Source: https://www.druganddevicelawblog.com/tag/fda-evidence
Timestamp: 2019-04-19 11:01:44+00:00

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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.
Section 510(k) Clearance: While it Doesn’t Support Preemption, Is It Relevant Evidence at Trial?
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.
“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.
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.
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.
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.
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).
Summer used to be the season of sun, fun, and nothing of consequence happening. We remember when courts were like dormant reptiles in July and August. After June, there would be no major rulings, and certainly no trials, until the temps dropped under 85 and the kids marched sullenly back to school. Even television lazily took the Summer off. It was rerun time, and the three networks were reduced to pitching that ‘It’s new to you if you haven’t seen it.” In between the reruns, failed pilots were burned off, like greasy chicken-bits on a grill.
It’s different now. Seasons hardly matter. Some channels seize Summer as the time to introduce major, and very good, shows, such as The Bridge. Further, not all shows are introduced by ‘channels’ at all. Just as it did with Arrested Development and House of Cards, Netflix recently unleashed Orange is the New Black on the viewing populace. It has become the critics’ new darling. Moreover, watching reruns has drastically mutated, now that we can catch up on things we missed via binge-watching on demand or on DVD. For example, we took a cue from a couple of recent books about TV’s current Golden Age – Alan Sepinwall’s The Revolution was Televised and Brett Martin’s Difficult Men — and zipped through all seven seasons of the underrated The Shield (“Good cop and bad cop left for the day. I’m a different kind of cop.”). We have made it most of the way through the prematurely-ended Deadwood, where the f-bombs approach Midnight Run territory, and where the soliloquies could have been lifted from Macbeth — adding the f-bombs.
Speaking of premature endings, the death of James Gandolfini at age 51 made us rue all the great future performances we have been cheated out of (HBO had started shooting a series where Gandolfini was going to play the part of a lawyer) and remember his transcendent work as Tony Soprano. (More than one correspondent on this blog mourns Gandolfini’s passing, as evidenced here.) Without any planning, almost reflexively, we ended up binge-re-watching The Sopranos. Over 86 hours, Gandolfini turned in as impressive a body of acting work as we are ever likely to see. Make no mistake – as Carmela’s shrink says to her, “You have been told” – Tony is evil. But Gandolfini let us feel the complexity and banality and humanity of that evil. As high school students we were forced to write an essay on whether Arthur Miller’s “Death of a Salesman” was a legitimate expression of tragedy. How can someone fall from greatness if they were never really great in the conventional sense? Or can ‘great’ stem from representing something significant? If schools in the future manage to get things right, students will be asking the same thing about David Chase’s television show.
We are not exactly binge-watching drug and device law cases. But if you’ve been paying attention to this blog you know that a lot has been happening. The Mensing/Bartlett mosaic continues to assemble. California keeps emitting weird food law cases. The courts in our fair Commonwealth never miss an opportunity to make us reopen the hornbooks and reconsider our sanity. And there are even a few drug and device trials trudging through the heat.
If somebody were to ask us whether as a general proposition it’s relevant to the presentation of a product liability case about a prescription medical product that the FDA had approved/cleared the product and the defendant had complied with FDA regulations, our immediate reaction would be “Duh, of course, it’s relevant.” We may have an overriding preemption or standing argument under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), but relevance? Particular aspects of FDA approval or compliance might not pertain to the particular defect allegations in a given case, but in general, the relevance of the fact the FDA has allowed the product on the market, and that the manufacturer complied with pertinent FDA regulations, seems unassailable.
Ask that to the other side, however, and the answer will be “only if it helps me win.” Plaintiffs are more than happy to offer evidence of FDA approval/compliance evidence – but only if it’s about non-approval/noncompliance. If the FDA pedigree of a particular product doesn’t include any sort of FDCA violation, then the same counsel who so zealously advocated the relevance of the FDA last week is quite happy the next week to disavow every word of it. That happened to us recently, hence this post.
When an application is required to sell an FDA-regulated product (including almost all such products likely to be involved in litigation), the manufacturer cannot sell it in the U.S. until and unless the FDA says ‘yes.’ Indeed, over a dozen states have statutes that, to one extent or another, presume that products passing FDA muster aren’t defective. For reasons such as these, the overwhelming majority of the caselaw recognizes the relevance of the FDA’s decisions.
Putting aside preemption (which is predicated on federal, not state, legal principles) the general state-law rule is that a product’s compliance with FDA regulations – whether they’re characterized as “minimum” or otherwise, is relevant, albeit not controlling, in product liability litigation.
[A] product’s compliance with an applicable product safety statute or administrative regulation is properly considered in determining whether the product is defective.
The overwhelming majority of jurisdictions hold that compliance with product safety regulation is relevant and admissible on the question of defectiveness, but is not necessarily controlling.

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