Ivy, the court is asked to decide whether FDA has inherent authority to correct what it considered a massive screw-up and whether it behaved rationally—as opposed to arbitrarily and capriciously—in its correction. In other words, as a big-boned Colorado kid would demand respect for his authority in any situation, is FDA’s inherent authority to be respected when it takes unusual steps to correct a prior abuse of its authority?
We will not recap every twist and turn of the regulatory history of Menaflex, a collagen scaffold apparently developed to replace the natural meniscus in a human knee after it has been replaced. As with any medical device, the classification as Class I (general controls), Class II (510(k)), or Class III (PMA) and the intended use of the product compared to products already on the market were key issues. In short, the manufacturer positioned Menaflex as a surgical mesh (Class II) with the intended use of “reinforce[ing] and repair[ing] soft tissue” and filed a 510(k) in 2005. That was rejected, as was the requested rehearing, and appeal to the Office of Device Evaluation (ODE), basically because the Agency personnel determined that repairing/replacing a meniscus was different than what surgical meshes on the market did. The manufacturer submitted a second 510(k), describing the intended use as “repairing and reinforcing meniscal defects.” After getting additional information, the second application was denied in August 2007. Then the manufacturer apparently enlisted some lobbying assistance and some Senators and Representatives leaned on FDA, which apparently led the long-time Director of Center for Devices and Radiological Health (CDRH) to suggest that there be a third 510(k) application with an intended use of “surgical procedures for the reinforcement and repair of soft tissue injuries of the meniscus.” Even though the review staff determined that the third application should not be cleared, a meeting of the Orthopedic Advisory Panel was convened. Based on a questionable (per a later FDA report—wait for it) summary of that proceeding and with an unusual discussion between the Directors of CDRH and ODE, the third application was cleared and the product was classified as a Class II surgical mesh in December 2008.
Then the Wall Street Journal did an exposé and other folks from Congress got involved and FDA did an internal review, which resulted in a report in September 2009 with the subtle title of “Review of the ReGen Menaflex: Departures from Processes, Procedures, and Practices Leave the Basis for a Review Decision in Question.” By this time, there was a new CDRH Director and he concluded “the integrity of our processes for a reaching a decision was compromised in this case and so we are revisiting and re-evaluating the records and the basic for making that decision.” What followed was a meeting with the manufacturer, a re-review of the third application by a new team, a second Advisory Panel Meeting, a recommendation from the review team that the device was “not substantially equivalent to legally marketed predicates,” and notification to the manufacturer that prior clearance would be rescinded and the product re-classified to Class III (PMA). After the manufacturer declined a hearing, that is what happened in March 2011. The decision hinged on the finding that the intended use of the device was to “replace meniscal tissue that has been surgically excised rather than to repair and reinforce soft tissue.” This is the decision that the manufacturer (and its successor) contended was arbitrary, capricious, and an abuse of discretion.
Again, we will not slog through every detail of the APA part of this. Because 21 U.S.C. § 360(e)(1)(A) specified a procedure for reclassifying a device and revoking a prior clearance based on “new information” and because FDA had not followed that procedure with Menaflex, the manufacturer contended that FDA had no authority to do what it did. Slogging through a bunch of cases, but ultimately relying on the Supreme Court in Boesche v. Udall, 373 U.S. 472 (1963), the court found that the FDA had inherent authority to reevaluate past decisions that had been based on “numerous departures from normal agency practice”—which is a nice way of saying, as FDA did in its “Departures” report, an “unprecedented” “acquiescence to the Company’s demands” based on “the most extreme” “pressure from the Hill.” 2013 U.S. Dist. LEXIS 51763, **14-15, 33-34. The court then determined that the FDA had to have acted within a “reasonable period of time,” which it did, and needed to have acted within its statutory authority on the substantive decisions on how the device should be classified and whether the third 510(k) application demonstrated substantial equivalence. Id. at **34-46. As you would expect, the decisions on classification and substantial equivalence were viewed as being based on “a rational connection between the facts found and the choice made,” both because the use was to replace excised meniscus (which no cited predicates did) and because there were technological differences between Menaflex and the cited predicates. Id. at *46-56. So, the FDA got summary judgment and the manufacturer did not.
We are not here to say whether any of the decisions by FDA along the way were right or whether the court was right in its analysis of inherent authority. We do, however, think that, for products cases, recognitions of FDA inherent authority is a good thing. We also think that deference to FDA’s last word on an issue, even if the path has been tumultuous, makes sense. Courts sometimes struggle with the interplay between state statutes that create a defense or presumption based on FDA approval, while carving out an exception for fraud-on-the-FDA or bribery, and federal preemption under Buckman. We have sometimes argued that the apparent tension is really a matter of whether the plaintiff has the proof needed based on a subsequent determination by FDA. FDA is supposed to determine if it has been defrauded and take action. In Ivy, FDA determined that the integrity of its processes were compromised and took actions to correct it pursuant to its inherent authority. Under the standard of review here at least, the correct actions were given deference. So, maybe we can use Ivy. If nothing else, it might make a good movie. Maybe McConnell, whose usual posting day we are taking this week and is the resident cinematic expert, or Bexis, who has written some fiction, can write the script.