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 in the tiny town of Gander, Newfoundland on September 11, 2001.  On that infamous day, Gander opened its doors, and its collective heart, to many thousands of U.S.A.-bound airline passengers whose planes were forced to land when U.S. airspace was closed in the wake of the 9-11 attacks.  Despite the tragedy in the background – and in the foreground for some characters unable to confirm whether relatives were victims of the attacks – the play is an exquisitely energetic and joyful celebration of the openness of the human heart and the resilience of the human spirit.  On the last note of the last song, the cheering audience rose in unison in a manner we have rarely seen.

As in Come From Away, tragic facts are common in our line of work, but they can sometimes provide the framework for a silver lining. In the hands of a rigorous judge committed to correct application of the law despite the pull of sympathy, difficult facts can produce laudable precedent.   Such is not the case in today’s decision out of the Depakote litigation in the Southern District of Illinois.

In E.R.G. v. Abbott Laboratories, Inc., 2017 WL 3055520 (S.D. Ill. July 19, 2017), the plaintiff was a child who was conceived while his mother was taking Depakote and who was born with spina bifida and other birth defects.  At trial, the jury found for the plaintiff on his claim of negligent failure to warn and awarded fifteen million dollars in compensatory damages.  (The jury found that the evidence did not support an award of punitive damages.)  The defendant filed a post-verdict motion for judgment as a matter of law, arguing that: 1) the plaintiff did not produce evidence that the defendant failed to provide adequate warnings of the risk of spina bifida; 2) the plaintiff did not produce evidence that the defendant failed to provide adequate warnings of other birth defects; and 3) the plaintiff failed to prove warnings causation because no doctor testified that a stronger warning would have altered his prescribing decision.  In the alternative, the defendant moved for a new trial, citing evidentiary issues and improper comments during closing argument.

  1.  Motion for Judgment as a Matter of Law

                        Adequacy of Label Warnings

The defendant argued that the label warnings were adequate as a matter of law because the label contained a black-boxed warning of the (correct) 1-2% incidence of spina bifida when the drug was taken during pregnancy. This portion of the decision – like much of the rest – is confusing, but the judge seems to say that, notwithstanding the accurate spina bifida warning, it might have been the case that other portions of the label were inadequate and that the plaintiff’s mother might be saying that other proper warnings would have resulted in a decision to stop taking the drug when she was pregnant.  It’s not clear where the judge is getting any of this, because none of this hypothetical testimony is cited in the decision.  The judge also states that the plaintiff did not “concede” that the spina bifida warning was adequate.  Instead, according to the judge, the jury could adopt the plaintiff’s expert’s theory that the spina bifida labeling was not adequate because it did not state that the drug should be used by pregnant women “only as a last resort.”  In an opinion rife with wrong, we found this “last resort” argument to be the furthest from the mark.  We know of nothing in law or regulation that invites a judge to deem that only specific semantics would have rendered a warning adequate, when the label warned of the precise risk that befell the plaintiff and included an accurate statement of the incidence of that risk.

Finally, the judge held that the jury could reasonably infer that the label was “materially misleading” when it stated that all antiepileptic drugs carried a risk of birth defects, based on evidence that the defendant’s drug carried a higher risk of spina bifida than other drugs in the class. As such, the judge held, the jury could conclude that the defendant “watered down” the spina bifida risk when it lumped the drug in with others that carried a “much lower risk of spina bifida.” E.R.G., 2017 WL 3055520 at *3.  The judge concluded, “Ultimately, there was more than enough evidence presented in Plaintiff’s case in chief to support an argument that the label, including the spina bifida waning was inadequate.” Id. 

            Warnings Causation 

Because the plaintiff’s mother’s physicians testified that they were aware of Depakote’s teratogenic effects when they prescribed the drug, the defendant argued that the plaintiff had not established that any inadequacy of the drug’s warnings was a proximate cause of the plaintiff’s injuries. The plaintiff countered that the issue was not whether the defendant “failed to warn generally of ‘teratogenic effects’” but whether the defendant “provided full, accurate, and complete information about Depakote’s total teratogenic risks and instructions on the safe use of Depakote in women of childbearing age . . . .” Id. Forgive us, but we fail to see the distinction here.  One of the last two physicians to prescribe the drug before the plaintiff was conceived testified that he would have advised the plaintiff’s mother to stop taking the drug if he had been advised to use it as a “last resort” (the chosen language of the plaintiff’s expert and the judge), but he later testified that he would not have “taken away” the drug if the plaintiff’s mother had insisted on taking it.  The judge concluded, “. . . [A] reasonable jury could find that . . . a stronger warning would have caused [the last prescriber] (who was already on the fence about the efficacy of Depakote for [the plaintiff’s mother], to stop prescribing the drug.” Id. at *4.   We think this is a stretch, given the testimony.

The judge may have thought so, too, because she made a confusing attempt to justify her conclusion.   She postulated, “If the jury believed that [the doctor] would have discontinued [plaintiff’s mother’s] prescription in favor of a different [drug], then the jury could reasonably infer that she would still have been off of Depakote when she went to see [the other doctor] for her final visit” to the doctors’ clinic. Id. “Nothing in the testimony of [the second doctor] indicates that if [the plaintiff’s mother] had shown up for her appointment on [a different drug], he would have independently restarted the Depakote prescription.  [The second doctor] that, while he did make an independent assessment of [the plaintiff’s mother] at her last visit, he repeatedly asserted that he was ‘refilling’ her medication.” Id. (citation omitted).   Have trouble following that?  Can’t figure out what it has to do with warnings causation?  Neither can we.  Bottom line is that the prescribers knew that the drug could cause spina bifida and prescribed it anyway.  And, even if the imaginary “last resort” language had been included, the doctor would not have taken the drug away from the plaintiff’s mother if she wanted to keep taking it.  We fail to see how any of this adds up to warnings causation, except in the mind of a judge who didn’t want to grant the defendant’s motion.

  1.  Motion for New Trial 

Predictably, the judge also denied the defendant’s motion for a new trial. Some highlights of that decision:

Mother’s Testimony

In this case, unlike what we are used to seeing in the prescription drug context, the patient – the plaintiff’s mother – was apparently warned about birth defects while the plaintiff alleged that the prescribers weren’t. This led to an upside-down trial in which plaintiff didn’t call his mother in his case in chief while the prescribers testified live.   When the defendant learned that plaintiff’s mother was not being called, it filed a motion to compel her to sit for a de bene esse deposition.  The judge denied the motion, and this denial was one of the bases of the defendant’s motion for a new trial.  The judge held that her denial of the defendant’s motion was proper because the defendant had not adequately explained why the mother’s fact deposition (which was not videotaped) “did not accurately capture her testimony.” Id. (This in spite of the fact that, in our experience, plaintiffs routinely win motions like these.)

“Top 3” Opinion 

The defendant challenged the admission of one of the plaintiff’s expert’s opinions that Depakote was one of the “top three” teratogenic drugs in the PDR, arguing that the opinion was not the product of a reliable methodology. The court disagreed, holding, “While a different expert may come to a different conclusion or may even use a different methodology to determine what the three worst drugs are in terms of teratology, that is not the test for excluding an opinion under Daubert.” Id. at *6.

Improper Comments in Plaintiff’s Closing Argument 

The defendant argued that prejudicial comments in the plaintiff’s closing argument entitled it to a new trial.   These included the comment that the defendant was “guilty as hell” (the judge had to explain to the jury that this was not a criminal trial), as well as comments suggesting that compensatory damages should be based on the defendant’s alleged “bad behavior” (the judge halted this line of argument after the defendant objected that it was an argument for punitive damages, not compensatories) and that the jury, through its award “had a chance to make a decision about the kind of world [it] wanted to live in.” Id. at *7 (citation omitted).  The judge, predictably, held that none of the comments was “overly prejudicial.” Id.  

And so the verdict was allowed to stand. While we reiterate that we were not always able to follow the judge’s reasoning, our takeaway was that she started with her desired result and worked backwards.   As for us, our next foray onto the Great White Way occurs next week, when we accede to a request from the Drug and Device Law Rock Climber that we accompany her to the production of 1984 currently playing at the Hudson Theatre.  This production is notable for the proliferation of audience members fainting and vomiting during the torture scene, so we suspect that cheerfulness may not permeate our description.  And we will have to find a case that makes us queasy so we can easily tie it in.  Based on today’s decision, we suspect this will not be too difficult.  We’ll keep you posted.

There’s a problem with attorney advertising in the prescription medical product space – but it’s not the one you normally hear us defense-side litigators kvetching about. Quite apart from its litigation-generating effects, attorney advertising can have adverse public health consequences when all the anti-pharma hyperbole causes patients to cease taking targeted products in violation of their physicians’ orders.  That problem is worse with some products than with others.  Currently, plaintiff-side lawyers and their litigation funder enablers have decided to target virtually all modern anticoagulant drugs (e.g., Effient, Eliquis, Plavix, Pradaxa, Xarelto) because they can cause (surprise) severe bleeding.  That’s a big problem because abruptly stopping those medications can very easily be fatal.  Nor is it the only example.  Halting, say, an anti-diabetes medication can lead to serious complications, although one would hope not in such a dramatic fashion as a stroke.

Congress held hearings on patient injuries caused by attorney advertising last month. Here’s a link to the testimony of the witnesses.  Two doctors testified about the impact of sensationalistic lawyer advertising on their patients, including patients who had died after being induced to stop taking their medicine by all the bombast.  A law professor testified about a law review article that discussed the difficulties of bar associations regulating such advertising, when it is often carried out by non-lawyers whose physical locations (lawyers are regulated on a state-by-state basis) are unclear.  A lawyer also testified, who raised First Amendment objections essentially to any regulation of attorney advertising – even when limited to issues affecting the public health.

We want to address that last point.

To the attorney advertisers, we say “welcome to the club.”  Our medical device and pharmaceutical clients, when they engage in advertising – including direct-to-consumer advertising – are engaged in the same type of speech as our adversaries, at least from a First Amendment perspective.  It’s all commercial speech.  We’ve written lots of blogposts on commercial speech, most being variations on the theme that the FDA can’t ban truthful commercial speech.  We readily extend the same consideration to our opponents.  The government can’t ban truthful attorney advertising either.

That said, the First Amendment isn’t an obstacle to the kind of regulation that was considered at the recent hearing.  Disclaimers?  Those are child’s play, constitutionally.  Judicial opinions recommend them frequently, when they hold disclaimers to be an alternative to advertising bans of various types (not just involving drugs).  E.g., ECM BioFilms, Inc. v. FTC, 851 F.3d 599, 617 (6th Cir. 2017) (“the Commission was not required to adopt the least restrictive disclaimer”); Pearson v. Shalala, 164 F.3d 650, 659 (D.C. Cir. 1999) (“we suspect that a clarifying disclaimer could be added to the effect that ‘The evidence in support of this claim is inconclusive.’”); American Home Products Corp. v. FTC, 695 F.2d 681, 696-702 (3d Cir. 1982) (agency may order advertiser making unsubstantiated scientific claim to include a disclaimer to that effect).  Indeed, as to attorney advertising itself, the Supreme Court pointed out:

[Attorney’s] constitutionally protected interest in not providing any particular factual information in his advertising is minimal.  Thus, in virtually all our commercial speech decisions to date, we have emphasized that because disclosure requirements trench much more narrowly on an advertiser’s interests than do flat prohibitions on speech, warnings or disclaimers might be appropriately required in order to dissipate the possibility of consumer confusion or deception.

Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626, 651 (1985) (citation and quotation marks omitted).  The proposal during the hearings that attorney advertisements, at least those concerning certain products, be required to state, with equal emphasis, that under no circumstances should anyone stop their treatment without first consulting their doctor, is 100% constitutional.

Indeed, if anything, that proposal is constitutionally conservative.  Attorney advertisers targeting prescription medical products are simply the flip side of prescription medical product manufacturers in this regard.  Anything the FDA can require our clients to do, it could, constitutionally at least – require attorney advertisers to do – if it had the regulatory authority.  Theoretically, Congress could confer on the FDA the power to regulate all advertising concerning FDA-regulated products, not just that originating with the entities that the FDA now regulates.  We don’t advocate doing this, because we think that the FDA has more important work to do than evaluate attorney advertising.  Nor are we wild about giving an FDA imprimatur to whatever attorney advertisements that could survive the agency’s standards.  But from a constitutional perspective the FDA could undertake such regulation.  Since commercial speech is commercial speech, the FDA (or some other regulatory body) could impose on lawyer advertising the same standards for balance and scientific support that our clients’ advertising, both DTC and otherwise, must already meet.  Moreover, an agency could make the attorney advertisers pay for the review process, just as our clients do, through user fees.

The bottom line is this:  Lawyer advertising holds no preferred position among types of commercial speech.  Indeed, there are no “types” of commercial speech – it’s all the same constitutionally.  So when attorneys on the other side advocate bans on truthful manufacturer speech, because supposedly even truthful off-label information is a threat to the public health, they should remember that the same thing can be said about truthful attorney advertising.

We’re quite willing to apply the same standards to both sides. Truthful commercial speech about prescription medical products (or anything else) cannot be banned, but that doesn’t prohibit the FDA (or some other entity) from exercising the power at least to review it first.  As far as disclaimers, look no further than 21 C.F.R. §101.93(c)(2).  Every lawyer advertisement about FDA-regulated products could quite constitutionally be required to state, “These statements have not been evaluated by the Food and Drug Administration.”

Last week, like most weeks during the past year, we spent a lot of our time on airplanes. One of those trips fell on a day with “lots of weather.”  All of our flights were delayed, although we were luckier than many.  When we landed at Dulles for our connecting flight home, the queue at the customer service booth comprised hundreds of stranded passengers looping around and around like the approach to Space Mountain, hoping, with varying degrees of impatience and panic, to reschedule canceled flights.  But our connecting flight was only late – very late.  We sat at our gate for almost three hours, then were finally allowed to board.  We buckled in, we watched a taciturn flight attendant demonstrate the seat belts we were already wearing, and then we sat.  For forty more minutes.  (By now, it was 12:30 a.m.)  Finally, the “flight deck” made an announcement:  we were sitting still because the trash can in the galley lacked a lid, and this was a “safety hazard” that had to be rectified before we could take off.  And so we were waiting for the “caterer,” a contractor, to bring a new trash can.  Eventually, a truck pulled up, but it was carrying the wrong type of trash can.  Ultimately, someone went next door to a plane that was done flying for the night — as all sane people were, by that point – and stole a trash can.  And we were on our way.

So who was at fault?   Was it the contractor, which (twice) provided the wrong trash can? Or was it the airline, which shall remain nameless because (trust me) it doesn’t need any more bad publicity and which specified and installed the trash can?  Depends on the nature of the claim, under a (very very) loose interpretation of today’s decision from the Eastern District of Wisconsin.

In Janusz v. Symmetry Medical, Inc., 2017 U.S. Dist. LEXIS 88895 (E.D. Wis. June 9, 2017), the plaintiffs alleged that the femoral neck of their artificial hips systems broke, requiring additional surgeries to replace the hip system.  The femoral neck was a component, manufactured by the defendant according to specifications and instructions provided by the hip system’s fabricator (which was bankrupt by the time of suit).  The plaintiffs asserted claims sounding in negligence and strict liability against both companies, and the component manufacturer moved for summary judgment, asserting the so-called “contract specification defense” to the plaintiffs’ claims.  This is a component part manufacturer’s defense, and not one we have ever discussed here.  Hence, our interest in Janusz.

Under this defense, a manufacturer that “makes a product strictly in accordance with the design specifications of another is not liable in negligence unless the specifications are so obviously defective and dangerous that a contractor of reasonable prudence would have been put on notice that the product was dangerous and likely to cause injury.” Januscz, 2017 U.S. Dist. LEXIS 88895, at *11 (citation omitted).  And, while this defense is not among the five defenses listed in Wisconsin’s product liability statute, the court held that the statute supplemented but did not supersede common-law doctrines that weren’t inconsistent with it.  While Wisconsin common law had not adopted the contract specification defense, either, it had adopted the “government contractor defense,” the underlying principles of which — declining to hold a contractor liable when it manufactured a product according  to the specifications of another – overlap those of the contract specification defense.  Under the government contractor defense, a contractor that “makes a product strictly in accordance with the design specifications of another is not liable in negligence unless the specifications are so obviously defective and dangerous that a contractor  of reasonable prudence would have been put on notice that the product was dangerous and likely to cause injury.” Id. at *12 (citation omitted).  This is essentially the same test used in the contract specification defense generally. See Restatement (Third) of Torts: Products Liability §5, Reporters’ Note to Comment a (1998) (a “majority of courts” hold “that a manufacturer of a component part . . . cannot be held strictly liable . . . so long as the specifications provided are not so obviously dangerous that it would be unreasonable to follow them”) (citation and quotation marks omitted).

In Januscz, however,  the court drew a distinction between negligence and strict liability that does not exist generally.  It held that, “[i]ntuitively,” it made sense that “an entity that has no role in designing a product should bear no liability if the product is defectively designed.” Id. at *12.  But “that intuitive  reaction follows only when plaintiff’s theory of recovery is negligence.” Id. (citations omitted).  And, “in Wisconsin, product liability was and is a matter of strict liability.” Id. at *13 (citations omitted).  In the strict liability context, unlike in negligence, “the focus is on the dangerousness of the product regardless of the defendant’s conduct.  Thus, a defendant may be blameless but strictly liable.” Id. (internal punctuation and citations omitted).  The court concluded that, given  the  “recent codification of product liability law reaffirming Wisconsin’s commitment to  the principles of  strict liability, if  presented with a question of whether the contract specification defense applies to a question of strict liability under Wisconsin law, the Wisconsin Supreme  Court would hold  that it does not.” Id. at *24. Januscz declared that “strict liability means strict liability.   It exists to shift costs associated with unsafe products to those  who are in the best position to disperse  those costs (be it through insurance, indemnification,  or some other means.” Id. at *25.  And, the court held, the “contract specification defense significantly undermines the policies underlying strict liability.  Therefore, the court concludes that the defense does not exist  under Wisconsin law.” Id. at *26.

This result is simply wrong under Wisconsin law. The Januscz court completely failed to cite the most relevant case, Schreiner v. Wieser Concrete Prod., Inc., 720 N.W.2d 525 (Wis. 2006), in which the Wisconsin Supreme Court expressly adopted Restatement Third §5 as “consistent with Wisconsin law.” Id. at 530.  Thus, Wisconsin law does not distinguish between negligence and strict liability, particularly in the context of product specifications and component parts. See also Spychalla v. Boeing Aerospace Operations Inc., 2015 WL 3504927, at *3 n.2 (E.D. Wis. June 3, 2015) (recognizing Wisconsin’s adoption of §5 after enacting of tort reform statute).  Indeed, after correctly holding that the Wisconsin tort reform statute only “supplements” the common law Januscz failed even to cite Restatement Third §5 – the relevant Wisconsin common law for component parts under Schreiner.  If anything, the statute reinforces use of the Third Restatement in Wisconsin, since the statute generally adopted that Restatement alternative design defect test and its “not reasonably safe” defect terminology. See Wis. Stat. §895.047(1)(a) (“A product is defective in design if the foreseeable risks of harm posed by the product could have been reduced or avoided by the adoption of a reasonable alternative design by the manufacturer and the omission of the alternative design renders the product not reasonably safe.”).

Rather than actually follow Wisconsin law, the court simply repeated the truism that “strict liability does not mean absolute liability.”  2017 U.S. Dist. LEXIS 88895, at *26 (emphasis in original).  To wit, a component manufacturer could escape liability if its component part underwent substantial change when it was included in the assembled device.  But, the court held, the defendant’s femoral neck component did not undergo such change.  And so the court denied summary judgment on the plaintiffs’ strict liability claims, though it granted summary judgment for the component manufacturer on the plaintiffs’ negligence claims.

While this interesting decision appears thorough at first glance, in fact it completely omits essential Wisconsin law, Schreiner and Restatement Third §5, and thus its discussion of the philosophical underpinnings of strict liability, based on Restatement Second §402A, which Wisconsin no longer follows, is (to be polite) open to question.  We hope that the defendant eventually convinces the court of the error of its ways.

 

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

We understand that illnesses and injuries can be emotional; sometime extremely emotional and rightfully so. We understand that some treatments can add to the stress. We certainly understand that when a treatment results in complications or does not turn out as hoped, an already tense situation can become intense. We don’t deny the “personal” side of personal injury cases. But drug and device products liability cases are not infliction of emotional distress cases. Which is what the court found in Ripple v. Davol, Inc., 2017 U.S. Dist. LEXIS 82867 (S.D. Fla. May 31, 2017).

Plaintiff brought most of the standard products liability causes of action – negligence, strict liability, failure to warn, breach of implied warranty, negligent misrepresentation, and fraud – but also included claims for both intentional and negligent infliction of emotional distress.  Id. at *2. The court dismissed the warranty claim for lack of privity, id. at *10-11, and misrepresentation and fraud for failure to satisfy the heightened pleading requirement. Id. at *11-13.

On infliction of emotional distress, the court explained that under either an intentional or negligence standard, plaintiff has to allege “conduct so outrageous in character, and so extreme in degree, as to go beyond all possible bounds of decency, and to be regarded as atrocious, and utterly intolerable in a civilized community.” Id. at *7 (citations omitted). Just read that again and let it sink in. We think it is immediately apparent that such a claim does not belong in a drug or medical device case. We are talking about products that had to be approved by the FDA before being sold and the levels of testing, analysis, monitoring, and reporting that goes along with that. Satisfying all the FDA requirements and then marketing a medical device that can only be obtained via a licensed surgeon who must also implant the device is hardly an atrocity that would offend the bounds of decency.

Plaintiff’s only response was that her infliction of emotional distress claims were based on defendant’s failure to properly test or properly design the device. Id. at *8. The opinion contains citations to the type of conduct that does rise to the “utterly intolerable” level and the horrors described even briefly in the parentheticals make it abundantly clear that failure to test/design doesn’t even come close. Id. at *8-9.

If plaintiff’s allegations were sufficient, “any manufacturer who is liable for strict products liability or negligence is also liable for the infliction of emotional distress upon those damaged by the product.” Id. at *9. An infliction of emotional distress claim cannot be solely premised on ordinary products liability and negligence. It must involve a degree of “physical contact” or “severely threatening behavior.” Id. at *10. Neither of which is present in this case or in any drug/device case (at least that we can think of). With no supporting case law and no supporting facts, the court dismissed the claims with prejudice.

We don’t see a lot of infliction of emotional distress claims in this arena, probably for the very reasons discussed in Ripple. But the court’s explanation for why these claims are not viable is among the best we’ve seen.

 

Parties often file motions in limine on fairly case-specific issues, building on the history of discovery and motions practice in the case.  Applying a ruling on in limines from one case to another can be a dicey proposition as potentially significant differences in the facts, law, claims and defenses asserted, and other rulings can usually be identified.  Plus, many pre-trial decisions on evidence do not last once doors get opening and evidence can be cumulative, among other reasons why judges’ minds change.  Still, we do posts on rulings on motions in limine that we guess might have some relevance to other cases our readers have.  When we do, we can be hamstrung by the limited information in these opinions on the facts, allegations, and other rulings, such as rulings on motions for summary judgment that would typically be rendered before the in limines are decided.

In In re Depakote, No. 15-CV-702-NJR-SCW, 2017 WL 2126837, *2 (S.D. Ill. May 16, 2017), we have rulings on a grab bag of motions in limine after the court issued partial summary judgment for the drug manufacturing defendant based on “preemption of label changes related to development delay” after fetal exposure of the medication.  If this summary judgment ruling sounds familiar, then you might need a hobby.  You also might have read any number of our posts on the Rheinfrank case and the ultimate affirmance of its preemption decision and defense verdict by the Sixth Circuit.  Like here, here and here.  As we said of the appellate decision, “The court held, ‘[g]iven, then, that as of 2008 the FDA did not believe the state of the data supported a developmental delay warning, it stands to reason that as of 2003, with even less data to go on, the FDA would similarly have rejected a developmental delay warning.’ Thus, Rheinfrank joins those courts that have drawn a preemptive line barring all plaintiffs who used a drug prior to an FDA insufficient evidence decision concerning the risk at issue.”  We also wondered how the case got to a jury given trial court’s preemption decision and the requirements of Ohio law.  We have similar wonderment at the instant case, which involved 2006 fetal exposure.  The decision is sparse on facts, but it is hard to imagine a viable product liability claim for the plaintiff’s injury when plaintiff cannot prove that the label in place when the drug was prescribed to the mother should have said something different about the risk of the injury in question.  Some sort of warnings claim seems to be pending, along with a claim for punitive damages.

With that background, we turn to the subset of the 28 total motions in limine that we think matter most.  First, consistent with the preemption ruling and the applicable regulation, plaintiff could not preclude the manufacturer from explaining that a proposed change to the label through the CBE regulation is still subject to FDA’s decision to accept, reject, or modify the proposed change.  2017 WL 2126837, *2.  What the CBE regulation has to do with plaintiff’s surviving warnings claim or whether it could have used (e.g., based on new evidence of safety) is unclear. Second, plaintiff’s red herring argument about whether FDA is required to do its own post-marketing studies did not preclude the defendant from presenting evidence that it followed labeling regulations.  Third, while the court allowed some speculative evidence from the plaintiff’s mother in connection with the inquiry on proximate cause for failure to warn—which should not happen unless a different developmental delay warning has been articulated—this opened the door to some amount of evidence on what she knew and how she behaved. Id. at **2-3.

As to the defendant’s motions, the post-conception labeling and regulatory communications were excluded and defendant agreed not to raise pre-conception discussions with FDA about labeling changes that were not yet approved. Id. at *3.  (With the limited information presented in the opinion, we cannot say if there was evidence that FDA rejected or discouraged whatever labeling change plaintiff was allowed to urge in the case.)  The court also excluded a 2009 FDA alert about the risk of birth defects with the drug, although plaintiff was allowed to discuss any pre-conception studies that went into the alert. Id. at *4.  Limiting warnings evidence to what existed before the prescription at issue makes sense, but it also makes sense that there needs to be a claim based on what the warnings should have said instead at that point.  Along those lines, plaintiff was not allowed to argue that the drug should have been contraindicated for use in pregnancy because plaintiff offered no expert who disclosed such an opinion. Id. (And such an opinion would have had some preemption problems, we think.)  Plaintiff was allowed, however, to offer evidence about foreign labels for the drug in place before plaintiff’s conception, holding that the manufacturer’s knowledge of these labels was relevant to its duty to warn. Id. at **7-8.  Breaking somewhat from its previously firm line on the irrelevance of the post-conception evidence to the warnings claim, the court did not foreclose the possibility that some post-conception marketing materials could be relevant if “they contain pre-2006 facts.” Id. at *6.  Again, we would think the pre-2006 facts would need to relate to whatever about the 2006 warnings for developmental delay that plaintiff was allowed to claim should have been different.

There was one last ruling that bears some discussion.  The defendant had pleaded guilty to a misdemeanor and paid a very, very large fine related to allegations of off-label promotion for use of the drug for schizophrenia and elderly dementia, which were not labeled indications. Id. at *9.  The plaintiff’s mother did not use the drug for these conditions and there was no evidence to “connect these activities with the 2006 Depakote teratogenicity warning.” Id. So, there was far too much prejudice compared to the probative value to let the jury hear about the plea or fines.  However, plaintiff was allowed to “introduce evidence regarding the off-label marketing and sales efforts . . . regarding bipolar disorder,” which was an indication added during 2006 (based on our quick look). Id.  The court saw this evidence as supporting plaintiff’s claim for punitive damages.  It seems to us that a plaintiff’s punitive damages evidence is not relevant unless it tends to show that the underlying conduct giving rise to liability was done with the requisite intent.  It does not sound like there is any connection between an alleged, non-preempted issue with the 2006 warnings for developmental delay and any off-label promotion issue, but maybe that link was just not spelled out in the opinion.

 

When this blogger hears “negligent undertaking,” my mind does not automatically turn to products liability – but rather to pre-teen children. Pre-teen children are at the age where they are asked (actually required) to “undertake” more and more duties and responsibilities. But often these duties are undertaken in a rather haphazard or lackadaisical way that some might say rise to the level of negligence. Dishes with food left on them put back in the cabinet. Wet laundry left in the dryer for more than a day. And as for cleaning up after the dog, well enough said. And as one of the two arbiters of whether such pre-teens have failed to act in good faith, I admit to guilt in an expanding definition of what constitutes negligent undertaking. The New Jersey courts fortunately have stricter and more precise guidelines than mood and level of tolerance on any given day to guide them and those rules led them to dismiss plaintiff’s negligent undertaking claim in Nelson v. Biogen Inc., 2017 WL 1382910 (D.N.J. Apr. 17, 2017).

The product at issue is Tysabri, a drug used to treat multiple sclerosis. Patients who test positive for anti-JC Virus antibodies were shown to be at an increased for developing a certain brain infection with use of the drug. Id. at *1. Plaintiff contracted the infection after being treated with the drug for three years.

It is worth pointing out some of the procedural history here to understand that his was a bit of a hail-Mary by the plaintiffs. Plaintiff’s initial and first amended complaints contained a claim for negligence that was dismissed because in New Jersey the sole remedy for products liability is the New Jersey Product Liability Act (NJPLA). Id. at *2. All products liability claims, except express warranty, are subsumed by the Act. So plaintiff’s second amended complaint alleged design defect and failure to warn under the NJPLA. Defendants moved to dismiss the design defect claim as preempted and plaintiff withdrew the claim before the court could rule on the motion. Id.   Which left plaintiff with only a failure to warn claim in his third amended complaint. After two years of discovery, plaintiff moved to amend his complaint for a fourth time, this time to add a negligent undertaking claim.

The basis for the claim, argued plaintiff, was that defendants had entered into a licensing agreement with the NIH to allow defendants to use the NIH’s JC virus antibody assay to develop the assay for commercial use. The assay would allow doctors to test for the antibodies to determine if their patients were at an increased risk for the brain infection. Id. The licensing agreement was entered into in 2006 and defendants released their JC virus antibody assay in 2012. Plaintiff alleges that when defendants entered into the licensing agreement, they were voluntarily undertaking the duty to develop the assay and that they failed to do so in a reasonable and timely manner. Id. at *3.

First, the court held that this negligent claim, like the negligence claim in plaintiff’s original complaint, was preempted by the exclusivity of the NJPLA. Plaintiff argued that negligent undertaking was different than other negligence claims because it is not based on a pre-existing duty. Not only did plaintiff have no New Jersey or other authority for this argument, it is a distinction without merit. As the court pointed out, “the application of the NJPLA is not premised on the timing of the duties incurred.” Id. at *4. Further, most duties (unlike those in my household) are at some point voluntarily assumed. “For example, before Defendants decided to develop, market, and sell Tysabri, they had no duty to do so. Once Defendants voluntarily decided to produce Tysabri, they then had a duty to act with reasonable care in doing so.” Id. Negligent undertaking is precluded by the NJPLA.

Second, the court found it would be an unprecedented expansion of liability to use negligent undertaking to create third-party negligence obligations to non-parties to the license, or indeed to any contract.  Plaintiff cited no cases in which a party who agreed to a license was held liable for negligent undertaking. Id. at *5. Acknowledging significant policy concerns, the court suggested that the more appropriate way to address issues of the type raised by plaintiff would be to deal with them specifically in the contract. The NIH could have included a time limit by when defendants should have developed the assay or the license would be revoked. Id.

Further, plaintiff failed to allege an essential element of negligent undertaking – reliance. Id. at *6. Plaintiff alleged that his status as a third-party beneficiary to the license agreement satisfied the reliance requirement, but he cited no authority for that proposition. So, closely adhering to the Erie doctrine, the court concluded that “If the courts of New Jersey believe that such an extension is appropriate, then they are in a better position to expand their own common law in the first instance.” Id.

This means plaintiff is back to his third amended complaint – failure to warn only. And as we just reported last week, there is good precedent on the adequacy of the Tysabri warnings and on Wyeth v. Levine preemption. And precedent has much more bearing in the courtroom than in the laundry room – where when prior rulings are cited to the judges they can be summarily ignored with a simple – “that was then, and I’ve changed my mind.”

 

I hope to see many of you at the 2017 DRI Drug and Medical Device Seminar on May 10-12th in New Orleans.  The meeting will feature its usual stellar lineup of presentations by in-house and outside counsel, a federal judge, deans of the drug and device defense bar, and – this is new – the US Chamber Litigation Center.  This seminar is the foremost educational and networking opportunity for practitioners in the pharmaceutical and medical device defense space. Connect with clients and colleagues and learn from cutting-edge presentations. We hope you join us in New Orleans!

If you want to chat, I’ll be in my usual front and center seat.

If you want to register, do it here

Regular readers of this blog know that we have a pretty jaded view of many MDLs. Obviously consolidation makes sense, at least on paper, in terms of efficiency and the best use of scarce court resources.  But, in practice, many MDLs promote a litigation “mob mentality,” in which the merits of individual cases are not important at the outset and, in the world of “settlement inventories” and “mass settlements,” may never draw the scrutiny of the judge or anyone else.   Though we continue to hope that “Lone Pine” orders will burgeon and raise the standards for plaintiffs seeking to fly under the radar and await settlement, many MDLs remain “safe havens” for plaintiffs who can’t satisfy the burden of proving their claims.

And a recent decision from the hip implant MDL does nothing to disturb this reality. In that MDL, a longstanding “Explant Preservation Order” requires preservation of hip implant devices removed from plaintiffs during explant surgeries.  The order requires plaintiffs to “make good faith efforts to ensure that [medical facilities] preserve” explanted devices and provides options for plaintiffs’ counsel to claim devices within 60 days of explant or, in the alternative, for the devices to be sent to the defendants.  It  requires all parties to handle explanted devices in accordance with a written protocol or consistent  with “methods and practices accepted by those in the field of inspection and testing of orthopedic devices,” to notify each other of devices in their possession before the date of the order, and to make devices available to each other after inspection and testing.   All of this, obviously, ensures that the critical evidence in this product liability MDL is preserved and handled in a fair and consistent manner.

In Marquis v. Biomet, Inc., et al., 2017 U.S. Dist. LEXIS 28465 (N.D. Ind.  Mar. 1, 2017), the defendants moved for summary judgment against six plaintiffs.  Five of these plaintiffs had had their devices explanted before they filed suit, or after they filed suit but before their cases were transferred into the MDL, and did not know what happened to their devices after they were explanted.  The sixth plaintiff had several revision surgeries.  During the first, the femoral head of her hip implant was replaced, and she asked for the explanted femoral head.   She explained, “I figured I paid for it.  I wanted it.”  She kept the femoral head in her closet, didn’t disclose on her fact sheet that she had kept it, and didn’t tell anyone she had it until her deposition.  The devices explanted during her subsequent surgeries were not preserved.

Continue Reading Hip Implant MDL Denies Summary Judgment on Claims of Plaintiffs Who Failed to Preserve Explanted Devices

Our weekly search for new drug/medical device cases for 1/13/17 turned up something unusual – not of particular substantive significance, but unusual. Two of the opinions included citations to Wikipedia.

Wikipedia?  You mean the comprehensive online encyclopedia that is crowd-sourced, so that anybody – even us – can edit/alter the information contained on the entries (at least, most of them)?  That’s it.  Since the provenance of the information on Wikipedia is unknown, as lawyers we’ve been taught never, ever to cite to it as authoritative in filed papers (we often cite to it on the blog).  After all, given the high stakes of most of our litigation, an attorney citing to Wikipedia could have just added the information to which s/he is citing.

[I]f Wikipedia were regarded as an authoritative source, an unscrupulous lawyer (or client) could edit the Web site entry to frame the facts in a light favorable to the client’s cause. Likewise, an opposing lawyer critical of the Wikipedia reference could edit the entry, reframing the facts and creating the appearance that the first lawyer was misrepresenting or falsifying the source’s content.

Peoples, “The Citation of Wikipedia in Judicial Opinions,” 12 Yale J. L. & Tech. 1, 24 (2010) (quoting Richards, “Courting Wikipedia,” Trial, at  (April 2008)).  Obviously, that kind of bootstrapping oneself into authority isn’t allowed.  If lawyers want to cite ourselves, we should at least have to write law review articles.

So we thought it would be fun to see what we could find in the way of Wikipedia references in judicial opinions involving product liability litigation or prescription medical products, and even both. This post details what we found.

First, courts (or masters) have gotten in trouble for excessive reliance on Wikipedia.  In a Vaccine Act case, a special master declined to hold a hearing, and instead relied on internet sources such as Wikipedia.  That produced a reversal.  As to Wikipedia, the court stated:

[T]he exhibit introduced by the Special Master indicates that its information was drawn from Wikipedia.com, a website that allows virtually anyone to upload an article into what is essentially a free, online encyclopedia. A review of the Wikipedia website reveals a pervasive and, for our purposes, disturbing series of disclaimers, among them, that:  (i) any given Wikipedia article “may be, at any given moment, in a bad state: for example it could be in the middle of a large edit or it could have been recently vandalized;” (ii) Wikipedia articles are “also subject to remarkable oversights and omissions;” (iii) “Wikipedia articles (or series of related articles) are liable to be incomplete in ways that would be less usual in a more tightly controlled reference work;” (iv) “[a]nother problem with a lot of content on Wikipedia is that many contributors do not cite their sources, something that makes it hard for the reader to judge the credibility of what is written;” and (v) “many articles commence their lives as partisan drafts” and may be “caught up in a heavily unbalanced viewpoint.”

Campbell v. Sec’y HHS, 69 Fed. Cl. 775, 781 (2006). But see Keeler v. Colvin, 2014 WL 4394467, at *3 (D. Colo. Sept. 4, 2014) (allowing administrative law judge to cite Wikipedia in vaccine case; “[t]his Court finds no per se prohibition on citing Wikipedia in judicial opinions”).

Continue Reading Pitfalls Of Judges, Lawyers, And Experts Citing Wikipedia

These past two weeks, our loyal readers have descended into “The Pits” and then climbed to “The Peaks” with us as we reviewed the 10 worst and 10 best cases of 2016.

If you found yourself wanting more information on these cases and their impact – perhaps with a side of CLE credit – we’re pleased to announce that three of your bloggers (Bexis, Eric Alexander, and Steven Boranian) will be presenting a free 90-minute webinar on “The Good, the Bad and the Ugly: The Best and Worst Drug/Medical Device Decisions of 2016” on January 18 at 12 p.m. EST.

The webinar is presumptively approved for 1.5 general CLE credit in California, Illinois, New Jersey, Pennsylvania, Texas and West Virginia. (For lawyers licensed in New York, it’s eligible for 1.5 credit under New York’s Approved Jurisdiction Policy.)

The program is free and open to anyone interested in tuning in, but you do have to sign up, which you can do here.