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).

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

This discussion of an opinion in the Pelvic Mesh litigation once again comes only from the Dechert side of the blog. The MDL court in the pelvic mesh litigation issued rulings on motions in limine last week.  In re: Bard, Inc. Pelvic Repair Sys. Prods. Liab. Litig., MDL No. 2187, 2:11-cv-00195, 2:11-cv-00012, 2:10-cv-01224, 2:11-cv-00114, 2013 U.S. Dist. LEXIS 90210 (S.D.W.V. June 27, 2013).  In previous pretrial rulings, the defense made out well, winning summary judgment on a number of plaintiffs’ claims, including a failure to warn claim in one case (see here and here), and winning a number of key Daubert motions (here).  Things didn’t go as well with the in limine motions.  It was more of a mixed bag.  Here are a few of the issues addressed by the court.

FDA 510(k) Clearance 

This was plaintiffs’ motion.  They wanted to exclude evidence related to the FDA’s clearance of the Avaulta products through its 510(k) process.  Id. at *4-6.  Seems pretty relevant, doesn’t it?  It’s the process established by the industry’s primary regulator as to what the industry must do and how it must do it in order to be able to bring its product to market.  Yet the court granted plaintiffs’ motion.

Continue Reading Pelvic Mesh Litigation: In Limine Rulings

Not quite a year ago we had a little fun commenting on the Daubert dismissal of a suit involving something called an “ear candle.”  As we said back then:

[W]e never thought about lighting a candle in our ear.  That seems a little strange.  Maybe even a little risky.  We can’t think of a good

Bexis gave blood last weekend at the Red Cross – not just any old donation, either, but pheresis, a procedure that takes a couple of hours to complete.  Because pheresis takes that long, the Red Cross supplies donors with movies to watch.  This time it was the 2006 James Bond remake, “Casino Royale,” the type of movie that Bexis waits for the Red Cross rather than actually spends money to see.  In “Casino Royale” a delectable baddie poisons 007’s martini with digitalis, nearly causing him to die from a v-fib.

Bexis being Bexis, James Bond’s digitalis overdose got him wondering about whatever happened to the Digitek MDL, which involved an FDA-approved form of digitalis, called Digoxin.  We hadn’t posted anything about it in well over a year, since the court blew out some meritless economic loss class actions.  Before that, we were impressed by the MDL court’s Rule 11-based order requiring the plaintiffs’ counsel to demonstrate that they’d done a bare minimum of investigation of their clients’ supposed “cases” before filing suit.

Turns out, we didn’t have long to wait.  Yesterday, Madeleine McDonough over at Shook Hardy was good enough to tip us off to the ignominious end of that MDL.  Yesterday, the MDL court filed three orders (documents 70, 149, and 608) that, frankly, all look pretty much the same to us.  They all go under the general description of PTO (that’s “pre-trial order” for you laypeople) 87, so we’re only attaching the one that’s actually called that.

Our first reaction:  My God!  Has there ever been a more meritless MDL?  We thought Bone Screw was bad, since the plaintiffs never in ten years of litigation were able to find a practicing orthopedic surgeon who would opine on defect.  But at least in (some of) those cases there were broken screws.  In Digitek, the plaintiffs couldn’t even prove exposure to the allegedly defective product!  The alleged “defect” was that some Digitek tablets were manufactured bigger than they were supposed to be and thus contain too much of the active ingredient (see James Bond).  But it turns out that, after years of litigation, no plaintiff ever proved that a single one of the supposedly defectively too large Digitek tablets was ever sold to any consumer.

Continue Reading The Ignominious End Of The Digitek Mass Tort

Last week, the court in a pain pump case, Musgrave v. Breg, Inc., 2011 U.S. Dist. LEXIS 113661 (S.D. Ohio Oct. 3, 2011), denied ten plaintiff motions in limine. That, in itself, is good news. The rulings aren’t especially intricate. You might even call them easy. Some of the language employed by the court to explain why the rulings were so easy might give some of us defense hacks reason to pause. We’ll get to that in a moment.

We’re not saying the Musgrave case isn’t interesting — it is. But we have to admit that it’s not nearly as interesting as the Martin Scorsese documentary on George Harrison that aired on HBO last week: Living in the Material World. Harrison is the Drug and Device Daughter’s favorite Beatle, and it’s easy to respect that choice. The Quiet Beatle was spiritual and cool. It was inevitable that he would be overshadowed by the Lennon/McCartney songwriting juggernaut, but Harrison did pretty well in his own write. “Don’t Bother Me” was a great early Beatles song, and “Something” was a great late one. Moreover, Harrison’s post Beatles career suggests that he was a better collaborator than the others. George worked successfully with Clapton, Dylan, Petty, and Orbison. By contrast, John worked with Yoko. Paul worked with Linda. Ringo has worked with assemblies of All Stars, but only to redo old hits, not to create something new. And Harrison single-handedly saved Monty Python’s Life of Brian.

So as a silly way of honoring Harrison and keeping ourselves amused, we’re going to ‘cite’ some Harrison songs while discussing the Musgrave rulings.

It Don’t Come Easy – Yes, it’s a Ringo song, and Harrison isn’t credited, but Harrison actually co-wrote it and a demo exists of George performing it with a guide vocal for Ringo. Before the Musgrave court issued its rulings, it spent time – way too much time – emphasizing how tough it is to preclude evidence via in limine motions: “To obtain the exclusion of evidence under such a motion, a party must prove that the evidence is clearly inadmissible on all potential grounds.” 2011 U.S. Dist. LEXIS 113661 at *5. The court expressed a strong preference not to issue in limine rulings but, rather, to wait for trial proceedings to supply “proper context.” Id. at *6. It almost sounds like a presumption against in limine rulings. But waiting for “context” isn’t always necessary. It can make trial preparation and/or settlement more difficult, and that “context” might mean that the inadmissible, prejudicial material has already been paraded in front of the jury. So while we like this court’s rulings, we aren’t fans of the prologue.

Continue Reading Heading for the Light: Something for Everyone in Recent Pain Pump In Limine Rulings

As much as we like blogging, first and foremost we’re lawyers who represent clients in court.  Our clients tell us how much we can say about litigation we’re involved in, and when they say “not much,” that’s what we do.  If that has the odd effect that we’re sometimes more effusive about other lawyer’s wins