Wednesday, April 30, 2008

He's No Grippando, But . . .

The May issue of the ABA Journal is out, and it includes a story about the success of the ABA's efforts in book publishing.

Herrmann's contribution to that cause, The Curmudgeon's Guide to Practicing Law, didn't earn the photograph at the top of the article, but it did land the tag-line at the end.

We do wish, however, that he were just a bit more articulate . . . .

Learned Intermediary Bill In California

Today's Daily Journal (subscription required) reports (at page 2) that the Judiciary Committee of the California Assembly yesterday passed a bill meant to eliminate the learned intermediary doctrine and to make drug manufacturers responsible for giving warnings to patients using prescription medical products. The bill now moves to the Assembly floor:

"The California Assembly's Judiciary Committee approved a bill Tuesday that would make drug companies solely responsible for warning consumers about potentially harmful prescriptions that are marketed directly to the public.

"The legislation, AB 2690, is heavily favored by plaintiffs' lawyers. But it has met with strong opposition from pharmaceutical companies, which claim the measure would do nothing other than create a slew of baseless litigation against them."

The Civil Justice Association of California opposes the bill.

And, if anyone cares, we haven't studied the bill, but we oppose the concept.

MDL Transfer After Section 1404 Denial?

Here's a weird one:

A party files a motion with a trial judge to transfer a case to a different venue. That motion is made under 28 U.S.C. Sec. 1404, for the convenience of the parties and witnesses. The trial judge denies the motion. Can the party then file a new motion, with the Judicial Panel on Multidistrict Litigation, seeking to transfer the same case (to the same proposed transferee court) based on the MDL transfer statute, 28 U.S.C. Sec. 1407?

This is a hard question for us -- not because it's a particularly tough legal issue, but because we might find ourselves on either side of the question some day. So we're not going to commit to the correct answer, because we might (unfairly) be forced to eat those words in some case years from now. We'll just describe the lay of the legal landscape.

Presented with this issue, what would we scratch our heads about?

First, are the legal questions presented by the two motions identical? Section 1404 authorizes transfer "for the convenience of parties and witnesses, in the interest of justice." Section 1407, in dull contrast, authorizes transfer "for the convenience of parties and witnesses" where transfer "will promote the just and efficient conduct of such actions."

Is there a difference there?

We decline to say; it's up to you.

Second, are there non-statutory differences in the standards governing transfer? The MDL Panel has said that it can consider, for example, the effect that transfer could have on the likelihood of settling the coordinated cases. See, e.g., David F. Herr, Multidistrict Litigation Manual Sec. 5.48, at 161 (2007). That is not a factor that courts consider in deciding whether to transfer under Section 1404.

Does that change the analysis?

We decline to say; it's up to you.

Third, would the law of the case control the result before the MDL Panel? The second motion is, after all, being filed in the same case as the original one, although circumstances may have changed before the later motion was filed.

Absent changed circumstances, should law of the case control?

We decline to say; it's up to you.

Fourth, transfer under Section 1404 is for all purposes, including trial of the transferred case. Transfer under Section 1407 is for pretrial purposes only.

Does that matter?

In In re Air Crash Disaster, 346 F. Supp. 533, 534 (J.P.M.L. 1972), the Northern District of Illinois denied a motion to transfer under Section 1404, and the MDL Panel later granted a motion to transfer (to the same transferee court) under Section 1407 in part because MDL transfer is for pretrial purposes only.

And in In re American Financial Corp. Litig, 434 F. Supp. 1232, 1234 (J.P.M.L. 1977), a trial court had denied transfer under Section 1404. The MDL Panel said that the considerations for transfer under Section 1407 were different from the considerations under Section 1404, but the Panel nonetheless agreed with the earlier decision that transfer should be denied. See also In re Radioshack Corp. "ERISA" Litig., 528 F. Supp. 2d 1348, 1349 (J.P.M.L. 2007) (Granting a motion to coordinate under Section 1407 after earlier denial of motion to transfer under Section 1404: "Factors in a denial of a Section 1404(a) transfer are different from the criteria for Section 1407 centralization.")

One last point: David Herr notes in his treatise that many judges are reluctant to order transfer under Section 1404 until discovery has taken place and likely trial witnesses can be identified. Transfer under Section 1407, which is for pretrial purposes only, does not depend on the identity of trial witnesses. See Herr, Sec. 5:9, at 116. If the trial judge expressly declines to order transfer under Section 1404 until discovery has started, that would offer an easy point of distinction in a later motion to the MDL Panel. Even if the trial judge did not expressly make that point, counsel could argue that this distinction permits different results in the two motions.

Please don't assume that this little post offers comprehensive research on this point; it does not.
It's just that someone asked us this question recently, and we couldn't resist poking around.

Are we weird, or what?

We can only hope that we'll personally face this issue some day, and at least we'll have this starting point for research when the time comes around.

If only we remember, years from now, that we posted on this topic.

Tuesday, April 29, 2008

A Far Cry From Drugs And Devices

This post has absolutely nothing to do with drug and device law.

But, if you're having a really bad day at the office, click here and feel better.

(HT to Bob Kraft's P.I.S.S.D.)

Monday, April 28, 2008

Slow Boats From Europe

When American courts hand down important decisions, we try to act quickly. We link to the decisions as soon as we hear about them, and we try to publish an analytical post within 24 hours.

That's the life of a blogger.

When stuff comes from Europe, we're a little slower.

We don't hear about those decisions quite as quickly and, even after we read them, we're not always sure what they mean.

But ignorance has never stopped us before, and we won't let it get in the way now!

It looks to us as though two fairly important decisions came down in Europe last Fall.

On September 17, 2007, the Court of First Instance (don't even think of asking what that entity is; we're bluffing here) seemingly held, in line with existing case law, that only communications between corporations and outside counsel are protected by the attorney-client privilege. Communications between corporations and their own in-house counsel are generally not privileged. Joined Cases T-125/03 and T-253/03 Akzo Nobel Chemicals and Akcros Chemicals v. Commission. In lieu of a legitimate citation (which would send us scurrying back to a Bluebook, and we're way too old for that), here's a link to the opinion.

The case involved a governmental antitrust investigation. The defendants asserted attorney-client privilege. So far as we can tell, the money quotes (we assume they're valued in euros) appear in paragraphs 166 to 169 of the opinion. The Court of Justice had previously held that privilege applies only "to the extent that the lawyer is independent, that is to say, not bound by a relationship of employment." (Para. 166.) "It follows that the Court expressly excluded communications with in-house lawyers, that is, legal advisers bound to their clients by a relationship of employment, from protection." (Para. 167.) The Court of First Instance therefore held "that the correspondence exchanged between a lawyer bound to Akzo Nobel by a relationship of employment and a manager of a company belonging to that group is not covered." (Para. 169.)

We had long been aware that the attorney-client privilege skated on thinner ice in Europe than it does in the United States. To our untrained eyes, this decision makes the ice thinner still.

The second European news that finally sailed its way over the Atlantic is a ruling by the European Court of Justice deciding the enforceability of German advertising laws that were more stringent than a directive on the same subject issued by the European Parliament. The case is Gintec International Import-Export GmbH v. Verband Sozialer Wettbewerb eV. , Case C-374/05, and we're again providing this link in lieu of a decent cite.

There, the court held that the European Community Code is meant to remove barriers to trade between members. To that end, the Community Code enumerates when Member States may adopt stricter legislation than that enacted by the Community as a whole. Unless the Community creates an option for member States to impose more restrictive terms, the standard set by the Community creates both a minimum and a maximum standard. Member States may not impose limitations on pharmaceutical advertising that is more restrictive than the Community's law.

There will surely be disputes in the future about how that ruling by the European Court of Justice applies in particular Member States, so don't go hog-wild with your advertising campaigns based on what we've written here.

But, from where we sit, it looks as though Europe is gradually creating uniform advertising standards that will make it much easier for drug companies to do business overseas.

Thursday, April 24, 2008

Colacicco Rehearing Petition Filed

To the surprise of absolutely nobody, the Plaintiffs filed their petition seeking rehearing en banc in Colacicco/McNellis late on Tuesday. We obtained a copy late yesterday (thanks Chilton!). The plaintiffs could have decided not to seek rehearing and could have proceeded with a certiorari petition to the Supreme Court. Instead, they’ve decided to slow the Colacicco appeal down.

We think the main reason for that is that the Colacicco/McNellis plaintiffs do not want any chance for the facts of these two cases to get to the Supreme Court before the Levine appeal is decided. Now, we’ve said before that we’re quite happy with the facts in Wyeth v. Levine: (1) good, FDA approved warnings about the precise risk at issue (mentioning it 4 times, including in bold-face, allcaps print), (2) prior, specific FDA review of the precise risk and precise medical procedure involved, resulting in ratification of the label’s language; (3) the case fits within one of the six situations where the FDA has taken a position that there should be preemption; and (4) of no suggestion of any regulatory violation or withholding of information from the FDA. We reiterate that we like the factual positioning of Levine.

But while Levine has excellent facts, Colacicco/McNellis are SSRI-suicide cases, and those cases present what are probably the best possible facts for preemption – because of the sheer magnitude of more than a decade of intense FDA involvement, and the Agency’s repeated conclusions (through the present day) that the plaintiffs’ warning proposals lack scientific support. See Colacicco v. Apotex Inc., 521 F.3d 253, 2008 WL 927848, at *12-13, 15-16 (3d Cir. April 8, 2008), describing in detail this long history of FDA review.

Indeed, it was the SSRI litigation that caused the FDA to file its first amicus brief supporting implied preemption in an otherwise ordinary product liability case involving a prescription drug. The FDA has briefed SSRI preemption five times, far more than any other preemption fact pattern. Readers can find all those briefs here.

So we can understand why the plaintiffs would want to keep Colacicco/McNellis as far away from the Supreme Court as possible.

They won’t be able to keep Colacicco away from the rest of the court system, though. Just recently an Illinois district court in Mason v. Smithkline Beecham, 546 F. Supp.2d 618 (C.D. Ill. Apr. 23, 2008), relied upon Colacicco to find preemption in yet another SSRI suicide case. The handwriting’s on the wall for this type of claim, it appears, but our side will keep trying to produce more good preemption (and other) precedent as long as SSRI/suicide claims are being litigated.

So with the preliminaries out of the way, what are the plaintiffs saying to try to change the Third Circuit’s mind?

You can tell before even getting to the petition itself that plaintiffs’ are hanging their hat mostly on a Supreme Court case, Sprietsma v. Mercury Marine, 537 U.S. 51 (2002). In a “statement of counsel,” (required to deter frivolous petitions), they claim that there’s a “direct conflict” with Sprietsma. They, of course, proceed to make the same argument in their papers. Petition at 7-12.

We frankly don’t see where Sprietsma gets plaintiffs – and neither did the plaintiffs in Colacicco/McNellis the first time around, at least not very much.

In McNellis (#06-5148), the plaintiff’s appellate brief mentioned Sprietsma exactly once, on page 52, and made no claim of any “conflict” direct or otherwise, between that case and what the defendants were arguing. In Colacicco (#06-3107) the plaintiff did make a Sprietsma argument, but not very prominently – only as the third argument, only for about 4 pages. And the plaintiff’s reply brief in Colacicco did even less with Sprietsma than his initial brief.

The plaintiffs’ desultory reliance on Sprietsma is reflected in the Third Circuit’s Colacicco opinion. Sprietsma is cited only twice: a “see, e.g.” cite as a “minimum standards” case, 2008 WL 927848, at *12, and a “cf” cite (the weakest possible positive cite), id. at *14, for the proposition that agency action can have preemptive effect.

What's more, the dissent in Colacicco – which otherwise favored the plaintiffs’ position – thought so little of plaintiffs’ Sprietsma arguments that it didn’t cite the case at all.

And now plaintiffs are trying to make Sprietsma the centerpiece of a rehearing petition? Ouch!

It looks like plaintiffs have been using Sprietsma to play bait and switch with the court – hide it, invite “error,” and then seek rehearing.

Then again, there are very good reasons why plaintiffs did not argue Sprietsma very strongly the first time around. Those same reasons demonstrate that their belated attempt to gin up a conflict now doesn’t hold water.

Sprietsma involved a decision of an administrative agency not to regulate.

Colacicco/McNellis involves – as we’ve said and as the court lays out in excruciating detail – over ten years of intensive, affirmative agency action.

Let’s take a short look at Sprietsma. The case involved outboard motors, not drugs, and the Coast Guard rather than the FDA. The Coast Guard considered whether or not outboard motor propellers should be covered with guards to protect swimmers (and manatees) against being cut up if they were run over, but couldn’t reach a definitive conclusion. While the guard would protect against the propellers themselves, the size of the guard was much larger than just the propeller, so the guard would cause more collisions with more things.

So the Coast Guard closed its consideration of propeller guards without doing anything.

The question in Sprietsma was whether that failure to regulate had preemptive effect against a common-law tort claim that failure to guard an outboard propeller was a product defect. The Court held unanimously that it did not. First of all, Sprietsma involved express preemption – the interpretation of statutory preemption language (which Colacicco does not). 537 U.S. at 62-63. The preemption clause in Sprietsma was limited only to state “law or regulation,” which the Court found, in the context of that statute, meant only “positive” state enactments. Id. at 63.

Implied conflict preemption of the sort involved in Colacicco has been applied over and over again to common-law tort claims, most notably in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), and Geier v. American Honda Motor Co., 529 U.S. 861 (2000). So simply as a legal proposition, any analogy between Sprietsma and Colacicco doesn’t hold water.

As a factual proposition, the analogy is even worse. The Sprietsma Court held:

It is quite wrong to view that decision [not to adopt a regulation] as the functional equivalent of a regulation prohibiting all States and their political subdivisions from adopting such a regulation. The decision in 1990 to accept the subcommittee’s recommendation to “take no regulatory action,” left the law applicable to propeller guards exactly the same as it had been before the subcommittee began its investigation.
537 U.S. at 65.

The Bush Justice Department (which plaintiffs usually can’t resist attacking) filed an amicus brief in Sprietsma supporting the proposition that mere agency inaction is not preemptive. Id. at 67-68. The Supreme Court relied in its decision on the fact that the result it reached was in line both with the position of the agency and Justice Department. Id. at 68 (“the Solicitor General, joined by counsel for the Coast Guard, has informed us that the agency does not view the 1990 refusal to regulate or any subsequent regulatory actions by the Coast Guard as having any pre-emptive effect”).

The SSRI facts could hardly be more diametrically the opposite of the agency inaction scenario in Sprietsma – well over a decade of FDA administrative action, repeated FDA review and Agency conclusions that the scientific data do not support the warnings plaintiffs demand, all kinds of FDA pronouncements to that effect, and repeated amicus filings stating that the FDA did intend that its decision on this precise matter should have preemptive effect. 2008 WL 927848, at *12-13, 15-16.

The Sprietsma situation just ain’t here, folks.

Not unless black is white.

Even better, the Supreme Court had advice in Sprietsma for agencies that, unlike the Coast Guard in the case before it, wanted their decisions not to enact formal regulations to have preemptive effect. The court “recognized” that a no regulation decision by an administrative agency can have preemptive effect under certain circumstances:

[W]e have recognized that a federal decision to forgo regulation in a given area may imply an authoritative federal determination that the area is best left unregulated, and in that event would have as much pre-emptive force as a decision to regulate.

537 U.S. at 66 (citations omitted) (emphasis added). Thus an agency can’t just decide not to act if it wants there to be preemption. Rather, the agency must “take the further step of deciding that, as a matter of policy, the States and their political subdivisions should not impose” what the agency had decided not to do. Id. at 67.

And unfortunately for the Colacicco plaintiffs, an “authoritative federal determination” is exactly what the FDA has provided in the SSRI area. The FDA has said so five times in amicus briefs, and again in the 2006 Preemption Preamble that it intends its multiple decisions not to require adult suicide warnings to have preemptive effect.

Again, we go back to the facts. On the SSRI facts, Sprietsma actually becomes a pro-preemption decision. That's why we like to argue preemption in SSRI/suicide cases. The facts are so good that they flip cases like Sprietsma.

What else besides Sprietsma is there in the plaintiffs’ rehearing petition? They continue to make the argument, contrary to the very purpose of implied preemption, that express congressional “intent” is required. Petition at 6. We’ve already discussed the Colacicco court’s recognition that the entire reason there is such a thing as “implied” preemption, is to address situations where preemption arises by conflict, rather than intent. We think that logic is unavoidable – it’s what “implied” means.

There’s another rehash of the presumption against preemption. Petition at 6-7. We also addressed that in our prior post. The simple fact is that plaintiffs cannot and do not point to a single Supreme Court case applying a presumption against preemption in an implied conflict preemption case.

What plaintiffs really want to do is abolish implied preemption altogether: “Predicating preemption only on positive federal law – statutory or regulatory law – preserves judicial focus on … congressional intent.” Petition at 9 n.1. Their claim that only formal regulations can be preemptive is contrary not only to all the other cases holding SSRI suicide claims preempted, but also, at least, to Dowhal v. Smithkline Beecham Consumer Healthcare, 88 P.3d 1, 10 (Cal. 2004); and Whitson v. Safeskin Corp., 313 F. Supp.2d 473, 477-78 (M.D. Pa. 2004), which also find preemption in the absence of formal FDA regulations. There are undoubtedly more decisions on this point, but we’re trying to get this post done.

The petition also attacks the majority opinion in Colacicco for giving any deference to the FDA’s preemption position. Petition at 12-13. Actually, as we’ve pointed out before, judicial deference to administrative positions on preemption, typically expressed in amicus briefs, has more or less been the rule, rather than the exception. In fact, the only recent case in which the Supreme Court hasn’t agreed with the relevant administrative agency’s position on preemption is Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005), and even there the Court still found some preemption.

Next plaintiffs argue that the Colacicco majority “failed to appreciate” the essential “harmony between tort law and FDA regulation.” Petition at 13-14. Aside from sounding rather New Age, this claim of “harmony” is belied by what the petition says – specifically that “State courts provide a check on agency power.” Id. at 14 (quoting Colacicco dissent).

Since when has it been the role of a state court to “check” anything the federal government is doing? Not in the last century and a half, anyway. We fought a civil war over precisely this point. “Interposition” is dead – just as dead as John C. Calhoun.

Sure, a state court can declare something the feds do to be unconstitutional, but that’s not at all what the plaintiffs want here. They just want money. Specifically, they want the defendants to pay them despite having obeyed to the letter what the FDA told them – specifically and repeatedly – to say in their warnings about these drugs and suicide.

Beyond that, and putting aside plaintiffs’ rather unique view of state power under the Supremacy Clause, the very idea of state tort suits intentionally seeking to “check” the exercise of federal administrative authority doesn’t exactly fit with the argument they are trying to make – that there’s “harmony” between these tort suits and the FDA’s regulation of the drugs at issue.
A “check” isn’t “harmony.” Nor are state-law tort suits somehow a fourth branch of the federal government – not any more than Dick Cheney.

The last point the plaintiffs’ petition makes (p.15) was the first one we made. Plaintiffs’ urge the pendency of the Wyeth v. Levine matter in the Supreme Court as a reason to grant rehearing in Colacicco – essentially to have the Third Circuit sit on these appeals and wait for Levine. We said at the outset that the main thing we think that these plaintiffs are trying accomplish is to keep these cases, which are the most advanced SSRI appeals, away from the Supreme Court until after Levine. This final argument only confirms the accuracy of our initial reaction to the plaintiffs’ decision to seek rehearing in Colacicco.

Ackermann: Affirmed on Learned Intermediary Grounds

Moments ago, the Fifth Circuit handed down its decision in Ackermann v. Wyeth, No. 06-41774, slip op. (5th Cir. Apr. 24, 2008).

This was an appeal from a grant of summary judgment (based on the learned intermediary doctrine) in an antidepressant-suicide case.

Wyeth sought affirmance on the ground of the learned intermediary doctrine, but also presented alternative grounds to affirm based on preemption and the Texas Civil Practice & Remedies Code.

The Fifth Circuit affirmed based on the learned intermediary doctrine and chose not to reach the alternative grounds for affirmance.

The court also held that Texas would not adopt a "read and heed" presumption in the context of learned intermediaries.

We're sorry that this post is short and cryptic, but Bexis hasn't read the thing yet, and Herrmann, who argued it in the Fifth Circuit, is already popping the champagne.

CPSC Preemption (Bic Pen v. Carter)

We just saw this post at the Product Liability Profs Blog, telling us that the Texas Supreme Court, in Bic Pen v. Carter, last week reversed a verdict for plaintiff based on Consumer Product Safety Act preemption. The case involved a disposable lighter, which the CPSC specifically regulates.

The profs tell us that the court relied in part on an analogy to the preemption analysis in Riegel v. Medtronic, and the profs' post provides a link to the decision itself.

Wednesday, April 23, 2008

A Thought On Standard of Review

Many moons ago, one of us clerked in the Ninth Circuit.

We learned two lessons from that experience.

Actually, we learned many, many lessons from that experience, but we're sharing only two today.

First, during the first week of the clerkship, one of our predecessor-clerks asked, "Do you think the standard of review on appeal makes any difference?"

We were about to pop off: "Of course not. The key is to build some emotional appeal into your statement of facts. That will make the court want to rule in your favor. No matter what the standard of review is, the court will find a way to rule in favor of the side that it likes."

Fortunately, the predecessor-clerk answered his own question before we had a chance to speak: "Standard of review decides cases. As in: Decides cases."

That proved startlingly true during the course of the clerkship year. We quickly came to learn that the "abuse of discretion" standard of review meant that we should get out the "affirmed in a heartbeat" stamp, while a "de novo" standard of review meant that there would be a serious shooting match.

We've carried that lesson with us in the years since. We've always done what's possible to find an issue subject to de novo review when we represent an appellant, and we've always tried to explain why review was only for clear error or abuse of discretion if we were representing an appellee.

The second thing we learned that year was that the Ninth Circuit had a comprehensive outline discussing standards of review, created over the years by a permanent staff attorney on the court with an encyclopedic knowledge of Ninth Circuit law. That outline was invariably the starting point for research when we were writing the standard of review portion of a bench memo or draft opinion. And we saved that outline -- even though it was dated 1983 -- for years afterwards, because we never saw any better research aide on that subject.

We tossed our old hard copy only when that standard of review outline became available on-line.

The outline has been publicly available for a while now, but we were recently startled to hear from someone who didn't know that it existed.

Now our readers, at least, know about, and have quick access to, that outline. And remember: If your appeal is in a circuit other than the Ninth, you can still use the Ninth Circuit case cites to find a West key number that will lead you to authority from other circuits.

The Ninth Circuit standard of review outline is an awfully important research tool. Don't overlook it.

Tuesday, April 22, 2008

Seidel Subpoena (vaccine-autism blog) Quashed

We posted yesterday that Public Citizen had volunteered to represent Kathleen Seidel in her attempt to quash a subpoena seeking all of the records relating to her blog, which offends plaintiffs' lawyers in the vaccine litigation.

Seidel reported last night at her neurodiversity blog that the subpoena has been quashed (and sanctions threatened), although apparently the court did not reach the first amendment issues.

Monday, April 21, 2008

Hear, hear, Public Citizen!

We don't often type the words that comprise the title of today's post.

Given the opportunity, we just couldn't resist.

Kathleen Seidel hosts the blog, in which she critiques the evidence supporting, and litigation over, whether vaccines cause autism. Seidel sees no link, which naturally infuriates the plaintiffs' bar.

Earlier this month, Clifford Shoemaker, a plaintiff's lawyer in the vaccine litigation, served a subpoena on Ms. Seidel demanding that she produce basically every document relating to her blog, including e-mail correspondence, bank records, and information about her use of research tools, such as Lexis and Pacer. That story has been covered widely in the blogosphere, including at Overlawyered, the Legal Blog Watch, the New York Personal Injury Law Blog, and elsewhere.

No matter where you come out on the merits of requiring the production of those materials, we can surely agree that Ms. Seidel is entitled to top-notch legal representation to help her present the first amendment and other possible defenses to the subpoena.

We're pleased to tell you that our frequent opponents from Public Citizen volunteered for the task.

Public Citizen's first amendment team has now volunteered to represent Ms. Seidel on a pro bono basis.

Good for you, Public Citizen!

We express no opinion on whether the position you're advocating on behalf of Ms. Seidel is right or wrong, but we salute you for providing the legal representation that she deserves.

The Future is Now

We suspect most readers of this blog are living the same lives we are: We've now submitted either the Supreme Court's decision in Riegel or the Third Circuit's decision in Colacicco as supplemental authority in our pending cases, and we're seeing the plaintiffs' responses. Those responses may give us a clear view of our future (Bexis had a Ouija board, after all) if, knock on wood, the Supreme Court rules in favor of preemption in Wyeth v. Levine.

In Riegel, the Supreme Court noted that express preemption in the medical device context "does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case 'parallel,' rather than add to, federal requirements." Riegel v. Medtronic, No. 06-179, slip op. at 17 (U.S. Feb. 20, 2008). So plaintiffs are now insisting in every case that manufacturers violated FDA regulations, and the lawsuits should proceed unabated.

(That's no surprise. We could see that argument coming, and we've previously suggested answers to it.)

Plaintiffs' argument can take many forms: The drug company engaged in off-label promotion, supposedly dissolving the preemption defense; the manufacturer did not report all required data to the FDA, supposedly dissolving the preemption defense; the manufacturer failed to change its package insert as allegedly required (according to plaintiffs' counsel, not the FDA ) by CBE or other regulations, supposedly dissolving the preemption defense, and so on.

We have no idea whether the Supreme Court will repeat in Wyeth v. Levine the language about parallel state law claims. If it does, however, we've seen the future, and it is now: Plaintiffs' counsel will be drawn to that supposed loophole as moths are drawn to light, and we'll spend our lives fighting over three huge issues:

First, what does it mean for a state to have "provided a damage remedy for claims premised on a violation of FDA regulations"? That can't simply mean that every plaintiff can add a paragraph to every complaint pleading that "the defendant violated FDA regulations" and then go on to pursue run-of-the-mill strict liability, negligence, and warranty claims. Nor can it mean that plaintiffs can re-cast all of their run-of-the-mill claims as "negligence per se" and so avoid preemption. Rather, the Supreme Court's language means that a state must have passed a statute with the express intent to create a damages remedy for a violation of federal law. That's battleground number one.

Second, where's the line between privately actionable "parallel state law requirements" and non-actionable "fraud on the FDA"? Buckman tells us that private plaintiffs cannot pursue claims for fraud on the FDA. Isn't a claim that a manufacturer failed to disclose required data to the FDA effectively a claim of fraud on the FDA? And isn't every other claim that a manufacturer violated an FDA regulation really an effort by a private plaintiff to enforce rules that are meant to be enforced only by the FDA, in the exercise of its reasonable prosecutorial discretion? Perhaps, as we've suggested before, the issue will turn on whether the FDA's regulation was meant to govern the FDA's interaction with a drug manufacturer (which would not be enforceable by a private plaintiff) or the manufacturer's interaction with the public (which is arguably different).

Finally, what proof is required that a manufacturer in fact violated an FDA regulation? We saw this coming, too, and we stand by what we wrote. In the rare situation when a plaintiff finds a state law that authorizes a damages remedy and a duty that runs from the manufacturer to the public, the plaintiff must then plead and prove the existence of a regulation that in fact declares illegal particular conduct that is causally related to the plaintiff's alleged injury. Proof of the violation should ordinarily be proven through fact witnesses, rather than purported experts on the FDA regulations who will give their interpretations of what the FDA's regulations supposedly mean.

We saw that The American Lawyer [free registration required] was concerned about what the pharmaceutical product liability defense bar would do if Riegel and Levine wiped out our practice area.

Would that it were so.

We'd be delighted to see America's system of regulating drugs become a little more rational (although we'd really miss you guys, because we'd have to shut down our little experiment in blogging).

But we fear that we've seen the future, and we'll spend the years from now to retirement fighting about what the Supreme Court meant when it wrote the words "parallel state law claims."

One "can live greatly in the law."

Thursday, April 17, 2008

Colacicco and Judicial Notice

We’ve previously offered our collective four cents worth about tactical considerations that pharmaceutical defendants need to think about in deciding whether or not to bring preemption motions in particular cases. Given the importance of the issue, and (until 2008) the relative equipoise in the opposing positions, we strongly recommended the Hippocratic Oath – “First, do no harm.” Or, as they say more bluntly in Herrmann’s Chicago, “Don’t back no losers.”

That’s impossible, of course. There’s no way, short of never filing any preemption motions at all, not to risk ending up with a decision that goes on the minus side of our drug preemption scorecard (updated, of course, to include Colacicco). Still, there are considerations that raise or lower the odds.

One of those odds shifters that we discussed was procedural posture. We’ve discouraged raising preemption through motions to dismiss, because as we learned in Civil Procedure 101, Rule 12 (and state equivalent) motions are based solely on the allegations in the plaintiff’s complaint. In litigating conflict preemption, it’s critical that the record demonstrate the full scope of the preemptive conflict as clearly and as starkly as possible. Defendants can’t do that if their side of the story is procedurally irrelevant. We’d pointed out in our prior post that Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), the biggest preemption loss our side has suffered, was decided on a motion to dismiss.

We’d even been worrying (in private, of course) that procedural points about what was and was not properly before the court in the two consolidated Colacicco appeals could lead to a bizarre result. That’s because, while Colacicco itself was brought on a motion to dismiss, the companion case, McNellis, arose from a summary judgment motion where the full FDA record, in all its detail, was indisputably properly in evidence. We’d wondered whether the Third Circuit might recognize preemption on the full FDA record in McNellis, affirm dismissal of GSK in Colacicco on independent state-law grounds (GSK didn’t even make the generic product that the plaintiff actually took in Colacicco), and remand Apotex (the generic manufacturer) in Colacicco for “further proceedings” that would have been an almost immediate summary judgment motion to take advantage of the postulated McNellis ruling.

See how hypertechnical lawyers can get?

And how wrong. That didn’t happen, of course. And the reason it didn’t happen was judicial notice. We’ve discussed judicial notice before, in a somewhat different context. Judicial notice, we explained then, was a quick way to get facts into the record that were sufficiently established that there couldn’t really be a fight about them:

Again, so that non-lawyers aren’t left scratching their heads, “judicial notice” is when something is so definitively known (for any number of reasons) that it doesn’t have to be proven with first-hand testimony of that fact. Judicial notice is usually concerned with facts that aren’t really subject to dispute, such as did a particular date fall on a Tuesday, or is a town being located in a particular county or state. In such situations, it’s a waste of time to require evidence to prove that kind of fact. So the judge “notices” it – conclusively declaring it to be so.
There, that's probably the first time we've ever block quoted ourselves.

In the Colacicco half of Colacicco v. Apotex Inc., 521 F.3d 253, 2008 WL 927848 (3d Cir. April 8, 2008), the Third Circuit judicially noticed just about the entire history of FDA regulatory activity involving (generic) Paxil specifically, and SSRI antidepressants more generally. Here’s a rundown of exactly what items the Third Circuit took judicial notice of in the Colacicco half of the Colacicco opinion:
  • The FDA’s rejection of three citizen’s petitions, filed against Prozac, a drug not involved in Colacicco. 2008 WL 927848, at *12.
  • Several FDA approval letters for Paxil. Id. at *13 n.16.
  • The FDA’s 2003 approval letter for generic Paxil. Id. at *13.
  • FDA talk papers from 2003 and 2004. Id. at *13, 15.
  • The FDA’s 2003 Public Health Advisory, concerning pediatric suicide. Id
  • The labeling for Paxil. Id. at *15 n.18.
  • The FDA’s 2007 public notice on “Antidepressant Use in Children, Adolescents and Adults.” Id. at *16.
  • The FDA’s 2007 class revisions to SSRI labeling. Id. at *16 & n.20.
  • An FDA news bulletin about the 2007 class revisions. Id. at *16.
The first thing that needs to be pointed out is that the Colacicco court didn’t do this for the purpose of deciding whether the FDA had ultimately made the right decision. That would have been an improper use of judicial notice, because whether SSRIs cause suicide was hotly disputed. Rather, the court took judicial notice of the fact that the FDA had considered the issue of suicide warnings on quite a few occasions, and also of the fact that the FDA had resolved that issue, at various times, on the evidence before the Agency, and in ways that left no doubt that it would not have permitted the different warnings the plaintiffs were urging. See Colacicco, 2008 WL 927848, at *12 n.13 (judicial notice is “not for the truth of their [FDA public records] contents” but only as demonstrating the “information” that was “provided by [the FDA] to the relevant regulated parties”).

Again, the Court never offered any opinion about whether the FDA made the “right” decision. Id. at *18 (“we express no view as to the merits of the issue whether SSRIs contribute to adult suicidality. . . . That is within the FDA’s authority”). The FDA’s actions were of independent significance. The “fact” that the FDA had acted, rightly or wrongly, was important. That’s because the scope of the FDA’s actions taken within its delegated “authority” were what determined the scope of preemption. Id. at *14, 16, 18.

For those of you out there contemplating preemption motions in the aftermath of Colccicco, and wondering if you can save your client the (considerable) expense of discovery by raising the issue on the pleadings, you’re going to have to look for precedent that supports the kind of judicial notice that the Colacicco court allowed. Colacicco cited Anspach v. City of Philadelphia, Dep’t of Public Health, 503 F.3d 256, 273 n. 11 (3d Cir. 2007) (taking judicial notice of FDA public records). 2008 WL 927848, at *12 n.13.

Is there more than that?

You betcha. Why do you think we’re blogging on this issue?

Doing what we do best, here’s a head start – some more cases we’ve found on judicial notice of FDA records. Meyers v. Bayer AG, 735 N.W.2d 448, 467-68 (Wis. 2007) (drug approvals and possibly other FDA documents); Horne v. Novartis Pharmaceuticals Corp., 541 F. Supp.2d 768, 2008 WL 818819, at *5 (W.D.N.C. March 25, 2008) (“the Court may take judicial notice of and consider the public records of the FDA, such as the Public Health Advisory”); Schering-Plough Healthcare Products, Inc. v. Schwarz Pharma, Inc., 547 F. Supp.2d 939, 2008 WL 582738, at *5 n.1 (E.D. Wis. Feb. 29, 2008) (“The court may take judicial notice of the FDA letters submitted by the parties”); In re Amgen Inc. Securities Litigation, 544 F. Supp.2d 1009, 2008 WL 999058, at *7 (C.D. Cal. Feb. 1, 2008) (judicially noticing several items, including drug labeling, FDA health advisories, and the transcript of an FDA drug advisory committee meeting); Ebel v. Eli Lilly & Co., 536 F. Supp.2d 767, 781 (S.D. Tex. 2008) (drug labeling); Matthews v. Donald, 2007 WL 2593086, at *1-2 (N.D. Ga. Sept. 4, 2007) (FDA press release); Rozzelle v. Rossi, 2007 WL 2571935, at *7-8 (W.D. Pa. Aug. 31, 2007) (drug labeling); Wright v. Henderson, 2007 WL 2484317, at *2 (N.D. Ga. Aug. 28, 2007) (FDA press release); Sykes v. Glaxo-SmithKline, 484 F. Supp.2d 289, 293, 295, 310 (E.D. Pa. 2007) (FDA talk paper; FDA vaccine approvals; FDA guidances); Fellner v. Tri-Union Seafoods, L.L.C., 2007 WL 87633, at *1 (D.N.J. Jan. 9, 2007) (FDA consumer advisory; FDA letter to state attorney general; FDA compliance guide). We’ll stop there. These ten cases are just the leading edge – FDA judicial notice cases going only back to the beginning of 2007. There are lots more out there. We’ve barely reviewed a third of the cases that a very simple computer search generated.

The takeaways from this little exercise are two: First, the Third Circuit’s use of judicial notice in Colacicco, while extensive, is well supported by precedent (probably why the dissent in Colacicco raised no objection to the majority’s use of judicial notice), and second, because of judicial notice, we may have to re-evaluate some of our previously stated views on preemption motions and procedural posture.

In Colacicco, judicial notice became the vehicle for ensuring that, notwithstanding Rule 12’s restrictions on looking beyond the complaint, the entire FDA regulatory history of a drug could be put before the court on a motion to dismiss. Where any motion requires a court to decide whether there’s a conflict with FDA activity that warrants preemption, the availability of a complete regulatory record demonstrating what the FDA actually did is critical.

Judicial notice can also be taken of the records of prior legal proceedings. Colacicco, 2008 WL 927848, at *12 n.13, citing Jean Alexander Cosmetics, Inc. v. L’Oreal USA, Inc., 458 F.3d 244, 256 n. 5 (3d Cir. 2006). This is a common use of judicial notice, so no free research. From this proposition, the Colacicco court goes on to cite one of the FDA’s amicus briefs in SSRI cases as further evidence of what the FDA’s position was on the suicide/causation question at a particular time. See 2008 WL 927848, at *13 (citing the FDA’s 2002 Motus brief).

Colacicco thus stands in stark contrast to the court’s refusal to even consider FDA amicus briefs in Collins v. Smithkline Beecham Corp., 2008 WL 744070 (Pa. C.P. Philadelphia Co. March 11, 2008), a case we’ve already discussed. In Collins the court dismissed the FDA’s briefs as “hearsay.” We don’t think that FDA briefs, at least when considered for the limited purposes of establishing what positions the FDA took and when, are hearsay at all, since they’re not being admitted for the truth of what they say (for non-lawyers, “for the truth” is the classic definition of hearsay). But even if they were, judicial notice (not mentioned in Collins) would have been another alternative.

Pa. R. Evid. 201, concerning judicial notice, “adopted” “the approach of the Federal Rule.” Id., Official Comment. The Pennsylvania rule even makes clear that “Judicial notice may be taken at any stage of the proceeding,” in order to overturn precedent that disapproved of judicial notice “at the pleading stage.” Id. Thus, judicial notice of FDA regulatory positions has been approved by other Pennsylvania courts. Cosom v. Marcotte, 760 A.2d 886, 893 (Pa. Super. 2000) (several FDA actions involving bone screws), vacated on other grounds, 808 A.2d 177 (Pa. 2002); Bacon v. Upjohn Co., 2 Phila. Co. Rptr. 285, 296 (Pa. C.P. Philadelphia Co. 1979) (drug approval). It doesn’t appear from the opinion that judicial notice was sought in Collins.

Was that a mistake? We can’t say that, and here’s why.

Any defendant considering whether to request judicial notice must ask if a judge – like the judge in Collins – who is not favorably disposed to preemption in the first place, would nevertheless permit a defendant to make its record through judicial notice. That’s a judgment call that counsel must make in each case based upon their familiarity with the judge. That’s the same basic consideration inherent in deciding to make the preemption motion in the first place.

We will say this. If judicial notice is available in a particular case, then a lot of our hesitation about making early preemption motions goes away.

As defense counsel, there’s nothing we like better than to win cases without putting our client through the great time and expense of discovery. Not only is it cheaper and faster, but anytime discovery is avoided, so is the possibility that somebody on the other side will make improper use of what our clients have to produce. Winning preemption on motions to dismiss, rather than through summary judgment, accomplishes this.

Colacicco demonstrates the value of judicial notice. Through judicial notice defendants can build the kind of detailed record of administrative history necessary to establish the existence of preemptive conflicts – notwithstanding procedural limitations that otherwise restrict the ability of the court (and the parties) to look beyond the allegations of a plaintiff’s complaint. But the “judicial” half of “judicial notice” provides the final cautionary note. Defendants need to think long and hard about the inclinations of the judge hearing their case when choosing this route.

Taylor v. Sturgell and Virtual Representation

The Supreme Court's decision about lethal injections was the big news this week for society.

But mass tort lawyers should keep an eye on Taylor v. Sturgell.

That case involves the Freedom of Information Act and so may not naturally be on your radar screen.

But it raises the question whether the government must relitigate against different plaintiffs its responses to FOIA requests. There's an obvious analogy to class action litigation, as the folks at the Mass Tort Litigation Profs Blog make clear in this post describing both the issue and yesterday's argument.

Wednesday, April 16, 2008

Michigan Law Review book review issue

We noticed two things in the recent "book review" issue of the Michigan Law Review.

First, Anthony Sebok's review of Richard Nagareda's book, Mass Torts in a World of Settlement, is worthwhile for those who toil in the same field that we do, but haven't yet found time to read the whole book.

Second, in his review of Not a Suicide Pact: The Constitution in a Time of National Emergency, Judge Stephen Reinhardt, of the Ninth Circuit, writes this of Judge Richard Posner, of the Seventh:

"The problem with Posner is not his writing, which is excellent. The problem is his judgment, which is not."


Here's a link to the table of contents of the book review issue. From there, you can click in turn to the individual reviews.

The FJC's Latest Report On CAFA -- The Trends Continue

This guest post was written by Sean Costello. Mr. Costello is an associate resident in the Atlanta office of Jones Day. This post is entirely his work. It, of course, represents only his views, and not the views of his clients or firm:

The Federal Judicial Center released its Fourth Interim Report on the Class Action Fairness Act last week. You can find it here. This latest report is the most comprehensive examination of CAFA’s impact on the federal courts and class actions to date, and it’s worth a look if you have an interest in CAFA’s effects on class action litigation. I have guest-posted before about the FJC’s second and third interim reports [here and here, so I thought I’d highlight some of the report’s conclusions and offer a few comments about this latest report, as well.

First, this isn’t a scoop. Unlike the second and third interim reports, the FJC’s latest report has gotten some attention already, so you’re not reading about it here first or exclusively. The folks at Product Liability Law 360 published an article late last week pointing to “kinks” in CAFA, using the FJC’s Fourth Interim Report as the springboard for that discussion. See Ron Zapata, Kinks Persist in Class Action Fairness Act: Experts, Product Liability Law 360 (April 9, 2008). You need a subscription to read the article, but here’s a link to the website. It’s a good article, and worth a read. Heck, it even quotes Herrmann on the scourge of nationwide class actions.

Second, as you might have expected, the FJC’s latest report shows that class action filings have increased post-CAFA, just like the earlier interim reports. This time, however, the FJC researchers had a lot more data to work with. Moreover, they don’t merely conclude that class actions have increased; they conclude that “[c]lass action activity in the federal courts has increased dramatically.” Fourth Interim Report at 12. Specifically, the researchers “found a 72 percent increase in class action activity in the eighty-eight district courts . . . studied.” Id. at 1. What you might not have expected is that the largest increase in class action filings in federal court can’t be pinned on CAFA. Federal question cases (mainly Fair Labor Standards Act cases) accounted for a substantial percentage of class actions in the federal system post-CAFA. Id. at 3. The FJC compared July-December 2001 with January-June 2007 and found that federal labor law class actions accounted for nearly 25 percent of all class actions in the earlier period, but accounted for almost 47 percent of all class actions in the latter period! So, for all of those critics of CAFA who argued that Congress had effectively “federalized” class actions through changes in procedural and jurisdictional law, the numbers suggest that the federalization of substantive law remains a pretty good scapegoat for those who think such developments are a bad thing.

Third, with respect to diversity-based class actions, original class action filings remain at much higher levels than before CAFA, while removals have returned to just about their pre-CAFA levels. Pre-CAFA, there were about 12 original diversity class action filings per month, on average. Post-CAFA, the average is 34.5. Id. at 2. While removals of diversity-based class actions increased substantially in the months immediately after CAFA, they have tapered off significantly and are now about where they were before CAFA. From March 2005 through June 2006, there were, on average, about 25 removals of diversity-based class actions per month, compared to about 17 per month pre-CAFA. But in the July 2006 through June 2007 period, that number had declined to 18 per month. Id. at 6. The FJC researchers read all of this to “strongly suggest that CAFA has altered class action plaintiffs’ forum choices.” Id. at 7.

I think there are at least two parts to this explanation. First, for about a year after CAFA was passed, the remand battles centered around a couple of issues: when does a case “commence” under CAFA (CAFA applies only to cases commenced on or after its effective date); and who has the burden of establishing jurisdiction under CAFA. There were debates over whether removing a case effectively “commenced” it (allowing removal of a case filed months or years before), whether filing or service “commenced” a case (the answer depends on whether state law defines “commence” as filing or service), and to what extent changes in claims or parties effectively “commenced” a case as to all or certain defendants, entitling one or more of them to remove it. As time passed, the question of whether a case was commenced on or after CAFA’s effective date became less likely to be of any significance, and, thanks to the fact that CAFA allows for appellate review of remand decisions, the federal appellate courts generally came up with fairly uniform approaches to the issue, though there are some exceptions.

In addition, there were countless debates about who has the burden of establishing jurisdiction and what sort of proof is required to do so. Winners have been declared in these debates, too, and, for better or worse, there are now established rules that plaintiffs and defendants understand – or are expected to understand – even if they don’t agree. In other words, a lot of CAFA’s blank slate has been filled in. For the most part, litigants know if a case is going to be in federal court under CAFA or not, and they don’t waste time on expensive, time-consuming battles over jurisdiction. Initially, I thought that plaintiffs might at least make defendants go to the trouble and expense of removing a case. I guess the plaintiffs’ bar is not as sadistic as I thought. Second, perhaps the class action plaintiffs’ bar has learned that, just as there were “magnet courts” in the state system, there are courts in the federal system that are more likely to certify class actions than other courts, and the class action plaintiffs’ bar is now focusing efforts in those courts. Thus, maybe the class action plaintiffs’ bar is not simply resigned to being in federal court; they are now learning to take advantage of the situation. Which brings me to the next finding of the FJC report.

Fourth, there’s a certain amount of bunching up going on. While there were more class actions in virtually every federal court post-CAFA (except, curiously, Minnesota, where both original filings and removals actually declined after CAFA), id. at 9, some circuits and district courts are seeing a lot more class actions than other circuits and district courts. The FJC’s statistics tell a remarkable story. Comparing the period 2002-2003 with the July 2005-June 2007 period, the Eastern District of Louisiana “saw an elevenfold increase” in original, diversity-based class action filings; the District of New Jersey and the Southern District of Florida each saw seven times as many original, diversity-based class action filings after CAFA than they saw before CAFA; and the Central District of California saw five times as many such cases. Id. at 10.

This could suggest that there are “magnet courts” in the federal system, just as there were (and still are) in the states. In fact, that’s one possibility suggested by the Product Liability Law 360 article I mentioned at the outset. Maybe; maybe not. You’d have to look behind the numbers to draw any sound conclusions. Plus, there are other possibilities – including external forces – that might help explain why there were such whopping increases during the time frame studied. To take one obvious example, Hurricane Katrina struck in August 2005 (the same year that CAFA took effect), and it famously spawned a number of class action lawsuits, most of which were filed in the Eastern District of Louisiana, which had never been known as a jurisdiction hostile to class actions. Moreover, as bad as things might get in a particular district, there’s always Rule 23(f), and, ultimately, the United States Supreme Court to ensure that Rule 23 doesn’t become the bludgeon it had become in the state system. Thus, it would seem that any “magnet court” phenomenon in the federal system would be short-lived. Indeed, just look at what happened recently in the McLaughlin lights cigarette class action that Judge Weinstein certified in the Eastern District of New York. As Herrmann and Beck discussed in a post last week, the Second Circuit decertified that case in devastating fashion. What had threatened to be one of the largest class actions in history was “snuffed out,” thanks to Rule 23(f)’s interlocutory appeal option.

Finally, the trends that the FJC spotted in its earlier interim reports have held true. Personal injury class actions have remained flat post-CAFA. In the post-CAFA world, there have been, on average, just over six such cases filed or removed per month, compared with just over seven in the pre-CAFA period. According to the FJC researchers, this is not a statistically significant difference. Fourth Interim Report at 12. At the same time, consumer “protection” or fraud class actions have multiplied. Post-CAFA, nearly 10 such class actions have been filed in or removed to federal court every month, on average That’s a threefold increase over the pre-CAFA period, when there were only 2.81 such filings and removals per month. Id. As I observed in an earlier guest post, and as many others have pointed out as well, the consumer fraud class action has taken the place of the personal injury class action as the class action plaintiff bar’s lawsuit of choice.

The FJC researchers have promised future reports examining CAFA’s effect on judicial workload “by hanging the contours of class certification” (whatever that means), “other pretrial aspects of class action litigation, and judicial review of settlements.” Id. That should make for some interesting reading. It might even yield some insights into how the federal courts are actually handling class actions that they had rarely dealt with before CAFA. Can’t wait. You’ll read about it here, though you might not read about it here first.

Tuesday, April 15, 2008

Overseas Class Actions Come Of Age

We share an awful lot of our thoughts with readers of this blog. (Yeah, yeah. We heard you mutter, "Too many.")

But here's one we've never shared: We've often thought that someone should write a book about class actions worldwide. Like Linda Mullenix's treatise on class actions in state courts, the book would have one chapter devoted to the class action (or other aggregate litigation) procedures available in each country around the globe.

We never shared that thought, because we had half a mind to actually write that book, if we ever found the time.

We've seen three items recently that made us realize that the book would no longer be worth the effort.

First, Stanford has created the Global Class Actions Clearinghouse, which contains essays and materials about class actions in many countries around the world. That's an awfully useful resource, and we've created a permanent link to that site over in the right-hand column of this blog.

So much for writing the book. We'll just have to stick to blogging instead.

Second, we recently stumbled across this SSRN description of Richard Nagareda's recent article (doesn't that guy ever put down his pen?) about the problems posed by the internationalization of class actions. Nagareda argues that the growth of class actions in individual countries will tend to recreate the difficulties seen in the context of nationwide class action litigation within the United States. That's an interesting thought, and it seems as though people are already considering solutions to the problem that our little book would only have begun to identify.

Finally, we noticed that the ABA is trying to design a protocol to coordinate class actions that are pending simultaneously in the United States and Canada.

Our book may be too late, but overseas class actions have plainly come of age.

We're Actually Worth Something To You!

The folks at the American Conference Institute saw our announcement that we'd be co-hosting ACI's seminar about preemption that runs from July 14 through 16, 2008 in Philadelphia.

The ACI promptly decided to offer a discount of $200 off the registration price to readers of this blog. (Since the blog is open to all, we're not sure that offer should make you feel too special. But it certainly makes us feel special.)

If you're interested in the discount, use the 619L08.S code when registering and ACI will deduct $200 from the registration price.

Here's the agenda for the conference.

Monday, April 14, 2008

Rehearing Granted In Despain

Last month, we noted that the Arkansas Supreme Court's decision rejecting preemption in the context of a PMA-approved medical device was no longer good law in light of the U.S. Supreme Court's later decision in Riegel v. Medtronic. See Despain v. Bradburn, __ Ark. __, __ S.W.3d __ (Feb. 7, 2008).

The Arkansas Supreme Court has now drawn the same conclusion. On April 10, the Arkansas Supreme Court granted the manufacturer's petition for rehearing and issued a substituted opinion affirming the trial court's order granting summary judgment on the ground of preemption. Despain v. Bradburn, __ S.W.3d __, 2008 WL 1067202 (Ark. Apr. 10, 2008).

St. Jude is Heavenly

We've now had a chance to read the Eighth Circuit's short (ten-page) decision in In re St. Jude Medical, Inc., Silzone Heart Valve Prods. Liab. Litig., No. 06-3860, slip. op. (8th Cir. Apr. 9. 2008) (link) (now reported at, 522 F.3d 836). Sometimes good things come in small packages.

St. Jude recalled all Silzone prosthetic heart valves that had not yet been implanted. Plaintiffs were the patients who had been implanted with the valves.

In 2004, the trial court certified a nationwide class to resolve issues under three Minnesota statutes -- the False Advertising Act, the Consumer Fraud Act, and the Deceptive Trade Practices Act. In 2005, the Eighth Circuit reversed the trial court's certification of a subclass of plaintiffs seeking injunctive relief in the form of medical monitoring, because the issues were too individualized for classwide treatment. And the Eighth Circuit remanded the consumer protection subclass for the trial court to conduct a more thorough choice-of-law analysis before deciding whether to apply Minnesota law to the claims of all plaintiffs.

On remand, the trial court recertified a nationwide consumer protection class to be decided under Minnesota law.

Last week, the Eighth Circuit again reversed.

Here's the pearl in this little oyster:

(Shoot! We're second-guessing ourselves again. We can already imagine some plaintiffs' lawyer dropping a footnote in some appellate brief we'll file in the Eighth Circuit next year: "Beck and Herrmann called this court an oyster! The very nerve!" This blogging is dangerous business for practicing lawyers.)

Anyway, here's the diamond in this magnificent ring:

In any fraud- or misrepresentation-based drug or device case, there will be a ton of individualized issues of reliance. Physicians will have heard different information from the product manufacturer, and patients will have heard different information from their treating physicians. Those individualized issues naturally preclude certifying a class.

The St. Jude plaintiffs asserted that those issues should not bar certifying a class under the Minnesota consumer protection statutes, because those statutes supposedly eliminated the need to prove individual reliance. Id. at 5.

The Eighth Circuit rejected that position, because the statutes require that a defendant's conduct cause a plaintiff's injury, whether or not there's an express requirement to prove reliance. For claims based on alleged misrepresentations, "'as a practical matter it is not possible that the damages could be caused by a violation without reliance on the statements or conduct alleged to violate the statutes.'" Id. at 6, quoting Group Health Plan, Inc. v. Philip Morris Inc., 621 N.W.2d 2, 13 (Minn. 2001).

That's nice.

But wait! There's more!

The Eighth Circuit went on to hold that "Group Health surely does not prohibit St. Jude from presenting direct evidence that an individual plaintiff (or his or her physician) did not rely on representations from St. Jude. When such evidence is available, then it is highly relevant and probative on the question whether there is a causal nexus between alleged misrepresentations and any injury." Id. at 7. It was therefore "clear that resolution of St. Jude's potential liability to each plaintiff under the consumer fraud statutes will be dominated by individual issues of causation and reliance. The need for such plaintiff-by-plaintiff determinations means that common issues will not predominate . . . . " Id.

That's the heavenly part of St Jude:

Even if a state consumer protection statute eliminates the need to plead and prove reliance, defendants still have the right to offer individualized evidence that would disprove causation and reliance. The individualized nature of the defendants' disproof precludes certifying a class.

Not bad.

And this holding, to our eye, may extend beyond consumer protection statutes. Suppose a plaintiff convinces a court that statistical, rather than individualized, proof should be sufficient to carry the burden of proving some element of plaintiff's case. Even if statistical proof could carry plaintiff's burden, individualized disproof would still be possible, and that individualized disproof should preclude certifying a class.

We thus read St. Jude to be a helpful precedent to avoid class certification in cases involving either consumer protection acts or attempts to use statistical proof in place of individualized evidence in product liability or consumer fraud cases.

Needless to say, we're on Cloud Nine.

Saturday, April 12, 2008

Schwab Affects Pharma

We just noticed this piece in Bloomberg News (via Pharmalot) about a hearing before Judge Weinstein on Thursday, April 10, in the consolidated Zyprexa cases.

Presumably keenly aware of the Second Circuit's recent reversal of his decision to certify a consumer fraud class in the tobacco litigation (about which we posted here), Judge Weinstein suggested that he probably will not certify a similar class of purchasers of Zyprexa.

That decision is not surprising. Trial court judges are, of course, supposed to learn from and follow circuit precedent.

But the "comments" over at Pharmalot are more suprising. Readers are accusing Judge Weinstein of "hypocrisy" and being on "Lilly's take" because of what he said at the hearing.

Lord knows that we, too, are occasionally a bit shrill, but we try not to criticize folks who are simply trying to do their jobs conscientiously and in good faith.

Friday, April 11, 2008

They Write, But Can They Speak?

A couple of folks think we know something about drug and device law.

That's a "couple" as in "two": Bexis thinks Herrmann knows something, and Herrmann thinks Bexis knows something.

Good news: Someone else has fallen for it, too! The two of us will be co-hosting the American Conference Institute's Drug and Device Preemption Conference in Philadelphia from July 14 through 16, 2008. Here's the conference brochure. The conference will feature an all-star cast, including many of the lawyers on the defense side of the preemption trilogy of Riegel, Kent, and Levine in the Supreme Court.

Unlike the ACI deal, our other upcoming talk is awfully wide of our power alley, as any reader of this blog well knows.

Herrmann will be speaking at the Wisconsin State Bar Annual Convention on Thursday, May 8, on a panel titled, "This Blog's For You!" (Here's a link to the conference materials.)

One of us on blogging?

Soon they'll be asking us to speak about fashion trends.

Thursday, April 10, 2008

Delving into Colacicco

We promised you that we would be “mining the depths” of Third Circuit’s opinion in Colacicco v. Apotex Inc., 521 F.3d 253, 2008 WL 927848 (3d Cir. Apr. 8, 2008), affirming implied prescription drug preemption. That, of course, assumes that our doing so is a good thing. But we have to believe that most of the eyeballs that stop this way are, if not quite as interested in (some would say obsessed with) preemption as we are, at least it's close. So that’s what we’re assuming – and that's what we're going to do.

We’ve got our shovels out and we’re ready to start digging. But it’s a big job, so don’t expect us to finish it in one post. We don’t have that much free time on our hands, since we're busy incorporating Colacicco into our pending briefs, for one thing.

Colacicco, of course is only one opinion by one circuit court, so it's important to keep things in perspective – especially with the Supreme Court poised to tackle many of the same issues next term in the Levine case. That said, winning sure beats losing, and we're quite happy with the perspective that the Third Circuit did take.

The Third Circuit points out that, “The FDA has actively monitored the possible association between SSRIs and suicide for nearly twenty years, and has concluded that the suicide warnings desired by plaintiffs are without scientific basis and would therefore be false and misleading.” Colacicco, 2008 WL 927848 at *12.

Why start there? Well it goes back to our Bone Screw days, where we adopted the unusual strategy of trying to beat a mass tort by surviving the MDL and then winning the individual cases on remand. But how can you possibly do that? you ask. Weren’t there hundreds of them? There sure were – thousands actually – but there was also stare decisis (for you non-lawyers, that's the doctrine that courts, for the sake of legal stabilty, are supposed to follow their previous decisions). And that’s what ultimately helped us win.

We realized that the Bone Screw cases, factually, were not very sympathetic for the plaintiffs. The details don’t matter, because the point is that the relatively good facts for us gave us a leg up on a variety of legal propositions – from alternative designs in design defect determinations, to warning causation under the learned intermediary rule, to preemption of fraud on the FDA, to Daubert motions – and we set out to make as much good legal precedent as we could. The strategy was that we’d win enough motions, and then enough appeals, that the other side would eventually cave once they figured out that stare decisis meant that all this pro-defense precedent we were creating would be around to haunt them for quite some time.

It took us over 180 grants of summary judgment, but it worked, and the rest of the cases ended up settling very cheaply. We were right about stare decisis, too. The good law we made is still tripping up the other side, almost a decade after we started getting it. Ever heard of Buckman? It was a Bone Screw case. So are three quarters of the favorable FDCA negligence per se decisions in Florida, the construction of the design defect statute in Louisiana, the absence of cross-jurisdictional class action tolling in Tennessee and Virginia, application of the learned intermediary rule to medical devices in Ohio…. We could go on and on.

We could see the same thing happening with the SSRI suicide cases and preemption. If the other side is going to insist on bringing them, defendants might as well try to use the very favorable facts – especially the regulatory facts – in those cases to create as much favorable preemption (and other) precedent for the defense side as possible. Maybe the other side, as with the Bone Screw plaintiffs, will eventually decide that the suicide cases aren’t worth the candle.

If they do, we hope that there will be plenty of good precedent left behind for us to cite for the next decade or more to come.

We know that there will, at least, be Colacicco.

The dissent in Colacicco refers to a “sea change” with respect to preemption. Id. at *26. Judge Ambro was specifically discussing the FDA’s attitude towards preemption, but we already had that phrase written down in our marginal notes well before we ever got to the dissent.

We think we might just be seeing a sea change in judicial attitudes toward preemption in tort cases. When we were still relatively new at this game, and Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992), came down, we were quite surprised. Preemption in product liability cases wasn’t something we even thought about very much, it was that rare. So then we started thinking about it. When Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), came down and took preemption away from us in most of the medical device cases we were handling at the time, we were disappointed, but not particularly surprised. Preemption was still something that didn’t happen much in product liability cases.

When Geier v. American Honda Motor Co., 529 U.S. 861 (2000), came down, we were relieved and grateful. We did no-airbag cases back then, and we knew how much time, effort, and coordination that industry had put into getting the law to that point – and still the Geier decision was only 5-4.

But implied preemption had come to product liability litigation.

Not only did Geier kill the no-airbag litigation, but it was another example of product liability litigation being fought on a battlefield where the facts favored the defense. Under stare decisis, that precedent is still paying dividends.

Then we Bone Screwers brought implied preemption to the FDA’s regulatory scheme with Buckman. That decision was 8-1, and the preemption beachhead grew a bit.

Now it’s just possible that we’re seeing a preemption breakout – with the SSRI cases playing the role of Patton’s tanks heading across northern France. We’ve already discussed the Supreme Court’s recent similarly lopsided decision in Riegel v. Medtronic, Inc., 128 S. Ct. 999 (U.S. 2008). One of the things that struck us about Riegel was the tone of the discussion – the Court’s attitude towards preemption was no longer grudging. Preemption was no longer an odd thing, but now an affirmatively a good thing.

[E]xcluding common-law duties from the scope of pre-emption would make little sense. . . . Indeed, one would think that tort law, applied by juries under a negligence or strict-liability standard, is less deserving of preservation [than a] state statute, or a regulation adopted by a state agency [which], could at least be expected to apply cost-benefit analysis similar to that applied by the experts at the FDA. . . . A jury, on the other hand, sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court. . . . [I]t is implausible that [Congress] meant to grant greater power (to set state standards different from, or in addition to federal standards) to a single state jury than to state officials acting through state administrative or legislative lawmaking processes. That perverse distinction is not required or even suggested. . .in the MDA, and we will not turn somersaults to create it.

Riegel, 128 S. Ct. at 1008 (emphasis added) (various internal quotation marks and citations omitted). Seven justices signed onto this indictment of the tort system in Riegel, at least in the product liability context.

There’s a similar, although not as blunt, tone to Colacicco (indeed, the language of both the majority and dissent in Colacicco is quite measured) – a tone that is more accepting of the role of preemption in protecting society from the excesses we’ve discussed of the modern product liability/mass tort litigation game.

The Third Circuit’s attitude towards preemption in Colacicco indicates that it’s now an accepted defense, and that the “presumptions” against it are beginning to fall away. We see that in the court’s conclusion about the role of “explicit” congressional preemptive intent:
[T]he lack of a Congressional directive expressly approving or rejecting preemption in the context of drug labeling regulations is not determinative. Rather, the conflict preemption analysis is designed to determine the propriety of preemption where Congress has not explicitly stated its intent. Seen in this light, [defendant’s] argument that the presumption against preemption is inapplicable in the context of implied conflict preemption has more force [than plaintiffs’ arguments].

Colacicco, 2008 WL 927848, at *8 (emphasis added).

Hallelujah. One of our very first substantive posts, way back in November, 2006 when we first began blogging (that seems a lot longer ago to us than it does to you, dear reader, because you don’t have to feed the blog beast), was that the “presumption against preemption” shouldn’t apply at all to conflict preemption cases. We demonstrated that the Supreme Court in fact hadn’t applied that presumption in conflict preemption cases – those that arose from the direct operation of the Constitution's Supremacy Clause. The scope of the actual conflict, we argued, should determine the scope of preemption without any thumb on the scale.

Well Colacicco heard us – or more likely paid heed to some of the excellent briefing, including amicus briefing by PLAC and others, that made the same argument we had made in our post. The Colacicco court’s analysis, 2008 WL 927848, at *8, of the role that the presumption against preemption did and did not play in Hillsborough County v. Automated Medical Laboratories, Inc., 471 U.S. 707 (1985), in particular, could have been taken straight out of our inaugural post. Thus we enthusiastically agree with Colacicco’s discussion of “the tension between such a presumption, which emphasizes the “clear and manifest purpose of Congress,” and implied conflict preemption, which analyzes preemption in the absence of any explicit intent.” 2008 WL 927848, at *8 (quoting Lohr, 518 U.S. at 485).

While it’s not entirely clear from the Third Circuit's discussion of the presumption against preemption in Colacicco whether it’s “recognizing” that preemption only in some general sense, or in the particular case, 2008 WL 927848, at *8, we think that the dissent’s characterization of the weight the majority gave to the presumption against preemption in its analysis is pretty accurate. “[T]he presumption is performing virtually no analytical work” in the majority opinion. Id. at *20.

After Colacicco, the propriety of applying any presumption against preemption at all in conflict preemption cases is nicely teed up for briefing in and decision by the Supreme Court in Wyeth Laboratories v. Levine. Since we’ve already done a case by case analysis of every time the Supreme Court has mentioned the presumption against preemption, we’re confident in stating that the existence of any such presumption in conflict preemption (as opposed to field or express preemption) cases is quite an open question. If the Supreme Court in Levine (contrary to the Third Circuit in Colacicco) were to apply a presumption against preemption, it would be doing something it has never done before.

That’s just one place where we see a more accepting attitude towards preemption in Colacicco. Another is its view of the role of that branch of conflict preemption called “obstacle” or “frustration” preemption (there’s an excellent discussion of the different flavors of conflict preemption on pages *9-10 of the opinion). Obstacle preemption, the Third Circuit holds, is an “established” part of “ordinary preemption principles” in product liability litigation:
It is not only state statutes that may stand as obstacles to the achievement of federal objectives. It is now established that law suits based on state tort law, as well as on state statutes, may be viewed as presenting obstacles to the federal objectives and hence barred as preempted. . . . [O]rdinary preemption principles apply to a state tort action where an actual conflict with a federal objective is at stake.

Colacicco, 2008 WL 927848, at *10 (emphasis added). When we were starting out as product liability defense attorneys, implied preemption of common-law tort actions was anything but “established” and anything but an application of “ordinary tort principles.”

The times they are a changin' (we hope).

The notion that the common law was somehow “different” than state statutes or regulations for preemption purposes has been thrown at us by the other side in preemption cases for as long as we can remember. It’s dead as a doornail now – run over by one of Patton’s tanks.

Another place where we detect that “sea change” change in judicial attitudes towards preemption is a little further on, in the course of the Third Circuit’s comparison of the FDA’s long history of administrative activity concerning suicide and SSRI (that’s “selective serotonin reuptake inhibitor,” for you gluttons for punishment) anti-depressants to the extensive administrative record concerning airbags in Geier. Sounding a lot like our prior quotation from the Supreme Court in Riegel (although Riegel is not cited for the point), the Third Circuit discusses one of the problems with product liability litigation that preemption protects against:
State common-law tort actions based on the manufacturers’ failure to warn present the pharmaceutical manufacturers with particular difficulties. State standards of care undoubtedly differ from state to state. Absent a determination that the FDA-approved labeling and the FDA’s refusal to require the warnings suggested by plaintiffs in this case preempt state tort actions, the manufacturers may be subjected to considerable liability based on varying standards, with no benchmark that they should follow.

2008 WL 927848, at *11 (emphasis added). This is every bit as fundamental a critique of the chaotic nature of product liability litigation (and, indeed, of the tort system as a whole), as the Supreme Court’s appraisal of the jury system in Riegel. Preemption, the Third Circuit holds, is what the constitution has provided to ensure that, once the FDA has taken what the court calls “actions taken pursuant to. . .statutory [or “regulatory”] authority,” those actions are not subject to challenge in state-law tort actions. Id. at *14, 16, 17.

That's all we have time to do today. There are lots of other aspects of Colacicco that merit discussion:

  • The court’s extensive use of judicial notice in the context of a motion to dismiss, and how that might impact the tactical decision of what's the best procedural posture in which to raise the preemption defense.
  • The preemptive effect that the court gives to a variety of FDA administrative actions other than notice-and-comment rulemaking. There are other cases giving preemptive effect to FDA actions less formal than agency regulations, but no other decision discusses the issue in so much depth.
  • The role of congressional intent in implied preemption situations (we’ve just scratched the surface of that).
  • The court’s fascinating discussion of deference to the FDA, and the distinctions it draws between factual determinations and legal positions.
  • The (quite respectful) back and forth between the majority and the dissent concerning whether the FDA has been “inconsistent” in its positions towards preemption, as to which we would offer our own “original research” on what the FDA has actually published in the Federal Register about preemption since 1977.
  • The court’s refusal to require defendants asserting preemption to jump through formalistic hoops (such as submission of CBE supplements) that the FDA does not require as a matter of administrative practice.
  • The court telling plaintiffs arguing fraud on the FDA to take their complaints to the FDA.
  • The preemption questions that the court specifically states it is not deciding.
  • The role of administrative activity in setting the boundaries of conflict preemption.
  • The court’s treatment of the “conflict” language in the 1962 FDCA amendments.
However, you’ll just have to wait. This particular tank covered a lot of ground, and it will take us foot soldiers some time to fully occupy it.

Wednesday, April 09, 2008

The Composition of the Third Circuit

Colacicco has been on the books for only one day, and we've already been asked this question several times: What's the political breakdown of the Third Circuit?

There's no natural political constituency for preemption, so we're not quite sure what this tells you, but here's the count: The active judges on the Third Circuit are evenly divided between judges appointed by Democratic presidents and judges appointed by Republicans.

For those desperate for more details:

Scirica: Reagan
Ambro: Clinton
Barry: Clinton
Fisher: Bush II
Fuentes: Clinton
McKee: Clinton
Rendell: Clinton
Sloviter: Carter
Smith: Bush II
Chagares: Bush II
Jordan: Bush II
Hardiman: Bush II

At that point, you're on your own.

Class Cert Reversed Again in St. Jude Medical

Earlier today, the Eighth Circuit reversed certification of a class in a heart valve case. Here's a link to St. Jude Medical, Inc., Silzone Heart Valve Prods. Liab. Litig, No. 06-3860, slip op. (8th Cir. Apr. 9, 2008) (now reported at, 522 F.3d 836).

Are we quick, or what?

Here's the court's summary of its holding:

In litigation concerning the Silzone prosthetic heart valve, the district court erred in certifying a consumer protection class of plaintiffs; the record shows that there are material variations in the representations made concerning the valve, as well as material differences in the kind and degree of reliance; since the trial will require physician-by-physician inquiry into each doctor's sources of information about the valve, the case is not suited for trial as a class action; class certification was inappropriate for the further reason that the record shows that individual issues would predominate the remedial phase of the proposed class action, as plaintiffs have requested highly individualized medical monitoring as part of the remedy.

We'll try to add some meat to these bare bones when we have a chance to read the thing and work up the energy to write about it.

Easy Cases Make Good Law

On some days, it's hard to get back into the routine.

We'd rather keep mining the depths of Colacicco to see what nuggets we can unearth there.

But we owe it to you to provide a short post about the California Supreme Court's decision in Johnson v. American Standard, Inc., 179 P.3d 905, No. S139184, slip op. (Cal. Apr. 3, 2008) (here's a link). When duty calls, there's an outside chance that one of your humble scribes will rise to the occasion.

Here's the deal: Product manufacturers must warn about certain dangers associated with using their products. But manufacturers don't have to warn about obvious dangers -- because people already know about them. Warning people about dangers they're already aware of won't change anyone's conduct or avoid any accidents.

Suppose a manufacturer sells a product to particularly knowledgeable -- sophisticated -- users. An average person might not be aware of the risk associated with the product, but the people who actually buy the product are well aware of the risk. Must a manufacturer warn about non-obvious dangers of which the sophisticated users are aware?

(Astute readers will recognize that "sophisticated users" are, in many respects, a lot like physicians -- who are sophisticated users of prescription medical products. Although the analogy may be imperfect in certain ways, we read sophisticated user cases in part with an eye toward how their analysis might apply in the drug and device context. More on that in a minute.)

In any event, William Johnson was a certified heating, ventilation, and air conditioning technician. He took a year-long course on HVAC systems and earned "universal" certification from the Environmental Protection Agency by passing a five-part exam. "Universally" certified technicians are trained in tasks that include welding air conditioning units.

Large air conditioning systems often use R-22, a hydrochlorofluorocarbon refrigerant, which can decompose into hazardous phosgene gas when exposed to high heat. Here's what made this a relatively easy case: Beginning in 1997, every time Johnson bought R-22, he "received, and sometimes read, an MSDS" (material safety data sheet) that explained the risks associated with R-22. Johnson, slip op. at 2.

American Standard manufactured an evaporator that contained R-22 and was installed at a branch of the Bank of America. Johnson welded refrigerant lines on that HVAC system and later filed a product liability complaint pleading that he developed pulmonary fibrosis as a result of exposure to phosgene gas.

The trial court granted American Standard's motion for summary judgment based on the sophisticated user defense. Johnson knew, or should have known, of the risks associated with R-22, so American Standard owed no duty to warn of those risks. The Court of Appeal affirmed, and the California Supreme Court in turn unanimously affirmed.

As drug and device lawyers, we particularly liked the Supreme Court's language about the dangers of over-warning: "Not all warnings, however, promote user safety. Requiring manufacturers to warn their products' users in all instances would place an onerous burden on them and would 'invite mass consumer disregard and ultimate contempt for the warning process.'" Slip op. at 15 (citations omitted). The FDA has often used similar language to describe the decisions it makes when deciding what warnings should appear on prescription drugs and devices.

The Supreme Court went on to explain the contours of the sophisticated user defense in California.

First, the defense applies not only to users who were actually aware of a particular risk, but also to users who should have known about that risk. Id.

Second, the sophisticated user defense applies to both negligence and strict liability causes of action. Id. at 16.

Finally, the user's sophistication is judged as of the date the sophisticated user is injured and knew or should have known of the risk. Id. at 19.

The court did not directly address one question: When the manufacturer sells not directly to a sophisticated user, but only to a sophisticated intermediary, and the product then injures a third party, does the defense nonetheless apply?

That omission doesn't bother us.

The court cited with approval an earlier state court case in which the defendant sold a skeleton truck to a company that then installed a refrigeration unit on the chasis. When a truck driver was later injured in a fire, the court held that the manufacturer wasn't liable, because the sophisticated intermediary, which installed the refrigeration unit, was aware that gasoline is volatile and sparks can ignite it. The manufacturer did not have to warn the sophisticated intermediary of those risks. Id. at 12.

The court also cited with approval a federal case that recognized the sophisticated user defense in the context of a sophisticated intermediary. When an asbestos manufacturer sold asbestos to a sophisticated intermediary -- the Navy -- the manufacturer could be absolved of liability for the Navy's failure to warn its employees of the product's danger. Id. at 13.

We're confident that the California Supreme Court will hold that the sophisticated user defense applies when a sophisticated intermediary stands between the manufacturer and the allegedly injured party.

One last point merits thought:

We've often explained that the "learned intermediary doctrine" is just that -- a doctrine, and not an affirmative defense. Plaintiffs bear the burden of proving causation as part of their case-in-chief. Plaintiffs must therefore prove that a different warning on a drug's package insert would have changed the physician's conduct and avoided an alleged injury. Because the learned intermediary doctrine is not an affirmative defense, defendants do not bear the burden of proof.

"Sophisticated users," however, is described as a "defense," not a doctrine. That may be appropriate because the defendant may bear the burden of proving that the user was sophisticated.

All physicians are presumed to be learned by virtue of those many years in medical school and residencies. Courts are not as naturally aware of the education of HVAC technicians, so defendants might be required to prove that HVAC technicians are sophisticated. In that sense, the sophisticated user defense requires a defendant to offer proof and is thus an affirmative defense.

Once the defendant makes that showing, the sophisticated user defense arguably becomes more potent than the learned intermediary doctrine. Sophisticated users are presumed to know the hazards associated with a product, and plaintiffs are forbidden to offer proof that a particular user was in fact ignorant of the risk. Thus, the sophisticated user defense eliminates liability for risks that the user should have known of, whether or not he actually knew of them.

That's not the case in many states under the learned intermediary doctrine. In many states, so long as the physician was not in fact aware of a particular risk (and testifies that awareness would have changed the prescription), the manufacturer may still be on the hook.

Where's the justice in that, we ask you?

Shouldn't we drug and device lawyers be striving for that same standard in the learned intermediary context? If a physician should have known of a risk associated with a drug, the manufacturer should have no duty to warn. A manufacturer should not be blamed for a particular physician's actual ignorance of a specific risk. After all, as the California Supreme Court wrote, "Legal duties must be based on objective general predictions of the anticipated user population's knowledge, not case-by-case hindsight examinations of the particular plaintiff's subjective state of mind." Id. at 19 (citation omitted).

Perhaps defense lawyers should seek to broaden the learned intermediary doctrine to apply not only to risks that physicians did know about, but also to risks the physicians should have known about, independently from other sources. That interpretation would bring the learned intermediary doctrine in line with the sophisticated user defense.

(Frankly, we're still turning that idea over in our minds. There's a certain complexity to the physician's decision-making -- what does it mean, for example, for a physician to "heed" a warning? -- that appears in the learned intermediary cases and may not apply directly in the sophisticated user context. But we plan to keep thinking about this until we figure out why it works, and how it helps us.)

Maybe that's why we read sophisticated user cases.