September 2016

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As we blogged at the time, we believe that the Ninth Circuit made a historic error in Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir., 2013) (en banc), when it equated routine product liability inadequate warning claims with indirect third-party warning claims where the third party is a governmental agency – that is, the FDA.  Validating such allegations could have much broader implications – on everything from statements made to insurance regulators to child abuse reporting requirements – but, even limited to the FDA, it creates precisely the same perverse incentive “to submit a deluge of information that the [FDA] neither wants nor needs” that supported preemption of other tort claims challenging the accuracy/completeness of FDA submissions in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 351 (2001). But the Supreme Court denied certiorari in Stengel, so life goes on.

To the extent that Stengel had any redeeming feature, it is found in the 7-judge concurrence (a majority opinion, really, since 11 judges were sitting for the en banc decision), which recognizes that causation is particularly problematic where a federal agency with preemptive power is a middle-man in state-law litigation:

Because they predicate their claim on [defendant’s] reporting duty to the FDA, as they must to avoid express preemption, [plaintiffs] face a causation hurdle that would not otherwise exist.  To prevail, they will ultimately have to prove that if [defendant] had properly reported the adverse events to the FDA as required under federal law, that information would have reached [the prescribing] doctors in time to prevent [plaintiffs’] injuries. But at this juncture − a request for leave to amend their complaint – [plaintiffs’] allegations of causation are adequate.

Stengel, 704 F.3d at 1234-35 (concurring opinion). Stengel cited to the causation theory described in Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011):

[Plaintiff’s] primary causation theory is that if [defendant] had reported the true number of injuries and malfunctions related to [the risk] caused by the [device], this information would have appeared on the FDA’s MAUDE internet database [of adverse events reported about medical devices] and in medical journals, and with this information [the prescriber] would not have recommended the [device] to [plaintiff] for treatment.

Id. at 776.

Continue Reading Causation Issues in Failure-To-Report Cases – Post-Stengel Precedent

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Today we have a guest post from Reed Smith‘s Jaclyn Setili, about one of our pet peeves – MDL plaintiffs (and their counsel) who think they don’t have to do any work at all on their cases, and simply show up come settlement time with their hands out.  In this instance, they received a much deserved comeuppance.  As is the case with all our guest posts, Jaclyn deserves all the credit for what follows, as well as any blame.

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At last, friends, it’s that time of year again. Time to dust off the sweater vest, memorize your favorite college football team’s schedule (Go Blue), and indulge in the ubiquitous pumpkin-spice-flavored everything.  In fact, just the other day as we were jogging along the Schuylkill River Trail, after an oppressively hot and humid summer, we glimpsed the first few yellow leaves of the year as they gently, and gracefully, made their journey to the asphalt, and our heart leapt with joy and relief.

Unlike spring, however, autumn is not a time for fresh hope or new beginnings.  Rather, the season reminds us of the inescapable promise that another year is nearing its eventual terminus.  A recent opinion from the Southern District of Florida, In re Denture Cream Products Liability Litigation, — F. Supp.2d —-, 2016 WL 4582185 (S.D. Fla. Aug. 31, 2016), encapsulates that idea:  the fundamental truth that every summer—like every lawsuit—must come to an end.  Winter, friends, is always coming.

In re Denture Cream is another order from the denture cream MDL, which we have covered on several prior occasions, i.e. here and here.  To remind you, the JPML consolidated multiple cases in MDL 2051 on September 12, 2011, finding that they all shared common questions of fact concerning allegations that the level of zinc found in certain brands of denture cream may cause copper deficiencies and neurological injuries.  The opinion we discuss today, however, involves a frequent bane of MDL defendants – the plaintiffs who try to lie back, hide in the weeds, do as little as possible, and share in an eventual settlement.  This time, it didn’t work out so well for those plaintiffs.Continue Reading Guest Post – With No General Causation Experts, Denture Cream Plaintiffs Drop Like Leaves In Autumn

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Tell us that that the feds prosecuted a doctor for using a medical device off-label, and the hairs on the back of our neck start to rise and do the samba.  After all, off-label use can be good medicine, even the best.  Then tell us that the same doctor also faced the music for using an “adulterated” device and our knees grow weak.  The word “adulterated” gets thrown around an awful lot in the FDA regulations.  You (and most jurors) might think of the old Upton Sinclair investigative journalism reports about fingers turning up in tubs of margarine, but “adulterated” can also refer to technical issues, such as labels that do not say quite enough.   The recent case of U.S.  v. Kaplan, 2016 WL 4709870  (9th Cir. Sept. 9, 2016), is arresting because it makes us wonder whether good facts (Bad facts?  Weird facts?) might make bad law.

The defendant in the Kaplan case was a medical doctor accused of conspiring to violate 18 USC section 331(k) – using an adulterated medical device held for sale.  Like the semi-adequate federal prosecutor we used to be, let’s start with the factual headline:  this doctor reused single use prostate biopsy needles.  Think for a moment about how prostate biopsy needles are used, then think about the impact of expert testimony to the effect that cleaning single use needles would not do the trick, and that the needles became discolored after use.  Yuck.  Then think about the effect of evidence that the doctor started reusing the single use needles for purely economic reasons, that he did not pass any savings along to the patients, and that other people in his medical practice told him to stop reusing the needles.Continue Reading Has the Ninth Circuit Criminalized Malpractice, Adulteration, and Off-Label Use?

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The decision in Carl v. Johnson & Johnson, 2016 WL 4580145 (N.J. Super. Law, Sep. 2, 2016) is masterful. It is a well-researched, well-vetted, and well-written decimation of plaintiffs’ expert case. It is the type of Daubert opinion that defendants long for. It is lengthy and there is so much in it that is good, to cover it all we’d simply have to re-print the decision here. Which we won’t do. However, we strongly encourage you to read this decision. If you aren’t embroiled in an expert battle right now, bookmark this case and come back to it. The thoroughness and attention to detail by the court in the face of an obvious lack of those things by plaintiffs and their experts makes this a real page-turner.

The decision actually was entered in two cases, both brought by women who were diagnosed with ovarian cancer who in these lawsuits allege their cancer was caused by their use of powder containing talc. Defendants filed motions challenging all five of plaintiffs’ experts and moved for summary judgment on the grounds that absent expert testimony, plaintiffs could not meet their burden of proof. Id. at *2. The court held a Daubert (in NJ Kemp) hearing and heard testimony from both plaintiffs’ and defense experts. In addition, the court requested that the parties provide the court with copies of “all reports, abstracts, epidemiology studies, and peer-reviewed articles” relied on by any of the experts in formulating their opinions.   Id. (emphasis added). That resulted in the court receiving approximately 100 pieces of scientific literature – which the court apparently read and used in analyzing the expert evidence presented. Id. A serious undertaking. One which clearly inured to the benefit of the defense in this case, and frankly a deep dive on the science most often favors the defense. We welcome an informed and educated court. As this court stated at the outset: “Courts are experts in the law, not science.” Id. And juries are experts in neither. Which is why we greatly appreciate a court that takes seriously its role as the crossing guard at the intersection of science and law in the courtroom.Continue Reading New Jersey – At the Intersection of the Scientific Method and the Rule of Law

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This post is not from the Dechert side of the blog.

The United States Supreme Court has said it – the test for implied preemption under 21 U.S.C. §337(a) (the FDCA’s no-private-enforcement provision) is whether the purported state-law cause of action would exist even in the absence of the FDCA/FDA: Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 353 (2001) (preemption applies to “claims exist solely by virtue of the FDCA disclosure requirements” and to all claims where “existence of these federal enactments is a critical element”).  So have federal courts of appeals.

If the claim would not exist in the absence of the FDCA, it is impliedly preempted. In other words the conduct on which the claim is premised must be the type of conduct that would traditionally give rise to liability under state law − and that would give rise to liability under state law even if the FDCA had never been enacted.

Loreto v. Procter & Gamble Co., 515 F. Appx. 576, 579 (6th Cir. 2013) (citations and quotation marks omitted). Accord Caplinger v. Medtronic, Inc., 784 F.3d 1335, 1339 (10th Cir. 2015) (“§337(a) preempts any state tort claim that exists ‘solely by virtue’ of an FDCA violation”); Perez v. Nidek Co., 711 F.3d 1109, 1119 (9th Cir. 2013) (preempting a “fraud by omission claim [that] exists solely by virtue of the FDCA  requirements”) (citation and quotation marks omitted); Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372, 379 (5th Cir. 2012) (following Buckman; “tort claims are impermissible if they existing solely by virtue of the FDCA disclosure requirements”).Continue Reading Another Make Work Project In New Jersey – Duty To Update Claims

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We spend the vast bulk of our professional life working in the context of MDLs.   We know the drill:  plaintiff lawyers file hundreds or thousands or tens of thousands of cases.  At some point, the cream rises to the top in the form of “bellwether” cases – cases with enough merit that a plaintiff expert of (relative) repute can verify the injury and attest to a causal link between that injury and our client’s product.  But that leaves the vast bulk of the docket — plaintiffs who may have seen an ad on late-night television, or received a cold call, or heard that a friend made some money in a tort suit.  These cases will never be the focus of the plaintiff lawyers’ attention, and most will remain untouched until they queue up, hands outstretched, as part of a “settlement inventory,” unless defense counsel mount pro-active efforts (and expend their resources and the court’s) to weed them out through dispositive motions.

In recent years, MDL judges have become more aware of, and less patient with, this reality, prompting increasing (and laudable) use of “Lone Pine” orders. We love Lone Pine orders, as we’ve discussed here and here.  But Lone Pine orders are remedial – while they may eventuate in the dismissal of meritless cases, they do not operate, in any significant fashion, to deter the filing of such cases in the first instance or the failure to dismiss them when their lack of merit first becomes clear.Continue Reading Put Up or Pay Up: Mentor Obtape MDL Judge Promises Sanctions to Plaintiff Attorneys Filing Meritless Cases

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We here at the DDL Blog try to stay on top of the goings on at the FDA. We’ve learned that on September 14, 2016, the FDA will hold an advisory committee meeting to review the results of a recently completed, randomized, placebo-controlled clinical trial (Evaluating Adverse Events in a Global Smoking Cessation Study or “EAGLES”), as well as findings from other studies that have assessed the neuropsychiatric effects of Chantix (varenicline).  See September 14, 2016: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.  The committee will consider whether data from these studies supports changing the Chantix product labeling, including potentially removing the boxed warning regarding serious neuropsychiatric events.  The meeting comes approximately three years after Pfizer agreed to pay nearly $300 million to settle thousands of lawsuits filed by plaintiffs alleging that they experienced adverse neuropsychiatric effects while taking Chantix.  See Pfizer 2012 Financial Report, at 107.

This chain of events seems to be a clear cut example of litigation marching ahead of the science, and at that cost, we thought we’d probe the situation a little deeper. Chantix was approved by FDA in May 2006.  It was the first new smoking cessation medication to come to market in more than a decade, and was recognized at the time to be one of the most effective treatments available to help smokers break their addiction to nicotine.  The following, year, however, a highly publicized incident involving a Texas musician named Carter Albrecht raised concerns about potential adverse neuropsychiatric effects of the medication.  The musician, who was taking Chantix and was heavily intoxicated at the time, was shot and killed by a neighbor who thought that Mr. Albrecht was burglarizing his home.  Mr. Albrecht’s girlfriend publicly blamed Mr. Albrecht’s behavior on his use of Chantix.  The incident sparked national media attention, which led to an increasing number of anecdotal reports of patients experiencing neuropsychiatric events while taking Chantix.

Based largely on these anecdotal reports, the FDA instructed Pfizer to include warnings about potential neuropsychiatric effects in the Chantix product labeling, and, in July 2009, mandated the addition of a boxed warning.  The boxed warning advised that patients being treated with Chantix should be monitored for neuropsychiatric symptoms “including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide” and recommended stopping Chantix if any of these symptoms are observed.   To further evaluate this issue, FDA also asked Pfizer to conduct a clinical trial—the recently completed EAGLES study—to assess the neuropsychiatric safety of Chantix.Continue Reading Chantix: A Lesson in Why Litigation Should Not Be Allowed to Get Ahead of Science

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An article forthcoming in the California Law Review has been posted on SSRN and is worth reading:  Bradt & Rave, “The Information-Forcing Role of the Judge in Multidistrict Litigation.”   The authors describe how MDL proceedings have come to dominate the federal civil docket – making up nearly half the caseload.  MDLs have to some extent supplanted class actions, while sharing some of the principal-agent problems that plague class actions.  The authors insist that the most serious problem is that the plaintiff lawyers making many of the key decisions in an MDL (usually adorned with the regal title of “the plaintiff steering committee”) do not represent all the plaintiffs.  That problem rears its head in a particularly ugly fashion when it comes to settlements.  Individuals get treated as an aggregate and some make out better than others for no reason grounded in rationality or fairness.  It can hardly arrive as news that plaintiff lawyers might steer more dollars toward their cases than others.  But while a class action judge has a well-defined role/duty to approve or disapprove class action settlements, MDL judges lack such authority.  The authors are distressed by this state of play, because, in their view, MDLs are built for settlement:  “The MDL statute was developed as a judge-centric model – its framers intended that judges would wrest control of cases from the litigants and guide the litigation to a conclusion that would relieve the federal courts of potentially crushing caseloads.”

What’s the solution to the principal-agent dilemma in MDLs?  The authors point with favor to the judge in the World Trade Center Disaster Site Litigation who expressed the view that a proposed settlement was not enough.  That judge, according to the authors, based his authority to reject the settlement on a quasi-class action theory created by Judge Weinstein the Zyprexa MDL.  The WTC judge acted as an ‘information intermediary.”  Once he put it out there that the settlement was, by his lights, unfair, it was not possible to cram down the settlement when most of the plaintiffs would have heard what the judge said.  Bradt & Rave argue that this information intermediary role is an important one for MDL judges, because the MDL lawyers are not reliable sources of information.  It is hard to argue with that last point.

But how reliable are judges?  To the authors’ credit, they acknowledge points made by other scholars questioning the quasi-class action model.  Many (most? all?) judges have a strong interest in settling cases.  The danger of that predilection is, according to the authors, that judges might approve settlements that are unfair to some plaintiffs.  That’s true as far as it goes.  Nevertheless, there is another unfairness danger, and it  does not seem to bother the authors much or at all:  judges in some aggregated proceedings do their utmost to strong-arm settlements that are unfair to defendants.  In the conclusion of the article, the authors tell us that “Settlement is good.”  That’s sort of a Mom and apple pie sentiment, isn’t it?  Yes, there is a Lincoln quote out here somewhere praising the concept of settling litigation.  Fine.  We know we’ll get a reaction as if we passed gas in church when we say this, but, hey, Not All Settlements are Good.  Some are neatly wrapped packages of extortion.   A sentence or two later, the authors write that “the beauty of MDL is that, by gathering all of the players into a single forum under the watchful eye of a coordinating judge with substantial flexibility, it creates a fertile environment to facilitate a comprehensive resolution.”  Fertile, indeed.  There is a lot of fertilizer in that field. Most of the cases in any MDL inventory are meritless – plaintiffs who suffered no injury, or suffered the injury before they used the product, or never used the product at all.  And yet far too many MDL judges act as if any defendant who does not gallop over to the plaintiff steering committee with a settlement offer, a grid, and an open checkbook needs a spanking.  We have seen judges rule against defense motions, or fail to rule at all, as a way of punishing defendants who seem insufficiently eager to settle.  Even more commonly, when a judge wants to inspire defendants to settle, the judge will order absurd trial schedules, often with cases consolidating plaintiffs so as to maximize prejudice and the specter of huge verdicts.  Information forcing?  Call it what it really is: settlement forcing.Continue Reading MDL Judges: Information-Forcing or Settlement Forcing?

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It’s been over two years since the FDA – in March, 2014 Draft Guidelines and then in its June 2014 “grant” of an industry-submitted citizen’s petition – promised to review its restrictions on so-called “off-label promotion” by regulated drug and medical device manufacturers.  We were skeptical at the time that all we would get is “still more agency bobbing and weaving.”

Then two years with zilch – save more Agency First Amendment losses in off-label promotion cases.  Then industry gets sufficiently frustrated by FDA inaction on off-label communication issues that it starts to take matters into its own hands.

So, a month later, we finally hear from the FDA again.

Finally, some action?

Don’t bet on it.

On August 31, 2016, a notice appeared in the Federal Register entitled “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Public Hearing; Request for Comments.”

Wonderful.  More talk, and the FDA kicks the can further down the road.  Once again the Agency refuses to recognizes the constitutional bind in which it finds itself.  Indeed, the term “First Amendment” doesn’t appear anywhere – not even once – in the notice.  Nor does the FDA so much as utter the phrase “off-label.”  Except for citations, the FDA uniformly uses the more pejorative term “unapproved.”

If not the First Amendment, then, what do we have?Continue Reading More Talk – No Action – From FDA on Off-Label “Communication”

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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