Tuesday, January 30, 2007

Silly MDL Tricks

We've all seen 'em; it's time to talk about 'em: silly MDL tricks.

It starts with a few plaintiffs filing a motion with the MDL Panel to centralize a set of product liability cases. Then the loonies spring into action.

A subset of plaintiffs' counsel believe that the MDL Panel is more likely to centralize cases in the jurisdiction where the "most plaintiffs" have complaints pending. These clowns thus file bigger and bigger class actions, so they can lay claim to the most expansive complaint in the country. They tell the Panel that "everyone in the state of Illinois is part of a putative class action pending in the Northern District of Illiois," so the cases should be transferred to a federal court in Chicago. Or "the only national class action is pending in the S.D.N.Y.," or "we have a global class pending in the C.D. Cal." We haven't yet seen it happen, but why not an intergalactic class? Surely the Panel would ship the cases to the only jurisdiction with a lawsuit pending on behalf of the citizens of Mars.

What's the logic behind this? We suppose it comforts plaintiffs' counsel to be able to say that they have the most expansive class pending in their preferred transferee district. But, particularly in product liability cases, the likelihood of a class actually being certified decreases as choice of law issues multiply. Why should the Panel be influenced by the pendency of an uncertifiable putative class action? (Frankly, in our experience, the Panel does not appear to be influenced by this silliness, so the real question is why certain plaintiffs' counsel continue to play this game.)

Another silly MDL trick is for plaintiffs to name an unnecessary "alphabet defendant" -- a trade association that can be named on a conspiracy claim, or some other tangential defendant that can be joined in every product case -- to create a common question of fact. "There must be a common question of fact," plaintiffs argue, "because the AAQQ is named as a defendant in every case, and discovery about the AAQQ will be common to all cases."

This trick is not quite as transparently silly at the ever-expanding class dodge, but the Panel should nonethelss be wary of it. Cases that share no fundamental factual questions in common should not lightly be centralized simply because clever plaintiffs' counsel choose to name a trade association as a common defendant in all of the cases. The trade association is unlikely to lie at the heart of any individual case, and the ruse of naming a trade association can be used too easily to try to create commonality among cases that in fact vary widely.

There's another MDL trick that's less silly. The Panel does, in fact, try to identify a jurisdiction in which the cases are "most advanced" when the Panel selects a transferee district to oversee the centralized cases. Plaintiffs' counsel therefore often press to have the case in their preferred transferee district become the "most advanced." This may mean only propounding voluminous discovery, which is burdensome, but poses no threat to judicial administration. On the other hand, seeking to "advance" a case can also mean pressing aggressively for discovery leading up to a preliminary injunction hearing. Surely, counsel reason, a court that has already held a preliminary injunction hearing is most knowledgeable about the cases and deserves to be the transferee judge.

We can't really fault the plaintiffs' bar for playing this game; the Panel thinks about which cases are "most advanced," so these lawyers are only looking our for their own interest by trying to accelerate their case. (We almost typed "their clients'" interest there, but in the MDL jockeying contest, clients have nothing to do with the game.)

Our problem here is with the other players in the system. Why do potential transferee judges fall for this trick? Permitting multiple sets of plaintiffs' counsel to race for competing preliminary injunctions imposes a terribly unfair discovery burden on the defendant. Generating massive duplicative discovery records plainly undercuts the goal of coordinating discovery (and minimizing costs) for which the MDL Panel was created. And it is simply not true that "the discovery we do in my court will be useful in any later MDL proceeding." The plaintiffs' lawyers who didn't participate in one court's accelerated discovery will insist on re-doing that discovery later, when they can participate and after additional documents have been produced. The early, accelerated discovery will almost surely be repeated after the cases are centralized.

Happily, most district court judges see through the smoke and mirrors and do their best to avoid permitting massive discovery in individual transferor courts that will later be re-done in a coordinated proceeding. Perhaps, because we're exposing the silly MDL tricks here, even fewer judges will be fooled by them in the future.

Monday, January 29, 2007

Litigation preparedness and IT upgrades

Corporations adopt new computer applications for business purposes. Corporations weigh the costs of software licensing, installation, hardware, and application management against the projected value of the new application and increased productivity and improvements in products and services. We hate even to write these next words, but perhaps corporations should consider one other factor, too. Corporations might want to consider the litigation implications, and related potential costs, of new computer applications and the new information they may create.

The litigation considerations involved in information technology upgrades include:

1. Will the application create new bodies of information or communications that the corporation did not previously generate or did not generate in a documented form? The classic example is e-mail. E-mail has to some extent replaced telephone calls and face-to-face conversations and has created a written record of those previously undocumented communications. Voicemail and instant messaging are similar examples. Less obvious examples include shareware and teamsites that provide for team or project message boards and shared drafts for review and editing. Similarly, extranet sites developed for communications and conducting business with suppliers generate a written record. Information technology that creates new written records will generate increased costs (and increased risks) if litigation arises.

2. Will the application replace forms of information or communications that were routinely produced in hard copy and now will exist only in digital formats? If so, the task of gathering and producing that information in future litigation may become more onerous.

3. If the answer to either of the first two questions is yes, what is the likelihood that the information might be relevant to issues in pending or future litigation?

If the newly generated (or preserved) information is likely to be discoverable, can the potentially relevant information be saved and, if so, at what cost? Some applications are not designed to save generated information because the information has no continuing business value. Nonetheless, if relevant to pending or reasonably anticipated litigation, the corporation may be required to preserve the information or face possible spoliation claims or lose potentially valuable affirmative evidence.

4. Even if the new information is not required to be saved, will the newly created information be saved automatically by the application itself(or saved intentionally by the application managers) beyond its useful business life cycle and beyond any legal or regulatory retention requirements? If so, an IT upgrade can create caches of information that the corporation must retrieve and review for litigation purposes at significant cost -- even though there were neither business reasons nor legal obligations to save the information in the first place.

These considerations all fall on the cost side of the ledger. Of course, a new application also may generate documentation that helps the corporation defend or prosecute litigation. Those potential litigation benefits should not be ignored.

We hate to suggest that corporations must consider litigation-related issues when making the business decision whether to buy a new computer application. But, given the cost of retaining, collecting, and producing e-documents in litigation, that issue is becoming increasingly relevant. As those costs predictably increase even more in the future, the folks who develop computer applications may start thinking about these issues, too, and may develop applications that either do not retain information or, if they retain information, do so inexpensively and in an easily searchable format.

Oh brave new world that hath such concepts in it.

Saturday, January 27, 2007

CAFA and choice of law

We read at the Mass Tort Litigation Blog about Professor Samuel Issacharoff's forthcoming article on choice of law in class actions that will appear in the Columbia Law Review. Professor Issacharoff apparently argues that the enactment of the Class Action Fairness Act lends strength to the position that courts should apply a defendant-corporation's home state law to the claims of all plaintiffs in a nationwide class action. We haven't yet read the article, so we're hesitant to comment on it. But not so hesitant that we won't go ahead and comment anyway; heck, we've made fools of ourselves before and we'll surely do so again in the future.

We have three uninformed reactions to the apparent thesis of this forthcoming article. First, as readers of this blog know, we don't believe in applying the defendant's home state law to the claims of all plaintiffs in a putative nationwide class action. As we've said in earlier posts, no one would think of applying that rule outside of the class action context, and the class action procedure is not supposed to alter substantive law. Moreover, if the defendant's home state law governed all claims in nationwide class actions, then corporations would predictably reincorporate in states with more favorable laws. After most American corporations had reincorporated in states that, for example, forbid the recovery of punitive damages, everyone -- plaintiffs' lawyers included -- might be unhappy with the unintended consequence of tinkering with the law.

Second, we're not sure why the Class Action Fairness Act, which was heralded as a procedural reform to move class actions from state to federal court, necessarily says or implies anything about choice of law rules in class actions. As we said, we haven't yet read Issacharoff's article, so maybe we're missing something, but it would take a heck of a good argument to persuade us that CAFA actually speaks to choice of law. (Frankly, given what we do for a living, we probably couldn't admit publicly that we were persuaded, even if we were. But Issacharoff could take comfort in believing that, in our silent heart of hearts, he had convinced us.)

Finally, if CAFA truly somehow reinforces the need for a single body of law to govern nationwide class actions, why should it be the defendant's home state law? Why not a single body of federal regulatory law -- such as endorsing the doctrine of federal preemption and letting expert agencies draft regulations that apply nationally and displace state law? Now that's a proposal for a unitary body of law that we can endorse, but it's unlikely to satisfy the folks who file putative nationwide class actions for a living.

We are, as we said, writing sight unseen, and Professor Samuel Issacharoff may have answers to what we've written. Sam is, after all, a pretty smart guy, and he gets paid for thinking about these abstract issues; the two of us (nutcases that we are) simply blog about them in our spare time. But there's plenty of room for argument here, and we'll follow those arguments with interest.

Friday, January 26, 2007

More Thoughts On Pharmaceuticals Class Actions

Bexis got an unexpected present for his 51st birthday yesterday. The court denied certification of a nationwide suicidality class in the latest Paxil litigation. See Blain v. Smithkline Beecham Corp., 2007 WL 178564 (E.D. Pa. Jan. 25, 2007). This got us thinking more about what’s really going on with pharmaceutical class actions. We can’t talk about Paxil specifically, of course, given our representations, but Blain is paradigmatic of several current trends.

First, it doesn’t matter which pharmaceutical becomes the “flavor of the week” for plaintiffs’ counsel looking to create the next mass tort, as surely as night follows day someone’s going to file a purported class action. It doesn’t seem to matter how wildly different the facts of the supposed class member claims are, the class action complaints just keep on coming. Something else is at work here.

Second, when confronted with the class members’ individual circumstances – especially in personal injury putative classes – class counsel retreat to Rule 23(c)(4) “issue certification,” truly the “last refuge of a scoundrel” in this type of case. Fortunately most courts, like Blain, refuse to buy the expansive view of (c)(4) that would permit certification of any common issue at all, without regard to the overwhelming predominance of individualized issues in pharmaceutical personal injury class actions. Suicide, with its multiplicity of societal, familial, and medical aspects, is a archetype of the individualized injury. Throw in the learned intermediary rule and the added complication of off-label use and the divergent legal approaches states take to such use, and one has to wonder what the plaintiffs are thinking. On the criminal side, where we never practice, there’s a saying that a good prosecutor can get a grand jury to indict a ham sandwich. If the plaintiffs’ view of (c)(4) were to get any legal traction, it would allow courts to certify ham sandwiches as a class. Fortunately, the courts haven’t yet gone that route, at least in cases like Blain.

Third, when faced with the widely varying product liability laws of the fifty states, plaintiffs resort to claiming that the law of the state of incorporation should prevail over the law of all the states where the plaintiffs reside and were injured. Hello? We’ve both got some clients incorporated in places like North Carolina or Michigan that would just love to have their home state’s law applied to all their claims. If that argument ever catches on, then eventually there will be an exodus of businesses out of tort-friendly jurisdictions similar to the flow of corporations to Delaware once that state figured out how choice of law enabled it to export its corporate law all over the country. But again most courts have refused to bite – as this sort of choice of law argument is almost never seen outside of the class action context. Class actions, after all, are supposedly just a procedural device with no effect on substantive law. Yeah, right.

Fourth, except for a couple of recidivist district judges as to whom the question “what part of ‘reversed’ don’t you understand” might be asked, the vast majority of courts refuse to certify classes in prescription medical product tort actions. Blain is just the latest in a long line of such cases. See In re St. Jude Medical, Inc., 425 F.3d 1116 (8th Cir. 2005); In re Vioxx Products Liability Litigation, ___ F.R.D. ___, 2006 WL 3391432 (E. D. La. Nov. 22, 2006); Sanders v. Johnson & Johnson, 2006 WL 1541033 (D.N.J. June 2, 2006); Sweet v. Pfizer, 232 F.R.D. 360 (C.D. Cal. 2005); In re Prempro Products Liability Litigation, 230 F.R.D. 555 (E.D. Ark. 2005); Zehel-Miller v. AstraZenaca Pharmaceuticals, L.P., 223 F.R.D. 659 (M.D. Fla. 2004); Bostick v. St. Jude Medical, Inc., 2004 WL 3313614 (W.D. Tenn. Aug. 17, 2004); Harris v. Purdue Pharmaceuticals L.P., 218 F.R.D. 590 (S.D. Ohio 2003); In re Baycol Products Liability Litigation, 218 F.R.D. 197 (D. Minn. 2003); Benner v. Becton Dickinson & Co., 214 F.R.D. 157 (S.D.N.Y. 2003); In re Paxil Litigation, 212 F.R.D. 539 (C.D. Cal. 2003); In re Rezulin Products Liability Litigation, 210 F.R.D. 61 (S.D.N.Y. 2002); In re Phenylpropanolamine Products Liability Litigation, 208 F.R.D. 625 (W.D. Wash. 2002); In re Propulsid Products Liability Litigation, 208 F.R.D. 133 (E.D. La. 2002). That’s five years – enough free research on the point. So why do plaintiffs keep beating their heads against this wall?

There is, of course, the off chance that they will score big with some judge somewhere. These days, however, that’s a pretty forlorn hope – particularly in the federal system where CAFA ensures that these putative class actions will now wind up. As far as we know, there has not been a single contested class action in product liability, personal injury litigation that’s been affirmed anywhere in the federal system in the decade since the Supreme Court put the kibosh on such things with its Ortiz and AmChem decisions. That’s not limited to just pharmaceuticals, that’s every kind of product that’s made.

What has to be going on is some advantage inherent in the mere filing of a class action complaint, no matter how patently unmeritorious the class action allegations are. There’s only one such advantage that we know of – class action tolling of the statute of limitations (we won't get into procedural wrangling amongst the plaintiffs' bar inter se). Since American Pipe, the Supreme Court has embraced the rather bizarre doctrine that plaintiffs should be rewarded with classwide suspension of the statute of limitations simply because a class action complaint is filed. Whether the complaint has any merit doesn’t matter at all. That’s a most peculiar proposition. We can’t think of any other area where a party gets a substantive legal advantage just for filing a piece of paper that’s a stone cold loser.

American Pipe justified its unusual conclusion on practical grounds – that if class actions didn’t have a tolling effect, the courts would be inundated with duplicative filings by other plaintiffs worried that the statute of limitations would run against their claims if they waited. But then it became too much of a hassle to worry about whether anyone actually relied on a class action filing, so that element got removed, and tolling's justification became purely utilitarian.

Well, if anybody’s been watching, it’s become rather clear that the reason there’s a “mass” in “mass torts” is because courts are being inundated anyway. So as a justification for conferring a substantive advantage upon the mere act of filing, the “we’ll be swamped” argument has gotten pretty threadbare. More importantly, at the time American Pipe was decided, the concept of multi-district litigation was in its infancy. Today, we have (at least in the federal system) procedural mechanisms that make dealing with an avalanche of similar filings, if not routine, then at least routinized.

All of this leads us to a modest proposal. It’s time to stop rewarding the mere filing of meritless class actions. The laws of economics are at work here – as long as there’s benefit to doing something, people will keep doing it. The class action tolling rule has created a market for otherwise worthless putative pharmaceuticals (and other) class actions. Tolling is no longer saving the courts anything administratively that they aren’t well equipped to handle through the MDL process. Instead, it’s burdening the courts with meritless, yet “bet your company” sized cases, that demand a great deal of time and resources from both the parties and the courts to dispose of.

Chief Justice Roberts and company – how about getting rid of a bad idea whose time has passed? It’s well past time to abolish the failed doctrine of class action tolling.

Thursday, January 25, 2007

Defenses to FDCA-Based Negligence Per Se

In this post we discuss something that most definitely is not near and dear to our hearts. In fact it’s just the opposite. We hate it. And if you defend FDA-regulated manufacturers, you should hate it too – unless you enjoy hearing your client called a criminal, or worse. The “it,” of course, is negligence per se based upon claims that the defendant somehow violated the Food, Drug & Cosmetic Act (“FDCA”).

Pull up a cyberchair and pay attention because we’re going to explain some ways of defeating such claims – as a matter of law – that you probably haven’t considered.

First, a little bit on why FDCA-based negligence per se is so dangerous and difficult a cause of action to deal with. The obvious danger from such claims is the effect on a jury when the plaintiff’s counsel stands up and accuses your client of breaking the law – not just any law but the law overseen by the omniscient Food and Drug Administration (“FDA”); the law intended by Congress to keep us safe from adulterated drugs and misbranded medical devices. You may cue the violins now. Anyway, take it from those of us who have been on the receiving end. The atmosphere in the courtroom is not exactly the best if you’re defense counsel.

The less obvious danger from FDCA-based negligence per se claim is that there doesn’t have to be anything wrong with the product. In both negligence and strict liability, a successful cause of action requires either breach of duty (negligence) or product defect (strict liability) before the case can get to the jury. That requires a detailed investigation of the product and how it was made, and almost invariably expert testimony. It’s not all that easy for the plaintiff to prove, and it can be quite an expensive proposition.

Negligence per se, on the other hand, does away with this requirement because the violation of law substitutes for a finding either breach or defect. Under negligence per se, if a jury finds that your client broke the law, then there can be liability even if there was nothing intrinsically wrong with the product – a scary proposition for defendants, and the Holy Grail for plaintiffs.

The biggest legal problem defendants face with FDCA-based negligence per se is that the Restatement has never restated everything it should with respect to negligence per se. The Second Restatement conditions negligence per se liability on violation of an enactment that met four “purposes”:
(a) to protect a class of persons which includes the one
whose interest is invaded, and
(b) to protect the particular interest which is invaded, and
(c) to protect that interest against the kind of harm which has resulted, and
(d) to protect that interest against the particular hazard
from which the harm results.
Restatement (Second) of Torts §286 (1965) (emphasis added). The black letter of the Third Restatement, concerning product liability is even less precise:
In connection with liability for defective design or inadequate instructions or warnings. . .a product’s noncompliance with an applicable product safety statute or administrative regulation renders the product defective with respect to the risks sought to be reduced by the statute or regulation[.]
Restatement (Third) of Torts: Products Liability §4 (1997) (emphasis added).

The problem with both of these formulations is that they fail to address (at least in the black letter) all of the legal prerequisites for negligence per se – and the elements they choose to “restate” are absurdly easy for FDCA violation claims to satisfy. The FDCA’s a safety statute, right? Sure, perhaps the classic example of such an act. Thus it protects consumers of prescription medical products from personal injury, and since the Act covers both warnings and design it’s equally easy to say that the “particular hazard” causing injury is within the statute’s scope as well.

Right? It’s very easy to answer “yes,” and some courts have done so – with little or no thought to the consequences. Thus, in Ezagui v. Dow Chemical Corp., 598 F.2d 727, 733 (2d Cir. 1979), the court took all of a paragraph to conclude that an FDCA violation could serve as the basis for negligence per se under New York law. Orthopedic Equipment Co. v. Eutsler, 276 F.2d 455, 460 (4th Cir. 1960), devoted two paragraphs to a similar holding under Virginia law.

Under most state’s laws, however, the answer isn’t as cut and dried as the Ezagui and Eutsler courts make it out to be. There are other elements of negligence per se – those not found in the Restatement formulations – that defendants can use to defeat FDCA-based claims. Here they are, in a nutshell:

(1) Negligence per se is improper where it is inconsistent with the legislative intent of the enactment that was allegedly violated.
(2) Negligence per se is improper where it would impose novel duties that are not analogous to any existing common-law duty.
(3) Negligence per se is improper in some jurisdictions where only a regulation, and not a statute, was violated. It is improper everywhere where the alleged transgression involved something that lacks full force of law.
(4) Negligence per se is improper where the allegedly violated statute is vague or imprecise.
(5) Negligence per se is improper where the allegedly violated statute only required that the defendant obtain a license of some sort.

Legislative Intent – The most important of these additional elements of negligence per se is that of legislative intent. One has to look deep into the comments of the Restatement to find it, but it’s there: when “the legislature has indicated no intention that it [a statutory provision] shall be so applied” in a tort suit, courts “treat the provision as inapplicable.” Restatement (Second) of Torts §286, comment d (1965), see Restatement (Third) of Torts, Products Liability §4, comment d (1997) (“purpose” is to be taken “into account in determining whether noncompliance. . .renders the product defective”). Most states have adopted some sort of legislative purpose limitation on the use of negligence per se. The language used by the New York Court of Appeals is representative:


[W]e must, most importantly, determine the consistency of [negligence per se] with the purposes underlying the legislative scheme. For, the Legislature has both the right and the authority to select the methods to be used in effectuating its goals, as well as to choose the goals themselves.

Sheehy v. Big Flats Community Day, Inc., 541 N.E.2d 18, 21 (N.Y. 1989). “Where a statute creates legal duties and provides a particular means for their enforcement, the designated remedy excludes all others.” Gammill v. United States, 727 F.2d 950, 953 n.3 (10th Cir. 1984). Most other states' law contains similar statements if one digs hard enough.

This point becomes critical because the FDCA contains express language that forbids anyone but the government itself from seeking to prosecute violations of the act: "[A]ll such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States." 21 U.S.C. §337(a). In the context of a product liability action, the Supreme Court held that §337(a) means no private enforcement of purported violations, because it “leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions” and is “clear evidence that Congress intended that the [statute] be enforced exclusively by the Federal Government.” Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 349 n.4, 352 (2001).

There are other federal statutes that likewise contain language that in one way or another restricts their usage in private tort actions, most notably OSHA. Courts considering whether violations of those statutes could support negligence per se claims have predominately (but not unanimously) held that they cannot. E.g., Elliott v. S.D. Warren Co., 134 F.3d 1, 4 (1st Cir. 1998); Myers v. United States, 17 F.3d 890, 901 (6th Cir. 1994); Albrecht v. Baltimore & Ohio Railroad Co., 808 F.2d 329, 332-33 (4th Cir. 1987).

The same rationale – that Congress did not intend private enforcement of the FDCA – has also been used to preclude Lanham Act claims asserting FDCA violations as the predicate act under that statute. E.g., PDK Labs, Inc. v. Friedlander, 103 F.3d 1105, 1113 (2d Cir. 1997); Mylan Laboratories, Inc. v. Matkari, 7 F.3d at 1130, 1139 (4th Cir. 1993); Sandoz Pharmaceuticals v. Richardson-Vicks, 902 F.2d 222, 231 (3d Cir. 1990).

The defense that private actions alleging FDCA violations as negligence per se fail as contrary to congressional intent has been successfully employed to defeat such claims. The Supreme Court of Illinois held:

[T]he instant plaintiffs seek to premise a private cause of action in State court upon defendant’s alleged violation of Federal legislation. Therefore, to determine whether a cause of action. . .exists, we examine whether such a cause of action has been recognized by the Federal courts or whether recognizing such a cause of action comports with Federal legislative intent. This inquiry forecloses plaintiff’s cause of action. Federal courts have uniformly refused to imply a private cause of action under the Food, Drug and Cosmetic Act.

Martin v. Ortho Pharmaceutical Corp., 661 N.E.2d 352, 355-56 (Ill. 1996). Accord, e.g., In re Orthopedic Bone Screw Products Liability Litigation, 193 F.3d 781, 789-90 (3d Cir. 1999); In re Shigellosis Litigation, 647 N.W.2d 1, 10 (Minn. App. 2002); Bish v. Smith & Nephew Richards, Inc., 2000 WL 1294324, at *3 (Tenn. App. Aug. 23, 2000); Osburn v. Danek Medical, Inc., 520 S.E.2d 88, 93 (N.C. App. 1999), aff’d, 542 S.E.2d 215 (N.C. 2000); Friedlander v. HMS-PEP Products, Inc., 485 S.E.2d 240, 242 (Ga. App. 1997); Scott v. CIBA Vision Corp., 44 Cal. Rptr. 2d 902, 912 (Cal. App. 1995); Hackett v. G.D. Searle & Co., 246 F. Supp.2d 591, 594 (W.D. Tex. 2002) ; Alexander v. Smith & Nephew, P.L.C., 98 F. Supp. 2d 1299, 1308 (N.D. Okla. 2000); Blinn v. Smith & Nephew Richards, Inc., 55 F. Supp. 2d 1353, 1361 (M.D. Fla. 1999); Cali v. Danek Medical, Inc., 24 F.Supp.2d 941, 954 (W.D. Wis. 1998); Zanzuri v. G.D. Searle & Co., 748 F. Supp. 1511, 1516 (S.D. Fla. 1990).

Typical of these decisions is the recent opinion in Vanderwerf v. SmithKlineBeecham Corp., 414 F. Supp.2d 1023, 1027 (D. Kan. 2006), which addressed a negligence per se claim under Kansas law. In Kansas, legislative intent was one of the elements of negligence per se. “[T]he tort of negligence per se in Kansas is limited to violations of a statute where the legislature intended to create an individual right of action for injury arising out of a statutory violation.” Id. at 1028. Because congress did not exhibit any such intent in the FDCA, “a violation of the FDCA cannot give rise to a negligence per se claim.” Id. The Vanderwerf opinion is well researched and references numerous other courts that reached the came conclusions under various states’ laws.

Novel duties – Some states only allow negligence per se where the duty being imposed is parallel to some already-recognized common-law duty. Texas is chief among these jurisdictions. Statutes “do not. . .automatically create duties cognizable under local tort law. The pertinent question is whether the duties set forth in federal law are analogous to those set forth in the local tort law.” Johnson v. Sawyer, 47 F.3d 716, 729 (5th Cir. 1995). Rejection of novel negligence per se duties has occurred the FDCA context. “[T]he negligence per se doctrine does not create new causes of action. Rather, it recognizes a legislatively created standard of care to be exercised where there is an underlying common-law duty.” Talley v. Danek Medical, Inc., 179 F.3d 154, 158 (4th Cir. 1999). Accord Ehlis v. Shire Richwood, Inc., 367 F.3d 1013, 1017 (8th Cir. 2004); King v. Danek Medical, Inc., 37 S.W.3d 429, 460 (Tenn. App. 2000); Bish, 2000 WL 1294324, at *2; Hackett, 246 F. Supp.2d at 594; Alexander, 98 F. Supp.2d at 1321; Baker v. Smith & Nephew Richards, Inc., 1999 WL 811334, at *9 (Tex. Dist. June 7, 1999), aff’d mem., 2000 WL 991697 (Tex App. July 20, 2000).

Administrative regulations – While the Restatement, and most states, permit negligence per se for violations of administrative regulations, a number of states – including some of the largest, do not. See Elliott v. City of New York, 747 N.E.2d 760, 763-64 (N.Y. 2001); Chambers v. St. Mary’s School, 697 N.E.2d 198, 202-03 (Ohio 1998); Harwood v. Glacier Electric Cooperative, Inc., 949 P.2d 651, 656 (Mont. 1997); Price v. Sinnott, 460 P.2d 837, 840 (Mont. 1969); Town of Kirklin v. Everman, 29 N.E.2d 206, 206-07 (Ind. 1940); Ridgecrest Retirement & Healthcare v. Urban, 135 S.W.3d 757, 763 (Tex. App. 2004); McKinney v. H.M.K.G. & C., Inc., 123 S.W.3d 274, 280-281 (Mo. App. 2003); California Service Station & Automobile Repair Ass’n v. American Home Assurance Co., 73 Cal. Rptr. 2d 182, 188 (Cal. App. 1998), Murray v. Briggs, 569 So. 2d 476, 480 (Fla. App. 1990); La. Civ. Code Art. 2317(D).

Less Than Administrative Regulations – Many times, however, the FDA provides substantive content to the Act through means less formal than administrative regulations having the force of law – particularly “guidances,” but also proposals for regulations that remain in “draft” form indefinitely. The Restatements explicitly limit negligence per se to statutes or regulations. Restatement (Third), Products Liability §4; Restatement (Second) of Torts §§285-288C (1965). Nor does any state that we are aware of allow negligence per se for the "violation" of something, such as a guidance or a draft that lacks full force of law. A few representative cases rejecting negligence per se where what was supposedly violated was only advisory, or otherwise lacked legal force are: Gatter v. Nimmo, 672 F.2d 343, 347 (3d Cir. 1982); Flechsig v. United States, 991 F.2d 300, 304 (6th Cir. 1993); Jacobo v. United States, 853 F.2d 640, 641 (9th Cir. 1988); Schaerrer v. Stewart’s Plaza Pharmacy, Inc., 79 P.3d 922, 931 (Utah 2003); Smith v. Pulaski County, 501 S.E.2d 213, 214 (Ga. 1998).

Vagueness – Whether FDCA-related negligence per se lies for purported violations of administrative regulations – or even less – is particularly important because the most frequently invoked sections of the Act are rather broad and vague as to what constitutes, for example, adulteration or misbranding. To the extent that these sections are given more precise substantive content, that precision is found in the Agency’s regulations. Negligence per se is generally not permitted where the statutory standard that the defendant allegedly violated is vague or non-specific.

Implicit in virtually all discussions of negligence per se is the unspoken assumption that the regulation in question establishes a clear minimum standard of care. If the regulation fails to do so, the reason for applying the doctrine fades. An ambiguous or contradictory regulatory standard defeats the certainty on which the rule of per se liability rests. Persons affected are deprived of a sure standard upon which they may fashion their affairs.

Dougherty v. Santa Fe Marine, Inc., 698 F.2d 232, 235 (5th Cir. 1983). Accord, e.g., In re TMI, 67 F.3d 1103, 1115 (3d Cir. 1995); Ridge v. Cessna Aircraft Co., 117 F.3d 126, 131 (4th Cir. 1997); Parra v. Atchison, Topeka & Santa Fe Railway Co., 787 F.2d 507, 509 (10th Cir. 1986); Young v. Commonwealth DOT, 744 A.2d 1276, 1279 (Pa. 2000); Perry v. S.N., 973 S.W.2d 301, 307-08 (Tex. 1998); Shahtout v.Emco Garbage Co., 695 P.2d 897, 899 (Or. 1985); Griglione v. Martin, 525 N.W.2d 810, 812 (Iowa 1994); Rains v. Bend of the River, 124 S.W.3d 580, 590-591 (Tenn. App. 2003).

For this reason, quite a few attempts to assert FDCA-based negligence per se have failed because the standard allegedly set by the FDCA (or similar state “little FDCA” statutes) was impermissibly vague. Talley, 179 F.3d at161; Shanks v. Upjohn Co., 835 P.2d 1189, 1200-01 (Alaska 1992); Goodman v. Wenco Foods, Inc., 423 S.E.2d 444, 452 (N.C. 1992); Messer Griesheim Industries, Inc. v. Eastman Chemical Co., 194 S.W.3d 466, 483 (Tenn. App. 2005); Shigellosis Litigation, 647 N.W.2d at 10-11; King, 37 S.W.3d at 458; Jones v. GMRI, Inc., 551 S.E.2d 867, 873 (N.C. App. 2001); McNeil Pharmaceutical v. Hawkins, 686 A.2d 567, 582 (D.C. App. 1996); Baraukas v. Danek Medical, Inc., 2000 WL 223508, at *4 n.2 (M.D.N.C. Jan. 13, 2000).

Licensing Statutes – Almost all states refuse to hold unlicensed persons – usually, but not always, somebody driving a car – automatically liable on an negligence per se theory simply because they lacked the necessary licenses. See R.P. Davis, “Lack of Proper Automobile Registration or Operator’s License as Evidence of Operator’s Negligence,” 29 A.L.R.2d 963 §5 (1953 & Supps.) (collecting cases). Some representative non-drivers-license cases reaching the same result are: Cooper v. Eagle River Memorial Hospital, Inc., 270 F.3d 456, 461 (7th Cir. 2001); Beaver Valley Power Co. v. National Engineering & Contracting Co., 883 F.2d 1210, 1221-22 (3d Cir. 1989); Flint City Nursing Home, Inc. v. Depreast, 406 So. 2d 356, 357-60 (Ala. 1981); Lingle v. Dion, 776 So.2d 1073, 1077 (Fla. App. 2001); Leal v. Hobbs, 538 S.E.2d 89, 93 (Ga. App. 2000); Business Men’s Assurance Co. v. Graham, 891 S.W.2d 438, 455-56 (Mo. App. 1994); Turek v. Saint Elizabeth Community Health Center, 241 Neb. 467, 488 N.W.2d 567, 571-72 (Neb. 1992); Leahy v. Kenosha Memorial Hospital, 348 N.W.2d 607, 612-13 (Wis. App. 1984).

Likewise, negligence per se claims seeking to hold defendants automatically liable because their products allegedly lacked the necessary marketing approvals from the FDA have also failed.

The administrative requirement [of] approv[al] by the FDA. . .is only a tool to facilitate administration of the underlying regulatory scheme. Because it lacks any independent substantive content, it does not impose a standard of care, the breach of which could form the basis of a negligence per se claim. Its breach is analogous to the failure to have a drivers license.

Talley, 179 F.3d at 161. Accord Knoth v. Smith & Nephew Richards, 195 F.3d 355, 358 (8th Cir. 1999); King, 37 S.W.3d at 457-58; Lillebo v. Zimmer, Inc., 2005 WL 388598, at *4-5 (D. Minn. Feb. 16, 2005); Alexander, 98 F. Supp.2d at 1321; Holland v. Smith & Nephew Richards, Inc., 100 F. Supp.2d 53, 56 (D. Mass. 1999); Johnson v. Smith & Nephew Richards, Inc., 1999 WL 1117105, at *2 (N.D. Okla. Sep. 30, 1999); Uribe v. Sofamor, S.N.C., 1999 WL 1129703, at *15-16 (D. Neb. Aug. 16, 1999); Bell v. Danek Medical, Inc., 1999 WL 335612, at *4 (E.D. La. May 24, 1999); Flynn v. Biomet, Inc., 1993 WL 540570, at *9 (E.D. Va. July 23, 1993).

One of us has written a book – well, both of us have written books, but only one on this topic – that addressed these negligence per se issues in considerably greater detail. Anyone interested in learning more about these defenses to FDCA-related negligence per se can find about that book here.

Wednesday, January 24, 2007

2003 Amendment to Rule 23

Yeah, we're way down the routing list.

We just saw the article by James Muehlberger and Nicholas Mizell in the December 4, 2006, issue of The National Law Journal. But we liked what they said, so we'll post about it here.

The authors note, as all practitioners in this field know, that the 2003 amendments to Rule 23 eliminated the provision permitting "conditional certification" of a class. According to the new Advisory Committee Notes, "A court that is not satisfied that the requirements of Rule 23 have been met should refuse certification until they have been met."

The interesting part of the article, however, is where the authors suggest that amended Rule 23 should permit closer analysis of expert scientific testimony offered in support of class certification. The elimination of conditional certification "lends weight to the argument" that scientific evidence submitted in support of class certification "should be subject to a rigorous Daubert analysis, just as it would be at any other stage in the proceeding."

Couple that thought with the Second Circuit's recent pronouncement in the IPO litigation that courts can analyze merits-based issues that overlap class certification issues. It's looking more and more as though classes should only be certified if sound evidence, not mere junk science, supports that result. That is, of course, as it should be, since the stakes on class certification are so high.

Monday, January 22, 2007

Plaintiffs' counsel "hijacking" the news cycle

The Bulldog Reporter's Daily Dog is probably a journal that most lawyers don't read regularly. But the January 10 issue has an interview with Jon Harmon, Director of Communications Strategy at Ford Motor Company, in which he describes how plaintiffs' counsel have become media savvy and now drive the news cycle every day when a mass tort hits. The editors refer to this as "'hijacking' . . . the news cycle."

Here's a link for anyone who's interested.

Rule 706 experts on e-discovery

At a recent ABA conference, Judge Eldon Fallon (of the Eastern District of Louisiana) noted that it's entirely proper to use a court-appointed expert under Federal Rule of Evidence 706 to assist the court with e-discovery issues.

Depending on the scope of requested discovery, that suggestion may make sense even in a run-of-the-mill product liability case. (The amended Federal Rule of Civil Procedure requiring the parties to sort out e-discovery issues early in all cases makes this a particularly timely suggestion.)

It is in mass torts, however, where the requested discovery is sure to be overwhelming and the cost of preserving and producing electronic records sure to be staggering, that the judge's suggestion has real appeal. Very recent appointees to the federal bench may have been in practice at a time when e-discovery requests inflicted severe pain on the receiving parties. But judges who have been on the bench for a decade or more may have no personal experience with the burdens of e-discovery, and the quality of those judges decision-making may be dramatically improved by getting a little neutral expert help in this field.

If Judge Fallon likes the idea of appointing Rule 706 experts to help with e-discovery issues, other judges may like the idea, too. Stick that thought in your book of tricks for possible use in your next mass tort case.

Saturday, January 20, 2007

Zyprexa First Amendment Hearing

We haven't yet heard the results of the two-day hearing before Judge Weinstein over the propriety of his injunction seeking to recover internal Eli Lilly documents about Zyprexa that were leaked to the New York Times and elsewhere.

But Professor Bill Childs, at the Torts Prof Blog, has tracked down two reports online. Here's a link to Bill's post, which will, in turn, direct you to two accounts of the hearing.

If we hear more, you'll hear more.

Friday, January 19, 2007

Hearings On Hatch-Waxman Settlements

On Wednesday, January 17, the Senate Judiciary Committee held hearings entitled “Paying Off Generics to Prevent Competition with Brand Name Drugs: Should It Be Prohibited?” The Committee conducted the hearings in connection with its consideration of the Preserve Access to Affordable Generics Act, a bill proposed by Senator Kohl of Wisconsin, and, as proposed in the previous Congress co-sponsored by Senators Leahy, Grassley and Schumer.

The bill focuses on what some call “reverse-payment” settlements under the Hatch-Waxman Act. The Act permits companies that would like to offer a generic drug that is the bioequivalent of a brand company’s drug to make an Abbreviated New Drug Application (ANDA) that includes a statement of the generic’s views concerning the patent status of the brand drug. If the generic company states that it believes that the brand company’s patent is invalid or that its generic substitute would not infringe the patent, the statement constitutes a statutory act of infringement and allows the brand company to sue for a determination of its patent rights. In recent years, brand and generic companies have settled some of the patent disputes resulting from these statements in deals in which the brand company pays the generic money (sometimes tens or hundreds of millions of dollars) and the generic company agrees to withdraw the patent challenge and not to compete. These “reverse-payment” settlements have, in turn, spawned antitrust litigation in which the Federal Trade Commission, consumers, and others have argued that the settlements are illegally anticompetitive. Courts have split over the antitrust issues.

The proposed bill would establish a bright line rule making it illegal for brand companies to pay anything of value to generic companies in exchange for an agreement to stay off the market. It would not prevent brand and generic companies from settling by, for example, agreeing on a date before the expiration of the patent in which the generic could enter the market. It would prevent the parties from moving that date back in exchange for payment.

At the hearing, the Committee heard testimony from FTC Commissioner Jon Leibowitz; Billy Tauzin (a former Representative from Louisiana and the current CEO of PhRMA, the trade association for brand drug companies); Merril Hirsh (a partner at the Washington, D.C. office of Ross, Dixon & Bell, LLP, who represents self-insured companies that purchase drugs); Bruce Downey (the Chairman and CEO of Barr Pharmaceutics, Inc., a generic drug manufacturer), and Michael Wroblewski from the Consumers Union.

In general, Commissioner Leibowitz, Hirsh and Wroblewski supported the legislation and former Representative Tauzin and Conley opposed it. At the hearing, Senators Leahy, Kohl and Schumer also spoke strongly in favor of the legislation, arguing that the payments are payoffs that prevent competition that would lower prices to consumers. Senators Spector and Hatch agreed that at least some of these settlements were improper and that something should be done about it, but were more skeptical about whether the proper solution was a bright line rule or some sort of case-by-case review, perhaps requiring judges to approve proposed settlements at the time they are made, against antitrust challenge.

The witnesses' written testimony and statements by some of the Senators are available at http://judiciary.senate.gov/hearing.cfm?id=2472.

On the same day as the hearing, the FTC issued a report indicating that reverse-payment settlements (which had disappeared for several years after initial rulings against their legality) had recently become more common. A press release concerning the report is available at: http://www.ftc.gov/opa/2007/01/drugsettlements.htm, and the Report itself is available at: http://www.ftc.gov/reports/mmact/MMAreport2006.pdf.

The Consumers Union issued a press release concerning Mr. Wroblewski’s testimony. It is available at http://www.consumersunion.org/pub/campaigndrugcostslearnmore/004164.html.

For an article that Merril Hirsh submitted with his written testimony, see http://www.rdblaw.com/files/News/b2383914-25ae-41ca-8785-0bd69e9e07dd/Preview/NewsAttachment/72fbb496-9eb9-48bf-a618-12c4e5152e1c/Health%20Care%20Chronicle%20Summer%202005.pdf

Ruminations on bellwether trials

We love the word "bellwether" -- a noun meaning "a male sheep that leads the flock; it normally wears a bell."

We don't love bellwether trials, but we'll take 'em, because they're the best an MDL judge can offer.

On the one hand, a bellwether trial in an MDL (or statewide coordinated) proceeding isn't very informative. Trying one or two cases out of a collection of hundreds, or thousands, certainly doesn't give any statistical information about the value of the cases. The one or two cases are not a statistically significant cross-section of the mass of litigation.

Moreover, the many pending cases (at least in the product liability field) probably differ from each other in ways that make their settlement values vary. Trying one case may not say much about the value of the next. And the performances of witnesses, trial counsel, and judges, and the make-up of juries, will vary across trials, too, so a few early trial results aren't particularly meaningful.

A few early trial results can, however, have unfortunate effects. They can, for example, decrease the chance of a prompt global resolution of a mass tort. A big plaintiff's verdict may unreasonably raise the expectations of the plaintiffs' bar; a resounding defense win may make the defense too stubborn. And, ultimately, global settlements turn on what the parties are willing to pay (and accept) to resolve the cases, which may have little to do with the results at trial.

On the other hand, what's the alternative to holding bellwether trials? Discovering up 5000 cases simultaneously without trying any? That's a disaster. Discovering up 5000 cases and setting them all for trial? That's silly (and impossible). Cobbling together classwide trials in situations that don't merit them? That's both bad law and bad policy. Trying to devise a "trial by statistics" that doesn't suffer from the due process and other concerns discussed by the Fifth Circuit in Cimino v. Raymark, 151 F.3d 297 (5th Cir. 1998), and elsewhere? That's a procedural morass.

And bellwether trials do provide some information. They force plaintiffs' counsel to do the work needed to prepare their standard trial package, and the early trials give some sense of how sound that package is. The bellwether trials force the court to resolve legal questions that arise only as a trial actually approaches and witnesses begin to take the stand. And the bellwether trials test the expert witnesses and give both parties a sense of how much it costs to try a case.

Finally, for a judge who's considering certifying a class, trying one (or several) bellwether trials might be very informative. There's nothing like a real trial to help assess whether plaintiff's proposed class trial plan is workable, whether claims and defenses are in fact individualized, and to shed light on other class certification issues. In some categories of cases, one could reasonably argue that judges should be required to try a case or two before deciding to certify a class.

Bellwether trials are not the perfect way to resolve mass torts, but they're basically all that an MDL judge has to offer. Until someone suggests a viable alternative, we'll settle for the best that's available.

Guest Post - Medical Monitoring, Prescription Products & ALI

We're always open to guest posts on topics relevant to the defense of prescription medical products. Here's the first. Sean Wajert is a partner at Jim's firm, Dechert, and specializes in pharmaceutical defense. It's about a hot topic - the use and abuse of medical monitoring claims in this type of case.

Introduction

On January 16, 2007, the Appellate Division of the Superior Court of New Jersey handed down a decision in the putative class action case, Sinclair v. Merck, No. A-5661-04T5. The court remanded the matter to the trial court for further proceedings concerning plaintiffs’ claim for the establishment of a court-administered medical screening program, funded by Merck to provide for and/or reimburse the proposed class for certain medical and diagnostic tests. The plaintiffs claimed no present physical injury, but alleged that the cost of diagnostic testing represented a harm or ascertainable economic loss for which they were entitled to compensation.

While I cannot comment directly on the Sinclair case because Dechert is involved in the Vioxx litigation, the decision is but the latest in a series of developments in the controversial area of “medical monitoring.” As this highly unsettled area of the law develops, the ALI in its Council Draft of the Restatement of the Law (Third) Economic Torts and Related Wrongs (Council Draft No.1, §21) explores whether it should state a general rule concerning the availability of medical monitoring. Simultaneously, courts struggle with whether medical monitoring should ever be allowed in the context of prescription drugs or medical devices, which are far different from the environmental, toxic tort origin of this kind of clain. This post comments on the drug and device question, and the Restatement situation.

Background

Those jurisdictions recognizing medical monitoring general imposed some version of these elements: significant exposure; to a proven hazardous substance; through defendant's tortious conduct; resulting in significantly greater risk of a serious latent disease; for which periodic diagnostic testing different from what would be proper in the absence of the exposure is reasonably necessary; and those tests make early detection of the disease possible. Of course, there is significant variation in the black-letter law among jurisdictions allowing medical monitoring claims. Another aspect of medical monitoring is the procedurally parasitic nature of the claim - it is almost never pursued, except via class action.

Drugs and Medical Devices

So how does this relate to drugs and medical devices? Although originally arising in environmental toxin cases, the medical monitoring notion has been applied to pharmaceuticals, with the drug as the “toxic” substance, voluntary ingestion by prescription the “exposure,” and potential future side effects as the increased risk of disease. An example is Thompson v. Pfizer Inc., No. H-05-1985 (S.D. Tex. filed June, 2005), the usual class action alleging that Viagra®, causes eventual blindness, and demanding “future medical monitoring after taking Viagra.” Implantable (and allegedly defective) medical devices have also been analogized to toxic substances. In Brennan et al. v. Guidant Corp., No. 1:05-cv-0827 (S.D. Ind. filed June, 2005), plaintiffs proposed a nationwide class of people who were implanted with defibrillators that allegedly short circuit. Among other relief, the case seeks medical monitoring.

But do these fit? The elements of a medical monitoring claim were fashioned for environmental tort actions, including the requirement of significant toxic exposure above background levels – saomething that makes no sense with respect to drugs or devices, or other things that just aren't in the environment. The earliest, foundational cases make clear that the remedy was designed to deal with environmental exposures. Friends For All Children, Inc. v. Lockheed Aircraft Corp., 746 F.2d 816 (D.C. Cir. 1984), probably the first reported monitoring case, involved possible effects of sudden airplane cabin de-pressurization. In re Paoli Railroad Yard PCB Litig., 916 F.2d 829, 850 (3d Cir. 1990), involved alleged PCB exposure. Ayers v. Twp. of Jackson, 106 N.J. 557 (1987), arose from chemical contamination of plaintiffs’ water supply.

The policy justification for medical monitoring recovery was the nature of an environmental tort action made proving specific causation difficult, and there was no adequate governmental program for testing possible victims of environmental toxic exposures. These factors are likewise absent in most (non-environmental) product liability cases - especially those involving voluntary consumers of a prescription drug regulated by the FDA and prescribed by a licensed doctor legally responsible for weighing product risks and benefits. Proving and establishing causation in the environmental context, say a cancer case with numerous possible alternative causes and no way to establish exposure levels, is a far cry from FDA-approved drugs, extensively tested in clinical trials, and prescribed by physicians making individual medical evaluations and keeping precise prescription records. Exposure is knowing and voluntary, and dosage exposure easily established. The evidentiary gaps medical monitoring was designed to fill a gap just don't exist in the drug and device context. Moreover, the existence of FDA oversight of product approval, and the publicity that normally surrounds drug withdrawals negate the policy rationale of the environmental cases.

The link between a polluter's conduct and increased disease risks from pollution is direct, apparent, and logical. Prescription medical products are different, since the risk of bodily harm wasn't created by the defendant. That's because all prescription products carry risks - why they require a prescription in the first place. “Safe” does not mean risk-free, any more than “effective” means that every patient is cured. The FDA weighs the safety and efficacy of the drug in general, and the prescribing physician weighs individual risks and benefits. No exposure is often not an option. Rather, the alternative is frequently a competitive drug in the same class, carrying similar risks. Unless the risk of adverse effects is so widespread and serious - the Restatement Third, Products Liability test of risk so great that no reasonable doctor would prescribe for any class of patient - the mere risk of future bodily harm should not be actionable in this context.

The Restatement Question

The ALI in its Council Draft of the Restatement of the Law (Third) Economic Torts and Related Wrongs is currently exploring whether a general rule can be formulated concerning the availability of medical monitoring. Section 21 of this draft would recognize an action to recover monitoring expenses (1) to prevent or mitigate a risk of serious bodily harm when the defendant would be liable to the plaintiff if the bodily harm became manifest, (2) if the expense is required by a risk of bodily harm created by the defendant, (3) the expense provides no other material benefit to the plaintiff, (4) when the plaintiff has incurred or will incur the expense, and (5) if the liability is not “indeterminate.”

That's badly premature - and it's certainly not "restating" any general rule recognizing medical monitoring. Rather courts are badly split on even whether such a claim should exist. Actually, the trend over the last several years has been against the recognition of medical monitoring claims where there's no present injury. The most recent case cited in the Reporter Note as supporting medical monitoring is seven years old, and the Supreme Court decision in Metro-North Commuter R. Co. v. Buckley, 521 U.S. 424 (1997), stands as an inexact but unmistakable turning point away from expanding the law. Since then most courts have passed on this type of claim. See Wood v. Wyeth-Ayerst Labs., 82 S.W.3d 849, 857 (Ky. 2002); Hinton v. Monsanto Co., 813 So.2d 827, 831 (Ala., 2001); Henry v. Dow Chemical Co., 473 Mich. 63, 701 N.W.2d 684 (Mich. 2005). Several federal courts have weighed in, also in opposition to letting uninjured peopld sue for medical monitoring. Norwood v. Raytheon Co., 414 F.Supp.2d 659 (W.D. Tex. 2006); Paz v. Brush Engineered Materials, Inc., 351 F.Supp.2d 580, 586 (S.D. Miss. 2005); but see Algood v. General Motors Corp., 2006 WL 2669337 (S.D. Ind. Sep. 18, 2006).

Beyond the existential point, the doctrine is so new in most jurisdictions that appellate courts have yet to evolve workable elements based on practical experience drawn from real-world fact patterns. This immaturity shows up in the confusion over the wrongful conduct element of the claim. Some jurisdictions, such as Pennsylvania require causation by a defendant’s negligence; others, any type of “tortuous conduct” - a term broad enough to embrace faultless conduct, such strict liability and many consumer fraud act claims. Given the extraordinary nature of the relief - payments to uninjured people - any Restatement rule should be limited to negligence or intentional fault.

Another unsettled area is causation - not surprising, since there's no present injury. Does the defendant’s conduct need to cause the exposure, or the increased risk, or both? Must the defendant’s conduct cause the need for medical monitoring? Plaintiffs predictably argue that any point in the causal chain, no matter how remote, is enough. Their preferred causal chain runs: (1) defendant commits some unreasonable act regarding a product; (2) plaintiff uses the product; (3) product use entails a risk of future harm. This amounts to negligence “in the air”: conduct related only to the product, but not to either the plaintiffs’ use of the product or the alleged need for medical monitoring. It is enough, they assert, that use of the product caused their risk.

The current Restatement Draft is not altogether clear, but apparently requires that the a risk of harm be created by the defendant. Mere sale of a product as to which some aspect of the defendant's design, manufacture, or marketing can be criticized is not creation of risk. Rather, risk is "created" when the defendant’s wrongful conduct causes the risk for which the plaintiff seeks monitoring for, both by creating (or negligently permitting) the hazard of the product and causing plaintiff to be exposed to the risk improperly. This is important in the drug/device context. When a company produces, say, a drug that has significant medical benefit - but also real and definite hazards (potential side effects), it is usually theoretically possible to monitor those risks. But the FDA must approve the drug on a risk/benefit analysis. Who "created" the risk? The company that submitted the drug for FDA approval, or the FDA in approving it as more beneficial than risky? The risk is known, and has been accepted by the government as reasonable under the circumstances. Later, suppose there is wrongful conduct in marketing, say a misrepresentation as to efficacy - but the plaintiff (or prescribing physician) did not rely on that representation and voluntarily encounters the risk. Once again causation is absent. The conduct may have created an abstract risk, but did not create risk to this plaintiff. It ought to be clear that this is not “creation of the risk.”

"Risk" also needs clarification. Even jurisdictions recognizing medical monitoring that do not require the future harm be likely or certain typically require more than a bare increased risk. Instead there must be a significant risk, an increased risk, a medically significant risk, or similar formulation. The Restatement draft needs to be clarified not to sanction litigation over de minimis, insignificant, or essentially background level risks. See O’Neal v. Department of the Army, 852 F.Supp. 327, 336 (M.D. Pa. 1994). Also, it should be clarified that the requisite "risk" – whatever levels it may be – is the risk to an individual plaintiff created by the harmful exposure above and beyond the background risk for that injury in the relevant population and above and beyond that created by plaintiff-specific risk factors from other causes. To some degree “over and above” is reflected in the requirement that the monitoring provide no other material benefit to the plaintiff. But it is more than that. Plaintiffs typically argue that monitoring need only be different from testing appropriate for the population at large, and that "risk" means no more than use of a product increasing some risk in some of the people using the product. But such generic increased risk should not be enough do support recovery without present injury. It's the "in the air" problem once again. Plaintiffs must do more than establish that a product generally causes an increased risk in some users. Rather, the requirement should be that the product sufficiently increased the risk of future disease in each particular plaintiff seeking medical monitoring. This is a crucial distinction, since specific causation has traditionally been the standard in tort. In re Prempro Products Liability Litigation, 230 F.R.D. 555 (E.D. Ark. 2005).

The Restatement draft requires that the “expense is required by a risk of bodily harm.” For the expense to be “required” by the risk, there must be a scientific and medical underpinning to the monitoring regime requested. States allowing monitorint typically require that the monitoring be reasonably medically necessary. Thus monitoring must have more than speculative medical value. Public health experts also routinely weigh the necessity, risks, and benefits of medical monitoring programs. Critical factors include whether monitoring can detect – reliably, accurately, and consistently – the disease earlier than it would otherwise be detected; whether early detection can improve mortality – as opposed to other less precise measures of outcome; whether available diagnostic testing itself has risks – either because it is invasive or because it has a high rate of “false positive” results that might lead to invasive follow-up testing; and economic costs. Medical monitoring proposals created for litigation may be touted as “required” by plaintiffs’ experts, while containing testing not prescribed routinely by physicians in actual practice, and/or studied and rejected by the public health community. The danger here is creation of a cause of action for the early detection of disease that is at odds with the medical community’s view on prevention. Plaintiffs should not be allowed to urge “required” medical testing that is not routinely prescribed – and may be expressly rejected – by the medical standard of care.

A final point on the Restatement: §21(d) of the Draft requires that liability not be "indeterminate." If that means relief cannot be class-based, then it's a good thing. Liability is indeterminate when a potential liability is so uncertain in time, class, or amount that an actor cannot fairly or practically be expected to account for the potential liability in determining the conduct giving rise to the potential liability. As ordinarily demanded, medical monitoring virtually always risks indeterminate, class-wide liability. That's why, as a practical matter, the claim uniquely does not exist outside the class action context; very few individual medical monitoring claims have ever been brought. In the class context, liability virtually always is unlimited and unpredictable. Until the final stage of the litigation, class size is merely estimated for the limited purpose of assessing numerosity. Actual interest of absent class members in participating in the testing is assumed without empirical basis. The peculiarly future-oriented nature of the relief - unconstrained by present injury - begs several questions. What is the effect of a change in medical technology? If testing is approved by the jury as having met the appropriate standard, but is later shown not to work (as occurred with chest x-rays for detecting lung cancers), how is the monitoring halted? If medicine evolves a new test that appears to work better, can plaintiffs sue again? Can a court somehow modify an existing award of medical monitoring and order defendant to pay more for tests that were not the subject of the trial? What showing would plaintiffs need to make to get new testing? If existing programs – designed to last for decades given the latency periods of many diseases – are not modifiable to reflect changing state of the art, what good are they from a public health and tort policy perspective?

Wednesday, January 17, 2007

The First Amendment and Off-Label Use

One thing that’s always bothered us about how FDA goes about regulating drug and medical device manufacturers is the Agency’s penchant for declaring information that’s actually entirely truthful to be “misleading” by defining that term in a rather Orwellian fashion – that “misleading” is whatever FDA says it is. Combine that with regulations that allow truthful statements to make a product “misbranded” or “adulterated,” and we have all the makings of a significant constitutional dispute.

That’s because the First Amendment essentially prohibits the government from suppressing truthful speech – even if it’s commercial. This dispute has surfaced several times in recent FDA regulatory history. In the early 1990s, when FDA was hell-bent on restricting off-label use, it issued regulations mandating that even 100% truthful scientific speech – peer reviewed articles and continuing medical education – violated the law if manufacturers were involved and the information concerned off-label uses. The Washington Legal Foundation – an essentially libertarian public interest law center (read “anti-regulation gadfly”) – took FDA to court and the Agency found itself rather uncomfortably enjoined. See Washington Legal Foundation v. Friedman, 13 F. Supp. 2d 51, 56 (D.D.C. 1998); Washington Legal Foundation v. Henney, 56 F. Supp. 2d 81 (D.D.C. 1999), appeal dismissed, 202 F.3d 331 (D.C. Cir. 2000). The Agency managed to wriggle off the hook by more or less repudiating its own authority. FDA mooted some of the injunction by conceding that “nothing in either of the provisions challenged ... provides the FDA with independent authority to regulate manufacturer speech.” Washington Legal Foundation v. Henney, 202 F.3d 331, 336 (D.C. Cir. 2000). This litigation was only the opening salvo.

In Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999), FDA ran afoul of the First Amendment again – this time for fashioning a prior restraint on dietary supplement health claims – not because those claims were false (although some of the things being claimed on late night TV sure seem to skirt the line) – but because simple lack of prior FDA review made them “inherently misleading” regardless of truth. The DC Court of Appeals took a decidedly dim view of this and held that as long as there was a disclaimer of FDA review, the FDA had no business banning truthful commercial speech. Id. at 656, 658-59.

FDA couldn’t keep its hands out of the free speech cookie jar, however. It tried to ban truthful speech about pharmacy compounding – essentially any sort of advertising of this service – because it feared (probably with reason) that some large-scale compounders were nothing more than disguised, unlicensed manufacturers of pharmaceuticals. This dispute went all the way to the Supreme Court, and FDA got its head handed to it.


[F]orbidding advertising [must be] a necessary as opposed to merely convenient means of achieving [governmental] interests…. If the First Amendment means anything, it means that regulating speech must be a last – not first – resort. Yet here it seems to have been the first strategy the Government thought to try.

Thompson v. Western States Medical Center, 535 U.S. 357, 373 (2002) (emphasis added). There were lots of other things FDA could have done to regulate compounding directly, rather than suppress speech as a proxy. These included: (1) banning equipment needed for commercial-scale compounding; (2) prohibiting compounding beyond existing prescriptions; (3) limiting, by dollar value or volume, how much compounded product could be sold in a given period, and (4) limiting the percentage of sales revenue that could be earned through compounding. Id. at 372. The First Amendment meant that FDA had to try these approaches first, before attempting to ban truthful speech.

The last two of these alternatives, in particular, suggest analogous alternatives in the off-label use context.

Anyway, after losing Western States, FDA briefly had second thoughts. Within a few months of that decision, FDA sought public comments on the constitutionality of prohibiting truthful promotion of off-label use. 67 Fed. Reg. 34942 (May 16, 2002). But that was all. Over four years have passes and FDA hasn’t even bothered to respond to the comments it solicited. Nor has it changed its antediluvian restrictions on truthful promotion of off-label use.

First Amendment protection of commercial speech has been recognized until 1976, but FDA’s definition of “intended use” hasn’t changed since 1952. Thus any statement by a manufacturer – true or not – can create a new “intended use,” and thus a misbranded or adulterated product: Truth is not even a consideration. Indeed, even mere knowledge of an off-label use is theoretically enough to create an unapproved “intended use” and call down the wrath of FDA.

[I]ntent may, for example, be shown by labeling claims, advertising matter, or oral or written statements…. The intended uses of an article may change after it has been introduced…. [I]f a manufacturer knows, or has knowledge of facts that would give him notice that a device…is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling ...for such other uses.

21 C.F.R. §801.4 (meaning of intended use) (medical devices) (emphasis added); see id. §201.128 (same definition for prescription drugs).

Maybe WLF, Pearson, and Western States made FDA somewhat gunshy, but for whatever reason the only case since then in which FDA’s put its off-label use arguments up against a First Amendment defense is United States v. Caputo, 288 F. Supp. 2d 912 (N.D. Ill. 2003). It won. While these criminal defendants might well have been prosecuted successfully simply for untrue statements, see generally United States v. Caputo, 456 F. Supp. 2d 970 (N.D. Ill. 2006), the government chose to gild the lily – including a number of truthful statements within its prosecutorial net. Maybe FDA believes this is the case that will end its First Amendment losing streak.

Lovers of free speech that we are, we certainly hope not. That’s why one of us just filed an amicus curiae brief in the Seventh Circuit in the pending Caputo appeal. Representing – surprise, surprise – WLF, the brief collects and applies the most recent First Amendment precedent to argue that FDA can’t constitutionally suppress truthful speech, whether or not it might be “promotion,” by manufacturers about off-label use. Here’s the link: WLF Amicus Brief

We’re posting the brief here, not just out of pride of authorship (not to say we don’t have any) but because the First Amendment can be a defense, as well, to a tort claim or to a qui tam Medicare fraud claim. Tort claims are just as subject to the First Amendment as any other governmental attempt to punish free speech. E.g., NAACP v. Claiborne Hardware, 458 U.S. 886, 920 (1982); New York Times Co. v. Sullivan, 376 U.S. 254, 265 (1964); In re Asbestos School Litigation, 46 F.3d 1284, 1294-96 (3d Cir. 1994). Application of the First Amendment to a qui tam action attacking truthful commercial speech would conceptually be even easier – it’s just another statute being applied to suppress speech in the name of the government.

As long as the speech is objectively truthful, the First Amendment should provide a defense. Don't forget to take advantage of this defense in appropriate cases.

Another off-topic post: Overtime wage litigation

We typically post about product liability (and mass tort) issues affecting pharmaceutical and medical device companies. But we're taking a short detour today simply to note that pharmaceutical companies are now facing another litigation threat: overtime wage cases.

Since September 2006, a consortium of law firms that includes Kingsley & Kingsley, APC; Spiro Moss Barness & Barge, LLP; and Joseph & Herzfeld, LLP has filed similar overtime class and collective actions against ten different pharmaceutical companies. The companies that have been sued to date are Amgen, Inc.; Astrazeneca Pharmaceuticals, L.P.; Bayer Corp.; Boehringer-Ingelheim Corp.; Eli Lilly, & Co.; GlaxoSmithKline, PLC; Hoffman-LaRoche, Inc.; Johnson & Johnson; Pfizer, Inc.; and Sanofi-Aventis U.S., Inc.

Plaintiffs' claim in these cases is that the defendant erroneously classified pharmaceutical sales representatives as exempt from federal or state overtime requirements. Plaintiffs assert that these sales reps do not meet the requirements of any exemption under federal or state law. In a recent press release, for example, plaintiffs' counsel argued that pharmaceutical sales representatives do not qualify for an outside sales exemption because their "work is promotional -- they don't actually sell anything." Counsel also contended that sales representatives do not qualify for the administrative exemption, which requires that the employee exercise discretion and independent judgment, because they lack autonomy in their work.

We probably won't be posting on this again, because labor law is too far removed from the topic of this blog. But we're figured that pharmaceutical companies (and lawyers representing them) who weren't already involved in this fray would be curious to hear about this.

So stay tuned, but not to this channel. You'll surely be reading more about this elsewhere in the future.

Tuesday, January 16, 2007

More on Multiple Misjoinders

We posted last week (on January 11) about the overwhelming trend in the courts to sever the unrelated claims of multiple plaintiffs that are misjoined in product liability complaints.

Magistrate Judge David A. Baker of the Middle District of Florida recently recommended sua sponte that the court sever the claims of more than 6,500 Seroquel plaintiffs and require those claims to be filed separately. Although we can't provide a link, the cite is In re Seroquel Prods. Liab. Litig., MDL No. 1769, No. 06-md-1769 (M.D. Fla. Dec. 22, 2006).

Monday, January 15, 2007

An off-topic post: Judicial pay

We really shouldn't type these words.

We know it. We feel it in our bones. But we can't resist.

Chief Justice Roberts, in his 2006 Year-End Report on the Federal Judiciary, has once again raised the topic of judicial pay. He says that lawyers in private practice earn many multiples of what federal judges earn. This makes lawyers reluctant to accept federal judgeships and is creating a crisis in the federal judiciary.

We beg to differ.

Believe me, we know these are foolish words to speak. We spend our lives, after all, arguing cases before federal judges. The last thing in the world we want to do is to annoy those judges. In fact, let us say right now: We love you guys. You should be paid all you want. The richs of Croesus; the whole federal treasury; whatever. (Not only that -- Beck insists that Herrmann is typing these words, and Herrmann insists that Beck is. Now neither of us can be blamed for the following blasphemy.)

Is low pay really making it difficult to fill federal judgeships? We doubt it.

First, the median salary for a lawyer in the United States with 20 years of experience is $120,000 per year. District court judgeships pay $165,200 per year, and appellate ($175,100) and Supreme Court ($212,000) judgeships more still. That means that far more than half of the lawyers in the country would be receiving pay raises if they accepted federal judgeships. How hard can it be to fill those jobs?

It's true that -- with all due respect to ourselves -- fancy pants lawyers at white shoe firms earn a gazillion dollars per year, and those folks might be reluctant to accept federal judgeships for a mere $165,200 per year. But there are obviously lots of lawyers -- working at small firms, public interest firms (on either the liberal or conservative side of the spectrum), the government, or academia -- who would make fine judges and would willingly accept pay raises to hold those jobs.

Second, what the Chief Justice is probably saying, subconsciously or not, is that lawyers who look like him -- lawyers at the most prestigious white shoe firms -- make an economic sacrifice to become judges. That is surely true, but it leaves two unanswered questions. First, do we really need those lawyers on the federal bench? Can't we fill all the vacant judgeships with the available supply of competent lawyers who don't earn a king's ransom every year?

And, second, is it really true that those well-compensated lawyers at large firms regularly decline federal judgeships that are offered? Maybe a few of them do, but many of them would surely accept judgeships, if offered. The job is a fascinating one; many people would like to give back something to the society (and profession) that has treated them so well; many have saved enough money to take the financial "hit" of becoming a judge; and the possibility of a job offering a more civilized lifestyle (with life tenure) surely appeals to many.

The problem is not that lawyers at fancy firms won't accept these jobs; the problem is that nobody's asking. People are lobbying aggressively for federal judgeships; the administration is not cold-calling competent lawyers at large firms and offering them judgeships. If the government were to call, we're confident that many lawyers -- even those at large firms earning spectacular salaries -- would heed the call.

Hey, Beck's at Dechert and Herrmann's at Jones Day. You know the names, Mr. President, look up the numbers. We're not making any promises, but give us a try.

Zyprexa and the First Amendment

We were pleased to read in today's New York Times (page C3) that Judge Weinstein is holding a hearing to determine the proper scope of his injunction that seeks to recover copies of documents leaked in apparent violation of a protective order in the Zyprexa litigation. (We first posted about that issue on December 18, 2006, and we've watched it with interest since.) The question tomorrow will be whether the First Amendment permits a court to compel the return of all copies of documents that were originally leaked in violation of a protective order, but have now passed from hand to hand, and website to website, so that many people possessing copies of the documents had nothing to do with the original leak.

This is a difficult issue for us: We're fans of both pharmaceutical companies and the First Amendment.

On the one hand, it is certainly true that, once documents have been posted on the web and are in the hands of anyone who chose to store or download them, it's awfully hard to get all of the copies back. As Professor William Childs put it on his TortsProf blog (and was quoted in the Times), Judge Weinstein is seeking to "unring [a] bell hanging around [the] neck of [a] horse [that is] already out of [a] barn being carried on [a] ship that has sailed." On the other hand, both Eli Lilly and the court should properly be outraged that someone apparently leaked documents in violation of a court order to Lilly's detriment. The hard part is picking a constitutionally permissible remedy.

We don't hold ourselves out as constitutional scholars (heck, it's not clear that we're any kind of scholars at all), but how's this for an answer: If it is unconstitutional (or just bad policy) to try to recover all of the copies of leaked documents in the hands of third parties, then Judge Weinstein can't fix the problem in the Zyprexa litigation. But if, as we suggested in our December 18 post, plaintiffs' counsel (or, here, perhaps an expert) routinely violate protective orders, Judge Weinstein can set a standard that will help in the future. Even if the leaked documents cannot be recovered, Judge Weinstein can impose an appropriate (and by that we mean "severe") sanction on the people who leaked the documents. The court will thus send a message that violations of court orders in mass torts will not be tolerated in the future. It may be too late to solve the problem in the Zyprexa litigation, but it's not too late to begin to address this problem as it relates to mass torts generally.

Friday, January 12, 2007

An MDL Bibliography

We are frequently asked, both within our firms and by external clients, for basic materials about the operation of the Judicial Panel on Multidistrict Litigation. Clients who are being drawn into the MDL process for the first time are curious; our colleagues who have never practiced before the Panel need guidance. Here are the references that we usually share.

First, so far as we are aware, there's only one book about practice before the MDL Panel:

· David F. Herr, Multidistrict Litigation Manual (2006).

In addition, there are a fair number of articles about practice before the MDL Panel. The following are the most useful:

· Gregory Hansel, "Extreme Litigation: An Interview With Judge Wm. Terrell Hodges, Chairman of The Judicial Panel On Multidistrict Litigation," 19 Maine Bar J. 16 (Winter 2004).

· Note, "The Judicial Panel And The Conduct Of Multidistrict Litigation," 87 Harv. L. Rev. 1001 (1974).

· Mark Herrmann, Geoffrey J. Ritts & Katherine Larson, "Multidistrict Litigation," Statewide Coordinated Proceedings: State Court Analogues to the Federal MDL Process, ch. 2 (Thomson-West 2d rev. ed. 2004).

· Mark Herrmann, "To MDL Or Not To MDL? A Defense Perspective," Litigation, Summer 1998.

· Patricia D. Howard, "A Guide to Multidistrict Litigation," 124 F.R.D. 479 (1989).

· Earle F. Kyle, IV, "The Mechanics of Motion Practice Before the Judicial Panel on Multidistrict Litigation," 175 F.R.D. 589 (1997).

· John L. Strauch and Robert C. Weber, "Multidistrict Litigation," Business and Commercial Litigation in Federal Courts, ch. 11 (Robert L. Haig ed.) (West Group & ABA 1998).

· "Interview, Chair of Judicial Panel Sees Role as Gatekeeper," The Third Branch, Nov. 2005, at 11.

· Comment, "The Judicial Panel on Multidistrict Litigation: Time for Rethinking," 140 U. Penn. L. Rev. 711 (1991).

· Stanley A. Weigel, "The Judicial Panel on Multidistrict Litigation, Transferor Courts and Transferee Courts," 78 F.R.D. 575 (1977).

With that bibliography in hand, practitioners will be reasonably well-armed for their first appearance before the MDL Panel.

Class Actions – Merits Review Is “In” in the Second Circuit

It’s a securities case – but a big one – and it bears mentioning here. In In re Initial Public Offering Securities Litigation, 471 F.3d 24 (2d Cir. 2006) ("Miles"), the Second Circuit started what might be a sea change in how class actions are certified. We’re not going to get into details, because anyone can read the opinion and lots of people will no doubt comment, but it does bear mentioning here. Miles reads almost like a Daubert analysis of the methodology of class certification, and holds that class certification requires definitive proof for each element of Rule 23 and that the plaintiff must meet a preponderance of the evidence standard to establish that every claim can be proven on a predominately classwide basis. “Some showing” is not enough. Id. at 32.

The certifying court must make formal determinations at to each of the Rule’s requirements. Id. at 40.

The judge must examine the relevant factual disputes, figure out what facts are relevant to each Rule 23 requirement, and state how the classwide proof standard is met. Id.

Inquiry into the merits is specifically permitted (good-bye Eisen, see 471 F.2d at 33-34), indeed encouraged, and the obligation to determine predominance cannot be shirked by calling something a “merits issue.” Id. at 40-41.

The district court can tailor discovery both to ensure predominance is addressed and to prevent certification from becoming a pre-trial trial. Id. at 41.

It does not escape our notice that the district courts of the Second Circuit have been the source of some of the most extreme attempts at class certification in the product liability area. We also doubt that this fact escaped the Second Circuit’s notice. Now that the Second Circuit has adopted the most stringent approach to class certification review that we have yet seen, we trust that district courts in the Second Circuit – and elsewhere – will be less tempted than in the past to aggregate product liability claims through questionable class certification decisions.

If the district courts can’t be deterred, we hope that the Second Circuit enforces its new standard as “rigorously” as the Miles opinion promises.

Thursday, January 11, 2007

Mass Torts and Multiple Misjoinders

It now happens at the outset of almost every major mass tort. Plaintiffs' counsel, having through various forms of solicitation amassed a “great unwashed” of nominal clients about whom they know next to nothing, chooses to dump them all on one unfortunate court in a single complaint. Of course, by filing a single complaint, counsel pays only one filing fee.

So now, as defense counsel, we’ve got a mess on your hands. One complaint – hundreds, maybe thousands, of plaintiffs – and no information about any of them. It amounts to an instant mass tort. Often it’s worse, in that otherwise diverse plaintiffs are fraudulently misjoined with non-diverse plaintiffs (or non-diverse defendants against which only very few plaintiffs have a claim) in an attempt to defeat removal of the action to federal court under diversity jurisdiction.

Obviously, the first thing that runs through our heads is to move to sever on grounds of misjoinder. The law’s pretty clear nowadays that these gigantic complaints are completely improper under Fed. R. Civ. P. 20(a) and most state joinder rules. A great deal of case law in federal and state courts holds 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.” Janssen Phameceutica, Inc. v. Armond, 866 So. 2d 1092, 1096 (Miss. 2004); see In re Prempro Products Liability Litigation, 417 F. Supp.2d 1058, 1059-60 (E.D. Ark. 2006); In re Silica Products Liability Litigation, 398 F. Supp.2d 563, 651-54 (S.D. Tex. 2005); Jones v. Nastech Pharmaceutical, 319 F.Supp.2d 720, 728 (S.D. Miss. 2004); In re Diet Drugs (Phentermine, Fenfluramine, Dexfenfluramine) Products Liability Litigation, 294 F. Supp. 2d 667, 679 (E.D. Pa. 2003); In re Baycol Products Litigation, 2003 WL 22341303, at *3 (D. Minn. 2003); In re Baycol Products Litigation, 2002 WL 32155269, at *2 (D. Minn. July 5, 2002); In re Rezulin Products Liability Litigation, 168 F. Supp.2d 136, 145-47 (S.D.N.Y. 2001); In re Diet Drugs (Phentermine, Fenfluramine, Dexfenfluramine) Products Liability Litigation, 1999 WL 554584, at *4 (E.D. Pa. July 16, 1999); Simmons v. Wyeth Laboratories, Inc., 1996 WL 617492, at *4 (E.D. Pa. Oct. 24, 1996); Purdue Pharma, L.P. v. Estate of Heffner, 904 So. 2d 100, 103 (Miss. 2004); Adams v. Baxter Healthcare Corp., 998 S.W.2d 349, 358 (Tex. App. 1999); Blalock Prescription Center, Inc. v. Lopez-Guerra, 986 S.W.2d 658, 663-64 (Tex. App. 1998).

Other precedent holds the same thing in the context of consolidation. In re Repetitive Stress Injury Litigation, 11 F.3d 368, 373 (2d Cir. 1993) (granting mandamus and vacating order consolidating repetitive stress injury claims); Graziose v. American Home Products Corp., 202 F.R.D. 638, 641 (D. Nev. 2001); (“This case should be six separate cases. They will each involve separate discovery, separate claims, separate damages, separate defendants, separate [products], separate physical conditions and history, and. . .separate witnesses. The Court will sever the claims”); Janssen Pharmaceutica, Inc. v. Grant, 873 So. 2d 100 (Miss. 2004) (rejecting the aggregation for trial of four drug cases because the “litigable events” underlying each plaintiff's claims were different); Sapiro v. Sunstone Hotel Investors, L.L.C., 2006 WL 898155, at *2 (D. Ariz. Apr. 4, 2006) (rejecting attempt to consolidate two Legionnaires’ Disease cases); In re Consolidated Parlodel Litigation, 182 F.R.D. 441, 447 (D.N.J. 1998); (same; fourteen prescription drugs cases); Glussi v. Fortune Brands Inc., 714 N.Y.S.2d 516, 518 (App. Div. 2000) (same; eight cigarette cases).

This wasn’t always the case. Back when we first met one another, laboring in the Orthopedic Bone Screw vineyards, it was still an open question whether plaintiffs were going to get away with this kind of thing. One of the earlier opinions prohibiting joinder simply because all the plaintiffs used the same product and claimed the same injuries was ours. In re Orthopedic Bone Screw Products Liability Litigation, 1995 WL 428683 (E.D. Pa. July 17, 1995). Even there, the court allowed what we consider misjoinder if unrelated plaintiffs all had the same prescriber. Getting these mega-complaints split up is still dicey in some locales, as Kemp v. Metabolife International, Inc., 2003 WL 22272186 (E.D. La. Oct. 1, 2003), illustrates.

So one thing we’ve learned in these situations is that we have an ally in an unexpected place – the court clerk. Almost all clerk’s offices are not organized to handle complaints of this nature. It is difficult or impossible for them to set up individualized, plaintiff-specific files where there is only one docket number. Also, many clerk’s offices make a significant portion of their revenues from collection of filing fees and they know when they’re being gypped. Well, it just so happens that judge’s chambers and clerk’s offices deal with one another constantly. So when we’re wondering how to get the judge to listen to us out-of-state (usually) defense counsel as against a “home-court” (again, usually) plaintiff’s counsel, consider getting a letter or other support from the court clerk complaining about the misjoinder. It’s helped a lot, particularly in state court.

Wednesday, January 10, 2007

Law and science

Science affects law, but law also affects science. As litigators, we often think about the former; we less often think about the latter.

A recent article in Neurology journal, written by two physicians and two lawyers, bemoans "The impact of litigation on neurologic research." Here's a link. The article discusses a couple of cases in which litigants have sought to require the disclosure of scientists' research data, and the article recommends several possible solutions to this perceived problem. Among other things, the authors advocate "comprehensive federal legislation recognizing a research scholar privilege and ensuring that research data are uniformly protected against disclosure in all states."

This is another one of those issues about which we really can't speak publicly. We've been involved in cases where litigants (plaintiffs, of course, given what we do for a living) improperly relied on harebrained scholarship, and the only way to protect our clients' interest was to obtain the underlying data and discredit the research. And we've been involved in cases in which litigants (our defendant-clients, of course, given what we do for a living) were legitimately relying on impeccable scholarship, and plaintiffs improperly sought disclosure of the underlying research data to discredit the results. Well, you get our drift, anyway, and you see why we're not able to speak publicly on this topic.

But we can safely say these two things: First, the law of unintended consequences applies fully to judicial precedents. Now that Daubert is the law of the land, we have seen recidivist expert witnesses planning how to get their cockamamie theories in print, solely to increase the chance that silly opinions would become admissible in court. And we can certainly imagine Daubert distorting the natural progress of science on both sides of the "v."

Second, the law must balance, on the one hand, the need for scientific research that is unfettered by the burden of possible discovery in litigation with, on the other hand, the due process rights of litigants who may be adversely affected by inaccurate research results. That may not be an easy balance to reach, but it is surely a subject that demands intelligent thought and a good-faith effort to reach a fair solution.

Tuesday, January 09, 2007

The apocalypse is upon us (overwarnings)

Over ten years ago, Lars Noah (now on the faculty of the University of Florida College of Law) wrote on the subject of product warnings. In his article, he noted that it was theoretically possible for a plaintiff to sue a defendant not just for failing to warn, but for the opposite -- for over-warning. Professor Noah noted that he was not aware of any such claim actually having been pursued and that "such an outcome is not to be encouraged." Lars Noah, "The Imperative to Warn: Disentangling the "Right to Know" from the "Need to Know" about Consumer Product Hazards," 11 Yale J. on Reg. 293, 379-80 & n.435 (1994).

We now read, at overlawyered.com, that, "In the Vioxx litigation, Mark Lanier has accused Merck of making too many warnings, and thus 'hiding' its warning of VIGOR cardiovascular data." Now we (or at least the one of us typing these words) are not involved in the Vioxx litigation, and we (or at least I) have not seen the trial transcripts. But if this description is right, the plaintiffs' bar is now seeking to impose a strict liability duty of perfection (and, perhaps, prescience) on the pharmaceutical industry. If manufacturers can be sued for both underwarning and overwarning, then a product label must identify the precise side effect that a particular patient will suffer and warn about that event, but not warn about too many other possible adverse events.

This is all the more reason for courts to rule in favor of preemption: Let the FDA dictate the appropriate terms of pharmaceutical and medical device labeling, analyzed before the fact and rationally, and then stand by those decisions. But don't let lay juries, in the presence of an injured plaintiff, decide after the fact whether the product manufacturer should be held liable for either -- take your pick -- giving too few warnings or giving too many.

If Mark Lanier's argument is as overlawyered.com describes it, that's this week's sign that the apocalypse is upon us.