Wednesday, October 17, 2012
FDA Can Still Be A Pain to Products Plaintiffs Even When It Gets Burned
Here's another guest post from Reed Smith's Eric Alexander, who is inching (being hauled) towards full blogger status, but who isn't there yet - so we're posting this for him.
We warn our readers that there will be a neck-snapping segue later in this post. You might want to stretch before reading. The segue was in no way necessitated by our sloth in posting on the second case discussed here, which had already received enough press (sometimes not too accurate press) before we might have posted on it solo. Instead, we are presenting a two-fer because cases that mostly deny summary judgment do not usually merit individualized attention here. So, with more advance disclaimers than you get with winning “free” stuff on the internet, here goes.
The case leading to the opinion in Cross v. Amtec Med., Inc., No. 3:09-CV-00168-HTW-LRA, 2012 U.S. Dist. LEXIS 141508 (S.D. Miss. Sept. 30, 2012), seems like what we imagine is a typical pain pump product liability case. The plaintiff has a complicated medical history, decides to sue fairly late in the game after trolling the internet—gee, maybe some lawyer websites popped up—sues a mix of pump distributors and manufacturers (but not drug manufacturers), and asserts a range of theories, including that the pump allegedly at issue was marketed off-label in violation of the FDCA. After some discovery, the defendants moved for summary judgment and partial summary judgment. They contended that Mississippi’s three year statute of limitations with statutory discovery rule was not met when plaintiff waited almost nine years after the post-surgery use of the product allegedly at issue to sue, with complaints of shoulder pain—roughly the injury in the suit—and medical care for it throughout much of the pre-suit period. Well, some of her providers said her shoulder was normal and some said she had regular tendinitis or arthritis (a four-syllable word in parts of the country) so there were genuine issues of material fact as to whether she should have known the cause of her injury within three years of when she sued. Not too remarkable, but she also had something lacking for many plaintiffs who sue over an injury they say they have had for a while before they sued: an actual pre-lawyer, new medical diagnosis. So, summary judgment on the statute of limitations denied.
Next up was product ID. Plaintiff’s evidence on which pain pump she used nine years before she sued was pretty sparse—”[n]one of [the] evidence presented by the parties provides a contemporaneous identification of the pain pump brand.” (Hey, sparse evidence on stale cases is one of the justifications for having statutes of limitations and repose, in the first place.) But the plaintiff had two documents relating to billing—one over a year after the alleged use—that the court said created a genuine issue. So, no summary judgment on product identification.
On to partial summary judgment. The defendants tried to knock out the warnings claims by arguing there was no proof of inadequate warnings back when the product was allegedly used in 2000 and there is no post-sale duty to warn under Mississippi law. This one ended like the first two, with the court finding genuine issues of material fact precluding summary judgment, but we are confused by the result. While the court said plaintiff came up with “numerous studies in existence prior to 2000 that linked joint cartilage toxicity with exposure to foreign substance,” none of them involved the pump or medication at issue here. (The opinion does not say they involved medications at all, let alone pain medications delivered into the intra-articular space of the shoulder.) There was also no indication that the plaintiff had an expert offering an opinion that these pre-sale studies required a warning not given with the product. And there was no discussion at all of whether there was any evidence that any such hypothetical warning would have mattered at all to the surgeon who prescribed/placed the plain pump. This is not just our usual call for attention to proximate cause. In this case, the surgeon in this case was the lead author of a study published in 2000 that noted no complications with pain pumps delivering pain medication into shoulders after shoulder surgery. If the surgeon knew about these “foreign substance” studies or likely would have said “so what” if warned about them—either of which seems plausible here—then the plaintiff cannot make out a prima facie for failure to warn. But the opinion did not go into this issue and just denied partial summary judgment on warnings.
After these three denials, the defendants’ win—wait for it—may seem a little like the BlackKnight getting his blood on King Arthur after sustaining a few flesh wounds, but partial summary judgment was granted. The plaintiff apparently based part of her failure to warn claims on the argument that her use of the pain pump was beyond the indication for the product as cleared by FDA and that the defendants had promoted such off-label use in violation of 21 C.F.R. § 801. She apparently, however, did not assert a freestanding claim for violating regulations or otherwise defrauding FDA. That may be why the court granted partial summary judgment “on the plaintiff’s off-label use claim” without mentioning preemption or Buckman. It is nice to get the straightforward analysis, like we used to urge when moving on per se negligence claims based on alleged regulatory violations, that “plaintiff is barred from seeking redress for violations of the FDCA because that Act has not provided for a private right of action,” leaving enforcement up to the government. Given its analysis, the court was able to duck the harder question of whether there was any off-label promotion given the regulatory history and absence of evidence on promotion to the surgeon in the case. (The latter point being that proximate cause issue completely ignored in denying summary judgment on the broader warnings claims.) Without belaboring the regulatory history on the scope of the approved indication for the pain pump here, suffice it to say that how the court viewed FDA’s authority and competence and the deference shown different FDA decisions would likely have played a role if the court had to decide whether there was off-label promotion. More generally, the idea that courts (or their civil juries) should stay out of certain issues in drug and device products cases involves at least a legislative deference to FDA’s competence and authority.
Which brings us to PREVOR v. FDA, No. 11-1187 (RMC), 2012 U.S. Dist. LEXIS 136569 (D.D.C. Sept. 25, 2012). (We urged stretching of necks in the first paragraph. Do not make some sort of inadequate typeface argument; that would be preempted.) That is the recent case where a federal court concluded on summary judgment that “FDA acted arbitrarily and capriciously” (even accepting FDA’s evidence as true and giving FDA the benefit of all justifiable inferences) and directed FDA to reverse its prior decisions. In part because of the amici, Washington Legal Foundation and big manufacturers who can’t wait and are resourceful by nature, this was a heavyweight battle over what may seem at first blush like a fairly narrow issue: the regulatory pathway FDA selected for something called Diphoterine Skin Wash (DSW—not the place for cheap shoes) used to prevent/minimize chemical burns when there is no running water handy. You would expect more litigation over the effects of industrial chemicals getting on eyes or skin than on whether a canistered liquid propelled by pressured gas—like a fire extinguisher, we suppose—is a drug, device, a combo product that is mostly a drug, or a combo product that is mostly a device. That is what FDA’s Office of Combination Products (OCP) and then Office of Special Medial Programs (OSMP) decided, leading to a challenge under the Administrative Procedures Act (APA) by DSW’s manufacturer. (To add to the alphabet soup frenzy, PREVOR seems to like its nom in all caps.) PREVOR wanted DSW to be regulated as a device, as it apparently is in other countries, and FDA said would be regulated as drug-device combo assigned to CDER—the drug Center, as opposed to CDRH, the device Center—because the product works “primarily” as a drug.
While the fight centered on how FDA interpreted the word “primary” and got into its Latin derivations, it is the dynamic of how FDA decisions play out in litigation that really interested us. (Okay, we really did wonder why the court did not realize that “primary” is like the feminine genitive plural form for “first” in Latin, which would have gone a long way in the case and why courts get “de minimis” wrong.) As an initial matter, the ability for regulated entities to challenge the regulating body’s rules or (draft) guidelines issued to interpret its regulations promulgated pursuant to statutes enacted by Congress touches on all sorts of funky issues we do not normally see directly in litigating drug and device products cases. We do see, on the back end, how early decisions from FDA on whether medical products have to be approved as drugs, approved as PMA devices, cleared as 510(k) devices, or something else can affect, well, just about everything. We will resist the Bexian urge to elaborate on the divergent treatment of federal preemption based on a medical product’s regulatory pathway and history.
Now, we do not see how the PREVOR decision itself comes into evidence or would filter into the jury’s thinking about FDA, which is more likely to be influenced by news about E. coli in spinach. But judges are also sensitive to perceptions about FDA and not just from the usual plaintiff repetitions of criticisms from IOM, GAO, and Sid Wolfe. In PREVOR, it was a manufacturer (with its amici) pushing to have FDA’s decisions labeled as “arbitrary, capricious, and unsupported by law,” which sounds worse than “the product of understaffing and tight deadlines” we sometimes hear from the products plaintiffs. Other than just urging your judge that the regulatory process worked like it was supposed to work for the drug or device whose manufacturer you are defending a product case, we think that a little deeper dive into the impact of FDA’s goal of promoting public health may help.
In PREVOR, FDA never explained why it took a position on interpreting the word “primary” that would increase the chances that a medical product would be treated as a “drug” or a combination product over which the drug Center (CDER) would have principal purview. It seems obvious that the interpretation policy was in fact driven by the result rather than simply making it easier for OCP to handle Requests for Determination of how a medical product would be classified. In general, drugs are harder to get approved than devices, certainly new drugs are harder to get approved than non-PMA devices. Drug-device combo products assigned to CDER have a harder path than drug-device combo products assigned to CDRH. It so happens that CDER has more medical professionals on staff than CDRH and probably more review staff overall. In terms of public criticisms of approval/clearance staffing and performance, CDRH has gotten hammered even more than CDER. (On complaints about post-marketing surveillance, CDER is clearly the favorite target.) So, from a resources and public relations perspective, FDA management may want to make as many products—particularly the burgeoning number of combo products—go through CDER to get to market as possible. It probably increases total user fees to pay for more reviewers. Maybe that even furthers public health. Maybe the FDA erring on the side of promoting public health is consistent with why pain pump plaintiffs should be “barred from seeking redress for violations of the FDCA” or why FDA decisions on approvals and labeling should lead to federal preemption or at least useful presumptions under some state product liability acts. Maybe. It is certainly more palatable than trying to argue to a judge that the products plaintiff should not be able to pursue some of all of her claims because of FDA actions that could very well have been arbitrary and capricious.