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 guest posters deserve 100% of the credit (and any blame) for their thoughts published here.  We only provide the forum.

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In Merck Sharp & Dohme Corp. v. Albrecht, the Solicitor General as amicus curiae argues that judges, not juries, are best suited to evaluate the scope of an FDA determination. Brief of the United States as Amicus Curiae Supporting Petitioner, Merck Sharp & Dohme Corp. v. Albrecht, (No. 17-290), 2018 WL 4562163 (filed Sept. 20, 2018).  Judges, he says, “are trained and experienced in construing legal documents and are far better equipped to understand agency decisions in light of the governing statutory and regulatory context.”  Id. at *15.

To support his argument, he cites the Administrative Procedure Act’s statement that a reviewing court shall “determine the meaning or applicability of the terms of an agency action,” 5 U.S.C. § 706, and precedent that has looked to judges to interpret the meaning of prior adjudications.  See id. at 18-20.

While that case has nothing to do with either medical devices in general or 510(k) clearance in particular, Supreme Court agreement with the Solicitor General on this point could radically alter the way courts view the admissibility of 510(k) clearance, at least where Class II devices are concerned.  To gain 510(k) clearance, unless the FDA decides that more is required, the manufacturer need only establish that a new device is as safe and effective as an existing lawfully marketed device.  No other evidence of safety and effectiveness is required in the absence of FDA action.

At present, courts have treated the meaning of 510(k) clearance as a subject for warring expert testimony as to its meaning, as discussed here on the blog (discussing In re Cook Medical, Inc. IVC Filters Mktg., Sales Practices and Prod. Liab. Litig., 2018 WL 6617375 (S.D. Ind. Dec. 18, 2018)).  In other cases evidence of clearance has been excluded, with one explanation being the mistaken theory that the evidence was of such slight probative value that the battle was best avoided.  In re C.R. Bard, Inc. MDL No. 2187, 810 F.3d 913, 922 (4th Cir. 2016). [Ed. note: Other cases, collected and discussed here, admit evidence of FDA device clearance.]

But if the United States Supreme Court decides that preemption issues are treated as purely legal, the courts will be forced to examine the statutory context that controls Class II clearance using 510(k).  That context shows that such a clearance is almost always an FDA “determination” that the device, with whatever special controls that the FDA ultimately imposes, does not present a potential unreasonable risk of illness or injury.  Nothing could be more relevant to a product liability claim.

To begin at the beginning, in 1976 Congress directed the FDA to engage in a sort of regulatory “triage.”  Triage sorts patients according to the seriousness of their injuries and gives them different levels of care.  The FDA’s statutory scheme sorts devices according to the seriousness of the risks they present and requires different levels of premarket review.

More precisely, Congress directed the FDA to engage medical panels to classify medical devices according to their need for regulation.  Congress specified the qualifications the panel members were to have. 21 USC § 360c(b).  The FDA methodically proceeded over the ensuing decades to classify device types into classes I, II or III according to the risk they present.  It convened the panels, held hearings, published panel recommendations, entertained comments from the public, and fixed the classifications.

Devices that present little risk, such as tongue depressors, were put in Class I and do not need FDA review before they are sold to the public.

Moderate risk devices, such as surgical suture, were put in Class II and, if not exempt, must be “cleared” by the FDA before they are marketed.  To gain Class II clearance, the manufacturer must show in a §510(k) submission that they are as safe and effective as an existing Class II legally marketed device that presents a moderate risk.

Finally, devices that may “present a potential unreasonable risk of illness or injury” or are for sustaining life, such as a pacemaker, were put in Class III and generally must be “approved” by the FDA based on extensive independent evidence of their safety and effectiveness.  21 U.S.C. § 360c(a)(1)(C).

On its face, this is a reasonable way to regulate medical devices.  In fact, Congress stated in the statute that it believed this system of classification and review provided “reasonable assurance” of safety and effectiveness for each class of medical device.  21 U.S.C. § 360c(a)(1)(A), (B), (C).

It is encouraging, but not necessary, to observe that the FDA’s sorting of devices seems to have worked.  Even though they receive less FDA scrutiny, “cleared” devices of moderate risk are less likely to result in a serious recall than “approved” devices that may present an unreasonable risk.  One study showed that while 510(k) cleared devices constitute 98% of all devices, they account for only 71% of serious recalls.  And the 2% of devices that are PMA-approved made up 19% of serious recalls.  Jeffrey Shapiro, Substantial Equivalence Premarket Review: The Right Approach for Medical Devices, 69 Food & Drug L.J. 365, 389-390 (2014).

But that is not all. According to the statute, placement in Class II is itself a determination of safety.  If a device is a Class II device, then, with special controls, it usually does not present “an unreasonable risk of illness or injury” that would require it to be in Class III.  21 U.S.C. §360c(a)(1)(C).  The FDA has made that determination based on the initial work of a medical panel and information in the §510(k) which confirmed that the specific device fell within the panel’s classification of the device type.  Otero v. Zeltiq Aesthetics, Inc., 2018 WL 3012942 *3 (C.D. Cal. June 11, 2018).  This can be confirmed when the decision classifying the device type expresses the opinion that there is no unreasonable risk, or uses words to that effect.

In other words, clearance of a moderate risk device using 510(k) is normally a sign of relative safety, even though the FDA review of more risky Class III devices is more rigorous.  That is what the statute says, and experience seems to bear that out.

If the Supreme Court should agree that the interpretation of an FDA decision is a matter of law for the court, then in any case involving a Class II device, the defendant should be entitled to an instruction on the meaning of that decision.

If the FDA decision classifying the device type rests on a finding of no unreasonable risk then, as a matter of law, the defendant should be entitled to an instruction that “The United States Food and Drug Administration has cleared this device for marketing as a Class II device.  That clearance is a determination that there is reasonable assurance of its safety and effectiveness and that, with whatever special controls may have been imposed, the device does not present a potential unreasonable risk of illness or injury.”

Such an instruction would, of course, be radically different from the treatment courts have recently given §510(k) clearance.  Those courts have not only mistakenly allowed juries to decide the meaning of §510(k) clearance, but they have done so in part because of fundamental legal error in the way they have examined §510(k) clearance.

The fundamental error of those courts has been to overlook the distinction between the normal use of §510(k) to clear devices of a type placed in Class II, and the increasingly rare transitional use of §510(k) to clear devices in Class III based on a pre-1976 predicate.

The use of pre-1976 predicates originated in an interim provision Congress adopted in 1976, when the statutory scheme was new. Congress put all implantable devices in Class III as presenting an unreasonable risk pending medical panel review to reclassify them.  Then, anticipating that it would take medical panels a long time to do their work – and has taken more than 40 years – it allowed these devices to be “cleared” using §510(k) if they could be shown to be equivalent to a device on the market in 1976.  This process, unlike the normal use of §510(k), did not involve any medical panel review and did not require equivalence to a classified device.

This increasingly rare scenario was what the Supreme Court addressed in Medtronic v. Lohr, 518 U.S. 470, 477 n.3 (1996), which, quite incorrectly, has been taken as being representative of all FDA clearance decisions.  But it is not. In fact, now that the medical panel reviews of devices with a potential high risk appear to have been almost completed, the scenario is not representative of practically anything that the FDA is still doing today.  See FDA, FDA Has Taken Steps to Strengthen The 510(k) Program 7 (November 2018).

Where a device has been placed in Class II in what is now the ordinary fashion − based on equivalence in safety and effectiveness to a predicate device placed by a medical panel in Class II because its risks are reasonable − that decision, as a matter of simple statutory interpretation, is a determination of safety.  Even if juries are free to disagree with it, they should not be allowed to ignore it. What the Supreme Court tells us in Merck Sharp & Dohme Corp. may have effects far beyond the resolution of the case at hand.

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 liability litigation involving FDA-regulated drugs and devices.  In 2013 we found a half dozen §510k cases directly on point. Block v. Woo Young Medical Co., 937 F. Supp.2d 1028, 1047 (D. Minn. 2013); Placencia v. I-Flow Corp., 2012 WL 5877624, at *6 (D. Ariz. Nov. 20, 2012); Musgrave v. Breg, Inc., 2011 WL 4620767 (S.D. Ohio Oct. 3, 2011); Pritchett v. I-Flow Corp., 2012 WL 1340384, at *5 (D. Colo. Apr. 18, 2012); Miller v. Stryker Instruments, 2012 WL 1718825, at *9 (D. Ariz. Mar. 29, 2012); In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, 2007 WL 1964337, at *7 (D. Minn. June 29, 2007); Corrigan v. Methodist Hospital, 874 F. Supp. 657, 658 (E.D. Pa. 1995); Strum v. Depuy Orthopaedics, Inc., 2013 WL 3184765, at *1 (Ill. Cir. March 8, 2013).

Then, in the Mesh litigation, rulings began to change the law on the premise that, because the United States Supreme Court in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), had held that §510k clearance was not preemptive – that is, not entitling a defendant to judgment as a matter of law – it was not even relevant in product liability litigation.  This argument turned on taking a phrase from Lohr out of context:  “[T]he 510(k) process is focused on equivalence, not safety” (id. at 493) and applying it in the evidence context.  As we had pointed out, so doing was contrary to the Supreme Court’s Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), decision holding that §510(k) clearance was intended “to ensure . . . that medical devices are reasonably safe and effective.” Id. at 349-50.  Our more recent blogposts have pointed out:  (1) that the FDA now considers §510k clearance to involve considerations of safety and effectiveness, and that (for a variety of reasons) the continued viability of Lohr itself is open to question.

Nonetheless, defendants in mesh litigation have largely been deprived of well-established FDA compliance evidence, and based on the capacious abuse of discretion standard applicable to evidentiary decisions at trial, such rulings have been upheld on appeal. See Eghnayem v. Boston Scientific Corp., 873 F.3d 1304, 1317-18 (11th Cir. 2017) (discussed here); In re C.R. Bard, Inc., MDL. No. 2187, Pelvic Repair Systems Products Liability Litigation, 810 F.3d 913, 921-22 (4th Cir. 2016) (discussed here) (“Cisson”); but see Winebarger v. Boston Scientific Corp., 2015 WL 5567578, at *7 (W.D.N.C. Sept. 22, 2015) (rejecting MDL rulings and admitting §510k clearance evidence in mesh case).

Yesterday, however another MDL judge considered the admissibility of §510k evidence, and held it admissible, flatly rejecting the Mesh decisions.  See In re Bard IVC Filters Products Liability Litigation, 2018 WL 582542 (D. Ariz. Jan. 29, 2018).  In IVC Filters, Judge David Campbell allowed the defendant’s “FDA defense,” ruling that the jury should be allowed to hear about §510k devices’ FDA pedigree.  Id. at *2.  Such evidence was doubly relevant under relevant state law:

  • “Georgia courts have adopted a risk-utility analysis for design defect claims. . . . One of the many factors a jury may consider in its reasonableness determination is the manufacturer’s compliance with federal regulations.” Id. at *2 (citation omitted).
  • “The evidence is also relevant to Plaintiff’s punitive damages claim. Under Georgia law, . . . [c]ompliance with federal regulations is not sufficient to preclude an award of punitive damages, but it is probative.” Id.

Coincidentally, Cisson also purported to interpret Georgia law, but reached a diametrically opposite conclusion.

IVC Filters rejected the false equivalence between preemption and relevance, and Mesh courts’ misapplication of Lohr:

Plaintiffs note, correctly, that the 510(k) process focuses on device equivalence, not device safety.  [Lohr citation omitted]  But this does not render evidence of the 510(k) process irrelevant to the reasonableness of [defendant’s] conduct.  The FDA grants 510(k) clearance only where the device “is as safe and effective as a [predicate device] and does not raise different questions of safety and efficacy than the predicate device.” Safe Medical Devices Act of 1990, Pub. L. No. 101-629, § 12(a)(1)(A)(ii).  The 510(k) process may not speak directly to the applicable standard of care . . ., but it does have probative value in the determination of this action.

Id. at *2 (citation omitted).  See also Id. at *3 n.2 (a preemption decision does “not address[] any evidentiary issue” and even as to preemption “the 510(k) process can in some circumstances preempt state law claims”) (citations omitted).

The excuses given for exclusion in Cisson, the jury giving clearance undue weight and a possible “mini-trial” regarding compliance, could “be adequately addressed without excluding relevant evidence to the detriment of Defendants.”  Id. at *3.  Reasonable “time limits” for each side’s evidence would prevent FDA issues from devolving into any “mini-trial.”  Id. at *4.  On the merits:

Both sides, through appropriate expert testimony or other admissible evidence, will be permitted to tell the jury about the role of the FDA in its oversight of medical device manufacturers, the regulatory clearance process for devices such as IVC filters, and [defendant’s] participation in the 510(k) process and its compliance (or lack thereof) with that process.

Id.  “[A]ny potential confusion” did not require exclusion, but only “a limiting instruction regarding the nature of the 510(k) process.”  Id. Indeed, IVC Filters correctly observed that the issue of jury confusion more likely cuts the other way – in favor of admission of FDA evidence:

[T]he absence of any evidence regarding the 510(k) process would run the risk of confusing the jury as well.  Many of the relevant events in this case occurred in the context of FDA 510(k) review, and much of the evidence is best understood in that context. Attempting to remove any references to the FDA from the trial would risk creating a misleading, incomplete, and confusing picture for the jury.

Id.  “[I]f the evidence was half-baked, containing some references to the FDA but not explaining what role the FDA played with respect to the [IVC] filters, the jury would be left to speculate about the FDA’s involvement and conclusions.”  Id.

Until IVC Filters, we had feared that a single mass tort, under a discretionary standard of review and with the unwillingness of appellate courts to require MDL do-overs, could tilt the evidentiary playing field towards what IVC Filters cogently described as “a misleading, incomplete, and confusing picture for the jury” that excluded §510k clearance evidence that previously been admissible almost as a matter of course.  Now our side has a clearly articulated and compelling opposing view to argue.

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.

Continue Reading FDA Off-Label Promotion Memo Should Affect §510k Preemption & Evidence

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.

Continue Reading Fourth Circuit Flubs Admissibility of 510k Clearance

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.

Continue Reading Section 510(k) Clearance: While it Doesn’t Support Preemption, Is It Relevant Evidence at Trial?

“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.

Continue Reading Warning Letters and Jurisfiction

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.

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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).

Continue Reading FDA Alert based on Adverse Event Reports Admitted in Med-Mal Case

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.

Continue Reading Hip Rulings on Split Screens, Expert Fees, Recalls, Collateral Source, and 510(k) Clearance

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.

Restatement (Third) of Torts, Products Liability §4(b) (1998).  The supporting Reporters’ Note to §4(b) confirms:

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.

Continue Reading FDA Device Clearance – Clearly Relevant