We’ve blogged numerous times about the tentative, non-final, and informal status of FDA warning letters (and untitled letters and similar enforcement precursors like Form 483s). We’ve cited precedent, FDA internal manuals, FDA’s own position taken in formal briefing, and learned treatises on FDA law. That an FDA warning letter has no binding legal effect (indeed,
Today’s guest post, by Luther Munford of Butler Snow, engages in one of our currently favorite activities, that being informed speculation on what might be the consequences of a favorable Supreme Court resolution of its currently pending preemption appeal in Merck Sharp & Dohme Corp. v. Albrecht. We hope he’s right. As always, our…
As we demonstrated in a post back in 2013, FDA compliance evidence generally − and the fact of a medical device’s clearance as “substantially equivalent” in safety and effectiveness to a predicate device under §510k of the Medical Device Amendments (now 21 U.S.C. §360c(f)(1)(A)) specifically – had for decades been admissible evidence in product…
Remember how Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), dismissed the §510k “substantially equivalence” medical device clearance as non-preemptive because it was supposedly “focused on equivalence, not safety”? Id. at 493. In the same vein:
“[S]ubstantial equivalence determinations provide little protection to the public. These determinations simply compare a post − 1976 device to a pre − 1976 device to ascertain whether the later device is no more dangerous and no less effective than the earlier device. If the earlier device poses a severe risk or is ineffective, then the later device may also be risky or ineffective.”
Id. (quoting from pro-plaintiff law review article).
Most of our readers know that this characterization, assuming it was true for the 1980s-era (implanted 1987) device that the Court considered in Lohr, was no longer true, even at the time Lohr was decided, and certainly hasn’t been the case since the FDAAA was passed a year after Lohr was decided. Still, this anachronistic view of §510k has flourished for twenty years, affecting first preemption and now (thanks mostly to Mesh MDL rulings) admissibility of evidence.
That’s why we were interested in what the FDA had to say about today’s §510k clearance process in its recent memorandum entitled “Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products,” which is available here. One of our guest bloggers, Liz Minerd, recently discussed the First Amendment aspects of that document, here.
This post is from the non-Reed Smith side of the blog.
We’ve put it off long enough – time to deal with the awful decision in C.R. Bard v. Cisson, __ F.3d __, 2016 WL 158814 (4th Cir. Jan. 14, 2016). When we posted our 2015 Top Ten, we noted that we were watching Cisson because it had the potential to be among our top or bottom 10 of 2016. Well, the top is definitely off the table and while it’s still early, the bottom is certainly in the running.
A quick background of the case. Cisson is an appeal from the first trial in the massive Pelvic Mesh MDL. Plaintiff underwent implantation of defendant’s pelvic mesh device and began experiencing pain. Two years later, she had surgery to remove the device, but the “arms” of the device could not be removed. Id. at *1. In 2013, defendant won summary judgment on many of plaintiff’s claims leaving only design defect and failure to warn to proceed to trial. Id. at *2. The trial resulted in a plaintiff verdict, including a sizeable punitive damages award. Id. at *1.
This post comes from the non-Reed Smith side of this blog.
With some courts, the § 510(k) clearance of a medical device is not only insufficient to support preemption. It’s not probative enough to be discussed at trial. The MDL court in the Boston Scientific Pelvic Repair System Products Liability Litigation is one such court, consistently excluding from trial evidence of 510(k) clearance of the pelvic mesh device. According to a recent decision by one of the courts overseeing a trial on remand from the MDL, the MDL court read Medtronic v. Lohr to hold that § 510(k) clearance addresses only the device’s equivalence with an already marketed device, not safety. Winebarger v. Boston Scientific Corp., 2015 U.S. Dist. LEXIS 126616, at *13-14 (W.D.N.C. Sept. 22, 20150) (describing the basis for the MDL court’s decision).
We’re not so convinced. The 510(k) process is not a complete abandonment of safety considerations. And it certainly provides evidence of whether the manufacturer behaved reasonably. Congress enacted the 510(k) process, in part, to enable quicker clearance for new devices that are equivalent to devices that have already been on the market and have accumulated some sort of safety and efficacy record. Moreover, the 510(k) process is an inescapable reality for device manufacturers. A discussion of the process, how it was followed, and the safety information that was provided or available through the marketing of equivalent devices is relevant to assessing the reasonableness of the manufacturer’s actions. If plaintiffs want to minimize its importance, establish that it says nothing about safety, or show what the manufacturer failed to do, they are free to present such evidence. The jury can then decide the relevance of this evidence.
Fortunately, the remand court, applying North Carolina law, got this right – sort of. In North Carolina, a jury may consider the “extent to which the design or formulation [of the device] conformed to any applicable government standard.” Winebarger, 2015 U.S. Dist. LEXIS, at *19 (quoting North Carolina’s Product Liability Act). And so, unlike the MDL court, the remand court determined that evidence of § 510(k) clearance is admissible. But introduction of that evidence will likely come with a fairly severe limiting instruction:
The fact that BSC followed the requisite 510(k) protocol – limited as it is – prior to marketing its Uphold device has minimal probative value regarding BSC’s efforts to adhere to FDA processes and procedure generally. . . . Admissibility might depend upon a limiting instruction that 510(k) clearance is not to be considered as evidence that the FDA authorized the Uphold as safe and approved its intended use as such; that 510(k) clearance is not evidence that BSC satisfied any standard of care in designing the Uphold device. For these reasons, the Court’s preliminary ruling on Plaintiff’s motion is that the 510(k) clearance process is admissible subject to a limiting instruction consistent with the terms of the instant Order.
Id. at *22-23.
“Jurisfiction” is a word coined by Jasper Fforde, author of the Tuesday Next series, one of the more sophisticated set of children’s works that has come to populate this post-Harry Potter era. To be very brief, Jurisfiction is the fictional police force for BookWorld, one of Fforde’s fictional universes. Tuesday is a Jurisfiction agent (sometimes rather more than that).
“Jurisfiction,” unfortunately, is also something we see in our line of work, sometimes making us wonder whether the likes of Emperor Zhark, the Red Queen, and Pinky Perkins may have aliases who serve in the all-too-real judicial branches here in the States. Jurisfiction is shorthand for a decision that gets a legal issue totally bollixed – perhaps applying the UltraWord to the issue – allowing the user to control the plot, garbling it, and ultimately making all precedent useless.
We recently ran across a shining example of jurisfiction in the discussion of FDA warning letters found in Mihok v. Medtronic, Inc., ___ F. Supp.3d ___, 2015 WL 4722847 (D. Conn. Aug. 10, 2015). Here’s what Mihok held on that subject:
The Complaint is rooted in FDA Warning Letters which state that [defendant] failed to comply with the CGMP regulations. . . . While perhaps not dispositive on the issue, the FDA’s conclusions and interpretations of its own regulations are likely to receive a considerable degree of deference. See, e.g., Conroy v. Dannon Co., Inc., No. 12 CV 6901(VB), 2013 WL 4799164, at *6 (S.D.N.Y. May 9, 2013) (stating that the FDA’s interpretations of its own regulations promulgated under title 21 “are ‘controlling unless plainly erroneous or inconsistent with the regulations’ or there is any other reason to doubt that they reflect the FDA’s fair and considered judgment”) (citing and quoting PLIVA, Inc. v. Mensing, ––– U.S. ––––, ––––, 131 S.Ct. 2567, 2575, 180 L.Ed.2d 580 (2011)); Dorsey v. Housing Auth. of Baltimore City, 984 F.2d 622, 632 (4th Cir. 1993) (finding district court abused its discretion in refusing to consider regulatory agency’s assessment of defendant’s compliance with agency regulations and noting that the district “court should welcome [the agency’s] appraisal of [the defendant’s] compliance with regulations, given its concern for deference to agency interpretations of its own regulations”). Indeed, it is precisely when a court is called upon to interpret the regulations, i.e., when they are ambiguous, and where their application to facts raises complex issues, that the court is most likely to defer to the FDA’s prior determinations. See Wilson v. Frito-Lay N. Am., Inc., 961 F. Supp.2d 1134, 1142 (N.D. Cal. 2013) (noting that “an agency’s informal interpretation of its own ambiguous regulation is [typically] controlling” but declining to give “deference to two warning letters that the FDA sent” because neither party to the case “contended that the FDA regulations . . . [w]ere ambiguous, and the Court d[id] not find that they [we]re”); James T. O’Reilly, et al., 1 Food & Drug Admin. §4:56 (4th Ed. 2015) (“The FDA is allowed great deference in the interpretations of its own regulations…. The more complex the issue, the more scope is likely to be given for the FDA to draw the interpretations.”).
As to deference, Defendants cite a non-binding case, Schering-Plough Healthcare Prods., Inc. v. Schwarz Pharma, Inc., 547 F. Supp.2d 939 (E.D. Wisc. 2008), for the proposition that “a warning letter from the FDA is not considered a final agency action,” and contend that, as a result, “Plaintiffs’ allegations … raise legal questions as to the potential effects of various actions by a federal agency … [which] should be decided in a federal forum.” The Second Circuit has not taken a position on whether an FDA Warning Letter is considered a final agency action. Even if it is not, such letters may still be entitled to deference. See Cmty. Health Ctr. v. Wilson-Coker, 311 F.3d 132, 138 (2d Cir. 2002) (“[E]ven relatively informal [agency] interpretations, such as letters from regional administrators, warrant respectful consideration” where the statute at issue is complex and the regulatory agency possesses “considerable expertise”) (citations and quotations omitted). Regardless, they may serve as evidence of regulatory violations. Gelber v. Stryker Corp., 788 F. Supp.2d 145, 155–56 (S.D.N.Y. 2011) (finding plaintiffs who provided FDA Warning Letters as evidence of violations of FDA regulations stated claims for manufacturing defects).
Mihok, 2015 WL 4722847, at *5-6 (citations not omitted, for once). Under this analysis, there being no undecided FDA-related issue, Mihok was remanded to state court.
In an embarrassment of riches, we have two guest posts in one day. This one is by Luther Munford and Erin Lane of Butler Snow. They wish to point out that they represent Ethicon in surgical mesh litigation, which is the context that their post concerns. We have mesh involvements of our own, so our normal disclaimer goes double for this one: The views expressed by our guest bloggers are their own. They get all the credit, and any blame, for what appears in this post, the subject matter of which is the admissibility of FDA 510k clearance in mesh litigation. That’s related to a post we did a couple of years ago on this same general topic.
Without further ado, we give you Luther and Erin.
Congress said in the Medical Device Act of 1976 that the purpose was to provide “reasonable assurance” that devices were safe and effective. 21 U.S.C. §360c(a)(1). Yet, here we are in 2014 and a skillfully-written plaintiff’s brief says, with a straight face, that the administration of the Act allows devices on the market “without any safety review.” Opening Brief of Appellees/Cross Appellants Donna Cisson and Dan Cisson, United States Court of Appeals for the Fourth Circuit No. 15-1102(L), June 1, 2015, p.33.
How could this be?
It is a slight-of hand worthy of a shell game, but it is a game to which many observers have fallen victim, even those who have looked very carefully.
The shell under which the bean appears to be hidden is, of course, Medtronic v. Lohr, 518 U.S. 470, 493 (1996). In that 1996 decision, the Supreme Court in dictum declared that the “focus” of most of the FDA’s medical device regulation process was “not safety.” The Court said this because Congress had allowed the FDA to clear for sale new devices “equivalent” to others that had “never been formally reviewed … for safety or efficacy” because they were sold before the medical device law went into effect in 1976. In other words, Congress had grandfathered them.
Even those critical of Lohr have assumed that it is where the bean lies. They have just argued that the shell has morphed into something different. They have assumed that grandfathering remains important and have just contended that statutory amendments have strengthened the requirements for clearance. See Ralph F. Hall and Michelle Mercer, Rethinking Lohr: does “SE” Mean Safe and Effective, Substantially Equivalent, or Both?, 13 Minn. J.L. Sci. & Tech. 737 (2012); James M. Flaherty Jr., Defending Substantial Equivalence: An Argument for the Continuing Validity of the 510(k) Premarket Notification Process, 63 Food & Drug L.J. 901, 907-916 (2008) (survey of statutory and regulatory changes). See also FDA, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]/Guidance for Industry and Food and Drug Administration Staff (2014) at p. 6 (“principles of safety and effectiveness underlie the substantial equivalence determination in every 510(k) review”).
But in fact, for most of the medical devices that enter the market today, grandfathering is irrelevant. It is irrelevant because the 1976 Act established an alternative to grandfathering, i.e. clearance based on post-1976 predicate devices classified after what can be called a very “formal review” of their risks and benefits. To stretch the metaphor beyond the breaking point, the shell under which the bean truly lies today is not grandfathering, but classification.
In the Act, Congress instructed the FDA to convene medical panels to classify devices. And where after 1976 the FDA classified a device or group of devices as presenting a low or moderate risk, the statute authorized clearance based on
equivalence to the classified device. As stated in 21 U.S.C.§ 360c(f)(1)(A), clearance can be based on a predicate device marketed after 1976 which “has been classified in class I or II.”
So where a device group has been classified, the answer to the question, “equivalent to what?” is quite different from the answer given by Lohr, which dealt with a Class III device for which this alternative was not available. It is not “equivalent to
my grandfather” as was the case in Lohr. It is “equivalent to a device classified by the FDA as being reasonably safe and effective” after 1976.
In order to look at how the classification process has worked, it is helpful to examine the governing law as it has been
applied to the product group at issue in Cisson, surgical mesh.…
Continue Reading Guest Post – Classification: When “Equivalence” Means “Safety”
Bad news arrives in all sorts of vehicles, not just product liability suits. For example, in a medical malpractice case, the E.D. of Tenn recently issued a ruling that admitted an FDA Alert into evidence. Guthrie v. Ball, 2014 U.S. Dist. LEXIS 148900 (E.D. Tenn. October 17, 2014). That ruling displeased us, but since to be forewarned is to be forearmed, we share it with you in an effort to get all of the week’s nasty rulings behind us before we are halfway through hump day.
In Guthrie, the plaintiff’s counsel sought to use an FDA Alert sent to physicians regarding the risks of fentanyl patches. Specifically, the plaintiff’s counsel used the FDA Alert during depositions of expert witnesses. It appeared that the plaintiff’s counsel was attempting to use the FDA Alert to establish the standard of care. The doctor defendant filed a motion in limine to exclude the FDA Alert on the ground that it was inadmissible hearsay to which no exception applied, including the 803(8) hearsay exception. Among other things, the defendant argued that the FDA Alert did not contain a statement identifying the office responsible for the alert or reflect the FDA’s activities, did not indicate whether it pertained to a matter observed under a legal duty to report, and did not appear to reflect actual findings from a legally authorized investigation. Rule 803(8) creates an exception to the hearsay bar for “[a] record or statement of a public officer if: (A) it sets out: (i) the office’s activities; (ii) a matter observed while under a legal duty to report …; or (iii) in a civil case …. factual findings from a legally authorized investigation; and (B) the opponent does not show that the source of information or other circumstances indicate a lack of truthworthiness.” Fed.R.Evid. 803(8).