Warning Adequacy

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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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It wasn’t a complete win, but the summary judgment outcome in Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 4743056 (S.D. Ohio Aug. 10, 2015), has to put a spring in the step of the defendants as they approach trial.  What’s left doesn’t strike us as a very good warnings case.  Rheinfrank involved claims that the antiepileptic drug Depakote caused the minor plaintiff’s birth defects.  Make no mistake about it, Depakote has a known association with such injuries.  First approved in 1983, it’s been a Pregnancy Category D drug since 1988, meaning, according to FDA regulations, that:

there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.

21 C.F.R. §201.57(c)(9)(i)(A)(4).  Not only that, since 2003, this drug has carried a black box “teratogenicity” warning, as well as other quite explicit, and all-caps, language to the same effect.  For details, see 2015 WL 4743056, at *2-3.

Plaintiff-mother had used Depakote for years, through four previous uneventful pregnancies.  Id. at *1.  On her fifth pregnancy, even though Depakote came with all these warnings, she continued to take it.  Id.  Her allegations did try to change the subject, however.  In addition to claiming that the black box warning (more about that later) and all the other teratogenicity language were inadequate, she asserted that the defendants failed to warn altogether about “developmental delay.”  Id. at *5.Continue Reading Preemption (and Other Things) Defanging Depakote Claims

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“I’m not a doctor, but I play one on TV” – shorthand for “I am pretending to know what I’m talking about, but I really don’t.”  We have blogged frequently about experts inclined to such pretense and about courts’ varying levels of tolerance for experts who lack expertise or who render opinions lacking foundations and reached without reliable methodologies.  Recently, in Hexum v. Eli Lilly & Co., 2015 U.S. Dist. LEXIS 106153 (C.D. Cal. Aug. 10, 2015) – a Cymbalta “discontinuation case” — the United States District Court for the Central District of California did a noteworthy job of precluding two experts from testifying about opinions they had no business rendering.

In Hexum, plaintiff claimed that she suffered severe “discontinuation” symptoms after ceasing to take Cymbalta, an SSRI manufactured by defendant Lilly, because Lilly’s Cymbalta label provided her treating physician with inadequate warnings about such adverse events. Before trial, Lilly moved to exclude the testimony of two of plaintiff’s experts: 1) a psychiatrist, rendering opinions, inter alia, about the adequacy of Cymbalta’s label; and 2) a “social psychologist,” offering opinions about how “a reader” would interpret various portions of the label.Continue Reading Central District of California “Discontinues” Much of Plaintiffs’ Experts’ Testimony in Cymbalta “Discontinuation Symptoms” Case

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Happy birthday, Louise Fletcher, who won an Academy Award for her portrayal of the sadistic Nurse Ratched in One Flew Over the Cuckoo’s Nest (1975).  Happy birthday also to Albert Brooks, writer/director/star of Modern Romance (1981), Lost in America (1985), Defending Your Life (1991), and a gaggle of other comedies.  Brooks also did fine work as an actor in several non-comedies, such as Taxi Driver (1976), Broadcast News (1987), and Drive (2011).  But for our money, his best performance is in Out of Sight (1998), where Brooks played a Michael Milken-esque financier-turned-prison-inmate.  By the way, Brooks’ birth name was Albert Einstein.  Brooks changed his name for obvious reasons.  He cracked that the great physicist had changed his name to Albert Einstein simply to sound smart.  Finally, happy birthday to Don Henley of The Eagles.  Henley sang and co-wrote “Hotel California” (1977), an allegory about SoCal showbiz excess.  The best line in the song is “We are all just prisoners here of our own device.”

Does that trio of birthdays suggest a theme?  Indeed, it does:  drugs and prisoners.  Today’s case is Flowers v. Eli Lilly & Co., 2015 U.S. Dist. LEXIS (D. Nevada July 10, 2015), in which a pro se plaintiff prisoner claimed that Zyprexa gave him diabetes.  The plaintiff had been prescribed Zyprexa at the beginning of his incarceration in 1997, went off it in 2003, and then back on it in 2009, continuing up through the filing of the lawsuit in 2014.  The plaintiff was diagnosed with diabetes in November 2012.  After learning of the diagnosis, the plaintiff requested that he be taken off Zyprexa.  The request was denied.  Remember, the plaintiff was a prisoner.  Patient choice seldom matters from a legal point of view in these cases (because of the learned intermediary doctrine, discussed below), but in this case it really, really does not matter. Zyprexa is an antipsychotic drug that can be used to treat very serious conditions such as schizophrenia and bipolar disorder.  The court’s opinion does not tell us why the prison wanted the plaintiff to be on an antipsychotic, but odds are there was a very good reason.Continue Reading Little Reprieve for Prisoner Zyprexa Suit

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Without pulling back the curtain all the way on how we find out about new decisions worth a pithy post, we occasionally re-learn about decisions when they are published or added to an electronic reporting service a few months later. When there is a slow week, this dynamic may prompt us to talk about an older decision, even if has already been the subject of a breaking news post. The summary judgment decision in In re Accutane Litigation, No. 271 (MCL), 2015 N.J. Super. Unpub. LEXIS 1216 (N.J. Super. Law Div. Apr. 2, 2015) was the subject of a breaking news post two months ago, but deserves another look, more for the story it tells about drug litigation than for its direct precedential value.

We have posted through the years about the tortured course of Accutane litigation over the risk of inflammatory bowel disease (“IBD”). (There have also been cases about birth defect and suicidality, but we are not focusing on those here.) In general, the news out of the MDL proceeding has been good for years, both on expert issues and the substance of plaintiffs’ claims.   For years, the news from the coordinated proceeding in New Jersey has been very bad, including a few large plaintiff verdicts. Issues with the judge who had overseen the New Jersey proceedings were highly publicized (but not by us), and it is easy to say that her assignment to a new post explained the sea change.

We can guess that the new judge’s look at old issues has been more balanced (from our view), as has the Appellate Division’s review of old decisions. There has also, though, been development in the case law on the New Jersey Product Liability Act (NJPLA) that undercut the legal basis for old (bad) decisions. The persistence of the defendant and willingness of the new judge to consider broad issues late in the life of the litigation bring us to the decision finding the IBD warnings since April 2002 to be adequate as a matter of law under the NJPLA, which sets up a potential adoption for cases where other state law may control.

The history of Accutane’s IBD warnings from the approval of the drug in 1984 through the discontinuation of its sale in 2009 is so extensive that we wonder how warnings claims—the only claims we think should be typically available for a prescription drug—ever could have had legs. As discussed below, we also wonder about other reasons why warnings claims should not have been viable. The court provides detailed findings of fact about the warnings for IBD, which included mechanisms for providing warnings not seen with most prescription drugs. Id. at **15-26. We assume the extra measures were driven by concerns about suicidality in teenage patients and birth defects in their offspring, but IBD was also described in the warnings accompanying blister packs (the only means of distribution since 1990), a guide that physicians had to acknowledge receiving in order to prescribe the drug, a guide that pharmacists had to provide to patients while filling their prescriptions, and brochure that physicians were encouraged to give to patients. Combined with a paragraph in the Warnings section of the package insert, the information provided to physicians warned them up, down, and side to side about the risk of IBD. That sounds a lot like an adequate IBD warning as a matter of law under any state’s law on prescription drug warnings.
Continue Reading Deeper Dive on New Jersey Accutane Summary Judgment Decision

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Today’s date is rich in literary history.  It is the birthday of Vladimir Nabokov, one of two writers whose prose style makes us want to snap our Pilot Varsity pens in despair, so great is the gap between those authors’ mastery and our pedestrian scribblings.  Perhaps the biggest laugh-out-loud moment a book ever gave us was from Lolita, when the Humbert character travels a long way to visit a family that has at least one member he is especially, um, interested in, only to be greeted at the train station by the patriarch, who shared “the news that his house had just burned down – possibly, owing to the synchronous conflagration that had been raging all night in my veins.”

Today is also the birthday of Henry Fielding, the great British novelist of the 18th century.  In high school we were forced to read Joseph Andrews and Tom Jones, and we grumbled about it, especially upon getting a peek at the girth of Tom Jones (we mean the book).  But the joy, wisdom, and energy of Fielding’s words, often propelling the most ribald adventures, converted our dread into a wholly unforced pleasure, indeed. There is a sentence in Tom Jones that stopped us abruptly in our tracks. Fielding on many occasions spoke directly to the reader, and at one point he explained his intention to “fill my pages with humour till mankind learn the good nature to laugh only at the follies of others and the humility to grieve at their own.”  Has any writer ever articulated a more noble goal?Continue Reading Maryland, My Maryland: Aldara Case Dismissed for Multiple Reasons

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Today’s newsflash:  winning is good.  Winning is better than losing.  Winning at trial is especially good.  Winning at trial enhances the chance of winning on appeal.  But are there ways to win at trial that improve the odds of winning on appeal?  Funny you should ask.   A recent unpublished California appellate opinion, In Re Infusion Pump Cases, Super. Ct. No. JCCP 4615 (Cal. 4th App. Dist. March 2, 2015), offers an interesting object lesson.  The plaintiff claimed a chondrolysis shoulder injury from the pain pump.  We’ve heard that before.  There were causes of action for, inter alia, strict liability and negligence.  We’ve heard that before.  The jury returned a verdict for the defendant.  We’ve heard that before.  The plaintiff appealed and argued that the court had wrongly excluded certain evidence.  We’ve heard that before.  But the appellate court’s reasoning in affirming the defense verdict causes us to think more about how to try cases, causes us to think more about how to frame verdict forms , and causes us to think more about causation.

The plaintiff underwent shoulder surgery in 2002.  The doctor used the defendant’s pain pump to control plaintiff’s post-operative pain.  The pain pump was connected by a catheter to the plaintiff’s shoulder for about two days after the surgery. Between 2002 and 2008, the plaintiff rode dirt bikes and all-terrain-vehicles, played golf, and went snowboarding and skiing.  In 2008, after he could not finish painting a room in his house due to shoulder pain, the plaintiff visited several physicians.  One orthopedist diagnosed him with arthritis. Another, who later became the plaintiff’s expert witness, concluded that the pain pump had caused chondrolysis.

One of the plaintiff’s claims at trial was that the defendant had not warned about the unreasonable risks of using a pain pump in the shoulder joint.  The plaintiff contended that the defendant should have warned physicians that its pain pump had not been cleared for intra-articular or orthopedic uses.  The plaintiff alleged that the defendant unsuccessfully tried to secure the FDA’s clearance to include orthopedic use in the pain pump’s indication for use statement.  According to the plaintiff,  the FDA refused such clearance due to safety concerns. Nevertheless, the court excluded evidence concerning the defendant’s submission to, and contact with, the FDA for clearance to market defendant’s pain pump.  Meanwhile, the parties’ expert orthopedic surgeons disagreed on the cause of the plaintiff’s problems.  As referenced above, the plaintiff’s expert opined that the plaintiff had chondrolysis.  By contrast, the defendant’s expert opined that the plaintiff had needed a shoulder replacement due to arthritis.Continue Reading Specific Causation + General Verdict = Pain Pump Defense Win

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This post comes from the non-Reed Smith side of the blog.

* * *

We’ve already blogged about Judge Sweet’s decision last November in the Cymbalta litigation and why it was important.  McDowell v. Eli Lilly, 2014 WL 5801604 (S.D.N.Y. Nov. 7, 2014).  Its most important aspect was Judge Sweet’s holding that the label’s warning of the withdrawal risks associated with discontinuing Cymbalta was sufficient as a matter of law even though it didn’t include the clinical trial statistics that plaintiffs argued should have been included.  The language of the warning was sufficient, so the statistics were unnecessary.  Another important aspect of the decision was the nurse practitioner’s knowledge of the withdrawal risks of Cymbalta, which eviscerated plaintiff’s warnings causation case.

Judge Sweet had another opportunity to address these same issues just last week.  The plaintiff had moved for reconsideration.  See McDowell v. Eli Lilly, 2015 U.S. Dist. LEXIS 23445(S.D.N.Y. Feb. 26, 2015).  Maybe he shouldn’t have.  The court’s opinion reminds us of the ruling that Lieutenant Commander Galloway received from the bench after her follow-up “strenuous objection” in A Few Good Men.  That ruling triggered this bit of sarcasm from Lieutenant Weinberg as the court was emptying: “I strenuously object?” Is that how it works? Hmm? ‘Objection.’  ‘Overruled.  ‘Oh, no, no, no. I STRENUOUSLY object.’”

The first time around, plaintiff argued that the warning should have laid out the percentage of patients in the “Perahia” study – 44.3% – who had experienced withdrawal symptoms, rather than the descriptive language in the actual label and the list of identified withdrawal symptoms that had occurred in greater than or equal to 1% of the patient population.  The study and the argument weren’t new issues for the court.  Plaintiff used them in his opposition to summary judgment.  This time he simply attached the study to a belatedly filed expert report.Continue Reading Statistics Are Still Unnecessary for a Label To Be Adequate

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Courtesy of Mike Imbroscio of Covington (who was on the winning team) today’s post is about a very satisfying Cymbalta win – not only did warning causation fail under the learned intermediary rule, but the warning for the drug was held adequate as a matter of law.  The case is McDowell v. Eli Lilly & Co., ___ F. Supp.3d ___, 2014 WL 5801604 (S.D.N.Y. Nov. 7, 2014).  It involved injuries (such as “brain zaps,” whatever those might be) allegedly suffered by the plaintiff when she was weaned from the drug too quickly.

We’ll briefly touch on the causation part first.  Under New York’s learned intermediary rule, a prescriber’s “independent knowledge” of a supposedly unwarned-of risk breaks any causal connection between the warning’s inadequacy and the plaintiff’s injuries.  2014 WL 5801604, at *15.  The prescriber (a nurse practitioner – we think McDowell is the first nurse-as-learned-intermediary decision under New York law) “testified that, based on her clinical experience and training, she was aware of the risk of discontinuation symptoms with abrupt cessation of [drug] treatment.”  Id. (there’s a lot more than just that statement).  Because the alleged understatement of the risk wouldn’t have changed the prescribing decision, plaintiff lost.  Id. at *17-18.  Plaintiff’s attempt to mislead the prescriber at her deposition with statements about the drug that had no basis in fact couldn’t create a disputed issue of fact.  Id. at *18 (pointing out “the absence in the record of any support for the claim”).  We also like the causation standard employed in McDowell:

[U]nder New York’s proximate cause standard, a plaintiff must demonstrate that had a different, more accurate warning been given, his physician would not have prescribed the drug in the same manner.  Summary judgment is appropriate where a plaintiff fails to establish that a prescribing physician’s decision to prescribe a particular medication would have changed had a different warning been given

Id. at *16 (citations and quotation marks omitted).  We’ve discussed as some length recently the muddle in New York law concerning the heeding presumption, with some federal courts ignoring state-court precedent that there’s no such animal.  No such laxity appears in McDowell.Continue Reading Statistics Not Necessary For Adequacy as a Matter Of Law

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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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