2015

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The Pope came to Philadelphia this past weekend.  That’s not the first time this has happened (JPII stopped by in 1979), but the level of paranoia this time around led to four days of street shutdowns, parking prohibitions, and all-around dystopian security that closed roads all the way from Conshohocken to City Line Avenue to the Ben Franklin Bridge.  Commercial strangulation by the unprecedented security caused Bexis’ firm shut down its Philly office for two days.

Bexis, not being a Catholic, decided that the better part of valor was simply to get out of Dodge.  So he went to New York where instead he could follow the Devil’s Path instead.  It was good, very good – some parts considerably more perpendicular than horizontal.  The Devil’s Path and nearby areas beat the literal “hell” out of anything in Pennsylvania.  The only downside is the New York State Thruway, which in its southerly direction is prone to traffic jams for no discernable reason (of course, so is the Schuylkill Expressway in Philly, except when closed entirely for Papal visits).

While walking the Devil’s Path has its benefits, so does walking the path of compliance.  In an early blogpost on the subject of punitive damages, we collected all of the caselaw we could find where compliance with government regulatory standards precluded punitive damages.  Of all the cases we found, only a couple were from state supreme courts.  Now we have another one.  While the Pope was visiting Washington, DC, the Kentucky Supreme Court reversed a multi-million dollar punitive damages award in Nissan Motor Co., Ltd v. Maddox, ___ S.W.3d ___, 2015 WL 5626432 (Ky. Sept. 24, 2015), holding that the defendant’s undisputed compliance with (and in some ways exceeding) federal regulatory standards for automobiles precluded a finding of “gross negligence” or “reckless disregard,” which is the Kentucky standard, id. at *2, to support punitive damages.  That compliance precluded punitive damages as a matter of law even under a “slight care”/gross negligence standard is particularly notable, since many states set the bar higher for punitive damages than merely gross negligence.Continue Reading Walking the Regulatory Compliance Path Defeats Punitive Damages

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Today’s case gives us a lesson and a laugh.  The lesson is that a court can be persuaded to prevent enterprising plaintiff lawyers from turning warning adequacy and the learned intermediary rule into not-so-funny jokes.  The laugh comes from watching plaintiff lawyers invoke preemption [!] to keep frail claims alive.  The case is Small v. Amgen, Inc., et al., Case No. 2:12-cv-476 (M.D. Florida Sept. 25, 2015).  You can read the slip opinion here.  The plaintiff claimed that Enbrel, which she was taking to treat her rheumatoid arthritis, eventually caused her to suffer from a diverticulitis infection.  Before we get to the matters at hand in this opinion, we learn that the court had earlier dismissed claims for negligence per se and negligent failure to test or inspect.  That’s a nice start.  [These earlier decisions in the Small case were mentioned here and here.]  Now the defendants moved for summary judgment on the remaining claims, arguing that they were barred by the learned intermediary doctrine.

The Small case looks like it should be a big problem for the plaintiff, since the Enbrel package insert identified infections as a primary risk.  The defendants also distributed an FDA-approved medication guide that warned patients of the risk of serious infection.  Moreover, before starting her Enbrel treatment, the plaintiff was given a consent form that warned of “life-threatening infections.”  The plaintiff attempted to vault past these inconvenient facts by pointing out that there were no warnings that Enbrel could cause “asymptomatic serious infections,” and that the defendants failed to school doctors and patients “on how to mitigate and manage the risks associates with the use of Enbrel.”  None of that should matter, because the treating doctor was very knowledgeable and testified that any of this new information would not have changed her mind about prescribing Enbrel. Under the learned intermediary rule (Florida is not one of those screwy states that abrogated the learned intermediary rule or cobbled together a silly exception), the failure to warn claims should fail.Continue Reading M.D. Fla. Shuts Down Attempted End-Run Around Learned Intermediary in Enbrel Case

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So, we were preparing a post for today on Sparks v. Oxy-Health, LLC, et al, Case No. 5:13-cv-649-FL, slip op. (E.D.N.C. Sept. 15, 2015) – an opinion we pulled off a national news source.  But, we just learned that the opinion was filed under seal and subject to a confidentiality order.  Unlike mainstream reporters, as…

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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, 2015) (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?

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We learned a new word the other day while watching TV:  Autoantonym. An autoantonym is a word that means one thing, but it also means the opposite.  The word is its own antonym, and it is remarkably easy to think of examples once you set your mind to it.  The verb “dust” means to spread dust (“Bexis likes how the corner bakery dusts its pumpkin muffins with powdered sugar”). And it also means to remove dust (“Our mother judges people by how well they dust their living rooms”).  The word “fast” means moving along quickly (“Usain Bolt is really fast”).  And it also means staying firmly in one place (“The tree is holding fast against the strong wind”).  Many people think “inflammable” is an autoantonym, but it is not. It means only one thing—easily set ablaze. The antonym is “fireproof.”
Our autoantonym for today is “sanction,” which means both to punish and to permit.  Long before we learned that there was such a thing as an autoantonym, we stopped using the word “sanction” in briefs unless it was crystal clear from the context what we meant, owing to the word’s inherent ambiguity. We mention this today because two different district judges from the Southern District of Illinois decided two motions to remand on the same day last week, each presented with similar facts, and they somehow came to diametrically opposed conclusions.  That is to say, one “sanctioned” the plaintiff’s joinder of a local pharmacy to defeat removal jurisdiction, resulting in an order remanding the case; and the other “sanctioned” the plaintiff’s joinder of a local pharmacy to defeat removal jurisdiction, resulting in an order retaining jurisdiction.
Go figure.  In Peoples v. Novartis Pharmaceuticals Corp., No. 15-cv-0670, 2015 U.S. Dist. LEXIS 122790 (S.D. Ill. Sept. 15, 2015), the plaintiff sued a number of drug manufacturers in St. Clair County, Illinois, a forum in which plaintiffs often want to be.  To that end, they named an Illinois-based pharmacy as a co-defendant, thus purporting to block removal with the presence of a local defendant.  Id. at **1-2.  The defendants removed the case to the Southern District anyway, and when the plaintiff raised subject matter jurisdiction with the court, the defendants argued that the local pharmacy was fraudulently joined and that its Illinois citizenship should be
disregarded.  Id.

Continue Reading Illinois Federal Court “Sanctions” Fraudulent Joinder of Pharmacies

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We have alluded on a couple of occasions to the likelihood that the recent generic drug implied impossibility preemption decisions in PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), can provide the basis for using this type of preemption in certain cases involving medical devices cleared under the FDCA’s §510(k) “substantial equivalence” process.  These are mostly Class II devices, but also encompass some falling into Class III (go here for more on that).  We’ve also noticed that, in the two years since Bartlett added the most significant piece to this puzzle, there’s hardly any case law on point – only one decision, In re DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation, 2014 WL 3557392, at *10-11 (N.D. Tex. July 18, 2014), which is both superficial and adverse.

We intend to rectify that today, laying out the implied impossibility preemption argument in some detail, but we do so with this bolded and all caps warning (which we would box if we knew how):

DO NOT RAISE THIS ARGUMENT EXCEPT IN CASES WHERE YOU BELIEVE THIS NOVEL DEFENSE-SIDE ARGUMENT WILL RECEIVE FAIR CONSIDERATION AND BEARS A COLORABLE CHANCE OF SUCCESS.

As we’ve said before, strange things seem to happen in product liability cases involving preemption, and usually that’s not good for our side.  If you are not before a good judge, this argument will likely be a waste of your time, and your client’s money, while making bad precedent for the rest of us.

The Mensing/Bartlett implied impossibility preemption argument doesn’t apply to all claims involving §510(k) devices.  Unfortunately, the good guys lost the broader express preemption arguments almost twenty years ago in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).  Lohr, however, was solely an express preemption case.  The surviving implied preemption argument we envision lies primarily against design defect claims, because those claims inherently conflict with the FDA’s regulatory scheme in the same way that the warning and design claims did with a different regulatory scheme in Mensing/Bartlett.  This argument can also apply to all medical device design claims, but we’re focusing on the §510(k)s because PMA devices are already protected against design claims by express preemption under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  Should a PMA design claim somehow slip through the Riegel cracks, the implied preemption argument we’re making here could serve as a fall-back – but our warning about judges does, too.Continue Reading In Case of Good Judge, Break Glass – Implied Impossibility Preemption in Cases Involving §510(k) Cleared Medical Devices

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Failure to warn cases remind us of sports talk radio and paleontology.  Especially on Monday mornings in the Fall, Philly sports talk radio is a festival of woe and recrimination.  The Iggles are terrible, their deficiencies are many and obvious, and the people running the team are dunderheads.  Mind you, the callers and radio hosts are the same people who a few short weeks ago anticipated Super Bowl glory.  But there is a reason for the phrase “Monday morning quarterback.”  There is also a reason why we DDL defense hacks worry about hindsight bias.  At first blush (though what plaintiff lawyer has ever blushed?) a failure to warn claim seems so reasonable and modest.  It does not ask for scientific innovation.  It asks only that the company tell the truth about its product.  Ah, but what truth?  The truth is that the company probably believed (and the FDA concurred) that the relevant risks had been adequately disclosed.  Sadly, reality in the form of an unfortunate, sympathetic plaintiff seems to disclose a new risk, or a risk that calls for a louder, brighter warning.  The reality also is that nobody hid anything.  Stuff happens.  Looking back, we all always wish we had done more and done better.

Hindsight is 20-20.  What it sees is corporate omniscience.  What it demands is perfection.  That’s when we start reflecting on paleontology – or, to be more precise, the debate between paleontology and creationism.  Creationist critics point to “gaps in the fossil evidence” as refutation of evolution.  Where is the missing link?  That ploy creates no end of frustration among actual scientists.  Produce a new piece fossil in the evolutionary chain, and the critics will now gleefully point to two new gaps in the evidence.  You cannot win, because you are dealing with people who care much more about the end result than the integrity of the process.  The same is true with drug or device warnings.  Whatever is warned about, it is all too easy after the fact to find something that was not warned about, or was not warned about with enough fury and poetry. It gets worse when the court admits evidence of subsequent warnings.  Not only is the perfect the enemy of the good, but so is the better.  What we wish courts (or legislators or regulators) would do is establish a bright line rule that when a label warns of the injury suffered in the case, the failure to warn claim (and all of the parasitic claims essentially alleging the selfsame thing) must be dismissed.  The court should not pass along to the jury as a bogus, hindsight fact-issue whether the warning could have been more robust.

Something like what we want – a rigorous, disciplined approach to warning adequacy – happened in Becker v. Cephalon, Inc., 2015 U.S. Dist. LEXIS 123670 (SDNY Sept.15, 2015).  The court’s clear-headedness is particularly impressive because it was a wrongful death case, and the claim was that the decedent had come down with the horrific burning and peeling skin condition known as Steven Johnson Syndrome (SJS) and Toxic Epidermal Necrosis (TEN).  That dreadful injury would provoke sympathy in anyone.  The decedent had been diagnosed with leukemia in 2000.  He was treated with allopurinol in late 2010, and was also treated with the medicine at issue, Treanda, on multiple dates in late 2010 and early 2011.  Then came the SJS/TEN.
Continue Reading SDNY Sacks Treanda Failure to Warn Claim

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This post is from the non-RS side of the blog.

Plaintiffs in the Cymbalta litigation tried and failed to create an MDL.  They filed cases in California, followed up with more filings in 23 other states around the country, and then asked the Judicial Panel on Multidistrict Litigation to consolidate all of it for them. 

…

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