Search We the Jury

We are beginning to feel like the Drug and Device Law theatre critic. Or perhaps we should say “theatre cheerleader,” as we rarely wax critical (at least about the stuff we include in our blog posts).  Last week, we saw the wonderful new musical Come From Away.   It is a true story, and it begins…

It is quite unusual for a state trial court to depart from that state’s highest court precedent.  But consider that old Hebrew National frankfurter advertising campaign: “We answer to a higher authority.”  If the United States Supreme Court comes out with a case that renders your state supreme court’s opinion null, void, or wrong, you…

Next week, we are traveling to Budapest, with a side trip to Vienna. We are visiting the Drug and Device Law Rock Climber, who is spending this semester abroad studying computer science (in Budapest) and climbing rocks (in Majorca, etc.).  Aside from the beloved visage of our only child, we are most excited about seeing…

A multidistrict litigation (MDL) can be a sound way of managing a mass tort.  Efficiencies are available (e.g., deposing company witnesses only once) and the U. of Chicago part of us dreams of economies of scale.  Then again, an MDL can be vexing, as plaintiff lawyers park their weak cases in the MDL and find ways to push their relatively few strong cases up front.  Think of the MDL as a vast kennel, with all of the associated dangers and bad smells.  Then again, an MDL can be an out-and-out disaster, as the old If-you-build-it-they-will-come model oft-described by blogger emeritus Mark Herrmann takes hold.  The very existence of the MDL itself makes the mass tort massive.  The MDL becomes a magnet for the meritless.  Plaintiff lawyers resist any discovery of individual cases – there are too many! – and insist on dedicating the MDL to endless discovery of company conduct, as that is common to all cases and, viewed through the MDL lens, is always proportional, no matter how intrusive or expensive.  (At least that is the plaintiff argument.  But now some courts have finally grown weary of MDLs becoming festivals of discovery about discovery, and decided that proportionality applies even when the MDL case inventory has reached four or five digits.  See here, for example.)

We have gone through this evolution of thought in the course of a single MDL, watching good intentions morph into an extortion racket.  We have also seen courts gradually catch on to what has gone wrong with the MDL system.  Is this an instance of phylogeny recapitulating ontogeny? Legislation has been revived in Congress that aims to cabin the insanity of MDLs and class actions. And, mirabile dictu, some MDL judges have started to rein in asymmetrical discovery and have even demanded that plaintiff lawyers furnish evidence of such niceties as usage of the product and medical causation.  We’re not saying let’s make MDLs great again, but can we at least make them less miserable?  Or maybe just make them less.  Perhaps we don’t need an MDL every time there’s an alarming study or an uptick in adverse events.Continue Reading JPML Refuses MDL for Proton Pump Inhibitor Kidney Injury Cases

Drug and device cases regularly involve plaintiffs who have suffered serious injuries, the type that engender sympathy, even from defense attorneys. It’s understandable that a plaintiff who suffered such trauma would turn to the courts for redress. But bad experiences do not make a viable drug or device claim. Drugs and devices have inherent risks, so the law requires more than injury due to those risks for a viable products liability claim. Generally, the injury must result from a defect of some sort, such as a design, manufacturing or warning defect. If a plaintiff doesn’t allege such a defect, the court must dismiss the claim, no matter how traumatic the plaintiff’s injury.

Smith v. Pride Mobility Products Corp., 2016 U.S. Dist. LEXIS 149955 (N.D. Cal. Oct. 28, 2016), illustrates this. The plaintiff was wheelchair-bound and claimed that, while attending a Renaissance Fair, the power to her wheelchair gave out as she was trying to climb a steep hill. Ultimately, the wheelchair went into a free-wheel fall at a sharp angle down the hill, throwing plaintiff from the wheelchair to the ground. Plaintiff claimed serious injury to her neck and knee, permanent disability to one of her toes, whiplash and serious psychological and emotional distress resulting from the event and her injuries.

These allegations no doubt suggest great trauma for the plaintiff. But do they state a claim? The initial consideration for a court is not the severity of the injuries or the trauma that led to them but whether the plaintiff’s allegations are sufficient to state a viable products liability claim. Here, the Smith court did its job. It reviewed plaintiff’s allegations dispassionately and determined that plaintiff had not made the type of allegations necessary to state a manufacturing defect claim:

In order to allege a strict products liability claim under a manufacturing-defect theory, a plaintiff “must identify/explain how the [product] either deviated from [the company’s] intended result/design or how the [product] deviated from other seemingly identical” models of the product.

Here, Plaintiff states that the wheelchair started “freewheeling down [a] hill” after Plaintiff placed the wheelchair in reverse on a hill and that the wheelchair “was either defective or . . . deliberately designed to” freewheel in such a manner. The complaint does not state how the wheelchair that Plaintiff purchased is different from the design of the wheelchair that Defendant intended or from other identical models of the wheelchair. Rather, “Plaintiff[] make[s] only conclusory allegations” that the product is defective, which is insufficient to allege a manufacturing defect claim.

Id. at *25-26 (citations omitted).Continue Reading Bad Experiences and Serious Injury Do Not Make a Drug and Device Law Claim

Bexis, who took some lumps in probably the worst Wisconsin product liability decision ever (he filed PLAC’s amicus brief in Thomas v. Mallett, 701 N.W.2d 523 (Wis. 2005)), just read what we believe is the best Wisconsin law decision ever – at least in the drug/medical device sandbox that we inhabit. The decision is In re Zimmer Nexgen Knee Implant Products Liability Litigation, 2016 WL 6135685 (N.D. Ill. Oct. 21, 2016) (since the caption is a mouthful, we’ll call it “ZNKI“).

Here’s why ZNKI is favorable on Wisconsin legal issues.

First, as our longstanding 50-state survey on the learned intermediary rule points out, Wisconsin is one of nine states in which only federal courts predicting state law have had occasion to adopt the learned intermediary rule.  Looking more closely at these nine, Wisconsin is one of only two states (South Dakota being the other) where only federal district courts have reached this holding.  What isn’t there, but is discussed in ZNKI, is that some courts have (without much reasoning) refused to predict Wisconsin’s adherence to the rule.  Refusing to dodge the issue, ZNKI forthrightly examines both Wisconsin precedent and the general state of the law and concludes that Wisconsin would join the nationwide learned intermediary consensus:

[F]ederal courts applying Wisconsin law have reached different conclusions about the doctrine’s applicability.  The vast majority of states, however, do employ some version of the doctrine.  In addition, this court’s research suggests that those courts that have declined to apply the doctrine under Wisconsin law have done so in cases involving prescription drugs, not medical devices, and those courts offer no reason to believe that the Wisconsin Supreme Court would not adopt this majority rule if presented with the issue.

In the context of .　.　. surgery, a patient must rely on the experience and judgment of his or her surgeon, who selects the appropriate implant and educates the patient about the particular risks − based on the patient’s particular circumstances and physiology.　.　.　.  Given that context, and given the widespread acceptance of the doctrine throughout the country, the court believes it is likely that the Wisconsin Supreme Court would apply the learned intermediary doctrine in this case.

ZNKI, 2016 WL 6135685, at *19-20 (numerous citations omitted).  As we’ve pointed out recently, the learned intermediary rule is, if anything, enjoying a renaissance, with thirteen straight state high court adoptions since the infamous Karl case (since overruled by statute) was the only supreme court to go the other way.

Continue Reading Probably the Best Wisconsin Law Decision We’ve Ever Seen

Here we go. Again. The third bellwether trial in the Pinnacle Hip Implant MDL starts on October 3 (less than two weeks away), and the parties began picking a jury two days ago. The lawyers are, no doubt, hunkered down in their hotels and war rooms preparing for a trial that could last through the start of the holidays. And much of the mass tort world will be watching. That’s because the jury in the last bellwether trial came back with an incredible half-billion-dollar verdict at the end of a multi-plaintiff trial in which the court issued a long series of controversial evidentiary and procedural rulings.

And now, even before opening statements, there are ominous signs for the defense at this third bellwether trial. Three days ago, the court issued an order sua sponte—that is, with no briefing—confirming that it is consolidating six different plaintiffs at this one trial. That’s a lot of plaintiffs and no doubt a lot of differences. It’s hard to imagine jurors effectively keeping straight the case-specific evidence presented by each of these half-dozen plaintiffs, all while trying to sift through and understand mountains of complex scientific and medical information and avoid allowing their feelings as to any one plaintiff to affect their judgment as to the others. Without even considering the facts of the cases, a six-plaintiff trial is not good for defendants. There’s a reason that plaintiffs’ lawyers prefer multi-plaintiff trials and that defendants do not.Continue Reading Here Comes the Next Bellwether Trial in the Pinnacle Hip Implant MDL

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Bexis’ Book

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