The district judge in the In re Zimmer Nexgen Knee Implant Products Liability Litigation MDL issued a summary judgment order in October 2016 that we called “the best Wisconsin law decision we have ever seen.”  What was the reason for our unusually unbridled enthusiasm?  The district judge debunked the idea that the learned intermediary rule does not apply in Wisconsin.  We have often heard that refrain, but we have always been skeptical.  The truth is that Wisconsin’s appellate courts have not addressed the issue, and the In re Zimmer Nexgen judge predicted that Wisconsin’s Supreme Court would adopt the learned intermediary rule if given the opportunity.

The Seventh Circuit has affirmed that order, so its opinion now inherits the mantle of “Best Wisconsin Law Decision We’ve Ever Seen.” That title is cemented not only by the adoption of the learned intermediary doctrine, but also the rejection of a heeding presumption, which is also very helpful.  We note that the three judges who issued this opinion have spent a combined 83 years on the Court of Appeals and that the author of the opinion spent five years on the Wisconsin Supreme Court.  Maybe the latter fact was considered when assigning the opinion; maybe it was not.  Regardless, it is a clear-minded and well-reasoned opinion that we commend to anyone who has grappled with warnings claims in Wisconsin.

Here is what happened. The plaintiff sued a knee implant manufacturer alleging design, manufacturing, and failure-to-warn claims after his prosthetic knee replacement loosened, which is a known complication of all joint replacement procedures. In re Zimmer Nexgen Knee Implant Prods. Liab. Litig., No. 16-3957, — F.3d –, 2018 WL 1193431, at *1 (7th Cir. Mar. 8, 2018).  Following summary judgment, the plaintiff raised only the warnings claims on appeal and argued that the manufacturer failed adequately to warn both the plaintiff and his surgeon.

Of course, an alleged failure to warn the plaintiff raises the application of the learned intermediary rule, which “holds that the manufacturer of a prescription drug or medical device fulfills its duty to warn of the product’s risk by informing the prescribing physician.” Id. at *2.  Because neither the Wisconsin Supreme Court nor the state’s intermediate appellate courts have addressed the rule, the Seventh Circuit undertook an Erie analysis. Id. at *3.

Although we would like to believe that the Seventh Circuit reviewed our frequently updated 50-state survey on the learned intermediary rule, it is more likely the court did its own research or relied on that provided by the manufacturer.  What it found was one Wisconsin trial court opinion applying the doctrine and noting its widespread acceptance. Id. at *3 (citing Staub v. Berg, No. 00-cv-0117, 2003 WL 26468454 (Wis. Cir. Ct. Jan. 6, 2003)).  The Court also found three federal district court opinions invoking the learned intermediary doctrine under Wisconsin law, and one case called Maynard v. Abbott Labs observing that “Wisconsin does not apply the learned intermediary doctrine.” Id. On this last point, the Seventh Circuit was particularly blunt:  “That statement is incorrect—the Wisconsin Supreme Court has never weighed in on the topic [and] Maynard itself is bereft of any analysis on the point.” Id.

The Seventh Circuit also relied on the learned intermediary doctrine’s “broad support in other jurisdictions,” including 48 states where the highest court or the intermediate appellate courts have adopted the doctrine in some form. Id. Finally, the rationale for the learned intermediary rule applies even more forcefully in cases involving surgical implants because “it is not reasonably conceivable that an individual could obtain and implant a device that requires a trained surgeon without the intervention of a physician.” Id. Amen.

The following holding and the reasoning upon which it is based are what make In re Zimmer Nexgen the Best Wisconsin Law Opinion We’ve Ever Seen:

In short, there is good reason to think that given the opportunity, the Wisconsin Supreme Court would join the vast majority of state supreme courts and adopt the learned-intermediary doctrine for use in defective-warning cases like this one involving a surgical implant. We predict the state high court would do so.  Accordingly, to the extent that [the plaintiff’s] defective-warnings claim is based on [the manufacturer’s] duty to warn him, it is foreclosed by the learned-intermediary doctrine.

Id. at *4.  For good measure, the Seventh Circuit held that the plaintiff’s direct warnings claim failed also because the plaintiff did not identify any danger about which that the manufacturer should have warned him and because he had no evidence of causation.  Even if the plaintiff would have heeded a different warning, “[he] didn’t select the NexGen Flex implant.”  His surgeon did.  Id.

The Seventh Circuit likewise rejected the plaintiffs’ argument that the manufacturer failed adequately to warn the surgeon.  The plaintiff cited the defense expert’s testimony that he would have used more cement to place the implant and argued that the manufacturer failed to warn about the amount of cement needed. Id. at *4.  But that was not sufficient because “no evidence supports [the plaintiff’s] contention that it was [the manufacturer’s] responsibility to instruct surgeons about the amount of cement they should use.” Id. at *5.  This surgeon relied exclusively on his education and training, not on any materials from the manufacturer, and the plaintiff offered no expert opinion that the warnings were inadequate in any event. Id.

Finally, the Seventh Circuit rejected the warnings claims on causation. The surgeon did not read the instructions for use and could not been affected by a different warning. Id. at **5-6.  The plaintiff urged the Seventh Circuit to apply a “heeding presumption,” i.e., a presumption in the absence of proof that the surgeon would have read and heeded a proper warning. Id. at *5.  But Wisconsin law squarely places the burden of proving causation on the plaintiff.  As the Seventh Circuit held,

Here again, the state appellate courts have not addressed this doctrine [the heeding presumption]. We seriously doubt that they would adopt it in this context.  [¶]  To the contrary, as we’ve already noted, the state court of appeals has recently held that “[a] plaintiff who has established both a duty and a failure to warn must also establish causation by showing that, if properly warned, he or she would have altered behavior and avoided injury.”

Id. (citing Kurer v. Parke, Davis & Co., 679 N.W.2d 867, 876 (Wis. Ct. App. 2004)).  In other words, since Wisconsin law already places the burden of proving causation on the plaintiff, the Seventh Circuit would not alter that law by creating a presumption.

The plaintiff’s last request was to certify questions to the Wisconsin Supreme Court, which the Seventh Circuit rejected because “[n]o genuine uncertainty exists here.” We could not agree more and would not be surprised to see this opinion on our Ten Best list at year end.

We don’t often get to discuss decisions from Maine. In fact, a quick spin through the blog and you’ll see Maine really only comes up in various canvases or surveys of state law. We don’t dislike the state. We love the lobster — that they take very seriously. We can’t say we love the winters there (at least this blogger doesn’t), but the coastline is beautiful in summer. And perhaps our vision of Maine is just ever so slightly skewed by Stephen King having set so many of his horror novels there. While King’s frightening tales are set in fictional towns, avid readers and explorers have suggested that you can visit several real places in Maine that seem to have inspired King’s work. For instance, if you’re looking for Derry, you want to stop in Dexter, Maine (mind the sewers). If you are more of a Cujo or Needful Things fan, Castle Rock is supposedly based on Woodstock, ME. You won’t find a giant dome in Rumford, but you’ll probably notice its otherwise close resemblance to Chester’s Mill (Under the Dome). And finally, there is King’s hometown of Bangor which is rumored to be the inspiration for the town of Haven from The Tommyknockers.

So, we were quite pleased when Dustin Rawlin and Bill Berglund of Tucker Ellis sent us their recent, far from creepy, win from the 23rd state. The case is Novak v. Mentor Worldwide LLC, 2018 WL 893914 (D. Maine Feb. 14, 2018) and the primary issue is statute of limitations. Statute of limitations cases are also not something we spend too much time on here, but this one has a notable ruling specific to prescription medical products liability cases – the discovery rule does not apply.

In 2004, plaintiff underwent surgery during which defendant’s product, a vaginal sling, was implanted to treat stress urinary incontinence. Id. at *1. Around 8 months to 1 year after the surgery, plaintiff started to experience pain during intercourse and by the end of 2006 was experiencing vaginal leaking and bleeding. Id. at *2. Before the end of 2006, plaintiff informed her surgeon of her problems. He ordered tests, the first round of which were inconclusive and plaintiff failed to undergo furthering testing. Id. In 2013, plaintiff attributed her problems to defendant’s product which was partially removed in another surgery in 2014. Id. Plaintiff filed suit in 2016. Id. at *1.

Maine’s statute of limitations for all civil actions is 6 years from when the cause of action accrues. Id. at *3. Further, Maine follows the date-of-injury rule when it comes to accrual. “[M]ere ignorance of a cause of action does not prevent the statute of limitations from running.” Id. In other words, generally Maine does not apply the “discovery rule” to determine when the statute starts to run (in states that do, a claim does not accrue until the plaintiff discovers or should have discovered the wrongdoing or misconduct). There are, however, exceptions where Maine has expressly applied the discovery rule: legal malpractice, foreign object and negligent diagnosis medical malpractice; and asbestosis. Id. General products liability claims not included.

Maine has also acknowledged the continuing tort doctrine where the alleged tort occurs over a series or chain of incidents. In such cases, the claim would not accrue until the last act in the chain – such as cases of pollution or contamination. Id. at *4. The continuing tort doctrine does not apply in cases where plaintiff’s alleged injuries, while occurring or perhaps worsening over time, are allegedly caused by a single act of negligence. Id.

Because plaintiff filed suit in 2016, her claims are time-barred if they accrued before 2010. As we noted above, her surgery was in 2004 and her complications appear to have started within the first year thereafter. So, unless the court applied the discovery rule, her claims would be barred.

Plaintiff’s first argument was that the presence of the defendant’s medical device in her body constituted a continuing tort that didn’t end until the product was removed in 2014. Id. at *5. But the continuing tort doctrine isn’t about continuing harm. What plaintiff here, or in almost any drug or device products liability case is alleging is a “finite act or set of acts (manufacture, design, inadequate warning, or misrepresentation) that led to her injuries.” Id. Once the device was implanted, the alleged wrongful act was over.

[Plaintiff] underwent only one, readily-identifiable exposure to the [device] (her surgery), and all of [defendant’s] allegedly tortious conduct took place before that point. . . . [defendant’s] wrongful conduct may have caused the [device] to deteriorate, which in turn may have caused injuries over time. However, once those injuries had manifested, the fact that their full scope remained unknown did not stop the statute of limitations from running.

Id. at *9, n.6.

Plaintiff’s second argument was that there was a genuine dispute regarding whether her earlier symptoms, pre-2006, were caused by the defendant’s medical device. Perhaps plaintiff should have thought of that argument before submitting an expert report tying those early symptoms to the medical device. Id. at *6. Nor could plaintiff rely on her surgeon not identifying a connection between the device and her symptoms when his tests were only inconclusive and plaintiff opted not to do further testing. Id. For a jury to conclude that plaintiff’s early injuries were not caused by defendant’s product would require “complete speculation.” Id. The statute started to run when plaintiff first experienced symptoms, regardless of how minor those symptoms were. Id. at *9, n.7.

While the statute of limitations did away with almost all of plaintiff’s claims, her fraud based claims remained. On those, as well as any other claim based on a failure to warn, defendant argued plaintiff failed to meet her burden to prove causation – plaintiff had no evidence that a different warning or information would have changed her surgeon’s decision to implant the device. Id. at *7. First, it is noteworthy that the court applied the learned intermediary doctrine. Id. at *8. Maine’s high court has never discussed the rule. The court relied on other federal courts interpreting Maine law on the issue.

So, applying the learned intermediary, the court’s focus correctly shifted to plaintiff’s surgeon. Plaintiff did not dispute that her doctor was aware of various risks, including those experienced by plaintiff. Id. Instead, plaintiff’s tried to meet their causation burden by arguing that the doctor “may very well have decided” not to implant the device if he had been provided different warnings. Id. But, that is either an unsupported fact or mere speculation and neither are evidence. Id. Plaintiff next showed the court some medical literature concerning the risks of the medical device and the doctor’s deposition transcript. But offered no connection between the two.

[The doctor’s] deposition transcript reflects that [plaintiff’s] counsel failed to ask him whether additional information would have altered his decision to go ahead with [plaintiff’s medical device] surgery.

Id. at *9. While not discussed directly in the opinion, requiring affirmative evidence that the doctor would have changed his use of the product for plaintiff to survive summary judgment is certainly an implicit rejection of the heeding presumption. Nor was it defendant’s obligation to ask these questions at the doctor’s deposition. Id. at *9, n.14.

So, while Maine may more quickly bring to mind images of butter poached crustaceans or mysterious floating red balloons, it’s not a bad place for prescription medical products cases either.

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

The recent decision of the New York Court of Appeals in In re New York City Asbestos Litigation, ___ N.E.3d ___, 2016 WL 3495191 (N.Y. June 28, 2016) (“NYCAL”), was not too good for asbestos defendants – as it permitted, under certain circumstances, non-manufacturers to be sued for failure to warn of a risk that the product they manufactured didn’t have (exposure to asbestos), where they “encourage[ed]” the use of products containing that risk with their products and thereby benefitted economically:

[A] manufacturer’s duty to warn of combined use of its product with another product depends in part on whether the manufacturer’s product can function without the other product, as it would be unfair to allow a manufacturer to avoid the minimal cost of including a warning about the perils of the joint use of the products when the manufacturer knows that the combined use is both necessary and dangerous. And, the justification for a duty to warn becomes particularly strong if the manufacturer intends that customers engage in the hazardous combined use of the products at issue.

*          *          *          *

[W]here a manufacturer creates a product that cannot be used without another product as a result of the design of the product, the mechanics of the product or the absence of economically feasible alternative means of enabling the product to function as intended, the manufacturer has a substantial, albeit indirect, role in placing the third-party product in the stream of commerce. . . .  Specifically, when the manufacturer produces a product that requires another product to function, the manufacturer naturally opens up a profitable market for that essential component, thereby encouraging the other company to make that related product and place it in the stream of commerce.

NYCAL, 2016 WL 3495191, at *__ (for some reason there is no Westlaw star paging at the moment).  This opinion is very bad news for the affected companies, who are now sucked into the maw of interminable asbestos litigation on the basis of products they didn’t even make, but it should not open the door to innovator liability type claims against our medical product manufacturer clients, and it’s good on causation, too.

Here’s why.

Continue Reading New York Decision Not Good For Asbestos, But Not Bad For Drug/Device

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 are pleased to have left the bullpen and joined the starting rotation of contributors to this blog. We will strive for the relevance and style our colleagues’ posts consistently display.

We adopted a Drug and Device Rescue Cat this week.  Her housemates, two Drug and Device Rescue Dogs, are poodle mixes, so we haven’t dealt with the issue of shedding since we last had cats, years ago.   We have discovered a nifty tool that claims to dramatically reduce the hair deposited on furniture and clothing, reminding us of our fondness for anything that strips away the clutter of useless underbrush and leaves only what is neat and firmly rooted.   And that is the (admittedly tenuous) segue to today’s case, in which the United States District Court for the Northern District of West Virginia bushwhacks through plaintiff’s detritus to arrive at a solid holding and a (mostly) tidy opinion.

In Muzichuck v. Forest Laboratories, Inc., No. 1:07-CV-16, 2015 U.S. Dist. LEXIS 5440 (N.D.W.Va. Jan. 16, 2015), the Court considered defendant’s Motion for Summary Judgment in a Lexapro suicide case.   Plaintiff, who opted out of the global Lexapro settlement, alleged that defendants, Forest Laboratories, Inc. and Forest Pharmaceuticals, Inc. (“Forest”) failed to warn her decedent-husband and his prescribing physicians of the risk of suicide associated with the antidepressant Lexapro.

Continue Reading Opt-out Out of Court: Northern District of West Virginia Dispatches Lexapro Warnings Case

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 like juries. Jurors give us their time and attention, sometimes for weeks or months at a time, and they receive little or nothing in terms of tangible benefit in return. The vast majority take the task seriously and give us their best on topics that are at once human and very complex. We sometimes embrace their results, and sometimes we appeal from them or move to set them aside, but either way we respect the process without reservation.

Not every issue, however, is best left to juror discretion, and juries require guidance, mainly in the form of instructions on the law and rulings on the evidence. The former provides a proper legal referent against which to render a verdict. The latter regulates the information they receive so they consider material that is relevant and helpful, and not information that is misleading, improper, or tends to show nothing of consequence to the issues in the case. And the court should provide a necessary check against jury discretion with its power to decide issues as a matter of law and grant new trials.

Juries operating outside these parameters might not come to fair results, through no fault of their own, and we think that is what went wrong in Cox v. KLS Martin, L.P., 2013 U.S. Dist. LEXIS 114708 (W.D. Mo. Aug. 14, 2013). As with many bloggable cases, the facts provoke sympathy. Cox involved an implanted medical device known as a mechanical intraoral distracter, which was used as intended to treat Pierre Robins Sequence, a rare disorder in which an infant’s lower jaw is underdeveloped. As the court described it, mandibular distraction involves cutting through bones on both sides of the patient’s mandible behind the molars and securing a mechanical intraoral distraction device to both sides of each cut. By then turning an activation mechanism, each distractor slowly separates the bone sections, allowing the formation of new bone. Id. at *1-*2.

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