One of the (many) things that made last year’s decision in Barron v. Abbott Laboratories, Inc., ___ S.W.3d ___, 2016 WL 6596091 (Mo. App. Nov. 8, 2016), so hideous that it weighed in at #3 of our worst decisions of the year was that, virtually without discussion, it held that an FDA-approved black box warning was not only inadequate but so poor as to be worthy of punitive damages.  Id. at *7.  Fortunately the Missouri Supreme Court granted a transfer (on January 5, 2017, according to Westlaw) and (we hope) will restore sanity on at least some of the issues in Barron.  However, the mere fact that a boxed warning – the strongest FDCA warning there is – could be utterly disregarded as in Barron got us thinking.

How have courts treated boxed warnings in other inadequate warning cases?

Initially, we’re not dealing in this post with claims that, in order to be adequate, a defendant’s labeling should have included a boxed warning. We’ve dealt with that kind of claim elsewhere, and our position is that, since the FDA must pre-approve all boxed warnings, all “should have added” claims are preempted.  This post deals with prescription medical products that already have boxed warnings.  Preemption becomes an issue in existing black box cases only if the plaintiff claims that the black box should have been changed – since (as discussed in the posts linked to previously) changes to black box warnings require prior FDA approval.

Looking back through our posts, we see we’ve described one decision, Hain v. Johnson & Johnson, No. ATL-L-8568-11 MT, slip op. (N.J. Super. L.D. June 20, 2013), reaching such a result. Hain recognized that “[a] ‘black box’ warning is the strongest warning required by the FDA.”  Id. at 6 (citing 21 C.F.R. §201.57(c)(1).  Regardless of what might be the case with other, similar products:

[B]y mandating each manufacturer include the strongest type of warning possible to warn of [the risk at issue], the FDA ensured each prescriber’s attention would be focused on the risk. . . .  [A] boxed warning required by the FDA existed in the package insert at the time [plaintiff] ingested [the drug].  Courts have previously held prescription warning labels containing a boxed warning, mandated by the FDA, are adequate as a matter of law.

Id. at 7.

In In re Chantix (Varenicline) Products Liability Litigation, 881 F. Supp.2d 1333 (N.D. Ala. 2012), the primary authority cited in Hain, the court determined that under the law of any state in the country, an on-point black box warning was adequate as a matter of law.  Such a warning was “the highest level warning possible, prominently displayed at the beginning of a drug’s official prescribing information.”  881 F. Supp.2d at 1339.  There could be no doubt that such a warning “was sufficient to alert to the possibility of the harm actually suffered.” Id. at 1340.  Plaintiff’s quibbles about when the drug should be used failed because they sought to tell physicians how to practice medicine.  “[T]he decision as to use [of] a medication as a first-line treatment is uniquely up to the prescribing medical professional and based on a decision concerning his or her individual patient.  Id.

Unlike the majority of cases reviewed by this court, the plaintiffs seek to pursue their failure to warn claims post the 2009 black box warning, not for failing to warn of possible complications from [the drug], but for failing to tell physicians when to prescribe it. . . .  [Even] the plaintiffs recognize that a black box warning is “the most serious warning in the FDA’s arsenal”. . . .  For the foregoing reasons, the court finds the 2009 black box warning adequate as a matter of law.

Id. at 1342-43 (citation omitted).  Accord In re Chantix (Varenicline) Products Liability Litigation, 889 F. Supp.2d 1272, 1304 (N.D. Ala. 2012) (“the court finds that [the] black box warning is adequate as a matter of law”).

Similarly, in Christison v. Biogen Idec, Inc., 199 F. Supp.3d 1315 (D. Utah 2016), the court held that a boxed warning of a usually fatal condition was adequate to warn physicians of that risk as a matter of law:

[I]t is undisputed that as a condition of [the drug’s] re-approval . . . the FDA required that the prescribing information contain a “black box” warning about [the risk] which is the strongest warning  required or permitted by FDA.  The black box warning, as the most serious warning available, can be reasonably expected to catch the attention of the consumer. . . .  [T]he intensity of the warning matched the magnitude of the risk.  The black box warning . . . was not qualified or minimized in any way because the magnitude of the risk − death or severe disability − was of the highest possible degree.

Id. at 1343-44 (footnotes omitted).  Accord Amos v. Biogen Idec, Inc., ___ F. Supp.3d ___, 2017 WL 1316968, at *5 (W.D.N.Y. April 10, 2017) (adequacy as a matter of law; the drug’s “label contained this information in a black box warning, the strongest warning available”); Gentile v. Biogen Idec, Inc., 33 Mass. L. Rptr. 607, 2016 WL 4168942, at *6 (Mass. Super. July 28, 2016) (“[t]he black box warning in effect when [the prescriber] first prescribed [the drug] to [plaintiff’s decedent] explicitly warned against the precise risk . . . that [she] ultimately suffered, and fully disclosed the serious consequences of that disease”).

In Aaron v. Wyeth, 2010 WL 653984 (W.D. Pa. Feb. 19, 2010), the product’s black box warning “advised physicians of the specific risks at issue in the instant case,” thus the court found “no evidence that [defendant] breached its duty to exercise reasonable care to inform [the prescriber] and others similarly situated of the risks associated with” taking the drug in question, even though the prescriber testified that he did not remember the warning correctly.  Id. at *10.  In Whiteside v. Johnson & Johnson, 2015 WL 11120989 (Mag. N.D. Tex. Mar. 13, 2015), adopted, 2015 WL 11120990 (N.D. Tex. July 8, 2015), the court dismissed the action with prejudice when the plaintiff abandoned ship in the face of the defendant’s summary judgment motion.  The court noted that the “Plaintiff’s prescription postdat[ing] . . . Defendants’ addition of an adequate ‘black box’ warning about the risks associated with the drug in question . . . would be fatal to Plaintiff’s claims.”  Id. at *1 n.1. See also Holland v. Hoffman-La Roche, Inc., 2007 WL 4042757, at *2-3 (N.D. Tex. Nov. 15, 2007) (black box warning held adequate as a matter of law; Texas presumption unrebutted); Clark v. Hoffman-La Roche, Inc., 2006 WL 1374516, at *7 (N.J. Super. May 2, 2006) (boxed warning “satisfied [defendant’s] burden under either New Jersey or Utah law to provide an adequate warning with respect to the risks” at issue); cf. In re Actos (Pioglitazone) Products Liability Litigation, 2014 WL 4364832, at *34 (W.D. La. Sept. 2, 2014) (characterizing post-prescription boxed warning as “hav[ing] full and adequate warnings”).

In a couple hours of looking we found more than a half-dozen cases where boxed warnings were held adequate as a matter of law.  Thus any court “unaware of any court holding that such a [boxed] warning is per se adequate as a matter of law,” Hutchens v. Abbott Laboratories, Inc., 2016 WL 5661582, at *6 (N.D. Ohio Sept. 30, 2016), either didn’t look very hard, or wasn’t willing to accept what it found.

In our view, the bottom line with boxed warnings is: one, the presence of a boxed warning concerning the relevant risk of a prescription medical product demonstrates that the risk is adequately warned about and sufficiently emphasized, making the warning adequate as a matter of law; and in any event two, since the FDA controls the content of black box warnings, any allegations that existing boxed warnings are inadequate are necessarily preempted.

We’ve often thought that tort reform should be a major goal of those interested in preserving women’s reproductive choice. Every prescription medicine has risks, which is why the FDA requires a prescription in the first place, and prescription contraceptives are no exception. But ever since the very first birth control pills, back in the 1960s, the other side of the “v.” has consistently attacked every innovation in contraceptive technology and attempted to drive it off the market. It’s happened over and over again – with IUDs, Norplant, OrthoEvra, Yasmin, NuvaRing, Mirena, Essure. Except for the Dalkon Shield IUD forty years ago (and occasional idiosyncratic manufacturing errors), all these products were (or are being) ultimately vindicated, and the FDA continues to consider their designs to be both safe and effective. Unfortunately their users have had to pay a significant tort tax in order to continue exercising their personal choice of contraceptive method.

Niedner v. Ortho-McNeil Pharmaceutical, Inc., ___ N.E.3d ___, 2016 WL 5106479 (Mass. App. Sept. 21, 2016), is both an example of the plaintiff’s bar’s ongoing attempt to deprive women of reproductive choice and an exemplar of how to beat such efforts. Niedner involved a time-release contraceptive patch:

The patch prevents pregnancy by transferring synthetic forms of the hormones estrogen and progestin through the skin. Unlike oral birth control pills, which must be taken at the same time each day, the patch is applied to the skin once per week for three weeks, followed by a fourth patch-free week.

Id. at *1. The decedent decided to use this product in preference to both condoms and daily birth control pills.  Id.

Risks.

It is a well-known scientific fact that any hormonal contraceptive places its user at an increased risk of stroke, myocardial infarction, and blood clots generally. This product was no exception:

[The prescribing physician] informed [the decedent minor and her mother] of the risks associated with using the patch, including that all hormonal contraceptives come with a risk of suffering blood clots. When the prescription was filled by [the] pharmacy, the package included an insert prepared by . . . the manufacturer[], as well as a leaflet from the pharmacy, both of which set forth the risks associated with use of the patch, including the risks of stroke, heart attack, and blood clots.

Id. Unfortunately, after three months use the decedent suffered a fatal “massive bilateral pulmonary embolus.”  Id.

Continue Reading Massachusetts Rebuffs Latest Plaintiff Attack on Reproductive Choice

Anyone who has checked our post-Levine innovator drug & vaccine cheat sheet lately has no doubt noticed our two most recent entries, Gentile v. Biogen Idec, Inc., 2016 WL 4128159 (Mass. Super. July 25, 2016), and Christison v. Biogen Idec Inc., No. 2:11-CV-01140-DN-DBP, slip op. (D. Utah Aug. 5, 2016).  With respect to preemption and innovator drug warnings, these cases provide further support to an emerging, common-sense bright line in the otherwise all-too-murky world of “clear evidence” – that a warning change rejected by the FDA for lack of scientific evidence must be “clear evidence” that this change would have also been rejected at any earlier date.  The logic is inescapable that, if there was insufficient scientific evidence at moment X, there is no more, and usually less, evidence on the same issue at any time before X.

Looking at our cheat sheet, the first case to so hold appears to be In re Fosamax (Alendronate Sodium) Products Liability Litigation, 951 F. Supp.2d 695 (D.N.J. 2013). Fosamax involved the FDA’s partial rejection of a prior approval supplement after the date of the plaintiff’s injury.  Id. at 703 (FDA rejection occurred “approximately one month after” plaintiff’s injury).  The label change failed because “the data that FDA has reviewed have not shown a clear connection” between the drug and the risk at issue.  Id. at 699.

[C]lear evidence exists that the FDA would not have approved a label change to the Precautions section of the [drug] label prior to [plaintiff’s] fracture because Defendant submitted a label change and the FDA rejected it, and the FDA never required Defendant to submit new language or change the label, which demonstrates that the FDA did not think that the label should have been changed at that time.

Id. at 703-04. See In re Fosamax Alendronate Sodium Products Liability Litigation, 2014 WL 1266994, at *11 (D.N.J. March 26, 2014) (applying this ruling “to those Plaintiffs’ whose injuries occurred prior to [the FDA rejection date], without allowing additional discovery”).

Continue Reading Two Favorable Tysabri Rulings Add Clarity to “Clear Evidence” Preemption Standard – and More

We were not able to make our annual pilgrimage to the Westminster Kennel Club Dog Show this year, so we had to settle for watching the televised portions on the couch with the Drug and Device Law Rescued Ragamuffins.  And the cat.  (We mostly resisted the all-day live feed of the breed judging.)   Since the Best in Show lineup didn’t include a Standard Poodle, our “breed of the heart” (a cute Bulldog named Annabelle beat Ricky, the stunning black Standard Poodle, in the Nonsporting Group), and being nothing if not bandwagon jumpers, we were rooting for “Rumor” a gorgeous German Shepherd who was the top winning show dog of 2015 by many, many points.  And she showed beautifully.  But she was defeated by “C.J.,” a German Shorthaired Pointer. While we don’t count ourselves as sporting breed fanciers, C.J. is a cool dog.  And, most interestingly (maybe not, but it gives us a hook to transition to our case in a minute), C. J.’s grandmother, Carlee, was Best in Show in 2005. Carlee was known for her flawless “free stack” – instead of needing her handler to place her feet in the right positions and stretch out her neck – “stack” her – for the judge’s examination, she did it all by herself in the most striking of fashions.   Westminster trivia:  like the Adamses and the Bushes, Westminster can count one example of a father siring his eventual successor:  Robert, the English Springer Spaniel, was Best in Show in 1993.  His daughter, Samantha, “took the Garden” seven years later.  The ostensible point of dog shows is to reward the best specimens of each breed so they will pass their genes to future generations, so it is neat when a judge’s good decision is affirmed.

And so it was recently in the Third Circuit.  In In re Avandia Marketing, Sales Practices and Products Liability Litigation (Linda and John Schatz, appellants), — Fed. Appx, –, 2016 WL 574074 (3d Cir. Feb. 12, 2016) (applying Pennsylvania law), the panel considered Judge Cynthia Rufe’s grant of summary judgment to the defendant manufacturer in a case in the Avandia MDL. The plaintiff, who had taken Avandia, sustained bone fractures in two accidents and alleged that the manufacturer had failed to adequately warn of the risk of such fractures.  The manufacturer had informed doctors of this risk and, shortly thereafter, updated its warnings to include this information.  While it was not clear whether the plaintiff had already stopped taking the drug at this time, it was undisputed that she resumed taking it for a short time after the “bone fractures” warning was added to the label.

Continue Reading Solid Affirmances: Avandia Summary Judgment, and Westminster

Sometimes it takes an outsider to point out  something that should be blindly obvious.  In this case, that role was performed by a couple of our colleagues earlier this month at the annual ACI Drug and Medical Device Litigation Conference.  They both told us how useful they found the new – adopted in 2015 − Pennsylvania Suggested Standard (Civil) Jury Instructions (“Pa. SSJI Civ.”) on the learned intermediary rule in prescription drug and medical device litigation.  So we thought we’d introduce them to you.  Here they are:

23.00 (Civ) Duty to Warn − Reasonable Care

In the case of prescription [drugs] [medical devices], the manufacturer has an obligation to exercise reasonable care to inform the plaintiff’s prescribing physician about the risks of its product.  Such a manufacturer has a duty to warn about risks of its products that are not generally known, if the manufacturer knew or reasonably should have known about the risks of its product.

23.10 (Civ) Duty to Warn Physicians, Not Patients − Learned Intermediary Rule

A drug or medical device manufacturer only has a duty to warn the [prescribing] [implanting] physician about the dangers of its [drugs] [medical devices].

It does not have a duty to warn patients directly.

If you find that the defendant adequately warned the plaintiff’s [prescribing] [implanting] physician, even if the physician did not transmit that information to the plaintiff, you must find for the defendant on the failure-to-warn claim.

23.20 (Civ) Different Warning

The plaintiff has the burden of proving both of the following:

  1. that the defendant did not adequately warn the [prescribing] [implanting] physician about the risks of its [drug] [medical device], and
  2. that the [prescribing] [implanting] physician would not have [prescribed] [implanted] the [drug] [medical device] if a different warning had been provided.

23.30 (Civ) Physician’s Knowledge − Other Sources

A pharmaceutical or medical device manufacturer that fails to adequately warn the [prescribing] [implanting] physician about the risks of its [drug] [medical device] is not liable if the physician was aware of the risks from medical literature or other reliable sources.

If you find that the plaintiff’s [prescribing] [implanting] physician already knew about the risks of the defendant’s [drug] [medical device] when he or she decided to [prescribe] [implant] it [to] [in] the plaintiff, then you must find for the defendant on the negligent failure-to-warn claim.

Continue Reading Introducing the New Pennsylvania Learned Intermediary Jury Instructions

This post comes from the Cozen O’Connor side of the blog, not the Reed Smith side.

Last July, in the Tapia v. Davol, Inc. hernia patch case, Davol won its motion to dismiss the plaintiff’s failure to warn claim.  2015 U.S. Dist. LEXIS 98521 at *16-17 (S.D. Cal. July 28, 2015).  The court was clear on why.  While plaintiff alleged facts on what was supposedly missing from the warnings, he alleged no facts suggesting that his own doctor didn’t receive a warning or that, if he had, he would not have prescribed the patch to plaintiff.  In other words, plaintiff did not allege facts to suggest proximate causation.  The court was explicit:

As to Defendant’s second argument regarding causation, while Plaintiff alleges the specific defect in Defendants’ product and specific warnings they failed to provide, he does not allege that Defendants failed to warn his own prescribing physician and that his own physician would not have used the Patch if warnings had been given.

Id. at *16-17.  Allegations about “‘physicians’ in general and the ‘healthcare community’” didn’t provide facts to suggest the existence of proximate causation.  Plaintiff needed to allege “facts as to his own prescribing physician.”  Id. at *17.

Continue Reading How Easy Is It to Allege Proximate Causation in a Medical Device Case

Warning:  You have heard all this before.

Still reading?  Okay.  But please don’t tell us later that our warning was inadequate and that you would have clicked over to Scotus or Grantland or TMZ if we had been more forthcoming.  As we have mentioned/kvetched what seems like 2814 times before (according to Blogger, that is how many posts we have put up — you’re welcome), most of the drug and device cases we encounter center around an allegation of failure to warn.  And most of those cases are weak and/or incoherent.  Yet most of those cases cost our clients a lot of money, if only because of the dysfunctional, asymmetrical meat-grinder called “discovery”.

Instead of ushering nuisance cases to the exit, too many courts are too inclined to find a purported issue of fact as to whether a warning is inadequate or whether a better warning would have made a difference.  Again, we’ve said it before and will doubtless say it again in the face of judicial obstinacy or lassitude, but courts should insist that plaintiffs state exactly what the warning should have been and show that such a warning would have prompted the doctor to make a different prescribing decision.

Continue Reading Lack of Warning Causation Dooms Aredia-Zometa Case

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

 

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

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