Mulligan Stew: Second Circuit Refuses to Overturn Cap on Attorney Fees

Here's what passes for our light reading lately: cases involving plaintiff lawyers griping about their fees. We recently posted about a battle royale among ex-partners in a plaintiff firm. Now we have a Second Circuit opinion where a plaintiff lawyer chafed under fee limitations imposed by Judge Weinstein in the Zyprexa MDL. Mulligan Law Firm v. Zyprexa MDL Plaintiffs' Steering Committee II and Eli Lilly and Co., No. 07-3815-cv (2d Cir. Feb. 3, 2010).


It's not as if we're obsessed by plaintiff attorney fees. Mostly it's none of our business -- consenting adults and all that. But sometimes it's like driving past a car accident; you know that rubber-necking doesn't do anybody any good, but you still slow down and glance at the wreckage. Further, turnabout is fair play. We've read way too many plaintiff briefs where, apropos of nothing, they make snarky comments about how much money the defendant is paying its lawyers. (Most of our clients are public companies and disclose these matters.) It's as if the plaintiff attorneys are bleating that the defendant should stop defending itself and should, instead, short-circuit the process by simply handing the money over to them. Of course there is that minor distinction between paying for a valid defense versus shelling out bucks for an inflated inventory of cases, most of which are comically deficient. Plus, the problem with paying nuisance values is like the problem with voting: it only encourages them.

The other amusing thing about plaintiff lawyer fee disputes is that they remind us of what really is driving these folks -- and it usually isn't civic virtue. Plaintiff lawyers like to rail against corporate greed. The next case where a plaintiff lawyer doesn't wheel out the "dollars over lives" rubric will be the first. Meanwhile, we've seen some lawyers treat their plaintiff-clients more like pawns or obstacles than like, um, clients. To our eyes, the theme of these fee disputes is so ugly we are loath to utter it, but it begins with "hypo" and ends with "crisy."

So much for our Monday screed. Now to the case.

As part of the Zyprexa settlement, Judge Weinstein issued two orders on plaintiff attorney fees that rubbed at least one firm the wrong way: (1) capping plaintiff attorney fees at 35%, and (2) requiring 3% of settlement proceeds to be set aside for a common benefit fund, which would go to a plaintiffs' steering committee. That's why one of the appellees is "Zyprexa MDL Plaintiffs' Steering Committee II." Therefore, in challenging these provisions, the Mulligan law firm is fighting against not only the defendant, but also other plaintiff lawyers. So we've got that going for us, which is nice.

Judge Weinstein's orders seem neither novel nor crazy. 35% sounds like the going rate. As for the common fund, our experience in MDL's is that the level of effort among the various plaintiff firms is ... diverse. Usually there are a couple of firms that do all the heavy lifting (document analysis, depositions, briefing, general annoyance) while most merely sit on the sidelines and collect marginal cases. Where do we hear the most vivid kvetching about lazy, bottom-feeding plaintiff attorneys? Out of the mouths of lead plaintiff lawyers, that's where.

The Mulligan firm didn't like the 35% cap because it had negotiated a 40% rate with its clients. It also - big surprise - didn't like paying 3% to its co-counsel. How to escape these cramps on its style? Mulligan argued that 61 of its Zyprexa cases -- brought by over 1,000 (!) plaintiffs -- had been improperly removed. Mulligan had moved to remand, and those remand motions were still pending at the time of the appeal. Well, that argument is sort of clever. There's only one problem: the Second Circuit held that it lacked jurisdiction over the appeal.

Mulligan filed an interlocutory appeal under 28 USC section 1292(a), which confers on appellate courts jurisdiction over, inter alia, "[i]nterlocutory orders of the district courts ... granting, continuing, modifying, refusing or dissolving injunctions, or refusing to dissolve or modify injunctions ...." The Second Circuit interprets that provision to authorize an appeal only from an injunction that gives substantive relief. Hence, the question is whether attorney fees are "substantive." The Second Circuit answered that question in the negative: "Indeed, it does not so much as relate to the substantive issues in the litigation." An injunction under 1292(a)(1) must grant at least part of the ultimate relief sought by the moving party. The Second Circuit pointed out that to the extent there was a "moving party" here, it was the plaintiff steering committee -- which is not a party to the litigation itself and was not seeking ultimate coercive relief.

We're not done. In the alternative, Mulligan sought mandamus. That's a drastic remedy. It is reserved for extraordinary cases where there is judicial usurpation of power or a clear abuse of discretion. The Second Circuit saw none of that here.

Judge Lewis Kaplan (SDNY) was sitting on the panel by designation. As some of you doubtless know, Judge Kaplan has been busy dealing with some high-profile financial cases. But he was not, apparently, too busy to write an extensive and thoughtful concurring opinion in this case where he favors an "advisory mandamus" on the issue of whether Judge Weinstein could legally apply the 3% set-aside to plaintiffs whose remand motions were pending. Judge Kaplan contends that in mass tort cases a shrewd judge might want to focus on issues other than remand, and that a common fund might make sense in terms of pretrial management and overcoming inevitable free-rider problems.

The majority opinion expresses "sympathy with the carefully reasoned concurring views of Judge Kaplan," but concludes that those complex issues simply need not be addressed at this point.

We view this result with equanimity. We don't have a dog in this hunt. We're not working on the case, and we don't have any rooting interest among the various plaintiff lawyers. To the contrary.

In the end, what is most interesting about this case is something we've seen a lot lately, at least where judges are smart and probing: jurisdictional questions can be paramount, and can offer elegant ways of disposing of thorny issues. No matter what legal issue is being teed up, at least one member of a legal team should spend some quality time focusing on jurisdictional issues. That can include time traipsing through Westlaw, LEXIS, and White & Miller. It can also include closing the door, sitting back, and thinking.

Recall as Subsequent Remedial Measure

We covered the topic of product recalls being excludable as subsequent remedial measures in some detail in our Total Recall post, including a list of all the cases we were aware of (whether they involved drugs/devices or not) that had excluded recalls for this reason.  There wasn't a single federal court of appeals in the lot (the only appellate case to consider it had allowed admission despite it being a SRM under a theory that's since been amended out of Rule 407.

That's why we were delighted this morning when we came across Rutledge v. Harley-Davidson Motor Co., No. 09-50533, slip op. (5th Cir. Feb. 3, 2010), which affirmed exclusion of a motorcycle (what else) recall as a subsequent remedial measure.

We would have been even more delighted if Rutledge had been published, but unfortunately it isn't.

Plaintiffs’ Experts And Peer Review Don’t Mix

Just the other day we brought you news that the British medical journal Lancet issued a full retraction of an purported scientific article by a plaintiffs’ expert in autism litigation. The author, who was at the time also serving as a plaintiff-side expert, described parts of his research in a manner that “have been proven to be false.”

Something similar seems to be happening in the Accutane litigation. There’s a new opinion, Palazzolo v. Hoffman-La Roche Inc., No. A-3789-07T3, slip op. (N.J. Super. App. Div. Feb. 3, 2010), in which another plaintiff’s expert has gotten called out for essentially the same thing – publishing an article in a medical journal that failed to accurately describe what was actually done.

Be ready to hold your nose, here's what went down, and it ain't pretty:

In Palazzolo the plaintiff’s expert, James Bremner, was hired to offer an opinion that Accutane caused depression and suicide. The sticky situation began when, in the words of the Court, “Plaintiffs paid Bremner to undertake a further study. There is no dispute that the study was commissioned specifically for use in this litigation.” Slip op. at 3. That study – bought and paid for by plaintiffs’ counsel – was nevertheless published at J. Douglas Bremner, M.D., et. al., “Functional Brain Imaging Alterations in Acne Patients Treated With Isotretinoin,” 162 Am. J. Psychiatry 983 (May 2005). Slip op. at 4.  You can read the whole thing on line here.

According to the opinion, the study protocol (we use the term advisedly) injected some patients with “radioactive glucose” and then “sliced” their brains with something called a “PET scan” – “PET” being short for "positron emission tomography.” Slip op. at 3. However, there didn't seem to be much dispute that PET scans can’t diagnose depression, therefore, the court held a hearing. Id. at 4 (“the judge questioned how the PET scan study, which all parties agreed did not diagnose depression, nonetheless allowed Bremner to reach the conclusion that Accutane caused depression”).

That hearing was beginning of the end for Dr. Bremner’s study, because the court ordered him deposed, and cross-examination brought out what four judges (the trial judge and the unanimous three-judge panel) all agree happened:

• “Bremner did not actually use the methodology he claimed to have used. Although his PET scan article was peer-reviewed, he admitted that he did not in fact follow the steps described in the article.” Slip op. at 10.
• “[C]ontrary to representations made in the article, he did not get before-and-after. . .questionnaires from many of the subjects.” Id. at 10-11.
• "Bremner also could not document much of the data on which his published results were based."  Id. at 11.
• “[H]e admitted that some of the statistical analysis was inaccurate. For example. . .Bremner admitted that, for each study participant, comparing the activity in the orbital frontal cortex with the activity in the whole brain revealed no difference between the subjects who took Accutane and those who took antibiotics.” Id.
• “[H]e testified. . .that the ‘absolute metabolic rates’ for the two groups was significantly different, and contended that was the key finding of the PET study. However, Bremner. . .could not produce the source data for that analysis because [it] was on an optical computer drive that could not be opened.” Id.
• “[H]e admitted that some of the [data] he used in his calculations were inaccurate, [but] could not check the accuracy of the remaining numbers because the original data could not be retrieved.” Id. at 12.

Thus the court affirmed throwing the study out even under New Jersey’s relatively liberal standard for admissibility of expert evidence. “An expert's scientific peers cannot fairly judge the expert’s written work. . .if his article does not accurately represent either the underlying data or what the author did to produce his results.” Slip op. at 12. Four judges unanimously agree that “Bremner’s study was not soundly and reliably generated.” Id.

But just when we're getting ready to cheer the panel for calling out Dr. Bremner's faked article, we nearly swallow our tongues.  The trial court's order excluded Bremner altogether, probably (we haven't seen it) reasoning along the lines of the old legal maxim, "falsus in uno, falsus in omnibus."  State v. Wesler, 59 A.2d 834, 837 (N.J. 1948); see, e.g., Howard v. Fortuna, 2009 WL 2031060, at *7 (N.J. Super. A.D. July 15, 2009) (unpublished, affirming trial judge's decision on basis of "false in one, false in all" doctrine). 

The appellate court reversed the total exclusion and – despite all the findings about how the article had been faked – remanded at plaintiff's insistence to determine if, "without reference to the PET study," Dr. Bremner could nonetheless give a causation opinion.  Slip op. at 20.  Our own words fail us, so we rely upon Joseph Welch's retort to Sen. Joseph McCarthy:  "Have you no sense of decency, sir, at long last? Have you left no sense of decency?" 

Thus, even after holding that Dr. Bremner's main basis for his testimony was an "article [that] does not accurately represent either the underlying data or what the author did," the court was nevertheless willing to allow him to offer an opinion in the same matter.  Amazing.
On a more general level, we are, frankly, sick and tired of hearing the academic types and the popular press moan and wring their hands about the fact that our clients fund a lot of published studies in the medical literature. If they didn’t, there wouldn’t be very much literature, and the journals would have to print more junk science along the lines of the Lancet and the American Journal of Psychiatry articles.

Compared to that kind of litigation-inspired trash, the safeguards built into FDA-regulated clinical trials are ... well, there's no comparison, really.  A drug manufacturer’s studies have to meet rigorous FDA standards. These studies are subject to written, detailed protocols, those protocols have to be followed or there’s Hell to pay (and a great deal of money down the drain), every step of the way has to be documented, and after that, everything is submitted for review by independent FDA scientists who can require submission of any additional data that they want.

Those are a lot of reasonable guarantees of genuineness – to steal a phrase from hearsay evidence cases. They’re not perfect, of course, but FDA-regulated clinical trials are already subject to pretty stringent standards.

What’s really appalling is what happened twice this week – exposure of the kind of shenanigans that turn up all too often when studies are actually paid for by litigants for litigation purposes. Where's the outrage (other than here)?  We think that if academic journals don’t already ask authors whether they’ve been retained as experts in litigation concerning any drug/device/vaccine they are studying, they damn well should.

And mere disclosure's not enough.  The ordinary peer review process doesn't seem to be robust enough to ferret out litigation-driven academic fraud.  So we think that if the answer to the disclosure question is “yes,” more needs to be done.  If there’s a litigation expert seeking to publish about anything litigation related, we think academic journals – to safeguard their own integrity – should include at least one opposing-side litigation expert in the peer review process.

Note that we’re not limiting our proposal just to plaintiff-side experts, although that seems to be from where most of the “smoke” is now rising. That's because:  (1) we trust our experts more than we trust the other side’s, so we’re comfortable with increased scrutiny across the board, and (2) if we’ve got a bad apple with a rotten study, we’d like to know about that sooner rather than later.

If special scrutiny is not paid to studies being pushed by litigation experts, there are only going to be more embarrassments on the order of what we’ve seen this week. Junk science doesn’t stop being junk science just because some academic journal is bamboozled into publishing it.

Smoke 'Em If You Got 'Em (The FDA May Try To Take Them Away)

What does a smokeless “electronic cigarette” have to do with drugs and medical devices?  Well, according to the FDA, an electronic cigarette is a "drug-device combination."  Lately, however, it seems that the Agency’s position has become a strategic misstep. It gave rise to this a recent opinion by Judge Richard Leon, Smoking Everywhere, Inc. v. FDA, ___ F.Supp.2d ___, 2010 WL 129667 (D.D.C. Jan. 14, 2010).  Although the effect of the opinion was recently stayed pending appeal, we think it could prove useful in off-label cases down the road – you know, off-label cases involving real drugs and devices.

 

The Smoking Everywhere case involved two electronic cigarette manufacturers who sought to enjoin the FDA from regulating electronic cigarettes as drug-device combinations and denying entry of those products into the US (the functional effect of removing them from the market). First of all, what the heck is an “electronic cigarette”? As far as we can tell, it’s little machine designed to look like a cigarette that vaporises nicotine extracted tobacco and delivers it by mouth to the user. There’s no smoke, so it can be used in increasingly prevalent “no smoking” areas – hence the name “Smoking Everywhere.”  2010 WL 129667, at *1.  It’s a frankly recreational product, offering to smokers the “pleasures” they associate with cigarettes when they can’t (or don't want to) light up.  Id.

 

The FDA decided to consider that a “drug/device combination,” rather than a “tobacco” product. The court said “unh-unh,” granted the preliminary injunction, and concluded:

 

[T]he plaintiffs are substantially likely to succeed on their claim that FDA cannot regulate and thereby exclude their electronic cigarettes from the United States on the basis that those products are an unapproved drug-device combination under the FDCA.

2010 WL 129667, at *10.

 

There’s a lot of discussion in Smoking Everywhere about the 2009 Tobacco Act and the extent to which the FDA may regulate “tobacco products.”  We're staying away from that.  First, it's all very interesting but not really the focus of this blog.  Second, we've got tobacco industry clients.

What caught our eye about the opinion was the discussion about whether the manufacturers were making “therapeutic” claims about their electronic cigarettes.  The argument the court rejected was classic FDA-speak:  We have already concluded that electronic cigarettes appear to be “intended…to prevent, mitigate, or treat the withdrawal symptoms of nicotine addiction.” Id. at *8. Therefore, electronic cigarettes aren’t “tobacco products” but are instead drug-device combinations that are being marketed for unapproved uses in violation of the FDCA. And don’t you dare second-guess us, because we’re the FDA and our opinions are entitled to “Chevron deference.” That last bit is FDA jargon for the deference accorded to certain administrative agency decisions by Chevron USA, Inc. v. Natural Resources Defense Council, Inc., 467 US 837 (1984). If you’re interested in that, we’ve ventured into that a number of times, including here.  Also, if you’re interested in that – get a life.

 

Not so fast, said Judge Leon. “Intended use” doesn’t turn on FDA diktat – rather, “[t]he ‘intended use’ of a product is determined by ‘the objective intent of the persons legally responsible’ for labeling the product.” 2010 WL 129667, at *8 (quoting 21 C.F.R. §201.128). Oops. The court took the FDA to task for advancing a position that was “unsupported by substantial evidence,” id., where the best the FDA could do (other than relying on its own prior conclusion that electronic cigarettes are intended to prevent nicotine withdrawal) was point to a couple of advertisements suggesting electronic cigarettes as “an alternative – albeit a healthier alternative – to traditional cigarettes.” Id. at *9. Ouch.

 

“Objective” intent in the context of off-label promotion claims is of significant interest to us.

So what should court look to as evidence of “objective intent” when determining the intended use of a drug or device?

• “‘Labeling claims, advertising matter, or oral or written statements’ by the labeler;” id. at *8; or
• “‘by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised.’” Id.

What’s not on that list? FDA conclusions about the “intended use” of the product. Of course, even these indicia of “objective intent” are subject to criticism because of their vagueness, as Allergan is pointing out in their case against the FDA (previous discussions here, here, here (way at the end), and here). But at a minimum, the FDA’s own conclusions shouldn’t be considered probative, let alone conclusive, of the “intended use” of a product.

 

This is an important point, particularly with the FDA unleashing its minions to issue enforcement letters without legal oversight, as we discussed in considerable detail in a recent WLF Legal Backgrounder.  So FDA letters need to be analyzed appropriately if they depend on "intended use" - it's the manufacturer's "objective" actions, not some bureaucrat's subjective reaction, that matters.  The Smoking Everywhere opinion will be of use to anyone who seeks to challenge FDA enforcement efforts based solely on the FDA's own views of a product's intended use.

 

More Evidence That Vaccine-Autism Link Is Garbage

The BBC is reporting that the British Medical Journal Lancet has issued a full retraction of the notorious 1998 article that claimed there was an increased risk of autism associated with use of the MMR vaccine.  Among the grounds for the retraction:  the lead author "was in the pay of solicitors who were acting for parents who believed their children had been harmed by MMR" and that author "was ruled last week to have broken research rules."

And it still took twelve years to get a full retraction.  Imagine the fuss if a defense expert had done something like that.

We've said before that we thought autism litigation against vaccine manufacturers was utterly meritless (not to mention harmful to children in particular and society as a whole).  Here's to another (belated) silver stake through the heart.

On Judicial Estoppel

Once upon a time, quite a few years ago, one of us had the pleasure of a having a case before the (late?) Hon. John Dowling of the Dauphin County (Harrisburg, Pa.) Court of Common Pleas. We still remember winning the case on summary judgment – after finishing our argument, the first words out of the judge’s mouth to the other side were, “How are you going to get out of that?” They didn’t.


Anyway, Judge Dowling had quite a literary bent, which he put to work in his opinions. You could always tell when you were reading a Dowling opinion. Once he had a case involving a party with a habit of taking contradictory positions. Ultimately he was forced to invoke the doctrine of judicial estoppel to put an end to that. His estoppel discussion began:

Not since Joan de Pucelle in Shakespeare’s Henry VI, Part I attempted to defend herself from a capital charge by proclaiming herself a virgin and then, seeing that that particular defense was unlikely to prevail, informed the judge that she was with child, has anyone argued a judicial point with a more breathtaking lack of concern for consistency.

Ligon v. Middletown Area School District, 110 Dauph. Co. R. 9, 11 (Pa. C.P. Dauphin Co. 1989) (quoted in Ligon v. Middletown Area School District, 584 A.2d 376, 379 (Pa. Commw. 1990).

Not exactly one of Shakespeare’s better known works – but that was Judge Dowling – a renaissance man.

We got thinking about Judge Dowling and Joan de Pucelle because of some antics by the other side in litigation that shall remain nameless. The other side first argued, after Wyeth v. Levine, 129 S. Ct. 1187 (2009), of course, that no, there was no preemption because the drug manufacturer was free to ignore and supplement the FDA approved labeling language due to (you guessed it) the FDA’s “Changes Being Effected” (CBE) regulation. In short, the plaintiff argued that there’s nothing mandatory, and therefore preemptive, about FDA-approved drug labeling.

Unfortunately, that’s a position that – after Levine – a lot of courts buy. We don’t think that’s how the FDA really works, but as we’ve said before, strange things happen when preemption meets product liability.

Be that as it may.

After the plaintiff took that position, and prevailed in the trial court, the case moves closer to trial. We move to exclude labeling changes and other FDA regulatory activity that took place after the plaintiff last took the drug. They’re subsequent remedial measures, we argue. The plaintiff’s response was no they’re not subsequent remedial measures at all because only voluntary actions qualify – and the FDA’s later actions are (you guessed it, again) mandatory.

Mandatory?

But didn’t the same plaintiff just win a preemption motion with that argument that FDA mandated labeling wasn't mandatory?

Our own words temporarily failing us, we thought of Judge Dowling and Joan de Pucelle. Then we thought of judicial estoppel, which is what Ligon was all about. The basic rule is quite simple – no party can take a position in open court, prevail on that position, and then assert the opposite position. There’s no judicial estoppel without winning the first go round (a party can lose and change its position), but after prevailing, well, a party that made its bed with respect to its winning legal position has to sleep in it. Thus as a legal matter a party can claim to be either a virgin or pregnant, but not both. There’s no exception for immaculate conception.

Don’t get us wrong, though, we don’t think much of the underlying argument either. We just might not have been moved to post about it without the blatant flip flop. But since we have….

We don’t claim to know about all states, but recalls, and subsequent drug label changes have been considered subsequent remedial measures in Pennsylvania – with no distinction between “voluntary” and “mandatory.”  See Incollingo v. Ewing, 282 A.2d 206, 222-23 (Pa. 1971) (subsequent drug label change a subsequent remedial measures; admitted under exception to rule); Matsko v. Harley Davidson Motor Co., 473 A.2d 155, 158 (Pa. Super. 1984) (“statutory” motorcycle recall “mandated by federal statute” is a subsequent remedial measure; subsequent remedial measures held admissible in strict liability), overruled on other grounds, Duchess v. Langston Corp., 769 A.2d 1131, (Pa. 2001) (subsequent remedial measures equally excludable in negligence and strict liability); Hardin v. Upjohn Co., 47 Pa. D. & C.3d 66, 70 (Pa. C.P. Philadelphia Co. 1986) (FDA recall an excludable subsequent remedial measures). If Pennsylvania is any indicator, there are probably bunches of cases that consider government-ordered conduct to be subsequent remedial measures. If our plaintiff keeps this up, that’s probably going to force us to look for those cases at some point.

But since we’re about drugs and devices, we turn to Bexis’ book, where we find loads of precedent holding that subsequent changes in drug labeling, and other FDA actions (such as recalls) are considered subsequent remedial measures: Chlopek v. Federal Insurance Co., 499 F.3d 692, 700 (7th Cir. 2007) (label change); Stahl v. Novartis Pharmaceuticals Corp., 283 F.3d 254, 270 n.10 (5th Cir. 2002) (label change); Kehm v. Procter & Gamble Manufacturing Co., 724 F.2d 613, 622 & n.7 (8th Cir. 1983) (recall; allowed in strict liability under pre-1997 version of Fed. R. Civ. P. 407); DeLuryea v. Winthrop Laboratories, 697 F.2d 222, 227-29 (8th Cir. 1983) (label change excludable under pre-1997 version of Fed. R. Civ. P. 407); Lindsay v. Ortho Pharmaceutical Corp., 637 F.2d 87, 94 (2d Cir. 1980) (label change excludable under pre-1997 version of Fed. R. Civ. P. 407); Werner v. Upjohn Co., 628 F.2d 848, 853 (4th Cir. 1980) (label change excludable under pre-1997 version of Fed. R. Civ. P. 407); Smyth v. Upjohn Co., 529 F.2d 803, 804-05 (2d Cir. 1975) (label change) (label change excludable under pre-1997 version of Fed. R. Civ. P. 407); Hughes v. Boston Scientific Corp., 2009 WL 3817586, at *12 (S.D. Miss. Nov. 12, 2009) (recall); Gerber v. Hoffmann-La Roche Inc., 392 F.Supp.2d 907, 919 (S.D. Tex. 2005) (label change); Appleby v. Glaxo Wellcome, Inc., 2005 WL 3440440, at *6 n.7 (D.N.J. Dec. 13, 2005) (label change); Swank v. Zimmer, Inc., 2004 WL 5254312, at *1 (D. Wyo. April 20, 2004) (Dear Doctor letter and recall); Figueroa v. Boston Scientific Corp., 2003 WL 21488012, at *4-5 (S.D.N.Y. June 27, 2003) (recall); In re Propulsid Products Liability Litigation, 2003 WL 1090235, at *2 (E.D. La. March 11, 2003) (recall); [why the big 1989-2002 snooze, we don't know]; Kociemba v. G.D. Searle & Co., 683 F. Supp. 1579, 1581-82 (D. Minn. 1988) (recall); Martinkovic v. Bangash, 1987 WL 28400, at *1 (N.D. Ill. Dec. 18, 1987) (label change); Richardson-Merrell, Inc. “Bendectin” Products Liability Litigation, 624 F. Supp. 1212, 1239 (S.D. Ohio 1985) (recall), aff’d, 857 F.2d 290 (6th Cir. 1988); Wetherill v. University of Chicago, 565 F. Supp. 1553, 1557-58 (N.D. Ill. 1983) (FDA submission seeking label change); Wolf v. Procter & Gamble Co., 555 F. Supp. 613, 623 (D.N.J. 1982) (recall); Skill v. Martinez, 91 F.R.D. 498, 509 (D. N.J. 1981) (label change); Janssen Pharmaceutica, Inc. v. Armond, 866 So. 2d 1092, 1100-01 (Miss. 2004) (label change); Wagner v. Roche Laboratories, 671 N.E.2d 252, 258 (Ohio 1996) (label change); Cosgrove v. Merrell Dow Pharmaceuticals, Inc., 788 P.2d 1293, 1296-97 (Idaho 1989) (recall); Northern Trust Co. v. Upjohn Co., 572 N.E.2d 1030, 1038 (Ill. App. 1991) (label change); Witherspoon v. Ciba-Geigy Corp., 1986 WL 2138, at *2 (Tenn. App. Feb. 12, 1986) (label change); Ortho Pharmaceutical Corp. v. Chapman, 388 N.E.2d 541, 560-61 (Ind. App. 1979) (label change); Smith v. E.R. Squibb & Sons, Inc., 245 N.W.2d 52, 58 (Mich. App. 1976) (label change), aff’d, 273 N.W.2d 476 (Mich. 1979).

Whatever comes, we’re ready. And thank you Judge Dowling for the Shakespearean inspiration.

Ex Parte Animal

Have you ever noticed how you notice the same thing everywhere when you're thinking about it? If you're contemplating purchase of a station wagon, you see station wagons all over the place (sort of like the parking lot of a 1970's Bobby Sherman concert).

We've been thinking about ex parte interviews with treating doctors. We're working on them for paying clients. We blogged about a recent case here. And what do we get?  A reader sent us a November 2009 unpublished decision from a Missouri appellate court, State ex rel. Proctor v. Messina, 2009 WL 3735919 (Mo. App. W.D. Nov. 10, 2009). Sorry to say it, but we like this Missouri opinion even less than we like station wagons.

 

Before we get to the grisly details, let's review the basics about ex parte interviews of doctors:

 

• We like them. What treating doctors say is terribly important. Some jurors toss out the competing expert opinions and trust the treaters. The treaters developed their opinions in the course of treating a real human being and they made important - maybe even life-and-death - decisions. Their patient's health, and their own reputation (and malpractice exposure) was on the line. It's music to our ears when treaters say that the plaintiff needed the drug, the drug helped the plaintiff, the drug did not hurt the plaintiff, and, knowing what the doctor knows today, the doctor would still prescribe that drug to plaintiff.
• We really don't like an unlevel playing field. It's a huge litigation advantage if the plaintiff’s lawyers can talk to the doctors before depositions but the defense lawyers cannot. It's especially vexing if the plaintiff’s lawyer is spending time with the doctor saying things like, "My client is not suing you - yet. And he doesn't want to. Etc". And that "Etc" is big. We're not saying anybody is doing anything unethical. But there's some pretty aggressive sausage-making out there. Or boudin. Or hot links. (It all depends on where the plaintiffs' lawyers call home.) Further, plaintiffs' lawyers like to trot out internal company “hot docs” or call notes in an effort to anger the doctors and enlist them as oath-helpers. That's why the recent In re Ortho Evra Products Liability Litigation, MDL No. 1742 (N.D. Ohio Jan 20, 2010) decision furnishes some relief. It tells plaintiff lawyers they can discuss only their patient's condition with doctors; they cannot practice their closing argument in front of the poor treaters.
• In terms of a level-playing field, we prefer both-sides-can-talk to neither-side-can-talk. It's better if both sides can make an early assessment of the case. Also, as the first amendment honchos like to say, the best remedy for bad speech is more speech, not restrictions on speech.

 

The Proctor case locks in the unlevel playing field, and for all the wrong reasons. It ends up saying that HIPAA stops defense lawyers from talking with doctors, even about issues that the plaintiff has put fully in play in the litigation, and that such HIPAA rule is either consistent with Missouri law or, if it isn't, it preempts it. It is a bad result that is badly reasoned. 

 

To begin with, the Proctor court acknowledges that under existing Missouri precedent, Brandt v. Pelican, 856 S.W. 2d 658 (Mo. banc 1993) (Brandt I), and Brandt v. Med Defense Assocs.. 856 S.W. 2d 667 (Mo. banc. 1993) (Brandt II), “there was no statutory basis in Missouri for concluding that voluntary ex parte communications between defense counsel and plaintiffs counsel were prohibited.” Proctor, 2009 WL 3735919 at *7 (emphasis in original). No great revelation there; we said that much in our 50 state survey on ex parte communications.

 

 But then Proctor says that HIPAA changed everything because it prevents ex parte communications with doctors save for certain exceptions, none of which (according to the court) applies here. 

 

Well, now we know the court hasn’t read our blog, because we’ve already made a compelling argument that HIPAA does not preempt state litigation practice on ex parte communications with doctors. Missouri, which had been a safe, friendly place for ex parte communications with doctors should remain so. But alas.

 

The Proctor court first says preemption isn’t necessary, because Missouri law does not require ex parte contacts. Rather, it is silent. And HIPAA harmonizes perfectly nicely, thank you, with such silence. But even if there is any conflict, then HIPAA preempts. This despite the presumption against preemption. This despite the government’s clear statement that HIPAA was “not intended to disrupt current practice whereby an individual who is a party to a proceeding and has put his or her medical condition at issue.” 65 Fed. Reg. 82462, 82530. The better reasoned opinions on this subject (from, for example, New Jersey and New York) have concluded that HIPAA does not preempt state discovery practices regarding informal treater interviews. See our discussion here.

 

Look, it’s pure double talk for the Proctor court to say it’s not really deciding preemption, but if it is, then it’s all for it. Existing Missouri law permitted ex parte communications. Now, courtesy of HIPAA, such communications are verboten. Sounds like preemption to us.

 

But we think the main problem with the Proctor decision is its crabbed reading of HIPAA’s exceptions. HIPAA permits disclosure “in the course of any judicial … proceeding” or “in response to an order of a court,” or “[i]n response to a subpoena, discovery request, or other lawful process, that is not accompanied by an order of a court.” 45 C.F.R. §164.512(e)(1)(i)(ii).

 

Under any ordinary understanding of the litigation process, or of plain English, an ex parte communication with potential witnesses could find a home in one of those exceptions. But the Proctor court says that a “judicial proceeding” is limited to proceedings where the court is actually present or where the court somehow empowered the proceeding to take place. So doctors can testify in court or be deposed.  That's the court's "plain English" reading of "proceeding" -- the presumption against preemption, the Levine court's supposed "cornerstone," be damned.  

 

Of course it occurs to any half-bright litigator (and we hope we’re at least that) that the court can empower an ex parte communication by making some sort of order permitting it to happen, perhaps with the sort of limitations in Ortho Evra. And here is where we end up in Catch 22 or Through the Looking Glass. The Proctor court interprets Missouri precedent to preclude such an order. Under Brandt II, courts cannot order doctors to submit to such ex parte communications. We don’t have a problem with that. Doctors are busy, and if they don’t want to have a nice, informal chat, that’s their business. But the Proctor court interprets State ex rel. Woytus v. Ryan, 776 S.W. 2d 389 (Mo. banc 1989), to prevent courts from ordering plaintiffs to sign medical authorizations consenting to ex parte communications with treating physicians. According to the Proctor decision, “Woytus ‘shows a judicial philosophy that discourages ex parte conversations with plaintiff’s doctor.’” 2009 WL 3735919 at *7 (quoting Brandt I, 856 S.W. 2d at 661).

 

It is clear that such hostility to ex parte communications animates the Proctor opinion. But the one-sided result makes no sense. First, Brandt II correctly concluded that plaintiffs who had put their medical condition at issue had waived the physician’s testimonial privilege and duty of confidentiality on such issues. Second, if, as both the Woytus opinion and the Proctor concurring opinion say, ex parte contacts with doctors “could disintegrate” into discussions of the “physician’s professional reputation,” “the notion that the treating physician might be the next person to be sued, and other topics which might influence the treating physicians’ views” (Proctor, 2009 WL 3735919 at *14 (concurrence) (quoting Woytus, 776 S.W. 2d at 395)), all of that exists at least as much, and probably a whole lot more, when plaintiffs’ lawyers start bending the ears of their clients’ doctors. 

 
Here is where we are: the Proctor decision has changed Missouri law, and for no good reason. Until it is overturned, the smart move by a defense lawyer is probably to seek out an Ortho Evra-type order that at least makes a gesture in the direction of limiting plaintiff lawyers from preloading doctors.

 

Some of you may have noticed that we've criticized a couple of Missouri opinions lately. The Nuvaring MDL (which, by the way, did a much better job on ex parte doctor interviews) is in Missouri, and we've been lobbing unkind words at it. Let's be clear: we've got nothing against Missouri. Cardinals baseball fans are the best. Truman was an admirable President. When we were kids, we were keen on the Pony Express. We hear that the Andy Williams show in Branson really rocks. And Missouri has the best state motto: Show Me. We just wish the courts there would start showing us some good law. 

 

Fraud on the FDA - It's Garcia over Desiano in Texas

Texas, like Michigan, imposes a strong presumption of non-defectiveness on drug labeling approved by the FDA.  As to the Michigan statute (which has been around longer), the Sixth Circuit (where Michigan is located) ruled that an exception to the presumption for fraud on the FDA was preempted by Buckman.  Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961, 965-66 (6th Cir. 2004).  The Second Circuit, which ordinarily has nothing to do with Michigan, held to the contrary in Desiano v. Warner-Lambert & Co., 467 F.3d 85, 98 (2d Cir. 2006), aff'd by equally divided court, 552 U.S. 440 (2008).  Everyone knows we prefer Garcia (where Bexis filed an amicus brief) to Desiano - and that overall Garcia's been winning.

We're pleased to say that the streak continues.  The other day a federal court in Texas came down strongly on the Garcia side of the line, holding that the Texas exception for fraud on the FDA was preempted:

this court determines that the rationale in Garcia is persuasive and that extending the holding of Buckman to fraud-on-the-FDA exceptions is warranted. The court finds that the concerns in Buckman hold true not only where a plaintiff brings a fraud-on-the-FDA claim but also where it seeks to show an exception to the presumption here. To avoid any intrusion upon the FDA's right to police fraud itself, the court follows Garcia and finds that section 82.007(b)(1) [the Texas fraud on the FDA exception] is preempted in some circumstances, including as here, where Plaintiffs ask the court to reach the conclusion opposite of that reached by the FDA, that Defendants did not withhold information or mislead it.

Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 2010 U.S. Dist. Lexis 6390, at *32 (N.D. Tex. Jan. 27, 2010).  Because there was no dispute that the drug's label was approved, the failure to warn claim was dismissed.

There's other interesting stuff in Lofton, some good, some bad, but we'll save that for some other post.