More On Big Firm Blogging

A couple of weeks ago, Herrmann noted in passing that, although many big firms now sponsor blogs, none of the ten firms with the highest profits per partner (that much-despised, but oft-cited metric) do.

You don't have to say much to set off an avalanche in the blogosphere.

Many folks contacted us, on or off-line, to suggest why lawyers at the most profitable firms don't blog.

We're staying out of this fray, but we offer for your consideration the six things we heard:

1. Lawyers at the most profitable firms are stupid:

"'Profitable' large law firms don’t see the need or the benefit of doing blogs. Clearly, if they are already doing well, why go to the trouble and work involved in blogging, when too many BigLaw lawyers still believe that the work will always be there. A mistake of course, but a perception nonetheless."

2. Lawyers at the most profitable firms are too busy:

"The reason they are so profitable is that everyone is working their heads off – nobody has time to blog."

3. Lawyers at those firms won't stoop to blog:

"They are so profitable that they don’t think they need to stoop to marketing (which is what they think blogging is)."

4. Lawyers at those firms don't want to give away their product for free:

"Lawyers at the top ten PPP firms wouldn’t want anyone at the firm to blog because they might divulge the firm’s precious secrets."

5. Lawyers at those firms lack the necessary skill set:

"Those high-profit firms are so profitable because they are very good at making money, but the skill sets required for being good at making money may not be the same as the skill sets required to blog."

6. Lawyers at those firms correctly believe that blogging is unlikely to yield a decent return on investment because of the nature of the firms, the work they do, and their clients:

"When your firm name is already well known and your reputation that well established, you wouldn't add any value by blogging."

As we said, we're staying out of this fray. Although we have a pretty strong opinion on this subject, we're keeping it to ourselves. But we thought we'd share with you the competing possibilities that had come over the transom.

Whither The Heeding Presumption?

About a month ago, the Nevada Supreme Court took a look at the so-called “heeding presumption” – and rejected it outright. Rivera v. Philip Morris, Inc., ___ P.3d ___, 2009 WL 1563373 (Nev. June 4, 2009). Not only that, the decision was unanimous. Obviously, given the caption, Rivera wasn’t a drug or device case (which is why we didn’t jump on it right away). But, like drugs and devices, cigarettes have inherent risks that cannot be designed away. So some of the arguments we’ve used against the heeding presumption in drug cases would apply to cigarettes. Indeed, the degree of public knowledge concerning risks in cigarette cases is much greater than in the average drug case. So it may be that cigarettes represent an a fortiori situation.


But an unavoidably unsafe product analysis wasn’t the Nevada Supreme Court did in Rivera. The court didn’t split the baby like some courts have done – limiting the presumption to certain types of products or kinds of situations. Rather, Rivera rejected the heeding presumption entirely, as against all defendants in any case. That’s worthy of our attention, even though the subject matter is outside of our sandbox.


Rivera’s facts aren’t all that unusual; a typical smoking case with allegations of inadequate warnings about the risks of smoking. The defendant tobacco company moved for summary judgment on the warning claim, which was denied. The trial court interposed a heeding presumption, and stated that the defendant had not overcome it. 2009 WL 1563373, at *2. However, since the case was in federal court, Nevada procedure permitted certification of controlling questions of law to the Nevada Supreme Court. That’s what happened with the heeding presumption. Id.


The Rivera court first stated the general rule: “the burden of proving causation can be satisfied in failure-to-warn cases by demonstrating that a different warning would have altered the way the plaintiff used the product or would have prompted plaintiff to take precautions to avoid the injury.” 2009 WL 1563373, at *4. That’s essentially the same standard we use in our drug cases to win summary judgment in learned intermediary cases based upon independent physician knowledge and other doctor-related facts that preclude causation.


The heeding presumption, however, “departs from well-settled and established Nevada law.” Id. It would change the burden of production on warning causation:

Instead of requiring that the plaintiff prove each element of a strict product liability case, a heeding presumption removes the plaintiff’s responsibility to carry the initial burden of production as to the element of causation. A heeding presumption “allow[s] the fact-finder to presume that the person injured by product use would have heeded an adequate warning, if given. Therefore, a heeding presumption shifts the burden of production from the plaintiff to the manufacturer, who must rebut the presumption by proving that the plaintiff would not have heeded a different warning.

Id. (various citations and quotation marks omitted).


The court didn’t want to go there. First, it got rid of a couple of cases plaintiffs advanced by construing them as holding no more than, under the facts, the plaintiffs could have met their burden of proving causation. 2009 WL 1563373, at *5.


Then it turned to the crux of the heeding presumption – the language in Restatement (Second) of Torts §402a, comment j (1965): “[w]here warning is given, the seller may reasonably assume that it will be read and heeded; and a product bearing such a warning, which is safe for use if it is followed, is not in defective condition, nor is it unreasonably dangerous.” Courts adopting the heeding presumption claim, as a some sort of symmetry, that a plaintiff presumptively would have followed a non-existent adequate warning.


That argument, of course, puts the rabbit squarely in the hat, because the comment j language really doesn’t give defendants anything. After all, if the warning is adequate, as the comment, postulates, the defendant doesn’t even need to get to causation to win. The defendant wins because there was nothing wrong with its warning – whether anybody read them or not. That means there’s really no “symmetry” or “corollary” at all. Instead, the heeding presumption effectively gives plaintiffs something of significant value (shifting the burden of, at least, production, on causation) for nothing (cases the defense wins anyway on adequacy of warming).


But we digress.


The Rivera court held that, while it had agreed with other parts of comment j in the past, in Allison v. Merck & Co., 878 P.2d 948 (Nev. 1994), it had not adopted all of comment j, and specifically had not adopted the language about presumed reliance upon warnings. 2009 WL 1563373, at *5 (“the manner in which we have previously cited to comment j indicates that we will not stray from the principle that the plaintiff carries the burden of production of the element of causation”). Coincidentally, Allison is the case where, when the votes of a splintered court are added together, a majority of the court followed the learned intermediary rule.


After discussing Allison, the court in Rivera comes out and says it: “It is a firmly rooted part of Nevada law that the plaintiff in a strict product liability case bears the burden of proving all the elements of his case, including causation.” 2009 WL 1563373, at *6. Rivera cites several other cases from around the country that refuse to adopt the heeding presumption. Id. (citing Riley v. American Honda Motor Co., 856 P.2d 196, 200 (Mont. 1993); DeJesus v. Craftsman Machinery Co., 548 A.2d 736, 744 (Conn. App. 1988); Harris v. International Truck & Engine Corp., 912 So.2d 1101, 1109 (Miss. App. 2005)).


Rivera also rejected the heeding presumption on public policy grounds. It's basis was somewhat unusual. The court concluded that it didn’t really like warnings very much, and that manufacturers should instead be encouraged to design products differently:

[W]e strongly adhere to the principle that a manufacturer must make products that are not unreasonably dangerous, no matter what instructions are given in the warning. Therefore, we conclude that it is better public policy not to encourage a reliance on warnings because this will help ensure that manufacturers continue to strive to make safe products.

2009 WL 1563373, at *6. We're not sure how we feel about that rationale, as there are a lot of product risks – in cigarettes, and in prescription drugs – that simply cannot be designed away. That’s what the unavoidably unsafe product concept is all about.


One thing we don’t have any qualms over, however is the court’s alternative policy ground, recognizing that presuming even adequate warnings will be heeded is an out and out fiction:
[I]t is not logical to presume that a plaintiff would have heeded an adequate warning, if provided. Warnings are everywhere in the modern world and often go unread or, where read, ignored.
Id. (citation and quotation marks omitted).


Rivera got us thinking about the heeding presumption generally. We’ve examined it previously, but that was limited to the context of prescription drugs and medical devices. We also discussed Ackermann v. Wyeth, 526 F.3d 203 (5th Cir. 2008), a case both of us had a hand in (it was Herrmann’s case, and Bexis contributed an amicus brief). Ackermann wiped out the heeding presumption in prescription drug cases brought in Texas:

Further, we doubt the Texas Supreme Court would apply such a presumption here, when it would not serve its intended purposes. . . . In the learned-intermediary context, however, it is [the prescriber], not [the plaintiff], who had to testify about his decision to prescribe [the drug. . . .] [T]o “read and heed,” in the context of a learned intermediary, means only that the physician would have incorporated the additional risk into his decisional calculus.

526 F.3d at 213. See also Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806, 814 (5th Cir. 1992) (no presumption in unavoidably unsafe products because the effect of a presumption on an inherent risk would be to presume that nobody would ever use the product); Lineberger v. Wyeth, 894 A.2d 141, 145, 149-50 (Pa. Super. 2006) (heeding presumption limited to products involuntarily encountered in the course of a plaintiff’s employment).


But while we’ve considered the presumption’s applicability with respect to unavoidably unsafe products, we’ve never considered the existential question of “to heed or not to heed, is there a presumption?” Apologies to The Bard for that one.


We’ll do that now.


As we expected, the Nevada Supreme Court in Rivera cited most of the best cases. In Riley, the Montana Supreme Court methodically shot down the various “policy” arguments that were advanced in support of the heeding presumption:

First, the dissent contends that it is “common sense” that if an adequate warning is given the plaintiff would have read and heeded it. While this might be common sense in an ideal world, our own experience does not support it; warnings are everywhere in the modern world and often go unread or, where read, ignored. We conclude that the presumption is not appropriate running in either direction, to the manufacturer/seller where a warning is given or to a plaintiff where it is not.

856 P.2d at 200. That sounds like “common sense” to us. We don’t read every warning that we encounter – and we’re defense lawyers. Like Riley, we don’t think anybody else does either.

Next, the dissent raises the perceived difficulties involved in requiring a plaintiff to establish the causation element. We note that the evidence required to establish this element is not qualitatively different than other testimony given by a party in support of her or his prima facie case. Concerns that the testimony may be speculative or self-serving and that a plaintiff may die before the testimony is given are not unique to this cause of action.

Id. We’d go a step further. If plaintiffs are inclined to commit perjury in support of possible recovery, that’s no reason at all to reward them by shifting the burden of proof.

Finally, the dissent argues that the presumption is consistent with the policy behind strict products liability. This may be so; so too would many other changes in a plaintiff's burden of establishing a prima facie case-including the elimination of any burden at all-be consistent with that policy. We are unwilling to shift the respective parties’ burdens in such a fashion. . . . A defendant certainly is in no better position to rebut a presumption which totally excuses a plaintiff from meeting the causation element than a plaintiff is in establishing the causation element as part of the prima facie case.

Id. We've seen plaintiffs trot this tired argument out in favor of abandoning any and all legal rules that can preclude recovery. Thus, there are lots of cases that, like Riley, reject it in various contexts. Here’s one we happen to have lying around: Strict liability “policies, however, have not been, and cannot be, applied to remove all forms of restriction imposed upon plaintiffs’ proofs in products liability actions.” Duchess v. Langston Corp., 769 A.2d 1131, 1145 (Pa. 2001) (subsequent remedial measures admissible in strict liability).


In Harris, the court declined to create a heeding presumption in a case involving a truck accident. The court observed that its state supreme court had, in a prior warning causation case (one involving a prescription vaccine), held: “Assuming arguendo that the warning was inadequate, [the plaintiff] still had the burden of showing that an adequate warning would have altered [the doctor's] conduct.” 912 So.2d 1109 (quoting Wyeth Laboratories, Inc. v. Fortenberry, 530 So.2d 688, 691 (Miss.1988)). This causation standard, Harris held, precluded any heeding presumption:

The fact that our supreme court has ruled on cases where a heeding presumption could easily have been applied to aid the plaintiff in a products liability case and declined to do so indicates to us that the [court] has no intention or desire to adopt or create a heeding presumption as a part of our jurisprudence with respect to product liability cases. Therefore, we decline to create one as well.

Id.


DeJesus, in contrast, was more of a statutory case, involving causation language in the Connecticut product liability statute. The statute, however, was silent about what “proving’ causation entailed. The court held that it did not entail a heeding presumption:

[Plaintiff’s] argument is untenable. The plaintiff, the claimant herein, acknowledges that [the statute] specifically places upon him the burden of proving proximate cause, but then argues that the statute is vague by not providing guidelines as to how a claimant can satisfy this burden. . . . The language of the statute is clear. There was no presumption of proximate cause that arose on the jury’s finding that [defendant] had failed to provide adequate warnings.

548 A.2d at 744.


Beyond the cases cited in Rivera, there’s a lot of law, perhaps predictably, in New York and California.


In New York, “[u]nder well settled law, to prove proximate cause, a plaintiff has the obligation to adduce proof that had a warning been provided, she would have read the warning and heeded it.” Mulhall v. Hannafin, 841 N.Y.S.2d 282, 287 (N.Y.A.D. 2007). Accord Sosna v. American Home Products, 748 N.Y.S.2d 548, 549 (N.Y.A.D. 2002) (“in this State, it remains plaintiff’s burden to prove that defendant’s failure to warn was a proximate cause of his injury, and this burden includes adducing proof that the user of a product would have read and heeded a warning had one been given”); Topliff v. Wal-Mart Stores East LP, 2007 WL 911891, at *43 (N.D.N.Y. March 22, 2007) (no heeding presumption in New York; at most an “inference”); Smallwood v. Clairol, Inc., 2005 WL 425491, at *2 (S.D.N.Y. Feb. 18, 2005) (“plaintiff has the burden to establish “that he would have read and heeded a different warning had one been given”).


In California, all the law’s on the trial court level, but it holds that California would not recognize a heeding presumption. In Motus v. Pfizer Inc., after a lengthy discussion of California precedent, the court summed up:

Given that other no other court applying California law in this context has adopted the presumption, and several courts have failed to do so when the presumption could have been critical, this Court will not apply it here.

196 F. Supp.2d 984, 994-95 (C.D. Cal. 2001), aff’d, 358 F.3d 659 (9th Cir. 2004). Accord Nix v. SmithKline Beecham Corp., 2007 WL 2526402, at *2 (D. Ariz. Sept. 5, 2007) (“California. . .has not adopted a rebuttable presumption that the physician would have heeded an adequate warning”); Latiolais v. Merck & Co., 2007 WL 5861354, at *4 (C.D. Cal. Feb. 6, 2007) (plaintiff “improperly invokes the ‘rebuttable presumption’ doctrine. . ., as no California court had adopted it”), aff’d, 302 Fed. Appx. 756 (9th Cir. 2008); Lord v. Sigueiros, 2006 WL 1510408, at *4 (Cal. Super. April 26, 2006) (concluding that Motus “accurately summarize[s]” California law), aff’d, 2007 WL 4418019 (Cal. App. Dec. 19, 2007) (unpublished).


Elsewhere, courts have concluded that Alabama, Georgia, Minnesota, New Hampshire, South Carolina, and Wisconsin do not recognize the heeding presumption. See Gurley v. American Honda Motor Co., Inc., 505 So.2d 358, 361 (Ala. 1987) (warning cases “cannot be submitted to a jury unless there is some evidence that the allegedly inadequate warning would have been read and heeded and would have kept the accident from occurring”); Porter v. Eli Lilly & Co., 2008 WL 544739, at *11 (N.D. Ga. Feb. 25, 2008) (“there is no indication in Georgia law, however, that it would apply this comment in the manner of a ‘heeding presumption’ that would vitiate the need for a plaintiff to establish proximate cause for her injuries”), aff’d, 291 Fed. Appx. 963 (11th Cir. 2008); Tuttle v. Lorillard Tobacco Co., 377 F.3d 917, 925 (9th Cir. 2004) (“Minnesota state courts have not adopted the so-called ‘heeding presumption’”); Wilson v. Bradlees, Inc., 250 F.3d 10, 16 (1st Cir. 2001) (“New Hampshire has not adopted the 'read and heed' presumption, and we will not do so on its behalf”); Odom v. G.D. Searle & Co., 979 F.2d 1001, 1003 (4th Cir. 1992) (“There is no such presumption under South Carolina law, and we are unwilling to create one”); Kurer v. Parke, Davis & Co., 679 N.W.2d 867, 876 (Wis. App. 2004) (“[e]ven in the event that a warning is inadequate, proximate cause is not presumed”).


So, while there are quite a few states that adopted heeding presumptions – mostly during product liability law’s “free lunch” period in the 1970s and 1980s – there’s hope yet. Rivera demonstrates that, when an appellate court actually takes a hard look at the underpinnings of this spurious presumption, there’s a good chance that it will be rejected.

Device Preemption Win In Louisiana

A tip of the cyberhat to blog reader Ed Fitzgerald at Gordon & Rees for sending us the latest preemption win in the post-Riegel device world. It's Bencomo v. Guidant Corp., slip op. (E.D. La. June 30, 2009). The case involves a PMA-approved stent. It's all about express warranty claims because the plaintiff abandoned everything else in the complaint and chose to hunker down with that single remaining claim.

That claim was based upon alleged discrepancies between the stent's Patient Guide (which the plaintiff claimed - only by omitting significant language - promised to "capture all emboli") and the device's labeling. Slip op. at 2.

Didn't work. Preemption applied to the express warranty claim for several reasons.

First of all, not only the labeling, but the patient guide as well, had been presented to the FDA and approved. Slip op. at 13 (there's a long discussion of Riegel on the intervening pages). Preemption precluded plaintiff from basing an express warranty claim on FDA-approved language. Id. at 14. Any alleged inconsistencies between the patient guide and the device labeling were "of no moment" because both documents had FDA approval, and plaintiff's claim was a state-law attempt to change one or the other:

The plaintiff raises the issue of an alleged discrepancy in an effort to prove that the Guide that he read was untrue. Even assuming arguendo that there are inconsistencies. . .the plaintiff's argument is of no moment. Both [documents] were approved by the FDA as a part of the premarket approval process. . . . The plaintiff argues that the inconsistency is important because it will enable him to prove that the statements he relied upon in the Guide were untrue. . . .[I]t is for the precise reason that the plaintiff must demonstrate untruthfulness under [state law] that the. . .breach of warranty claim. . .is preempted.

Id. at 15.

Then the court dealt with plaintiff's obligatory "parallel violation" argument. Slip op. at 16-17. That failed as well. Plaintiff claimed broadly "that FDA regulations require that all labeling of medical devices must accurately represent the device. . .consistently with the [labeling]." Id. at 16. On its face the court found that this claim "relate[s] to and [is] potentially inconsistent with" the FDA's approval of both documents. Id. at 17.

Congrats to Guidant and its counsel. Keep those wins coming.

An Avandia Removal Spat

Egad -- yet another post on removal!

We'll try to keep it mercifully brief.

In In re Avandia Marketing, Sales Practices and Prods. Liab. Litig., [That caption about covers the waterfront, doesn't it?] MDL No. 1871, 2009 U.S. Dist. LEXIS 51558 (E.D. Pa. June 18, 2009), GlaxoSmithKline removed two "Avandia supposedly increases the risk of heart attack" cases from state court. GSK removed the Martinez case from a state court in New Mexico and the Brown case from North Carolina. Both were then transferred to the MDL in Philadelphia, and Judge Rufe ruled on plaintiffs' motions to remand.

In Martinez, the main question was whether the GSK detail representative, Carmen Hoss, was fraudulently joined on a product liability claim. Plaintiff alleged that GSK deceived the world about the supposed cardiac risks of Avandia. But plaintiff also pleaded that Hoss was aware of those cardiac risks and supposedly misrepresented them, so plaintiff could sue Hoss for the misrepresentation. 2009 U.S. Dist. LEXIS at *13-*14. GSK said that Hoss wasn't aware of any supposed cardiac risks of Avandia and so was fraudulently joined.

Think for a minute about plaintiff's alleged scam: GSK is supposedly trying to hide the risks of its drug from the world, but nonetheless tells its sales reps about those very risks?! Judge Rufe acknowledged that "GSK's argument [that there was no suggestion that the sales rep knew of the alleged risks] has some appeal -- it is difficult to imagine a scenario in which a drug company divulges otherwise secret information about the dangers of its products in training materials or educational sessions given to sales representatives." Id. at *17.

But New Mexico state law doesn't require specificity in pleading, and the general (and implausible) allegations of Hoss's knowledge of Avandia's risks "are potentially sufficient under New Mexico law." Id. at *20. The court thus remanded the Martinez case.

We have three reactions to that.

But we can't reveal the first reaction in polite company, so we'll keep it to ourselves.

Our other two reactions are legal, so we'll keep typing: First, this holding means that removal is easier in states with rules that require fact pleading (such as Pennsylvania) than in states that permit mere notice pleading (such as New Mexico). The additional details required in a fact pleading state will make it harder to support spurious claims. That's a curious result, but it's not necessarily wrong: State court rules govern pleadings in state courts, and those rules may affect removal issues.

Second, we assume that the Twombly/Iqbal pleading standards (which we've discussed here and here, among other places), which now apply in federal court, will over time be adopted in some state courts -- particularly state courts with rules of procedure modeled on the Federal Rules. Thus, over time, "implausible" state court complaints will no longer state claims, and defendants will have more opportunities to remove based on fraudulent joinder.

The other Avandia removal was in the Brown case. The question there was whether GSK's principal place of business was in North Carolina or Pennsylvania. (Brown was a citizen of North Carolina. If GSK's PPB was in North Carolina, then the parties would not be diverse, and the court would have to remand the case.) Applying the "center of activities" test, which the Third Circuit uses to determine a corporation's principal place of business, Judge Rufe found that, as of late 2008, GSK's principal place of business was in Pennsylvania. Diversity existed, and plaintiff's motion to remand Brown was denied. Id. at *29.

As to that holding, we note only that on June 8, the Supreme Court granted certiorari in Hertz v. Friend, No. 08-1107, which presents the question "[w]hether the location of a nationwide corporation’s headquarters can be considered for purposes of determining principal place of business for diversity jurisdiction citizenship under 28 U.S.C. § 1332." The cert petition (here's a link, courtesy of SCOTUS blog) notes that courts currently use four different tests to determine a corporation's principal place of business; the Third Circuit's "center of activities" test is just one of the four.

Thus, a decision in Hertz v. Friend (which the Supreme Court will presumably decide in late 2009 or early 2010) may provide guidance on the appropriate way to determine a corporation's principal place of business.

Another Severance Of Med Mal Claims To Preserve Diversity As To Products Defendants

We posted earlier this month about Joseph v. Baxter, in which Judge James Carr (of the Northern District of Ohio) severed and remanded claims against the non-diverse health care providers to create diversity as to the drug company defendant.

We raised a few questions at the end of that post, asking, among other things, whether the holding was limited to situations where (1) the drug company removed before it was aware that health care providers had been named as defendants or (2) a federal multidistrict litigation proceeding was pending.

Judge Carr's back!

And we learned moments ago that the answer is "no" -- to both of our questions!

In Judge Carr's court, if a plaintiff sues both non-diverse health care providers (on medical malpractice claims) and an out-of-state drug company (on product liability claims), the federal court can sever and remand the med mal claims and retain jurisdiction over the then-diverse products claims.

That's the result in DeGidio v. Centocor, No. 3:09CV721, slip op. (N.D. Ohio June 29, 2009) (here's a link). Ohio citizen DeGidio sued non-resident drug companies -- Centocor, Johnson & Johnson, and Ortho-McNeil Pharmaceutical -- on product liability claims and, in the same complaint, sued Ohio resident health care providers -- Dr. Ray Miller and Nurse Jane Doe -- on medical malpractice claims related to DeGidio's ingestion of the drug Remicade.

The drug companies rolled all their strength up into one ball and removed the case to federal court. DeGidio moved to remand. The drug companies asserted that the health care providers were dispensable parties, so the federal court could sever the claims against the medical malpractice defendants and remand them to state court, creating diversity jurisdiction as to the product liability defendants.

That's exactly what Judge Carr did: He severed and remanded the claims against Dr. Miller and Nurse Doe, and then retained jurisdiction over the remaining, diverse product liability lawsuit.

At that point, the judge didn't have to address the drug companies' arguments that the health care providers had either been fraudulently joined (because plaintiff hadn't provided an affidavit of merit as to the med mal claims) or fraudulently misjoined (because the med mal and products claims couldn't properly be brought in a single case, under the logic of Tapscott v. MS Dealer Serv. Corp., 77 F.3d 1353, 1360 (11th Cir. 1996)).

If Judge Carr's logic catches on with other judges, we predict that you'll see an awful lot of drug companies removing cases on this ground and asking federal courts to sever and remand the med mal claims.

Wham, Bam; Thank You, Kamm!

You know the "review of remand order" story, because we wrote about it earlier this month:

28 U.S.C. Sec. 1447(c) authorizes a federal trial court to remand a case to state court for either (1) lack of subject matter jurisdiction or (2) defects "other than lack of subject matter jurisdiction." Objections to subject matter jurisdiction can of course be raised at any time. But motions to remand "on the basis of any defect other than lack of subject matter jurisdiction must be made within 30 days after the filing of the notice of removal."

Section 1447(d) then says that a remand order "is not reviewable on appeal or otherwise." Courts have interpreted section 1447(d) to apply only to remand orders issued under section 1447(c). Thus, if a trial court remands a case on a ground not specified in 1447(c), the remand order may be reviewable.

We're simple guys, and our heads spin easily. We thus keep trying to simplify our world, so we can understand it and explain it to our clients.

We figure there are three kinds of motions to remand: (1) Motions to remand based on lack of subject matter jurisdiction (i.e., a lack of diversity or less than $75,000 in controversy, or the absence of a federal question), (2) motions to remand based on defects in the removal procedure (e.g., the defendant blew the deadline for removing the case or all defendants didn't join in the notice of removal), and (3) motions to remand that involve decisions on substantive questions of law apart from subject matter jurisdiction or the removal process (e.g., a motion to remand based on an abstention doctrine).

The first kind of motion to remand -- for lack of jurisdction -- can be made at any time. The second kind of motion -- for a defect in the removal process -- must be made within 30 days or is waived. The third kind of motion -- based on substantive law unrelated to jurisdiction or the removal process -- is not governed by section 1447 at all.

And -- take a deep breath -- the first two types of motions are not reviewable by appellate courts, but the third type may be.

Turns out this is exactly right.

But what a mess it is.

Kamm v. ITEX Corp., No. CV-06-00943-AJB, slip op. (9th Cir. June 15, 2009) (link here), involved a contract dispute. The contract contained a forum selection clause saying that any action for breach of contract would "be filed . . . in the courts of the State of Oregon." Id. at 7108. Kamm filed a complaint in state court. ITEX removed. Kamm moved to remand thirty-one days later. Id. The trial court granted the motion to remand, and ITEX appealed.

What result?

The facts seem so easy, but somehow it feels like we're in our first year of law school all over again.

The case turns on how the court categorizes a motion to remand based on a forum selection clause.

That kind of motion ain't jurisdictional. A forum selection clause does not deprive a federal court of subject matter jurisdiction. M/S Bremen v. Zapata Off-Shore Co., 407 U.S. 1, 12 (1972).

So is removal in violation of a forum selection clause a "defect other than lack of subject matter jurisdiction"? If it is, then Kamm had to move to remand within 30 days, which he had failed to do (and thus had waived his objection to removal). Also, if a forum-selection-motion-to-remand involves a "defect other than lack of subject matter jurisdiction," then that motion falls within section 1447(c) and the corresponding bar on appellate review contained in section 1447(d). If appellate review were barred, then the Ninth Circuit would have had to dismiss ITEX's appeal.

Judge William Fletcher spied all the issues and wrestled with this nicely.

He concluded that a motion to remand to enforce a forum selection clause does not involve a "defect" in the removal process, but rather involves an independent legal question. Id. at 7112-14. Thus, Kamm was not required to bring that motion to remand within 30 days, and the Ninth Circuit had jurisdiction to hear the appeal. The Ninth Circuit thus reached the merits and affirmed the trial court's remand order. Id. at 7115.

In one sense, we're happy: We generally root for defendants at this blog, but we'll get over that here. The Ninth Circuit reached a reasonable result, and the court grappled with this issue comprehensively.

In another sense, however, we're sad: As practicing lawyers, we have to live in this crazy, mixed up world, and we have to explain it to our clients, and we have to provide legal services at a fair price.

And here's the state of play: Whenever a plaintiff moves to remand on a non-jurisdictional ground, we must figure out whether the non-jurisdictional ground qualifies as a "defect" within the meaning of section 1447. If it does, then the plaintiff must move to remand within 30 days, and there will be no appellate review of a remand order. But, if the motion does not involve a "defect," then the motion need not be made within 30 days (although it must still be made "on a timely basis," id. at 7114), and appellate review will be available.

And remember: That's just in the Ninth Circuit!

Other circuits may classify "defects" differently or may solve this entire riddle in some other way.

And all of that is just to decide which court will hear your case! Only after we decide that can we start to worry about who should actually win on the merits.

We're not really here to cry on your shoulder.

But we will anyway.

Please don't blame us for the high cost of providing legal services. Sometimes it's the law itself that inflicts these things on us.

WSJ On Twombly and Iqbal

Today's Wall Street Journal has an article advising the world that Ashcroft v. Iqbal was one of the most important cases for business in this year's Supreme Court Term.

Film at 11!

Here we criticized ourselves when we didn't publish a post about Iqbal until May 26, a full week after the decision had come down. (But we quickly recovered, joining the fray in the blogosphere here and here.)

Thank you, Wall Street Journal, for making us feel better about our original sluggishness.

Cost Of Litigation Drives Accutane Off The Market

Bloomberg News reported this moments ago:

"Roche Holding AG, the world’s biggest maker of cancer drugs, is pulling its Accutane acne medicine from the U.S. market after juries awarded at least $33 million in damages to users who blamed the drug for bowel disease."

Here's our take: The cause of inflammatory bowel disease is unknown. There's essentially no scientific evidence linking Accutane to that condition. (Here's a link to our post from a couple of years ago reporting on the MDL judge's rejection of plaintiffs' general causation evidence supposedly linking Accutane to IBD.) Despite the absence of scientific evidence, juries have repeatedly awarded millions of dollars to folks who developed IBD after taking Accutane. (Here's a link to one example.) So Roche Holding is now giving up the ship.

If you ever need another example of the cost of litigation driving a beneficial drug off the market, add Accutane to your list.

UPDATE: Here's a link to the New Jersey Lawsuit Reform Alliance's statement on this subject, which resembles ours. A reader has also advised us that Accutane faces generic competition, which folks thinking about this situation should consider.

Scratch Three More Zyprexa Plaintiffs

Judge Weinstein granted three more summary judgment motions yesterday in the Zyprexa mass tort. The reasoning is essentially the same for two of them - the statute of limitations ran, and there was no warning causation under the learned intermediary rule. The third case had no statute of limitations issue, and was solely a causation decision. Briefly:

In Morrison v. Eli Lilly, the drug helped the plaintiff with fewer adverse effects than any of the other medications he tried. There was evidence that the plaintiff refused to be taken off the drug despite weight gain. Plaintiff's medical records and his treater's deposition demonstrated knowledge of associations between the drug and weight gain/diabetes, well before the statute of limitations ran. Thus, under the Missouri discovery and learned intermediary rules, the claims were time barred. There was also no causation, as the physicians prescribed and maintained the plaintiff on the drug with knowledge of its potential effects because it was effective in treating the plaintiff's psychological condition.

In Leggett v. Eli Lilly, the plaintiff had been locked up as criminally insane, but the drug helped enough that he could be released. For almost twice the period of the relevant California statute of limitations, plaintiff's medical records and his treater's deposition demonstrated knowledge of associations between the drug and weight gain/diabetes. There was also no causation under the learned intermediary rule because the treater testified that he would prescribe the drug regardless of any diabetes warning because it helped the plaintiff so much.

In Neal v. Eli Lilly, use of the drug alleviated the plaintiff's various auditory hallucinations and suicidal depression. All four of the treating physicians were aware of the alleged diabetes association, and prescribed the drug anyway, given its beneficial effect on his condition. Because no additional warning would have changed the result, there was no causation under California law. There was no medical causation either, because the plaintiff's expert had been thrown out, and his treaters doubted that the drug caused plaintiff's diabetes.

Some Thoughts On Pleading And Proving FDA Actions

This post is largely about drug and medical device litigation “inside baseball.” Some of it’s going to be really technical. So if you’re looking for philosophical musings, or just a chuckle or two over the latest bizarre goings on in our neck of the woods, come back later.

But if you’ve ever had to worry about pleading and proving FDA actions without formal discovery – especially doing it on Rule 12 motions to dismiss or motions for judgment on the pleadings – pull up a cyber chair.

The problem of getting what we know that the FDA did properly before a court on a motion that’s largely based upon the pleadings is something we’ve touched upon before. That post examined the use of judicial notice in Colacicco v. Apotex Inc., 521 F.3d 253 (3d Cir. 2008). Colacicco was (and we do mean "was", since the opinion was vacated on other grounds by the Supreme Court after Wyeth v. Levine) a drug preemption case.

One of the defendants in Colacicco (it was a consolidated appeal) had done something we consider to be rather risky – it raised a preemption issue via a motion to dismiss. We’ve always been hesitant about doing that because a motion to dismiss is limited to considering the complaint, and we think that preemption motions have a greater chance for success when they present a more detailed record of what the FDA actually did - as opposed to just what the plaintiff claims the FDA did.

Colacicco was important in that respect because the court employed judicial notice to bring an extensive FDA record before it on a motion to dismiss:

• FDA rejection of several citizen’s petitions involving a different drug. 521 F.3d at 269.
• FDA approval letters for the drug in question. Id. at 270 & n.16.
• Certain FDA talk papers concerning either the drug in question or that class of drug. Id. at 270, 273.
• An FDA Public Health Advisory, concerning the risk at issue and the class of drug. Id. at 270-71, 273.
• The drug’s labeling. Id. at 273 n.18.
• An FDA public notice concerning the risk at issue and the class of drug, that took place after the injuries in question. Id. at 273.
• Revised classwide labeling, also post-dating the injuries in question. Id. at 273-74 & n.20.
• An FDA news bulletin concerning the revised classwide labeling. Id. at 273-74.

Judicial notice in Colacicco offered a way around the record problems otherwise inherent in a pleadings-based motion. Basically, if the information is available on the FDA’s website (or presumably on other unimpeachable Internet sources), it’s subject to judicial notice under Colacicco.

Several things have happened since then. First, and most notably, Colacicco itself was vacated in the wake of Levine. That’s hardly fatal to the evidentiary points we discussed in our prior post, since the plaintiffs only appealed the preemption issue – and nothing having to do with judicial notice. That much is clear from the plaintiffs’ petition for certiorari and reply in support of that petition. Still, in light of the Colacicco GVR (grant, vacate, remand) order, it’s prudent to look for other cases that also involve judicial notice of FDA actions and related information.

Second, the Supreme Court decided Levine and raised the bar for implied preemption based upon FDA actions concerning prescription drugs. Given the various preemption criteria set out in Levine, we don’t expect to see many preemption motions brought in prescription drug cases before the summary judgment stage – which means after substantial discovery. The problem of getting evidence of FDA actions before the court is thus unlikely to arise very often in future prescription drug preemption motions.

Third, the Supreme Court’s decision in Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), recognizing broad express preemption in cases involving PMA medical devices has had the opposite effect. With express preemption firmly established in PMA medical device cases, we expected, and have seen (see our post-Riegel device preemption scorecard for details), a lot more medical device preemption motions being made on Rule 12 motions.

Getting FDA information – including but not limited to the fact of PMA approval – properly before the court on such motions becomes critical. See Kavalir v. Medtronic, Inc., 2008 WL 4087950, at *4 (N.D. Ill. Aug. 27, 2008) (denying preemption motion without prejudice where “FDA internet pages” offered as evidence of PMA approval did not establish the “specific form” of approval that the “specific” product involved in the litigation had received). The most persuasive source for establishing PMA approval is, of course, the FDA itself.

Fourth, the Supreme Court has toughened up pleading standards under Fed. R. Civ. P. 8, first in Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), and more recently in Ashcroft v. Iqbal, 129 S. Ct. 1937 (U.S. 2009). We’ve been all over this issue, here, here, here, and here, from the moment Twombly was first decided two years ago.

While we’ve naturally concentrated on how the heightened standard affects plaintiffs, it’s possible that our side might have to – or, more likely, want to – plead more FDA-related allegations in support of our defenses. That would be another way to get around the problem that occurred in Kavalir, since under Fed. R. Civ. P. 10(c) “[a] copy of a written instrument that is an exhibit to a pleading is part of a pleading for all purposes.”

Fifth, there may be other reasons, having nothing to do with preemption, that we want to take judicial notice of a particular FDA action in a particular case.

Before we discuss cases, we wish to point out, as we have before, that to the extent the FDA action in question is formalized and published in the Federal Register, it is subject to mandatory judicial notice. Congress has said so. 44 U.S.C. §1507 (“[t]he contents of the Federal Register shall be judicially noticed”); Thuringer v. American National Red Cross, 2006 WL 406353, at *3 (N.D. Iowa Feb. 17, 2006) (“the plain language of §1507 states that judicial notice of the regulation is mandatory”). See McKenney v. Purepac Pharmaceutical Co., 83 Cal. Rptr.3d 810, 819 n.1 (Cal. App. 2008) (FDA’s views on preemption published in the Federal Register subject to judicial notice); Alpharma, Inc. v. Pennfield Oil Co., 2008 WL 1990783, at *9 (D. Neb. May 5, 2008) (FDA “rules” published in Federal Register “are judicially noticed”) (citing statute).

As far as cases, here’s what we’ve found. In Heisner v. Genzyme Corp., 2008 WL 2940811 (N.D. Ill. July 25, 2008), the court did exactly what we’ve been talking about – it took judicial notice of the defendant’s PMA approval in the context of a Riegel-based motion to dismiss:

Plaintiff argues against taking judicial notice of facts surrounding the FDA’s approval, stating that “disputable findings exist concerning the Defendant's compliance. . . .” However, this does not contradict the putative fact in question, which is only that the FDA approved [device] as a Class III device pursuant to the PMA process. . . . Neither of these [compliance-related] questions contradict the clear, undisputed, and publicly available fact put forward by Defendant; that the FDA approved [the device] as a Class III device. As a matter of law, this approval is granted only upon completion of the PMA process. Therefore, this Court takes judicial notice of the fact that [the device] is a Class III device approved by the FDA pursuant to the PMA process.

Id. at *1 (emphasis added). Heisner was followed, as to judicial notice, in Bausch v. Stryker Corp., 2008 WL 5157940, at *3 (N.D. Ill. Dec. 9, 2008). See Rivelli v. MH & W Corp., 890 A.2d 978, 982 (N.J. Super. A.D. 2006) (taking judicial notice of FDA drug approval).

Another important judicial notice case is In re Epogen & Aranesp Off-Label Marketing & Sales Practices Litigation, 590 F. Supp.2d 1282 (C.D. Cal. 2008). In Epogen/Aranesp the court had this to say about jurisdiction of drug labeling:

On a motion to dismiss, the Court may take judicial notice of facts that are not “subject to reasonable dispute.” Under Fed. R. Evid. 201, a fact is not subject to reasonable dispute when it is “capable of accurate and ready determination by resort to sources whose accuracy cannot reasonably be questioned.” The Court grants [the] request as to . . . labels for [the drug] that are publicly available on the FDA website, finding that the labels are documents not subject to reasonable dispute.

Id. at 1286. The court (Judge Gutierrez) relied upon its prior decision in securities litigation involving the same drugs. In that earlier case, also on a motion to dismiss, the court granted judicial notice of drug labeling and an FDA public health advisory – both of which were were available on the FDA’s website. In re Amgen Inc. Securities Litigation, 544 F. Supp.2d 1009, 1023 (C.D. Cal. 2008). Labeling was also granted judicial notice in: Horne v. Novartis Pharmaceuticals Corp., 541 F. Supp.2d 768, 776-77 (W.D.N.C. 2008), and Ebel v. Eli Lilly & Co., 536 F.Supp.2d 767, 781 (S.D. Tex. 2008), aff’d, 2009 WL 837325 (5th Cir. March 30, 2009) (unpublished).

Judicial notice is routinely given to FDA guidance documents, which are also available on the FDA’s website. See Johnson v. Pozen, Inc., 2009 WL 426235, at *1-2 (M.D.N.C. Feb. 19, 2009); In re Nuvelo, Inc., Securities Litigation, 2008 WL 5114325, at *2 (N.D. Cal. Dec. 4, 2008); Construction Laborers Pension Trust of Greater St Louis v. Neurocrine Biosciences, Inc., 2008 WL 4370010, at *5 (S D Cal. Sept. 23, 2008); Construction Laborers Pension Trust of Greater St Louis v. Neurocrine Biosciences, Inc., 2008 WL 2053733, at *7 (S.D. Cal. May 13, 2008); In re Intrabiotics Pharmaceuticals, Inc. Securities Litigation, 2006 WL 708594, at *8 (N.D. Cal. Jan. 23, 2006); see McGuire v. Dendreon Corp., 2008 WL 1791381, at *4 (W.D. Wash. April 18, 2008) (taking judicial notice of “FDA regulatory protocols,” which we guess means guidance documents).

An FDA public health advisory received judicial notice in Horne, 541 F. Supp.2d at 776-77. The same is true of FDA press releases in Matthews v. Donald, 2007 WL 2593086, at *1-2 (N.D. Ga. Sept. 4, 2007), and Wright v. Henderson, 2007 WL 2484317, at *2 (N.D. Ga. Aug. 28, 2007), and of an FDA safety alert in Rozzelle v. Rossi, 2007 WL 2571935, at *6-7 (W.D. Pa. Aug. 31, 2007).

The filing of adverse event reports with the FDA was granted judicial notice in Rollins v. St. Jude Medical, 583 F. Supp.2d 790, 804-05 (W.D. La. 2008).

A chart of drug approval dates in a document posted on the FDA’s website received judicial notice in Dimmick v. United States, 2006 WL 3741911, at *6 n.1 (N.D. Cal. Dec. 15, 2006).

Unspecified “FDA letters” were granted judicial notice in Schering-Plough Healthcare Products, Inc. v. Schwarz Pharma, Inc., 547 F. Supp.2d 939, 945 n.1 (E.D. Wis. 2008), amended, 2009 WL 151573 (E.D. Wis. Jan. 22, 2009). Unspecified evidence that certain advertisements were submitted to the FDA received judicial notice in In re Bextra & Celebrex Marketing Sales Practices & Product Liability Litigation, 2006 WL 2374742, at *11 (N.D. Cal. Aug. 16, 2006).

FDA amicus briefs concerning preemption were judicially noticed in McKenney, 83 Cal. Rptr.3d at 819 n.1.

Finally, we’re not exactly sure what FDA documents were subject to judicial notice in In re Zyprexa Products Liability Litigation, 549 F. Supp.2d 496 (E.D.N.Y. 2008), but since Judge Weinstein literally “wrote the book” on evidence (including Fed. R. Evid. 201 governing judicial notice), we felt we should include it. The Zyprexa opinion first states generally that “[p]ublic documents issued by government agencies such as the Food and Drug Administration (“FDA”) may also be considered.” Id. at 501 (discussing judicial notice). Thirty pages later – following an extensive discussion of the history of the drug, the opinion concludes, “[t]o the extent that judicial notice was taken of any evidence, the court complied with” Rule 201. Id. at 530-31. See also Meyers v. Bayer AG, 735 N.W.2d 448, 332 n.1 (Wis. 2007) (blanket judicial notice of various FDA “public records”); Sykes v. Glaxo-SmithKline, 484 F. Supp.2d 289, 203 & n.4 (E.D. Pa. 2007) (same).

On a related topic, in Banks v. County of Allegheny, 568 F. Supp.2d 579, 596 & n.9 (W.D. Pa. 2008), the court took judicial notice that a particular drug was “a medically acceptable course of treatment, relying upon “strategies” for control of the disease in question that were available on the website of the Centers for Disease control.

One last thing that we found – not specifically FDA-related, but still of interest – is that there is recent precedent for taking judicial notice of the contents of published medical literature. See United States v. Pfizer, Inc., 2009 WL 1456582, at *10 (E.D.N.Y. May 22, 2009).

Beyond judicial notice, there’s a technical issue about getting proper links to FDA PMA approval data that's available on the FDA’s website. This has been a pain in the you-know-what because, while individual PMA approval information is available (if you know where on the FDA’s website to look), the weblinks aren’t stable. By that we mean the links generated by the search function on the FDA site expire in about a month or so.

Thus these FDA-generated PMA links aren’t very good to put in briefs supporting a dispositive motion, because by the time the briefing is finished, the links in the initial brief don’t work any more. Recently, however, we got this tip from Dave Gossett over at Mayer Brown on how to solve that problem.

Here’s what to do. The trick to creating FDA website addresses for PMAs that don’t go bad in a few weeks is not to use the link for the database search result that appears with the results of performing a search. Those expire. Instead, it’s necessary to find and use the URL for the actual search itself.

Don’t understand? Well, neither did we at first. So we’ll give you an example. We’ll use the ninety-ninth supplement to the nine hundred and ninety ninth PMA that the FDA received in 1999 (like the FDA would ever approve that many devices in one year). That way we won’t have to worry about numerical typos, at least.

We could do the links with actual PMA and PMA supplement numbers, but we don’t want to single out any particular device. So remember, that since we’re using made up numbers, the made-up links aren’t going to go anywhere.

From the FDA’s PMA search page (assuming this was an actual PMA, which it isn’t) the following link would bring up the approval data for PMA #P990999, Supplement S099:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?start_search=1&PMANumber=P990999&SupplementNumber=S099

It’s just a matter of plugging in the PMA number and PMA supplement number for the device that’s of interest. These numbers, if not already known to counsel, will be available from the client once the identity of the particular device in question is established. It’s always been available, so we guess that this sort of track-back capability exists for all PMA-approved devices.

Whenever a different PMA number or PMA supplement number is desired, just change the numbers that appear after the “PMANumber” or “SupplementNumber” parts of the URL we just posted. Note that (most practitioners, of course, already know this) the first two numbers of the PMA number are for the year in question. If that number is less than a thousand, a “zero” is necessary right after the year. Ditto for any PMA supplement with a supplement number under one hundred. It’s necessary to include the proper number of zeros as place holders.

The same process should work to link to FDA approval information for any supplement to any PMA that’s on the FDA’s system. If only the original FDA-approved PMA is desired (no supplement), just replace the “SupplementNumber” portion of that search screen with the phrase “SupplementType=NONE”. That is,

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?start_search=1&PMANumber=P990999&SupplementType=NONE

will give you a link to the original PMA (no supplement) for the first example we used above. Also, on the search result for any PMA supplement, there’s a link directly to the approval data for the original PMA.

Now, it’s not always necessary to know the details of the device (or to bother the client for them) in order to get this information. The search functions on the FDA’s search page aren’t limited to PMA and PMA supplement numbers. It’s possible to search for devices in other ways – such as using the trade name for the device or the date that the PMA (or supplement) was approved. Once the necessary PMA and PMA supplement numbers are obtained, they can be plugged in as already described.

Since URLs in the form of:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?start_search=1&PMANumber=P******&SupplementType=****

trigger the search function itself, they will automatically link to a newly created temporary file on the FDA website each time they are used. Thus they won’t expire like the URLs for the actual search results do. For that reason, this type of link stays active permanently and can be used in filing briefs that the court might not read for several months.

If you use FDA evidence as often as we do, this is good stuff to know.

Strike Three; You're Out!

It only took five years and two reversals on appeal, see In re St. Jude Medical, Inc., 425 F.3d 1116, 1119-21 (8th Cir. 2005); In re St. Jude Medical, Inc., 522 F.3d 836 (8th Cir. 2008), but the class action allegations in the St. Jude/Silzone litigation are finally history. The trial court reluctantly ("on a blank slate" the court would have certified the class, yet again) struck those allegations the other day. Here's a copy of the opinion. In the wake of the latest reversal (which we discussed here), the plaintiffs had tried to substitute "omissions" for affirmative misrepresentations in their allegations, but even a class-action-friendly judge couldn't stomach that hair splitting.

We doubt the Eighth Circuit would permit a third Rule 23(f) interlocutory appeal.

The long-running St. Jude saga is an excellent example of why class-action tolling of the statute of limitations in mass tort cases is inequitable and should not be allowed, a subject we've discussed before (just click on our "tolling" label on the right hand side of the screen (scroll down) for those posts). There's no way in logic or law that dilatory plaintiffs suing over this device should be entitled to over five years of tolling based upon meritless allegations of a supposed nation-wide class based upon extraterritorial application (questionable in and of itself) of one state's consumer fraud statute.