Thursday, July 31, 2008

Tuckered Out

As most of our regular readers no doubt already know, not quite two weeks ago, we had to flip one of the cases in our Drug Preemption Scorecard. Specifically, the pro-preemption decision Tucker v. SmithKline Beecham Corp., 2007 WL 2726259 (S.D. Ind. Sept. 19, 2007) (“Tucker I”), became the anti-preemption decision, Tucker v. SmithKline Beecham Corp., 2008 WL 2788505 (S.D. Ind. July 18, 2008) (“Tucker II”). As the FDA Law Blog indicated, in a post on Tucker II that blatantly invaded our turf, we do keep our scorecards religiously up to date.

So why did we just sit there and take it from the FDA Law Blog?

Well, we thought they were on our side, for one.

Which necessarily means that we, in fact, have a side.

Darn right we do. As we’ve said over and over again, we publish this blog from the perspective of defense lawyers in product liability litigation. We’re in litigation – not regulatory. That means (among other things) that we’re biased in favor of our clients’ litigation positions. We are. We always will be. And we’ve always been very up front about that.

Stop being oblique, guys, what does any of this have to do with Tucker II?

Specifically, Tucker II is a slip opinion from a court (in this case, a federal district court) that is not automatically published or obtained by online services, such as Westlaw or Lexis . When we encounter an adverse case of this sort, it’s not our policy to discuss it until it’s got a reported citation. Until that happens, there’s a possibility that the adverse case might drop from sight without a trace.

We're not in the business of helping the other side make bad law (not intentionally, anyway).

And that possibility does happen, we know of at least two-and-a-half (don’t ask, because we aren't telling) instances just in the preemption area. Conversely, we know of at least seven instances where we took affirmative steps to ensure that favorable drug preemption decisions did make it on to the services (and, in two cases, got officially reported). We're a full-service blog.

No such luck here. Tucker II got a Westlaw (and presumably a Lexis) citation the other day.

That means we can now have at it.

So where do we think Tucker II went wrong?

Where didn’t it? That would be a shorter post.

But not as interesting for our readers or as satisfying to write for us.

Well, just looking at the FDA Law Blog’s discussion of Tucker II (even though they’re poachers, they’re very competent poachers), we see two glaring problems with the rationale of the decision.

The first problem is that Tucker II is completely inconsistent when it comes to retroactivity.

Here’s what we mean. First, as FDA Law Blog describes, Tucker II bought the argument that:

even if there is a conflict as a result of class-wide antidepressant labeling changes implemented in 2007 concerning suicide, “no conflict existed in 2002 when [defendant] could have warned [plaintiff] or his physician about [the drug’s] alleged association with suicidality.”
They’re describing what Tucker II held at *9 of the Westlaw opinion:

[T]o preempt [plaintiff’] claims based on actions by the FDA in 2007 would have the effect of retroactively absolving [defendant] of a duty it might have owed to [plaintiff] in the fall of 2002. Regardless of what the FDA ordered in 2007, if [defendant] had evidence of a reasonable association between [the drug] and adult suicidality in 2002, it had the duty then under the FDA’s regulations to strengthen the warnings on [the drug’s] label. [Defendant] had no way of knowing in 2002 what the FDA would order in 2007.
Thus, Tucker II refused to give effect to anything the FDA did (such as the 2006 Preemption Preamble) retroactively – even though the preamble states (which is why it’s an informal opinion in this respect) that it’s reiterating a “longstanding” position.

But when retroactivity favors the plaintiff, Tucker II takes the opposite tack. That’s the case (so the opinion holds) with new scientific knowledge under the CBE (“changes being effected”) regulation, 21 C.F.R. §314.70(c)(6)(iii). In that instance, Tucker II holds that, for some reason, a subsequent scientific advance would be retroactively relevant to defeat preemption even though the plaintiff was injured in 2002:

[I]n spite of the FDA’s direction regarding [the drug’s] label in May 2007, [defendant] still had (and has) the obligation to revise its label to strengthen a warning upon reasonable evidence of an association of a serious hazard, particularly with respect to this individual drug. If [defendant] were to receive such evidence, it would be obligated to revise its label in spite of the FDA’s directive in May 2007. . . . In other words, the FDA’s revisions were not necessarily the final word on [the drug’s] label and did not put [defendant] into a position where it was impossible for [defendant] to comply with both state and federal law.

FDA Law Blog, quoting Tucker II, 2008 WL 2788505, at *8.

Even putting aside preemption, this is profoundly unsettling reasoning, because Tucker II is ignoring the scientific state of the art. That’s because, in an SSRI (“selective seratonin reuptake inhibitor”) case such as Tucker II, there’s no way to argue credibly that information actually known at the time of a 2002 (or 2003 or 2004 or 2005 or 2006 or 2007) adult suicide could form the basis of a CBE revision. During this period, the FDA did in fact look (over and over again) at all available information, and the Agency positively rejected proposals to add suicide warnings.

So, to avoid the result that, under existing science, plaintiffs can’t use the CBE loophole to evade preemption, Tucker II invokes speculative (“if defendant were to receive”) changes in existing scientific knowledge that haven’t even been discovered yet (let alone back in 2002) to hold that there can’t be preemption because something might require/support/allow a CBE label change in the future.

Not only does the anti-preemption ruling in Tucker II require a rather dramatic resort to speculation – it’s also in direct conflict with the substantive state-of-the-art rules of almost every state in the country, including plaintiff Tucker’s home state of Indiana (Tucker I, 2007 WL 2726259, at *1). Indiana’s state-of-the-art rule in drug cases does not permit liability to turn on scientific information not known at the time of injury:

But, in the view of this court, that is where the reason for the rule ceases and the rule of “strict” liability itself should stop. To exact an obligation to warn the user of unknown and unknowable allergies, sensitivities and idiosyncrasies would be for the courts to recast the manufacturer in the role of an insurer beyond any reasonable application of the rationale expressed above. We are persuaded that the duty to warn under Comment K does not arise until the manufacturer knows or should know of the risk. . . . [D]ates are vitally important with respect to the duty to warn. Because a manufacturer cannot be required to warn of a risk unknown to science, the knowledge chargeable to him must be limited to that of the period during which the plaintiff was using the product in question.

Ortho Pharmaceutical Corp. v. Chapman, 388 N.E.2d 541, 548 (Ind. App. 1979) (citations and quotation marks omitted) (emphasis added). Accord Phelps v. Sherwood Medical Industries, 836 F.2d 296, 305 (7th Cir. 1987) (“[defendant] only had a duty to warn of those dangers which it knew or should have known at the time it distributed its [medical device]”) (applying Indiana law). See generally Bexis’ book §2.04[1] at footnote 17 (collecting state-of-the-art citations from drug and device cases in 35 states, the District of Columbia, and Puerto Rico).

So that’s one thing – one pretty big thing – that we think is wrong with the anti-preemption rationale in Tucker II. Not only does the decision apply, or refuse to apply, retroactively in a result-oriented fashion, but it does so in a way that’s inconsistent with supposedly controlling substantive tort law.

A second major issue that we have with Tucker II is it’s treatment of the FDA’s Preemption Preamble itself. Again the FDA Law blog usefully describes the relevant holding:

Citing a recent essay authored by former FDA Commissioner Dr. David Kessler and Georgetown University Law Professor David Vladeck, Judge Hamilton states that “FDA’s current position on preemption is not ‘long standing’ but is in fact a ‘180-degree reversal’ from its earlier stance.” Thus, “[t]he court, on reconsideration, gives relatively little weight to the FDA’s opinion on the preemptive effects of its regulations.”
See Tucker II, 2008 WL 2788505, at *5.

We object to this aspect of the decision because, first, it’s simply not correct, and second because, as we’ve blogged about before, we like our advocacy straight here at Druganddevicelaw – not masquerading as something academic. We’ve found that a lot of what passes for scholarship in the tort/preemption area is really thinly disguised advocacy for one side or the other. And just as the law review article we dissected in the prior post misrepresented the legislative history of the FDCA, the law review article cited in Tucker II – David A. Kessler & David C. Vladeck, “A Critical Examination of the FDA’s Efforts to Preempt Failure-to-Warn Claims,” 96 Geo. L.J. 461 (2008) – has taken very biased look at the FDA’s previous statement about preemption.

Allow us to deconstruct (like you had any choice).

What do Kessler and Vladek cite for the proposition that the FDA has done a 180º turn on implied preemption in the drug area? Tucker II helpfully points us to to footnote 59 of their article, so that’s where we look. That footnote precedes the proposition, “Among other things, the agency asserts that its pro-preemption position reflects the agency’s’ ‘longstanding view,’ even though the available evidence suggests otherwise.” That certainly looks like the right place.

So what do we find in footnote 59? That footnote cites five things:
  • In re Bextra & Celebrex Mktg. Sales Practices & Prod. Liab. Litig., No. M: 05-1699 CRB, 2006 WL 2374742, at *8 (N.D. Cal. Aug. 16, 2006) (observing that “the FDAs current view of the preemptive effect of its labeling regulations is a 180-degree reversal of its prior position”)
  • Brief for Public Citizen as Amicus Curiae Supporting Cross-Appellee at *12, Motus v. Pfizer, Inc., 358 F.3d 659 (9th Cir. 2004) (Nos. 02-55372, 02-55498), 2003 WL 22716063
  • Davis, supra note 10, at 25 n.140 and accompanying text.
  • Additionally, the proposal for the rule change stated that the new rules would not have a preemptive effect. See Prescription Drug Product Labeling; Medication Guide Requirements, 63 Fed. Reg. 66,378, 66,384 (Dec. 1, 1998) (to be codified at 21 C.F.R. pts. 201, 208, 314, 601, & 610) (“[T]he written patient medication information provided does not alter the duty, or set the standard of care for manufacturers .... FDA does not believe that the evolution of state tort law will cause the development of standards that would be at odds with the agency's regulations.”).
  • The FDA itself has acknowledged in amicus briefs that this pro-preemption stance is a change from past views held by the agency. See Brief for the United States as Amicus Curiae Supporting Appellee at *3, Horn v. Thoratec Corp., 376 F.3d 163 (3d Cir. 2004) (No. 02-4597), 2004 WL 1143720 (“We acknowledge that ... this [preemption] position represents a change for the United States.”).
Well, you can knock out the last one right away. We know Horn. Horn is a friend of ours. And Tucker II is no Horn. Rather, Horn was a case that involved express preemption and medical devices, not (as in Tucker II) implied preemption and drugs. The FDA admittedly changed its position on express preemption – but did so successfully. The Third Circuit accepted the FDA’s new position in Horn, see 376 F.3d at 178-79, and more importantly the Supreme Court agreed with the FDA’s position in favor of preemption in Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008).

Scratch one citation.

We’re also going to throw out the second citation. Amazingly, that’s to an amicus brief filed by Public Citizen, a pro-plaintiff group without any pretense of being an unbiased or evenhanded. That would be like a law review article citing us as authority for a pro-preemption proposition. Finding a citation to something like that in this article only reinforces our suspicions about exactly what is being passed off as scholarship.

Another one bites the dust.

Back to the top, then. Bextra/Celebrex, 2006 WL 2374742, at *8 (N.D. Cal. Aug. 16, 2006), certainly says that the FDA’s current drug preemption view is a “180-degree reversal.” What Kessler/Vladek doesn’t mention is that the Bextra/Celebrex court (like Horn) deferred to the FDA anyway.

Drilling down further, we see that Bextra/Celebrex cites three FDA actions (which is two more than Kessler/Vladek do): 44 Fed. Reg. 3735 (FDA 1979); 63 Fed. Reg. 66384 (FDA 1998); and 65 Fed. Reg. 81082 (FDA 2000). Fortunately, we discussed all three of those before.

The 1979 citation (a typo, by the way – the proper page citation is 37437) doesn’t involve preemption at all. It’s a general statement about the FDA’s “intent” “not” “to influence civil tort liability.” The FDA made that statement while fielding a complaint about manufacturers adding things to labeling that helped them make adequacy as a matter of law arguments, not preemption. Later in the same release, FDA said (also, not in a preemption context): “the decision as to whether a warning is legally required for the labeling of a drug must rest with the agency.” 44 Fed. Reg. at 37447.

Obviously, a statement, such as the 1979 quote, that’s not about preemption cannot fairly be counted as a change in the FDA's preemption position. But we’re talking advocacy here, not scholarship.

The 1998 citation, like the one in 1979, had nothing to do with preemption and, indeed, nothing to do with drug labeling generally. The FDA was expanding a regulation that required the package inserts of certain drugs to include material that doctors could give directly to patients. That raised tort concerns, and back in 1998 the Agency expressed a rather benign view of tort liability:

FDA does not believe that the evolution of state tort law will cause the development of standards that would be at odds with the agency’s regulations. FDA’s regulations establish the minimal standards necessary, but were not intended to preclude the states from imposing additional labeling requirements.
Once again, the 1998 submission doesn’t address preemption. Nor did it deal with allegations that FDA-approved drug labeling is defective. At most, on the basis of its 1998 statements, the FDA could be accused of changing its mind about “minimum standards” – not about preemption.

Finally, the 2000 statement stated the FDA’s belief about the preemptive effect of a particular proposal before it received public comments about what ultimately became the 2006 Final Rule. The FDA modified a lot of other things about that same rule. If divergence between a proposed and a final version of the same rule is all it takes to create a “contradiction” that eliminates administrative deference, than a lot of final rules are in jeopardy. This aspect of the anti-deference argument proves too much, and would turn administrative law on its head if applied outside beyond this one instance (which is why it probably hasn’t been – we’re not administrative lawyers, so we can’t say for sure).

In 2000, the FDA specifically requested, “If it is believed that product liability concerns have not been adequately addressed, the agency seeks comment on whether it could take different or additional measures to alleviate product liability concerns.” 65 Fed. Reg. at 81088. The requested product-liability-related comments to the 2000 proposal raised preemption concerns that the Agency hadn’t anticipated, so in that sense, yes, the Agency changed its mind about preemption with respect to that pending proposal.

But why are administrative agencies required to obtain comments in the first place? Isn’t it sort of the idea that an agency is supposed to be willing to alter a proposed position in response to public comment. Denying administrative deference because an agency reconsidered some aspect of a proposal in light of public comments doesn’t make much practical sense. We don’t think that can possibly be the law generally. It’s a litigation-inspired argument, that’s all.

So, we’re still looking for that 180º change of FDA position as to drug preemption generally.

The next Kessler/Vladek citation is a little harder to follow. The full cite is for “Davis” is Mary J. Davis, “The Final Battle for Preemption: The FDA and Prescription Drug Labeling Product Liability Actions” (Berkeley Elec. Press, Working Paper No. 1591, 2006). The "working paper" is available here.

First of all, the Davis paper is “electronic.” That means it’s an unpublished paper. It’s also a "working paper," which means it’s not even a final draft. In litigation, something like that would draw a Daubert challenge, as unworthy of even being cited.

Second, Kessler/Vladek cite to note 140 “and accompanying test” of the Davis paper. Well, that particular note of the Davis paper states, in its entirety, “See supra note 131 and accompanying text.” That’s it. Still looking for anything substantive.

Third, the “accompanying text” to note 140 states: “that description appears at odds with prior statements of the FDA.” While that restates the conclusion Kessler/Vladek (and, thus, Tucker II) is trying to justify, it does not independently support it.

Fourth, our next step in this academic version of a snipe hunt takes us to footnote 131 of the Davis article. Here, we finally find four citations: (1) the aforementioned “Motus Amicus Brief of Public Citizen”; (2) certain “Hearings Before Subcomm. of Comm. on Commerce on S. 1944, 73d Cong., 2d Sess. 400, 403 (1933)” (but only as “cited” in the Public Citizen brief) – these 70-year old hearings aren’t even from the same Congressional session that passed the 1938 FDCA, and they’re certainly not a position taken by the FDA; (3) Borden Co. v. Liddy, 200 F. Supp. 221, 225 (S.D. Iowa 1961), a case about food, not drugs, decided before the 1962 FDA amendments; and (4) “Porter, supra note 7 at _,” which is not even a complete cite (a peril of relying on unpublished papers), so we’re not going to bother with it.

Thus, while purporting to address the “prior statements of the FDA,” the Davis paper doesn’t cite a single such statement. It amounts to “we think it’s so because Public Citizen says so.”

Some scholarship this is turning out to be. But, frankly, we’re not surprised. Kessler/Vladek is all about advocacy, not academics.

One more to go.

The last thing Kessler/Vladek relies on for its attack upon the consistency of the FDA’s position is – drum roll please…. Wait a minute! We’ve already gone over 63 Fed. Reg. at 66384. That’s the FDA’s patient package insert rule that didn’t have anything to do with preemption.

There’s essentially nothing there.

So adding up everything Kessler/Vladek footnote 59, all we find is, (1) a pro-plaintiff litigation brief (cited more than once, it turns out), (2) three Federal Register citations – two not about preemption at all, and one about a proposal that was changed before it became final, (3) a drug preemption case that deferred to the FDA and found in favor of preemption, (4) an unpublished draft article citing nothing from the FDA at all, and (5) the express preemption Horn case where preemption also prevailed.

That’s a very thin reed, indeed.

Not only that, but Kessler/Vladek – and by extension Tucker II – don’t bother mentioning what the FDA actually did say about preemption. How about this?

Were a State to enact a law that conflicts with this regulation or if, contrary to FDA’s understanding, such laws currently do exist, those State laws would be preempted. The agency disagrees with comments that have inferred such laws would be permissible under the provision. . .that allows States to establish more stringent requirements.
62 Fed. Reg. 55852, 55932 (FDA Oct. 28, 1997).

There’s also this:

Under the Supremacy Clause of the Constitution, State laws that interfere with or are contrary to Federal law are invalid. Federal preemption can be express (stated by Congress in the statute) or implied. Implied preemption can occur in several ways. Preemption may be found where the scheme of federal regulation is sufficiently comprehensive to make reasonable the inference that Congress left no room for supplementary state regulation, or where the federal interest is so dominant that the federal system will be assumed to preclude enforcement of state laws on the same subject.

Federal preemption may also be found where Federal law conflicts with State law. Such conflict may be demonstrated either when compliance with both federal and state law is a physical impossibility, or when State law stands as an obstacle to the accomplishment and execution of the full purpose and objectives of Congress. State law is also preempted if it interferes with the methods by which a Federal law is designed to reach its goals.

Additionally, a federal agency acting within the scope of its congressionally delegated authority may preempt state regulation and hence render unenforceable state or local laws that are otherwise not inconsistent with federal law. Federal regulations have no less preemptive effect than federal statutes.

When an agency’s intent to preempt is clearly and unambiguously stated, the Court’s inquiry will be whether the preemptive action is within the scope of that agency’s delegated authority. If the agency’s choice to preempt represents a reasonable accommodation of conflicting policies that were committed to the agency’s care by statute the regulation will stand unless it appears from statute or its legislative history that the accommodation is not one that Congress would have sanctioned. . . FDA possesse[s] the authority to promulgate regulations preempting . . . local
[litigation] rules that compromise adverse reporting systems that are essential to postmarketing surveillance and protection of the public health.

Conflicts between State and local disclosure laws and Federal law on adverse event reporting justify FDA’s preemption of these laws. Although Congress did not expressly preempt State law in this area, the agency’s action is appropriate because State and local laws significantly interfere with the methods by which the Federal law is designed to achieve its goals.

60 Fed. Reg. 16962, 16965-66 (FDA Apr. 3, 1995) (citations and internal quotation marks omitted).

And the third time’s the charm:

Although Congress did not expressly preempt State law in this area, the agency finds Federal preemption to be appropriate because such State or local laws, rules, regulations, or other requirements would impede FDA’s ability to monitor product safety after approval to ensure that human drug products, biologics, and medical devices are safe and effective for their intended uses. Thus, under principles of preemption law, congressional intent to preempt State law can be inferred.
60 Fed. Reg. 16962, 16963 (FDA Apr. 3, 1995).

All three of these FDA positions specifically concerning preemption (and a number of others that we won’t bore you with here) were taken while Mr. Kessler was Commissioner of the FDA.

Strike three, Vladek/Kessler are outta there.

It’s inconvenient, but quite true, that what passes for scholarship in the area of tort preemption needs to be regarded with a much more jaundiced eye than occurred in Tucker II.

Moreover, those three quotes hardly scratch the surface of what the FDA has actually said about preemption and product liability law. For a more complete review, readers should click on this link to our prior post, “Ruminations on Executive Orders and the Federal Register.”

In short, the FDA could not, as Tucker II states, have made “a 180-degree reversal from its earlier stance.” 2008 WL 2788505, at *5. That’s because the Agency didn’t have an “earlier stance” to reverse. The only inconsistency in the FDA’s preemption positions occurred back before 2000, that is, before the Buckman case brought the FDA to a consistently pro-preemption stance. Before then, the FDA’s position was quite variable, with the FDA sometimes favoring preemption and on other occasions opposing it.

So on that point, Tucker II is – plain and simple – wrong. And on that point Kessler/Vladek either have amazingly selective memories or amazingly poor research help.

Those are our two main beefs with the reasoning in Tucker II. We could go on at length, but we won’t. Briefly, some other low points of the opinion:

Item: Tucker II refuses to recognize a conflict unless there’s actually been a government prosecution. “If the FDA exercises its power to disapprove the revised label, the FDA's disapproval is not retroactively illegal; the manufacturer simply stops distributing the new label.” 2008 WL 2788505, at *3; id. at *3 n.2 (FDA “must proceed to court for a judicial determination in an enforcement action”). But actual prosecution has never been the test for implied preemption – not in Geier v. American Honda Motor Co., 529 U.S. 861 (2000), where auto manufacturers were not forced to defy air-bag mandates, and not in Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), where the Court did not require either a successful, or an unsuccessful, prosecution for fraud on the FDA before preemption would attach. This preemption “requirement” is made up from whole cloth.

Item: Tucker II appears to hold (even we’re not sure exactly what’s going on at this particular point) that preemption requires “a specific example of a runaway jury verdict in which a jury found for a plaintiff in a failure-to-warn case.” 2008 WL 2788505, at *6. That can’t be right, either, as the same two Supreme Court cases (Geier and Buckman) demonstrate. Neither involved any verdict at all. That’s not to say that a runaway verdict can’t help a preemption argument. See Wyeth v. Levine. But, again, such a preemption “requirement” (if that’s what it is) seems to be something conjured in Tucker II simply for the purposes of this particular case. There’s certainly no precedent for it.

Item: There’s the statement, “[i]t is worth recalling here that under the defendant’s preemption theory here, a plaintiff could not recover for an injury or death even if the plaintiff could prove beyond reasonable dispute: . . . (c) that the FDA regulatory process had failed to identify a significant danger.” Tucker II, 2008 WL 2788505, at *7. While we’d love to have preemption where the risk in question wasn’t even “identified” during the drug’s approval process, that’s not what SSRI cases are all about. The suicide risk in Tucker II had been “identified” to a farethewell. Suicide and SSRIs were reviewed by the FDA over and over again – both before and after the 2002 suicide at issue in the case. That’s why, as we’ve already discussed, Tucker II had to ignore the state of the art in the first place. Moreover, in the 2006 Preemption Preamble, none of the six preemptive circumstances the FDA recognized involves a situation where the FDA had not reviewed the risk.

Have you ever sat down and stared really hard at a printed word? Almost any word more than two syllables long will do. Look at a word long enough, and you can almost always convince yourself that the word is somehow misspelled, even though it isn’t. We think something similar happened in Tucker II after the court had gotten preemption right the first time around.

Wednesday, July 30, 2008

Is That A Half Pint Or A Half Gallon?

When we finished reading the majority opinion in Kovach v. Alpharma, Inc., No. 49A04-0707-CV-406, 2008 WL 2746509 (Ind. App. July 16, 2008), we were thinking of publishing a post titled: "Hire Us, Alpharma!"

The Kovach majority decision entirely overlooked what seemed to be the dispositive issue in the case, so we figured that defense counsel had blown it; maybe we could have helped.

But we kept reading, and our first impression was wrong.

The dissenting opinion focused on the right issue, so the error was not defense counsels'.

Here's what happened:

Nine-year-old Matthew Kovach was prescribed 15 ml of Codeine, which is one half of the volume of a graduated medicine cup. Instead of giving Matthew a half cupful, Nurse Robinette may have given him a whole cupful. Later that day, Matthew died of asphyxia due to an opiate overdose; the autopsy revealed more than twice the recommended therapeutic dose of Codeine in his blood.

Plaintiffs sued everyone in sight. As to the cup manufacturer, plaintiffs' expert testified that the "graduated measurement markings of the Cup" did not create a clear contrast, and the cup's "graduated measurements are not sufficiently visible." Id. at *5.

We gotcha.

And if the nurse was supposed to administer 8 ml, but she administed 9 ml instead because she couldn't read the markings on the cup, plaintiff might have a point.

But that's not what happened here. The nurse was supposed to administer a half cup, and she apparently administered a whole one instead. Someone might be at fault here, but the injury didn't have anything to do with the graduated markings on the cup.

You can tell a half pint from a half gallon even if the "1/4 ounce" markings are a little blurry. The markings on this cup simply could not have caused the nurse's error that led to Matthew's death.
The majority opinion, however, doesn't mention this dispositive issue. The majority tells us that "children are more sensitive to an overdose of medication than adults," the measurement markers "are located on the interior surface of the Cup," and "it would have been reasonable to include a warning with the Cup, stating that it should be used with caution when dispensing precise doses of medications." Id. at *7.

Holy toledo, Batman! What happened to causation -- seemingly the dispositive issue in the case? The supposed obscurity of the lines for individual milliliters couldn't have had anything to do with this child's death. Had defense counsel for the product manufacturers really overlooked that point?

Then we read the dissent.

"The nurse administered at least double the recommended dosage of the drug to Matthew. No reasonable factfinder would conclude that her actions were the result of a measuring error." Id. at *13. "[T]he Kovachs have failed to show that the alleged defect, failure to warn, . . . was the proximate cause of Matthew's death." Id.

We can't blame defense counsel for this; they obviously got it right.

The lawyers raised the issue, and the majority was not persuaded.

We're a bit surprised at the result, but we can't use this case as a chance for brazen self-promotion.

Maybe next time.

Tuesday, July 29, 2008

A Public Service Announcement

Until very recently, we were clueless about this little spat:

"A few months back, Shannon Brownlee and Jeanne Lenzer wrote on Slate about potential conflicts of interest, addressing doctors who had received funds from pharma talking about SSRIs on public radio. They stated that they'd created a list of pharma-free experts for journalists. . . . " (We've now reached the limits of our technological capacity. We can't figure out how to link that quote to Torts Prof and yet keep the internal link to Slate. In any event, the preceding quote comes from Torts Prof -- here.)

Ted Frank, of the AEI and Point of Law, asked Brownlee and Lenzer for their list of "untainted" experts, but Brownlee and Lenzer refused to share it. Here's Ted's rant on that subject from a couple of months ago.

Brownlee and Lenzer have now shared their list with the world.

And here's the public service part of this announcement: We figure that readers of this blog, perhaps more than any other group on the face of the planet, can tell us which of Brownlee and Lenzer's pharma-free experts have accepted money to testify as experts for plaintiffs. (If you can provide accurate, verifiable information, feel free to name names -- specifying who received money from whom -- in the comments beneath this post.)

We, of course, don't think that it's necessarily "corrupting" for a scientist to perform work for a company and to be paid for his or her efforts. But we do think that sauce for the goose is sauce for the gander: Surely if it's worth noting the money that certain people have received from the drug industry, it's equally worth noting the money that other people have received from "Trial Lawyers, Inc."

A Texas 82.007 Preemption Win

This falls into the category of "almost breaking news":

On Friday, Judge Todd Campbell, who's handling the Aredia/Zometa MDL, entered an order granting partial summary judgment based on Texas Civil Practice and Remedies Code Sec. 82.007 as to all failure-to-warn claims. In re Aredia and Zometa Prods. Liab. Litig., 2008 WL 2944910 (M.D. Tenn. July 25, 2008).

(We've plowed this ground at this blog before. Please click here for the legal background; the following description is a shorthand version meant for folks already generally familiar with the underlying legal issue.)

Eight Texas residents sued for personal injuries allegedly caused by Novartis' drugs. Seven filed their complaints in New York; one filed in Texas. The MDL Panel transferred all of the case to the Middle District of Tennessee for pretrial proceedings.

Under both New York and Texas choice of law rules, Texas law governed plaintiffs' claims.

Texas Civil Practice and Remedies Code Sec. 82.007(a) provides that drug manufacturers are not liable for failure to warn if the warnings that accompanied their product had been approved by the FDA.

Plaintiffs can rebut that presumption by, among other things, proving that the defendant misrepresented to the FDA material information that was causally related to the plaintiff's injury. Tex. Civ. Prac. & Rem Code Sec. 82.007(b).

Citing Buckman Co. v. Plaintiffs' Legal Comm., 121 S. Ct. 1012 (2001), Judge Campbell found that the fraud-on-the-FDA exception is preempted, leaving only the immunity from failure-to-warn liability intact. Rejecting the magistrate judge's contrary decision in Ackermann v. Wyeth, 471 F. Supp. 2d 739 (E.D. Tex. 2006), Judge Campbell granted partial summary judgment in favor of Novartis.

Colacicco Update

Last week, plaintiff filed a motion to postpone the deadline for filing his petition for a writ of certiorari in Colacicco v. Apotex from August 3, 2008, to October 2, 2008.

On Thursday, July 24, Justice Souter granted that motion.

For those who must see proof with their own eyes, here's a link to the Colacicco docket on the U.S. Supreme Court's website.

Monday, July 28, 2008

Levine Oral Argument

It doesn't appear yet on the Court's docket or on the Court's oral argument calendar, but we have it upon good authority that Wyeth v. Levine will be orally argued on Monday, November 3, 2008.

Mirapex Bellwether Trials Begin

The Minneapolis Star Tribune reports:

"The first of three trials concerning the drug Mirapex and its alleged linkage to compulsive gambling is underway in U.S. District Court in Minneapolis before Judge James Rosenbaum, who will preside over all three 'bellwether' jury trials. The trials will be used by the 200-plus plaintiffs and defendant Boehringer Ingelheim Pharmaceuticals to determine the strengths and weaknesses of their respective cases."

HT to Torts Prof.

Do Bad Things Come In Threes? (Masquat v. DaimlerChrysler)

DaimlerChrysler lost the trifecta in Masquat v. DaimlerChrysler, __ P.3d __, 2008 WL 2600703 (Okla. July 1, 2008).

Masquat isn't a drug or device case, but it's such a run of bad luck in a class action context that we can't resist mentioning it.

In Masquat, owners of certain Dodge and Chrysler cars built on the LH platform brought a putative class action pleading a defect in the power rack and pinion steering system. DaimlerChrysler had allegedly introduced a newly designed bolt to its LH platform in late 2000 to keep the steering systems from failing, but it never provided the repair to previously-produced vehicles that shared the same platform. Plaintiffs pleaded claims for breach of express and implied warranties on behalf of a putative nationwide class.

To have this class certified against you, you'd have to go 0 for 3.

Guess what DaimlerChrysler went?

Most courts don't certify nationwide classes because (by definition in a "nationwide" class) plaintiffs bought the product in all 50 states. A trial court would have to do a plaintiff-by-plaintiff analysis to decide which state's choice-of-law rules applied to each transaction and then, depending on the result of that analysis, might have to apply the substantive law of 50 different states to the various plaintiffs' claims.

Not in Oklahoma. A few years ago, in Ysbrand v. DaimlerChrysler Corp., 2003 OK 17, 81 P.3d 618 (Okla. 2003), the Oklahoma Supreme Court held that the law of the defendant's home state had the most significant relationship to all of the plaintiffs' claims, so an Oklahoma trial court could apply Michigan law to the claims of all plaintiffs in a nationwide class.

Naturally, class action plaintiffs' counsel now gravitate to Oklahoma as moths to light.

And, naturally, Masquat sued DaimlerChrysler in Oklahoma.

DaimlerChrysler loses on the threshold choice of law question.

That's 0 for 1.

(As we've said before, we really don't like that choice-of-law analysis. It seems crazy to us that a resident of Tulsa could walk down Tulsa's auto row, buy a Ford, a Toyota, and a Hyundai on the same day from the same dealership, have the same problem with each car, sue each car manufacturer on the same legal theory -- and then learn that the claims were governed not by Oklahoma law, but by the laws of the home jurisdictions of the manufacturers: Michigan, Japan, and South Korea, respectively! But it's awfully hard to fix what we perceive as the Oklahoma Supreme Court's error in that regard. Either the Oklahoma Supreme Court must reverse itself to bring Oklahoma law into line with that of most other states or some litigant must entice the U.S. Supreme Court to grant cert and change Oklahoma's rule as a matter of federal constitutional law. Both of those are pretty tough rows to hoe.)

DaimlerChrysler wasn't yet out of luck.

In addition to the governing substantive law, the Oklahoma Supreme Court had to decide which state's statute of limitations (and related requirements for tolling the statute due to fraudulent concealment) would apply to plaintiffs' claims.

Michigan has a four-year statute of limitations for warranty claims; Oklahoma has a five-year statute.

Oklahoma's borrowing statute, "the reverse of most 'borrowing statutes'" (Masquat, para. 16 at n.3) -- borrows not the shorter of the two limitations periods, but the longer of the two.

The five-year statute thus applied in Masquat.

0 for 2.

So the trial court will apply Michigan's substantive law, but Oklahoma's statute of limitations, to all of the plaintiffs' claims.

Statute of limitations questions often present individualized issues. It's possible, of course, that one plaintiff was aware of the defect in a product sooner than some other plaintiff, so the statute of limitations might have expired as to some plaintiffs but not others.

The class thus still couldn't be certified against DaimlerChrysler if individual issues would predominate -- if the court must decide whether each class member individually "exercised reasonable diligence in learning of the allegedly concealed defect." Id. at para. 19. To have the class certified, a court must hold that "any question of variation in individual reliance is eclipsed by the common questions surrounding the allegation of fraudulent concealment."

Guess what decision we're quoting in that last sentence?

Right -- Daimler Chrysler goes 0 for 3 and faces a certified class containing over two million members.

The court did "cap" the value of the remedy that DaimlerChrysler would have to pay at $310 for some class members and $400 for others (id. at para. 6), so the maximum possible exposure is only

. . .

wait a second -- we're getting out a calculator.

Shoot! Only eight digits on that calculator. Hang on a second.


Good thing companies don't lose trifectas like that every day.

Friday, July 25, 2008

New PhRMA Voluntary Guidelines – Will No Good Deed Go Unpunished?

The Pharmaceutical Research and Manufacturers of America (“PhRMA”) released a new set of voluntary guidelines for the conduct of pharmaceutical marketing (called “Code on Interactions with Health Care Professionals”) on July 11.

That’s almost two weeks ago – an eternity in the blogosphere.

What can we say? We’re busy. We’re also lazy. So being both, we were hoping that somebody else would take the lead in synopsizing them for us.

And what can we say? We’re in luck. We’ve found two really good summaries going well beyond the general Internet pabulum about pens and meals and instead lay out the guts of the PhRMA guidelines in a way that us litigators can use. One comes courtesy of the folks over at the FDA law blog. The second summary, which includes a nifty side-by-side comparison of the new and old guidelines, was sent to us yesterday by our friends at Reed Smith.

So, if all you want is to find out what’s in the PhRMA guidelines, click on the links and we’ll see ya later.

We’ve said before, and we’ll say again – we’re not regulatory types here. Rather than having to parse through for ourselves exactly what the PhRMA guidelines say, we’d much rather do what we like to do best – think about the PhRMA guidelines with our litigators’ hats on.

A lot of what goes on in pharmaceutical mass torts (and a lot of other litigation) can best be understood by keeping the following in mind:


We've seen it more times than we can count. Our client finds out that its drug (say, DES - that's safely generic) has some unexpected risk (although perfectly safe for users, it causes a virtually unknown cancer in their children). So the client bites the bullet, and takes the drug off the market. It did the right thing, right?

We think so, but we're biased.

So the other side responds: You should have done that sooner! You should have paid attention to this or that red flag! You should have done this or that study sooner! You should have done a different study! You should have had a different warning from the beginning! You should have waited before putting the product on the market in the first place!

And that’s the way it goes, whether the product’s a drug or a medical device, and whether the client’s action is a market withdrawal, a warning change, compliance with an FDA directive, or releasing the results of an adverse study – you name it, they’ll sue over it.

And if they can’t find anything wrong with the product (or even if they can), they’ll go after our client’s marketing.

Anything to expand the scope (and the expense) of discovery. Because it’s almost inevitable – rummage through enough documents and emails of enough people (a quarter million or so will do) and eventually you’re very likely to discover somebody saying, or doing, or proposing something dumb. Or at least something that a jury probably won't like.

And because the other side looks at marketing, it’s also inevitable that they’ll look at the new PhRMA guidelines. Thus no good deed goes unpunished.

The guidelines are explicitly voluntary. The dictionary definition of “voluntary” includes “free will” and “subject to individual volition.” Also, the guidelines take effect in January, 2009. That means they're not in effect now and weren’t in effect last year.

But as litigators, we know what we’ll see:

First, courts will be asked to convert voluntary to mandatory – “Your client doesn’t follow the guidelines, therefore it’s liable.” That’s the “negligence per se” approach.

Second, courts will be asked to apply prospective guidelines retroactively – “Because you’re client didn’t follow the guidelines when my client was hurt, therefore it’s liable.” That's the "who cares about the state of the art" approach.

Needless to say, we don’t think either argument should fly.

As to the first point, there’s a lot of law out there holding that “violating” something that doesn’t have the force of law isn’t a basis for liability. In Ashworth v. Albers Medical, Inc., 410 F.Supp.2d 471 (S.D.W. Va. 2005), a case involving drug counterfeiting, the court refused to find the defendant liable for not following “certain proposed, but never implemented, FDA regulations.” Id. at 482. Likewise, in Schaerrer v. Stewart's Plaza Pharmacy, Inc., 79 P.3d 922, 31-32 (Utah 2003), the court refused to hold the defendant strictly liable because it had “run afoul” of an FDA “policy statement” that was “by no means binding.” There would be no liability “[s]o long as the pharmacy is acting within the rules and regulations set forth by the state and federal governments.” Id.

Those are only the most on-point situations. Liability has also been rejected where the defendant allegedly did not comply with the following materials that did not carry with them the force of law:
  • Internal agency manualsSloan v. HUD, 231 F.3d 10, 18 (D.C. Cir. 2000); Flechsig v. United States, 991 F.2d 300, 304 (6th Cir. 1993); Kugel v. United States, 947 F.2d 1504, 1508 (D.C. Cir. 1991); Gatter v. Nimmo, 672 F.2d 343, 347 (3d Cir. 1982); Jacobo v. United States, 853 F.2d 640, 641-42 (9th Cir. 1988); Young v. United States, 2002 WL 31340969, at *3 (E.D. Pa. Oct. 15, 2002); Shrieve v. United States, 16 F. Supp.2d 853, 858 (N.D. Ohio 1998); Marin v. United States, 814 F. Supp. 1468, 1482 (E.D. Wash. 1992); DFDS Seacruises (Bahamas) Ltd. v. United States, 676 F. Supp. 1193, 1205-06 (S.D. Fla. 1987); Kane v. Lamothe, 936 A.2d 1303, 1309 (Vt. 2007); Chisolm v. Mississippi Dept. of Transportation, 942 So.2d 136, 143 (Miss. 2006); Lugtu v. California Highway Patrol, 28 P.3d 249, 259 (Cal. 2001); Moorehead v. District of Columbia, 747 A.2d 138145 (D.C. 2000); Mervin v. Magney Construction Co., 416 N.W.2d 121, 124-125 (Minn. 1987); Haney v. Bradley County Bd. of Education, 160 S.W.3d 886, 891-93 (Tenn. App. 2004); City of Mission v. Cantu, 89 S.W.3d 795, 807 n.17 (Tex. App. 2002); Schonfeldt v. State of California, 72 Cal. Rptr.2d 464, 467 (Cal. App. 1998); McDaniel v. Sunset Manor Co., 220 269 Cal. Rptr. 196, 198 (Cal. App. 1990).
  • External agency manualsBrady v. Depew, 2005 WL 1667404, at *3 (M.D. Pa. July 15, 2005); Fondow v. United States, 112 F. Supp.2d 119, 131 (D. Mass. 2000); Spencer v. Lakeview School Dist., 2006 WL 1816452, at *3 (Ohio App. June 30, 2006); Christiansen v. Silfies, 667 A.2d 396, 403 (Pa. Super. 1995) (ruling manual inadmissible).
  • Informal agency policiesJones v. Otis Elevator Co., 861 F.2d 655, 660-61 (11th Cir. 1988); Simmons v. Osborne, 2005 WL 2000850, at *4 (W.D. Ky. Aug. 17, 2005); Staton v. United States, 566 F. Supp. 174, 179 (W.D. Va. 1983); Pollock v. Florida Dept. of Highway Patrol, 882 So.2d 928, 936-37 (Fla. 2004); District of Columbia v. Arnold & Porter, 756 A.2d 427, 435 (D.C. 2000).
  • Private industry standardization codesMutual Casualty Co. v. Collins & Aikman Floor Coverings, Inc., 2004 WL 840561, at *4-5 (S.D. Iowa Feb. 13, 2004); Knarr v. Chapman School of Seamanship, 2000 WL 433981, at *2 (E.D. Pa. April 14, 2000); Commonwealth, Transportation Cabinet v. Babbitt, 172 S.W.3d 786, 795 (Ky. 2005); Delaware Electric Co-op. v. Duphily, 703 A.2d 1202, 1209 (Del. 1997); Alabama Power Co. v. Marine Builders, Inc., 475 So.2d 168, 177 (Ala. 1985) (privately set standards inadmissible); Jorgensen v. Horton, 206 N.W.2d 100, 103 (Iowa 1973).
  • Internal policies of private entitiesCavcon, Inc. v. Endress & Hauser, Inc., 2008 WL 2004251, at *16 (S.D.W. Va. May 8, 2008); Gilson v. Metropolitan Opera, 841 N.E.2d 747, 749 (N.Y. 2005); Wal-Mart Stores, Inc. v. Wright, 774 N.E.2d 891, 894 (Ind. 2002); Morrison v. Mineral Palace Ltd. Partnership, 603 N.W.2d 193, 197 n.4 (S.D. 1999); Rupert v. Clayton Brokerage Co., 737 P.2d 1106, 1111 (Colo. 1987); Luckie v. Piggly-Wiggly Southern, Inc., 325 S.E.2d 844, 845 (Ga. App. 1984); Boone v. William W. Backus Hospital, 2003 WL 22332793, at *7 (Conn. Super. Sept. 26, 2003).
That's the first point. There ain't no basis for negligence per se, or some other way of creating a new duty out of whole cloth, because PhRMA isn't the government.

As to the second point, we’ve taken a look at whether a privately adopted standard can be retroactively applied to create liability for conduct taking place prior to the standard’s existence. Not only isn’t that allowed as a legal proposition, but the overwhelming majority of cases go further and hold that private policies – instituted only after the fact – are irrelevant and inadmissible. Thus, pharmaceutical defendants faced with the inevitable claims that they should have been doing all along what the 2008 PhRMA guidelines provide should respond by moving to have the guidelines declared inadmissible as to any prior conduct.
  • Alabama: Alabama Power Co. v. Brooks, 479 So.2d 1169, 1180 (Ala. 1985) (subsequently adopted private electrical safety code inadmissible); Benford v. Richards Medical Co., 792 F.2d 1537, 1539-1540 (11th Cir. 1986) (no abuse of discretion in refusing to admit evidence of 1981 industry standard where events material to plaintiff's claim occurred in early 1970s).
  • Arizona: George v. Fox West Coast Theatres, 519 P.2d 185, 190 (Ariz. App. 1974) (building codes not applicable to buildings built prior to their enactment not relevant in negligence action).
  • Georgia: Muncie Aviation Corp. v. Party Doll Fleet, Inc., 519 F.2d 1178, 1184 (5th Cir. 1975) (if “guidelines were not published until after the events in question occurred the court could properly exclude them for lack of relevancy”).
  • Indiana: Lueder v. Northern Indiana Public Service Co., 683 N.E.2d 1340, 1346-47 (Ind. App. 1997) (safety code “not yet adopted” properly excluded as “not relevant”).
  • Kansas: Rexrode v American Laundry Press Co., 674 F2d 826, 832 (10th Cir. 1982) (subsequent ANSI standard properly excluded “as irrelevant ‘post-sale’ evidence”).
  • Massachusetts: Dominick v. Brockton-Taunton Gas Co., 255 N.E.2d 370, 371-72 (Mass. 1970) (industry safety bulletin issued after events in question had “no relevance”); Touch v. Master Unit Die Products, Inc., 43 F.3d 754, 757 (1st Cir. 1995) (“evidence that the defendant designer or manufacturer met the pertinent industry safety standards prevailing at the time of manufacture would be material . . . even though its product’s design might not comport with safety criteria later embraced by the industry”) (emphasis original).
  • Michigan: Shears v. Pardonnet, 263 N.W.2d 373 375 (Mich. App. 1977) (to be admissible, private safety “standards must have been promulgated prior to the production or construction of the device in question”); Vroman v. Sears, Roebuck & Co., 387 F.2d 732, 737-738 (6th Cir. 1967) (error to admit industry standards published after sale of the product in question).
  • Mississippi: Fillingane v. Siemens Energy & Automation, Inc., 809 So.2d 737, 741-42 (Miss. App. 2002) (subsequently adopted standards properly excluded even though relevant language was same as applicable standard); Frazier v. Continental Oil Co., 568 F.2d 378, 383 (5th Cir. 1978) (“[t]he judge . . . could exclude . . . standards which were published after the incident in question occurred”).
  • Missouri: May v. Ernst-Eichman Machinery Co., 1990 WL 198832, at *13 (W.D. Mo. Nov. 26, 1990) (“[i]t would have been a waste of the Court’s and the jury's time to listen to evidence of post-[manufacturing ANSI] standards which was at best only slightly probative, at worst confusing”).
  • New Hampshire: Lemery v. O’Shea Dennis, Inc., 291 A.2d 616, 618 (N.H. 1972) (absent evidence that private safety code “had been promulgated by the council prior to the construction of the allegedly defective [structure]” it was “not relevant”).
  • New Jersey: Rodrigues v Elizabethtown Gas Co., 104 NJ Super 436, 250 A2d 408, (1969) (gas safety manual dated two years after accident “is not pertinent or relevant and we shall not consider it”).
  • Pennsylvania: Petrongola v. Comcast-Spectacor, L.P., 789 A.2d 204, 212 (Pa. Super. 2001) (subsequently promulgated standards inadmissible because “[n]owhere do the standards demand that all existing facilities be immediately reconfigured to conform to these newly promulgated standards”); Kiehner v. School District of Philadelphia, 712 A.2d 830, 832 (Pa. Cmwlth. 1998) (defendant “had no duty to retrofit or remodel its [property] to bring it in compliance with the current BOCA Code”); Wilson v. Savage Arms Corp., 305 F. Supp. 1163, 1165 (E.D. Pa. 1969) (objections sustained to questions addressing “present standards or principles prevailing at times subsequent to the time of manufacture of the [product]”).
  • South Dakota: Andrushchenko v. Silchuk, 744 N.W.2d 850, 857 (S.D. 2008) (plumbing code not adopted until after accident “was not relevant and had no tendency to establish a duty”).
Beyond that, there’s also a bunch of decisions holding government regulations – things having the force of law – inadmissible where they weren’t enacted until after the events involved in litigation (usually sale of the product). Since there’s usually a stronger argument for admitting something that has binding legal effect, we view these cases as a fortiori (in layman's parlance, "well, duh") where an after-adopted private standard of conduct is involved. See Kirk v. Hanes Corp., 16 F.3d 705, 711 n.6 (6th Cir. 1994) (after-enacted CPSC lighter regulations were “irrelevant”); Cover v. Cohen, 461 N.E.2d 864, 869 (N.Y. 1984) (admission of draft regulation, not finalized until after product was sold was “both improper . . . and highly prejudicial”); Turner v. General Motors Corp., 584 S.W.2d 844, 852 (Tex. 1979) (“post-event regulations are inadmissible”); Aller v. Rodgers Machinery Manufacturing Co., 268 N.W.2d 830, 841 (Iowa 1978) (standards promulgated after the sale of the product were “clearly irrelevant” and inadmissible); White v. Clark Equipment Co., 553 S.W.2d 280, 281 (Ark. 1977) (subsequent regulation “has no relevance to the question of whether [defendant] ordinary care”); Bennett v. Greeley Gas Co., 969 P.2d 754, 759 (Colo. App. 1998) (“absent evidence that a safety code or regulation was intended to apply retroactively, it has generally been held that evidence concerning them is not admissible to establish the standard of care at a time before their enactment”); Dunkle v. West Penn Power Co., 583 A.2d 814, 816 (Pa. Super. 1990) (“subsequently enacted regulations are irrelevant to establish an earlier duty of care”); Oberreuter v. Orion Industries, Inc., 398 N.W.2d 206 (Iowa App. 1986) (subsequent CPSC regulations inadmissible); Ball v. New Jersey Bell Telephone Co., 504 A.2d 29, 36 (N.J. Super. 1986); (“it can hardly be said that [defendant’s failure to comply with a regulatory standard that was not in existence at the time [of its conduct] constitutes proof of negligence”).

The new PhRMA marketing code is both voluntary and non-retroactive. We fully expect plaintiffs to try to get courts to ignore both of these features. Given what we’ve found, we’ve got good grounds to try to put a stop to such foolishness.

Thursday, July 24, 2008

Review Granted in County of Santa Clara v. Superior Court (Atlantic Richfield Co.)

In County of Santa Clara v. Superior Court (Atlantic Richfield Co.), 161 Cal. App. 4th 1140 (2008), the California Court of Appeal held that public entities may, in certain circumstances, hire outside attorneys to handle "ordinary civil cases" on a contingency-fee basis.

Yesterday, the California Supreme Court granted review.

The petition for review and other briefs can be found here.

Hat tip to (and more coverage at) The UCL Practitioner.

Wednesday, July 23, 2008

Nice Daubert Ruling Out Of The E.D. Pa.

Daubert rulings can make for tough sledding. The best of them often wallow in drug- or plaintiff-specific facts, so even the nicest result is both hard to describe and tough to apply as precedent in cases involving other drugs.

Perry v. Novartis Pharmaceuticals Corp., No. 05-5350, 2008 WL 2683047 (E.D. Pa. July 9, 2008), is no exception. In his 40-page opinion, Judge Dalzell describes at length the animal studies, case reports, results of clinical trials, and biological hypotheses arguably linking Elidel (a cream used to treat eczema) with a form of non-Hodgkins lymphoma ("NHL"), which Andreas Perry developed at age two.

Judge Dalzell also describes what's needed for an appropriate differential diagnosis to rule in a medication as a cause of disease when most cases of the disease have no known cause. Ultimately, Judge Dalzell concludes that one of the two plaintiff's experts presented a reliable opinion on general causation, but that neither proved specific causation. The court granted Novartis' motion to exclude plaintiffs' experts, which then resulted in a grant of summary judgment.

The science surrounding Elidel interests those involved in that particular litigation, but we read the opinion with an eye toward finding the broader principles that may apply in later cases. And we found a few.

When analyzing the existing epidemiological evidence, one expert chose to focus on aggregate data about lymphomas in general, rather than particularized data about any link between the drug and non-Hodgkins lymphoma, which was the disease involved in the case. "It therefore appears that Dr. Smith's analysis of the i3 report focused not on the findings that were most relevant to the hypothesis he sought to test but on the findings that were most helpful to his paying client. While this approach is, sadly, not uncommon, it is incompatible with the reliable application of the scientific method." Slip op. at 23-24.

In what is perhaps the most helpful language in the opinion, the court goes on to explain that plaintiffs bear the burden of proof in product liability cases and so cannot prevail in the absence of data supporting their claims:

"Before we examine those studies, however, we must make clear that the non-existence of good data does not allow expert witnesses to speculate or base their conclusions on inadequate supporting science. In cases where no adequate study shows the link between a substance and a disease, expert testimony will generally be inadmissible, even if there are hints in the data that some link might exist. This may mean that early victims of toxic torts are left without redress because they are unable to prove their cases with the scientific data that exists. While this is a regrettable result in those individual cases, it is an unavoidable reality of the structure of our legal system and is necessary to protect the interests of defendants who might otherwise be subject to crippling verdicts on the basis of slender scientific evidence."

Id. at 28.

Finally, the court turned to specific causation. "Here, the differential diagnoses . . . fail to exclude -- much less address . . . -- the likelihood that Andreas Perry's lymphoma had no known cause. . . . [M]ost NHL cases and, more specifically, most T-LBL cases, are idiopathic, having no known cause. . . . Faced with similar situations, our sister courts have excluded experts' differential diagnoses where they failed to adequately account for the likelihood that the disease was caused by an unknown factor." Id. at 31-32.

The court went on to suggest ways that plaintiffs could overcome this hurdle, but held that "analysis beyond a differential diagnosis will likely be required." Id. at 33.

Last, but not least, a helpful word on dosage: "The failure to address the issue of dosage in a scientific manner is just one more reason to conclude that plaintiffs' experts did not reach their conclusions on the basis of the scientific method." Id. at 38.

Perry is an impressive opinion, reflecting careful thought on a host of scientific issues. We're pleased to see a federal judge wrestle so conscientiously with issues as hard as these.

Tuesday, July 22, 2008

Levine Briefing Schedule

We've been asked, so here's what we know. According to the Supreme Court's Docket, an order was entered on July 9 extending the time for respondent's (plaintiff below) brief until August 7, 2008. That would make the briefs of plaintiff's amici due seven days later (that's August 14, 2008, for the mathematically-impaired). Petitioner/defendant Wyeth's reply brief (assuming no further extensions) would then be due on Monday, September 8, 2008 (the first business day falling after 30 days after the respondent's brief.

Enjoy the rest of your summer, folks.

Monday, July 21, 2008

Sharkey's "Colloquy" On Riegel Online At Northwestern

Northwestern University Law Review's Colloquy site has published the first installment of Catherine Sharkey's extended "essay post" on what Riegel v. Medtronic portends for FDA preemption. Here's a link.

Professor Sharkey proposes "that, when trying to determine whether or not state law should be preempted by federal agency action, courts should look to the regulatory record to determine whether or not an agency actually considered the risks that the state law attempts to protect against."

Whether or not we agree with Professor Sharkey's analysis, we're always pleased to see her laboring in this field.

Riegel Toothpaste (Adkins v. Cytyc)

When we mentioned Adkins v. Cytyc, No. 4:07CV00053, 2008 WL 2680474 (W.D. Va. July 3, 2008), last week, we called it an attempt to squeeze non-preempted claims out of the Riegel tube.

We're giving that toothpaste slightly more attention today.

In Adkins, plaintiff pleaded that a corporate representative of Cytyc -- presumably a sales representative -- was physically present in the operating room during a surgical procedure involving Cytyc's NovaSure medical device. The sales rep allegedly "advised and directed" the treating physician "on the proper way to measure the size of Adkins' uterus and to test the integrity of her uterine wall." Slip op. at 2. The physician allegedly messed up; the patient allegedly was injured; the lawsuit named the device manufacturer as a defendant.

Defendants moved to dismiss. The trial judge granted the motion, dismissing with prejudice "all those causes of action that sound in negligence or breach of a duty related to the design, manufacturing, and labeling of the NovaSure device." Id. at 3. Since the FDA had approved the NovaSure device under the premarket approval process, those claims were preempted under Riegel.

As to the remaining claims, however -- those pleading that Cytyc, by virtue of having had a representative in the operating room, had a duty to ensure that the treating physician used the device correctly -- the court dismissed only without prejudice. According to the court, the "FDA does not regulate interactions between corporate representatives and physicians on-site at a particular surgery, and . . . it does not specify how such an interaction at surgery must be performed." Id. at 5. In that situation, said the court, traditional common law claims might survive.

Adkins' complaint, however, did not plead "any facts that explain what Defendants' representative did or failed to do as part of his alleged duty, such that more than mere suspicion of a cognizable right of action is created." Under Twombley, a complaint that fails to plead those facts does not state a claim. Id.

Additionally, the complaint didn't specify whether Adkins' alleged injuries were caused by failure of the NovaSure device or by a treatment error induced by the sales rep's instructions. "Where there are two explanations for the damages complained of within the four corners of the Complaint, one of which would allow recovery if true and the other of which could not allow any recovery due to preemption, a plaintiff has failed to state a claim . . . ." Id. at 5-6. The court thus gave plaintiff leave to re-plead.

What lessons does Adkins teach?

1. Riegel, as we knew, is strong medicine in cases involving PMA-approved devices.

2. Twombley applies to product liability claims. We never doubted that, but we urge defense counsel to make full use of that precedent.

3. Plaintiffs will do whatever they can to avoid preemption. (Film at 11!)

4. Device manufacturers should think long and hard about instructing sales reps as to whether they should enter the operating room during surgery and, if so, what the reps should appropriately say.

5. Device manufacturers should make sure they have sufficient insurance coverage for claims such as the one pleaded in Adkins.

6. Faced with a case such as this one, don't overlook Kennedy v. Medtronic, 851 N.E.2d 778, 787 (Ill. App. 2006) ("Medtronic's clinical specialist attended the surgery to provide technical support and ensure that the lead parameters were correctly calibrated and the lead was functioning properly. This limited role did not entail her voluntarily assuming a duty, under section 324A of the Restatement (Second) of Torts, for the placement of the lead into the correct ventricle of the patient's heart.").

7. As the sign in the dentist's office says: "Don't floss all your teeth. Just the ones you want to keep."

Visit Beck and Herrmann: Law! Dental hygiene! The whole enchilada!

Thursday, July 17, 2008

Ideas, Random Thoughts and Musings from ACI Preemption Conference

Yours truly (trulies?) chaired the American Conference Institute’s preemption conference in Philly earlier in the week. We won’t try to be too modest here. It was a great seminar. But frankly that had little to do with us and everything to do with the all-star group of speakers that ACI assembled.

We continue to be flabbergasted by the compliments we get about the blog. Really. And by the end of the program we could hardly believe some of the things we heard (some of which we're not at liberty to repeat). Thanks to everyone for the more-than-kind words.

The scary part is now we have to live up to all these heightened expectations. What have you done for us lately, bloggers?

Not much today, I’m afraid. All we’ve done is put together some of the thoughts we had while we were listening to the various ACI presentations. There’s no particular theme, except that we wanted to get these down before, in the press of other business, we forget about them.

So here goes.

Watch out for disguised “manufacturing" claims.

We’ve already predicted that, after Riegel, we expect to see plaintiffs retooling their allegations to squeeze them into any perceived loopholes that they can find. Indeed, savvy plaintiffs were doing that already. See Adkins v. Cytyc Corp., 2008 WL 2680474 (W.D. Va. July 3, 2008) (including non-preempted claim about face-to-face interaction between physician and sales representative of company selling PMA device).

We’d (and plaintiffs, we suspect) mostly thought about that in terms of supposedly “parallel” violation claims, but another way for the toothpaste to squeeze out of the tube could be the proliferation of bogus “manufacturing defect” claims that really aren’t. In opposing that, it’ll be important to keep courts focused on what “manufacturing” defects really are.

In both the second and third Restatements, and in almost every state we know of (but don’t expect another state-by-state chart on this), a “manufacturing defect” is narrowly defined as a product that is not what the defendant intended it to be. A pacemaker that, because of some error, has a plastic coating that was not cured for as long as the manufacturer intended has a manufacturing defect. But, on the other hand, a pacemaker about which it is alleged that the manufacturer’s intended curing process somehow violates FDA Good Manufacturing Practices does not have a “manufacturing defect” as defined by state law. In that situation, because the resulting device was exactly what the manufacturer intended it to be, there is no “manufacturing defect.”

So any claim that mentions “manufacturing” isn’t necessarily a proper state-law “manufacturing defect” claim. We’ll need to watch carefully for plaintiffs trying to pass off what are really Riegel-preempted design defect claims or Buckman-preempted “solely from the violation of FDCA requirements” claims as so-called “manufacturing” claims. In doing so, the well-defined state-law definition of “manufacturing defect” in most jurisdictions will be our friend.

Post-Riegel trial court preemption decision

Another thing that happened at the conference is that we swapped information. We came away with a preemption decision we hadn’t heard of before, called Mullin v. Guidant. We think it’s the first state trial court decision to decide a medical device preemption motion after Riegel. It’s not long or profound, but it was (as far as we know) first. We found out about it, so now you know about it, too.

Buckman parallel requirements analysis could bar post-approval claims

We’ve discussed at length our view that Buckman’s analysis of what is and isn’t a “parallel” claim means that preemption bars a pure regulatory violation claim without any state-law counterpart. We just weren’t sure before the ACI conference whether that limitation would, in practice, eliminate that many claims that plaintiffs would really bring.

Then we heard one of the panels discuss how one type of claim that plaintiffs would probably pursue, because it hadn’t been directly addressed in Riegel, was that the defendant somehow violated post-marketing regulatory obligations. That is, plaintiffs would claim that the label as approved was OK, but that the defendant had not lived up to its obligations thereafter, and that for that reason the label should have been changed.

Well, that kind of claim sounded a lot like a post-sale duty to warn or failure to recall claim to us. Thus the question: “If the allegation is that the defendant violated an obligation to change the label after plaintiff had been prescribed the drug, and state law doesn’t recognize any post-sale duty to warn, then does there exist any common-law claim for the violation allegations to run ‘parallel’ to?” The answer, of course, was no.

So it looks like our Buckman analysis might have practical benefit in defending against post-Riegel claims after all.

Getting preemption protection for products prospectively

We confess (boy, do we confess) that we’re not FDA regulatory lawyers. But thankfully there were some of the regulatory types at the conference. They had this tip for minimizing exposure to plaintiffs’ arguments based upon the CBE regulation (those of you not up on the jargon, that’s the “you could have added or strengthened a warning without FDA pre-approval” argument). It's a tip that would be especially useful in the mass tort context.

We haven’t studied the regulations ourselves to verify it, but we trust the source – so here goes.

Companies can voluntarily choose to comply with the post-2006 “updated” form of labeling that includes the new “highlights” section. The post-2006 regulations provide that the CBE route for modifying labeling is entirely inapplicable to the “highlights” section. We’re told (this is what we haven’t verified) that the regs and commentary make clear that CBE is unavailable to change anything in the rest of the labeling that would, in turn, require a change to the “highlights” section. All contraindications, for example, must be stated in the “highlights.” Thus for drugs that use the post-2006 labeling, there’s no argument (like the Vermont courts adopted in Levine) that the manufacturer could have used CBE to add a contraindication.

Think about that.

Many, if not most, pharmaceutical mass torts involve risks that already appear on the labeling - if not at the very beginning, then at least sometime in the drug’s labeling history. Of course, the plaintiffs are going to claim that the warnings about such risks should have been strengthened. To try to escape preemption, in such cases, plaintiffs are going to argue that defendants could have used CBE to strengthen the existing warning.

Well, if the drug’s under the post-2006 labeling regime (which manufacturers can accede to voluntarily), then a label change of the type that mass tort plaintiffs would be advocating (for example, something that the FDA required later on) would almost always result in requiring the risk in question to go into the “highlights” as well. That’s because any risk serious (or widespread) enough to generate a mass tort would, almost by definition, be serious enough to warrant inclusion in the “highlights” section.

And if it’s serious enough to go into the “highlights” section, then under the FDA’s regulations, the CBE procedure is unavailable. If the CBE process isn’t available, then the requirement of FDA pre-approval probably means that the claim will be preempted. That means (at least the argument goes) that, in practice, a lot less mass tort litigation against drugs under the post-2006 label format should survive preemption.

We’d recommend that pharma manufacturers consult with their own regulatory counsel and verify this. If it’s true, then a conversion to the post-2006 regime could well have an extremely beneficial effect upon future (not existing) mass tort litigation.

And we keep repeating the “mass tort” adjective deliberately. There could be drawbacks in defending “one off” claims because drug manufacturers using the post-2006 labeling regime are, conversely, expected to reduce the clutter on their labeling by removing warnings that lack scientific basis. But in litigation, those laundry lists of everything that showed up during clinical trials are beneficial, since they provide a basis for arguing that the warning adequate as a matter of law as to any risk “specifically mentioned” in the labeling. So there’s a downside to being under the post-2006 labeling regime in peculiar individual cases.

Since we do mass torts, we’d love to see that tradeoff made, but it does need to be seriously considered.

And getting the FDA to issue a written order that the manufacturer remove this or that warning as unsupported would go a long way towards getting preemption to protect those claims as well.

In tough jurisdictions consider primary jurisdiction arguments in addition to preemption

We’ve already got Riegel. If we get a good result in Levine as well, then we will have succeeded in moving preemption beyond the “foundational” stage. That means we’ll then be asserting preemption in a lot more jurisdictions – ones unsympathetic to our side – where we wouldn’t have before.

One alternative that was bandied about at the ACI conference for possible use in such jurisdictions was FDA primary jurisdiction. In other words, it’s an argument that, rather than dismissing the plaintiff's suit outright, plaintiff should take the allegations to the FDA and let the agency decide them. If a defendant thinks that, realistically, the odds of the FDA agreeing with a plaintiff’s labeling critique are “slim and none, and Slim just walked out the door,” then giving a hostile court the out of telling the plaintiff to go to the FDA rather than outright dismissal may increase the likelihood of success.

But again, be careful. The “let the FDA decide” argument is in tension with the Supreme Court’s “agency inundation” argument in Buckman – so if Buckman’s also a big part of your argument, it’s best to leave primary jurisdiction alone.

Preemption is a reaction to an increasingly intrusive litigation environment

In essence, the FDA didn’t turn to preemption because it wanted to, but because it had to. We don’t know exactly where they were from, but one of the ACI conference speakers had stats on federal court prescription drug and medical device product liability filings. Such filings rose from 2,700 in 2001 to a peak of 22,400 in 2004, before dropping back slightly to 17,000 in 2005. In other words, there was a five-fold increase in federal-court prescription medical product liability litigation over the five years leading up to the FDA’s early 2006 preemption preamble.

And we thought we had it bad during the Bone Screw days.

One thing is obvious from those stats – the plaintiffs’ bar has been trying to turn the products the FDA regulates into the next asbestos. But you can’t manufacture a 500%+ increase in litigation over five years without changing the nature of the litigation itself … expanding its scope into areas previously unknown, such as attacking warnings even though they were specifically mandated by the FDA.

If preemption does no more than reduce the number of filings in our neck of the woods back to the 2001 level, it will have accomplished a lot.

A Levine win, and the CBE change, would let us breathe a little easier after 2008

Everybody in the preemption fight – both sides – uses January 20, 2009 as a reference point. There will be a new administration, and thus the FDA will be under new management. We don’t do partisan politics on this blog, but it’s certainly possible that the FDA’s new management will be cozier with the other side than current management is. And Congress could be more responsive to the other side as well.

Not good – at least for the folks on our side of the “v”.

But does it spell disaster for preemption?

Not necessarily.

If we get a ruling in favor of preemption in Levine – the consensus at the ACI conference was optimistic on that score – and the FDA finalizes its revisions to the CBE regulation to bring it into line with what the agency originally intended, then there’s reason for hope.

Nor is it likely that a new administration would try to reverse the government’s amicus position in Levine itself, because a move that blatantly political would destroy the credibility of the new Solicitor General with the Supreme Court.

If we get implied preemption on a reasonably broad rationale in Levine, then even if Congress were to take away the preemption clause that underlies Riegel, device manufacturers could rely on the same kind of implied preemption. Indeed, to the extent there’s an actual conflict, even §510k device manufacturers (the big losers in Lohr) would be able to rely on implied preemption after a favorable decision in Levine.

Because implied preemption is dependent upon conflict rather than congressional intent, it’s difficult for the litigation lobby to touch it. Indeed, there’s persuasive precedent (Dowhal) holding that they can’t touch it – that even the most explicit savings clause imaginable cannot authorize an actual conflict with supreme federal law. The litigation lobby would have to amend the Supremacy Clause itself, something that’s never been done in the nation’s history.

If the FDA acts to restrict availability of CBE changes to new information the FDA has not yet reviewed, it’s going to be hard to justify changing it back (administratively or legislatively) to the absurd meaning plaintiffs try to give the current language.

It just doesn’t make any sense for the CBE process to permit (and thus obligate, under plaintiffs’ view of the world), a manufacturer to ignore an FDA-mandated label by (as soon as the day after the FDA's decision) unilaterally changing the warning to something else. Plaintiffs' construction of the current CBE regulation would let (and thus obligate) manufacturers to repeat such changes again, and again, and again, over and over, each time the FDA rejects the proposed change – all without any new scientific evidence to warrant any change at all. To bring about such a blatantly nonsensical change would require the litigation lobby to make a huge investment of political capital.

So if we have implied preemption and a sane CBE regime, the litigation lobby would be forced to strike at the FDA itself, perhaps by trying to eliminate the preemptive conflict by reducing FDA-approved warnings to something that state law can ignore at will. But taking away the FDA’s control over labeling is not far away from abolishing the FDA itself. Theoretically Congress could do that, but there’s reason to question whether even the litigation lobby would be able to flex the kind of raw, political muscle necessary to do something like that.

So if we get preemption now, we may just be able to keep it.

Reverse Parlay

The public relations folks are often trying to parlay small items in the blogosphere into important coverage in the print media.

We ran a different experiment.

We've watched how our book review that originally appeared in yesterday's Wall Street Journal has since been picked up in the blogosphere.

Thanks to the Pharm Exec blog, the Mass Tort Litigation blog, and the D and O Diary for noticing the book review and continuing to spread the word.

Wednesday, July 16, 2008

Extra! Extra! Read all about it!

That's a throwback headline. An "extra" edition of a newspaper to report on breaking news? Our grandkids won't have a clue.

In any event, Alison Bass' new book, Side Effects: A Prosecutor, A Whistleblower, and A Bestselling Antidepressant On Trial, severely criticizes a couple of players in the pharmaceutical industry.

In his book review that appears on page A15 of today's Wall Street Journal, our own Herrmann explains that there are two sides to the antidepressant story, and Bass has told only one.

That's why Herrmann had an adverse reaction to Side Effects.

What Are The Drug And Device Mass Torts?

Every once in a while, you're asked to name the mass torts.

You typically start with asbestos and breast implants, and then stammer out a few more.

But one of us is now doing some work that requires focusing specifically on the drug and device mass torts, so -- cleverly combining client work with blogging work -- we thought we'd reproduce here our preliminary list of those cases.

We'll say at the outset that this list isn't any good. First, we're cheating. We didn't do much work to create this list; we simply went to the MDL Panel's website, copied the list of "product liability" MDLs, deleted the ones that didn't sound like drugs or devices, and reproduced the rest here.

Second, the list can't be trusted. It's surely over-inclusive, because the MDL Panel occasionally coordinates cases and the litigation then fizzles -- it never truly becomes a mass tort.

The list is also under-inclusive, for at least two reasons. First, it's possible that a mass tort lived its entire life without the MDL Panel ever having coordinated the litigation. (We suspect, however, that that's probably true only for litigation before 1995 or so. For the last decade, the MDL Panel has fairly regularly coordinated product liability cases, so litigants now routinely bring those issues to the Panel.)

Also, the MDL Panel list from which we extracted the information below appears to include only active MDLs. (For example, why isn't the Breast Implant MDL included on this list? We assume because the litigation is over, so the MDL Panel no longer lists it on this page of its website. With a little more effort, you could find those closed cases, too, and we'll probably pursue that avenue off-line. If you need a more comprehensive list, just whistle.)

So, without further ado . . .

(Actually, having said that we cheated to create the list and the list is no damn good, who needs any ado at all?)

. . . we present:

A More or Less Comprehensive List Of the Drug and Device Mass Torts

MDL-865 IN RE Showa Denko K.K. L-Tryptophan Products Liability Litigation (no website)

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

MDL-1014 IN RE Orthopedic Bone Screw Products Liability Litigation (no website)

MDL-1203 IN RE Diet Drugs (Phentermine/Fenfluramine/Dexfenfluramine) Products Liability Litigation

MDL-1348 IN RE Rezulin Products Liability Litigation

MDL-1355 IN RE Propulsid Products Liability Litigation

MDL-1387 IN RE ProtoGen Sling and Vesica System Products Liability Litigation (no website)

MDL-1396 IN RE St. Jude Medical, Inc., Silzone Heart Valves Products Liability Litigation

MDL-1401 IN RE Sulzer Orthopedics, Inc., Hip Prosthesis and Knee Prosthesis Products Liability Litigation

MDL-1407 IN RE Phenylpropanolamine (PPA) Products Liability Litigation

MDL-1431 IN RE Baycol Products Liability Litigation

MDL-1477 IN RE Serzone Products Liability Litigation

MDL-1481 IN RE Meridia Products Liability Litigation (no website)

MDL-1507 IN RE Prempro Products Liability Litigation

MDL-1574 IN RE Paxil Products Liability Litigation (no website)

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

MDL-1598 IN RE Ephedra Products Liability Litigation (okay, okay; we'll include dietary supplements) (no website)

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

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

MDL-1657 IN RE Vioxx Marketing, Sales Practices and Products Liability Litigation

MDL-1699 IN RE Bextra and Celebrex Marketing, Sales Practices and Products Liability Litigation

MDL-1708 IN RE Guidant Corp. Implantable Defibrillators Products Liability Litigation

MDL-1724 IN RE Viagra Products Liability Litigation

MDL-1726 IN RE Medtronic, Inc., Implantable Defibrillators Products Liability Litigation

MDL-1736 IN RE Celexa and Lexapro Products Liability Litigation

MDL-1742 IN RE Ortho Evra Products Liability Litigation (no website)

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

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

MDL-1769 IN RE Seroquel Products Liability Litigation (no website)

MDL-1785 IN RE Bausch & Lomb Inc. Contact Lens Solution Products Liability Litigation (we'll call this a borderline MDL for this list) (no website)

MDL-1789 IN RE Fosamax Products Liability Litigation (no website)

MDL-1836 IN RE Mirapex Products Liability Litigation

MDL-1842 IN RE Kugel Mesh Hernia Patch Products Liability Litigation

MDL-1871 IN RE: Avandia Marketing, Sales Practices and Products Liability Litigation

MDL- 1905 IN RE: Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation

MDL- 1909 IN RE: Gadolinium Contrast Dyes Products Liability Litigation (no website)

MDL- 1928 IN RE: Trasylol Products Liability Litigation (no website)

MDL-1934 IN RE Epogen and Aranesp Off-Label Marketing and Sales Practices Litigation (no website)

MDL- 1938 IN RE: Vytorin/Zetia Marketing, Sales Practices and Products Liability Litigation (no website)

MDL- 1943 IN RE: Levaquin Products Liability Litigation

MDL- 1953 IN RE: Heparin Products Liability Litigation (no website)

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

MDL- 1964 IN RE: NuvaRing Products Liability Litigation

MDL- 1966 IN RE: Shoulder Pain Pump - Chondrolysis Products Liability Litigation (no website)

MDL- 1968 IN RE: Digitek Products Liability Litigation

MDL- 1985 IN RE: Total Body Formula Products Liability Litigation (no website)

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

There's a little more information about these MDLs on the MDL Panel website, but we can't link to it directly. From this link, click on "docket information." Then click on "products liability." That will give you the list of MDLs we used. You can click on each individual MDL and get information such as the name of the judge and the court.

Tuesday, July 15, 2008

Are You "Less Protected" When Using An Overseas Litigation Vendor?

This guest post was written by David Booth Alden. Mr. Alden is a partner resident in the Cleveland 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.

As the price of long distance communication has fallen, many companies have outsourced information-related functions previously performed in the United States to foreign countries with lower labor costs. It is commonplace to speak with representatives located in India or other, lower-cost foreign locations when calling customer “help desks.” Not surprisingly, some firms have sought similar cost savings by outsourcing litigation support functions to foreign locations that are “only an e-mail away.”

But a declaratory judgment action filed by a Maryland law firm, Newman McIntosh & Hennessey, LLP v. Bush, No. 1:08-cv-787-CKK (D.D.C. filed May 12, 2008), seeks to end or drastically reduce foreign litigation support outsourcing. Newman has been the subject of some comment in the blogosphere. (See,,, and The basic issue there is whether the National Security Agency’s surveillance of international electronic data traffic either (a) waives otherwise applicable claims of attorney-client privilege or work product protection or (b) undermines the Fourth Amendment’s protection against unreasonable searches when U.S. entities communicate electronically with persons overseas.

The Newman defendants are (1) President Bush; (2) an Indian legal services firm, Acumen Legal Services (India) Pvt., Ltd.; (3) the Indian services firm’s U.S. affiliate, Acumen Solutions, LLC; and (4) John and Jane Doe defendants. The complaint alleges that (a) overseas foreign nationals lack Fourth Amendment rights; (b) when one party to an electronic communication is an overseas foreign national, the U.S. Government takes the position that there can be no reasonable expectation of privacy in the communication; (c) the NSA, acting in conjunction with other countries’ security agencies, “intercepts as many as 3 billion communications every day,” which are “relayed to NSA memory buffers” that “store five trillion pages of data;” and (d) the intercepts of attorney-client communications (i) waive Fourth Amendment rights, (ii) breach applicable claims of attorney-client privilege, and (iii) disclose confidential communications.

The Newman complaint may well suffer from threshold problems that will prevent consideration of the merits. For example, there may be no case or controversy, and the plaintiff law firm may lack standing to raise some or all of the claims. But, whatever the fate of the particular claims raised in the Newman complaint, litigants considering international legal outsourcing should be concerned if the mere fact of communicating materials overseas undermines otherwise applicable privileges and protections. Yet, at least on the limited facts revealed in the Newman complaint, that does not appear to be the case. Newman’s concerns about undermining attorney-client privilege and work product protection claims seem overblown, and the alleged Fourth Amendment problems appear to be moot.

Privilege and Work Product

With respect to attorney-client privilege and work product protection claims, an area in which I frequently dabble, the Newman complaint’s contention that NSA eavesdropping may result in a waiver is unpersuasive. No form of communication is entirely free from the possibility of eavesdropping, yet court decisions and ethics opinions generally uphold the privileged or protected status of communications exchanged by e-mail and cell phone. See, e.g., In re Asia Global Crossing Ltd., 322 B.R. 247, 255 (Bankr. S.D.N.Y. 2005) (“while disagreement exists, … the transmission of a privileged communication through unencrypted e-mail does not, without more, destroy the privilege”); ABA Formal Ethics Op. 99-413 (transmission of privileged or protected information by e-mail does not violate a lawyer’s obligation to preserve client confidences); Delaware State Bar Ass’n Ethics Op. 2001-02 (absent extraordinary circumstances, transmission of privileged or protected information by e-mail or cell phone did not violate a lawyer’s ethical obligation to preserve client confidences).

As comment c to § 71 of the Restatement (Third) of the Law Governing Lawyers (2000), notes, “[c]onfidentiality is a practical requirement” for purposes of the attorney-client privilege, and “[t]he privilege applies if the communicating person has taken reasonable precautions in the circumstances.” Here, “practical[ities]” should dictate that the risk of interception does not create a waiver because (1) the threat is a government surveillance program that, according to the Newman complaint, sweeps up huge volumes of communications and presents a fairly minimal risk that any given communication will be read by someone in the intelligence community; and (2) there do not seem to be “reasonable precautions” one could take to reduce or eliminate the threat short of not communicating.

The Fourth Amendment

With respect to the Fourth Amendment claims, an area well outside my normal practice, the claims raised in Newman are not new. A similar challenge to the NSA surveillance program that appears to be at issue in Newman – the “Terrorist Surveillance Program” or TSP – initially was successful in ACLU v. NSA, 438 F. Supp. 2d 754 (E.D. Mich. 2006). There, the district court found that (1) the ACLU had standing to challenge TSP; (2) the Fourth Amendment “requires prior warrants for any reasonable search,” 438 F. Supp. 2d at 771; and (3) enjoined warrantless TSP wiretaps.

On appeal, the Sixth Circuit first stayed the injunction and then, in a 2-1 ruling, vacated and remanded. ACLU v. NSA, 467 F.3d 590 (6th Cir. 2006) (entering stay pending appeal); ACLU v. NSA, 493 F.3d 644 (6th Cir. 2007), vacating and remanding 438 F. Supp. 2d 754 (E.D. Mich. 2006), cert. denied, 112 S. Ct. 1334 (2008). While the dissenting judge would have affirmed because, in his view, the TSP’s warrantless searches violated both the Foreign Intelligence Surveillance Act or FISA, 50 U.S.C. § 1801, et seq., and Title III of the Omnibus Crime Control and Safe Streets Act, 18 U.S.C. §§ 2510-22, the majority found that the plaintiffs lacked standing. ACLU, 493 F.3d at 713 (Gilman, J., dissenting); id. at 657 (majority opinion).

But more importantly for present purposes, the government represented in that appeal that, as of early 2007, the TSP had been altered to conform to FISA’s warrant requirements. 493 F.3d at 651 n.4. Specifically, then-Attorney General Alberto Gonzales stated that, following a January 10, 2007 Foreign Intelligence Surveillance Court order authorizing the government to target communications where there is probable cause to believe that one party is affiliated with al Qaeda, future TSP electronic surveillance would “‘be conduct[ed] subject to the approval of the Foreign Intelligence Surveillance Court.’” Id. (quoting Jan. 17, 2007 letter from Attorney General Gonzales).

If TSP now operates subject to FISA’s requirements as the government represented, claims that the NSA is conducting warrantless searches of international communications based on descriptions of TSP as it existed before 2007 seemingly would lack merit. Thus, Newman may be much ado about very little.