We understand the value of branching out and trying new things.  Recently, a close companion prevailed upon us to try calamari (thumbs down).   We signed up for a Zoom acting class during the pandemic.  And we are seriously considering a “new” hair color, to take advantage of the natural phenomenon that has occurred during the past thirteen months.  But sometimes it is satisfying to do the same thing over and over again.  One year, we returned five times to see a relatively obscure Broadway show.  We order green curry every single time we eat Thai food.   And we will happily report on every good “warnings causation” decision that comes down the pike.   (Witness this post and this post and this post and this post.)

As most of you know, a plaintiff asserting a failure-to-warn claim bears the burden of proving both that the defendant’s warnings were inadequate and that the inadequate warning proximately caused her alleged injuries.  In a prescription drug or medical device case, in most jurisdictions governed by the learned intermediary rule, a plaintiff satisfies her burden of proving causation by adducing evidence that a different or stronger warning would have altered her doctor’s decision to prescribe the drug or device.  In the absence of such evidence, if the judge applies the standard correctly, the defendant is entitled to summary judgment.  (There are wrinkles:  some jurisdictions muddy this standard by accepting evidence that the stronger warning would have caused the doctor to warn the plaintiff differently, stopping short of requiring evidence that the warning would have changed the doctor’s decision to prescribe the product.)

The exceptions are jurisdictions that apply a “heeding presumption.”  In its strongest form, the heeding presumption creates a rebuttable presumption that a doctor would have read and heeded an adequate warning.  Once the plaintiff demonstrates that the warning was inadequate, the presumption kicks in and the burden shifts to the defendant to adduce evidence that rebuts the presumption.  Needless to say, we hate heeding presumptions.  We think it skates close to a due process violation to shift the burden of proving an essential element of a substantive claim on the strength of a presumption based on sheer speculation.  Today’s case, Zember v. Ethicon, Inc., 2021 U.S. Dist. LEXIS 52878 (E.D. Wisc. Mar. 22, 2021), turned on whether or not the plaintiff was entitled to a heeding presumption and on how that affected the “warnings causation” analysis.

In Zember, a pelvic mesh case remanded from the mesh MDL, the plaintiff was implanted with the defendant’s mesh device to treat her stress urinary incontinence.  On her master complaint, she checked off eighteen (eighteen!) claims she was pursuing against the defendant, including all manner of product liability, warranty, and fraud-based claims.  The defendant moved for summary judgment on many of the claims.  The plaintiff responded only to the arguments addressing the strict liability failure-to-warn claim.  (The court granted the unopposed portions of the motion.)

With respect to the failure-to-warn claim, the defendant did not argue that the defendant’s warnings were inadequate, skipping to the causation element of the claim.  As a threshold matter, the court acknowledged that, while Wisconsin had not formally adopted the learned intermediary doctrine, the Seventh Circuit had predicted that the Wisconsin Supreme Court would adopt the doctrine.  “Thus,” the court stated, “[we] will proceed as though the learned intermediary doctrine applies under Wisconsin law.”  Zember, 2021 U.S. Dist. LEXIS 52878 at *9 n.4.   As the court described the relevant test, a Wisconsin plaintiff must establish causation by proving that a proper warning would have caused the doctor to alter his behavior and would have prevented the plaintiff’s injury.  Id. at *11.

The defendant argued that the plaintiff had adduced no evidence that her doctor would not have implanted the mesh device if a stronger warning had accompanied the device.  In opposition, the plaintiff first invoked the “neglectful mesh plaintiff’s lament,” arguing that she hadn’t had the “opportunity” to depose her implanting physician because he had “been out of the country.”  The court responded with a figurative eye-roll, noting that the case had been pending since 2012 and that it “came from the MDL court with specific instructions that discovery not be permitted to continue.”  Id. at *11-12.

Next, the plaintiff argued that the court should apply a heeding presumption; in other words, a presumption that the doctor would have heeded an adequate warning and would have changed his prescribing decision based on the warning.  Id. at *12.  The court explained that Wisconsin courts had not spoken to the applicability of a heeding presumption to failure-to-warn claims involving medical devices but that the Seventh Circuit had expressed “serious doubt” that Wisconsin would adopt the presumption in this context (and that Wisconsin had rejected the presumption in other contexts).  The court concluded,

The Court will not apply a presumption that [the doctor] would have heeded an adequate warning if he had been provided one.  Plaintiffs cannot make a showing of causation as they have not procured any testimony from [the doctor] that he either relied on the warning provided or would have acted differently if given an adequate warning.  Thus, Plaintiffs have not raised a genuine dispute as to causation, and the Court will award summary judgment to Defendants” on the failure-to-warn claim.

Id. at *13.  We love this decision.  We are delighted that the court added weight to the “no heeding presumption in Wisconsin” conclusion.  And we are pleased that the court understood and applied the correct burden of proof to the causation element of the failure-to-warn claim.   We never get enough of courts getting this stuff right, and we hope we can bring you more examples.  In the meantime, stay safe out there (and try the green curry).

 

We’ve made no secret of our dislike of the so called “heeding presumption.” We have a tag on this subject with multiple posts decrying this presumption — that juries may presume that if an alternative adequate warning had been given, it would have been heeded by the plaintiff (or, in prescription medical product cases, the prescriber). That is essentially a shift of the burden of proof on warning causation from plaintiffs to defendants without any justification. Warnings are ignored all the time.

Our posts note that it is a fairly even split between jurisdictions rejecting and those adopting the heeding presumption. But we’ve taken special note of New York law on the issue because it is a bit muddled. In a post a couple of years ago we explained how a bad Second Circuit decision on the issue (Liriano v. Hobart Corp., 170 F.3d 264 (2d Cir. 1999)) overreached and ignored New York state court precedent spawning a line of cases which purport to recognize a general heeding presumption. At that time we predicted it would require a decision from the New York Court of Appeals to clean up the mess the federal and lower courts had made. We came close to such a decision last year in In re New York City Asbestos Litigation, 59 N.E.3d 458 (N.Y. 2016) (“NYC Asbestos”). Unfortunately, the court determined that the defendant had waived the issue of whether the heeding presumption existed in New York. But, in dicta, went on to say:

[Defendant’s] current complaint about the court’s instructions on the presumption is unpreserved. Of course, our rejection of [defendant’s] claim on preservation grounds should not be taken as an acceptance or rejection of the trial court’s heeding instructions on the merits, and regardless of the propriety of those instructions, trial courts must continue to ensure that their jury instructions honor the principle that the burden of proving proximate causation, which in a case like this one includes the burden of demonstrating that the injured party would have heeded warnings, falls squarely on plaintiffs.

Id. at 482 (emphasis added).

We are happy to report today that that dicta has not gone unnoticed in the drug and device context. Last week, a New York federal court ignored the line of cases from Liriano and instead cited NYC Asbestos and basic New York causation law to hold that New York doesn’t recognize a heeding presumption. The case is Adeghe v. Janssen Pharmaceuticals, 2017 WL 3741310 (S.D.N.Y. Aug. 30, 2017) and involves allegations that plaintiff developed gynecomastia as a result of his use of Risperdal. Id. at *1.  In addition to NYC Asbestos, the court relied on other cases for the general proposition that plaintiff bears the burden of proof that the alleged failure to warn was a proximate cause of his injury and that plaintiff’s burden “includes adducing proof that the user of a product would have read and heeded a warning had one been given.” Id. at *6.

The court provided a strong rationale for why the heeding presumption is not justified in drug/device cases:

Particularly in a case involving failure to warn of the risks of a pharmaceutical product, depending on the plaintiff’s condition and treatment alternatives, one may not reasonably assume that a patient or his treating physician will forego a drug because of disclosed risks.

 Id.

This is an important reminder about just what it means to apply a heeding presumption in a pharmaceutical case. The warnings at issue for drugs and devices are warnings about potential risks. Risks that the prescriber, the learned intermediary, needs to weigh against his knowledge of his patient, his patient’s medical condition, other available alternative treatments (and their risks), and his general medical knowledge. All of that cannot be swept under the rug with a presumption that an alternative warning would have tipped the scales toward non-prescription. Doctors prescribe drugs/devices everyday despite any number of risks inherent in their use.   At best a heeding presumption in a pharmaceutical case, if applied at all, should only go so far as to assume that the alternative warning would have been read by the prescriber. But, it is simply too huge a leap to presume the effect that new warning would have had on the prescribing decision given all the other variables.

In Adeghe, the court found no evidence (no prescriber testimony) that plaintiff wouldn’t have been prescribed Risperdal if a different warning had been given. Id. at *7. Moreover, plaintiff did not adduce any evidence that when the risks of the drug were balanced against its benefits, it would not have been prescribed. Id. “Plaintiff cannot rely on mere speculation as to this medical determination to defeat summary judgment.” Id. Kudos to the court for distinguishing prescription drugs and devices from household consumer goods.

Summary judgment was granted on plaintiff’s failure to warn claim (and on express warranty for lack of any affirmation, id. at *5), but several other causes of action remain because summary judgment was denied on medical causation. The court found plaintiff’s expert had done enough, reviewed studies and considered and addressed alternative causes, to survive a Daubert challenge. Certainly not the worst expert we’ve seen and hardly as important as the heeding presumption decision both for its help in further clarifying New York law and in its acknowledgement of why the presumption has no place in prescription drug and device cases.

Devoted as we are to the defense of manufacturers of prescription drugs and medical devices, we have often advocated for the full implication of the fundamental—to us, at least—requirements that warnings claims focus on the decision making of the learned intermediary and that proximate cause matters.  One implication is that heeding presumptions typically make little sense for claims about these products.  It is one thing to say that a plaintiff should be allowed to proceed with a warnings claim when a prescriber is truly unavailable to provide testimony—like by dying before the plaintiff knew he had a claim—and the alleged missing warning would have clearly contraindicated the plaintiff from receiving the prescription product.  In such a case, it might make sense to presume, absent contrary evidence, that the physician would have heeded the warning and not prescribed the product to the plaintiff.  In just about every other prescription drug and device case we can imagine, the heeding presumption does not make sense.

We feel the same way about a post-sale duty to warn.  Not only do such duties run contrary to the typical focus in warnings cases on the notice to the manufacturer of potential risks before the product leaves its control (or is prescribed to plaintiff), but the proximate cause inquiry can quickly become an exercise in layered speculation.  Cases acknowledging such a post-sale duty have typically involved situations where the seller had a continuing relationship with the purchaser, with an obvious route for relaying additional information about the product in a way that allows a jury to evaluate whether injury would have been avoided.  In prescription drug and device cases, there tends not to be any direct relationship at any time and the manufacturer does not know the names or addresses of patients using its products.  Over time, patients move, change their physicians, and even see physicians for reasons unrelated to the reason they were prescribed a drug or device in the past.  Over time, manufacturers also stop selling specific products or product lines and may even go out of business.  When it comes to drugs with alleged remote effects or devices that are implanted for many years, these real world considerations make potentially unlimited post-sale duties to warn a folly.  We could go on, but we will not.

Continue Reading Heeding Presumption Only Goes So Far In Post-Sale Warning Case

Ever since this blog started, we’ve made plain that we have no use for the so-called “heeding presumption.”  This presumption posits that, because under Restatement §402A, comment j, a defendant providing an adequate warning can presume it will be heeded, a plaintiff should also be able to presume that an adequate warning, had it been granted, would have been heeded.  That’s false equivalence if we’ve ever seen it.  A defendant to such a warning claim needs no heeding presumption, since it wins on adequacy without ever getting to causation.  The comment j discussion really involves design defects (about which more below).  Plaintiffs, on the other hand, are getting a burden of proof shift on warning causation that simply has no basis in reality.  People disregard adequate warnings all the time.

So we fight the heeding presumption whenever it comes up.  Some states have good law on the issue.  N.C. G.S.A. §99B-5(a); Wis. Stat. §895.047(1)(e); Ford Motor Co. v. Boomer, 736 S.E.2d 724, 733 (Va. 2013); Rivera v. Philip Morris, Inc., 209 P.3d 271, 274 (Nev. 2009); Leaf v. Goodyear Tire & Rubber Co., 590 N.W.2d 525, 528-29 (Iowa 1999); Riley v. American Honda Motor Co., 856 P.2d 196, 199-200 (Mont. 1993); Deere & Co. v. Grose, 586 So. 2d 196, 198 (Ala. 1991); Huitt v. Southern California Gas Co., 116 Cal. Rptr.3d 453, 467-68 (Cal. App. 2010); Harris v. International Truck & Engine Corp., 912 So. 2d 1101, 1109 (Miss. App. 2005); McPike v. Enciso’s Cocina Mejicana, Inc., 762 P.2d 315, 319 (Or. App. 1988); DeJesus v. Craftsman Machinery Co., 548 A.2d 736 (Conn. App. 1988); Muilenberg v. Upjohn Co., 320 N.W.2d 358, 366 (Mich. App. 1982); Potthoff v. Alms, 583 P.2d 309, 311 (Colo. App. 1978); Payne v. Novartis Pharmaceuticals Corp., 767 F.3d 526 (6th Cir. 2014) (applying Tennessee law); Tuttle v. Lorillard Tobacco Co., 377 F.3d 917, 925 (8th Cir. 2004) (applying Minnesota law); Wilson v. Bradlees of New England, Inc., 250 F.3d 10 (1st Cir. 2001) (applying New Hampshire law); Christopher v. Cutter Laboratories, 53 F.3d 1184, 1192-93 (11th Cir. 1995) (applying Florida law); Odom v. G.D. Searle & Co., 979 F.2d 1001, 1003 (4th Cir. 1992) (applying South Carolina law); Muzichuck v. Forest Laboratories, Inc., 2015 WL 235226, at *13 (N.D.W. Va. Jan. 16, 2015); Luttrell v. Novartis Pharmaceuticals Corp., 894 F. Supp.2d 1324, 1345 n.16 (E.D. Wash. 2012).

Almost as many states are adverse.  House v. Armour, Inc., 929 P.2d 340, 347 (Utah 1996); Coffman v. Keene Corp., 628 A.2d 710, 717-19 (N.J. 1993); Eagle-Picher Industries, Inc. v. Balbos, 604 A.2d 445, 468-69 (Md. 1992); Bushong v. Garman Co., 843 S.W.2d 807, 811 (Ark. 1992); Arnold v. Ingersoll-Rand Co., 834 S.W.2d 192, 194 (Mo. 1992); Butz v. Werner, 438 N.W.2d 509, 517 (N.D. 1989); Harlow v. Chin, 545 N.E.2d 602, 606 (Mass. 1989); Bloxom v. Bloxom, 512 So.2d 839, 850 (La. 1987); Payne v. Soft Sheen Products, Inc., 486 A.2d 712, 725 (D.C. 1985); Wooderson v. Ortho Pharmaceutical Corp., 681 P.2d 1038, 1057-58 (Kan. 1984); Seley v. G.D. Searle Co., 423 N.E.2d 831, 838 (Ohio 1981); Menard v. Newhall, 373 A.2d 505, 506 (Vt. 1977); Cunningham v. Charles Pfizer & Co., 532 P.2d 1377, 1382 (Okla. 1974); Dole Food Co. v. North Carolina Foam Industries, Inc., 935 P.2d 876, 883 (Ariz. App. 1996); Ortho Pharmaceutical Corp. v. Chapman, 388 N.E.2d 541, 555 (Ind. App. 1979).

Continue Reading Heedless Heeding Presumptions – How New York Law Became a Morass

We’ve made no secret of our distaste for the so called “heeding presumption” – that juries may presume that any alternative “adequate” warning would have been heeded by the plaintiff (or, in prescription medical product cases, the prescriber).  We have a topic header on this subject with multiple posts decrying such presumptions, both generally and in the particular context of prescription medical products.

The biggest conceptual problem is that there are two fundamentally different kinds of warnings.  Most warnings concern a product’s use – that if you use (or don’t use) the product in a certain way, you are likely to get hurt; and if you follow the warning, you won’t.  Examples are not driving a riding lawnmower parallel to a slope (because you’ll tip over) or only handling asbestos while using a respirator (because breathing asbestos can do nasty things to you).  Most step-by-step directions also fall in this category.

While so-called “use” warnings occasionally arise as to prescription medical products – overdose instructions come to mind – that type of warning is not what most litigation involving these products is about.  Rather, with prescription-only products, most of the relevant risks arise whenever the product is used.  A warning about an inherent risk – a so-called “risk warning” – serves an entirely different purpose.

With inherent risks, people are warned so they can decide whether that risk outweighs the benefits that might be gained from using the product.  The only way to avoid the risk is not to use the product at all.  All prescription medical products have inherent risks – which is why the FDA requires a physician’s prescription in the first place.  For a case discussing the distinctions between these two types of warnings in detail, read Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806, 814 (5th Cir. 1992) (applying Mississippi law), which you can find later in this post.

Continue Reading Who Heeds The Heeding Presumption?

In the index to this blog, we list 39 posts about the Aredia-Zometa litigation.  After today it will be 40.  And counting.  That might actually be understating our coverage.  (We’re not always so punctilious at affixing topical labels to our posts.) Sometimes it seems as if one could understand all of recent drug and device law, from A to Z, just by looking at developments in the Aredia-Zometa litigation. Maybe that is so because so many of the Aredia-Zometa cases have gone so far through the litigation gristmill, including trials, and have thereby produced so many judicial opinions on so many different areas, such as design defect, warning causation, learned intermediary, bankruptcy estoppel, abatement, ghostwriting, loss of consortium, etc.

In fact, just one of the Aredia-Zometa cases, Dopson-Troutt, has been like a mini-industry churning out drug and device law rulings. We have blogged about that case on topics such as choice of law, punitive damages, comment k, warranty claims, and Daubert (including Parisian). Just a couple of days ago, Dopson-Troutt maintained its status as the A-Z gift that keeps on giving. In the pretrial order we discussed last week, the court went the right way in rejecting non-mutual, offensive collateral estoppel.

This week’s Dopson-Troutt ruling heaves in some lumps of coal amidst some shiny baubles.  The defendant filed an omnibus motion in limine.  The court’s opinion in Dopson-Troutt v. Novartis Pharmaceuticals Corp., 2013 U.S. Dist. LEXIS 135834 (Sept. 23, 2013), characteristically, covers a lot of ground.  (Maybe the “omnibus” term should have been a clue.)  Some of the terrain is lovely. Some of it is rocky.  First, the court correctly holds that Pennsylvania law does not recognize the heeding presumption in cases involving prescription products.  The court had little difficulty distinguishing the asbestos and OTC cases relied upon by the plaintiffs.  Dopson-Troutt, 2013 U.S. Dist. LEXIS 135834 at *10-11.  We like this ruling, but we are not exactly going to applaud when a court manages to  get something right that should be perfectly clear and obvious.  And we are definitely not going to applaud when the court proceeds to mangle the ruling by saying that testimony by nonprescribing doctors “could be relevant” to a jury’s determination of whether warnings would affect a “reasonable doctor.”  Id. at *12-13.   The court did not want to rule in a vacuum.  It wanted to see what testimony would be excluded.  Maybe the court will ultimately get this issue right and exclude a lot of speculative drivel.  But now we’re the ones who are speculating, aren’t we?

We love preemption.  We wish we could sprinkle a little preemption in our coffee in the morning and on our ice cream at night.  We try to sprinkle preemption in just about every case we have.  Sadly, not all courts share our taste for preemption.  In fact, we are starting to get the idea that some courts don’t like it at all. They make a face and spit it out whenever possible.  For some judges, preemption is ipecac. (And we are emetophobes.)  In Dopson-Troutt, the defendant mounted a fairly aggressive preemption defense against the failure to warn claim. The defendant argued that “a label change requiring prior FDA approval is preempted.”  Id. at *19.  Not surprisingly, the plaintiffs relied upon Levine.  The defendant tried to read Bartlett and Mensing as opening up new preemption ground, even for brand manufacturers.  We agree that Bartlett and Mensing have implications for brand preemption, and we have said as much before.  But it will take some guts for a court to reread Levine in light of Mensing/Bartlett.  Frankly, it would amount to a pleasant surprise.  A court that treats preemption as a red-headed stepchild simply isn’t going to go our way.  Let’s just say that the Dopson-Troutt court did not surprise us.  It discounted Bartlett and Mensing, saw the Levine decision as the colossus still bestriding brand manufacturer preemption law, and denied the defendant’s effort to cabin Levine.

The defendant sought to prevent the plaintiffs from arguing that the Zometa label should have disclosed that Aredia was safer.  The FDA requires certain types of evidence to justify comparative claims. The Dopson-Troutt court denied the defense motion but it seemed to be animated more by caution than logic.  The denial of the defense motion was without prejudice:  “Without knowing what comparisons and supporting studies are at issue, the Court lacks sufficient information to make a determination.”  Id. at **23-24. Maybe we are cockeyed optimists, but we bet that when the plaintiffs are forced to put up or shut up as to whether studies would have proved the claimed comparison, they will be forced to shut up.

The defendant fared much better on the plaintiffs’ claim that there should have been a black box warning.  FDA regulations clearly prohibit manufacturers from unilaterally adding a black box warning.  See, e.g., 21 CFR section 201.57(3); 44 Fed. Reg. 37434, 37448 (June 26, 1979).  The plaintiffs had no response save a rather silly one – that there is no instance of the FDA striking a black box warning used by a pharmaceutical company.  Id. at *25.  Yeah, but still.  And by “still,” we mean that the regulations still say what they say.  That, at least, is how the Dopson-Troutt court saw the issue, and it granted the defense motion to exclude the black box argument.

The plaintiffs challenged the form, as well as the content, of the Zometa label.  The quarrels over form included placement, bolding, and font size.  It is hard to believe that this sort of thing is not wholly entrusted to the judgment of the regulatory body.  The defendant cited the Pom Wonderful case in arguing that the plaintiffs’ desire to fly-speck the format of the label threatened the FDA’s primary jurisdiction.   Wonderful or not, the Dopson-Troutt court concluded that Pom Wonderful was inapplicable because it was a food, not drug, label case. The court denied most of the defendant’s motion, which strikes us as an invitation to plaintiffs to come forward and propose all sorts of dopey format changes.   Nevertheless, to the extent the plaintiffs insisted that the label use an FDA disapproved font, that claim was deleted.  Id. at **27-28.  Perhaps one should be grateful for small favors.

Finally, the defendant sought to exclude evidence of any corporate conduct post-dating the plaintiff’s tooth extraction (which plays a major role in determining onset of an A-Z plaintiff’s injury).  The court would not at this point agree to that exclusion ex ante, because there was the possibility that after-the-fact documents or actions might be somehow relevant, such as for showing prior knowledge.  Id. at *28.  This is a court that views in limine motions with almost as much trepidation and suspicion as preemption.  Even so, reserving judgment is better than indulging in bad judgment.  If the court wants to hold off on categorical rulings, so be it.  It’s all good so long as the court ends up making the right ruling, and does so before the plaintiffs manage to poison the jury well.

In other words, there is every reason to believe there will more rulings in the future.  We will hear from Dopson-Troutt again.

We previously discussed the Montana Supreme Court case of Riley v. American Honda Motor Co., 856 P.2d 196 (Mont. 1993) and touted it as one of the best rejections of the heeding presumption we’ve seen – rejecting all of the most often advanced arguments in favor of the heeding presumption.  So we were a bit surprised when we learned about that same court’s decision in Patch v. Hillerich & Bradsby Co., No. 2011 MT 175, slip op. (Mont. July 21, 2011) (unpublished) – applying the heeding presumption.

While not a drug or medical device case, Patch is definitely a step backward by the Montana Supreme Court and one that may well have implications for our clients.  Patch involves the tragic death of an 18 year-old boy who, while pitching a baseball game, was struck in the head by a ball hit using an aluminum bat manufactured by the defendant.  Patch, slip op. at 2.  A jury returned a verdict for the plaintiff finding that the defendant failed to adequately warn about the enhanced risks associated with its bat which allegedly increased the velocity speed of a batted ball.  Id. at 3.

On appeal, the defendant sought review, among other things, of the lower’s court’s denial of defendant’s motion for judgment as a matter of law on the failure to warn claim.  Id. at 2 (other aspects of the appeal raised issues related to decedent’s status as a bystander, the “workability” of providing a warning, and assumption of the risk, see id. at 5-8, 12-13).  The main issue – causation.  It is here that the Montana Supreme Court seems to do an about face.

The question in Patch was whether the trial court’s adoption of the heeding presumption violated the holding of RileyId. at 9.  Clearly, it does.  In Riley, the court specifically rejected the argument that the heeding presumption – i.e. shifting the burden of causation to the defendant – is necessitated by the policy underlying strict products liability.  Riley, 856 P.2d at 200 (“[w]e are unwilling to shift the respective parties’ burdens in such a fashion. . . . A defendant certainly is in no better position to rebut a presumption which totally excuses a plaintiff from meeting the causation element than a plaintiff is in establishing the causation element as part of the prima facie case.”).

Continue Reading Montana Takes a Flexible Approach to the Heeding Presumption

About a month ago, the Nevada Supreme Court took a look at the so-called “heeding presumption” – and rejected it outright. Rivera v. Philip Morris, Inc., ___ P.3d ___, 2009 WL 1563373 (Nev. June 4, 2009). Not only that, the decision was unanimous. Obviously, given the caption, Rivera wasn’t a drug or device case (which is why we didn’t jump on it right away). But, like drugs and devices, cigarettes have inherent risks that cannot be designed away. So some of the arguments we’ve used against the heeding presumption in drug cases would apply to cigarettes. Indeed, the degree of public knowledge concerning risks in cigarette cases is much greater than in the average drug case. So it may be that cigarettes represent an a fortiori situation.

But an unavoidably unsafe product analysis wasn’t the Nevada Supreme Court did in Rivera. The court didn’t split the baby like some courts have done – limiting the presumption to certain types of products or kinds of situations. Rather, Rivera rejected the heeding presumption entirely, as against all defendants in any case. That’s worthy of our attention, even though the subject matter is outside of our sandbox.

Rivera’s facts aren’t all that unusual; a typical smoking case with allegations of inadequate warnings about the risks of smoking. The defendant tobacco company moved for summary judgment on the warning claim, which was denied. The trial court interposed a heeding presumption, and stated that the defendant had not overcome it. 2009 WL 1563373, at *2. However, since the case was in federal court, Nevada procedure permitted certification of controlling questions of law to the Nevada Supreme Court. That’s what happened with the heeding presumption. Id.

The Rivera court first stated the general rule: “the burden of proving causation can be satisfied in failure-to-warn cases by demonstrating that a different warning would have altered the way the plaintiff used the product or would have prompted plaintiff to take precautions to avoid the injury.” 2009 WL 1563373, at *4. That’s essentially the same standard we use in our drug cases to win summary judgment in learned intermediary cases based upon independent physician knowledge and other doctor-related facts that preclude causation.

The heeding presumption, however, “departs from well-settled and established Nevada law.” Id. It would change the burden of production on warning causation:

Instead of requiring that the plaintiff prove each element of a strict product liability case, a heeding presumption removes the plaintiff’s responsibility to carry the initial burden of production as to the element of causation. A heeding presumption “allow[s] the fact-finder to presume that the person injured by product use would have heeded an adequate warning, if given. Therefore, a heeding presumption shifts the burden of production from the plaintiff to the manufacturer, who must rebut the presumption by proving that the plaintiff would not have heeded a different warning.

Id. (various citations and quotation marks omitted).

The court didn’t want to go there. First, it got rid of a couple of cases plaintiffs advanced by construing them as holding no more than, under the facts, the plaintiffs could have met their burden of proving causation. 2009 WL 1563373, at *5.

Then it turned to the crux of the heeding presumption – the language in Restatement (Second) of Torts §402a, comment j (1965): “[w]here warning is given, the seller may reasonably assume that it will be read and heeded; and a product bearing such a warning, which is safe for use if it is followed, is not in defective condition, nor is it unreasonably dangerous.” Courts adopting the heeding presumption claim, as a some sort of symmetry, that a plaintiff presumptively would have followed a non-existent adequate warning.

That argument, of course, puts the rabbit squarely in the hat, because the comment j language really doesn’t give defendants anything. After all, if the warning is adequate, as the comment, postulates, the defendant doesn’t even need to get to causation to win. The defendant wins because there was nothing wrong with its warning – whether anybody read them or not. That means there’s really no “symmetry” or “corollary” at all. Instead, the heeding presumption effectively gives plaintiffs something of significant value (shifting the burden of, at least, production, on causation) for nothing (cases the defense wins anyway on adequacy of warming).

But we digress.

The Rivera court held that, while it had agreed with other parts of comment j in the past, in Allison v. Merck & Co., 878 P.2d 948 (Nev. 1994), it had not adopted all of comment j, and specifically had not adopted the language about presumed reliance upon warnings. 2009 WL 1563373, at *5 (“the manner in which we have previously cited to comment j indicates that we will not stray from the principle that the plaintiff carries the burden of production of the element of causation”). Coincidentally, Allison is the case where, when the votes of a splintered court are added together, a majority of the court followed the learned intermediary rule.

After discussing Allison, the court in Rivera comes out and says it: “It is a firmly rooted part of Nevada law that the plaintiff in a strict product liability case bears the burden of proving all the elements of his case, including causation.” 2009 WL 1563373, at *6. Rivera cites several other cases from around the country that refuse to adopt the heeding presumption. Id. (citing Riley v. American Honda Motor Co., 856 P.2d 196, 200 (Mont. 1993); DeJesus v. Craftsman Machinery Co., 548 A.2d 736, 744 (Conn. App. 1988); Harris v. International Truck & Engine Corp., 912 So.2d 1101, 1109 (Miss. App. 2005)).

Rivera also rejected the heeding presumption on public policy grounds. It’s basis was somewhat unusual. The court concluded that it didn’t really like warnings very much, and that manufacturers should instead be encouraged to design products differently:

[W]e strongly adhere to the principle that a manufacturer must make products that are not unreasonably dangerous, no matter what instructions are given in the warning. Therefore, we conclude that it is better public policy not to encourage a reliance on warnings because this will help ensure that manufacturers continue to strive to make safe products.

2009 WL 1563373, at *6. We’re not sure how we feel about that rationale, as there are a lot of product risks – in cigarettes, and in prescription drugs – that simply cannot be designed away. That’s what the unavoidably unsafe product concept is all about.

One thing we don’t have any qualms over, however is the court’s alternative policy ground, recognizing that presuming even adequate warnings will be heeded is an out and out fiction:
[I]t is not logical to presume that a plaintiff would have heeded an adequate warning, if provided. Warnings are everywhere in the modern world and often go unread or, where read, ignored.
Id. (citation and quotation marks omitted).

Rivera got us thinking about the heeding presumption generally. We’ve examined it previously, but that was limited to the context of prescription drugs and medical devices. We also discussed Ackermann v. Wyeth, 526 F.3d 203 (5th Cir. 2008), a case both of us had a hand in (it was Herrmann’s case, and Bexis contributed an amicus brief). Ackermann wiped out the heeding presumption in prescription drug cases brought in Texas:

Further, we doubt the Texas Supreme Court would apply such a presumption here, when it would not serve its intended purposes. . . . In the learned-intermediary context, however, it is [the prescriber], not [the plaintiff], who had to testify about his decision to prescribe [the drug. . . .] [T]o “read and heed,” in the context of a learned intermediary, means only that the physician would have incorporated the additional risk into his decisional calculus.

526 F.3d at 213. See also Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806, 814 (5th Cir. 1992) (no presumption in unavoidably unsafe products because the effect of a presumption on an inherent risk would be to presume that nobody would ever use the product); Lineberger v. Wyeth, 894 A.2d 141, 145, 149-50 (Pa. Super. 2006) (heeding presumption limited to products involuntarily encountered in the course of a plaintiff’s employment).

But while we’ve considered the presumption’s applicability with respect to unavoidably unsafe products, we’ve never considered the existential question of “to heed or not to heed, is there a presumption?” Apologies to The Bard for that one.

We’ll do that now.

As we expected, the Nevada Supreme Court in Rivera cited most of the best cases. In Riley, the Montana Supreme Court methodically shot down the various “policy” arguments that were advanced in support of the heeding presumption:

First, the dissent contends that it is “common sense” that if an adequate warning is given the plaintiff would have read and heeded it. While this might be common sense in an ideal world, our own experience does not support it; warnings are everywhere in the modern world and often go unread or, where read, ignored. We conclude that the presumption is not appropriate running in either direction, to the manufacturer/seller where a warning is given or to a plaintiff where it is not.

856 P.2d at 200. That sounds like “common sense” to us. We don’t read every warning that we encounter – and we’re defense lawyers. Like Riley, we don’t think anybody else does either.

Next, the dissent raises the perceived difficulties involved in requiring a plaintiff to establish the causation element. We note that the evidence required to establish this element is not qualitatively different than other testimony given by a party in support of her or his prima facie case. Concerns that the testimony may be speculative or self-serving and that a plaintiff may die before the testimony is given are not unique to this cause of action.

Id. We’d go a step further. If plaintiffs are inclined to commit perjury in support of possible recovery, that’s no reason at all to reward them by shifting the burden of proof.

Finally, the dissent argues that the presumption is consistent with the policy behind strict products liability. This may be so; so too would many other changes in a plaintiff’s burden of establishing a prima facie case-including the elimination of any burden at all-be consistent with that policy. We are unwilling to shift the respective parties’ burdens in such a fashion. . . . A defendant certainly is in no better position to rebut a presumption which totally excuses a plaintiff from meeting the causation element than a plaintiff is in establishing the causation element as part of the prima facie case.

Id. We’ve seen plaintiffs trot this tired argument out in favor of abandoning any and all legal rules that can preclude recovery. Thus, there are lots of cases that, like Riley, reject it in various contexts. Here’s one we happen to have lying around: Strict liability “policies, however, have not been, and cannot be, applied to remove all forms of restriction imposed upon plaintiffs’ proofs in products liability actions.” Duchess v. Langston Corp., 769 A.2d 1131, 1145 (Pa. 2001) (subsequent remedial measures admissible in strict liability).

In Harris, the court declined to create a heeding presumption in a case involving a truck accident. The court observed that its state supreme court had, in a prior warning causation case (one involving a prescription vaccine), held: “Assuming arguendo that the warning was inadequate, [the plaintiff] still had the burden of showing that an adequate warning would have altered [the doctor’s] conduct.” 912 So.2d 1109 (quoting Wyeth Laboratories, Inc. v. Fortenberry, 530 So.2d 688, 691 (Miss.1988)). This causation standard, Harris held, precluded any heeding presumption:

The fact that our supreme court has ruled on cases where a heeding presumption could easily have been applied to aid the plaintiff in a products liability case and declined to do so indicates to us that the [court] has no intention or desire to adopt or create a heeding presumption as a part of our jurisprudence with respect to product liability cases. Therefore, we decline to create one as well.

Id.

DeJesus, in contrast, was more of a statutory case, involving causation language in the Connecticut product liability statute. The statute, however, was silent about what “proving’ causation entailed. The court held that it did not entail a heeding presumption:

[Plaintiff’s] argument is untenable. The plaintiff, the claimant herein, acknowledges that [the statute] specifically places upon him the burden of proving proximate cause, but then argues that the statute is vague by not providing guidelines as to how a claimant can satisfy this burden. . . . The language of the statute is clear. There was no presumption of proximate cause that arose on the jury’s finding that [defendant] had failed to provide adequate warnings.

548 A.2d at 744.

Beyond the cases cited in Rivera, there’s a lot of law, perhaps predictably, in New York and California.

In New York, “[u]nder well settled law, to prove proximate cause, a plaintiff has the obligation to adduce proof that had a warning been provided, she would have read the warning and heeded it.” Mulhall v. Hannafin, 841 N.Y.S.2d 282, 287 (N.Y.A.D. 2007). Accord Sosna v. American Home Products, 748 N.Y.S.2d 548, 549 (N.Y.A.D. 2002) (“in this State, it remains plaintiff’s burden to prove that defendant’s failure to warn was a proximate cause of his injury, and this burden includes adducing proof that the user of a product would have read and heeded a warning had one been given”); Topliff v. Wal-Mart Stores East LP, 2007 WL 911891, at *43 (N.D.N.Y. March 22, 2007) (no heeding presumption in New York; at most an “inference”); Smallwood v. Clairol, Inc., 2005 WL 425491, at *2 (S.D.N.Y. Feb. 18, 2005) (“plaintiff has the burden to establish “that he would have read and heeded a different warning had one been given”).

In California, all the law’s on the trial court level, but it holds that California would not recognize a heeding presumption. In Motus v. Pfizer Inc., after a lengthy discussion of California precedent, the court summed up:

Given that other no other court applying California law in this context has adopted the presumption, and several courts have failed to do so when the presumption could have been critical, this Court will not apply it here.

196 F. Supp.2d 984, 994-95 (C.D. Cal. 2001), aff’d, 358 F.3d 659 (9th Cir. 2004). Accord Nix v. SmithKline Beecham Corp., 2007 WL 2526402, at *2 (D. Ariz. Sept. 5, 2007) (“California. . .has not adopted a rebuttable presumption that the physician would have heeded an adequate warning”); Latiolais v. Merck & Co., 2007 WL 5861354, at *4 (C.D. Cal. Feb. 6, 2007) (plaintiff “improperly invokes the ‘rebuttable presumption’ doctrine. . ., as no California court had adopted it”), aff’d, 302 Fed. Appx. 756 (9th Cir. 2008); Lord v. Sigueiros, 2006 WL 1510408, at *4 (Cal. Super. April 26, 2006) (concluding that Motus “accurately summarize[s]” California law), aff’d, 2007 WL 4418019 (Cal. App. Dec. 19, 2007) (unpublished).

Elsewhere, courts have concluded that Alabama, Georgia, Minnesota, New Hampshire, South Carolina, and Wisconsin do not recognize the heeding presumption. See Gurley v. American Honda Motor Co., Inc., 505 So.2d 358, 361 (Ala. 1987) (warning cases “cannot be submitted to a jury unless there is some evidence that the allegedly inadequate warning would have been read and heeded and would have kept the accident from occurring”); Porter v. Eli Lilly & Co., 2008 WL 544739, at *11 (N.D. Ga. Feb. 25, 2008) (“there is no indication in Georgia law, however, that it would apply this comment in the manner of a ‘heeding presumption’ that would vitiate the need for a plaintiff to establish proximate cause for her injuries”), aff’d, 291 Fed. Appx. 963 (11th Cir. 2008); Tuttle v. Lorillard Tobacco Co., 377 F.3d 917, 925 (8th Cir. 2004) (“Minnesota state courts have not adopted the so-called ‘heeding presumption’”); Wilson v. Bradlees, Inc., 250 F.3d 10, 16 (1st Cir. 2001) (“New Hampshire has not adopted the ‘read and heed’ presumption, and we will not do so on its behalf”); Odom v. G.D. Searle & Co., 979 F.2d 1001, 1003 (4th Cir. 1992) (“There is no such presumption under South Carolina law, and we are unwilling to create one”); Kurer v. Parke, Davis & Co., 679 N.W.2d 867, 876 (Wis. App. 2004) (“[e]ven in the event that a warning is inadequate, proximate cause is not presumed”).

So, while there are quite a few states that adopted heeding presumptions – mostly during product liability law’s “free lunch” period in the 1970s and 1980s – there’s hope yet. Rivera demonstrates that, when an appellate court actually takes a hard look at the underpinnings of this spurious presumption, there’s a good chance that it will be rejected.

Since Herrmann argued this case, and Bexis contributed an amicus brief, we’re going to be quite guarded in what we write here. But please remember the existence of Ackermann v. Wyeth, 526 F.3d 203 (5th Cir. 2008), the next time you’re briefing whether a so-called “heeding presumption” applies in cases involving the learned intermediary doctrine.

On that issue, Ackermann hits the trifecta for the defense. Ackermann holds, first, that “the read-and-heed presumption does not apply to Texas cases involving learned intermediaries.” That’s strong precedent for cases pending in the Lone Star State, and one could plainly suggest that other states should follow Texas’s lead.

Ackermann holds, second, that, even if a read-and-heed presumption did apply, in the context of learned intermediaries, that presumption would mean “‘only that the physician would have incorporated the additional risk into his decisional calculus,'” not that the physician would automatically have decided not to prescribe the drug.

And Ackermann holds, third, that, “even if the [heeding] presumption applied, it would not change the result” in Ackermann itself, given the testimony of the treating physician.

That makes the Fifth Circuit decision in Ackermann an exceptionally strong precedent when plaintiffs assert that a court should presume that a physician would not have prescribed a drug if the package insert had contained some altered warning.

(Oh, yes: If you’ve ever arguing about whether a drug company should have included a “black box warning” in its package insert, Ackermann‘s footnote 13 is helpful on that score, correctly suggesting that manufacturers cannot unilaterally add black box warnings, but rather can give those warnings only when the FDA requires them.)

We are often mystified that courts rotely apply purportedly “general” product liability concepts to litigation involving prescription medical products without stopping to think whether these concepts make sense where: (1) the product cannot be marketed unless and until a federal agency approves them as safe and effective, and (2) because of its inherent risks, the product cannot be used by anyone except upon a doctor’s prescription.

One of these “cross-over” concepts is the so-called “heeding presumption” – adopted in a number of states – that “presumes” (in the absence of contrary evidence) if the defendant had given an adequate warning, the plaintiff would have heeded and followed it. This proposition has serious problems generally, so serious that the language giving rise to it was intentionally removed from the Restatement (Third) of Torts: Products Liability. That, however, is something for a different post.

In the case of prescription medical products, such a “heeding presumption” rarely, if ever, makes any sense at all. Yet, all too often we come across cases like Tingey v. Radionics, 2006 WL 2258872, at *10 (10th Cir. Aug. 8, 2006), and In re Diet Drug Litigation, 895 A.2d 480, 490-91 (N.J. Super. Law 2005), that apply the “heeding presumption” in prescription medical product liability litigation primarily because some earlier court applied it to an entirely different product that anybody could go out and buy at a hardware store.

Conversely it’s gratifying to read cases like Lineberger v. Wyeth, 894 A.2d 141, 145, 149-50 (Pa. Super. 2006), and Koenig v. Purdue Pharma Co., 435 F. Supp.2d 551, 556-57 (N.D. Tex. 2006), where the courts get it. These courts take the time to understand that not all products are the same – that drugs and devices are qualitatively different from step ladders and automobiles.

So what’s this big qualitative difference? Mainly, it’s that there are two fundamentally different kinds of warnings. Most warnings concern a product’s use – that if you use (or don’t use) the product in a certain way, you are likely to get hurt; and if you follow the warning, you won’t. Examples are not driving a riding lawnmower parallel to a slope (because you’ll tip over) or only handling asbestos while using a respirator (because breathing asbestos can do nasty things to you).

While so-called “use” warnings occasionally arise as to prescription medical products – overdose instructions come to mind – that type of warning is not what most litigation involving these products is about. Rather, with prescription-only products, most of the relevant risks arise whenever the product is used. A warning about an inherent risk – a so-called “risk warning” – serves an entirely different purpose.

With inherent risks, people are warned so they can decide whether that risk outweighs the benefits that might be gained from using the product. The only way to avoid the risk is not to use the product at all. All prescription medical products have inherent risks – which is why the FDA requires a physician’s prescription in the first place. For a case discussing the distinctions between these two types of warnings in detail, read Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806, 814 (5th Cir.1992).

What happens when a heeding presumption is imposed concerning a risk warning? In that situation, “heeding” the warning can only mean not using the product at all, because that’s the only way to avoid the risk. So applying a “heeding presumption” to an inherent risk lets plaintiffs argue, in effect, that the product should never have been sold – that every “reasonable” person would have “heeded” an adequate warning and not used it. But we know that’s not simply not true. For example, millions still smoke cigarettes, although those risks have been public knowledge for decades. Millions more use drugs and medical devices even though they carry the FDA’s strongest “black box” warnings. A “heeding presumption” in this situation is contrary to fact and to common sense.

But where a prescription medical product is involved there’s even more. Making the decision whether a product’s risks outweigh its benefits for society as a whole is precisely what we created the FDA to do. The Agency evaluates safety and efficacy for the products it approves and decides whether those products should be marketed at all and, if so, for what types of patients and for what types of medical conditions. Making that same decision on individual basis is the job of the prescribing doctor.

Doctors do for each of their patients what the FDA does for everybody – on an individual basis, they balance the risks of a product against its expected health benefit. Thus, the prescribing physician only “heeds” warnings in the sense of considering them while deciding how to prescribe the product and whether or not to tell the patient about the risk. It is unrealistic to presume physicians would “heed” any warning either in the sense of never using the product or that they would automatically telling every patient about every risk. Eck v. Parke, Davis & Co., 256 F.3d 1013, 1021 (10th Cir. 2001) (wrong to “construe [a treater’s] ‘heeding’ an adequate warning to mean [s/he] would have given the warning”).

So if an inherent risk of an FDA-approved prescription-only product is omitted (or not adequately discussed), does that mean that the law should “presume” that nobody would have used it – that everyone would have “heeded” a better warning and used something else (or have been content to use nothing)? Of course not. The FDA’s approval means that the product can be used for its approved uses. Unless the FDA determines the “new” risk is so serious as to affect that approval, it will deal with the risk by approving a new warning. Unless a “new” risk is great enough to tip the prescribing decision for a particular patient, at most a prescribing doctor will tell the patient about it. The prescriber might not even do that if the new risk is not viewed as very likely in that particular patient.

For these reasons, we believe that – logically and legally – the “heeding presumption” has no legitimate role in virtually all prescription medical product liability litigation.