Showing posts with label MDL. Show all posts
Showing posts with label MDL. Show all posts

Wednesday, September 26, 2012

Breaking Up is Easy to Do


We all know how easy it is to complain about bad decisions. Right now, sports pundits and fans are holding a gripeathon about the National Football League 's replacement referees. There has been more talk about the officiating mistakes than about the athletic performances. A sense of perspective is in order.  The comparison baseline is not perfection. It is not as if the regular referees got all their calls right. Does anybody remember Ed Hochuli (actually a very good ref who is also a Phoenix attorney) incorrectly calling a deadball?  And who stared at the Steelers-Seahawks Super Bowl in disbelief a couple of years ago, as every call of consequence went against Seattle? Still, there is no denying that the replacement refs have authored an amazing number of egregious errors already in only three weeks of football. The blown call at the end of the Monday night game (it benefitted the Seahawks, so some are saying Karma is at work, though it is hard to see why Karma would hose the Packers) is prompting some fans to call for a boycott. If either Obama or Romney could step up and do something about the referee lockout, he'd probably help his election campaign big time. He would certainly get Wisconsin's electoral votes.



One of the most interesting things about the replacement referee situation is the substitute teacher syndrome. Did you ever have a substitute teacher in elementary school who seemed sort of weak or clueless?  Wouldn't the class end up becoming incredibly disruptive? Even the kids who were ordinarily well-behaved started acting like delinquents. We remember back in seventh grade one of the star students hoodwinking a substitute teacher into thinking that his name was Billy Paul. Billy Paul was an R&B singer .  More specifically, he was a practitioner of  TSOP -The Sound of Philadelphia. Billy Paul’s big hit was "Me and Mrs. Jones." The teacher was puzzled at how the rest of us howled in laughter when she would scream in exasperation, "Billy Paul, get back in your seat!" "Billy Paul, you leave that girl alone!"  After NFL week one, it seemed that many players had sized up the replacement refs as being like bad substitute teachers -- tentative and insecure.  Just like 'Billy Paul,' the players took advantage.  By 'took advantage,' we mean that the players started perpetrating all sorts of mayhem on their opponents.  Things got chippy.  One especially devious Ram delivered a nasty shot to a Redskins receiver after a play was over.  The aggrieved receiver responded by throwing the ball at the offender.   Bad idea.  As so often happens, the ref saw the reaction, not the instigation.  The receiver drew a penalty and backed his team up.  The team's field goal attempt missed.  Game over.    



The substitute teacher syndrome is like the "broken glass" theory of policing. One of the most brilliant minds on governance and policing was James Q. Wilson, who died earlier this year. Some of us were lucky enough to take classes with Wilson, who was a dynamic speaker with an even more dynamic mind.  Some labeled Wilson a neocon, but he was really a policy skeptic.  He was a political scientist who liked to get his fingernails dirty with data.  He wrote about groundbreaking analyses of poverty and bureaucracy.  With all that, he was most famous for his writings on crime.  Wilson was brilliant on that topic, and he managed to make a difference.  Wilson wondered why people commit crimes.  Crime is a disease in the body politic.  It is an odd disease, because it is a product of human choice.  Most people do not choose crime.  Some do, they do so repeatedly, and they betray the social contract.  Wilson found that people are far more likely to make that destructive choice if they are in an environment that welcomes destruction.  If a window was broken in a neighborhood, and was not repaired, that appearance of disorder sent a message that disorder was okay. Crime rates would be higher in such areas. Wilson recommended that cops arrest people for quality-of-life crimes (disorderly conduct, etc.) and help create an appearance of order in the community. That approach, plus a relentless use of statistics (CrimeStat), seemed to play a significant role in reducing crime rates in American cities.  (Yes, we know there are other theories about that as well, including the controversial Freakonomics argument that increasing abortions led to decreasing crime.  We are not touching that one.) 



We wonder whether the substitute teacher or broken glass theory applies to litigation. If courts permit sloppy, absurd practices, they ineluctably invite more. Our home turf, the Philadelphia Court of Common Please, has been taking a beating for its pro-plaintiff, anti-business court system. We do not agree with all of the criticisms, but it is undeniable that when a judge explicitly invites plaintiffs to engage in litigation tourism, when the court as a matter of course makes nutty venue/forum non conveniens rulings, and when it allows plaintiff lawyers to cobble together multi-plaintiff cases that maximize prejudice against corporate defendants -- well, as Wilson showed, chaos begets chaos.  Pretty soon, Philadelphia's City Hall (which houses the Court of Common Pleas civil cases) rang out a clickety-clack of cowboy boots, and if you yelled  "Roll Tide!" in the hallways, you'd probably get at least a couple of high-fives.  Nevertheless, as an article in Monday's Wall Street Journal showed, there's a new sheriff in town.  Judge Herron has implemented many changes in the Philly courts, including a rule against consolidating plaintiffs in tort cases.  That is a welcome reform and it is a big deal.  We get how plaintiffs are supposed to be the master of the complaint, but the plaintiff lawyer is not supposed to be the master of the court docket.  When plaintiff lawyers self-consolidate multiple plaintiffs into a tort action, they create an artificial case with a perfect plaintiff who gets in every piece of corporate conduct and other evidence -- an array of awfulness that would not come in with a single plaintiff.  It stacks the deck and is unfair to defendants.  It is also unfair to the courts.  The consolidated cases are not only a method of beating defendants into settlements, they are also a method of beating the court out of the extra filing fees for separately filing plaintiff.  Courts are noticing all this.



So today's post is not a complaint at all.  Instead, we celebrate how courts are starting to get things right on joinder and severance issues.  Philly has taken a step in the right direction.  Other courts are taking similar steps.  We offer a tip of the cyber cap to Mike Imbroscio for sending us a recent severance victory in the Accutane MDL.  The particular case is called Aranda v. Hoffman-Laroche, Inc., No. 8:12-cv-1426-T-30TBM (M.D. Fla. Sept. 20, 2012), and we have written about it before.  It has, to say the least, a peculiar history.  The case was originally filed on behalf of 69 plaintiffs alleging injuries from Accutane.  It was filed in a state court with a hellholish reputation as bad as Philly.  But after a little fact-checking made clear that the plaintiffs’ effort to stymie diversity was phony, the case ended up in federal court.  Post MDL, the defendant moved to sever the plaintiffs.  In a refreshing and straightforward opinion, the court granted the motion and severed the cases.



First, the plaintiffs’ joinder was flat-out inappropriate under Fed. R. Civ. P. 20(a).  The plaintiffs resided in different states, allegedly ingested Accutane at different times, and were allegedly diagnosed with different adverse reactions to Accutane.  (Note the word "allegedly."  Based on the discovery provided by the plaintiffs, their Accutane use and adverse reactions was by no means established.)    Thus, the plaintiffs' claims did not arise "out of the same transaction, occurrence, or series of transactions or occurrences."  Fed. R. Civ. P. 20(a).  There were different Accutane warnings at different times, which would necessarily have a profound effect on liability issues, and could potentially confuse juries confronted with multiple plaintiffs.  Second, the Aranda court emphasized that "[m]any federal courts hold that product liability cases are generally inappropriate for multi-plaintiff joinder because such cases involve highly individualized facts and '[l]iability, causation, and damages will ... be different with each individual plaintiff.'" Aranda, slip op. at 1, quoting In re Prempro Prods. Liab. Litig., 417 F. Supp. 2d 1048, 1059-60 (E.D. Ark. 2006).  The Aranda court also cites supporting precedent from the Silica, Diet Drug, Baycol, and Rezulin litigations.   Third, the cobbling together of different plaintiffs with different claims and, no matter how much the plaintiff lawyers pretend otherwise, different legal theories, would "likely hamper the orderly, efficient, and expeditious handling of the plaintiffs' claims as the litigation progresses."  Tesfaye Abebe v. Takeda Pharmaceuticals (In re Actos Prod. Liab. Litig.), No. 6:11-md-02299 (W.D. La. May 3, 2012  The motion to sever in Aranda was brought under Rule 21, which relates to misjoinder of parties.  That rule makes clear that severance can be granted "[o]n motion or on its own, the court may at any time, on just terms add or drop a party."  Fed. R. Civ. P. 21.  The Aranda court cited both Rule 21 "and the Court's inherent authority to control its own docket."  Aranda, slip op. at 2.   Fourth, the court ordered that each "severed plaintiff shall also pay a filing fee to the Clerk of the Court."  Id. At 3.  For some plaintiff lawyers, that last bit hurts the most.    

 

The Aranda severance adds to a growing list of courts that are putting a stop to improper mass tort self-consolidations.  As we said earlier, it is easy to complain about bad decisions.  It turns out that it is even easier to praise good ones.       


Wednesday, September 5, 2012

Actos Judge Defends Self (Good), Defends Federal-State Coordination (Great), and Blasts Plaintiff Lawyers (Priceless)

Maybe this falls in the category of "people who live in glass houses..." but we think it is silly for lawyers to insult judges. At least when we rip an opinion, we endeavor to do so on sound doctrinal grounds. Further, when we have the temerity to jump on judicial reasoning, it is for a case where we are not involved. So call us fair-minded, cautious, or plain old chicken, but our inner compass and self of sense preservation tell us not to call our judge an oaf or an ogre. Judges can do a whole lot more to us (and our clients) than we can do to them. Mind you, we are talking about a situation where there actually is a legitimate criticism of a judge. Imagine how doltish one would have to be to call out a judge on specious grounds.




That is what recently happened in the Actos litigation. The federal MDL judge reached out to a New Mexico state court judge to try to coordinate schedules, and for some reason (we will get to that) that made a couple of plaintiff lawyers boiling mad. They wrote a letter to the federal judge accusing her of improper federal interference with the state court, violating comity, ex parte communications, and prejudicing the state court plaintiffs by delaying their case without proper notice. The answer came in the form of a judicial thunderbolt styled as a Memorandum Response in Dunlavey v. Takeda Pharmaceuticals America, No. 6:12-CV-1162, 2012 WL 3715456 (Aug. 23, 2012). It makes for fascinating reading. We like what the judge did, we like what the judge wrote, and we especially like the feeling of schadenfreude that washed all over us.



To begin with, there is absolutely nothing wrong with a federal judge reaching out to coordinate mass proceedings with a state court judge. The whole point of an MDL or any other aggregated proceeding is to increase efficiency. Presumably such efficiency benefits all parties, as well as the judicial system. The judge supplies ample cites from the Manual for Complex Litigation, the Manual for Cooperation between the State and Federal Courts, and many other sources demonstrating that federal-state coordination is "advised, encouraged and welcomed by both the federal and state courts." 2012 WL 3715456 at *2. Clearly, "Cooperation between state and federal judges is not only advised, it is advised often." Id. at *1 (emphasis in original). By contrast, the plaintiffs' argument against federal-state coordination is littered with citations that constitute an exercise in "cherry picking". Id. at *9. (We admit it - it is rich to see that term applied against the side that is always lobbing it at us.)



Most fundamentally, federal-state coordination does not constitute federal interference with state cases. The plaintiffs cite Younger and the Anti-Injunction Act, but nothing like an injunction was at issue here. As the court says, "this Court has not issued an injunction; this Court has not issued a temporary restraining order; this Court has not halted a legitimate state investigation; this Court has not enjoined a state officer - in short, only in the writers' correspondence do these wholly inapplicable, egregious scenarios exist." Id. at *4. Good stuff, right? Here, have some more: "Again, it is without question, any reference to an injunction exists only in the empty rhetoric and wholly unsupported and inapplicable argument of the writers' correspondence." Id. at *5. It is hard for lawyers to employ such vigorous language and make it work. From a judicial pen (or keyboard), it is powerful and terrifying.



We think the judge's ire is well-earned. There is no breach of comity when a federal judge invites a state court to coordinate proceedings. The federal court cannot make the state judge do anything she does not want to do. The Actos federal judge appears to take particular umbrage at the plaintiffs' implication that the state court judge "engaged in judicial misconduct by abdicating her role as a judge of the sovereign state of New Mexico." Id. It turns out that the only thing that that ticks off a judge more than incorrectly attacking that judge is incorrectly attacking a fellow judge. The plaintiffs' accusation against the state court judge is "wholly specious; the facts are nonexistent, and the legal argument is, again, prostituted." Id. at *8. Wow. In any event, if that state judge does something that the plaintiffs think is wrong, the plaintiffs can appeal. Id. at *6. Or do the plaintiffs contend that the federal judge has also assumed control over the state appellate courts?



The reality is that most federal and state judges want to coordinate proceedings. It simply makes sense. Good examples of that abound here in Philadelphia, where our local Court of Common Pleas judges have coordinated with federal judges. Not too long ago there was a joint federal-state hearing on admissibility of expert testimony. The lawyers and witnesses appeared at one hearing in front of the federal and state judges. That saved time and money. It does not mean that the federal court somehow hijacked the state proceedings. Indeed, everyone understood that different standards applied (Daubert in the federal court and Frye or Fraubert in the Pennsylvania state court) and that different rulings might result. Moreover, the state judge is fully free to decline to participate or to arrive at a different substantive ruling. Indeed, sometimes it is the state court judge that opens up the dialogue with the federal judge There is nothing wrong with coordination and everything right with it. The Memorandum Response shows that the plaintiffs' griping is wrong on the law, wrong on the facts, and wrong on policy.



The plaintiffs complained that the federal judge engaged in a forbidden ex parte communication with the state court judge. But ex parte means that a judge talked with one party without letting the other party in on it. No party was involved in the communication at issue. News flash: judges talk. They are allowed to talk. It is beyond silly for the parties to complain about lack of notice. Since when are judges forbidden from picking the brains of their colleagues without alerting the lawyers? As the Actos federal judge points out, both sides were actively involved in all the hearings where the judges made decisions about management of the cases, including scheduling.



The word "specious" repeatedly crops up in the Memorandum Response when referring to the plaintiffs' letter. That might be one of the kinder things the judge says about the plaintiff lawyers. While the plaintiffs lambaste the judge (both the federal and state judges, really) for imaginary ethical improprieties, the federal judge suggests that the plaintiffs are hypocrites of the worst sort. First, the plaintiffs' letter itself "was submitted unsolicited, wholly outside this Court's orders and the Federal Rules of Civil Procedure, and in total contravention to the extensive system set in place by this Court within the MDL for orderly and full interaction with the Court and among parties." Id. at *10. Second, the plaintiffs quoted from In re Palmisano, 70 F.3d 483 (7th Cir. 1995) in accusing the court of an ex parte contact, but the plaintiffs' quote was incomplete. The full quote from Palmisano was that the "federal courts, no less than state courts, forbid ex parte contacts and false accusations that bring the judicial system into disrepute. " 70 F.3d at 487. It was that last part that the plaintiffs omitted, and it was that last part that best describes the plaintiffs' letter.



The plaintiffs' criticism of the MDL judge's effort at federal-state coordination is so wrong-headed, such an obvious misstep, that one has to ask what could have prompted it. The court calls it "an attempt to intimidate or manipulate the involved courts." Id. at *9. If so, it does not look like it worked. We certainly hope so, anyway. Sometimes after a court takes a lawyer to task, the court then bends over backwards to be extra nice to that lawyer so as to show no hard feelings. But there isn't any need for that here. That is especially true when we consider the other likely reasons for the plaintiffs' intemperate, inaccurate letter:



1. The last thing the plaintiffs want is efficiency. They want multiple, inconsistent rulings, which would afford them the chance to forum-shop and then steer future filings to the courts with the most plaintiff-friendly rulings. It is funny how corporate defendants are always accused of trying to make proceedings unwieldy and expensive, turning litigation into a war of attrition. But we have not heard any in-house corporate lawyer talk that way for at least ten years. Companies are under cost-pressure and they hate litigation expenses. We know - we are an expense. Companies insist on cost reduction, not amplification. By contrast, some plaintiff lawyers act as if the best way to force settlement is to drag companies into multiple jurisdictions, to compel scientists and executives to appear for multiple depositions, and to make the whole litigation process a crazy-quilt mess. When judges from multiple jurisdictions try to coordinate schedules to streamline the process, they are derailing a key plaintiff strategy. Plaintiffs might write nasty letters about it. If we wrote anything, it would be a thank-you note.



2. Maybe this is inside baseball and an area where we have less than perfect knowledge, but in some litigations it seems like the most brutal battles are among the various plaintiff lawyers. In an MDL, lead lawyers are appointed. Not surprisingly, those lead lawyers get the most control and, eventually, the most fees. Fees are also affected by a plaintiff lawyer's activity, such as depositions, even if such depositions are pointless or poorly done. If a plaintiff lawyer is not one of the lead lawyers in an MDL, that lawyer might seek to gin up activity in another jurisdiction. It is understandable, but it is not a legitimate reason to prevent federal-state coordination. In such a circumstance, characterizing federal-state coordination as being illegitimate or unethical would not only be wrong and self-destructive, it would be an ugly act of petulance.



In the end, the plaintiffs' goals are irrelevant. What is relevant is that the Actos federal judge's commencement of federal-state coordination was correct, will continue to be correct, and, we hope, will continue to be undeterred.







Tuesday, June 5, 2012

Fraudulent Joinder, TwIqbal & MDLs, Oh My!


            For some reason, when we identify three things in a group, in our heads we hear them to the beat of “lions and tigers and bears, oh my!” from the Wizard of Oz.  It works with lots of things – apples, bananas and pears, oh my; iphones, droids and blackberries, oh my; vanilla, chocolate and strawberry, oh my!  And then that got us thinking about other things that come in threes.  Three strikes and you’re out and three goals in a hat trick.  There were Three Stooges (OK, technically there have been more Stooges, but we won’t go there) and Three Musketeers (again, you can argue with us about  D'Artagnan).    There are three Jonas Brothers and there were three Bee Gees.  Now, we feel like we are on an episode of the $10,000 Pyramid:  Blind mice, men in a tub, sheets to the wind – “things that come in threes.” 

            All that to segue into today’s case which touches on three of our favorite topics – fraudulent joinder, TwIqbal, and MDLs.  The case – Johnson v. DePuy Orthopaedics, Inc., 2012 U.S. Dist. LEXIS 74450 (N.D. Ohio May 30, 2012) is one of eleven essentially identical cases to be decided in the ASR Hip Implant MDL.  And, we are happy to report that the court decided that a claim brought against a local distributor constituted fraudulent joinder.  And, we are even happier to report that in reaching that conclusion, the court applied TwIqbal pleading standards to the motion to remand.

The context is quite familiar in our line of work.  Plaintiff sues diverse manufacturer and non-diverse distributor in state court; manufacturer removes to federal court on grounds of fraudulent joinder; plaintiff moves to remand; case gets transferred to MDL. 
          
            But here is where things get interesting.  To prove fraudulent joinder
the removing party must demonstrate there is no possibility that the plaintiff will be able to establish a cause of action against the nondiverse defendant in state court.

Id. at *4.  A defendant’s burden of proof on fraudulent joinder is “substantial” and all doubts are resolved in favor of the plaintiff.  Id. at *4-5.  Sounds a bit like the standard on a Rule 12(b)(6) motion to dismiss.  So, we applaud the court’s analogy to TwIqbal pleading standards, even though Rule 12 was not technically applicable to fraudulent joinder:

In sum, courts generally agree on the following two rules when deciding motions to remand that involve allegations of fraudulent joinder. First, even if the district court "pierces the pleadings" to consider summary-judgment-type evidence (such as depositions, affidavits, etc.), the proper standard for evaluating that evidence remains akin to that of a Rule 12(b)(6) motion  to dismiss, and is arguably even more deferential. Second, any contested issues of fact must be construed in the plaintiff's favor.

Id. at *5-6 (quoting Walker v. Philip Morris USA, Inc., 2011 WL 5119441, *7 (6th Cir. 2011).  Afterall, if the whole point of the fraudulent joinder doctrine is that parties are being sued for no good reason – then we wholeheartedly agree that on a motion for remand, plaintiff’s “factual allegations must be enough to raise a right to relief above the speculative level.”  Johnson, 2012 U.S. Dist. LEXIS at *13 (quoting Twombly). 

            In the 21-page Johnson complaint, the distributor was only mentioned four times – the distributor is a Kentucky company that distributes/promotes ASR hip implants in Kentucky and distributed/promoted the hip implant implanted in plaintiff.  Id. at *9-10.  The complaint then goes on to allege failure to warn, design defect, manufacturing defect, negligence, breach of warranty and assorted other claims collectively against all defendants.  Id. at *10-11.  Applying the TwIqbal standard to plaintiff’s motion to remand, the court found:

the allegations against [the distributor] . . . fall well below the threshold required to meet the plausibility standard required under Twombly, . . . Plaintiffs' allegations fail to distinguish between the [manufacturer’s] allegedly wrongful acts and those of [the distributor].  Assuming the facts as alleged against [the distributor] to be true, without a modicum of additional facts, Plaintiffs have failed to establish a colorable basis for liability. Additionally, there are no independent claims asserted against [the distributor] nor do Plaintiffs seek specific relief against this Defendant.

Id. at *13-14 (citations omitted).  The court cites several other cases where “global” or “collective” allegations were insufficient to state a cause of action.  Id. at *11-12.  With no factual support to back up his allegations against the distributor, plaintiff failed to state a claim against that non-diverse defendant, who was therefore found fraudulently joined, dismissed and the motion to remand was denied.  Id.  We like the legal analysis and we like the result – we hope more courts follow suit.   

            But we also promised you something about MDLs.  In addition to his motion to remand, plaintiff also filed a motion for reconsideration of Case Management Order No. 5 – an order addressing the Plaintiff Preliminary Disclosure Form applicable to all 4,400+ MDL cases.  Plaintiff argued he could not comply with CMO 5 until the court ruled on the motion to remand.  While the court recognized that threshold issues, such as subject matter jurisdiction, need to be decided before rulings are made on the merits, MDL orders that don’t go to the merits apply to cases despite pending jurisdictional remand motions.  Id. at *14-18.  In other words, because of the “unique challenges posed by complex litigation” – including that new cases enter the MDL throughout the pendency of the litigation – an MDL court has significant discretion in managing its docket.  Deciding all individual remand, jurisdictional or pleadings motions before addressing common issues – such as adoption of a disclosure form – “would undermine the goal of promoting the convenient, just and efficient conduct of the actions.”  Id. at *18-19.  Bottom line, as long as your case is pending in the MDL, you have to abide by the MDL rulings.   And, if TwIqbal is the standard for deciding fraudulent joinder, we hope many more cases stay in MDLs (or at least in federal court).

Tuesday, May 8, 2012

MDL Transfer May Precede Resolution Of Jurisdiction

Plaintiffs try all sorts of funny business to defeat federal jurisdiction – fraudulent joinder, fraudulent misjoinder, jurisdictional amount – you name it, they’ll tinker with it.  Defendants for their part, do what they can to match the plaintiffs strategem for strategem.  Can you say “removal before service?”


In any removal/remand situation, a competent plaintiff will try to push remand as hard and fast as possible, on the theory that the longer the case stays in federal court the more likely it will stay in federal court.  Defendants, on the other hand, frequently move that remand motions be held in abeyance pending transfer to multi-district litigation, and that such motions be decided by the MDL judge.

Is that a proper thing to ask for?  Can a case with questionable subject matter jurisdiction be the subject of an MDL transfer?

Well, last week, the Sixth Circuit said “yes” – at least in the context of a mandamus standard of review (for you non-lawyers, “mandamus” is a special, immediate sort of appeal, and is subject to tougher standards).  There’s not a lot of law on the subject, so we thought we’d mention this event.  In In re McConnell, No. 11-4265, slip op. (6th Cir. April 26, 2012) (unpublished), the federal district court to which the case (a hip implant action) had originally been removed waved it on through to the MDL without deciding a remand motion raising jurisdictional issues.  Upset about finding herself in the MDL, plaintiff McConnell (or rather, her lawyer) filed an appellate mandamus petition against the Judicial Panel for Multidistrict Jurisdiction demanding that the transfer order be vacated.

The Sixth Circuit found nothing in its precedents for the proposition that transfer of a case with pending jurisdictional motions was a per se abuse of discretion.  The closest case that the plaintiff found was a mandamus addressing the merits of a jurisdictional issue – hardly the same thing.  That wasn’t enough for mandamus to issue:

The court was not asked, and did not consider, whether the MDL Panel is authorized to transfer a case before the transferor court has ruled on a pending jurisdictional issue . . . and the court was careful to note that “[t]his is not to say that mandamus is appropriate at any time there is an issue of subject matter jurisdiction.”
McConnell, slip op. at 2 (quoting BancOhio Corp. v. Fox, 516 F.2d 29, 32-33 (6th Cir. 1975)).  Lack of controlling precedent alone defeated mandamus (which the court observed was the only way to challenge an MDL transfer order, id.).

Mandamus was also improper, McConnell held, because the nature of the order had not foreclosed any substantive right of the plaintiff:

The transfer order does not prevent [plaintiff] from challenging the defendants’ removal of her case from state court because, pursuant to the transferee court’s scheduling orders, [plaintiff] may re-file her motion to remand and obtain a ruling by the transferee judge on the merits of her motion. This leads us to conclude that the extraordinary circumstances necessary to utilize a writ of mandamus are not present in this case.

Slip op. at 3.

This is not a published opinion, to be sure, but once it is accepted that mandamus is the only basis for challenging an MDL transfer order, the result seems right.   Mandamus is:  (1) reserved for slam dunk error, and (2) limited to situations of substantial prejudice, neither of which will be present in a mere transfer situation.

It’s of course a matter of pure discretion whether, in the first place, a federal court decides to hold a remand motion in abeyance pending MDL transfer. If the court chooses to remand, there’s essentially no review at all.  But for those judges that are inclined to transfer, McConnell is a clear indication that such an order won’t get reversed.

Thanks to Susan Sharko over at Drinker for bringing this case to our attention and to their teammates at Tucker Ellis for winning it.

Tuesday, February 14, 2012

Drug and Device MDL Update

            Several years ago, we decided to try to name the drug and device mass torts.   You know, in case the longest-running products liability MDL is ever the Final Jeopardy answer.  Or, if knowing the largest pharmaceutical MDL to date is something you can use as an ice breaker.  Actually, if you know those things, as my grandmother would say – that and a nickel will get you a cup of coffee (she’s 95 and unfamiliar with Starbuck’s prices).
            But, we decided the list was worth updating anyway – including providing links to litigation websites where available.  Let’s start with the ones that are still around since our original post in 2008.  Some are shadows of their former selves; just a few cases hanging on for resolution:

MDL - 986 IN RE: "Factor VIII or IX Concentrate Blood Products" Products Liability Litigation (no website)

MDL-1596 IN RE Zyprexa Products Liability Litigation (no website)
MDL-1626 IN RE Accutane Products Liability Litigation (no website)

MDL-1629 IN RE Neurontin Marketing, Sales Practices and Products Liability Litigation (no website)




MDL-1736 IN RE Celexa and Lexapro Products Liability Litigation (no website)

MDL-1763 IN RE Human Tissue Products Liability Litigation (no website)

MDL-1769 IN RE Seroquel Products Liability Litigation

MDL-1785 IN RE Bausch & Lomb Inc. Contact Lens Solution Products Liability Litigation (no website)

But, some are still going strong and may well continue to generate law that we report on here:
MDL-1355 IN RE Propulsid Products Liability Litigation
MDL-1789 IN RE Fosamax Products Liability Litigation (no website)

MDL-1760 IN RE Aredia and Zometa Products Liability Litigation (no website)





MDL- 1959 IN RE: Panacryl Sutures Products Liability Litigation (no website)

MDL- 1964 IN RE: NuvaRing Products Liability Litigation (no website)


MDL- 2004 IN RE: Mentor Corp. ObTape Transobturator Sling Products Liability Litigation (no website)

            Now, how about the new (?) ones.  These aren’t all the drug/device MDLs that have been created since 2008, but they are the ones that are still listed as active by the Judicial Panel on Multidistrict Litigation:

MDL - 2023 IN RE: Bayer Corp. Combination Aspirin Products Marketing and Sales Practices Litigation (no website)


MDL - 2067 IN RE: Celexa and Lexapro Marketing and Sales Practices Litigation (no website)
MDL - 2087 IN RE: Hydroxycut Marketing and Sales Practices Litigation (no website)

MDL - 2107 IN RE: Budeprion XL Marketing and Sales Practices Litigation (no website)
MDL - 2120 IN RE: Pamidronate Products Liability Litigation (no website)
MDL - 2158 IN RE: Zimmer Durom Hip Cup Products Liability Litigation (no website)

MDL - 2190 IN RE: McNeil Consumer Healthcare, et al., Marketing and Sales Practices Litigation (no website)


MDL - 2226 IN RE: Darvocet, Darvon and Propoxyphene Products Liability Litigation (no website)

MDL - 2243 IN RE: Fosamax (Alendronate Sodium) Products Liability Litigation (No. II) (no website)

MDL - 2244 IN RE: DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation (no website)

MDL - 2272 IN RE: Zimmer NexGen Knee Implant Products Liability Litigation (no website)
MDL - 2299 IN RE: Actos (Pioglitazone) Products Liability Litigation

MDL - 2325 IN RE: American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation (no website)

MDL - 2326 IN RE: Boston Scientific Corp., Pelvic Repair System Products Liability Litigation (no website)

MDL - 2327 IN RE: Ethicon, Inc., Pelvic Repair System Products Liability Litigation (no website)

MDL - 2329 IN RE: Wright Medical Technology, Inc., Conserve Hip Implant Products Liability Litigation (no website)

            There you have it.  A list of what’s what in drug and device MDLs.  For the record – What is MDL 875--Asbestos Products Litigation? and Diet Drugs (according to JPML numbers).

Thursday, December 15, 2011

New Stuff #1

An anonymous friend of the blog recently passed along an unusual MDL order, along with the question had we ever seen anything like it?  The order (copy here) denies an uncontested motion to designate 34 cases as tagalongs in the Aredia/Zometa MDL.  As the order reflects, the 34 plaintiffs had sought tagalong status, and the defendant joined in the motion.


Nonetheless the J.P.M.D.L. (Judicial Panel on Multidistrict Litigation, for those of you unfamiliar with the nomenclature) denied transfer.  The Panel found that transfer was “not necessary to achieve the just and efficient conduct of the litigation.”  A/Z Order at para. 2.  Apparently the Panel had had some discussions and determined not to approve anymore tagalongs.  Id. (“[e]arlier this year the Panel determined that conditionally transferring actions to MDL No. 1760 would not serve the purposes of [MDL transfer]”).  These discussions must have been internal and without notice to anyone, because neither the plaintiffs nor the defendants evidently knew about this prior determination.  We suspect (and hope), however, that the Panel consulted with Judge Campbell, the MDL judge for Aredia/Zometa.

Here are the reasons for denial of transfer, as stated by the panel:

Common discovery has been completed in the centralized proceedings, and the transferee court has issued rulings on general causation. The remaining issues in the cases in the transferee court appear to be case-specific, and the transferee court has been suggesting remand of waves of individual cases once briefing on motions has been completed. . . . The parties also have not addressed why they cannot avail themselves of the documents and depositions accumulated [in] MDL No. 1760 while the cases move forward in their respective courts.
A/Z Order at paras. 2-4.

The closest thing we’ve seen to what happened in Aredia/Zometa occurred in our Seroquel MDL.  In Seroquel, the plaintiffs successfully opposed a tagalong motion that we filed, getting an earlier order vacated.  They argued that everything was on the verge of being remanded anyway.  The Panel agreed:

Multidistrict litigation is not static. . . .  Over the course of time, the relative merits of transferring additional cases can change as the transferee court completes its primary tasks.  The point of diminishing benefit in tag-along transfers is never absolutely clear.  After a certain point, however, the benefits of transfer should not be assumed to continue.  This is a concern which, in close consultation with transferee judges, we intend to give closer attention.
Seroquel Order at paras. 2-3.

Maybe Aredia/Zometa is an example of this “closer attention.”  Still, neither we, nor even our blogger emeritus Mark Herrmann (to whom the minutiæ of MDL practice is almost a hobby) had ever seen an MDL order cutting off tagalongs sua sponte while the MDL is still in litigation.  In Bone Screw, for example, Judge Bechtle continued to accept tagalongs right up until the eventual settlement, even after literally hundreds of cases were remanded.

We wonder whether these orders reflects some sort of emerging view by the Panel as to what is the proper scope of an MDL proceeding.  Is it merely for so-called “common discovery” – disproportionately burdening defendants – and “general causation” rulings?  We hope not.  Otherwise MDLs degenerate into exercises in using one-sided discovery expense as a weapon to force settlement.

In Bone Screw Judge Bechtle chose to conduct a fair amount of what the Panel might view as “individual case discovery” – especially:  (1) requiring a case-specific general causation expert in each case, and (2) deposing all plaintiffs’ treating physicians.  We found that kind of centralization made for significant efficiencies – for example, with well over 500 prescribers to depose, attorneys on the defense side (and we assume on the other side as well) got pretty well versed in the specific issues those depositions raised.

Other judges of course do things differently.  There aren’t many judges as “hands on” as Judge Bechtle was in his MDLs.  We’d like to think that the Panel is not strait-jacketing the MDL transferree judges into any particular vision of what is, and what isn’t, appropriate for MDL practice.  That’s why we hope that what was going on behind the scenes in Aredia/Zometa was nothing more than “close consultation” – Judge Campbell letting the Panel know that “I’m remanding cases, please don’t send me any more.”

Monday, December 12, 2011

A View from the Bench on MDLs

Last week we attended ACI’s Annual Drug and Medical Device Litigation Conference. As always, it was nice to be in New York City during the holiday season (though the persistent drizzle was less than festive) and even nicer to see so many friends.

The presentations were quite good and up-to-date. The Mensing discussion was especially enlightening. As usual, we were most eager for the judicial panel, and it did not disappoint. In fact, it was so good, we’re calling it an early Christmas gift.

The topic for the judges was recent MDL litigation. Judges Cogen, Cote, Herndon, Montgomery, and Waxse were all engaging and thoughtful. Here are a few of the highlights:

• The judges realize that there is virtually no agreement as to how much a transferee judge must accomplish prior to remand. (Well, maybe we already knew that).

• There are also a variety of approaches to selecting bellwether trials. Permitting the parties to select their strongest cases, even with vetoes, does not ensure trials of representative cases. And if they’re not representative, where’s the value for settlement? One judge tells each party to proffer cases along with arguments for why they are truly representative. He then chooses the most representative case. Like baseball arbitration, it builds in an incentive for each party to be reasonable.

• As that old Barbie doll said, “Math is hard.” So is science. But all the judges believe that Daubert forces judges to act as real gatekeepers. Consequently, judges – with plenty of help from the parties, lawyers, and experts – must do the homework to keep junk science away from the jury. It was pretty clear that all of the judges on the panel were hard workers and quick studies, and that they would not be the least bit shy to police expert evidence.

• It’s no surprise that all the judges dislike discovery disputes. What is a surprise is the array of creative techniques the judges use to resolve or curtail these disputes. Our favorite? Ordering the parties to videotape a follow-up meet-and-confer session. If the dispute isn’t resolved, the parties must send the tape to the judge. Guess what? Not a single tape has yet arrived.

• Fed.R.Civ.P. 26 has a couple of subsections that lawyers might want to read again (or, maybe, read for the first time). Here is what Rule 26(b)(2)(C) provides:


On motion or on its own, the court must limit the frequency or extent of discovery otherwise allowed by these rules or by local rule if it determines that:

(i) the discovery sought is unreasonably cumulative or duplicative, or can be obtained from some other source that is more convenient, less burdensome, or less expensive;
(ii) the party seeking discovery has had ample opportunity to obtain the information by discovery in the action; or
(iii) the burden or expense of the proposed discovery outweighs its likely benefit, considering the needs of the case, the amount in controversy, the parties’ resources, the importance of the issues at stake in the action, and the importance of the discovery in resolving the issues.

Thus, either in considering a party’s motion, or on its own, a court must limit discovery that isn’t worth the effort or expense. Proportionality matters. Wow. That’s an issue with most of the discovery we see. And here’s the kicker: Rule 26(g)(1)(B) requires lawyers to sign discovery requests and responses certifying that either they are complying with the discovery rules (including 26(b)(2)(C), and that what they are doing is

(iii) neither unreasonable nor unduly burdensome or expensive, considering the needs of the case, prior discovery in the case, the amount in controversy, and the importance of the issues at stake in the action.

If a certification violates Rule 26, the court “must impose an appropriate sanction on the signer, the party on whose behalf the signer was acting, or both.” Fed.R.Civ.P. 26(g)(3). It’s like a Rule 11 for discovery. One judge said that pretty much every discovery request and response he’s seen violates 26(b)(2)(C) and could conceivably warrant sanctions.

Take a look at the Notes to these provisions. Maybe courts seldom invoke these provisions, halt disproportionate discovery, and impose sanctions, but it’s clear that active judicial involvement was contemplated. For our part, we’re happy to have a judge engage in that proportionality analysis. We’re even happier when it’s done by judges who are smart, fair, and conscientious. Based on what we saw last week, we’re optimistic.

• We’re not sure this last point is the most significant in terms of jurisprudence, but it produced the single most lasting image from the conference. One judge said that looking through the activities in an MDL can be like going through the refrigerator, opening up Tupperware containers, and gaping in puzzlement and/or horror at the goodies within. Yeah – we’ve been there, both actually and metaphorically.

Sunday, November 20, 2011

Seventh Circuit Delivers Potential Circuit Split on MDL Procedure

We have offered multiple posts (83 and counting) on Multi-District Litigation. Some of those posts might seem at odds with each other. But as Emerson said, "A foolish consistency is the hobgoblin of small minds." As Whitman said, "Do I contradict myself? Very well then, I contradict myself. I am vast; I contain multitudes." And Charles Barkley, after all, once claimed he had been misquoted in his autobiography. The problem with taking any sort of position on MDL procedure is that you never know which side of the issue you might occupy.

The theory behind Multi-District Litigation is that consolidation of pretrial proceedings should produce efficiency. Who's against efficiency? You'd be surprised. (Or maybe you wouldn’t.) If an MDL really resulted in streamlined litigation that is less expensive, without any alteration in substantive rights and outcomes, one would be hard-pressed to squawk. But MDLs can change things in substantive ways. First, creating an MDL inevitably inspires plaintiff lawyers to file boatloads of iffy cases, with the idea of docking them in the MDL for the duration and eventually racking up additional settlements and attorney fees. Second, an MDL puts you in front of a different judge -- the transferee judge. That, friends, can make all the difference in the world. In all likelihood, one side will be much happier with the transferee judge, and the other side will pine for remand just to get away from the transferee judge.

This scenario showed up in the recent case of FedEx Ground Package System, Inc. v. United States Judicial Panel on Multidistrict Litigation, No. 11-2438 (7th Cir. Nov. 17, 2011). It's not a product liability case, but it addresses an interesting wrinkle of MDL procedure. FedEx delivery drivers filed class actions against FedEx, alleging that FedEx had inappropriately treated them as independent contractors rather than employees. The Joint Panel on Multi-District Litigation (the JPML -- the defendant in the Seventh Circuit case) sent the cases to a veteran district court judge in South Bend, Indiana. That judge issued a summary judgment in FedEx's favor, ruling that the drivers were, indeed, independent contractors. That ruling resolved all claims in 22 cases, teeing them up for appeal to the Seventh Circuit. But there were 12 other cases with some surviving claims. What would happen to them? The transferee district judge decided to remand those cases to the transferor districts, which would deal with the other claims. Any appeals, including appeals of the ruling by the transferee judge, would be appealed to the circuit court for that transferor court. That would, of course, open the prospect of inconsistent rulings on the contractor-employee issue.

Not surprisingly, FedEx was happy with the transferee court's substantive ruling as to how to characterize the drivers' status. For all we know, FedEx might've also been happy staying in the Seventh Circuit. So FedEx asked the transferee court to issue Rule 54(b) partial final judgments in the 12 cases, and all the cases would go up to the Seventh Circuit. Following FedEx's approach would ensure that the same appellate issues would go to the same court. Makes sense. But the transferee court decided that consolidated proceedings were over, and ordered remand of the cases to the transferor courts. Following the transferee court's remand approach would ensure "that all issues in the same case, involving the same parties and the same facts, will be appealed at once, and to the same circuit." Slip op. at 4. Arguably, that might also make sense.

The JPML thought it was a close issue, but gave great weight to the district court's remand recommendation: "In most instances the transferee judge has an acute sense about the procedural steps necessary to advance the litigation in the fairest and most efficient way." Id. at 5. Did FedEx take those rulings lying down? It did not. Instead, FedEx filed a petition for mandamus with the Seventh Circuit, seeking to overturn the JPML decision and to prevent what FedEx saw as a premature remand.

The Seventh Circuit, like the MDL panel, saw the issue as a close one, and concluded that the choice between the two methods was "best left to the transferee court and JPML, without trying to impose a rigid rule for all cases and circumstyances." Id. at 6. Given the tough standard for a mandamus petition, the JPML's ruling would stand.

That sort of case-by-case, defer-to-the-district-court ruling doesn't provide a lot of certainty for future litigants. It is also in tension with In re Food Lion, Inc., Fair Labor Standards Act "Effective Scheduling" Litig., 73 F.3d 528 (4th Cir. 1996). In that case, the Fourth Circuit issued a writ of mandamus to the JPML to undo its orders transferring cases back to their original transferor courts to ensure that all related appeals would go to the Fourth Circuit itself. So we have a circuit split, right?

The Seventh Circuit didn't think so. The Seventh Circuit did not understand the Fourth Circuit's Red Lion opinion to announce "a sweeping holding that all MDL cases must be managed to ensure that all related appeals go to only the circuit with jurisdiction over the transferee court." Slip op. at 7. Moreover, the claims in Red Lion arose under federal law, so uniformity was a key consideration. By contrast, the FedEx plaintiffs asserted "rights under the laws of many different states." Id.

Normally, we expect that circuit splits draw the attention of the Supreme Court of the United States. But maybe the Seventh Circuit's purported distinction will permit the SCOTUS to avoid the issue -- and, given the seeming desire of the SCOTUS to whittle its docket down to 19th Century levels, maybe that is exactly what will happen. In addition, it's not as if the issue inspires huge excitement or comes up all that often. After all, Red Lion came down 15 years ago.

As we said up top, we cannot take a position on this issue, because we could conceivably end up on either side of it. The prospect of dueling Daubert decisions in an MDL is not particularly palatable, and we foresee the usual plaintiff forum-shopping, but we've dealt with worse. And maybe we'll want to tease a remand out of a hostile judge. Believe it or not, opposing lawyers have sometimes seen fit to takes our blog posts and try to wedge them down our gullet and argue that we're being inconsistent. One would almost think they'd never read Emerson, Whitman, or Barkley.

Thursday, November 17, 2011

Hip Checked – Plaintiffs’ Ediscovery Ploy Rebuffed In New Jersey

Ediscovery is dreadfully expensive.  Plaintiffs are dedicated to keeping it that way, as they know that anything that drives up a defendant’s litigation costs (and mass tort ediscovery falls disproportionately on defendants) increases the settlement value of even meritless cases – and any mass tort has lots of meritless cases.

All too often judges, not wanting to get bogged down in the technical details of ediscovery (which is 99% of it), let the plaintiffs get away with running up the defendants tab.

But occasionally, even the judges get fed up with the obvious churning that goes on in ediscovery.

That’s what happened in In re DePuy ASR™ Hip Implants Litigation, No. BER-L-3971-11, slip op. (N.J. Super. Oct. 18, 2011).  In the course of telling rogue plaintiffs that they had gotten all the ediscovery they were going to get, the ASR court also struck a blow for federal-state coordination in mass tort cases, which makes this relatively short opinion doubly notable.

As is often the case with mass torts, there are parallel actions involving the ASR hip implant, a federal MDL and also a bunch of plaintiffs who managed to stay out of federal court by taking advantage of the “forum defendant” loophole to diversity jurisdiction.  In New Jersey, such state-court plaintiffs are aggregated in that state’s own mass tort program.

As also often happens, the federal ASR MDL was quicker out of the blocks. The federal plaintiffs and defendants got together and hammered out an ediscovery protocol.  Under that protocol, the defendant produced over 10,000,000 pages of electronic documents – more than any litigant (or probably group of litigants) could possibly hope to read.  All of this was done in strict accordance with the federal MDL agreement, which specified the formats and compatibilities that the production had to take.

Back in New Jersey state court, however, some plaintiffs decided that they didn’t like the federal protocol. At a cost of over $1,000,000 (to which, of course, these plaintiffs were not about to contribute a dime), they demanded a do-over with a different format, compatible with different (they claimed, cheaper) software.

The court said no.  The federal MDL protocol was the product of extensive negotiations, and was good enough for New Jersey as well.  It is important to coordinate federal and state mass tort litigation involving the same product:

[T]his Court is committed to the coordination of this litigation not only with the MDL but also with other jurisdictions. . . .  The Manual For Complex Litigation (Fourth) §20.31 (2009) . . . encourages cooperation by and between MDL and State Court judges. . . .  Furthermore, the Manual states "Federal and State Court Judges frequently cooperate informally and effectively to coordinate discovery and pre-trial proceedings in mass tort cases." Id. at §22.4.  The New Jersey Mass Tort (non-asbestos) Resource Book, (3d. Ed.), November 2007, embraces this concept. . . .  This Court is satisfied that the MDL Protocol is reasonable.  It is clear that the MDL Protocol is the result of a "give and take" by and between highly skilled counsel in the MDL and other State court jurisdictions.  The MDL Protocol is not the format initially proposed by defense counsel but, as indicated above, presents a reasonable accommodation after negotiations by and between counsel, all of whom were on equal footing. . . .  To permit or otherwise Order a format unique to New Jersey would cause an undue hardship on the Defendants . . ., [and] would be of no ascertainable benefit to . . . plaintiffs.
ASR, slip op. at 3-5.  Putting aside ediscovery, important as that is in and of itself, this is one of the best statements extolling federal/state cooperation that we've seen.

Bravo for the court for striking a blow for common sense – and for federal-state coordination.  And congratulations to Susan Sharko, over at Drinker Biddle, for advancing the cause of sanity in ediscovery.

Friday, November 4, 2011

The Ignominous End Of The Digitek Mass Tort

Bexis gave blood last weekend at the Red Cross – not just any old donation, either, but pheresis, a procedure that takes a couple of hours to complete.  Because pheresis takes that long, the Red Cross supplies donors with movies to watch.  This time it was the 2006 James Bond remake, “Casino Royale,” the type of movie that Bexis waits for the Red Cross rather than actually spends money to see.  In “Casino Royale” a delectable baddie poisons 007’s martini with digitalis, nearly causing him to die from a v-fib.


Bexis being Bexis, James Bond’s digitalis overdose got him wondering about whatever happened to the Digitek MDL, which involved an FDA-approved form of digitalis, called Digoxin.  We hadn’t posted anything about it in well over a year, since the court blew out some meritless economic loss class actions.  Before that, we were impressed by the MDL court's Rule 11-based order requiring the plaintiffs’ counsel to demonstrate that they’d done a bare minimum of investigation of their clients’ supposed "cases" before filing suit.

Turns out, we didn’t have long to wait.  Yesterday, Madeleine McDonough over at Shook Hardy was good enough to tip us off to the ignominous end of that MDL.  Yesterday, the MDL court filed three orders (documents 70, 149, and 608) that, frankly, all look pretty much the same to us.  They all go under the general description of PTO (that’s “pre-trial order” for you laypeople) 87, so we’re only attaching the one that’s actually called that.

Our first reaction:  My God!  Has there ever been a more meritless MDL?  We thought Bone Screw was bad, since the plaintiffs never in ten years of litigation were able to find a practicing orthopedic surgeon who would opine on defect.  But at least in (some of) those cases there were broken screws.  In Digitek, the plaintiffs couldn’t even prove exposure to the allegedly defective product!  The alleged "defect" was that some Digitek tablets were manufactured bigger than they were supposed to be and thus contain too much of the active ingredient (see James Bond).  But it turns out that, after years of litigation, no plaintiff ever proved that a single one of the supposedly defectively too large Digitek tablets was ever sold to any consumer.

Don’t take our word for it; we’ll let the Court describe it.  Keep in mind that the product recall that prompted the massive attorney solicitation that gave rise to the Digitek litigation took place in April 2008 and involved pills made in January 2008.  PTO 87 at 4-5:

The plaintiffs’ experts’ opinions rely on the one and only verified instance of an extra thick Digitek® tablet making it to market in 2004.  A pharmacist found and returned the tablet to [defendant].  A manufacturing investigation was conducted and the situation was reported to the FDA. After reviewing the investigation, the FDA said:

No additional complaints or reports ofthick tablets have been received for this high volume product.  The event was considered an isolated incident and corrective actions were put in place to prevent its reoccurrence.  Corrective actions (procedural enhancements and review of complaint files) were verified during the inspection.
(Def. Ex.71 at 6).

This is the only verified report of a thick tablet leaving [defendant’s] facilities. The tablet was made in 2003. All recalled Digitek® was produced in 2006 or later. Since 2003, over one billion Digitek® tablets have been made and distributed to the marketplace.  This single 2003-produced tablet is the only Digitek® tablet in the marketplace found and confirmed to be out of specification.
PTO 87, at 10-11.

Not one of the over 1000 Digitek MDL plaintiffs, id. at 11 – all claiming injury from taking supposedly too-large Digitek tablets – ever produced a single purportedly too big Digitek tablet at any time during the litigation.  Id. at 2 (“Thousands of plaintiffs alleged that double-thick tablets hit the market and injured consumers.  Not one of them produced a double-thick tablet.”).  Indeed, some Digitek plaintiffs affirmatively avoided having pills in their possession tested for conformity to specification.  Id. at 19 (“Plaintiffs possess, but have refused to test (or reveal any testing of), an ample supply of unused Digitek® tablets”).

The mind boggles.  So our first reaction is “good riddance.”  What a collossal and utter waste of time, energy, and money on completely bogus cases.  No wonder the court ordered a Rule 11-based inquiry.  Digitek should be the “hot coffee” moment of drug and device litigation, a poster child that demonstrates to everyone that litigation is entirely out of control and that legislation or a rules change - we'd suggest a more muscular Rule 11 applicable to any solicited case - is necessary to reign it in.

So what do plaintiffs do when they can’t even prove that the supposedly defective product ever actually existed?  They use a lot of scary words – like things that go “boo!” on Halloween.  There are a lot of good things in PTO 87 (including Daubert rulings on some very questionable experts), but to us the best part of it is the court’s blowing to smithereens the plaintiff’s misuse of the term “adulterated.”

“Adulterated” is an FDA regulatory term of art.  It means only that some FDA regulation wasn’t 100% complied with.  “Adulterated” doesn’t mean “unsafe” – not even close.  The discussion of the plaintiffs' "adulteration" bogie man in PTO 87 is as good an exercise in refuting a plaintiffs’ misuse of a “scary” regulatory term ("experimental," "investigational," and "misbranded" also come to mind) as anything we’ve ever read:

When a manufacturing process falls short of a cGMP [that’s FDA-speak for “current good manufacturing practice”] requirement, the product is referred to as “adulterated.”  This term has a specific meaning:

A drug or device shall be deemed to be adulterated ... if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter....
21 U.S.C. §351 (a)(2)(B).  If a drug is “adulterated” it may still be safe for consumption and as represented on the label.  The question is only whether the manufacturing process satisfied the FDA’s regulations.  A drug will be rendered “adulterated” if any aspect of the manufacturing process did not fully comply with any cGMP.  That could be something as mundane as inadequate lighting or the lack of hot and cold running water in the building.
PTO 87 at 7-8.  See Id. at 9 (“a pharmaceutically perfect drug could be manufactured, sealed, and packaged, and yet still be rendered ‘adulterated’ because the label on the drug is upside-down”).

Thus, FDCA-based claims of “adulteration” have no bearing on whether a prescription medical product is “defective” for product liability purposes because the FDA’s adulteration standard is based upon “a lesser showing of harm to the public than the preponderance-of-the-evidence or more-likely-than-not standards used to assess tort liability.”  PTO 87 at 21.  The Court took judicial notice of the FDA’s statement:

If a company is not complying with cGMP regulations, any drug it makes is considered “adulterated” under the law.  This kind of adulteration means that the drug was not manufactured under conditions that comply with cGMP.  It does not mean that there is necessarily something wrong with the drug. . . .  A drug manufactured in violation of cGMP may still meet its labeled specifications, and the risk that the drug is unsafe or ineffective could be minimal.
Id. (quoting FDA “Facts About Current Good Manufacturing Practices”) (emphasis added).

So in the end, all the smoke and mirrors in the world couldn’t help the Digitek plaintiffs in a litigation where there was ultimately no evidence that the purported defective product ever made it to the marketplace – period.  In the future, whenever we encounter a plaintiff screaming “adulteration,” Digitek PTO 87 is where we’ll go first to try to restore calm.

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.

Tuesday, July 19, 2011

Plaintiffs Strike Out Seeking Remand

            We love it when plaintiffs make our job easy – and when plaintiff’s counsel is both clueless and obnoxious – well, that’s cause to celebrate in and of itself.  When the case is also another decision from the Southern District of Illinois denying remand, well we just can’t help sharing our joy. 
It is a well-worn page from plaintiffs’ play book -- to avoid having product liability cases removed to federal court on the basis of diversity jurisdiction, include in the complaint medical malpractice claims against non-diverse treating physicians. In that situation, the removing product manufacturer must convince the federal court to sever (and remand) the malpractice claims, and to retain jurisdiction over the product liability claims.  Not an easy task, but also not insurmountable, as evidenced by the recent decision in In re: Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Products Liability Litigation (Cooke-Bates), 2011 U.S. Dist. LEXIS 74076 (S.D. Ill. July 10, 2011).
The game started in typical fashion.  First up, plaintiff (a resident of Virginia) sues Bayer (not a Virginia citizen) and her physician (a Virginia resident) in state court.  Bayer comes up to bat and removes the case to federal court based on diversity and argues that the claims against the doctor should be severed under Rule 21 either because of improper joinder or because the doctor was not a necessary and indispensable party. Id. at *3-4.  Not surprisingly, plaintiff’s next play is a motion to remand – and here they go down swinging.   
            It makes us smile when any decision starts off with a reprimand to plaintiff’s counsel about the “combative and discourteous tone” of their briefing.  Id. at *9.  Putting aside the substance of the legal issue for a minute, the court was displeased by plaintiffs’ accusations that defendant made intentional misrepresentations and blatantly disregarded prior orders – especially when those allegations were false and that it was actually plaintiff who made misrepresentations in her filings – including misrepresentations of the court’s own rulings.  Id. at *8-10.   Strike one.
            Now on to the substance.  After having thus completely forfeited any credibility with the court, plaintiff made three arguments in support of remand:  procedural misjoinder is not a proper basis for removal; plaintiff’s physician was properly joined; and severance of a non-diverse defendant is not allowed under Rule 21 absent a finding of fraudulent joinder.  Id. at *3.  Not until oral argument, several months later, did plaintiff argue for the first time that the removal was procedurally defective because the physician had not consented.  Id.  But, as we all know, a procedural defect is waived unless raised within 30 days of removal. See 28 U.S.C.A. § 1447(c).  Strike two.
            Ignoring the procedural defect due to the waiver, the court found that the plaintiff’s doctor was not a necessary party and severed and remanded the claims against him.  In re Yasmin at *6-7.  The case was then transferred to the Yasmin MDL -- after both plaintiff’s request to certify the issue for appeal and petition for writ of mandamus were denied (we’ll call those foul balls) -- where yet again plaintiff again moved to remand the case arguing that the transferor court’s severance of the physician was improper and therefore his citizenship still had to be considered in assessing diversity.  Id. at *7-8. 
Plaintiff tried to distance herself from the transferor court’s decision by styling her new motion as one to remand for lack of subject matter jurisdiction and not for reconsideration and arguing that therefore, the transferor court’s decision was irrelevant. Id. at 15.  But, while plaintiff was looking for low and away, the pitch came in high and tight for Strike three!
The authority of a district judge to reconsider a previous ruling in the same litigation, whether a ruling made by him or by a district judge previously presiding in the case, including (because the case has been transferred) a judge of a different court, is governed by the doctrine of the law of the case.
Id. at *17-18 (citation and quotation marks omitted). 
            Characterized as a motion for reconsideration and applying the law of the case doctrine, plaintiffs would have to have demonstrated a compelling reason for reconsideration “such as a change in, or clarification of, law that makes clear that the earlier ruling was erroneous.”  Id. at *20.  An MDL judge is not free to alter previous rulings of the transferor judge “merely because he has a different view of the law or facts from the first judge.”  Id. (citation and quotation marks omitted).   As we know, courts vary on
(1) whether a physician is a necessary and indispensable party in a product liability action against a drug manufacturer and (2) whether a district court may sever a dispensable non-diverse party to preserve diversity jurisdiction in an action that has been removed.
Id. at *22.  Therefore, at best the transferor court and the MDL court may have had a difference of opinion, but a difference of opinion isn’t enough to warrant reconsideration under the law of the case doctrine.   Without reconsideration, the case pending before the MDL court was completely diverse.   And with that, plaintiff remains in the game but has lost home field advantage.
We’re waiting to see if plaintiff chooses to argue with the ump again.