Today Time Magazine announces its Person of the Year.  The publisher called us a week or so ago to say we were PROBABLY going to be named Man (Person) (Blog) of the Year, but we would have to agree to an interview and a major photo shoot.  We said “probably” is no good and took a pass. Thanks anyway!

[None of that actually happened.  You might even call it fake news.]

Still, we can see why this blog would receive a major award for its literary achievements.  We admit that we are not quite on the same level as, say, James Joyce’s Ulysses, which 84 years ago on this date was found by an SDNY judge not to be obscene.  We also must ruefully acknowledge that our case analyses are not as funny and transgressive as Lolita, which Vladimir Nabokov completed 64 years ago on this date.  But we have occasionally encountered preemption issues as mystifying as Ulysses and plaintiff pseudo-experts who made the unhinged Humbert Humbert character in Lolita seem rational.

If there is a product liability issue that lends itself to literary invention, it is the issue of warnings.  All that even a minimally creative plaintiff lawyer needs to do is parse an existing warning, then dream up some specification or adjective that would frighten doctors or patients just a tiny bit more.  Stephen King is a fine writer, and odds are that he could do a splendid job of boosting terror in both warning labels and failure to warn claims. Of course, let’s remember that we are talking about fiction.

It is not fictional that there are many assorted asinine warning labels out there based on fear of lawsuits.  A hairdryer bears a warning against use by folks “while sleeping.” A tag on an iron helpfully advises against ironing clothes while worn on the body.  A bag of peanuts cautions us that the product … contains nuts.  The instructions for a chainsaw counsel against trying to stop the chain with one’s hands. An over-the-counter bottle of sleeping pills lists possible side effects, including … drowsiness.

There is more than a little fiction at work in the failure to warn claim in Cerveny v. Aventis, Inc., 2017 U.S. Dist. LEXIS 197194 (D. Utah Nov. 29, 2017).  You may remember the name Cerveny.  This litigation has already produced one of the best decisions of 2017.  The crux of this latest Cerveny decision was the fiction that the plaintiffs’ proposed warning would pertain to the plaintiffs. The court ultimately arrives at a sensible ruling on inapplicability of a warning about a risk to a population group that did not contain the plaintiffs.  The court also makes clear that in fraud/negligent misrepresentation claims, a contraindication is not intended to induce reliance.

The plaintiffs in Cerveny were the parents and their child, who was born with certain physical defects.  The mother had taken a prescription fertility drug before pregnancy, but not during the pregnancy.  That rather obvious and fundamental temporal fact is central to the case. The FDA at one point proposed a warning of possible fetal harm when the drug is taken during pregnancy.  That warning was not on the medicine when taken by the mother in this case, and one of the claims was that it should have been.  The failure to warn claim was essentially that the future mother would not have taken the medicine before pregnancy if she knew that taking it during pregnancy could cause birth defects.

Courts all too often are all too tolerant of plaintiff failure to warn theories.  Those claims all contain a dose of speculation, but some are speculative to the point of implausibility. It might be tempting for the court to pass the question, no matter how absurd, to the jury.  Not the Cerveny court: “When a proposed warning does not apply to the plaintiff, she cannot prove defect or inadequacy.”  The Cerveny court quotes from Rivera v. Wyeth-Ayerst Labs, 283 F.3d 315, 321 (5th Cir. 2002), which rejected as “absurd,” and “too speculative to establish Article III standing” a claim based on an allegation that an “extra warning, though inapplicable to [the plaintiff] might have scared her and her doctor” from using the drug.  Cerveny and Rivera recognize that there must be a limitation to how speculative a  failure to warn theory can be, and that Article III standing must actually mean something.  Accordingly, the Cerveny plaintiffs cannot prevail on a cause of action based on a failure to warn about the risk of a medicine used during pregnancy when the use in the case was only prior to pregnancy.  That is a notable result.  We already have a post collecting opinions that likewise reject warning claims based on inapplicable risks.

There was another ground for rejecting the failure to warn claim.  The label for the drug might not have contained an express warning, but it did contain a contraindication vs. use during pregnancy.  So if that is what the plaintiffs claim needed to be said, it was said in the contraindication section, and that is enough.

What about the plaintiffs’ misrepresentation claims?  The contraindication discussed above also said that “no causative evidence of a deleterious effect” of the medicine on the human fetus had been seen. The plaintiffs contended that the “no causative evidence” language was false.  But even if that is so, the contraindication was not directed to the plaintiff, and it was not intended to induce her to take the medication.  The purpose of the contraindication was to inform doctors that their pregnant patients should not take the medicine.  The plaintiff was simply not in that category. The failure to warn theory conjured up by the plaintiff lawyers was clever and creative, but it was also wrong.

In the mass torts world in which we find ourselves, glimmers of jurisprudential light can seem few and far between. Two things we love are good warnings causation decisions and sneaky plaintiffs getting caught at their own games.  Today’s case has both.  In Thompson v. Janssen Pharm., Inc., 2017 WL 5135548 (C.D. Cal. Oct. 23, 2017), the court considered simultaneous motions:  the plaintiffs’ motion for voluntary dismissal without prejudice and the defendants’ motion for summary judgment.

The plaintiff began taking Risperdal in 2001 after he was diagnosed with tics and other disorders, and he alleged that the drug caused him to develop gynecomastia (breast enlargement). Nevertheless, he continued – and continues – to take Risperdal (sixteen years, five doctors, and counting) because it effectively controls his tics, notwithstanding his alleged gynecomastia, his lawsuit, and his doctor’s recommendation that he stop taking the drug.

The Plaintiffs’ Motion for Voluntary Dismissal without Prejudice

The plaintiffs sued in the Central District of California, asserting the usual litany of claims. One day before the defendant moved for summary judgment, the plaintiffs moved for voluntary dismissal without prejudice so they could re-file their case in state court and park it in the already-existing JCCP, California’s version of an MDL.  They claimed that, though they had “been diligently seeking discovery” to prove their case, they were “unable to do so effectively” in federal court. Thompson, 2017 WL 5135548 at *4.

The court explained that factors relevant to its decision included: 1) the opposing party’s effort and expense in preparing for trial; 2) excessive delay and lack of diligence by the moving party in prosecuting the action; 3) insufficient explanation of the need for dismissal; and 4) the fact that the opposing party has moved for summary judgment. Id. at *5 (citations omitted).  Naturally, the plaintiff argued that all of these factors weighed in favor of granting the motion, but the court disagreed.

The court pointed out that, though the plaintiffs argued that they had been diligent in prosecuting his case, they had “failed to serve expert disclosure or expert reports.” Id. at *6.  Moreover, through the plaintiffs’ motion was “purportedly premised on their intention to join the pending state court [Risperdal litigation],” they gave “no explanation as to why they waited until . . . mere days before the summary judgment deadline” when they had notice of the state court litigation for more than a year. Id. The court concluded that this was “an insufficient explanation of the need for dismissal,” one of the factors to be considered. Id. (internal punctuation omitted).

In addition, though the defendants’ motion for summary judgment was not pending when the plaintiffs filed their motion (it was filed the next day), the defendants had notified the plaintiffs that they would be filing for summary judgment before the plaintiffs moved for dismissal. The court held that “the proximity of the two motions raise[d] the inference that that Plaintiffs’ motion might have been motivated by a desire to . . . avoid an imminent adverse ruling by way of Defendants’ summary judgment motion and also avoid the consequence of their failure to serve expert disclosures.” Id. (internal punctuation and citation omitted).

Simply put, as the court correctly perceived, the plaintiffs’ tactic was a transparent attempt to hide their meritless case in another mass proceeding on the chance that an inventory settlement would line their pockets at some point down the road.  The court concluded, “. . . Plaintiffs have not provided sufficient justification for voluntary dismissal given the untimeliness of the request and the proximity to Defendants’ motion for summary judgment.” Id.  Motion denied.

The Defendants’ Motion for Summary Judgment

It was undisputed that all of the plaintiffs’ claims were premised on the defendants’ alleged failure to warn about the rate of gynecomastia. As such, the defendants argued that all of the plaintiff’s claims failed because, inter alia: 1) the plaintiff assumed the risk by continuing to take the drug once he was aware of the alleged risk; and 2) the plaintiff could not prove “warnings causation;” in other words, he could not satisfy his burden of proving that that a different warning would have changed his doctors’ decisions to prescribe the drug for him. Id.

As to assumption of the risk, the defendants argued that the plaintiff was aware of the risk of gynecomastia but “continues to use Risperdal because he believes the benefits of the medicine in treating his condition outweigh the very risks that he has sued upon.” Id. at *7 (citation omitted).  The court disagreed, holding that the record did not clearly indicate that the plaintiff’s treating physicians discussed the risk of gynecomastia with the plaintiff.

But it was clear, on the record, that all of the plaintiff’s prescribing physicians were themselves aware of the risk of gynecomastia. And the plaintiff “provided no evidence that a different warning would have altered the physicians’ decisions to prescribe Risperdal.”  Therefore, the plaintiff could not “demonstrate the [warnings] causation required to survive summary judgment under California’s learned intermediary doctrine.” Id. at *8.

Nor were the plaintiffs’ claims saved by California’s “overpromotion exception.” As the court explained, “California courts have in the past recognized that the learned intermediary doctrine may not apply where a medication has been overpromoted to the extent that any warnings would have been nullified.” Id. at *9 (citation omitted).  But the overpromotion exception applies only in “unusual cases” (our California colleagues tell us that it is very rarely applied), and not “where a plaintiff’s prescribing physician did not rely on promotional statements when choosing treatment options.” Id. (citation omitted).  In this case, there was no evidence that any of the plaintiff’s prescribers relied on the defendant’s promotional activities, and the exception did not apply.

And so, in the absence of evidence of warnings causation, the court granted summary judgment for the defendants. The correct result, and a nice cautionary tale for plaintiffs thinking they can game the system, ignore both rules and law, and await the filling of their outstretched hands.  Does our defense heart good.

We write this in the first minutes of the eclipse, about 75 minutes from whatever “totality” will be visible here in southeastern Pennsylvania. We have our certified safety glasses at the ready, we have instructed the midday dog-walker to keep the Drug and Device Law Little Shaggy Rescues indoors (lest they unwittingly look skyward), and we have a continuous loop of the Fifth Dimension’s “Age of Aquarius” going around in our head. (Parenthetically, we accidentally typed “Fifth Amendment” just then for the name of the band.) The song has nothing to do with the eclipse, but it talks about the moon. And about Jupiter aligning with Mars. Appropriately thematic, we thought.

And, while “love steering the stars” may be a little strong to describe recent activity in Risperdal litigation, we have been pleased by a recent spate of positive developments. Last week, Bexis reported on two favorable decisions out of federal courts, one a post-BMS personal jurisdiction denial and the second a refusal to consolidate dissimilar cases for trial. Today we round out the triumvirate with a nice summary judgment decision from Pennsylvania’s state court system.

In In re: Risperdal Litigation: P.D. v. Janssen Pharmaceuticals, Inc., 2017 Phila. Ct. Com. Pl. LEXIS 231 (July 26, 2017), the (male) plaintiff allegedly developed gynecomastia – excessive breast tissue – when he was prescribed Risperdal (beginning when he was eight years old). He sued, including claims for design defect, failure to warn, and fraud. The defendant won summary judgment. The published decision occurs in a peculiar posture that is a creature of the Pennsylvania Rules of Appellate Procedure. Under Pa. R.A.P. 1025, when a grant of summary judgment is appealed, the trial judge prepares a written opinion in support of affirmance, arguing that there were adequate grounds for the summary judgment decision.

Design Defect

First, the court addressed the plaintiff’s design defect claims sounding in both strict liability and negligence. Because there were unresolved choice-of-law issues, the court considered these claims under the laws of both North Carolina, where the plaintiff was prescribed Risperdal and developed gynecomastia, and Pennsylvania, the forum state. Both states prohibit strict liability design defect claims against pharmaceutical manufacturers. While Pennsylvania, since Lance v. Wyeth, permits claims for negligent design defect, “a drug manufacturer can shield itself from liability for the design of drugs by including appropriate warnings; however, when it becomes known that a drug should not be used in light of the relative risks, the manufacturer can only avoid liability by removing it from the market.” P.D., 2017 Phila. Ct. Com. Pl. LEXIS 231 at *8-9. Here, the plaintiff did not offer “any evidence that Risperdal was so dangerous no warning could mitigate the relative risk of gynecomastia.” To prevail on a negligent design defect claim under North Carolina law, the plaintiff was required to submit evidence of a safer alternative design, and he had not “even address[ed] this requirement . . . , let alone submit evidence of a safer alternative design for Risperdal.” Id., at *9. As such, the court held, the plaintiff’s negligent design defect claims also failed under either body of applicable law.

Failure to Warn

The court’s dismissal of the plaintiff’s warnings claims rested on a finding that the plaintiff had not met his burden, under either North Carolina law or Pennsylvania law, of proving “warnings causation;” in other words, he had not proven that any alleged inadequacy of the product’s warnings was causally related to the his injury. We love this doctrine, because a successful argument can turn on the opportunistic exploitation of a plaintiff’s lawyer’s failure to ask a single question when deposing the plaintiff’s prescribing physicians.

The plaintiff’s warnings expert opined that the 2006 Risperdal label, in effect when the drug was prescribed for the plaintiff, should have included: 1) a recommendation for physicians to monitor prolactin levels; and 2) an indication that there was a statistically significant association between Risperdal use and gynecomastia. Id. at *12. But, as the court explained, “[a]lthough the parties deposed Plaintiff’s prescribing physicians, neither party elicited any testimony from [the doctors] concerning whether [the expert’s] proposed warnings . . . would have affected their prescribing decision.” Id. And so, the court concluded, “In light of the dearth of testimony from his prescribing physicians that [the expert’s] proposed warnings would have changed their prescribing decision, Plaintiff failed to establish proximate causation.” Id. (citation omitted).

The plaintiff attempted to save his warnings claim by arguing that the defendant engaged in illegal off-label promotion. The court held that, because the plaintiff was in an indicated population and was prescribed the drug for an indicated use, any discussion of off-label promotion was irrelevant to the case.

Fraud

Finally, the plaintiff argued that the court erred in dismissing his fraud claim. Again the court considered this claim under both North Carolina law and Pennsylvania law. Federal courts have interpreted Pennsylvania law as ‘barring [fraud claims]against pharmaceutical manufacturers.” Id. at *18 (citations omitted). Pennsylvania appellate courts have not addressed this issue. North Carolina law permits such claims, but not “where the purported misrepresentation was made solely to a third party.” Id. (citations omitted). “Because . . . neither Plaintiff nor Plaintiff’s mother relied on any representation” from the defendant in deciding whether to use the drug, “Plaintiff’s fraud claim must fail under North Carolina law.” Id.

The parties agreed that, where a true conflict of law existed, North Carolina law would apply, as that state, where the Plaintiff ingested the drug and developed gynecomastia, had a greater interest in the application of its law than did Pennsylvania, the forum state. “Ultimately,” the court held,

[I]t is immaterial whether Pennsylvania law permits a fraud claim in pharmaceutical cases. Assuming, arguendo, that Pennsylvania permits [such a claim], then Pennsylvania law conflicts with North Carolina law and North Carolina law would apply. Conversely, if Pennsylvania law prohibits such a claim, then Pennsylvania law applies. In either scenario, Plaintiff’s fraud claims would be dismissed.

Id. at *19.

We love a good summary judgment decision.  P.D. is sound and well-supported, and we trust that it will be affirmed on appeal. We will keep you posted. In the meantime, the [very cool] eclipse has come and gone. In the words of the Fifth Dimension, “let the sun shine!”

 

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.

No one can be all that happy with how the Accutane mass tort proceeding has played out in New Jersey. We have no involvement in that proceeding, but we have monitored it from afar, and it has been extraordinarily contentious.  The rub is that the parties have very little to show for the effort.  The latest shoe dropped last week when the New Jersey Appellate Division vacated (again) a jury verdict in favor of an Accutane plaintiff.  The unpublished opinion in McCarrell v. Hoffmann-La Roche, Inc., No. A-4481-12T1, 2017 WL 1683187 (N.J. App. Div. May 2, 2017), is interesting, both in its treatment of expert opinion and evidence on causation under Alabama law.

But before we get to that, let’s review very briefly what has come before. When plaintiffs first started suing in earnest over Accutane, they alleged a variety of injuries, including psychiatric conditions, birth defects, kidney disorders, vision problems, and musculoskeletal problems.  There has been some litigation on these issues, but the proceedings in New Jersey and elsewhere have focused largely on gastrointestinal disease, including inflammatory bowel disease.  IBD can be every bit as bad as the name makes it sound, and we can see why patients who experience IBD can garner substantial sympathy.  But the warnings on gastrointestinal disorders are robust, and a federal court in Florida ruled in 2012 and 2013 that the Accutane warnings as to IBD were adequate as a matter of law.

But not in New Jersey, where several cases have proceeded to trial. We have not surveyed the New Jersey verdicts lately, but the last time we did, we counted about half a dozen verdicts—all of which were vacated, with others pending on appeal.  There certainly are others that we are not counting here, but the trend is unmistakable:  Multiple trials presided over by a New Jersey mass tort judge who was championed by some as a hard-working jurist and vilified by others for placing a thumb firmly on one side of the scale.  Substantial verdicts in favor of the plaintiffs.  All of them vacated.  In the mass tort context, vacated verdicts represent a massive waste of both sides’ time and money.

Which is what happened again last week in McCarrell.  The case was first tried to a jury in 2007, resulting in a verdict for the plaintiff.  But the Appellate Division vacated that award and remanded for a new trial because of erroneous evidentiary rulings. McCarrell, 2017 WL 1683187, at *1.  The parties therefore tried the case again in 2010, which resulted in a larger verdict for the plaintiff.  On appeal from the second verdict, the Appellate Division reversed again and held that the claims were time barred.  But the New Jersey Supreme Court disagreed and remanded the case back to the Appellate Division to address the remaining issues on appeal. Id. at **1-2

That remand resulted in last week’s opinion, and the Appellate Division reversed again.  First, the trial judge ordered that it would not allow duplicate expert testimony.  As a result, the defense had its expert gastroenterologist address certain studies, but was prohibited from having an epidemiologist corroborate that testimony. Id. at *2.  The rubber hit the road in closing argument when plaintiff’s counsel emphasized to the jury that the defense gastroenterologist’s opinion stood alone.  That was a problem, particularly once the Appellate Division ruled in 2013 that “trial courts should not prohibit overlapping expert testimony in complex matters on a ‘central issue of liability.’” Id. at *2 (citing McLean v. Liberty Health System, 430 N.J. Super. 156 (App. Div. 2013)).  Under that ruling, the trial judge’s decision to disallow overlapping expert testimony about scientific studies was error. Id. at *3.  And in light of counsel’s emphasis in closing on the defendants’ expert as a “lone outlier,” the error was prejudicial.

Second, the court held that the plaintiff had not met his burden of proving causation. This was a failure-to-warn case, but no one asked the prescribing physician whether her decision to prescribe Accutane would have been different if the drug had come with a stronger warning. Id. at *4.  Regular readers of the blog know this is warnings causation 101, and because the plaintiff bears the burden of proof under the applicable law (Alabama in this case), the absence of this essential evidence caused his warnings-based claims to fail as a matter of law. Id. We agree wholeheartedly with this ruling, although we are somewhat puzzled that the Appellate Division suggested going out and deposing the doctor again.  Sure, the doctor was deposed in 2007, but the burden of proving warning causation is not obscure now and was not obscure then.  It is not obvious to us that a second bite at the apple is warranted, nor do we know if the prescriber can even be re-deposed, after another decade has passed.

So what do we mean when we say that no one can be happy with this? The opinion gives parties on both sides more leeway in presenting expert testimony, and we have guidance on proving failure to warn under Alabama law.  But in the larger scheme, this case is apparently heading for a third trial, having first b een tried ten years ago.  Other verdicts from New Jersey have met the same fate.  Plaintiffs are left empty handed, and the defendants continue to bear the burden of vigorous litigation in New Jersey, whereas the federal MDL wrapped up in the defendants’ favor years ago.  In the end, McCarrell is a defense win, but the cost has been high.

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

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

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

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

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

In terms of the legal gyrations plaintiffs try to avoid preemption, we’ve already expressed our opinion that so-called “failure to update” claims take the booby prize. There are good reasons, discussed in these prior posts, why plaintiffs not faced with preemption never bring claims for failure to update a warning – they’re simply lousy claims. The latest example of this fact is Woods v. Wyeth, LLC, 2016 WL 1719550 (N.D. Ala. April 29, 2016).

Woods is yet another metoclopramide case – that’s the generic drug that produced PLIVA v. Mensing, 131 S. Ct. 2567 (2011). Stuck between a rock and a hard place, the plaintiff:

Argue[d] that her claims are not preempted because they are based on the generic defendants’ “failure to update” their labels to be consistent with the brand name labeling.

Woods, 2016 WL 1719550, at *1. Woods, after examining various non-binding precedents, concluded that plaintiff “has set out a narrow claim that falls outside the scope of federal preemption” – the failure to update claim involving no more than the FDA-approved labeling. Id. at *8.

OK, so take generic preemption out of the mix entirely – what happens with Woods?

Same ultimate result as if the claim had been preempted; that is to say, judgment on the pleadings for the generic defendants.

Continue Reading Yet Another Failure-To-Update Claim Bites the Dust

We sat through The Revenant again this weekend, at the plaintive (not plaintiff) request of a Drug and Device Law Friend who had yet to see it. Last time, we barely stayed awake. This time, we lost the battle. We have heard all of the incredulous “how could you??” exclamations. Yes, there was lots of violence. There was the ursine animatronic latter-day cousin of “Bruce,” who, like his predecessor, failed to engage or convince us. Bottom line for us was that there was plenty of dramatic stuff going on, but none of it added up to a compelling story.

Without meaning to be flip about the truly tragic facts of today’s case, that was essentially what the court held. In Batoh v. McNeil-PPC, Inc., et al., — F. Supp. 3d –, 2016 WL 922779 (D. Conn. Mar. 10, 2016), the plaintiff’s decedent, her adult son, developed SJS/TEN (Stevens Johnson Syndrome/Toxic Epidermal Necrolysis) after taking over-the-counter Motrin. SJS and TEN are “severe cutaneous adverse reactions” (“SCAR events”) in which skin becomes inflamed, blistered, and necrotic, and sloughs off. The results can be catastrophic. In the plaintiff’s decedent’s case, the SJS/TEN left him with “significant wounds and scarring throughout his body, and damage to his nervous system, eyes, genitals, and feet.” Batoh, 2016 WL 922779 at *4 (citation omitted). A year later, he committed suicide, telling relatives that he could not tolerate living with these residual injuries.

The plaintiff sued the drug’s manufacturer, alleging violations of the Connecticut Products Liability Act based on theories of failure to warn, design defect, breach of warranty, and fraud/misrepresentation. The defendant moved for summary judgment on all of the plaintiff’s claims, and the plaintiff cross-moved on the defendant’s preemption defenses.

Continue Reading Silence Would Have Been Golden: Unnecessary Illogical Preemption Decision in Motrin SJS/TENS Summary Judgment Victory

We’re pleased to report that good things continue to happen in Atlantic County product liability proceedings following recent judicial turnover. On February 19, 2016, the Reed Smith Bard/Davol defense team scored a hat trick – going three for three on summary judgments in New Jersey hernia mesh litigation. The three decisions are: Goodson v. C.R. Bard, Inc., 2016 WL 743478 (N.J. Super. L.D. Feb. 19, 2016); Utech v. C.R. Bard, Inc., 2016 WL 743477 (N.J. Super. L.D. Feb. 19, 2016); and Yakich v. C.R. Bard, Inc., 2016 WL 743476 (N.J. Super. L.D. Feb. 19, 2016).

A bit of background. These three are not mass tort cases. They are examples of what happens when there is indiscriminate plaintiff-side advertising. People call up these 800 numbers because they had “mesh” implanted. They don’t have the targeted product but – what the hey? – it’s mesh and some of the raw materials are the same, so rather than turn away a potential plaintiff, the same attorneys file one-off cases against virtually every mesh product that exists, even if (as is true here) the particular product has been the medical standard of care for the relevant surgical procedure for decades.

As one might expect with pattern litigation, these three lawsuits, and thus these three opinions, look a lot alike. So we’ll concentrate on the Goodson opinion – if for no other reason than alphabetical order.

Continue Reading New Jersey Mesh Summary Judgment Hat Trick

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

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

Continue Reading Solid Affirmances: Avandia Summary Judgment, and Westminster