Returning to a Favorite Spot

            One member of our blogging team (we’ll let you guess who) recently returned from her (well, that narrows it down a bit) first real camping trip.  The kind with a tent, sleeping bags, no electricity.  You get the idea.  This wasn’t just a step, but rather a huge leap outside this blogger’s comfort zone – which runs more toward poolside bar service somewhere where the view is only obstructed by palm trees.  Before the trip images of big red welts from mosquito bites, spiders and ticks taking up residence in our hair, and critters of any size wandering around at night left us more than a little disconcerted.  An ample supply of wine was stowed with the gear.  A Google maps search had located nearby hotels.  And the iPhone car charger was packed.  We were ready for anything.

            Most importantly, as it turns out, we were ready for some fun.  The weather near the Appalachian Trail in Pennsylvania was almost perfect.  Sunny and warm during the day.  Just chilly enough at night to make you want to huddle around the camp fire.  Perfect weather for hiking, fishing, roasting marshmallows and hot dogs, and telling ghost stories.  The perfect environment for separating the kids from their DVD players, iPads and assorted other portable electronic devices – something we quickly realized was necessary when, as we drove into the mountains we heard from the back seat:  Wow, it’s like a real life 3D movie.  Yikes! (But don’t tell them about the car charger). 

            Perhaps best of all was the stillness of the early mornings.  No alarms going off.  No sounds of traffic congestion.  No being bombarded by streaming bad news from all over the world.  Just big, deep breaths of fresh air.  It made us think of …well, of camping again.  Much like the sandy beaches and umbrella drinks (which remain our top destination for relaxing) – when you discover a place you like, you find yourself wanting to return.  Even on the ride home, you start thinking about the next time.  Fun places are fun places.  So, we revisit them with fond memories of the last trip and anticipation that more fun is right around the corner.

            That’s sort of how we feel about the Aredia/Zometa litigation.  We’ve been there before, we generally like it, and so we go back again. 

            This week, the A/Z litigation added to its lengthy string of successes (see prior posts on A/Z cases here) with a Daubert (slip op.) and a summary judgment (slip op.) win all rolled into one in the case of Conklin v. Novartis Pharmaceuticals Corporation, No. 9:11-cv-00178-RC, (E.D. Tex. Sept. 19, 2012).  

While the case was pending in the Aredia/Zometa MDL, the court granted defendant’s motion for summary judgment on plaintiff’s (and 7 other TX residents’) failure to warn claims.  Daubert slip op. at 5.  Shortly after remand, in an attempt to avoid the implications of the MDL court’s ruling, plaintiff notified the remand court that the case would proceed on “design defect under Texas law.”  Id. at 8.  Plaintiff claimed that Dr. Robert Marx, an oral surgeon and one of plaintiffs’ leading MDL experts, had an alternative design theory that saved her remaining claims.  Id.   As Dr. Marx’s declaration was plaintiff’s sole support for those remaining design defect claims, the court first ruled on defendant’s motion to strike under Daubert.

Dr. Marx’s opinion was that a decreased dosage and/or frequency of Zometa administration would both reduce the risk of the side effect suffered by plaintiff (ONJ) and still efficaciously treat cancer-related bone damage.  Id. at 16.  Unfortunately for plaintiff, the court found both that Dr. Marx was unqualified to render such an opinion and that the opinion itself was unsupported.  First, the court noted that Dr. Marx is neither an oncologist nor pharmacologist and therefore not qualified to offer an opinion on what dosage of Zometa would effectively treat cancer-related bone damage.  Further, in disqualifying Dr. Marx, the court noted that he “had to rely on studies or opinions of other experts to opine of the efficacy or utility of his ‘safe alternative design.’”  Id.

But the court didn’t stop there.  Delving deeper into the shaky foundation of Dr. Marx’s opinion, the court stated:

The analytical gap, in Dr. Marx’s opinion is demonstrated by setting out his premises and conclusions:

Premise: Studies show that a certain regimen of Zometa helps treat cancer-related bone conditions, but may cause ONJ.  

Premise: Other studies show that less Zometa will result in less ONJ.

Conclusion: A regimen using less Zometa will help treat cancer-related bone conditions.

This is a classic logical fallacy—an irrelevant conclusion.

It is not helpful to the finder of fact for Dr. Marx to state that a drug used to fight cancer related diseases has a particular negative side effect, and that reducing the dosage and/or frequency of that drug will reduce the occurrence of the negative side effect. Rather, Dr. Marx must also provide some factual support that reducing the dosage and/or frequency of that drug will not only reduce the occurrence of the negative side effect, but will also be effective at fighting cancer-related diseases. Unfortunately, Dr. Marx offers no evidence as to the efficacy of a reduced Zometa regimen . . .

Id. at 18.  Based upon Dr. Marx’s inability to show that a reduced dose or duration of Zometa treatment would be as efficacious as the FDA-approved dose or duration, Dr. Marx’s “alternative design” opinion was stricken.

          The court then turned to defendant’s motion for summary judgment.  The MDL court having done away with plaintiff’s failure to warn, and by extension her breach of express warranty claims, Summary judgment slip op. at 8, the remand court was left to consider strict liability design defect, negligence per se and breach of implied warranty.  First, the court quickly recognized that plaintiff’s negligence per se and breach of implied warranty claims were “re-packaged design defect or failure to warn claims.”  Id.   Since the MDL court had ruled that plaintiff’s failure-to-warn claims were foreclosed, and since plaintiff had offered no admissible evidence of a safer alternative design -- the court granted summary judgment for defendant.  Id. at 9-11.    Two wins, no waiting.

          As you know from our prior posts, the Conklin decision is just the latest in a string of defense wins in the Aredia/Zometa litigation.  But just like a good vacation – we don’t mind revisiting if the trip brings a smile to our face.

          As always congratulations and thanks to our friend Joe Hollingsworth for keeping us up to speed on this litigation.

The Latest From Aredia/Zometa

Yeah, we know that Joe Hollingsworth − among his many other talents − likes to publicize his wins (who doesn't, we plead guilty).  But that’s okay.  When he sends us stuff from the Aredia/Zometa wars that’s worth publicizing, we’ll use it; otherwise, we blog about something else.  It just so happens that the latest items we’ve been graced with are worth knowing about.


First, there’s what looks like the end of the line for the Hogan case.  We’ve been following that one for several years.  Hogan was particularly notable because it involved a Rhode Island plaintiff, and there’s just not that much Rhode Island law on anything.

Our prior Hogan-related posts:

First, the defendant lost a summary judgment motion in the MDL, In re Aredia & Zometa Products Liability Litigation, 2009 WL 2513555 (M.D. Tenn. Aug. 13, 2009), as we mentioned here, in the context of keeping score.  At that point, we thought that the Zyprexa defense folks were having better luck with their summary judgment motions than the A-Z folks.

Then things got better.  The next time we looked in, Hogan had evidently been remanded from the MDL, because a court in New York (the forum choices in A/Z often leave us scratching out heads) took a pro-defense position on subsequent remedial measures − finding them to be “procedural” and thus applying the federal rules (rather than a peculiarly pro-plaintiff Rhode Island state rule).  Hogan v. Novartis Pharmaceuticals Corp., 2011 WL 1336566 (E.D.N.Y. April 6, 2011).

We checked back in not much later for a truly excellent Daubert ruling − excluding the notorious Dr. Parisian and another plaintiff’s expert.  Hogan v. Novartis Pharmaceuticals Corp., 2011 WL 1533467 (E.D.N.Y. April 24, 2011).  Unfortunately the court also dodged a prediction of whether Rhode Island would adopt the learned intermediary rule.  Id. at *9.  That meant Hogan only received an honorable mention in our 2011 top ten list.

So fortified, the defense then went out and won the trial.  We blogged on that, too, even though verdicts don't usually come with much to blog about, because at trial the court finally predicted − a first we believe − that Rhode Island would adopt the learned intermediary rule.  Rhode Island had previously been the only state in the country with no learned intermediary rule precedent at all.  We called it “The Closing of the Learned Intermediary Frontier.”

Well, now the defense has won the inevitable appeal in Hogan, too.  Here’s a copy of the opinion.  Did the plaintiff appeal the subsequent remedial measure ruling?  Doesn’t look like it.  Did the plaintiff appeal exclusion of Parisian?  Again, it’s not even mentioned in the opinion.  Finally, did the plaintiff appeal on the learned intermediary rule?  Nope.

With all these interesting legal issues in the Hogan case, what went up?

The only issue the Second Circuit discussed was whether the plaintiff’s screw up in failing to make timely arrangements to obtain the live testimony of one of the treaters.  Hogan, slip op. at 3-4.  After all that time and effort, what we’re left with is a discretionary procedural ruling.

Bravo Foxtrot Delta.

Thus endeth the Hogan litigation, with a whimper not a bang.

We get more bang for our blogging buck with the other recent A-Z opinion, Patterson v. Novartis, Inc., C.A. No. 11-402 ML, slip op. (D.R.I. Aug. 28, 2012).  First of all, Patterson was a statute of limitations dismissal.  We don’t usually cover those, because the facts are very case-specific, and the law is very state-specific.

But we have exceptions. One of those exceptions is the issue of cross-jurisdictional class action tolling of the statute of limitations.  We feel strongly enough about that ill-conceived notion that we devote one of our scorecards to it.

That issue came up in Patterson − but first, the case's rather tortured procedural history:

Plaintiffs initially pursued a claim against Defendant and the generic pharmaceutical drug manufacturers in the United States District Court for the District of Columbia on March 5, 2009.  On November 9, 2009, the claims against Novartis were separated from the claims against the generic drug manufacturers by the United States Judicial Panel on Multidistrict Litigation.  The claims against Aredia were transferred to the [Aredia/Zometa MDL]. . . .  Novartis moved to dismiss Plaintiffs’ claims against it pursuant to Fed. R. Civ. P. 12(c) on the ground that the use of “and/or” to describe the drug manufacturer was insufficient to state a claim for relief against Novartis.  Over Plaintiffs’ Objection, the [MDL] Court . . . granted the Motion and dismissed Plaintiffs’ Complaint pursuant to Fed. R. Civ. P. 12(c).  Plaintiffs appealed . . . and their appeal was denied. Shortly thereafter, Plaintiffs refiled the case in this District.

Patterson, slip op. at 2-3.

Basically the Patterson plaintiff failed to identify the defendant as the manufacturer, instead using weasel words “and/or” to muddy up his complaint.  Although plaintiffs used to be able to get away with that kind of thing, TwIqbal precludes that kind of vague language – as we discussed in this post, back in 2009, specifically about "and/or".

Only after playing out the string in the MDL did the plaintiff in Patterson bother with filing a new complaint.  By that time the statute of limitations had run.  It turns out that, despite filing the original complaint in DC, litigating it in Tennessee, and ultimately filing a second action in Rhode Island, plaintiff was really a Massachusetts resident.  Again, we have no idea why the plaintiff made some of the tactical choices he did − and apparently neither did the court.  Patterson, slip op. at 11.

The plaintiff offered four arguments why he should be allowed to skate under a three-year statute of limitations despite filing the complaint six years after the injury.  We don’t care about two of them:  the discovery rule (too fact specific), and equitable tolling (too state specific).

We care a little about the Massachusetts saving statute argument, but only because that demonstrates that a TwIqbal dismissal is on the merits, and not merely a “matter of form.”  “The case law is clear that a dismissal under Rule 12 is a final decision on the merits.”  Patterson, slip op. at 9.  A dismissal on the merits cannot be revived by a saving statute.

We care a lot about the cross-jurisdictional class action tolling issue.  The court (sitting in Rhode Island) refused to become the first court anywhere to predict that Massachusetts would allow an out of state class action (here, in the MDL court in Tennessee) toll its statute of limitations:

Plaintiffs’ cross-jurisdictional class-action tolling argument asks this Court to engage in an exercise of legal gymnastics to save Plaintiffs’ Complaint.  In particular, Plaintiffs argue that the filing of an Aredia class action in Tennessee tolled the statute of limitations nationally until such action was dismissed on November 14, 2007.  The issue of such tolling is controversial, and Plaintiffs have not identified any Massachusetts cases adopting the theory.  Moreover, the case law indicates that “few states” adopt such tolling for class actions filed in another jurisdiction and that “several federal courts have declined to import the doctrine into state law where it did not previously exist.”  I decline to apply cross-jurisdictional class action tolling in the present case, since Plaintiffs have not shown that Massachusetts has adopted tolling of this nature, nor that it would.  It is not this Court’s role sitting in diversity to create new state law in Massachusetts; thus I reject the arguments advanced by Plaintiffs on these grounds.

Patterson, slip op. at 10-11 (citations omitted).

Bingo!  Not only does Patterson go onto our cross-jurisdictional tolling scorecard as the first Massachusetts decision on the issue, but it warms our blogging hearts to see a federal court refusing to make wildly expansive predictions of state tort law under the Erie doctrine (another proposition we’ve advocated here at DDLaw since the beginning).

Thus, we follow Aredia/Zometa not because Joe makes it easy − although that helps − but because (like Bone Screw before it), that litigation raises a host of interesting issues.  We wish the defense well as it tackles the difficult task (again, like Bone Screw) of “winning” a mass tort after remand from the MDL.

Aredia/Zometa Motions in Limine

One of the remand courts in the Aredia/Zometa litigation recently issued a decision on various motions in limine.  See Brown v. Novartis Pharmaceuticals Corp., 2012 U.S. Dist. LEXIS 104985 (E.D.N.C. July 27, 2012).  Here’s the rundown of the “good,” the “not-so-good,” and the “it depends.”

The good:

·                     Post-injury label changes: The court excluded evidence of the defendant’s changes to the label of Zometa in 2007 and Aredia in 2008.  Id. at *38-40. Plaintiff’s injury was diagnosed in 2005, and the court held that these years-later label changes qualified as subsequent remedial measures. Of course they do.  This has long been the view of the majority of circuit courts, and getting this type of ruling has become easier with amended FRE 407, which now reads in part:  "When measures are taken that would have made an earlier injury or harm less likely to occur, evidence of the subsequent measures is not admissible to prove . . . . . a need for a warning or instruction."

·                     Emails by members of an Advisory Board to the defendant:  The court excluded these as hearsay.  Id. at *34-37.  Defendant appears to have had an advisory board of outside doctors who gave the defendant advice on its draft of a white paper.  Plaintiffs sought to admit emails from two of the advisors, arguing that the emails weren’t hearsay because the doctors were somehow agents of the defendant.  But agreeing to participate in an advisory board is far different from being an agent.  There was no evidence that the defendant controlled the two outside doctors or that the doctors acted on the defendant’s behalf.  They just gave advice.  Plaintiffs also argued that the emails were business records, but the court saw no evidence that serving on these advisory boards was regularly conducted business activity or that, even if it were, the emails were a regular part of that business activity. 

The not-so-good:

·                     Adverse Event Reports (AEs):  The court allowed plaintiffs to use AEs as evidence of causation and for notice.  Id. at *25-30.  We’ve blogged many times – because it’s right – that AEs should not be used as evidence of causation.  They’re hearsay, anecdotal, incomplete, and unreliable.  Unfortunately, this court will allow plaintiffs to do it here, so long as a plaintiffs’ expert testifies that he relied upon AEs to form a causation opinion.  We don’t think that finding an expert to offer such an opinion changes the deficiencies of AEs.  For those interested, we’ve compiled a cheat sheet of AE decisions that we believe got it right.  Additionally, by the way, the court allowed plaintiffs to use AEs for notice to the defendant, a much less controversial ruling. 

·                     Failure to warn non-prescribers.  The court recognized that under North Carolina law a defendant is not liable in a failure to warn case if the defendant gave an adequate warning to the plaintiff’s prescriber.  Id. at *33.  That’s good.  But plaintiffs also wanted to show evidence of a failure to warn non-prescribers.  That seems wholly irrelevant.  The prescribers were either warned or not.  Now, while the court did not issue a final ruling, it did hold open the possibility of allowing non-prescriber failure-to-warn evidence if plaintiffs showed that the actual prescribers were not warned.  Id. at *33-34.  This seems like an invitation to mischief.  Failure to warn does not occur in the air.  It must involve the relevant learned intermediaries – the prescribers. 

The "it depends":

·                     Choice-of-law on punitive damages.  It depends because all lawyers approach this issue by first determining which state’s law they would prefer applied.  Here, New Jersey law, the home of the manufacturer, allows no punitive damages because the FDA approved the drugs, while North Carolina law, where the plaintiff purchased, used and allegedly was injured by the drug, would allow punitive damages.  The court applied Restatement (Second) of Conflict of Law and chose New Jersey.  In short, the court held that, while North Carolina law properly applied to the underlying claim because it was aimed at protecting the plaintiff, New Jersey law should apply to the punitive claim because it was aimed at deterring any wrongful conduct of the defendant, a New Jersey company.  Id. at *10-24.  No matter how you look at this, though, it was a nice victory for the defendant. 

Breaking News - Another Aredia Win

Another remanded Aredia/Zometa case has apparently bitten the dust.  See Ingram v. Novartis Pharmaceuticals Corp., No Civ-05-913-L, slip op. (W.D. Okla. July 18, 2012).  Ingram threw out all of the plaintiff's on warning causation grounds, a strong defense in this litigation, which involves a drug used to treat cancer.  A basic problem that plaintiffs face in such situations is that, when the alternative is likely death by cancer, most prescribing oncologists aren't going to be swayed by the possibility of a much lesser injury (with bisphosphonates, osteonecrosis of the jaw).  So an allegedly defective warning about the lesser injury won't deter anything.

The law, in Oklahoma as elsewhere, requires warning causation - some material change in prescriber conduct:
Slip op. at 6.

Even if the plaintiff establishes a duty to warn and a breach of that duty, she must further establish proximate causation by showing that had defendant issued a proper warning to the learned intermediary, he would have altered his behavior and the injury would have been avoided.

Slip op. at 4. Oklahoma is one of those unfortunate jurisdictions that applies a heeding presumption even in pharmaceutical cases, but for the reasons we discussed above, it was easily rebutted in Ingram.

[The prescriber] testified that had he known of [the drug's] potential complication of osteonecrosis of the jaw, he would have prescribed it for [plaintiff's decedent] anyway.  This testimony establishes that although the prescribing physician . . . would have read and heeded the warnings regarding [the drug] and ONJ, this would not have changed [the prescriber's] decision to prescribe it to [the decedent].

As is also common in these cases, plaintiff tried to salvage the case with lesser causation evidence - that the prescriber, while still using the drug, now gives various advice about dental issues.  Slip op. at 6-7.  That didn't work in Ingram because even the plaintiff's own expert (a Dr. Marx - is that Harpo, Groucho, Chico, or Zeppo?) admitted that the decedent already had ONJ. Slip op. at 8:

When this finding [pre-existing ONJ] is kept in mind, it is clear that plaintiff’s arguments regarding [the prescriber's] changed prescribing practices are insufficient to discharge her burden of proof on proximate causation.  As demonstrated above, [the prescriber] has unequivocally testified that had he known in January of 1999 that [the drug] had the potential complication of ONJ, he would have prescribed it for [the decedent] anyway.

Slip op. at 8.

The court also throws out plaintiff’s wrongful death claim, because it wasn't supported by any expert testimony.  We've commented previously about the weakness of many of the cases we're seeing after remand from the A/Z MDL, and judging by the expert testimony here, Ingram looks like another.

In any event put another one in the "W" column for the Hollingsworth Aredia team.

Bessemer Process Yields Stainless Steel

Id. at *1.

We mentioned last Friday that the defense win in the Bessemer Aredia case had been affirmed.  We didn’t have time to gloat then, but we do now − at least a little.  The affirmance, which won’t be published, is now online here:  Bessemer v. Novartis Pharmaceuticals Corp., 2012 WL 2120777 (N.J. Super .A.D. June 13, 2012) (per curiam).  There isn’t much to this opinion; it’s basically an appellate endorsement of two of the trial court’s (Judge Jessica Mayer) opinions:

[W]e affirm substantially on the basis of the well-considered and thorough opinions of Judge Mayer, which are well supported by the evidence and legal precedent.

The two prior opinions in question are:  Bessemer v. Novartis Pharmaceuticals Corp., 2010 WL 6052544 (N.J. Super. L.D. Nov. 12, 2010) (denying post trial motions), and Bessemer v. Novartis Pharmaceuticals Corp., 2010 WL 6257855 (N.J. Super. L.D. April 30, 2010) (granting partial summary judgment).  Now that they’ve been confirmed as "well-considered and thorough," what we’d most like to see is these two opinions (particularly the summary judgment order) get published in the A.2d reporter − so Westlaw would give them page numbers, for one thing.

So what exactly did the Appellate Division endorse last week? Here’s a synopsis:

The post-trial motion decision (2010 WL 6052544) in Bessemer held:

• The testimony by plaintiff’s prescribing oncologist at trial that called causation into question was in response to plaintiff’s own question, and plaintiff, having asked the question, had to live with the answer.


• Plaintiff failed to place other objections to videotape deposition testimony on the record, and thus waived them.


• If plaintiff did not like the prescriber’s videotape testimony, she could have called him as a live witness, but failed to do so.


• The jury was told that the defendant paid the travel expenses for the treating physician who testified that plaintiff likely didn’t have the disease condition she claimed she did.


• The court acted properly in letting both sides speak informally to plaintiff’s treating physicians.


• The total number of patients with similar conditions (at least to what plaintiff claimed she had) was properly excluded as irrelevant and prejudicial, and in any event the jury never reached causation, having found for the defendant on defect.

If we had page numbers, we’d use them, but we don’t so we can’t.

Except for the informal interviews point − to which the Appellate Division spoke in its recent decision in the mesh litigation − these issues are very case specific and, frankly, seem rather makeweight.

The more important of the two Bessemer trial court decisions was its summary judgment decision (2010 WL 6257855). That opinion held:

• Plaintiff presented enough evidence of her warning theory to survive summary judgment (that’s why there was a trial).


• Defendant was under no obligation to warn a non-prescribing physician in a different field (dentistry) of the risks of what was a drug prescribed in the treatment of cancer.


• Plaintiff presented enough evidence of causation for her warning theory to survive summary judgment.


• Aredia was FDA approved, so punitive damages could not be assessed.


• Plaintiff failed to establish a design defect claim.


• There is no independent cause of action for implied warranty.

Of these rulings, the most important concern warnings to non-prescribing physicians in other fields and punitive damages. While we don’t like everything in this opinion, we think it deserves to be published.

Shooting Fish In A Barrel

The good guys in Aredia/Zometa won another one the other day.  The Sixth Circuit affirmed the exclusion of all the plaintiff’s experts − and thus entry of summary judgment − in Simmons v. Novartis Pharmaceuticals Corp., ___ Fed. Appx. ___, 2012 WL 2016249 (6th Cir. June 5, 2012).  So good for them.


But geez, reading Simmons we wonder what’s going on.  Those were really poor experts.  If the plaintiffs in the A/Z MDL are going with this kind of witness, we question how vigorously the litigation’s being pursued.

Here’s what we mean.  There were two experts in Simmons − both oral surgeons, whom we’ll call “Dr. O.” and “Dr. G.” Dr. O was “non-retained,” which we think means a treating physician.

The problem with Dr. O is that he didn’t even give a causation opinion.  He didn’t get close to opining to a reasonable degree of medical certainty (or a particular jurisdiction’s equivalent language) that the drug caused the plaintiff’s injury (osteonecrosis of the jaw, or “ONJ” for short).  Instead, as the court held:

[Dr. O] never opined that [the drug] caused [plaintiff’s] ONJ. Plaintiff relies on [Dr. O’s] statement that he found “a very close association” between ONJ and bisphosphonates. However, [Dr. O] also specifically acknowledged that he “didn’t establish causation” in evaluating [plaintiff’s] ONJ. . . . [Dr. O also] clarified that he was not aware of any evidence suggesting that by continuing to use [the drug, plaintiff’s] condition worsened. Furthermore, [Dr. O] agreed that the present level of evidence did not support a cause-and-effect relationship.

Simmons, 2012 WL 2016249, at *4 (emphasis added).  Huh?  That’s a plaintiff’s expert?  Sounds like someone on our side.

The second expert, Dr. G., was your classic litigation expert-for-hire.  He didn’t know anything he wasn’t spoon-fed by plaintiff’s counsel:

[T]he record reflects that [Dr. G] had no knowledge of the etiologies of ONJ prior to meeting [plaintiff], and then gained only a limited familiarity based on literature supplied to him by Plaintiff’s counsel.

Simmons, 2012 WL 2016249, at *6.  In his non-litigation practice, he’d never treated an ONJ patient nor diagnosed ONJ in anybody − if he ever encountered such a patient, he’d refer him/her to a specialist.  Id.  So much for expertise.  Dr. G’s methodology wasn’t any better:

[Dr. G’s] specific-causation opinion [w]as unreliable because it was not derived from scientifically valid principles but rather relied exclusively on the scientific literature provided by Plaintiff’s counsel.  [Dr. G] made no attempt to verify this information, such as doing his own research for other articles, and then drawing an independent conclusion.  . . . .[T]his court views with special caution expert testimony prepared solely for purposes of litigation. . . .  [Dr. G] conceded that he did not apply a differential diagnosis. . . .  [He] admitted that he did no research into alternative risk factors for ONJ.  [Dr. G] admitted that [plaintiff] had osteomyelitis, and that osteomyelitis can cause ONJ, and he conceded that he did not rule out osteomyelitis and [other] potential exacerbating factors.

Id. at *7 (emphasis added).

So Simmons involved two experts, one who offered no causation opinion at all, and a second who read only what plaintiff’s counsel handed him, and didn’t bother to do anything more, not even an attempt to rule out other possible causes.

So we wonder, what’s going on here?  We know that the other side has lots better experts available to them.  We see them regularly.  Why didn’t they bother getting them for one of their bellwether cases?  We don’t know the answer, but in general when the other side litigates on the cheap, such as by going with lousy experts (or not paying them to do anything), it’s indicative that they don’t value their cases very highly.

Winter Probably Discontented

We don’t like losing, but as we said not too long ago, unless you don’t try (or aren’t trusted with) hard cases, you’re going to lose every so often.  That goes for both plaintiffs and defendants.  So, after dropping a couple of big ones ($3.2 million in Stevens (Montana) and $1.2 million in Fussman (North Carolina)), the Aredia/Zometa folks had to be concerned when the jury came back last Friday in Winter. We’ve posted about certain – bad – legal rulings in Winter a couple of times here (letting Dr. Parisian testify, essentially unfettered) and here (allowing a fanciful “Dear Doctor” letter argument to avoid what should have been a slam-dunk failure to read learned intermediary defense). With a pro-plaintiff judge and Dr. Parisian it’s hard to be optimistic about the trial outcome.

******************
Errata:

We've been informed that the pro-plaintiff judge (even plaintiff's counsel can't deny that) who made the pre-trial rulings did not try Winter.  Rather a magistrate judge tried the case.  Thus, our comment about a "pro-plaintiff judge" at trial was unwarranted, given that fact, and we take it back.

******************

But after a little more than a day of deliberations, the Show Me State jury in Winter decided it hadn’t been shown very much : it brought back a plaintiff’s verdict, but only for $225,000 in compensatories.  That’s after the plaintiff sought $750,000 in compensatory damages and $7.5 million in punitive damages during closing arguments (so we’ve been told).  While that’s a “loss” for our side – in the sense the jury awarded the plaintiff damages – it’s losing only in the Pyrrhic sense.  The plaintiff’s lawyer’s cut of that (usually 33.3% or 40%) isn’t going to bring much of a return on the litigation investment of time and effort.  And we haven’t even begun to talk about costs….  Dr. Parisian doesn’t come cheap (volume discounts anyone?).  You’ve probably heard the phrase “going broke saving money.”. Well, it’s equally possible to go broke winning cases, if the “wins” are like Winter.

If you’re keeping score at home, Winter is the seventh A-Z case to be tried (in state or federal court) where juries are asked to balance the risk of osteonecrosis against that drug’s benefit in treating cancers that have metastasized to the bone.  The defense won four of the previous six – by that we mean outright defense verdicts – in Hogan (E.D.N.Y.); Brodie (E.D. Mo.); Kyle (W.D. Ky), and Bessemer (N.J. Super).

Congrats, then, to Joseph Price and Linda Svitak of Faegre; Gregory Chernack of Hollingsworth, and Deirdre Gallagher of Foley & Mansfield.

Aredia/Zometa – The Punitive Dance Continues

            When last we wrote of punitive damages in the Aredia/Zometa litigation, we predicted the parties were entangled in a dance that would involve back and forth on both sides and that wasn’t likely to end anytime soon.  See prior post.   We were right on both accounts. 

Then we brought you a favorable decision by the New Jersey Superior Court that New Jersey punitive damages law applied to a case brought by a Virginia resident against a New Jersey company in New Jersey.  See Irby v. Novartis Pharmaceuticals Corp., 2011 WL 5835414 (N.J. Super. Nov. 18, 2011).  Change the plaintiff to a California resident and the forum to California and you get the exact opposite result.  Or so said the court in Hill v. Novartis Pharmaceutical Corp., 2012 U.S. Dist. LEXIS 38516 (E.D. Cal. Mar. 20, 2012).  

This is a pro-defense blog and we don’t pretend be otherwise.  Our regular readers are fully aware of our feelings on preemption, Twiqbal and personal injury class actions.  Choice of law, however, is one of those legal issues that is difficult to take a firm position on.  Primarily because as good lawyers, we naturally want whatever law is more favorable for our clients.  Plaintiffs control where a lawsuit is brought.  While defendants can’t control what law is applied, at least we can be heard.  And, where the issue is punitive damages, our clients rightfully demand we be very vocal.    The reason is as clear as comparing the punitive damages law of the two states at issue in Hill.

In prescription drug cases, New Jersey has three limits on punitive damages.  First, the New Jersey Punitive Damages Act caps punitive damages at five times compensatory damages.  N.J. Stat. Ann. §2A:15-5.14(b).  Second, the New Jersey Product Liability Act prohibits punitive damages

if a drug . . . which caused the claimant’s harm was subject to premarket approval or licensure by the [FDA] . . . and was approved or licensed. . .  [except] where the product manufacturer knowingly withheld or misrepresented information required to be submitted under the agency’s regulations, which information was material and relevant to the harm in question.

N.J. Stat. Ann. §2A:58C-5.  Third, the New Jersey appellate courts have held that the fraud on the FDA exception in the statute is preempted.  See McDarby v. Merck & Co., 949 A.2d 223, 272 (N.J. Super. A.D. 2008).  So, where a product is FDA approved, application of New Jersey law is tantamount to a dismissal of the punitive damages claim.

On the west coast, things are a bit different.  Punitive damages are available in California “in any action for breach of a non-contractual obligation – including products liability actions” and “punitive damages awards in products liability actions are not statutorily limited.”  Hill, 2012 U.S. Dist. LEXIS 38516 at *7.  Pretty much a night and day situation.  But what to do about it?

California applies the governmental interest analysis to determine choice of law.  Id. at *3.    Three steps – 1.  Do the laws of the competing states differ such that there is a true conflict?  2.  If yes, does each state have an interest in having its own law applied?  3.  If yes, which state has the greater interest (or which state would be more significantly impaired if its law was not applied)?  Id. at *4-5. 

The first two are easy.  The law is different.  And, both states have an interest in the case.  Plaintiff is a California resident and alleges she was injured in California.  Id. at *14.  Defendant is headquartered in New Jersey.  So, the crux of the case comes down to which state has the greater interest.  This is where plaintiff’s choice of forum becomes difficult to overcome.  As this court said:

[W]hen the forum state undertakes its search to find the proper law to apply based upon the interests of the litigants and the involved states, it is understood that normally, even in cases involving foreign elements, the court should be expected, as a matter of course, to apply the rule of decision found in the law of the forum. The law of the forum, will be displaced only if there is a compelling reason for doing so.  It is applicable unless either the plaintiff or the defendant has been forced into a forum devoid of any such contact as would justify application of its own law. . . . Thus, California law presumptively applies unless Defendant can present a compelling reason why it should not.

Id. at *25-27 (quotation marks and citations omitted).   Unless there is no connection to the forum, a local court wants to apply its own laws.  We get that and the Hill court had some reasons why New Jersey law should cede to California law in this case.  They are what they are – all else being equal, we’ll apply our own law.  That’s not to say that the defendants didn’t have some good arguments – they did and they made them.  But asking a local court to apply foreign law to a local plaintiff is almost always going to be an uphill battle.  (Uphill, but not impossible.  See Deutsch v. Novartis Pharmaceutical Corp., 723 F. Supp.2d 521 (E.D.N.Y. 2010) (federal court in NY willing to apply NJ punitive damages law in an Aredia/Zometa case, discussed here).

Maybe that is the more significant difference between Hill and the earlier mentioned Irby v. Novartis case from New Jersey.  In Irby a Virginia resident sued a New Jersey based company in New Jersey, while in Hill, a California resident sued a New Jersey based company in California. So, in Irby, the New Jersey court placed greater emphasis on the fact that the alleged punitive conduct would have occurred in the defendant’s New Jersey corporate headquarters and “stem[med] from [defendant’s] New Jersey business activities.”  Irby, 2011 WL 5835414, slip op. at 8-10.  And with respect to conduct outside of New Jersey, the Irby court found that the drug (Zometa) “was widely distributed throughout the United States,” and “nothing in [defendant’s] sales, marketing, or distribution practices suggests that the alleged injury was more likely to occur in Virginia than in any other state.”  Id. at 7. 

In Hill, the California court was less persuaded by the location of corporate conduct argument and more focused on activity that occurred within its borders.  

Some of Defendant's misconduct undoubtedly occurred in New Jersey. Whether the misconduct occurred primarily in New Jersey, however, is not discernible from the pleadings or the competent and admissible evidence submitted by the parties. What is discernible is the misconduct extends into California. Plaintiff alleges Defendant "markets Zometa to physicians in California," "distributes and sells Zometa . . . in California," "compensates agents who pitch the drug to doctors . . . in California" and "sends instructional materials about the drug . . . to patients and physicians in California." Plaintiff further alleges Defendant failed to communicate the known risks of Zometa to doctors and patients in California. Under these circumstances, Defendant's misconduct arguably occurred as much in California as in New Jersey, if not more so.

Hill, 2012 U.S. Dist. LEXIS 38516 at *27-28.  Same drug, same general marketing activities.  Change the forum, change the result.

            Ultimately, the Hill court boiled the issue down to one of pure economics when, ignoring McDarby v. Merck, it concluded that

applying California's punitive damages  law would not impose an entirely new rule of punitive liability on Defendant. Its effect would be to raise the upper limit on any potential award of punitive damages. But this increased economic exposure . . . is nothing more than the cost of doing business.

Id. at *34-35.    And so the dance continues  . . . .

This New England v. New York Thing is Getting Old

Let’s get this out straightaway: it is gruesomely hard to come up with a Super Bowl theme for a post on drug and device litigation. It’s even harder for anyone in Philadelphia to come up with anything nice to say about New York or Boston. Philadelphia used to be the second-biggest English-speaking city in the world. But the Erie Canal and other factors propelled NYC past us, and we’re still smarting over the indignity. We probably harbor even harsher feelings for Beantown. Applying any objective measure, Philly trumps Boston (more history, better climate, closer to, um, New York). Nevertheless, denizens of “The Hub” carry around an unbearably smug Brahmin attitude while we cheesesteak-eaters are all-too-quick to poor-mouth our fair city. Let’s remember that Benjamin Franklin was born in Boston, but fled Red Sox Nation for greener pastures – Philly – where he became our most entertaining and randy Founding Father. Let’s also remember that the Patriots (the footballers, not the heroes of 1776) racked up their greatest victories while cheating – ever hear of Cameragate?

Yesterday’s New York-New England Super Bowl presented your average Philadelphian with a bitter choice. Manhattan chowder or New England? Bah – snapper soup tastes better than either. The Ramones or Aerosmith? Those guys are all dead or look like it. Today, The Roots rule. Melville or Emerson? Turgid transcendentalism is a literary snooze-fest, and why does it take 600 pages to get from “Call me Fishmeal” to the "devious-cruising Rachel" who "found another orphan"? (Sounds like a description of an ordinary Saturday night in an Alphabet City club, doesn't it?) Give us the legal fiction of former Dechert-ite Lisa Scottoline anytime.

Anyway, we spent too much time yesterday straining to come up with a Super Bowl angle for today’s post. Why not just pop open a Yuengling, forget that there ever was a disappointment called the Iggles, and enjoy the unofficial National Holiday? But we’re legal geeks, so we cannot help but compare Boston and New York in legal terms. Both have had some Pro Bowl jurists. Oliver Wendell Holmes was on the Massachusetts bench, and New York had Cardozo. But the glory that was Boston and the grandeur that was New York are no more. Now Boston is home to frivolous qui tam cases, and we tremble at the prospect of another social engineering magnum opus from E.D.N.Y.

So we’re setting up a new competition between New York and New England. There are a couple of cases where lower courts fumbled some pretty basic and important DDL concepts, and now it’s up to the First and Second Circuits to go under the hood and, after further review, reverse the calls on the field. To switch to another sport for a moment, we feel like Ted Knight in Caddyshack, grimacing and sputtering, “Well – we’re waiting!”

In New York there was the Caronia case, which we blogged about here and some other places. The constitutionality of the FDA’s prohibition against truthful off-label promotion is at issue. Since the Second Circuit favorably decided the Sorrell first amendment decision, later affirmed by the U.S. Supreme Court, we were optimistic that Caronia would be reversed. We are still optimistic, but are also increasingly impatient.

In New England there was the Bartlett case, which we blogged about here and several other places. Bartlett produced a couple of decent rulings, and then it produced some monstrous ones, followed by a $21 million verdict. It made our bottom ten list in 2010 mostly because the court permitted a design defect claim against an FDA-approved prescription drug, even where the plaintiff does not show an alternative design. The court also allowed failure-to-warn evidence that had no proper place in the case. The court apparently regretted the plaintiff counsel’s grotesquely unfair conduct, but did not do anything about it. In other words, the plaintiff’s counsel got away with it.

Football is fine, but it isn’t ultimately how we judge a city. We’re more likely to don a big foam finger or slip on a beer-tube helmet to honor whichever appellate court is first to tackle and reverse one of these rotten decisions.

* * * * * * *

While we are on the subject of keeping score, we thought we’d step back and take a look at what has happened in Aredia/Zometa trials. We've written about motion practice in Aredia/Zometa cases here, among other places. Last Tuesday, Joe Hollingsworth reported on a defense verdict in the Kyle case that was returned in just over two hours after a three week long federal Zometa trial in the Western District of Kentucky. That was pretty good. Then the next day, in Brodie v. Novartis Pharms. Corp., the jury found in favor of Novartis following a one and a half week trial in the Eastern District of Missouri. In Brodie, plaintiff Sharon Brodie alleged that her deceased husband, John Brodie (not the 49er quarterback), developed osteonecrosis of the jaw (“ONJ”) as a result of his use of Novartis’s cancer drug Zometa. The prescribing oncologist testified that he had been aware of the risk of ONJ as a result of a “Dear Doctor “letter. That was the third federal defense verdict in a row for Novartis and the second defense verdict in just two days in litigation arising out of the consolidated federal MDL pending in the Middle District of Tennessee, In re Aredia and Zometa Prods. Liab. Litig. (The fourth case is on appeal in the Fourth Circuit.) And in the only case arising from the New Jersey state court consolidated Aredia/Zometa litigation to be tried, Bessemer v. Novartis Pharms. Corp., the jury also found for Novartis. A number of Zometa trials are set for the remainder of 2012, including a trial arising out of the New Jersey consolidated litigation that’s scheduled to begin in March. We are cheering for Joe to keep running up the score.

Rules Matter, Part 2

Dr. Martin Luther King, Jr. once said, “Justice denied anywhere diminishes justice everywhere.” Maybe simply setting out that quotation, and not-so-simply meditating on it, would constitute an appropriate gesture on this day of service.


But, as usual, we have a few extra words to say before returning to the observances and pleasures of the holiday. Justice is not exactly the same thing as following rules. In fact, Dr. King showed that justice sometimes requires one not to follow the rules. That being said, the concepts of justice and consistent adherence to rules certainly reside in close quarters.



We’ve been thinking about rules while we spent much of the last few days watching contact sports. The National Football League had its best weekend of the year, and Ricky Gervais did his usual, tasteful job of hosting the Golden Globes. Rules played a big role for both. In football we expect enforcement of the rules. The Golden Globes is all about the violation of the rules (mostly by drunken entertainers and journalists whose immigration documents should be carefully checked -- perhaps twice). Nothing makes any sense without rules, even if those rules operate arbitrarily. Coloring outside the lines is cute only because there are lines. But, as lawyers, we're not out for cuteness. (Yes, we know: it shows.) We talk about the rule of law.



Understanding and following the rules is supposed to be a big part of what we do. That being said, it's almost surprising when judges enforce technical rules against plaintiffs who claim serious injuries. Sometimes the enforcement process threatens to become like the National Basketball Association, where referees don't call travelling or carrying if it looks like the player didn't obtain any advantage from the violation. In some courtrooms, the only thing judges ask about is whether there's any prejudice from a violation, not so much whether there was a violation. By contrast, last week we were pleased to report about a judge in the Aredia/Zometa litigation who actually followed the rules and employed them.



Well, the Aredia/Zometa defendants are on a roll. Our friends Joe Hollingsworth and Robert Johnston sent us another example where a fastidious federal judge applied the rules to dismiss a complaint. This happened on January 12, and what the judge specifically did was reject a plaintiff's untimely effort to designate a retained expert witness on specific causation. Harvey v. Novartis Pharms. Corp., No. 2:06-CV-1140-VEH (N.D. Ala. Jan. 12, 2012). The Harvey case was, for a time, part of the Aredia/Zometa MDL in Nashville, for which the appellate court is the Sixth Circuit. Later, the case was remanded to S.D. Alabama. While this case was still part of the MDL, it was subject to the case management order, which controlled the key deadlines. Pursuant to the CMO, the plaintiff in Harvey (originally Ms. Harvey, who suffered from cancer, and subsequently, after she died from cancer, her son) was required to file expert reports by February 21, 2011. The plaintiff (at that point Ms. Harvey's son) complied with the expert designation deadline by naming only the treating oral surgeon to testify about specific causation. That is, the plaintiff declined to designate a retained expert on the issue of specific causation, i.e., whether the drugs caused Ms. Harvey to develop osteonecrosis of the jaw. Op. at 3.



At the time that expert designations were due, the Aredia/Zometa MDL judge had already granted summary judgment in several other MDL cases in which the plaintiffs were represented by the same counsel as Ms. Harvey on the ground that those plaintiffs had not established that their treating physicians were qualified to provide specific causation evidence and had failed to designate any retained experts on that issue. Those summary judgments were later affirmed by the Sixth Circuit. Thomas v. Novartis Pharmaceuticals Corp., Nos. 09-6147, 09-6272, 09-6274, 2011 WL 3701816 (6th Cir. Aug. 23, 2011). We blogged about Thomas here. The Harvey case was remanded to S.D. Alabama on July 26, 2011. Alabama is in the Eleventh Circuit, not the Sixth Circuit.



Following remand, and following the Thomas decision (though not immediately following), the plaintiff moved pursuant to Fed. R. Civ. P. 16(b)(4) to modify the schedule to name a new expert. Op. at 4. Rule 16(b)(4) provides that “[a] schedule may be modified only for good cause and with the judge’s consent.” Under Eleventh Circuit precedent, a schedule should not be modified unless it cannot be met despite the due diligence of the party seeking the extension. So it all comes down to diligence. The plaintiff argued that he had no reason to believe that he needed to retain an expert witness on specific causation until after the Sixth Circuit affirmed the judgment in Thomas and stressed the importance of testimony on specific causation to the viability of his case.



The district court rejected these arguments, concluding that the plaintiff had not shown diligence sufficient to establish "good cause" under the rule. Op. at 8. Instead the court held that at the time expert disclosures had been due in the MDL, the plaintiff's counsel had "firsthand knowledge of potential obstacles pertaining to expert testimony on specific causation" due to his direct involvement in the Thomas cases. Op. at 8. Moreover, the Sixth Circuit decision was an unpublished opinion that was not controlling on the S.D. Alabama and, in any event, it’s not as if it was a bolt from the blue for a court to hold that treating doctors cannot opine on causation unless they are qualified to do so.



The court also observed that several other plaintiffs in the same group of cases had sought additional time to name a retained specific causation experts in the MDL given the Thomas rulings. Op. at 9. The “reactive” nature of the plaintiff’s motion in the wake of Thomas did not support a finding of due diligence. Id. The court stated that "any litigation tactic or strategy, such as waiting on an appellate decision" needed to be made within the time limits imposed by the MDL court. Op. at 10-11. The court also rejected the suggestion that the importance of the testimony to the plaintiff's case could substitute for a diligent effort to comply with the rules Op. at 10. In the end, the court found no evidence of diligence on the part of plaintiff and denied the motion. Op. at 11. Rules are rules.


We also think that justice was done in that case.


Happy Martin Luther King, Jr. Day.

Rules Matter

A long time ago, when we were just starting out as defense hacks, a mentor told us to beware of the double-standard that lawyers representing big corporations face: we are expected to be virtually perfect in our compliance with every possible rule (even rules whose existence and/or application are doubtful) while plaintiff lawyers can blow every deadline, botch every filing, bobble every rule, and get away with it because they are, pretend to be, or claim to represent, the little guy. For years we thought that double-standard applied. In front of some judges, we still fear the double standard. But we also have lots of friends among the plaintiffs' bar and we have heard them complain of a double-standard that they face. Maybe everybody in our business labors under the impression that they are uniquely oppressed. Maybe we want to portray ourselves as heroes confronting long odds.

Most judges try to enforce the rules but also try to inject a little bit of flexibility into the system. They will cut litigants some slack, until it becomes clear that the litigant is a serial offender. Indeed, as brutal as the combat can be between plaintiffs and defendants, more often than not we usually find ways to cut each other some slack. There is a bit of 'there but for the grace of God go I' in these extensions of merciful courtesies. Nevertheless, if it becomes clear that the rule violations form a pattern of indifference or sloppiness, and if the noncompliance is truly disruptive or prejudicial (and our clients have more than a little input in this sort of calculation) it becomes appropriate to ask the court for enforcement of the rules and implementation of the correct sanction or remedy.

In mass tort litigation, there are two areas where we almost always run into at least some plaintiffs (and their attorneys) who fail to cross the t's and dot the i's where it matters: (1) plaintiffs who declared bankruptcy but did not include their tort claims as an asset in bankruptcy, and (2) plaintiffs who died and were not appropriately substututed for per the relevant state procedure. Our friend Joe Hollingsworth called our attention to an example of the latter in the Aredia/Zometa MDL, which has already been so prolific in producing grist for our bloggy mill.

The United States District Court for the Western District of Arkansas granted Novartis Pharmaceuticals Corporation’s motion to dismiss in McDaniel v. Novartis Pharmaceuticals Corporation, Case No. 2:08-CV-02088 (W.D. Ark. Jan. 6, 2012), because a deceased plaintiff had not been properly substituted for, despite representations to the court that the substitution would be accomplished. The case was originally filed in the United States District Court for the Middle District of Tennessee and was centralized in the Aredia and Zometa MDL. The case was ultimately remanded to the Western District of Arkansas, where the plaintiff's family resided and was set for a February 2012 trial. At the time of trial, the putative plaintiff was the son of the allegedly injured party, who had died as a result of multiple myeloma.

But a lot had happened, or failed to happen, before February 2012. A Suggestion of Death had been filed, and the decedent's husband was provisionally substituted in as personal representative. But the husband never changed his status from provisional personal representative to personal representative by submitting to the MDL court an order of appointment, as was required by the court's case management order. Then the husband became incompetent to serve as personal representative. In early 2010, the son took over as provisional representative. But he never made application to be appointed administrator of his mother's estate and never changed his status from provisional personal representative to personal representative by submitting to the MDL court an order of appointment. No estate had ever been opened for the decedent, and no petition had ever been filed to appoint someone (husband or son) as personal representative. After the passage of substantial time (nearly four years), and on the eve of trial, the plaintiff filed a Motion to Amend Order of Substitution, while the defense filed a Motion to Dismiss the Case.

The plaintiff's motion was denied, and the defense motion was granted. The court was clearly reluctant to dismiss a case on what seems to be technical grounds, but was just as clearly constrained by the rules and the procedural posture of the case. The court found itself "in the unfortumate situation where, on the eve of trial, Plaintiff requests that this Court travel back in time and cure the procedural missteps done in the course of this litigation," which "the Court cannot and will not do." The husband's and son's failure to substitute in as personal representative violated three levels of rules: (1) they "failed to follow the terms of the MDL court’s case management order in substituting a proper party in interest within the time period specified by the order and prior to remand of the case" for trial; (2) they "failed to meet F.R.C.P. 25’s requirements for proper substitution of a deceased party"; and (3) they "failed to properly revive the claim according to A.C.A. § 16-62-108 [the Arkansas revivial statute] within a year of Mrs. McDaniel’s death." The court stated, "[t]he simple fact is that Plaintiff’s counsel had plenty of time to correct the procedural deficiency created by the death of Mrs. McDaniel." Moreover, the "procedural deficiency" is not merely technical. The court lacks jurisdiction over the matter because the husband and son had failed to revive the claim.

Because the rule at issue really mattered, and because the plaintiffs had no viable excuse for ignoring the rule over such a long period of time, the court had no choice. For some rules, there simply is no double standard.

Aredia/Zometa – One Step Forward, One Step Back

On November 18, 2011, the defense scored a victory in the New Jersey Zometa/Aredia mass tort program, when the court granted a motion to apply New Jersey punitive damages law.  The plaintiff was a Virginia litigation tourist who brought suit in New Jersey state court despite his treatment having nothing to do with the state.  See Irby v. Novartis Pharmaceuticals Corp., 2011 WL 5835414, slip op. (N.J. Super. Nov. 18, 2011).  Both sides had agreed on Virginia substantive law governing the plaintiff’s causes of action, but they scuffled over choice of law in punitive damages.


Why?  This isn’t the first time we’ve considered choice of law in punitive damages.  New Jersey has a statute that precludes punitive damages against FDA approved drugs.  N.J.S.A. 2A:58C-5(c).  Not only that, but the New Jersey appellate courts have held that the only significant statutory loophole – fraud on the FDA – is preempted.  See McDarby v. Merck & Co., 949 A.2d 223, 272 (N.J. Super. A.D. 2008).  So, where a product is FDA approved, application of New Jersey law is tantamount to a dismissal of the punitive damages claim.

The defense even had to overcome a presumption that the law of the place of injury (Virginia, in Irby) governs.  The court considered the various factors laid out by Restatement (Second) of Torts §145 (1965), to find that the presumption was defeated.  The court held that New Jersey had a more significant relationship than Virginia to the issue of punitive damages.  The location of plaintiff’s injury was “‘fortuitous’ because the place of injury bears little relation to [defendant’s] alleged punitive conduct,” given that it “is headquartered in New Jersey,” that the drug (Zometa) “was widely distributed throughout the United States,” and “nothing in NPC’s sales, marketing, or distribution practices suggests that the alleged injury was more likely to occur in Virginia than in any other state.” Slip op. at 7.

The court also held that the next §145 factor, location of the allegedly injurious conduct, favored New Jersey because conduct at issue for punitive damages would have occurred in the defendant’s New Jersey corporate headquarters.  Id. at 8-9.  The plaintiff failed to prove that the conduct occurred in the company’s international Swiss headquarters.  Id. at 9 & n.4.  Irby also held that the relationship between plaintiff and defendant was centered on New Jersey because plaintiff’s punitive damages claims “stem from [defendant’s] New Jersey business activities.”  Id. at 10.

A serious comity issue also popped up, since “punitive damages are generally intended to regulate conduct within the bounds of an interested state” and, based on the finding that the alleged misconduct occurred in New Jersey, “interstate comity would be least offended by the application of New Jersey law to the issue of punitive damages.”  Id. at 12.  That's a bit of a bootstrap, but it worked.  More importantly, New Jersey has decided to limit punitive damages by statute when FDA-approved drugs are involved, and plaintiff, having chosen to come to New Jersey when she could have filed suit in Virginia, was not really in a position to assert comity.  Id. at 15-16.  Finally, the court held that prior law was basically split concerning the punitive choice of law question.  Id. at 17.

Thanks to Joe Hollingsworth, of Hollingsworth LLP, both for winning the motion and passing it along.

Why there’s such a fierce fight over choice of law in punitive damages in the Aredia/Zometa litigation is demonstrated by another recent decision that’s not so favorable to our side.  In Fussman v. Novartis Pharmaceuticals Corp., 2011 WL 5836928 (M.D.N.C. Nov. 21, 2011), the court denied post-trial motions – most of them – in a case that had produced a verdict of $287,000 in compensatory damages, and $12,600,000 in punitive damages.  Id. at *1. When you’ve got runaway juries awarding blatantly unconstitutional punitives that run almost 44 times compensatories, there’s good reason to fight such claims tooth and nail.

Fortunately, North Carolina has a statute (N.C.G.S. §1D-25) that limits punitives to three times the compensatory award, so that post-trial motion, at least, was granted in Fussman.  Id.

The other motions were denied.  As to the motions for judgment, it’s hard to say exactly why, except that the court was not about to reverse the jury’s verdict.  Fussman, 2011 WL 5836928, at *3-4.  Where's the beef?

There’s not much more meat to the discussion of punitive damages in Fussman.  The court finds those claims unpreempted in light of Wyeth v. Levine, but doesn’t really explain itself.  Fussman, 2011 WL 5836928, at *4 (still where's the beef). But we did find an interesting footnote about fraud on the FDA, which states, in pertinent part:

[T]he claim presented in the present case was not based on alleged fraud on the FDA or alleged violation of any federal laws or regulations. . . .  Thus, while it is undisputed that “fraud on the FDA” claims are preempted by federal law, the present case does not involve “fraud on the FDA” claims.  Instead, the willful and wanton conduct alleged . . . involved . . . investigating side effects and communicating with medical professionals.

Id. at *4 n.6. On one hand, Fussman sheds some light on Irby – since it doesn’t look like the plaintiffs could muster a case under the New Jersey fraud on the FDA exception, even if it wasn’t preempted under McDarby.  On the other hand, since plaintiff was not claiming a violation in Fussman, we’re a bit surprised not to see anything about N.C.G.S. §99B-6(b)(4), which specifically requires consideration of “[t]he extent to which the labeling for a prescription . . . drug approved by the United States Food and Drug Administration conformed to any applicable government . . . standard that was in effect when the product left the control of its manufacturer.” We’ve already posted on the effect of governmental compliance on punitive damages.

In another interesting, and more disturbing, footnote, Fussman essentially nullifies the “reasonable likelihood” statutory (N.C.G.S. §1D-35) standard for risk of harm in punitive damages claims out of existence.  2011 WL 5836928, at *7.  The court holds that no particular percentage likelihood is required for a prima facie case of punitive damages to exist, only that there be an unspecified “connection.” That seems pretty shaky to us, since it would theoretically allow an increased risk from one in a bazillion to two in a bazillion to support a punitive award, notwithstanding the inclusion of a “likelihood” of harm element in the statute.  Nor is the cited precedent particularly persuasive.  Everhart v. O’Charley's Inc., 683 S.E.2d 728, 738 (N.C. App. 2009), discussed an entirely different statute – “related to” as used in N.C.G.S. §1D–15 – and so is not at all on point.  Benedi v. McNeil-P.P.C., Inc., 66 F.3d 1378, 1389 (4th Cir. 1995), was decided under Virginia common law, and thus has no conceivable relevance to the interpretation of a North Carolina statute.

It’s hard to say, given the vagueness of other parts of the Fussman opinion, but the likelihood point looks like a good appellate issue to us.  Maybe we’ll look into it in some future post

The evidentiary rulings in Fussman are more of "where's the beef?"  If the defendant actually did open the door to subsequent remedial measures by asserting them affirmatively, then we can’t fault that ruling.  See 2011 WL 5836928, at *7.

We can’t be as charitable to the court’s hearsay ruling, though.  The facts aren’t particularly important, but we don’t see how use of hearsay “to establish what information [defendant’s] employees had received from [its] consultants, and the actions [those] officials took in response,” id., can possibly be anything other than relying upon such evidence for “the truth” of what it states.  Id. Unless the information is considered to be true, then it’s not capable of proving any of those things.

The decision on admission of “national sales figures” to prove anything “related to” the plaintiff doesn’t make any sense.  How national sales could be relevant to one individual is beyond us.  Id. at *8. We’ve heard of this kind of thing being admitted in punitive damages cases on various reprehensibility grounds, but never on the rationale offered in Fussman.

So within three days of one another, each side won one in Aredia/Zometa.  That dance seems unlikely to end anytime soon.