Wednesday, August 31, 2011

Caronia, The Latest

The moment we saw the Supreme Court’s First Amendment decision in Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011), we knew it had implications for the FDA's suppression of truthful commercial speech concerning off-label uses, and we said so.  Not only that, the dissent in Sorrell caught the FDA angle, too.  Id. at 2678. Only the dissenters didn’t like it – we did.


It appears that the first place that the Sorrell rubber is likely to meet the off-label promotion road is in our old friend, the Caronia case, which has been on appeal in the Second Circuit for what seems like forever.  As readers may recall, Caronia was an FDA “sting” where a doctor, wearing a wire, affirmatively sought out off-label promotion, and (through the manufacturer's representative (Caronia)) drew another doctor (Dr. Gleason) who worked for a drug company, into a discussion of an off-label use.  Both the other doctor, and the rep, who facilitated the conversation, were prosecuted.  Nothing false was said, but the government went ahead anyway, and obtained a conviction.

Caronia had already been argued after Sorrell was decided.  The court (we think) on its own motion asked for additional briefing on Sorrell.  Those briefs were filed this past week.  The government’s brief – arguing in favor of criminal suppression of truthful promotion of off-label use – predictably takes the position that Sorrell doesn’t change anything.  Since we like to gripe, we'll spend most of our time on that one.

According to the government, the speech, even if truthful, wasn't itself banned, but was merely used as “evidence of intent.”  U.S. br. at 1.  Sorell was just more of the same, the government argued, simply another application of the Central Hudson test, and the court should ignore the Supreme Court’s references to “heightened" judicial scrutiny:

Read in this context, the Supreme Court’s references to “heightened judicial scrutiny” do not reflect a decision to abandon intermediate scrutiny in favor of a still more demanding level of judicial review. Instead, the term simply means a more rigorous form of judicial review than the rational-basis review employed by the First Circuit and urged by Vermont. The Court’s opinion makes clear that “heightened scrutiny” encompasses not only strict scrutiny, but intermediate scrutiny as well.
U.S. br. at 5.  The Court’s “heightened” scrutiny reference “singles out,” the government claims, Cincinnati v. Discovery Network, Inc., 507 U.S. 410 (1993), which was a Central Hudson intermediate scrutiny case.  U.S. br. at 5-6.

The only trouble with that last statement is that it’s far less truthful than anything the defendants were prosecuted for in Caronia.  We took a look at Sorrell, and Cincinnati was one of five, count ‘em, five cases cited to support the Court’s “heightened scrutiny” statement.  See Sorrell, 131 S. Ct. at 2664.  The other four, Turner Broadcasting System, Inc. v. FCC, 512 U.S. 622, (1994); United States v. Playboy Entertainment Group, Inc., 529 U.S. 803 (2000); Simon & Schuster, Inc. v. Members of New York State Crime Victims Board, 502 U.S. 105 (1991); and Minneapolis Star & Tribune Co. v. Minnesota Commissioner of Revenue, 460 U.S. 575 (1983), all suffer from the same problem, from the government’s perspective – they don’t even mention Central Hudson.  So, by a Phillies-like 4-1 score, in the actual opinion, strict scrutiny prevailed over intermediate scrutiny.

Next, the government argued that, even if more scrutiny than Central Hudson was required, it still doesn’t matter.

Remember that.  What that means is that, from now on, we're getting the government's position on so-called "strict scrutiny" - which is how restrictions on things such as political/religious speech are evaluated.

The government's positions are positively retro - as in 1984.

Under strict scrutiny, the would-be speech suppressors distinguish between a conviction for “conspiring to promote off-label uses” (supposedly not what happened) and a conviction for “conspiring to distribute [the drug] without adequate directions for use.”  U.S. br. at 6.  That’s a distinction without a difference.  An ancient FDA regulation (substantively unchanged since the 1950s), 21 C.F.R. §201.128, equates one with the other.  Promoting (truthfully or otherwise) off-label automatically changes the “intended use,” and the new “intended use,” since it’s off-label, by definition doesn’t have “adequate directions for use.”   The government's position seems uncomfortably close to an argument that "conspiring" to advocate, say, medicinal marijuana, could be equated, through regulatory hocus-pocus, to selling pot.

Building on its distinction without a difference, the government tries to describe the “adequate directions for use” language as creating some sort of “disclosure statute.”  U.S. br. at 7.  What would the government have these defendants disclose about off-label use?  Somehow, we don’t think there’s any additional “disclosure” that either defendant could have made that would have kept them out of jail – the more they said, the more they would get into trouble.  The only “disclosure” one can make about off-label use (if one works for an FDA-regulated company) is to say nothing.  Disclosure = silence; love = hate.
In another sleight of hand, the government argues that the prohibition is not “content based” for purposes of strict scrutiny because there is no “official hostility to the manufacturer’s message.”  U.S. br. at 8.  That’s contradicted, we suspect, by every Central Hudson brief the government has ever filed on the question of off-label promotion.  Of course there’s “official hostility” to off-label promotion.  It’s the “substantial government interest” that the government claims is advanced under the Central Hudson test.  The FDA is institutionally opposed to off-label promotion because it believes that to allow such speech (truthful or otherwise) reduces the incentive for companies to get new uses approved by the FDA.  The FDA's entire regime is based on “official hostility.”  Off-label promotion strikes at the FDA’s bureaucratic raison d’être.

Then the government inserts the other foot, claiming that its speech suppression isn’t even “speaker-based.”  U.S. br. at 8.  They put the man in jail, didn’t they?  How more speaker-based can you get?  Supposedly the FDA’s regulations aren’t “limited by their terms” to certain speakers, so they can constitutionally be used to convict particular speakers, even under strict scrutiny.  Id.  The government seems to believe that it can suppress speech all it wants if it does so vaguely enough.  Oh, and if it’s not “speaker based,” how come everybody in the universe not affiliated with a regulated entity (even us, if we wanted) can put their uninformed two cents in on this or that off-label use, but only FDA regulated speakers (probably the most knowledgeable) can’t?  That seems pretty “speaker based” - and dumb - to us.

Next, the government offers the following “distinction” from Sorrell:  “The Vermont law restricted the dissemination of information.  In contrast [the federal act] requires it.”  U.S. br. at 9. When we picked our jaws off the floor, we had to laugh.  These defendants were convicted because they opened their mouths, not because they didn't.  Later (in a different section of its brief), the government even states, “the court did instruct the jury that '[t]he manufacturer, its agents, representatives and employees, are not permitted to promote uses for a drug that have not been cleared by the United States Food and Drug and Administration.'” Id. at 12 (emphasis added).  "Not permitted" sure sounds like a "restriction" on "dissemination" to us.  Arguments like this - that the FDA’s total prohibition (outside of certain narrow categories) of off-label promotion is not a “restriction” on “dissemination” - is the kind of stuff that gives lawyers a bad name.

The government next tries to scare the court by demonizing off-label uses.  They are “unapproved,” “unproven,” and “potentially false.”  U.S. br. at 10.  But not actually false, and doctors engage in off-label use every day.  We don’t know about this particular use, but the government – through Medicare/Medicaid – actually pays for a large number of off-label uses.  The promotion of off-label use is no more unsafe or false (and probably less so) than the promotion of various “dietary supplements” we see us every time we turn on, say, the Weather Channel (which we did a lot recently).

Then, after discussing non-First Amendment issues, the government circles back and goes after off-label use again.  We see more scare tactics – using DES (used off-label to prevent miscarriage) as an example of a harmful off-label use.  U.S. br. at 14-15.  But DES was FDA approved without the “breast cancer” risk ever being discovered (it was before the 1962 FDCA amendments, for one thing).  And, as defense lawyers in prescription drug products liability litigation, we’d be remiss if we didn’t point the number of on-label uses for drugs that the other side alleges cause breast cancer or other potentially fatal injuries.

Certainly, there’s “no assurance” that an off-label use is safe or effective.  U.S. br. at 16.  But every drug on the market was originally an off-label use – before it was approved.  That lack of “assurance” doesn’t make any particular use less safe the day before the FDA approves it, than it was the day after.

Then the government states that the “new and qualitatively more reliable” information generated by FDA clinical trials “would never become available” if manufacturers could promote off-label uses.  U.S. br. at 17. That’s not true, either.  The FDA could easily abandon its speech-based prohibitions and simply mandate that off-label uses attaining some specified threshold of frequency must be submitted to the FDA for approval.  Not only would that be more effective, it would suffer from no constitutional deficiencies.

Finally, the government claims the FDA isn’t criminalizing “speech qua speech” because under the law it has to prove something else as well.  U.S. br. at 20.  What’s that something else that's supposedly sufficient to satisfy strict scrutiny?  Introduction into interstate commerce.  Id. Wow, if that’s all it takes to make any speech ban constitutional, I would hate to be a network broadcaster.

Defendant Caronia also submitted a brief, pursuant to the court’s direction.  Guess what?  We like it better than the government’s brief.  It emphasizes that the government’s parade of horribles simply isn’t implicated where the speech in question is true.  “The “typical” neutral justification for “why commercial speech can be subject to greater governmental regulation than noncommercial speech” is the "concern for fraudulent or misleading statements in commercial transactions.”  Caronia br. at 5.  Sorrell, of course, was all about “truthful” speech.  Id. at 9 (quoting Sorrell, 131 S. Ct. at 2671).

Caronia then argues that the FDA’s suppression of truthful off-label promotion was “content based” and “speaker based” just as was the governmental attempt to restrict on-label detailing in Sorrell.  Any other medical doctor would have been perfectly free to discuss off-label use with a colleague if not affiliated with a drug company.  Caronia br. at 9.  Like the detailers in Sorrell, a company-affiliated physician was within “a narrow class of disfavored speakers.”  Id.  And, like the restriction in Sorrell, it was also viewpoint based.  If either of the defendants had said “don’t do that,” instead of “do that” (assuming that’s what happened), neither would have been criminally prosecuted.  Id. at 9-10.  We’d have hoped that was so obvious it didn’t have to be stated, but apparently it does.  Nobody’s ever been prosecuted either for warning against off-label use (although in the past the FDA has sometimes taken the position, albeit not in court, that warnings are “promotion”) or for simply knowing about it without speaking.

Caronia then equates the banning-too-persuasive speech rationale of Sorrell with off-label promotion, Caronia br. at 10, calling the similarities “striking.”  Id.  We probably wouldn’t go that far, because the FDA bans all off-label promotion, whether it’s persuasive or not, but we do agree fully that what was unconstitutional in Sorrell and the similar problem with the speech ban in Caronia stem from the same root – that pharmaceutical promotion is constitutionally protected speech.  Nor is it just us being biased (which we freely admit to being) – as we mentioned at the beginning of this post, the Sorrell dissenters make the connection, too.  Frankly, we think the off-label ban is worse (as does Caronia, br. at 11), because it’s criminal and because it’s more overtly tied to the content of the information than were the restrictions on use of data in Sorrell.

And this just in - A group called the Medical Information Working Group also filed an amicus brief in Caronia.  We want to get this post done, so as to the substance we'll just say "what they said."  The MIWG brief is, in fact, closer to our First Amendment position than either of the parties' briefs, even Caronia's.  What might be even more significant than the legal argumentsit makes, is the makeup of the MIWG - eleven major pharmaceutical companies.  Finally, the big boys have had enough and are getting into the ring.  Rather than let their rights be determined in appeals of criminal prosecutions selected by the government, we're hoping to see big pharma pick the First Amendment playing fields from here on out.

Anyway, let's not forget that the Supreme Court in Sorrell resolved a First Amendment circuit split – affirming a pro-First Amendment ruling by the Second Circuit.  It’s not lost on us that Caronia is also in the Second Circuit.  We’re hoping that the Second Circuit, having received the Supreme Court’s good-jurisprudence seal of approval in Sorrell, sees fit to build on its First Amendment precedent in this area by reversing the conviction and holding unconstitutional the FDA’s outright suppression of truthful promotion of off-label uses.

Finally, thanks to Rich Samp of WLF and attorneys at Ropes & Gray (representing MIWG) for providing us copies of the Caronia briefing - since PACER inexplicably doesn't include most appellate briefing.

Monday, August 29, 2011

Sixth Circuit Aredia/Zometa Triple Play (Or: Goodnight Irene)

The problem with signing up for the "triple play" with your media provider is that when something like, say, a hurricane, knocks out the cable, you lose your television and your internet and your phone. Luckily, before Al Gore's invention abandoned us, we had printed out three opinions from the United States Court of Appeals for the Sixth Circuit affirming rulings in the defendant's favor in five Aredia/Zometa cases. Those opinions didn't exactly make up for missing this week's Curb Your Enthusiasm and Breaking Bad, but they gave us something to do while the winds roared outside like runaway freight trains. And, anyway, why not start the week out with good, good, good news?


In Patterson v. NPC, the Sixth Circuit affirmed the granting of a motion for judgment on the pleadings in a case in which the complaint did not "plausibly allege" that the plaintiff received name-brand Aredia. What the plaintiff alleged was that she was infused with "Aredia and/or generic Aredia (pamidronate)."

That "and/or" turns out to be fatal. What the "or" part in particular means is that it is just as plausible that the plaintiff did not receive the product made by the defendant as that she did. The complaint "fails to allege anything more than a mere possibility that she received Aredia infusions and, therefore, does not meet the requirements of Twombly and Iqbal." The appeals court further held that the district court did not abuse its discretion in denying plaintiff the right to take discovery. TwIqbal does not permit a plaintiff to take discovery to cure a pleading defect. The court also held that plaintiff could not rely upon evidence outside of the pleading because she failed to request that the defendant's motion on the pleadings be converted into a summary judgment motion. Finally, the district court did not abuse its discretion in denying leave to amend because the plaintiff's request "was not sufficiently particular" and the plaintiff was not entitled to what would amount to "an advisory opinion."

In Anderson, Melau, and Thomas v. NPC, the Sixth Circuit affirmed grants of summary judgment in the three cases. In all three cases the plaintiffs had no retained experts on the subject of specific causation, i.e., did Aredia and/or Zometa cause them to develop osteonecrosis of the jaw. Instead, they sought to rely upon the testimony of treating physicians to meet this burden. The district court held that none of these treating physicians was qualified to opine on this issue. On appeal, the Sixth Circuit affirmed, holding that the district court had not abused its discretion in excluding these witnesses on the issue of causation.

To begin with, the treaters disavowed expertise on the subject at issue. We all know that whenever we depose a purported expert, the first part of the deposition is collecting the list of "You're not an expert in ____." Doctors are especially modest and prone to disavow expertise. A GP will quickly admit that he or she is not an expert in, for example, oncology, even if he or she got an A in that class at med school and currently deals with those issues frequently. A doctor might think that "expert" means board-certified. Of course, an expert's idea of expertise might not square with the law's definition or, more importantly, the judge's definition. Some judges think that someone is an expert if they know more about something than the judge does. Then again, there are professional testifying experts who know how to play the game and never-ever disavow expertise.

We remember a plaintiff-expert who was a professor of marketing and would opine that the defendant's advertising was misleading. He would also try to opine on medical causation. Or anything else. If you deposed this fellow and asked if he was an expert in medical causation, he'd say something like, "Well, I am not a medical doctor. But in the course of working on this case I've acquired education and experience in that area and I think I know many things that would be very helpful for the jury." And then he would grin. He knew how to play the game. But the Sixth Circuit's opinion says that the expert's own opinion of his or her expertise is not dispositive. The court looked past the purported experts' disavowal of expertise on the subject at issue, and concluded that the plaintiffs had not met their burden to show that the treaters possessed the requisite qualifications to opine about causation. So it turns out that the non-experts in the case were actually correct in opining that they were not experts. Good for them. And now to cut to the chase: because the plaintiffs lacked causation evidence, summary judgment was properly granted.

In Emerson v. NPC, the Sixth Circuit affirmed a grant of summary judgment based upon a statutory presumption created by Florida law. Florida has enacted a government-rules presumption that, as applied in this case, means that Aredia and Zometa were not defectively dangerous because they were FDA approved. The parties agreed that the presumption applied, and the primary argument raised by the plaintiff to overcome this presumption was that the defendant had defrauded the FDA. Oops. All together now: Buckman preemption. Buh-bye.

The other assertions that plaintiff made in an attempt to overcome this presumption lacked particularity and incorporated all the pleadings in the MDL. As you can imagine, that is a massive volume of documents. The Sixth Circuit held that the district court was not required to do the work of plaintiff's counsel and perform a detailed review of the record. That's the lawyer's job. Trying to lateral that job over to the judges will not work. Indeed, it might even tick them off a bit.

(Just like we'll be ticked off if the cable is still out when we get home tonight. If we miss Weeds, in addition to missing Curb and Breaking Bad already, that will be the worst sort of triple play.)


Congrats and a tip of the cyber hat to Joe Hollingsworth for bringing these excellent results to our attention.

Friday, August 26, 2011

T for Texas

A couple of Texas Supreme Court developments of interest.  (1) the court reversed the adverse Vioxx decision in Garza - holding that the plaintiffs did not provide sufficient epidemiological evidence in a low dose case.  A copy of the opinion, which requires two epidemiological studies showing a relative risk of 2 or more, is available here.

We've blogged before about the adverse Centocor, Inc. v. Hamilton, 310 S.W.3d 476 (Tex. App. 2010), decision allowing a direct-to-consumer exception to the learned intermediary rule - and made it #4 on our botton-ten worst decisions for 2010.  Bexis also wrote an amicus brief in the case.  Well, today's order list (look for "cases granted") includes the Texas Supreme Court's grant of the long-pending appeal in Hamilton.  That's a very good sign for getting rid of the only non-New Jersey decision allowing a DTC exception.

Big-Deal Third Circuit Medical Monitoring Case

The Third Circuit has decided Gates v. Rohm & Haas Co., No. 10-2108, slip op. (3d Cir. Aug. 25, 2011).  Although not a pharmaceutical case, it's something our readers would want to know about.  Gates was decided under Pennsylvania law - somewhat bizarre because the contamination occurred in Illinois.  It pretty much kills medical monitoring class actions except possibly in single-event contamination episodes - and thus takes medical monitoring class actions effectively off the table in pharma mass tort actions.  The court refuses to allow plaintiffs to use statistical analyses to gloss over individual differences in terms of length, amount, and seriousness of exposure.
Plaintiffs cannot substitute evidence of exposure of actual class members with evidence of hypothetical, composite persons in order to gain class certification. . . .  The evidence here is not “common” because it is not shared by all (possibly even most) individuals in the class. Averages or community-wide estimations would not be probative of any individual‟s claim because any one class member may have an exposure level well above or below the average.  Attempts to meet the burden of proof using modeling and assumptions that do not reflect the individual characteristics of class members have been met with skepticism.
Slip op. at 20-21 (citations omitted).  Also, Gates refuses to apply prophylactic government regulatory exposure standards to civil litigation:
Although the positions of regulatory policymakers are relevant, their risk assessments are not necessarily conclusive in determining what risk exposure presents to specified individuals.  Thus, plaintiffs could not carry their burden of proof for a class of specific persons simply by citing regulatory standards for the population as a whole.
Id. at 25-26 (numerous citations omitted)

The court "questions" but does not decide whether medical monitoring could ever be a Rule 23(b)(2) class after the Wal-Mart. decision.  Slip op. at 15.  The court goes on to affirm denial of class certification under (b)(2), (b)(3), and (c)(4).  The court adopts the Principles of Aggregate Litigation for (c)(4), and affirms the court's finding that medical monitoring intertwines common and individual issues so that there are no "joints" at which to cut.  Slip op. at 35-37.  Denial of certification of a property damage class was also affirmed.  Slip op. at 31-34.

If you defend medical monitoring cases, whether in pharmaceutical cases or otherwise, you'll like Gates.

The Long And Weinstein Road To Fraudulent Joinder

We’d thought, because that’s what we’d seen, that subject-matter jurisdiction/fraudulent joinder issues in would-be diversity cases in federal court are to be decided early in the litigation.  Turns out that’s not necessarily so – at least according to the Second Circuit’s recent decision in a Zyprexa case, Brown v. Eli Lilly & Co., ___ F.3d ___, 2011 WL 3625105, slip op. (2d Cir. Aug. 18, 2011).


Brown was originally filed in Mississippi state court, and the plaintiff purported to bring negligent discharge claims against two local hospitals – along with the usual Zyprexa allegations – in order to destroy diversity and keep the case out of federal court.

The procedural posture (how the case got where it was) can only be described as “convoluted.”

Brown was originally filed in Mississippi state court in October, 2007.  Before removal, both hospitals filed dispositive motions in state court on statutory issues unique to:  (1) malpractice claims, and (2) Mississippi community hospitals.

Brown was removed to federal court in January, 2008.  That's more than 30 days after suit was filed, which is usually a no-no, but apparently the plaintiff didn’t notice, so timeliness of removal was waived.  Fraudulent joinder of the hospitals was alleged, tracking the hospitals’ pending motions.

A couple of months later, in rather leisurely fashion, the plaintiff moved to remand.

Later, in August, 2008, the MDL got involved and the case was transferred to the Zyprexa MDL – with all of the various motions still pending (nobody – plaintiff, defendants, or the court – seemed to have pressed things much during this seven-month period).

The Zyprexa MDL judge, of course, is Hon. Jack Weinberg, who rarely does things the same way as any other judge.  All these preliminaries are recounted at 2011 WL 3625105, *2-3.

In October, 2008, Judge Weinberg acted on the motion for remand.  One hospital was indubitably fraudulently joined, but as to the other the facts were unclear.  2011 WL 3625105, at *3.  Most judges would have granted remand in that situation, holding that there was at least a “plausible” basis for a claim – but not Judge Weinstein.  Instead, he ordered jurisdictional discovery, and ruled:

Upon completion of discovery, [the defendant hospital] may renew its motion for summary judgment and [defendant drug manufacturer] may renew its motion to declare joinder of [defendant hospital] fraudulent for removal purposes.
Id. at *3 (quoting district court order).

That’s quite unusual, but unusual is not the same as error.

Here’s what happened next:

In November, 2008, Judge Weinstein granted summary judgment in favor of the non-community hospital, on grounds of the statute of limitations and failure to comply with expert certification requirements.  2011 WL 3625105, at *4.  That judgment was certified (Rule 54(b)) as a final, appealable order in January, 2009.  Plaintiff appealed, but when the sufficiency of the certification was questioned, withdrew the appeal by stipulation a few months later.  Id.  The stipulation, entered by the Second Circuit clerk, purported to allow a later appeal, once the entire case had been disposed of.  Id.

In that sentence, as will be seen, the operative word is "purported."

Meanwhile, back at the Weinstein ranch, the other hospital completed discovery and renewed its motion to dismiss. The court ruled in April 2009 that the plaintiff didn’t have the right kind of expert required by the relevant Mississippi statute.  2011 WL 3625105, at *5.  In the same order, Judge Weinstein ruled that, in light of its grant of the other hospital’s motion, joinder was fraudulent as to all non-diverse defendants, and the case against the diverse drug manufacturer properly remained in federal court.  Id.

The judgment against this second hospital was also certified as final on May 29, 2011.  Plaintiff appealed that one on August 5, 2009 – more than 30 days later – another no-no.  Id.

In that appeal, Plaintiff ostensibly appealed against both hospitals, but since the order in question involved only the second one, the appeal as to the first hospital was more or less voluntarily dismissed.  Plaintiff had blown the appeal deadline against the second hospital, so that appeal was also dismissed.  All this occurred in December, 2009.  Brown, 2011 WL 3625105, at *5-6.

Meanwhile, back at the Weinstein ranch, Lilly (the pharmaceutical defendant) moved for summary judgment because, once again, the plaintiff blew a deadline – this time for the submission of a case-specific expert.  Judge Weinstein eventually granted that motion, on a date not stated.  Plaintiff appealed again, this time managing to do so in a timely fashion, and “purported to appeal every Order and Judgment entered in favor” of any and all the defendants.  Id. at *7.

Again, the operative word is "purported."

Thus, the Second Circuit was forced to sort out a procedural morass.

First, the appellate court held that the plaintiff's procedural missteps cost him both of his appeals against the hospitals. Those orders had both been certified as final appealable orders.  The appeal as to the second hospital was too late – filed beyond the 30-day window.  That’s open and shut.  Brown, 2011 WL 3625105, at *7.  The earlier appeal as to the first hospital, however, had been withdrawn, pursuant to a stipulation entered by the clerk, supposedly preserving later appellate rights. Oops.  Too bad, the clerk doesn’t have that power:

Apparently assuming that the judgment was a nullity, an incorrect assumption, the parties withdrew the appeal. . . .  Until a panel of this Court determines otherwise, a judgment such as the one subject of the stipulation, reciting that there is no just reason for delay and certifying final judgment pursuant to Rule 54(b), is final for all purposes.  Accordingly, the certified judgment in favor of [the first hospital] . . . stands as a final judgment and, the appeal from it having been voluntarily dismissed, the [current] Notice of Appeal . . . is untimely, and we are without jurisdiction.
Id. at *8.  Ouch.  Even we feel a little sorry for the plaintiff on that one, since the error was as much the clerk's as anyone's.  Subsidiary moral of story:  don’t rely on a court clerk’s say-so in agreeing to dismiss an appeal.  Until the court says a Rule 54(b) judgment is not properly appealable, assume it is.

That left the pharmaceutical defendant, and the far more interesting issue of how fraudulent joinder is to be determined.  Can the trial court order discovery, extensive briefing, and only then decide the question?  The Second Circuit said yes – so if you’ve got a District Judge that’s not a knee-jerk remander, you can litigate the merits of fraudulent joinder in depth.  The jurisdictional “defect” (if that's what it is) is curable.

[I]f a jurisdictional defect exists at some time prior to a district court's entry of judgment, the court's judgment is still valid if the jurisdictional defect is cured before final judgment is entered. . . .  [A] district court’s error in failing to remand an improperly removed case [is] not fatal to the ensuing adjudication where federal jurisdiction existed when judgment was entered.
Brown, 2011 WL 3625105, at 9.

Thus, a District Judge, faced with a knotty and fact-bound issue of fraudulent joinder, can keep the case, order discovery and briefing, and conclude months or years later that the plaintiff’s claim was bogus – thereby curing any initial jurisdictional defect.  Even if “complete diversity [is] lacking,” when “the non-diverse defendant had been dismissed with prejudice from the action before entry of judgment,” then diversity is properly created and the court had jurisdiction to decide the entire case.  Id.

While it is true that the existence of federal subject matter jurisdiction over an action removed from state court to federal court is normally to be determined as of the time of removal, the critical issue is whether there was complete diversity at any time before the entry of judgment.  Although the better practice is to verify jurisdiction in a diversity action early on, especially where complex issues of state law are presented, the elimination of non-diverse defendants prior to judgment saves the action from dismissal for lack of jurisdiction.
Id. at *10 (emphasis added).

Then, in a yawner, Brown affirmed dismissal of the pharmaceutical claims due to the plaintiff’s failure to name an expert.  2011 WL 3625105, at *10-11

We’re sure that, to non-lawyers (any who managed to read this entire post), this whole discussion seems arcane and technical – and we don’t deny it.  To lawyers, and courts, however, rules are important.  Sometimes, as here, they provide their own means of winning cases – particularly when one of the parties is inattentive and/or fails to meet deadlines.

In our product liability/mass tort line of work, we regularly remove cases on grounds of fraudulent joinder.  Thus, to us, and to our fellows in the defense bar, Brown and its jurisdictional rationale are of great interest.  Plaintiffs demanding remand frequently try to stampede district courts to act precipitously and remand at the first suggestion of there being a disputable factual or legal issue.  A lot of judges are only too happy to go along, since remands reduce their caseload.

But not all judges.

If a judge is inclined to give careful thought to a fraudulent joinder removal, and to resolve factual and legal issues, Brown provides the legal framework that allows the court to do so. Just make sure to pick off the non-diverse defendants first, so any inchoate jurisdictional defect is cured before attacking the core, pharmaceutical claims.

Thursday, August 25, 2011

Four More Reasons To Love TwIqbal

Bexis was away on vacation last week.  When he returned, he found four more reasons why we (on the defense side) should love TwIqbal. These four opinions have been duly added to our TwIqbal Cheat Sheet, but they deserve more mention than that:


Maybe An Advisory Opinion – But A Good One

In Leonard v. Medtronic, Inc., 2011 WL 3652311 (N.D. Ga. Aug. 19, 2011), the court TwIqballed everything that conceivably could have been considered a “parallel violation” claim in a PMA medical device case.  A plaintiff can’t get away with a bare allegation that the defendant “did not satisfy the Food and Drug Administration's Pre-Market Approval standards for the devices.”  Id. at *2.  Rather, a plaintiff must “specify [the] particular federal standard the manufacturing process violated” and “state how [defendant] violated that standard.”  Id.

In considering whether the plaintiffs had raised a parallel claim . . . a plaintiff cannot simply incant the magic words that a defendant has violated federal regulations.  Rather, the parallel claims must be specifically stated in the initial pleadings and the plaintiff must allege that the defendant violated a particular federal specification concerning the device at issue.  To properly allege parallel claims, the complaint must further set forth facts pointing to specific [pre-market approval] requirements that have been violated.  In short, a bare allegation, devoid of factual detail, that [defendant] did not satisfy the FDA’s Pre-Market Approval standards for the device is insufficient to satisfy the requisite elements of a parallel claim.
Id. at *5.  That's an excellent result in and of itself, but there's more.

Causation must also be pleaded – with facts establishing how the defendant’s “alleged noncompliance with the FDA premarket approval standards caused [plaintiff] harm.”  Leonard, 2011 WL 3652311, at *2; see id. at *6 (collecting causation cases and criticizing Hofts v. Howmedica Osteonics Corp., 597 F.Supp.2d 830, 840–41 (S.D. Ind. 2009)).  The plaintiff in Leonard needed a lot more than the boilerplate he pleaded:

Once the complaint’s conclusory statements and formulaic recitations are excluded, the terse factual allegations contained in the complaint do not satisfy Supreme Court standards. . . .  There is no allegation that the [device] improperly fired during the [alleged] incident or that the [it] injured [the decedent] at that time. In fact, the complaint never alleges that [the device] malfunctioned at any time.  Although the complaint alleges that [decedent] died as a result of [the device], the complaint fails to disclose when [he] died, why he died, or how his death in any way relates to [the device] or [the defendant’s] actions.

Id.

Nonetheless, because the plaintiff sought to file an amended complaint, the court denied the defendant’s motion to dismiss without prejudice.  Id. at *12.  It's a sort of strange way of winning by losing.  If the plaintiff’s amendment doesn’t meet the TwIqbal standards laid out by the court, we expect to see Leonard dismissed.


TwIqbal And Judicial Notice, Perfect Together

Another goodie is Salvio v. Amgen, Inc., No. 2:11-cv-00553, slip op. (W.D. Pa. Aug. 18, 2011), which TwIqballed a wrongful death action in a prescription drug case with no preemption overtones.  Of most interest is Salvio’s treatment of the plaintiff’s warning claim (the most important allegation in most such cases), because it involved another topic we’ve been watching – judicial notice of publicly available (often FDA) documents.

“To resolve a Fed. R. Civ. P. 12(b)(6) motion, a court may generally consider the allegations in the complaint, along with any exhibits attached to the complaint and matters of public record.”  Salvio, slip op. at 7 (citations omitted).  The plaintiff had referenced the drug’s warnings in the complaint, the defendant helpfully attached the actual package insert to its motion papers, and nobody disputed the authenticity of the document.  Id. at 8.  Thus, “the Court will consider the Package Insert in ruling on Defendants’ motion to dismiss.”  Id.

Boy, did the court consider it.

The plaintiff’s negligence count was the usual “vague laundry list of fifteen (15) generalized alleged breaches of duty.”  Salvio, slip op. at 8.  Pennsylvania follows the learned intermediary rule, id. at 9-10, so in pleading any warning claim, a plaintiff must plead how the alleged warning defect affected the prescribing doctor.  Id. at 9, 11.  The plaintiff didn’t come close to doing this.  In the first place, he didn’t describe the alleged defect at all:

Other than a vague reference that the FDA demanded a “strengthened” black box warning . . ., Plaintiff does not describe the alleged failure-to-warn.  Plaintiff also does not describe the differences between the “black box” warning on the [drug’s] package before and after the FDA’s demand.  Nor does Plaintiff plead sufficient facts about the timing of Decedent’s use of [the drug], the onset of her [injury], or how the alleged distinctions in the warnings would have had a causal effect.
Id. at 10 (emphasis added).  That’s good stuff right there – most complaints suffer similar deficiencies – before we ever get to the package insert.

It turned out that the drug’s warning, even before the alleged black box change, discussed the precise injury that the plaintiff alleged repeatedly, specifically and in bold-faced, capital letters.  Salvio, slip op. at 10-11.  The actual warnings – judicially noticed – “appear[ed] to . . . contradict[]” the boilerplate allegations of inadequate warnings that were in the complaint.  Id. at 11.  Thus, in a case where the package insert actually discusses the plaintiff’s alleged injury, the plaintiff must, at the pleading stage, provide facts that plausibly establish how some warning inadequacy affected the plaintiff’s treatment so as to cause injury:

At a minimum, Plaintiff has failed to plead facts regarding how this warning was not reasonable.  Plaintiff has also failed to plead facts showing that Defendants did not properly discharge their duty by warning Decedents physician through the Package Insert or otherwise.  He has also failed to provide any facts about how the change in the “black box” warning affected her choice to either continue taking [the drug], or stop taking it.  Without these facts, the Plaintiff cannot sufficiently state a cause of action for lack of both breach of duty and causation.  Thus, Plaintiff fails to state a claim for negligent failure-to-warn.
Salvio, slip op. at 11-12.  Thus, TwIqbal’s requirement that plaintiffs plead facts rather than conclusory boilerplate, combined with judicial notice of the actual warnings, allowed the defendant to demolish the warning claim in Salvio at the pleading stage.

Salvio thus holds that, to plead a viable claim, plaintiffs must allege facts addressing the twin issues of adequacy of the warning and warning causation.  Plaintiffs cannot escape Rules 8 and 12 with boilerplate and by omitting the actual warnings.  Rulings such as this will weed out implausible claims (the real purpose of TwIqbal) by requiring plaintiffs actually to investigate their claims a bit before filing.  Shades of Rule 11!

Good plaintiffs’ lawyers can, and will if required, do this, and defendants need to be prepared for the consequences – in particular an increase in ex parte communications between plaintiffs’ counsel and prescribing physicians.  However, with so many bad cases out there, on the whole we can’t be anything but pleased with TwIqbal as a more efficient way of getting rid of them.  Now if we can just get the MDL judges to follow the law….

There’s other good stuff in Salvio, particularly if you practice at all in Pennsylvania (as we do).  (1) There are no recognized claims for failure to test or negligent marketing.  Salvio, slip op. at 8-9.  (2) Plaintiff failed to plead an alternative design in her boilerplate negligent design claim.  Id. at 12 (“baldly stating that there are safer alternatives to [a drug], without providing factual support that they exist, is insufficient to survive a 12(b)(6) motion”).  (3) Pennsylvania doesn’t allow any strict liability claims in prescription medical product liability litigation.  Id. at 13-15.  (4) Pennsylvania doesn’t allow express or implied warranty claims in prescription medical product liability litigation.  Id. at 15-16.  (5) Punitive damages are not available without a viable substantive claim, and in any event, no facts suggesting “outrageous” conduct were pleaded.  Id. at 16-17.  (6) Ditto for wrongful death/survival – there must be a viable substantive claim.  Id. at 17-18.

Finally, plaintiff was granted leave to amend (negligence only) in Salvio, slip op. at 18-19.  A second bite at the apple is more or less a plaintiff’s right at the Rule 12 stage.  We’ll have to see, in light of the judicially noticed warning, if the plaintiff is able to come up with plausible facts that a different warning would have materially changed the physician’s conduct.

TwIqbal Applies To Claims Based Upon Comment K

In Rollins v. Wackenhut Services Inc., ___ F. Supp.2d ___, 2011 WL 3489442, slip op. (D.D.C. Aug. 10, 2011), the plaintiff’s suicide claim was TwIqballed (this one was judgment on the pleadings, but TwIqbal applied, 2011 WL 3489442, at *4).  The first two-thirds of the opinion dealt with the plaintiff’s weird (a negligent hiring claim brought on behalf of the person who was allegedly negligently hired?) claims against the decedent’s employer, but after disposing of those, Rollins turned to the drug-related claims.

After the boilerplate was disregarded, see 2011 WL 3489442, at *9, the court agreed that the drug-related claim in the complaint was “nothing more than that [the decedent] took [the drug] and months later committed suicide.”  Id.  There were no manufacturing or warning (odd) claims pleaded at all:

There are no facts alleged that would appear to relate to manufacturing defects in the [drug] doses taken by [the decedent], and, regarding the failure to warn claim, the Complaint’s allegations state only that [drug] did carry an FDA-mandated “black box warning” regarding suicide risk.
Id. at *10 (emphasis original).  Off-label promotion allegations were disregarded in the absence of any facts suggesting any off-label use in the case.  Id. at 10 & n.8.  So were other promotion-related claims, where no facts tied them to the plaintiff’s particular prescriber.  Id. at 11 n.9.

Presumably because of the black box warning, Rollins seems to have been primarily a design defect case.  That wasn’t properly pleaded either.  “To prevail on a design defect claim, the plaintiff would have to show the risks, costs and benefits of the product in question and alternative designs, and that the magnitude of the danger from the product outweighed the costs of avoiding the danger.”  Rollins, 2011 WL 3489442, at *10 (emphasis added).  The drug was a comment k product, and the complaint failed to plead the elements of a comment k claim:

The Complaint here does not allege that the pharmaceutical defendants failed to properly prepare [the drug] or failed to include proper directions and warnings.  Even if the plaintiff were to argue that Comment k is inapplicable here, the Complaint does not contain any specific allegations to suggest that the risks, costs and benefits of the product in question and alternative designs, and that the magnitude of the danger from the product outweighed the costs of avoiding the danger.  The Complaint does not allege that the risks of [the drug] outweigh its benefits or that there was any equally effective alternative design or manner of increasing the safety of the product.  Indeed, the Complaint does not attempt to identify what about [the drug] made it “defective,” other than its “known risks of increasing suicidality in certain patients” – a danger that the plaintiff admits was specifically described in the drug’s FDA-mandated warning materials.
Id. at 11 (emphasis added). Thus, Rollins, like Salvio, stands for the proposition that, if a plaintiff is going to pursue a non-warning claim, that plaintiff had better allege facts establishing a safer alternative design – and not just some different drug.

TwIqbal And The Peripheral Defendant

In Mills v. Bristol-Myers Squibb Co., 2011 WL 3566131, slip op. (D. Ariz., Aug. 11, 2011), the drug-related claim seems to have been a “throw in.”  The “facts” – if they can be called that – pertinent to this claim “are set forth in just one paragraph of the 123 paragraphs” of the complaint.  Mills, 2011 WL 3566131 at *1.  TwIqbal to the rescue.  More than an alleged injury following a prescription is required:

This does not allege how the product itself is defective, it only alleges the harm plaintiff suffered after taking [the drug], which may or may not have been caused by the drug.  Plaintiff should plead more specific facts about how [the drug] is defective and how it was the proximate cause of her particular injury.
Id. at *2. The plaintiff’s warning claim was particularly deficient:

As for the failure to warn claim, plaintiff must show that the product was defective because it contained an inadequate warning.  Plaintiff does not plead any facts about what the [drug] label said or how it was deficient.  Moreover, the warning did describe [the risk the plaintiff claimed].
Id. at *3.  As in Salvio, the court took judicial notice of the actual package insert.  Id. at *3 n.2 (“[w]e may consider the [drug] label attached as an exhibit to defendants’ motion to dismiss, because it is a matter of public record”).

In addition:  (1) the terms of any express warranty weren’t pleaded at all.  Mills, 2011 WL 3566131, at *3 n.3.  (2) “Outrageous” conduct sufficient to plead emotional distress wasn’t pleaded because the nature of the allegedly “withheld” information wasn’t stated.  Id.  (3) If plaintiff wants to amend, she must present an amended complaint.  Id.

* * * *

That’s four – count ‘em, four – excellent TwIqbal decisions in little over a week.  As TwIqbal discusses, the early dismissal of weak claims is essential to prevent defendants from being forced to settle lousy claims simply due to the expense of discovery.  While some of these plaintiffs might come back with something plausible, we doubt they all will.  It’s easy to plead boilerplate, and much harder to plead plausible facts – especially in cases (Salvio, Rollins, and Mills) where the package insert specifically mentions the alleged risk, or in cases (Leonard) where preemption limits the types of available claims.  In such cases, defendants would be well-advised to hold plaintiffs to their pleading obligations under TwIqbal, and to employ judicial notice to get undisputed facts that the plaintiffs would rather ignore before the court.

Wednesday, August 24, 2011

Screwy

Bone screws.  Yeah, we’d have to say we know a bit about them.  And Pennsylvania law – we know something about that as well.  Put those two together, and that’s why the Pennsylvania Superior Court’s recent decision in Wiggins v. Synthes (U.S.A.), ___ A.3d ___, 2011 WL 3524286 (Pa. Super. Aug. 12, 2011), just seems screwy to us.  Wiggins affirmed a significant jury verdict against the manufacturer of some bone screws that, when used in the hip joint, broke when there was a non-union (that is, adjacent bones were supposed to heal and knit together, but didn't).


 
Neither of the Superior Court’s two most critical medical device product liability decisions is even cited in the Wiggins opinion.  Those are:  Creazzo v. Medtronic, Inc., 903 A.2d 24 (Pa. Super. 2006), and Schindler v. Sofamor, Inc., 774 A.2d 765, 771 (Pa. Super. 2001) (yup, Bexis and Michelle did that one).

 
Creazzo is important because it holds that the Pennsylvania Supreme Court’s long-standing restrictions on the causes of action applicable to prescription drugs also apply to prescription medical devices.  Specifically:

 
[Plaintiffs] challenge the trial court's determination that their strict liability claim is barred by Restatement 2d of Torts section 402A, comment k. . . .  [T]he trial court applied this section to the [medical device], citing our Supreme Court's decision in Hahn v. Richter, 543 Pa. 558, 673 A.2d 888, 890-91 (1996), in which the high court adopted comment k, to conclude that strict liability could not be applied to prescription drugs where adequate warnings of the drugs’ potential risks had been provided.  In applying comment k here, the trial court reasoned that given the potential utility of [medical devices], no significant distinction can be drawn between the device and the drug upon which the Supreme Court based its decision in Hahn.  The court concluded accordingly that strict liability could not be a basis for liability in this case.  [Plaintiffs] contend that the trial court misconstrued Hahn, and that comment k does not apply to medical devices because the comment text does not mention them.  They cite no authority, however, for so restrictive an interpretation either of comment k or of Hahn, nor do they provide significant analysis of the language they seek to apply.  We find no reason why the same rational applicable to prescription drugs may not be applied to medical devices.
903 A.3d 30-31 (various citations omitted) (emphasis added).

 
So our first issue with Wiggins is why, in the first place, was the Superior Court even applying “strict liability” – and specifically the strict liability “malfunction theory,” 2011 WL 3524286, at *2 – in a case involving a prescription medical device (which all implantable bone screws are) governed by Creazzo?  Either the Superior Court ignored the controlling (prior Superior Court panel decisions in Pennsylvania are binding on subsequent panels) Creazzo precedent (not altogether implausible), or somebody on the defense side inexplicably decided to let the case go forward in strict liability.  Big mistake, if that's what happened.

 
Then there’s the Schindler case, which preceded Creazzo and thus was litigated under strict liability.  Schindler rejected the proposition that the “intended use” (which limits the scope of strict liability in Pennsylvania) of internal fixation devices (what bone screws are) was to hold bones together until they grew together (“union”), no matter how long that might be – even though some plaintiff-side expert so opined.  As to that point, Schindler held as a matter of law:

 
Determining the product’s intended purpose is critical to the court’s legal conclusions about whether the product can be deemed defective. . . .  [T]he intended use of a product is a conclusion of law, to be decided by the trial court.  In other words, the trial court is not bound by any party’s legal conclusions as to the intended purpose of a product, even if those conclusions are couched as averments of fact or presented as expert evidence.  To hold otherwise would force trial courts (and reviewing courts) to accept unrealistic, generalized, or distorted views of a product’s purpose simply because they are presented as factual evidence.
774 A.2d at 773 (emphasis added).  An inescapable fact of life where metallic implants are concerned is that, when a patient’s bones do not fuse together as expected, the metal will suffer fatigue from the body's repeated stress on it and eventually break.  The more fatigue, the faster the break.  The two most fatigue-prone areas of the body are the lower spine, and the hip – since they not only support the body’s full weight, but also anchor the biggest muscles in the body, which allow us to sit up, and to stand upright.

 
Thus Schindler recognized that the “intended use” of such a device – which determines the permissible scope of strict liability – cannot be to last, hell or high water, until fusion is achieved:

 
All parties agree that the [device] is designed to stabilize the spine “until” fusion takes place.  It is also undisputed that the [devices] generally do stay in place forever if fusion takes place.  Appellants would convert these statements of fact into a conclusion of law that the [device] is defective if it breaks before fusion takes place. . . . The trial court concluded that the [device] was never intended to last indefinitely in the absence of fusion. . . .  We see no error of law in this statement of the [device’s] intended purpose.  [Plaintiffs] presented no evidence that the [device] was intended to stabilize the spine indefinitely in the case of [non-union]. . . .  Based on the trial court’s appropriately-limited statement of the [device’s] purpose. . ., we see no error in the court’s conclusion that the product was not unreasonably dangerous as a matter of law.  JNOV was therefore appropriate.
774 A.2d at 774-75 (emphasis added).

 
So let's compare Schindler’s legal conclusions about implanted medical devices “never intended to last indefinitely in the absence of fusion” with what went on in Wiggins.  One difference is that the broken hip screws in Wiggins were discarded by the explanting physicians, so they could not be tested.  2011 WL 3524286, at *1.  Because of the erroneous (but unchallenged) assertion of strict liability in Wiggins, plaintiffs were allowed to proceed on the strict liability “malfunction theory” where defect (and causation, and defect at sale) were all “inferred” from the purported malfunction – the breaking of the screws.  Id. at *2.

 
Essentially, the court allowed the mere fact of the device breaking to suffice as a defect.  There’s quite a bit of precedent, which we discussed in our “Them’s the Breaks” post, that such reasoning is wrong – for the same reasons recognized in Schindler.  But since Wiggins didn’t even address it's prior decision in Schindler, it could hardly be expected to respond to precedent from other courts and other states.

 
Precisely as Schindler held courts shouldn’t do, Wiggins treated expert “opinions” that the screws should not break until whenever fusion occurs (if at all) as a matter of “sufficiency of the evidence.”  Here’s what the plaintiffs’ experts opined in Wiggins:
  • “[W]e see in this particular case is those screws broke before [the hip healed] and, therefore, it was ineffective in doing its job.”  2011 WL 3524286, at *4.
  • When we put an internal device. . ., what we’re saying is that – whatever we put in has to hold it together until the body takes over the job.”  Id. at *5.
  • “[I]f you, therefore, have a situation where the screws break, both of them break under this, when most of the time you only need one to hold, well, until the bone heals, what else can I infer other than that, that there was a defect in the screws?”  Id.
  • “[Plaintiffs’ expert] testified that the screws were supposed to keep the corrected hip in ‘position until the bone heals.’”  Id.
  • “[T]he failure was that the bone . . . did not unite before the screws broke."  Id. at *7.

 (Emphasis added throughout).

 
This testimony is no different to that rejected as a matter of law in Schindler:  that medical devices are somehow defective/ineffective/whatever simply because they can break before/don't last "until" fusion occurs. Nonetheless, without even citing the dead on-point (broken medical device; judgment n.o.v.), controlling (see above) Schindler decision, Wiggins concluded that the plaintiff had made out a case.  “[T]here was sufficient expert testimony to establish that the surgical screws malfunctioned, and thus, were defective.”  2011 WL 3524286, at *5.

 
That’s screwy.

 
The best we can say about Wiggins is that it’s unlikely to be repeated – as long as other defendants assert Creazzo and don’t allow other plaintiffs to get away with using strict liability theories in prescription medical device cases in Pennsylvania.

Tuesday, August 23, 2011

One and a Half Learned Intermediary Victories

            Not every decision we bring you is a quadruple scoop chocolate peanut butter sundae dripping in hot fudge sitting atop an extra fudgy brownie (OK, maybe we shouldn’t be blogging with the Food Network’s “The Best Thing I Ever Ate-Sweets” on in the background).  But sometimes, just a little taste of vanilla satisfies the sweet tooth – and we are always satisfied when a prescription drug case is dismissed based on the learned intermediary doctrine.  Last week, two courts (of which we are aware) rendered decisions regarding the learned intermediary doctrine and while both got the law right, because of the different procedural posture of the two cases, one was a total victory (a scoop of vanilla with whip cream and a cherry on top) and the other – well, let’s just say there is still work to be done (no cherry yet).
            First, the Northern District of Ohio, applying Louisiana law, granted defendant’s motion for summary judgment on plaintiff’s failure to warn claim in James v. Ortho-McNeil Pharmaceutical, Inc., 2011 U.S. Dist. LEXIS 91030 (N.D. Ohio August 12, 2011).  In this case, discovery was complete and the defendant had scored some fantastic deposition testimony from the prescribing physician:
  • He was aware of the risks associated with the drug at issue
  • He had read the package insert and the Dear Healthcare Provider letters (which advised of the risk at issue
  • He told the plaintiff about the risks
  • He would still prescribe the drug to plaintiff today 
James, 2011 U.S. Dist. LEXIS 91030 at *2.   And, while that testimony would have been more than enough to top off any good meal, defendant here got the equivalent of adding a perfect cup of coffee to that already scrumptious dessert.  Plaintiff testified that she “never reads package inserts” and that if she had read this package insert “she would have seen the numerous warnings” but she “would have used the patch in any event because she relied on her doctor’s decision.”  Id. at *3.  Yummy stuff.
            So, it is hardly surprising that the court granted summary judgment citing Louisiana law that “where a prescribing physician stands between the manufacturer and the ultimate user, the manufacturer satisfies its duty to warn by giving adequate warnings to the prescribing physician.”  Id. at *7 (citations omitted).  The plaintiff here most certainly didn’t meet her burden of showing that “a proper warning would have changed the decision of the treating physician; [and] but for the adequate warning, the treating physician would not have used or prescribed the product.”  Id. at *8 (citations and quotation marks omitted).
            So, if James is a complete win -- Mardegan v. Mylan, Inc., 2011 U.S. Dist. LEXIS 89787 (S.D. Fla. August 12, 2011), is more like the defendant is leading at the end of the first quarter – still a lot of game (discovery) left that could go either way (yep, just changed channels to pre-season football). 
            Here, defendant moved to dismiss plaintiffs’ strict liability and negligent misrepresentation claims based on Florida’s learned intermediary doctrine.  Mardegan, 2011 U.S. Dist. LEXIS 89787, at *10.  The court correctly cited to and relied on Florida’s learned intermediary law – “a prescription drug manufacturer’s duty to warn of a drug’s potential risks is directed to the physician rather than the patient.”  Id. at *11 (citations and quotation marks omitted).  In so doing, the court agreed with the defendant that to the extent plaintiff’s strict liability failure to warn claim alleged a failure to warn the ultimate consumer, it must be dismissed.  Id. at *12-13.  Similarly, plaintiff’s allegation that defendant made negligent misrepresentations to the “FDA, Decedent, physicians, pharmacists, as well as the general public,” was both “too broad and under the learned intermediary doctrine Defendants did not have a duty to warn the general public or the Decedent.”  Id. at *13.  The court was unwilling to bar plaintiff’s negligent misrepresentation claim in its entirety, agreeing with other courts that have held that such a claim can survive a motion to dismiss where plaintiff alleges a misrepresentation to her physician and it is the physician’s reliance that is at issue.  Id. at *13-14.
            So, defendant won its motions to dismiss, right?  Why aren’t we doing a celebratory dance in the end zone?  Because the court is allowing plaintiff to amend the complaint to properly allege failure to warn her physician and negligent misrepresentation to her physician.  Id. at *19.  Of course, that means the plaintiff (or her lawyer) should actually have to talk to the prescribing physician in order to obtain the facts necessary to file the necessary amendment.  If the prescriber is as firm as the one in James, maybe there won’t even be an amendment.
            By the way, for sake of completeness, we note that the Mardegan court also dismissed plaintiff’s breach of implied warranty claim for lack of privity, but denied defendant’s motion as to plaintiff’s express warranty claim citing conflicting decisions applying Florida law regarding the necessity of privity to the claim.  Id. at *15-18. 
            We will have to wait and see if the defendant in Mardegan has the same good fortune as the defendant in James.  If they can advance the ball through strong prescriber testimony, maybe we’ll be back to report on a game-ending summary judgment motion – with a cherry on top. 

Monday, August 22, 2011

Nothing for Something

You've probably heard of getting "something for nothing." We all want that, though we're skeptical that it's really possible. After all, there is no such thing as a free lunch. The late, great University of Chicago economist Milton Friedman was famous for saying that. And he was right. If a restaurant is offering free food, it is probably making it up with the drink prices. If we take a client out for lunch, they won't pay for the sandwiches but they are paying by lending us their time and ears. And as the Boss said, "the door's open/but the ride - it ain't free."

How about the opposite? Have you ever heard of getting nothing for something? That doesn't sound good, does it? Why would you pay for something that you could get for free? It doesn't take a University of Chicago scholar to figure out that getting nothing for something is dumb. But it apparently takes a University of Chicago graduate, professor, and Seventh Circuit judge to explain why getting nothing for something means that a class shouldn't be certified.

In Aqua Dots Products Liability Litigation, No. 10-3847 (7th Cir. August 17, 2011), the Seventh Circuit held that class certification was not appropriate for consumers seeking their money back for a defective product when the manufacturer already agreed to give them their money back. The author of the opinion is Judge Frank Easterbrook. For those of us who took Corporations and Securities classes from Professor Easterbrook at the University of Chicago Law School, the opinion offers everything we would expect. Professor Easterbrook was a notoriously tough grader. If you could regurgitate all the black-letter law accurately, that merely brought you up to a C (or at least the equivalent of that in U. of C's crazy grading system). To earn more points, you had to demonstrate a higher understanding of core principles and had to demonstrate depth and creativity. The Aqua Dots opinion displays depth and creativity.

The product at issue was a toy consisting of "colored beads that can be fused into designs when sprayed with water." Unfortunately, the manufacturer used an adhesive that, when ingested, can induce nausea or worse. Given the nature of the product, it was "inevitable" that some of the beads would be eaten by kids. Two kids fell into comas. The manufacturer recalled the product. Money-back requests were honored.

The purported class included purchasers "whose children were not harmed and who did not ask for a refund." The plaintiffs sought a full refund plus punitive damages. The defendant argued that the plaintiffs lacked standing because none of the plaintiffs or their children were physically injured. Nice try, but financial injury creates standing. So the court must address the key issue in this case: class certification.

The district court denied class certification under Fed. R. Civ. P. 23(b)(3), because the class action was not "superior to other available methods for fairly and efficiently adjudicating the controversy." In the eyes of the district court, the defendant's refund program wasn't exactly a form of "adjudication," but the better "policy approach" was to treat it as such and send the plaintiffs to the refund program rather than continue litigation that would needlessly leak money on attorney fees.

The Seventh Circuit granted interlocutory review and affirmed, though on different grounds. Judge Easterbrook agreed with the district court's attempt to "lower the transaction costs of dealing with a defective product." But the text of Rule 23 cannot be mangled in the process. It's clear that Rule 23(b)(3) was drafted with the legal understanding of "adjudication" in mind, and a refund process does not fit the bill.

Then Judge Easterbrook does what brilliant lawyers and judges do: he keeps thinking. After answering the black-letter issue in the negative (refund does not equal "adjudication"), he considers whether another basis exists for denying class certification. And it turns out there is, and it turns out to be a reason that goes to the heart of why the purported class in this case is ridiculous. The plaintiff lawyers were offering their clients nothing for something. The clients (a bit of a fiction for all those absent class members) didn't need no stinkin' class action. They could get their money back without losing a percentage of their recovery to the lawyers.

Rule 23(a)(4) says that a court may certify a class action only if "the representative parties will fairly and adequately protect the interests of the class." But a "representative who proposes that high transaction costs (notice and attorneys' fees) can be incurred at the class members' expense to obtain a refund that already is on offer is not adequately protecting the class members' interests." In fact, the class representatives and their lawyers harbored interests that were antagonistic to the absent class members.

Too many courts dodge the reality of what is really going on in aggregated litigation, and how it is all too often a vehicle for plaintiff lawyers to impose disproportionate settlement pressure on defendants, extract absurd attorneys' fees, and render almost no value to their 'clients.' But Judge Easterbrook (like his colleague Judge Posner) actually seems connected to litigation reality. "The principal effect of class certification, as the district court recognized, would be to induce the defendants to pay the class's lawyers enough to make them go away; effectual relief for consumers is unlikely."

That really does sound like nothing for something. You might ask, what about those punitive damages? Isn't that worth something above and beyond the refund program? But different states will have different laws about the availability of punitive damages in this case. Consequently, a nationwide class action is simply unmanageable. Even apart from variability of state laws, "individual notice would be impossible." No one knows who bought the toys or who had problems with them. The per-buyer costs of notice would easily outstrip the values of the toys. Again, the consumers would end up with nothing. Only the plaintiff lawyers would get something.

Judge Easterbrook's opinion makes sense in concluding that class certification in this case makes no sense. Nor is this judicial policy-making; the words of Rule 23 itself make clear that a class that pursues nothing for something should not be certified. And if we read the opinion with the same creativity with which it was written, we will likely conceive of many other circumstances where 23(a)(4) can be invoked against class certification.


Friday, August 19, 2011

Déjà Vu All Over Again

The goal for the other side in MDL litigation is to file as many complaints as possible and after that do as little work as possible – while waiting around for the almost inevitable settlement, be it large or small.  Thus, MDL plaintiffs want only one-way discovery.  Their side gets to discover the living daylights out of our clients, and drive up our expenses to the maximum extent possible.  But our side doesn’t get anything more than pieces of paper called “questionnaires” or “fact sheets.”


And even there, plaintiffs cheat.  Sometimes it’s just the desire to do as little work as possible; sometimes it’s deliberate, to preserve pathetically weak cases so everyone can feed at the settlement trough.  Either way, the result is the same.  Occasionally, however, there’s a judge who goes behind the Potemkin village of the MDL “fact sheet.”  Judge Bechtle nailed the plaintiffs for phony questionnaires in Bone Screw:

The court finds that [certain plaintiffs’ lawyers] violated Fed. R. Civ. P. 11 to the extent that certain answers provided on the 225 verified questionnaires submitted on behalf of their plaintiff clients had no evidentiary support and were either false or misleading in that a computer-generated “no” appeared in lieu of a truthful answer.  The court further finds that [these lawyers] were negligent and hence violated Fed. R. Civ. P. 37 to the extent that they failed to exercise due care in the manner in which they directed and supervised both their office staff and the implementation of the computer program they knew was to be used in completing said questionnaires, such negligence resulting in widespread false and misleading answers provided on the 225 verified questionnaires submitted in discovery pursuant to court Order.
In re Orthopedic Bone Screw Products Liability Litigation, 1997 WL 704719, at *1 ¶2 (E.D. Pa. July 24, 1997) (imposing over $100,000 in fines and ordering the lawyers to “report” to the court on “how they intend to restructure the servicing of their clientele” so they will provide “professional and competent service”).

Something similar seems to be brewing in the Yasmine/Yaz MDL, where the dismal MDL norm of one-way discovery evidently prevailed up until recently:

[I]n non-bellwether cases, discovery for the defendants has been limited to information provided by the Plaintiff Fact Sheet (“PFS”) submissions and the medical records secured through authorizations that accompany the PFS submissions.  Plaintiffs, on the other hand, have had the benefit of conducting full discovery with regard to the defendants and may conduct any investigation they choose into their own cases.
In re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation, 2011 WL 3035087, at *1 (S.D. Ill. July 25, 2011).  However, the defendants appear to have convinced the court that the plaintiffs have been submitting dross in their fact sheets – as discovery in the relatively few bellwether cases provided the defendants enough of a record to expose those fact sheets for the rubbish that they are:

[I]n bellwether cases core, case-specific discovery (such as taking the depositions of plaintiffs and treating physicians) has revealed that the PFS submissions are often inaccurate and/or incomplete.  For example, [defendant] states that in more than one-third of the cases selected by the parties as potential bellwethers, the PFS submissions had to be amended or supplemented just before, or during, the deposition process because they were incomplete or inaccurate. . . .  [I]f these bellwether cases had not proceeded to more fulsome discovery, the PFS inaccuracies would have remained undetected.  This experience, leads [defendant] to question the value of the information it has gathered via the PFS submissions (and medical record authorizations which are based on information provided in the PFS submissions) in the non-bellwether cases.
Id. at *2.

The defendant’s proof of pervasive fact sheet inaccuracies, like the similar proof submitted in Bone Screw, was apparently quite persuasive.  The court in Yasmin/Yaz has decided to allow non-bellwether discovery of the plaintiffs in 100 more cases.

The PFS deficiencies identified by the defendants raise questions about the credibility of the information that has been obtained.  Considering these deficiencies in conjunction with the parties’ arguments and the critical importance of obtaining accurate information during the discovery process, the Court will allow an expanded core, case-specific discovery program in the oldest 100 non-bellwether cases.  In particular, the Court will allow case-specific depositions of the plaintiffs in these individual cases.
Id. at *3.  If our Bone Screw experience is any guide, we’re pretty sure that the result of exposing the plaintiff’s questionnaires in Yasimine/Yaz to the light of discovery will be to reveal widespread inaccuracies – always in ways detrimental to defendants.

In the Bone Screw litigation, we ended up having full, two-way discovery.  Literally hundreds of treating physicians (not to mention, plaintiffs) were deposed, to devastating effect.  After remand, that full, two-way discovery provided the individual case records that resulted in almost 200 successful summary judgment motions (run a Lexis/Westlaw search for "pedicle screw"/"bone screw" in the 1997-2000 time frame, if you don't believe us), and the eventual settlement being less than a penny on the dollar of the other side’s original demand.

So we’ll be cheering on the Yasmin/Yaz defendants in their efforts to get the discovery necessary to show – as is almost inevitably the case – that the vast majority of the plaintiffs in MDL litigation have cases that are so weak that they can’t stand the kind of scrutiny that would be a defendant’s right if any particular case were filed separately.

Thursday, August 18, 2011

One On One

This is a post about one of our least favorite subjects – punitive damages.  We had to conduct some research recently that we thought we’d share with you.  It has to do with the lowest constitutional limit on punitive damages ratios that the Supreme Court has mentioned.  That occurred in State Farm Mutual Automobile Insurance Co. v. Campbell, 538 U.S. 408 (2003):
The converse is also true, however. When compensatory damages are substantial, then a lesser ratio, perhaps only equal to compensatory damages, can reach the outermost limit of the due process guarantee. The precise award in any case, of course, must be based upon the facts and circumstances of the defendant’s conduct and the harm to the plaintiff.
Id. at 425.  Thus, Campbell established that in cases involving “substantial” damages, there were situations, perhaps many, where no punitive award could exceed the amount of compensatory damages, depending upon case specific facts, including “harm to the plaintiff.”  In that respect, Campbell must have been referring to something about the harm other than than the mere amount – because that amount must, by definition, already be “substantial.”

The Court then elaborated on the one-to-one ratio in a non-constitutional case, Exxon Shipping Co. v. Baker, 554 U.S. 471 (2008), sounding in maritime law and arising out of the infamous Exxon Valdez tanker accident.  There, in determining excessiveness, the Court used the “more promising alternative” of “pegging punitive to compensatory damages using a ratio or maximum multiple.”  Id. at 506.  Looking at the averages for all punitive awards across many courts and a relative long period of time, the court arrived at a one to one ratio as a jurisprudential matter:

[W]e would expect that awards at the median or lower would roughly express jurors’ sense of reasonable penalties in cases with no earmarks of exceptional blameworthiness within the punishable spectrum . . . and cases . . . without the modest economic harm or odds of detection that have opened the door to higher awards.  It also seems fair to suppose that most of the unpredictable outlier cases that call the fairness of the system into question are above the median. . . .  On these assumptions, a median ratio of punitive to compensatory damages of about 0.65:1 probably marks the line near which cases like this one largely should be grouped.  Accordingly, given the need to protect against the possibility . . . of awards that are unpredictable and unnecessary, either for deterrence or for measured retribution, we consider that a 1:1 ratio, which is above the median award, is a fair upper limit in such maritime cases.
Baker, 554 U.S. at 513 (various citations omitted).

Drug/device product liability cases would seem to fit this picture.  Because personal injury is involved, in the worst cases (those involving punitive damages) there is often “substantial” harm measured in terms of large compensatory damage awards.  Likewise, companies making prescription medical products rarely, if ever, act with actual malice.  They don’t want their products to hurt their customers.  They wouldn’t be in business very long if they did.  Rather, it’s usually because they believe in the benefit of their products, that such companies may be slow to credit new risks as they arise.

Lawyers on the other side of the “v.” might disagree, but we have yet to encounter any pharmaceutical or medical device company that deliberately set out to harm anybody.  That kind of activity is almost exclusively the province of individual actors.

For these reasons, we thought our readers might find useful a comprehensive list of all the cases we’ve been able to find where a court held that, constitutionally, punitive damages could not be assessed in an amount greater than a one-to-one ratio.  So here goes.  Because Campbell is based on constitutional law, and because a significant number of these cases are decided under federal, rather than state law, we’ve decided to group the federal cases by circuit.  We've included a short description of the nature of the litigation for each case, as well as the verdict that the court considered "substantial."

  • First CircuitMendez-Matos v. Municipality of Guaynabo, 557 F.3d 36, 56 (1st Cir. 2009) (§1983 and related state claims) ($35,000).
  • Second CircuitDiSorbo v. Hoy, 343 F.3d 172, 189 (2d Cir. 2003) (§1983) ($75,000); Zakre v. Norddeutsche Landesbank Girozentrale, 541 F. Supp.2d 555, 566-67 (S.D.N.Y. 2008) (sex discrimination) ($600,000), modified, 2008 WL 2557420 (June 28, 2008), aff’d, 344 Fed. Appx. 628 (2d Cir. 2009); Thomas v. iStar Financial, Inc., 508 F. Supp.2d 252, 263 (S.D.N.Y. 2007) (race discrimination) ($190,000), aff’d, 629 F.3d 276 (2d Cir. 2010); TVT Records v. Island Def Jam Music Group, 279 F. Supp.2d 413, 461 (S.D.N.Y. 2003) (business torts) (three defendants, $125,000, $25,000,000 & $1,000,000), rev’d on other grounds, 412 F.3d 82 (2d Cir. 2005).
  • Third CircuitJurinko v. Medical Protective Co., 305 Fed. Appx. 13, 28 (3d Cir. 2008) (insurer bad faith) (slightly under $2,000,000).
  • Sixth CircuitMorgan v. New York Life Insurance Co., 559 F.3d 425, 443 (6th Cir. 2009) (age discrimination) ($6,000,000); Bach v. First Union National Bank, 486 F.3d 150, 156 (6th Cir. 2007) (credit reporting and related state-law claims) ($400,000); Cummings, Inc. v. BP Products North America, Inc., 2009 WL 3169463, at *3 (M.D. Tenn. Sept. 30, 2009) (business torts) ($535,000).
  • Eighth CircuitBoerner v. Brown & Williamson Tobacco Co., 394 F.3d 594, 603 (8th Cir. 2005) (product liability) ($5,000,000); Williams v. Conagra Poultry Co., 378 F.3d 790, 799 (8th Cir. 2004) (race discrimination) ($600,000); Kent v. United of Omaha Life Insurance Co., 430 F. Supp.2d 946, 960 (D.S.D. 2006) (deceit, breach of fiduciary duty) ($2,400,000), aff’d in part and rev’d in part on other grounds, 484 F.3d 988 (8th Cir. 2007).
  • Ninth CircuitDawe v. Corrections USA, 2011 WL 1047638, at *3-4 (E.D. Cal. March 18, 2011) (defamation and related torts) ($2,300,000); Paul v. Asbury Automotive Group, LLC, 2009 WL 188592, at *11 (D. Or. Jan. 23, 2009) (race discrimination) (four plaintiffs, $150,000 each); adidas America, Inc. v. Payless Shoesource, Inc., 2008 WL 4279812, at *15-16 (D. Or. Sept. 12, 2008) (trademark infringement) ($15,000,000 – less than one-to-one); Noyes v. Kelly Services, Inc., 2008 WL 2915113, at *13-14 (E.D. Cal. July 25, 2008) (religious discrimination) ($647,000), aff’d, 349 Fed. Appx. 185 (9th Cir. 2009); Keller v. City of Stockton, 2006 WL 2051043, at *13 (E.D. Cal. July 20, 2006) (§1983) ($100,000) (different plaintiff received a 2-1 award); Casumpang v. ILWU, Local 142, 411 F. Supp.2d 1201, 1221-22 (D. Hi. 2005) (First Amendment violation) ($240,000); Ceimo v. General American Life Insurance Co., 2003 WL 25481095, at *2 (D. Ariz. Sept. 17, 2003) (insurer bad faith) ($7,000,000), aff’d, 137 Fed. Appx. 968 (9th Cir. 2005).
  • Tenth CircuitGuidance Endodontics, LLC v. Dentsply International, Inc., ___ F. Supp.2d ___, 2011 WL 2470674, at *22-23 (D.N.M. May 9, 2011) (business torts) ($4,080,000).
  • Eleventh CircuitSlip-N-Slide Records, Inc. v. TVT Records, LLC, 2007 WL 3232274, at *30 (S.D. Fla. Oct. 31, 2007) (business torts) ($2,300,000); Richardson v. Tricom Pictures & Productions, Inc., 334 F. Supp.2d 1303, 1326 (S.D. Fla. 2004) (sexual harassment) ($500,000).
  • ArizonaHudgins v. Southwest Airlines Co., 212 P.3d 810, 830 (Ariz. App. 2009) (false arrest and related torts) (two plaintiffs $500,000 each); Security Title Agency, Inc. v. Pope, 200 P.3d 977, 1001 (Ariz. App. 2008) (breach of fiduciary duty) ($6,100,000).
  • CaliforniaRoby v. McKesson Corp., 219 P.3d 749, 770 (Cal. 2009) (wrongful discharge) ($1,900,000); Walker v. Farmers Insurance Exchange, 63 Cal. Rptr.3d 507, 513 (Cal. App. 2007) (insurer bad faith) ($1,500,000); Jet Source Charter, Inc. v. Doherty, 55 Cal. Rptr.3d 176, 183-84 (Cal. App. 2007) (fraud) ($6,500,000).
  • OhioBurns v. Prudential Securities, Inc., 857 N.E.2d 621, 659-60 (Ohio App. 2006) (investment-related torts) ($6,800,000).
  • PennsylvaniaFulton v. Gavlick, 63 Pa. D. & C. 4th 250, 266-67 (Pa. C.P. 2003) (breach of fiduciary duty, conversion) (2 plaintiffs, $104,000 & $78,000).

Note that there’s already one product liability case (Boerner) on the list.  We’d like to see more.  Actually, that’s not technically true, since we’d rather not see any punitive damages cases involving pharma companies at all, but unfortunately that’s not likely anytime soon.  So until the Rapture (when is that scheduled for this month?), a one-to-one ratio is a more realistic goal to shoot for.

Wednesday, August 17, 2011

Cross-Jurisdictional Tolling Certified

Cross-jurisdictional class action tolling.  Even though Bexis invented the phrase, we hate it.  We’ve lambasted that concept many times on this blog, see here.  Basically:  (1) the law should not reward the filing of meritless class actions by tolling the statute of limitations; (2) lawyers and courts in one jurisdiction should not be allowed to manipulate the statutes of limitations of other jurisdictions; and (3) each state is a sovereign, and should be able to set its own tolling (and other) rules without outside interference.  In fact, we’re so anti-cross-jurisdictional class action tolling that we maintain a scorecard concerning this rather arcane legal topic.


Another peeve that we’ve occasionally petted is the tendency of some courts – particularly in the Second Circuit – to assume that they know more about the law of other states than do those other states’ courts.

Those two threads come together in Casey v. Merck & Co., ___ F.3d ___, 2011 WL 3375104 (2d Cir. Aug. 5, 2011), where for once the Second Circuit decided not to play the “New Yorkers know best” card and instead certified the cross-jurisdictional class action tolling question to the Virginia Supreme Court.

Once again, the issue in dispute goes back to our Bone Screw days – when we first learned to hate cross-jurisdictional class action tolling.  The Bone Screw MDL plaintiffs filed an unsuccessful nation-wide class action (which back then was a lot less futile than personal injury class actions have since become).  Despite losing class certification, tardy Bone Screw plaintiffs around the country still claimed that their states’ statutes of limitations should be considered tolled by the unsuccessful MDL class action.

They lost.

One of the places they lost was in Virginia.  In Wade v. Danek Medical, Inc., 182 F.3d 281 (4th Cir.1999), the federal circuit court with jurisdiction over Virginia took a look at Virginia law and held, essentially, that there was no way that the Virginia Supreme Court would tolerate a bunch of damnyankee class action lawyers from Pennsylvania mucking around with the Old Dominion’s statute of limitations, particularly since Virginia doesn’t even have a state-law equivalent to Rule 23.  Of course Wade didn’t phrase it exactly that way, holding instead:

Having considered these cases – most of which do not discuss the issue in any detail – we conclude that the Virginia Supreme Court would not adopt a cross-jurisdictional equitable tolling rule.  First, and most importantly, the Commonwealth of Virginia simply has no interest, except perhaps out of comity, in furthering the efficiency and economy of the class action procedures of another jurisdiction, whether those of the federal courts or those of another state.  Second, if Virginia were to adopt a cross-jurisdictional tolling rule, Virginia would be faced with a flood of subsequent filings once a class action in another forum is dismissed, as forum-shopping plaintiffs from across the country rush into the Virginia courts to take advantage of its cross-jurisdictional tolling rule, a rule that would be shared by only a few other states. . . .  Third, if Virginia were to allow cross-jurisdictional tolling, it would render the Virginia limitations period effectively dependent on the resolution of claims in other jurisdictions, with the length of the limitations period varying depending on the efficiency (or inefficiency) of courts in those jurisdictions. And Virginia has historically resisted such dependency.
182 F.3d at 287-88 (various citations omitted).

Since Wade, however, some pro-plaintiff lower courts have seized upon an intervening Virginia Supreme Court decision – Welding, Inc. v. Bland County Service Authority, 541 S.E.2d 909 (2001), which had nothing whatever to do with class actions – for the proposition that Virginia would extend its tolling statute to out-of-state federal class actions, notwithstanding the Wade precedent.  See Torkie-Tork v. Wyeth, 739 F. Supp.2d 887, 893-94 (E.D. Va. 2010); Shimari v. CACI International, Inc., 2008 WL 7348184, at *2 (E.D. Va. Nov. 25, 2008).  We think that’s hooey as (1) Virginia does not even allow class actions, except where specifically authorized by statutes, and (2) is a generally conservative place legally (no strict liability; no crashworthiness, things like that).  But those cases are out there, as our scorecard points out.

In the Fosamax MDL, the court followed WadeIn re Fosamax Products Liability Litigation, 694 F. Supp.2d 253, 258 (S.D.N.Y. 2010), and found that a meritless Tennessee class action involving that drug – rejected in the wake of In re Fosamax Products Liability Litigation, 248 F.R.D. 389 (S.D.N.Y. 2008) (asserting medical monitoring, another legal theory Virginia does not recognize) – did not serve to toll the Virginia statute of limitations.

It took more than two years for the court in the Fosamax MDL to get around to denying class certification, so the upshot of the plaintiffs’ argument was that all this out-of-state maneuvering would have more than doubled Virginia’s statute of limitations for every Fosamax plaintiff in that state.

With the opportunity to certify, the Second Circuit punted.  Instead, it has certified the following questions to the Virginia Supreme Court:

(1) Does Virginia law permit equitable tolling of a state statute of limitations due to the pendency of a putative class action in another jurisdiction?

(2) Does Va. Code Ann. § 8.01-229(E)(1) permit tolling of a state statute of limitations due to the pendency of a putative class action in another jurisdiction?
Casey, 2011 WL 3375104, at *8.  That's better than "New Yorkers know best," at least.

As our scorecard (which provides precedent on both sides) demonstrates, cross-jurisdictional class action tolling is a distinct minority rule – particularly in tort cases.  We’re hoping that the Virginia Supreme Court reiterates the state’s conservative approach to tort litigation and follows the majority rule.