Friday, May 30, 2008

A Bad Idea Whose Time Has Passed

About a month ago, we posted about a really bad idea - legislative abolition of the learned intermediary rule - that had surfaced in California. We've just been informed by a regular reader from the state (you know who you are) that this bill was defeated yesterday. Here's what we've been told (the text reads like something an industry-side lobbyist would write):
AB 2690 (Krekorian), which sought to legislatively repeal the learned intermediary defense failed to pass the Assembly last night. The trial attorneys worked the bill on the Assembly Floor until the end but could not garner the necessary votes for passage.

The bill was lobbied as an anti-marketing bill by the trial attorneys but our arguments showed the bill for what it really was: an attempt by the trial attorneys to directly sue pharmaceutical companies. Because of California’s MICRA (Medical Injury Compensation Reform Act) which limits non-economic damages to $250K for medical malpractice suits, many legislators viewed the learned intermediary legislation as a way for attorneys to duck around MICRA and therefore make more money off of the health care system.

Hopefully this failure will help prevent the trial attorneys from introducing this legislation in other states.

FDA Proposed Pregnancy/Lactation Rule Discusses Preemption

The other day the FDA proposed a rule to revise those aspects of drug labeling dealing with pregnancy and childbirth. The FDA Law Blog has a good description of the proposed changes. The FDA proposal itself is at 73 Fed. Reg. 30831 (FDA May 29, 2008). We were, however, most interested in whether the proposed rule contained anything about preemption, since it amends the Physician Labeling Rule that produced the 2006 Preemption Preamble.

As it turns out, this latest proposal does have something - not a great deal - to say on the subject of preemption, and it's supportive of the defense position:

In this proposed rule, FDA is proposing to revise its existing requirements concerning the format and content of the ‘‘Pregnancy,’’ ‘‘Labor and delivery,’’ and ‘‘Nursing mothers’’ subsections of labeling for human prescription drug and biological products. To the extent that a State requires labeling that conflicts with these requirements, the State required labeling would be subject to implied conflict preemption. ... [T]his proposed rule would amend portions of FDA’s regulations that were recently revised by the PLR [Physician Labeling Rule]. When FDA finalized the PLR, the agency responded to ... [s]everal comments on the proposed PLR had raised concerns about State requirements on drug labeling, often as a result of product liability lawsuits, that conflict with federal requirements. As a result of those comments, and in discussing federalism issues, FDA restated its longstanding views on preemption. For further discussion of this issue, see 71 FR 3922 at 3933 through 3936 and 3967 through 3969. FDA’s statements in this regard are applicable to this proposed rule as well, and reflect the agency’s current position on this issue.

73 Fed. Reg. at 30861-62 (emphasis added).

The FDA thus states: (1) the pregnancy changes are intended to preempt any conflicting state law tort claims; (2) the Preemption Preamble "restates" a "longstanding" FDA position on preemption; and (3) the Preamble, continues to "reflect" FDA's "current position" on preemption.

Thursday, May 29, 2008

First Impressions of the Defense Position - Wyeth v. Levine

We posted Wyeth’s principal brief in Wyeth v. Levine as soon as we got it to ensure our readers’ “first on the web” priority (much like we did with today’s Vioxx decisions). That was a “sight unseen” post, something we don’t generally like doing. We’d much rather give you our take on things – we figure that’s why most of our visitors come here in the first place, since they can get pure “news” elsewhere – but sometimes things can’t be helped.

Anyway, that was then; this is now. Now we’ve read it. We’re impressed with the job Wyeth's brief does defending the preemption principle in a critical case. And we still think, like we did before, that the case itself is an excellent bridgehead for establishing the $64,000 question - preemption, or not - in the prescription drug product liability field.

We won’t rehash our prior post, where we discussed the favorable facts of Levine in depth, but we want to emphasize one key point – this isn’t just a failure to warn case, this is a failure to contraindicate case.

That makes a big difference, and it makes the preemption argument all the much stronger than it would be in “just” a warning case.

The plaintiff’s position in Levine is not that the warning of the risk (gangrene and amputation) of the use (intravenous (“IV”) injection) wasn’t explicit or detailed enough. No, her position is much more extreme. That position is that nobody should be allowed to use this drug for this FDA-approved purpose – ever. The plaintiff argued at trial, quite explicitly, that the FDA goofed:

Dr. Harold Green, another of respondent’s witnesses, also criticized FDA’s approval of Phenergan’s labeling, testifying that, in his opinion, “somebody at the FDA made an administrative error and approved it.” JA 82. In his view, the drug should not have been approved for intravenous administration. JA 79-80. Respondent’s FDA expert similarly “disagree[d] with FDA’s conclusions” to approve Phenergan’s labeling. JA 98. . . . During closing arguments, respondent’s counsel. . .invited the jury to override FDA’s labeling approval decision: “Thank God we don’t rely on the FDA to. . .make the safe[ty] decision. You will make the decision.” Id. “The FDA doesn’t make the decision, you do.” JA 212.

Wyeth Pr. Br. at 22-23. That’s some heavy-duty FDA-bashing. It’s facts like this that make the defense preemption argument much easier than it might otherwise be. That’s what we want in what has become the industry’s “point of the spear” case.

The alternative argument, of course, is that facts like this make anything the Supreme Court might say distinguishable. We don’t think the distinctions are all that great in terms of whether there should be preemption or not, but no matter. We’ll happily litigate any claimed distinctions once we get the core proposition – that FDA labeling decisions preempt state product liability claims – established.

That the plaintiff in Levine explicitly made (and was allowed to make) the John C. Calhoun argument that a jury applying state law can nullify supreme federal law just makes our side’s “Job 1” that much easier.

How much easier?

Well, it’s not every preemption brief that can start off with an “impossibility,” rather than an “obstacle,” argument in the lead position. Wyeth’s brief does. See Wyeth Pr. Br. at pp. 29-40.

Whoa, whoa, whoa…. Slow down guys. Cool it with the inside baseball jargon already.

OK, what we’re talking about here is that there are two main flavors of implied (that is, not by virtue of statutory language) conflict preemption: The first kind arises when, in the words of innumerable (that means so many that we won’t bother with citations) Supreme Court decisions, “compliance with both federal and state regulations is a physical impossibility.” That’s yes/no or can/can’t preemption. The feds say one thing and the state says something else, and doing one means you can’t do the other. It’s the best kind of conflict preemption to assert because the conflict is both easily apparent and complete.

It’s what happens when counsel, in closing arguments, tells the jury that they should give the FDA the old Bronx cheer.

The second form of preemption occurs, in the words of equally numerous Supreme Court decisions, “when state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” That’s “obstacle” preemption. It’s broader, but does not involve as palpable a degree of conflict. It’s also the type of implied preemption most commonly invoked in product liability cases.

Does impossibility work in Levine? Well, the FDA, after evaluating IV injection of Phenergan, approved the drug for that use – not once but several times. It approved labeling including that use and addressing the risks at issue in Levine. As Wyeth points out in its brief, FDA approval is “conditioned upon” the manufacturer using the labeling approved by the FDA “exactly as directed” by the Agency. Br. at 30 (quoting 21 C.F.R. §314.105(b)). The plaintiff’s verdict is based upon the theory that the FDA approved use should be contraindicated – that is, never allowed under any circumstances.

It’s rather difficult to comply with “yes, you must” and “no, you can’t” at the same time. So we’d say the impossibility argument works pretty well. But we’re biased, of course. That, and the opposing argument would seem to have a hard time passing the red face test.

Unless “yes” can be interpreted as “maybe.”

Which brings us to all plaintiffs’ favorite toy in preemption cases – the “changes being effected” (“CBE”) regulation, §314.70(c)(6)(iii), that allows manufacturers to make certain changes to their warnings without prior FDA approval. Just what those changes are is one of the key issues in the Levine case. The Vermont Supreme Court held that anything that arguably “strengthens” a warning is permitted by the CBE regulation, even if the information has been known for decades and already brought to the FDA’s attention. Wyeth argues for a narrower interpretation, that to qualify for this exception to prior FDA labeling approval the information must be something that’s “new.” Wyeth Pr. Br. at 31-32.

The argument that the CBE exception can’t be expanded so far that it swallows the ostensible rule requiring prior FDA approval of labeling is a strong one. As we’ve discussed before, all of the regulatory history supports limiting the exception to novel information that the FDA has not previously had occasion to review. The Agency itself not only supports this interpretation, but is in the midst of rulemaking that would bring the regulation’s language into line with longstanding regulatory intent. See 73 Fed. Reg. 2848 (FDA Jan. 16, 2008). As we pointed out at the time, the effect of this regulatory change would take the plaintiffs’ favorite toy away from them. In Levine, plaintiff’s reading of the CBE regulation would put manufacturers under a state-law duty to change FDA-approved labels unilaterally, even if the Agency’s approval had rejected that change and no new facts had arisen in the interim. Wyeth, of course, makes all of these points in its brief. Br. at 34-40. Not only that, but Wyeth did a lot more digging in the Federal Register than we did, in our post, so we highly recommend this part of the brief to anyone confronted with a similar CBE-based anti-preemption argument.

Anyway, Wyeth has an additional arrow in its quiver – the Supreme Court’s holding earlier this year in Riegel v. Medtronic, Inc., rejecting the contention that manufacturers had broad discretion to make unilateral post-approval changes to FDA approved devices. 128 S. Ct. 999, 1007 (2008) (“the FDA requires a device that has received premarket approval to be made with almost no deviations from the specifications in its approval application”). That same quote was point number two in our own long Riegel post, a point that Wyeth drives home in its brief:

In Riegel, the Court held that once a Class III medical device receives premarket approval, the FDCA (as amended by the Medical Device Amendments of 1976 (MDA)) forbids the manufacturer to make any change without FDA permission, including a change to the approved labeling, that would “affect safety or effectiveness.” Id. at 1005. Any change must be submitted by supplemental application for FDA approval before implementation. Id. The Court thus held that FDA’s detailed, individualized review of the safety and effectiveness of each Class III medical device imposed a federal-law “requirement” that approved devices be made “with almost no deviations from the specifications in its approval application,” and preempted conflicting state-law requirements applicable to the device. Id. at 1006-1007.

Wyeth Pr. Br. at 31. After all, as Wyeth points out, medical devices are governed by a substantively identical CBE regulation. Id. at 32. See also id. at n.13 (describing how the medical device approval process – found preemptive in Riegel – was generally modeled after the approval process for prescription drugs).

In our own Riegel post, we called the kind of Riegel-based arguments that we’re seeing in Wyeth’s brief “spillover effects.” There’s another one on page 33 – Wyeth’s argument that “[n]o less than a state statute or regulation, this common-law claim is preempted if it imposed a duty that conflicts with federal law.” The first case cited, once again, is Riegel, for its holding that “common-law liability is premised on the existence of a legal duty, and a tort judgment therefore establishes that the defendant has violated a state-law obligation.” 129 S. Ct. at 1008.

After finishing with its preemption by impossibility argument, Wyeth goes on to make the more conventional preemption by obstruction argument that prevailed in Geier v. American Honda Motor Co., 529 U.S. 861 (2000), and Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001) – and that we’ve seen be so successful in, inter alia, the SSRI warning cases. See Wyeth Pr. Br. at 40-51. This part of Wyeth’s brief makes the argument – now indelibly connected with Riegel (see the block quote in our post on that case), that allowing juries to disregard FDA drug approval decisions, puts such determinations in the hands of a legal system inherently incapable of properly balancing the benefits that drugs offer to society at large:

Vermont, by contrast, seeks to alter that balance by substituting the judgment of lay juries that focus on individual patients’ injuries on a case-by-case basis, effectively disregarding the countervailing benefits of the drug to the public as a whole. See Riegel, 128 S. Ct. at 1008. The Vermont judgment thus frustrates both Congress’s objective of having an expert agency serve as the ultimate regulator of the labeled conditions of use for which a drug is approved and FDA’s specific fulfillment of that objective.

Wyeth Pr. Br. at 40; see id. at 46. “The determination whether a drug is generally recognized as safe and effective. . .necessarily implicates complex chemical and pharmacological considerations” and is “peculiarly suited to initial determination by the FDA.” Id. at 43 (quoting Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645, 653-654 (1973)).

Following a lengthy discussion (which we will leave to our readers, since it’s case specific) of everything the FDA did to evaluate the IV administration of Phenergan, Wyeth Pr. Br. at 43-44, the defense argument takes on frontally the lower court’s FDA as “minimum standards” rationale.

The regulatory scheme that Congress established in the FDCA and that FDA implemented in the specific case of Phenergan serves competing goals: to protect the public from unreasonable risk of harm, while ensuring the availability of beneficial treatments, all of which carry a certain degree of risk. And an approved drug’s labeling must provide sufficient instructions for safe and effective use, while avoiding limitations that foreclose beneficial use of a drug in an effort to avoid all risk of human error. For these reasons, as the United States has explained, “FDA interprets the [FDCA] to establish both a “floor” and a “ceiling”’ with respect to drug labeling,” and “FDA’s approval of labeling for a new drug reflects FDA’s expert judgment that the labeling strikes the appropriate balance.”
Wyeth Pr. Br. at 45 (quoting 2007 amicus brief of the United States in support of granting certiorari; other citations and quotation marks omitted). The FDA’s administrative balancing of competing objectives is thus equivalent to the kind of administrative process that supported preemption of no-airbag claims in Geier. Wyeth Pr. Br. at 47-48.

The final portion of Wyeth’s brief deals with an otherwise rather obscure (sufficiently so that we’ve only just touched on it before here and here) point about an uncodified preemption/savings clause (§202 of the bill) dating from the 1962 Amendments to the FDCA. It’s more important in Levine because the lower court held that the “direct and positive conflict” language in that section somehow eliminated the aforementioned “obstacle” form of implied conflict preemption.

In a couple of pages (pp. 52-54), Wyeth slices, dices, and purées that argument: (1) citing precedent (Geier) holding the express and implied preemption work independently; (2) demonstrating that the “direct and positive” language is simply a phrase the Supreme Court has used to describe conflict preemption generally (although there are more recent cases for this proposition – see Swift & Co. v. Wickham, 382 U.S. 111, 132 & n.3 (1965); Farmers Educational and Coop Union v. WDAY, 360 U.S. 525, 540-41 (1959)); and (3) establishing that all this language was intended to accomplish was to prevent any claim of preemption of the field.

Whew! We finally reached the end of it.

Anyway, it’s obvious to us that Wyeth has done the entire industry a favor while carrying the flag for our side in the Levine matter. We’re crossing our fingers in hopes that good facts, combined with good arguments (and good lawyering), will produce good law.

More Breaking Vioxx News - Ernst Vioxx Verdict Reversed

Again, Herrmann's out of pocket and Bexis can't comment substantively because of his Vioxx involvement, but the 14th Texas Court of Appeals has just reversed the $253 million verdict against Merck in the Ernst case. Here's a copy of the opinion. Reversal is on the basis of lack of valid causation expert testimony. Judgment n.o.v. is entered for Merck.

Cona/McDarby - Split Vioxx Appellate Decision

This goes into the "breaking news" category. The New Jersey Appellate Division has rendered a split decision in the Cona/McDarby Vioxx appeal. A copy of the opinion is here. Bexis is involved in the case and thus conflicted out from saying anything substantive. Herrmann hasn't read it yet. In a nutshell, compensatory liabilty for failure to warn was affirmed against defense arguments based upon preemption, the NJ statutory presumption stemming from FDA approval, causation, and a variety of evidentiary and jury instruction points. Punitive damages were overturned based upon Buckman preemption. Damages - and, more importantly millions of dollars in attorneys fees, under the NJ Consumer Fraud Act - were overturned because the CFA was subsumed by the New Jersey Product Liability Act in product liability cases.

Wednesday, May 28, 2008

Curmudgeon to Lawyer2Lawyer

One half of your dynamic blogging duo taped a podcast yesterday for the weekly Internet radio show Lawyer2Lawyer (Coast to Coast) on the Legal Talk Network.

(Blogging? Podcasting? What's next? We'd be tempted to figure out what this Twitter stuff is all about, but we're afraid we'd bore ourselves to tears answering the required question.)

Lawyer2Lawyer is co-hosted by Robert Ambrogi and J. Craig Williams (both bloggers of some renown), and this week's program focused on "Books for Attorneys." Craig spoke about his forthcoming book, How To Get Sued, and Herrmann spoke about The Curmudgeon's Guide to Practicing Law.

The show runs about 30 minutes. For those who are interested, here's a link.

Small, But Nice

Good things can come in small packages.

In Greer v. Medtronic, No. 4;08CV042-P-B, slip op. (N.D. Miss. Apr. 25, 2008), plaintiff pleaded a host of product liability claims against Medtronic relating to an implantable cardiac defibrillator. But the decedent had died on January 22, 2005, and plaintiff didn't file her complaint until February 20, 2008, seemingly a month after the three-year statute of limitations had expired.

Plaintiff insisted that her complaint was timely, because she was not aware of the likely cause of the decedent's death until February 21, 2005, when she received a letter from Medtronic allegedly alerting her to a possible defect in the defibrillator.

A 2005 decision by a federal trial court in Mississippi held that Mississippi's "discovery rule" required a plaintiff to know of both an injury and its possible cause before the statute of limitations would begin to run. See Beck v. Koppers, 2005 WL 2715910 (N.D. Miss. 2005).

Medtronic asserted that a later Mississippi Supreme Court case, PPG Architectural Finishes v. Lowery, 909 So.2d 47 (Miss. 2005), focused on knowledge of only the injury itself, not its cause, and thus implicitly limited the discovery rule.

In Greer, the court rejected the gist of Medtronic's argument, but nonetheless ruled in the company's favor. (If you've gotta lose, that's the way to do it.)

The court held that, after Lowery, plaintiffs must still be aware of both the injury and its possible cause for the statute of limitations to begin to run.

But, said the court, in a case pleading wrongful death caused by the alleged failure of a defibrillator, the death itself put plaintiff on notice of the injury's possible cause. Plaintiff knew the decedent "died from heart failure on January 22, 2005. At that moment, with the exercise of reasonable diligence, she could have discovered that she probably had an actionable injury or knew or reasonably should have known that some negligent conduct had occurred." Greer, slip op. at 6. The statute of limitations thus began to run on the date of death and expired three years later.

In cases of wrongful death, or where an implant breaks, or in other situations where the alleged injury and its possible cause are related, defendants shouldn't be shy to assert that the discovery rule will not result in additional time within which to file a complaint.

Wyeth's Principal Brief in Levine Filed

Last night Wyeth filed its Principal Brief in the much-watched (but if you're reading this, you know that) Wyeth v. Levine preemption appeal in the Supreme Court. Here's a link to a copy. We'll have more to say once we've read it.

Tuesday, May 27, 2008

A Race in Which We Have No Horse

Usually, we comment on stuff that affects us.

That's way too limiting.

Today, we're going to comment on something that doesn't affect us at all.

Here's the spat, which we both observed last week at the annual meeting of the American Law Institute: Historically, the decision whether to settle a lawsuit has been reserved exclusively to the client. It's not the lawyer's decision, or a co-plaintiff's (or co-defendant's) decision, or anyone else's decision. The client alone decides whether to settle.

That rule can make life tricky in mass tort litigation. Assume the defendant, BigCo . . . . No! Wait! It's our blog, and we refuse to buy into that routine. We're calling the defendant GoodCo. No! HeavenlyCo. That's the ticket -- HeavenlyCo.

Okay -- we have that out of the way.

Our hypothetical plaintiffs' counsel represents 100 plaintiffs. Suppose HeavenlyCo wants to buy global peace -- with all 100 plaintiffs, thus putting the litigation behind it. If only 99 plaintiffs agree to accept the settlement, the one holdout may be able to receive a bigger settlement by threatening to torpedo the whole 100-plaintiff deal. That plaintiff enriches himself or herself simply by being part of a group.

Or suppose HeavenlyCo wants to settle a whole collection of cases with groups of plaintiffs represented by many different counsel. HeavenlyCo wants some protection against plaintiffs' counsel recommending that their clients with crappy cases accept the settlement, but recommending that the clients with strong cases refuse it. If that occurs, the defendant has paid a lot of money to resolve litigation, and the nasty part of the litigation remains outstanding.

It's easier to resolve mass tort litigation if it's possible to negotiate global peace. The rule of ethics that gives each client control over whether to accept a settlement causes the problem of strategic holdouts.

At this point, the smart guys at the American Law Institute enter the room. They propose a draft "Principle of the Law of Aggregate Litigation" that would allow an individual plaintiff to "agree in advance to be bound in a proposed settlement by the collective decisionmaking of a substantial majority of the claimants represented by one lawyer or group of lawyers who are covered by the proposed settlement." Principles of the Law of Aggregate Litigation (Tentative Draft No. 1) at Sec. 3.17(b).

Voila! No more strategic holdouts or inability to negotiate global peace. So long as a proposed deal is acceptable to a supermajority of the clients of one lawyer, all of the clients are bound.

Here's an illustration:

A plaintiff claims to have been hurt by HeavenlyCo's product. Let's call it . . . AngelStuff. We like that -- AngelStuff.

A plaintiff's lawyer has already signed up 99 other AngelStuff plaintiffs. This new plaintiff comes in and is asked to sign a retention agreement that says, for example, "HeavenlyCo and plaintiffs' counsel may find it mutually beneficial to settle all of counsel's AngelStuff claims at the same time. In that situation, so long as 75% of counsel's AngelStuff clients vote in favor of accepting the settlement, then you agree that you will be bound by that 75% vote and will settle your case on the proposed terms."

Nifty, no?

Maybe not.

A bunch of folks at the ALI raised a ruckus, saying that (1) all extant ethics rules require that the client, not the lawyer, decide whether to accept a settlement, (2) other ALI projects (such as the Law Governing Lawyers) are generally designed to protect clients, not to shift power in favor of lawyers, (3) unsophisticated clients will never fully understand, when they're at the beginning of a case and just hiring a lawyer, the true implications of what they're signing, yada, yada, yada.

The Reporters of this project respond: (1) Clients often benefit by being represented by a plaintiffs' lawyer who controls a large inventory of cases. That lawyer may obtain a better settlement for the group of cases than a lawyer representing just one client would obtain. (2) This new rule leaves the decision whether to settle in the hand of the clients, not the lawyer. It is expressly a supermajority of the clients, not the lawyer, who decide whether to accept a settlement. (3) The proposed new rule has many protections built in (which it does) to protect clients' rights. (4) Clients are allowed to waive things like the right to a jury trial and other constitutional rights. Surely clients can waive individual control over whether to accept a settlement offer. Anti-yada, anti-yada, anti-yada.

We basically have no horse in this race. We represent defendants, so we don't often meddle with the rights of plaintiffs when they're retaining counsel. We have an academic (and ehtical) interest in the relationship between plaintiffs and their counsel, but it's not really our turf.

Defense lawyers are of two minds as to whether they want it to be easier (or possible at all) to settle mass tort litigation. Some defense lawyers say they want it to be easier to settle these cases -- they're going to be filed; there should be a way to end them.

Other defense lawyers say that if the cases couldn't be settled, maybe fewer of them would be filed.

We won't take sides on that.

But we did have a couple of reactions to the ALI debate: First, the Reporters' suggestion that the ALI proposal leaves the decision whether to settle in the hands of the clients is hokum. Clever, elegant hokum, but hokum nonetheless.

When a plaintiffs' lawyer wants to agree to a settlement, that lawyer will surely be able to convince the vast majority of his or her clients to accept the settlement. The lawyer, after all, understands the law, is an authority figure, is the client's route to recovery, and holds all the cards. The client in a mass tort is some guy off the street who says that AngelStuff gave him a bad cough. You can say that the ALI provisions leave the decision in the hands of the clients, but you're fooling yourself. As a practical matter, it just ain't so.

Second, the clients are, in fact, very unlikely to understand the implications of the retention agreement they'll be offered under the ALI proposal. It's true that clients are permitted to waive a right to jury trial -- but when they make that decision, they're being advised by a lawyer who doesn't have an inherent conflict of interest. When clients are being asked by counsel to sign the new-form retention agreement, the lawyer wants the client to sign and so is not exactly a neutral adviser.

You could fix that by insisting that clients retain separate counsel to advise them whether to sign the retention agreement. But that solution makes the legal environment awfully expensive and complicated.

Finally, the question really isn't whether the new ALI proposal is perfect. The question is whether the new ALI proposal is better than what currently happens when mass torts are being settled. And we suspect, but we don't know, that there may be some pretty coercive stuff going on under current law when plaintiffs' counsel are trying to bring their strategic holdout clients into line. The ALI proposal may not be perfect, but it may well be better than the current reality.

Ultimately, the ALI did not vote on this provision, but rather approved certain other sections of the Principles and chose to defer consideration of this provision until next year.

That's not a bad solution. It'll give us time to make up our minds how to vote.

Friday, May 23, 2008

Reasonable Degree Of Certainty - Pennsylvania Stands Firm

We've blogged before about our objections to the ALI's propsal to do away with "reasonable degree of [fill in the blank] certainty" and replace it with the just "more likely than not" standard for deciding liability. We got into some vigorous debates with other legal bloggers about this issue, but we got run over by a train when we raised these objections before the ALI itself. ALI's train had already left the station.

Anyway, we're happy to report that at least Bexis' home state of Pennsylvania does not appear to be backing down one iota from its position that experts are supposed to express opinions to more certainty than the probverbial coin flip.

Earlier this week - ironically on the first day of this year's annual meeting of the ALI - Pennsylvania's intermediate appellate court decided Griffin v. University of Pittsburgh Medical Center-Braddock Hospital, ___ A.2d ___, 2008 WL 2081527 (Pa. Super. May 19, 2008). The court reaffirmed that the "reasonable degree of medical certainty" standard could not be satisfied with mere coin-flip, more likely than not testimony - even if the expert also uses "magic words."

What happened in Griffin, is that a medical expert, after reciting that his opinions were held "to a reasonable degree of medical certainty," proceeded to reduce that standard to mere 51%. Griffin was a medmal case involving an in-hospital injury, a dislocated/broken shoulder. The issue was whether that injury was caused by the patient being physically restrained (which could have been due to malpractice), or whether it was caused by a grand mal seizure (which could not have been due to malpractice).

In Pennsylvania, like many (perhaps most) states, an expert opinion selecting between these two asserted causes must be stated to a "reasonable degree of medical certainty." Well, after duly reciting the necessary magic words, the plaintiff's expert dumbed it right down to more likely than not (51%):
Q. Am I correct, Dr. Speer, that you are unable to state, with reasonable medical certainty, whether Ms. Griffin's injury was caused by a seizure versus forcible restraint?

A. My answer to your question is not as-as simple as I would like for it to be. I think the two possibilities that could have created her shoulder injury [sic]. One of the two occurred. Unfortunately, there's a void of evidence or a lack of documentation to support either. I think that from a reasonable degree of medical certainty, that is choosing one or the other, a fifty-one to forty-nine percent consideration, I think that the least implausible consideration would be the-that she was restrained and had-her shoulder was injured in her attempts to be restrained because she was resisting that.

Q. So you're giving that the fifty-one percent?

A. I am, yes, sir.

2008 WL 2081527, at *5 (emphasis added).

The trial court let the plaintiff's expert get away with this. There was a plaintiff's verdict, and on appeal the plaintiff claimed that form - the magic words - should control over substance. If the plaintiff had succeeded, in effect the ALI rule would have become Pennsylvania law, because "reasonable degree of medical certainty" would have become, in practice, 51%.

The court, however, was having none of it:
In the instant case, despite [plaintiff's expert's] use of any so-called “magic words,” the substance and totality of his testimony did not support the proposition, to the legally requisite degree of certainty, that forcible restraint caused [plaintiff's] shoulder injury. Rather, it appears that he rendered an opinion, to a “reasonable degree of medical certainty,” that there was a 51% probability that negligent forcible restraint caused the injury over a nearly equal 49% probability that a non-negligent factor, a seizure, caused the injury. This opinion does not equate to an opinion stating to a reasonable degree of medical certainty that negligent forcible restraint caused [plaintiff's] injury.

2008 WL 2081527, at *6 (footnote omitted) (emphasis added). Magic words to not permit an expert to equate "reasonable degree of medical certainty" with "more likely than not" and get away with it. Because expert causation testimony is an essential element of a malpractice case, not only was the verdict reversed, but the defendant received judgment in its favor - an expensive penalty, indeed, for plaintiff playing games with longstanding standards for expert testimony.

Pennsylvania, at least, remains determined to hold professionals to real professional standards, and not to the standards lay jurors use to decide cases.

We agree.

Thursday, May 22, 2008

Twombly Comes To Our Neighborhood

When the Supreme Court decided Bell Atlantic Corp. v. Twombly, 127 S. Ct. 1955 (U.S. 2007), we thought right away that there wasn’t any good argument to limit the Court’s toughened pleading standard to some discrete subset of cases, such as antitrust. We said:

As product liability practitioners, we’re drawn to the Court’s broader ruling that pleadings must actually plead the facts that justify the requested relief – which is something not limited by the legal theory before the Court. The federal rules are the federal rules. There’s not one set of rules for antitrust and another for what we do.
It took a bit of time, but it looks like we were right. Twombly has now come to prescription medical product product liability litigation.

The harbinger is Heck v. American Medical Systems, Inc., 2008 WL 1990710 (D. Md. April 30, 2008), a case that, if it weren’t for Twombly, we wouldn’t have spared a second glance. Heck is basically your garden variety poorly-pleaded product liability case – something we’ve encountered more times than we care to think about. Before Twombly, unless there were extenuating circumstances (that is, if we thought there was some benefit to making opposing counsel do some work that exceeded the cost of preparing a motion) we probably wouldn’t have even bothered filing the motion.

That’s because 99 out of 100 federal courts would have said, “that’s enough, you can find out what they’re really upset about in discovery.” After all, as has been repeated ad nauseum, the federal rules require notice, not fact, pleading.

But in Heck the same sorts of inadequacies, after Twombly, produced an outright dismissal. The case involved the alleged malfunction of a medical device – an implanted “artificial sphincter” – due to an allegedly “defective valve.” 2008 WL 1990710, at *1.

We know what you’re thinking, so stop it. No jokes, please, after all, life can be heck sometimes.

In fact, however, the complaint was a heck of a mess. Specifically, under Twombly, the “complaint failed to put the defendant on notice of the claim(s) [plaintiff] sought to bring … and the reasons he may be entitled to relief.” Id.

What exactly did the plaintiff do (or not do) that ran afoul of Twombly?

Let us count the ways.

In general, the dismissed complaint “failed to articulate in a clear fashion the theories [plaintiff] is asserting and the underlying facts necessary to satisfy the elements of his cause of action(s).” 2008 WL 1990710, at *1. Twombly, however, no longer lets plaintiffs get away with this sort of thing:

Following the Supreme Court’s ruling in Twombly, 127 S.Ct. at 1965, “[f]actual allegations must be enough to raise a right to relief above the speculative level, on the assumption that all the allegations in the complaint are true (even if doubtful in fact).” “Once a claim has been stated adequately, it may be supported by showing any set of facts consistent with the allegations in the complaint.” Id. at 1969. Moreover, the “plaintiff's obligation to provide the ‘grounds' of his ‘entitle[ment] to relief’ requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.” Id. at 1964-65.
2008 WL 1990710, at *2 (non-Twombly citations omitted).

Twombly was violated because the complaint:
  • “state[d] legally operative terms in a conclusory fashion.” Id.
  • “Fail[ed] to articulate the theory being pursued, the elements of that theory, and the facts that establish those elements.” Id.
  • “baldly conclude[d]” that the device was “defective.” Id.
  • “baldly conclude[d]” that “the defendant was “negligent” in the manufacture of the device. Id.
  • “baldly conclude[d]” that “the device was ‘warranted as good and in functional condition.’” Id.
  • “baldly conclude[d]” that “the defendant is liable for the defective device that was ‘used without any warning or knowledge’” by the implanting surgeon. Id.
  • merged together “language that could sound in tort, contract, or product liability law.” Id.
These are all no-nos after Twombly (we would have wished they were anyway), because “a viable complaint must offer more than these unsubstantiated ‘labels and conclusions.’” 2008 WL 1990710, at *2 (again quoting Twombly).

The plaintiff didn’t do himself any favors in his response to the motion to dismiss either. Despite all the mixed up language in the complaint, he argued that the suit was for “strict liability only.” Id. But the complaint didn’t contain facts that would support the elements of strict liability cause of action under the relevant state’s (Maryland) law. The complaint “failed to articulate a clear strict liability theory” because:
  • It did “not identify how [the device] was defective.” Id. at *3. All the complaint included was “vague language” that did not specify whether there was a warning, design, or manufacturing defect. Id.
  • The complaint contained language that tended to defeat the strict liability element of defect at sale. Id. (stating, instead, that “the product was activated several times by the surgeon, after it was implanted, ‘with resulting proper action’”).
  • There were no facts “suggest[ing] that [the product] was unreasonably dangerous.” Id.
  • The complaint ignored the strict liability element that the product reached plaintiff “without substantial change in its condition.” Id.
  • The plaintiff did not allege enough facts – only an “unsubstantiated legal conclusion” – to support the allegation of defect. Id. (plaintiff’s “only evidence” was an affidavit from his physician,” but the affidavit “simply concludes that the valve in the device was ‘defective’”).
The Heck court goes on to discuss, “for the sake of completeness” similar deficiencies in the plaintiff’s pleading of both negligence and warranty causes of action. Id. We won’t bore you with those because the deficiencies are more of the same – either not pleading elements or doing so in conclusory, unsupported fashion.

Heck is the first prescription drug or medical device product liability case that we’ve seen applying Twombly to allegations of the usual theories we see in that kind of litigation (let alone less common theories). What we take away from is that Twombly can have some real teeth. It requires (at least according to Heck): (1) both the type of defect (warning, design, manufacturing) and the specific nature of the defect must be alleged in a strict liability complaint; (2) all essential elements of a cause of action must be pleaded; (3) all the essential elements must be supported by enough facts to “suggest” a plausible case; (4) pleading facts that tend to defeat an essential element is fatal; and (5) a conclusory supporting affidavit is no better than a conclusory allegation in the complaint itself.

We don’t think it should be all that hard for a plaintiff with a real claim to satisfy these rather basic pleading requirements, but they may require at least some movement away from cookie-cutter, word processor complaints that don’t tell the other side anything substantive about the claim other than the type of product that’s involved.

We also note the suggestion in Heck, 2008 WL 1990710, at *3, that the plaintiff may have lost the device in question. That may well have contributed to the result – at least the court seemed to think so.

It remains to be seen how Twombly will affect more sophisticated mass litigation that includes that same sort of conspiracy and similar allegations that were actually before the Supreme Court, but at least we’ve had a demonstration of how tougher pleading requirements can be useful in eliminating one-off cases like Heck, especially when ambiguous pleadings are being employed to try to keep a deficient claim afloat for what looks like its nuisance value.
It’s a start. We hope it’s not a finish.

Wednesday, May 21, 2008

CAFA Intrigue (Pew v. Cardarelli)

This post will completely miss the point.

(Yeah, yeah: So how does that distinguish this post from all the rest of 'em?)

In Pew v. Cardarelli, No. 06-5703-mv, slip op. (2d Cir. May 13, 2008) (here's a link through the Second Circuit website), plaintiffs alleged that officers of an issuer failed to disclose, while marketing debt securities, that the issuer was insolvent. That sounds like a securities case, but the plaintiffs pleaded only claims under New York's consumer fraud statute, presumably to keep the case out of federal court.

As you well know, we don't do that securities stuff on this blog. (We have a running dispute over whether "10b-5" is spelled with a "b" as in "boy" or a "d" as in "dog.") We're not gonna break with tradition and start now.

Instead, we're going to focus on the CAFA aspects of Pew.

The Class Action Fairness Act of 2005 expanded federal diversity jurisdiction in several ways to permit cases of national importance to be heard in federal courts.

After a defendant removes a case under CAFA, a federal trial court may decide to remand the case to state court. Federal trial court remand orders are generally not reviewable "on appeal or otherwise." 28 U.S.C. Sec. 1447(d). CAFA, however, created an exception to that prohibition on review for cases removed under CAFA. CAFA authorized federal appellate courts to "accept an appeal from an order of a district court granting or denying a motion to remand a class action to the State court from which it was removed." 28 U.S.C. Sec. 1453(c)(1).

That left open several procedural issues.

First, for decades before CAFA was enacted, defendants had battled to obtain appellate review of remand orders. The Supreme Court opened the door to occasional appellate review in Thermtron Products, Inc. v. Hermansdorfer, 423 U.S. 336 (1976). But Thermtron left it awfully hard to tell what cases were reviewable by what appellate process. See generally Mark Herrmann, "Thermtron Revisited: When and How Federal Trial Court Remand Orders are Reviewable," 18 Ariz. St. L.J. 395 (1987). Moreover, some courts held that a defendant was required to obtain a stay of the remand order from the federal trial court, on the theory that the trial court lost jurisdiction when it mailed the remand order to state court -- and the federal appellate court at that same instant lost the ability to hear an appeal.

Mercifully, Pew says that a defendant is not required to seek a stay before taking an appeal under CAFA. Pew, slip op. at 8. For practitioners, that's a good result; it means that you don't have to remember to seek a stay before filing a petition for leave to appeal from a CAFA remand order.

(We're not sure that's as good a result for purists or legal scholars. If a federal trial court does, in fact, divest the federal court system of jurisdiction at the instant it mails its remand order, then appellate courts should lack jurisdiction to hear all appeals -- including those under CAFA -- after the remand order is dispatched.)

That jurisdictional stuff is way too theoretical for us. We just like to know what piece of paper to file and where. Pew answers that question, so we're happy -- don't bother seeking a stay in the trial court (at least in the Second Circuit).

We're less happy about a different procedural aspect of Pew.

In Pew, the defendant filed a petition for leave to appeal, and the Second Circuit chose to decide both whether to accept the appeal and "the merits of the appeal simultaneously." Id. at 11-12. A court's allowed to do that, of course, but it does make life much harder for those of us toiling out here in the fields.

When we're drafting a petition for leave to appeal under CAFA, what brief should we write? A brief that explains why the appellate issue is important (so the court should agree to hear it)? Or a brief that explains why my client's position is right (so I should win on the merits, if the court does accept the appeal)?

Those are two different issues, and it doesn't always make sense to merge them.

Lawyers can, of course, strike a middle ground -- "this appeal presents an important question for several reasons, and, in addition, here's a small taste of why my client is right." But if the court then simultaneously decides whether to take the appeal and the merits, you've given the court only a small taste of why you're right -- not the four-course meal that you otherwise had planned.

We can live with many different sets of rules.

But we'd sure like to know, ahead of time, what they are.

Courts should make clear whether they will (1) always combine the decision whether to accept an appeal with the merits of CAFA appeals or (2) always separate the two issues, first deciding whether to accept the appeal and then requesting separate briefs on the merits.

Or, if there won't be a bright-line rule, tell us what the gray line will be.

We can live in many environments, but it's only fair to let us know in advance the game that we're supposed to play.

Monday, May 19, 2008

The Limits of MDL Common Benefit Funds

After the MDL Panel coordinates a bunch of product liability cases, the transferee court is likely to appoint lead and liaison counsel for plaintiffs. Those lawyers often take the lead in conducting MDL-wide discovery, and they also "perform functions necessary for the management of the case but not appropriately charged to their clients." Manual for Complex Litigation (Fourth) Sec. 14.125, at 202 (2004).

How are those folks paid for their efforts?

MDL transferee courts often create "common benefit funds." Courts require settling parties to pay a small percentage of the settlement proceeds into that fund, and the fund is then used to reimburse lead and liaison counsel (and possibly others) periodically.

Lots of people don't like those funds, for lots of different reasons. Many plaintiffs' lawyers refer to those common benefit assessments as an "MDL tax" and choose to file their cases in state court, rather than federal, to avoid the MDL and, they hope, to avoid the tax.

The idea is that a federal court has jurisdiction to tax only cases pending before it. A federal court thus lacks power to tax a state court settlement.

Is that right?

MDL transferee courts may believe that the MDL lead and liaison counsel are doing work that benefits all plaintiffs -- state and federal alike -- so even state court settlements should contribute to the common benefit fund. A transferee judge may order, for example, that the settlement tax applies to all state court cases being handled by a plaintiffs' lawyer who has even one case pending in the federal MDL, or to all state court cases being handled by a plaintiffs' lawyer who has signed an agreement to cooperate with the MDL process. That type of order seemingly extends the MDL tax to cases over which the federal court lacks jurisdiction. Is that allowed?

In In re Showa Denko K.K. L-Tryptophan Prods. Liab. Litig. -- II, 953 F.2d 162 (4th Cir. 1992), the MDL transferee court assessed an MDL tax on "actions venued in state courts, untransferred federal cases, and any unfiled claims in which any MDL defendant is a party or payor." Id. at 166. The Fourth Circuit reversed in part, because an MDL transferee court lacks jurisdiction over cases that have not been transferred to it. Showa Denko has since been cited with approval by In re Baycol Prods. Liab. Litig., 2004 WL 1058105 (D. Minn.), and In re Linerboard Antitrust Litig., 292 F. Supp. 2d 644 (E.D. Pa. 2003).

We won't pass judgment on this issue (because, frankly, we have no idea where the bread may be buttered in some later case, so we're forced to be agnostic), but it's worth noting a procedural quirk:

When the MDL court is entering an order to establish a common benefit fund, the court will hear only from the parties before it -- the MDL plaintiffs and MDL defendants. The issue in dispute, however, primarily affects people who are not present in the MDL court -- plaintiffs and their lawyers who have filed cases in state court.

That's an awkward situation for a court, and it thus require special thought.

MDL transferee courts that are asked to create common benefit funds should consider how to protect the rights of lawyers and litigants who are not appearing in the MDL court, but who may be affected by entry of an order creating the fund.

Friday, May 16, 2008

500 Posts!

"Lord, I'm one;
Lord, I'm two;
Lord, I'm three;
Lord, I'm four;
I'm 500" posts away from home.

500 posts.

18 months.

200,000 pageviews.

"No rest for the weary,
ya just move on.
I guess you just keep goin' 'til you're gone.
Tired, Lord I'm tired.
Tired, Lord I'm tired."

Oh, To Be Known By The Company You Keep!

Herrmann's agreed to give a pair of talks at the ALI-ABA Mass Litigation conference that will be held in Charleston, South Carolina, from May 29 to 31, 2008. Here's a link to the conference agenda.

The cast of characters is mighty impressive, as ALI-ABA programs often are. Judges participating in the conference include Hon. Lee Rosenthal, Hon. Barbara Rothstein, and Hon. Shira Scheindlin. Academics include Francis McGovern and Richard Nagareda. Defense lawyers include David Bernick, Sheila Birnbaum, and Barry Ostrager. Plaintiffs' lawyers include Elizabeth Cabraser and Joseph Rice.

And then there's "who's he?," who will speak on Friday morning about the role of the MDL Panel and state counterparts in managing mass litigation and speak again on Saturday afternoon (they can't get enough of him) about punitive damages after Williams. (Heck, we even have a thesis or two about that second topic.)

If you can't attend in person, the program is also available by webcast.

Thursday, May 15, 2008

Off-Label Use - Is The FDA Missing An Opportunity?

As we mentioned last week, we’re both going to be speaking on the same panel at the American Enterprise Institute’s conference next week about off-label use. That’s got us thinking – surprise, surprise – about off-label use.

So we’ve been reading a couple of things. One of them is the Justice Department’s recent amicus brief concerning off-label use and False Claims Act liability. Here’s a link to the brief.

Another thing we’ve been reviewing is some of the comments to the FDA’s proposal to loosen, just a bit, its restrictions on off-label promotion involving medical journal articles and medical textbooks. We blogged about that proposal shortly after it first came out. Now the comment period has closed (no, we didn’t comment – that would have to be paying work) and we were curious about what the interested parties were saying.

You can find and review all 96 comments here. When you click on this link, you’ll get a list of all the comments, and next to them are icons that take you to the comments themselves.

So what do we think? Well, we don’t claim to be experts in False Claims Act (“FCA”) litigation, and while reading the Department of Justice’s brief, we were pinching ourselves to remember that the Department both prosecutes these suits and is responsible for protecting the government’s money. So we can’t say that we’re really very surprised that the government took what to our uninitiated minds seems like a rather broad interpretation of the statute.

But we’re interested primarily in off-label use – and especially in the dissemination of truthful information about such uses, an activity that we believe is First Amendment protected. So we read the government’s brief with an eye towards whether a “false” claim can lie where all of the information that a manufacturer gave out to promote the use is truthful.

A lot of the DOJ's brief is about the off-label uses that the government pays for under certain circumstances. That’s because, for Medicare purposes, there are off-label uses – and then there are off-label uses. The government pays for off-label uses that are “supported” by citations in certain designated (and authoritative) medical compendia. 42 U.S.C. §1396r-8(k)(6). The DOJ goes through an extensive argument about whether the mere presence of a citation in those compendia qualifies as “support,” and if not, how much beyond a “mere” listing is needed to qualify as “support.” We suppose that reasonable minds may differ on that.

More important, to us is the fact that the government pays for some of the very same off-label uses that the FDA is simultaneously prohibiting manufacturers from promoting truthfully. That fact undercuts the constitutional validity of the FDA’s prohibition by putting the Agency at cross purposes with other agencies.

The DOJ’s brief doesn’t address, one way or the other, truthful promotion of off-label uses that are not “supported” by any of these compendia. That’s because the specific case in which it was filed (called Rost) involved an arguably “supported” use.

In its “support” argument, however, the DOJ doesn’t seem to be taking a position, one way or another, about truthful statements about off-label uses. Rather its argument is about whether there could ever be a false claim, because if an off-label use is “supported,” the government is supposed to pay for it, and thus it can’t be “false” (without more) to submit a claim for a “supported” off-label use.

How much more?

Even if an off-label use is “supported” within the meaning of the statute, it can be “false” for other reasons, the DOJ argues. We don’t care about kickbacks, unlicensed doctors, or non-existent patients. Beyond those examples, the government states, “a claim [for a supported off-label use] may be rendered false if a drug manufacturer falsified studies or engaged on other unlawful, fraudulent conduct in the promotion of a drug….” DOJ br. at 7. Well, falsifying studies is certainly not truthful activity, and there is no “or” between “unlawful” and “fraudulent,” so it seems like the government is limiting liability to promotional activity that is not only “unlawful” (such as truthful promotion of off-label use) but also “fraudulent.”

So far, so good.

But that’s as far as anything good goes.

Things then go rapidly downhill. The government asserts:

This court has held that illegal off-label marketing that results in the submission of impermissible claims for reimbursement states a claim under the FCA. … Proof of falsity could entail a showing that the provider sought payment from a federal health care program that was off-label and not covered by the program. It is not necessary also to show (or allege) an express falsehood from the defendant to the provider to satisfy the “falsity” element.

DOJ br. at 8 (emphasis added). Well, are we talking about falsehood or privity here?

The next paragraph starts out OK, “Defendants correctly observe that to state a claim … there must be a false record or statement.” Id. That’s good by itself, but it’s not by itself. After that, the rabbit goes into the hat:

[R]equiring a false statement to be made by the defendant drug company is contrary to the plain meaning of the FCA. Although [the FCA] requires the existence of a false statement, it does not require the false statement to be made by the defendant.

Id. at 8-9 (emphasis original). In other words, a manufacturer’s entirely truthful promotion of off-label use can still subject a manufacturer to liability if somebody else (usually a prescriber) then makes some false statement in connection with a claim. In a footnote, the DOJ clarifies that liability isn’t contingent on any control requirement – the other party’s false statement can occur without any “affirmative” direction by the manufacturer engaged in truthful promotion of off-label use. Id. at 10 n.8.

So, yes, it appears that the DOJ is taking the position that even a manufacturer’s entirely truthful promotion of off-label use is, without anything more on its (as opposed to somebody else’s) part, sufficient to subject it to liability under the FCA.

And there’s more – another footnote indicates that such liability extends even to promotion using medical journal articles and textbooks that the FDA has proposed should be allowed. See DOJ br. at 9-10 n. 7 (pointing out that the FDAMA safe harbor for such promotion has expired and that the FDA’s new guidance is non-binding).

We’ve learned that, with government amicus briefs, it’s very important to read the footnotes.

Thus, truth, apparently, is not a defense to the FCA.

Think about that – under the FCA, truth can be “false.”

Where have we heard that before?

So yes, not only is Big Brother watching, he’s ready and willing to sue.

So why do we care?

We care because, at least since the Supreme Court’s decision in Thompson v. Western States Medical Center, 535 U.S. 357 (2002), it’s been pretty clear that the FDA’s current regime, which relies upon prohibition of truthful speech to control promotion of off-label uses, is vulnerable to First Amendment constitutional challenge. If you’re interested in the detailed argument, it’s all set out here.

Anyway, that’s our premise.

We’re wondering where that challenge might come from and how it might look. We know that most major manufacturers would much rather cooperate with the FDA than raise constitutional challenges to its actions – especially First Amendment challenges that strike very close to the FDA’s institutional purpose (approval of regulated products). After all, FDA regulated manufacturers have to deal with the FDA on a regular basis.

These FCA cases, however, are for big bucks – many millions of dollars – and they can be brought by private individuals, who are statutorily authorized to sue on the government’s behalf. Well then, if: (1) a company’s facing huge potential liability, (2) it’s not litigating against the FDA directly, and (3) the facts about the truthfulness of the promotion are good enough, a direct First Amendment appellate challenge to the FDA’s prohibitory regime could well emerge from this type of litigation.

It’s the second part of this equation – the truthfulness of the promotion – that had us looking through the comments to the FDA’s proposed reprint practices guidance. As we discussed at length in our first post on this subject, the FDA’s proposal is loaded with caveats designed to ensure the truth and validity of the medical journal articles and published medical textbooks that it proposes to allow manufacturers to disseminate about off-label uses.

And, indeed, the extent of those restrictions are the subject of some of the industry’s critiques of the proposal. Generally speaking the industry groups, such as PhARMA, MDMA, and ADVAMED (the site’s not letting us link directly to all, so we’re won’t favor one over the other, you can find them all here), would like to broaden the categories of materials that can be used (right now it’s limited to “adequate and well-controlled clinical investigations”), would like to see the “safe harbor” language less equivocal, and don’t want anything that limits other, existing exceptions or impinges upon the First Amendment protection of truthful commercial and scientific speech.

In the middle are groups like the AMA, Sen. Grassley, and others, who offer varying degrees of support for FDA’s initiative, but urge the Agency to tighten up various aspects of it, such as ghostwriting and oversight.

At the other end are the trial lawyers and various consumer groups, whose comments oppose any change, and mostly consist of examples of what they see as industry overreaching and general misconduct. That’s par for the course for them.

A lot of their complaints, as well, have to do with “ghostwriting” of medical articles. That seems to be their hot topic du jour.

We (not surprisingly) don’t view ghostwriting as at all central to the FDA’s proposal. We’re much more concerned with ensuring the truthfulness of what’s actually written than we are with the identity of who actually puts pen to paper. As long as doctors get accurate information, we’re not going to spend much time on the byline.

We’re lawyers, and in our profession ghostwriting happens every day. Precedent remains precedent, even if most of a judge’s legal opinion was actually written by a law clerk. That’s ghostwriting. Nor are we offended that every word of this or that professor’s law review article isn’t actually penned by the professor, but instead by by law students or other research assistants working under the professor’s guidance. That’s the way things are in the law, and we don’t expect them to be different in medicine or other parts of the academic world.

To us, truth is truth and false is false, no matter who actually writes it.

But to the extent that the FDA thinks that ghostwriting tends to inject difficult to control biases into medical literature, or to obscure the actual source of the information from the reader, we wouldn’t be all that exercised if the Agency either chose to require disclosure of the practice, or even to prohibit it in articles to be disseminated under the proposed guidance.

In the greater scheme of things, ensuring the truthfulness and accuracy of the content of the articles and textbooks themselves is to us far more important than who’s listed or not listed as the author.

What we do see in looking over the comments is a possible lost opportunity for the FDA to use this limited guidance concerning published journal articles and textbooks to provide a “test drive” of a less speech-restrictive – and thus less constitutionally suspect – regime of dealing with off-label promotion.

Complaint #1 – off-label promotion generates too much off-label use that’s totally outside any regulatory control.

OK, then how about requiring some record keeping/monitoring as part of the guidance so that the FDA can see whether that’s true or not, and also use the information to formulate more tailored responses to particular situations? Let’s find out if this is true, and if it is whether there’s anything that should be done about it.

Complaint #2 – off-label promotion reduces the incentive to submit new uses for FDA approval.

That’s probably true, but it doesn’t have to be. Based upon the aforementioned record keeping and monitoring, we doubt it would be that hard for the FDA to come up with some formula (percentage off-label use, or dollar value of off-label use, something else, or some combination) under which it could require some off-label uses subject to the guidance to be submitted for approval by the manufacturer (or manufacturers, if there are generics involved). This leads us to….

Complaint #3 – the kinds of studies that the FDA requires for regulatory approval are just too expensive and time consuming to make any requirement to conduct them worthwhile.

That’s certainly what torpedoed the old FDAMA safe harbor - it wasn’t worth the candle to use it. But remember, the FDA’s proposed guidance is for articles and textbooks already describing “adequate and well controlled studies.” If we’ve got that kind of data at the front end, there’s less need for it at the back end.

There are plenty of cheaper ways than blinded, controlled studies for figuring out whether an off-label use is safe and effective. As Bone Screw veterans, we know that the FDA finally dealt with that product’s off-label use (which had become the medical standard of care, thereby ethically precluding studies that withheld treatment to control groups) by ordering a retrospective study. See 63 Fed. Reg. 40025 (FDA July 27, 1998). The Agency could employ the same administrative flexibility with off-label uses subject to the proposed guidance. After all, these aren’t new drugs, and the off-label uses are taking place anyway. It would seem to make sense to capture this clinical experience for labeling purposes if at all possible.

That kind of regime – allowing truthful speech, but accompanied by non-speech regulations – avoids the First Amendment problems inherent in the FDA’s current regime.

Remember, what’s under consideration (at least at this point) is not off-label promotion generally, but off-label promotion using published, peer reviewed materials, clearly labeled as involving unapproved uses.

After Western States, the likelihood isn’t great that someone complying with the proposed guidance could be constitutionally prosecuted for truthful off-label promotion. Even in the recent Caputo case (discussed here), where the facts were quite bad for the defendants, the court nevertheless gave the government a shot across the bow – warning prosecutors that lumping truthful off-label promotion together with false and fraudulent promotion raised serious constitutional questions. See United States v. Caputo, 517 F.3d 935, 938-40 (7th Cir. 2008).

Thus, even dropping the FDA’s proposed guidance altogether at this point would not prevent some brave soul from following it as a form of constitutionally protected commercial speech.

More fundamentally, we have to believe that one reason for the claimed industry “abuses” described in the comments opposing the FDA’s proposed guidance is the lack of any legal way, at present, to conduct off-label promotion. If the Agency were to provide industry with an avenue for off-label promotion, both legal and practical, that provided physicians with truthful information about off-label use, the industry would be foolish not to use it.

We know this industry – it is not foolish.

Coverage of Yesterday's Preemption Hearing

Point of Law has this report (linking in turn to others) describing some of the action at yesterday's hearing on Capitol Hill about federal preemption of claims against drug and device manufacturers.

Wednesday, May 14, 2008

Huge Texas Vioxx Verdict Reversed

Bexis represents Merck, and Herrmann is on a plane right now, so we can't discuss substance, but the Wall Street Journal has reported that the $32 million Garza Vioxx verdict has been overturned by a Texas appellate court. Here's a link to the opinion for anyone interested.

Video of Today's Preemption Hearing In Congress

We're too busy to watch ourselves (Herrmann's on the road and Bexis is prepping for an appellate argument), but here's a link to what's supposed to be an online video feed of today's congressional hearing on preemption. Drop us a comment if you like once it's over so we'll know what we missed.

According to Pharmalot Congressman Waxman, a long-time plaintiff-side ally and thus preemption opponent has pretty well stacked the deck at this hearing with speakers opposed to preemption. Surprise, surprise. According to Pharmalot, not a single industry representative has been invited to testify.

Tuesday, May 13, 2008

Congressional Hearing on Drug and Device Preemption

The House Committee on Oversight and Government Reform will hold a hearing on Wednesday, May 14, 2008, titled, “Should FDA Drug and Medical Device Regulation Bar State Liability Claims?”

Here's the announcement of the hearing and names of the witnesses scheduled to testify.

The Pythagorean Integrity of the Law

We don't know what that title means; we just wanted to draw some mathematicians to our blog.

Well, no.

Actually, we just read United States v. Endotec, No. 6:06-cv-1281-Orl-18KRS, 2008 U.S. Dist. Lexis 35427 (M.D. Fla. Apr. 30, 2008), and two things about the opinion struck us as noteworthy.

This was an enforcement action brought by the FDA seeking to enjoin Endotec and certain of its officers from selling specified medical devices and seeking disgorgement of amounts that Endotec had been paid.

You can almost feel the tension in this decision as a company struggling to market new medical devices -- ankle, knee, and TMJ implants -- kept banging its head against the FDA's regulations. The company had submitted six 510(k) submissions seeking permission to sell its ankle devices. Those submissions had either been withdrawn by the company or rejected by the FDA. The company obtained an Investigational Device Exemption for one of its ankle devices, but the clinical study of the device had reached full enrollment, so patients could no longer be treated by that route. Surgeons, however, still wanted to implant the devices, and the evidence at trial convinced the court that the devices "provided greater benefits to patients than the alternatives available in the United States." Id. at *35-36.

The company should not sell devices illegally, of course. But you can feel in this decision a medical tension underlying the legal analysis.

Anyway, we'll start with the Pythagorean integrity that we noticed.

(The following discussion is phrased in very general terms. We're painting with a broad brush here, so please don't take the details of what we're saying as Gospel.)

Many judicial decisions explain that the Medical Device Amendments of 1976 required companies to conduct clinical studies of new medical devices before the devices could be sold. Companies finish the studies, submit the results to the FDA, and get approval to sell the products. That's the "premarket approval" process.

As of the date the Medical Device Amendments became law, however, those clinical studies had not yet been done. Conducting those studies would take time, and Congress didn't want to yank all existing medical devices off the market while manufacturers studied the devices for a few years. So Congress permitted devices that were already being sold in 1976 to stay on the market.

That posed a problem of its own: If existing devices stayed on the market and competitive devices had to go through the PMA process, the manufacturers of existing devices would have a temporary monopoly. The existing devices could be sold, but new, similar competitive devices would be gummed up in the PMA process.

To solve that problem, Congress created the premarket notification (or "510(k)") process, which allowed manufacturers to notify the FDA that they intended to sell devices that were "substantially equivalent" to predicate devices that had been on the market before 1976.

Presto! Revolutionary new devices would be judged for safety and efficacy; existing devices would remain on the market; and new devices that were similar to existing devices could also be sold, avoiding the monopoly problem.

That's PMA and 510(k).

A fair number of decisions also discuss the "Investigational Device Exemption" process.

That process allows a manufacturer to distribute medical devices for the purpose of conducting a clinical study to seek premarket approval. (Until the device is approved, the manufacturer can't distribute it. There has to be a way to distribute the device for the purpose of running the clinical study and thus seeking approval.)

Those are the big three: PMA, 510(k), and IDEs.

Decisions less frequently discuss "compassionate use" approval and the "custom device" exemption. Endotec nicely fills that void.

Suppose a device is not yet PMA- or 510(k)-approved for sale. A patient needs the device, but the patient is not (or cannot be) enrolled in a clinical study. How does the law permit the device to be supplied for that patient's benefit?

The manufacturer petitions the FDA for compassionate use approval, and the FDA can then authorize use of the device in a particular patient.

That leaves only one situation unaccounted for: What about medical devices that are unique -- manufactured for one specific patient or for use by one particular physician? To conduct a clinical study of a medical device, you need a bunch of devices that are all basically the same. There's no way to run a clinical study of a device that is custom-designed for one particular person.

The "custom design exemption" addresses that situation. Devices that are tailored for individual use, and so can't be studied in clinical trials, can be sold under the custom device exemption.

That's the first thing we liked about Endotec. It nicely describes the routes for selling devices outside of the standard PMA, 510(k), and IDE routes, and thus lets readers see that the law makes sense: If patients need medical devices, the law theoretically allows manufacturers to provide those devices.

We're not sure if that's precisely "Pythagorean integrity," but it's pretty cool.

Here's the second thing we noticed about Endotec: The court that conducted the bench trial tried to be practical and not to punish people who were trying to do some good.

Endotec didn't have PMA or 510(k) approval for its various devices, and its clinical study for an ankle device was fully enrolled. But physicians were still asking for the devices, and the company was still selling them.

At trial, the FDA insisted that the sales were unauthorized and illegal. Endotec responded that all of the sales were permitted, either as custom sales, compassionate uses, minor modifications of approved devices, authorized under certain interpretations of IDE study protocols -- whatever!

Maybe we're wrong -- we weren't there, and we're reading between the lines here -- but we get the sense that the trial judge leaned over backwards to try to do what was right. The evidence showed that Endotec's devices actually helped patients. The FDA did not allege "that Defendants have harmed any individual by manufacturing or distributing medical devices and has not alleged that any of Defendants' devices are dangerous or that their use poses any risk." Id. at *31. The "Government did not present any evidence to indicate that the ankle devices were potentially dangerous." Id. at *33.

In that situation, the court chose not to throw the book at anyone. The court found that the disputed ankle devices were all custom devices, so Endotec did not break the law. But the court did enjoin Endotec from advertising the devices and noted that the devices could be used by prescription only. The court also instructed Endotec to strictly adhere to the FDA's requirements for monitoring clinical trials.

The court found that Endotec did violate the law by selling its knee devices, and the court enjoined further sale of the devices until Endotec obtained PMA, 510(k), or IDE approval.

Endotec did not violate the law by selling its TMJ devices. Two sales were permissible under the IDE's investigational plan and another TMJ device was a custom device.

Finally, the court denied the government's request for an order of disgorgement -- the monetary sanction.

In addition to lecturing Endotec to be more careful and keep better records, the court also lectured the FDA: "[I]n the field of medical devices, the FDA might ask Congress to revise 21 U.S.C. Secs. 360a-360k to speed up procedures, so that citizens of the United States can benefit sooner from the fast-moving technology of the twenty-first century." Id. at *41.

What does Endotec teach?

First, the law makes sense: As a theoretical matter, the Medical Device Amendments permit devices to be distributed to all patients who need them.

Second, the FDA should be cautious: If it looks as though the Agency is acting too slowly and thus keeping helpful medical devices off the market, courts will be less willing to help the Agency in its enforcement efforts.

Third, manufacturers should be smart: They should obey the law. If they're operating near the edge of the law, they'd better be darn sure that the devices they sell help people and do no harm, as was apparently true of Endotec's devices.

Finally, society should get its act together: Let's fund the FDA sufficiently to permit it to do its job, and let's get beneficial drugs and devices on the market as quickly as reasonably possible. That would reduce -- or perhaps eliminate -- the tension between companies struggling to help patients and the letter of the law.

Monday, May 12, 2008

The Profs Have It!

Practitioners love to complain about the growing chasm between the academy and the practice of law.

It ain't so, Joe!

Just this weekend, we saw three posts from different sites on the Law Professors Network that were well worth reading.

First, over at Torts Prof, we learned that Provost Umphrey hired MOST Health Services, Inc., to screen 161 people for potential silicosis injuries. But MOST didn't comply with the Pennsylvania state regulations governing x-ray screenings. The Pennsylvania Environmental Hearing Board upheld an $80,500 fine that the Department of Environmental Protection levied on MOST. Torts Prof also links to the decision by the Hearing Board, in case you just can't resist.

Second, the Mass Torts Litigation Blog alerted us to Margherita Saraceno's recent article, "Group Litigation, Access to Justice and Deterrence." Professor Saraceno explains that assembling a group for purposes of litigation "is costly for victims to organize and reduces the injurer's liability costs by facilitating settlement and creating scale economics at trial. The combined effect might be a reduction, rather than an increase, in the deterrent effect of tort law."

We're not sure we like the route that the professor takes, but we kind of like the uses to which you could put her conclusion.

Finally, Civil Procedure Prof Blog turned us on to Elizabeth Thornburg's recent contribution to the academic literature, "Judicial Hellholes, Lawsuit Climates, and Bad Social Science: Lessons from West Virginia." The title, however, grabbed us more than the thesis. Professor Thornburg is not much of a fan of the American Tort Reform Association's annual list of "Judicial Hellholes."

Hats off to the law profs this weekend.

We thought those posts were a whole lot more interesting than typical academic fare -- you know, "Poetry, Granola, and the Law."

Friday, May 09, 2008

AEI Program On Off-Label Use

We're fools, pure and simple.

We don't just practice law; we blog, too.

And we don't just blog. We also get flattered when folks ask us to write and speak about issues that concern us, so we often accept writing or speaking invitations.

The American Enterprise Institute nabbed us both this time around.

The AEI is hosting a day-long seminar about the off-label use of drugs and devices in Washington, D.C., on Wednesday, May 21, 2008. Here's a link to the description of the program.

With two obvious exceptions, the day will feature an all-star cast, including former FDA chief counsel Daniel Troy, former deputy attorney general George Terwilliger, acting assistant attorney general for the Civil Division Jeff Bucholtz, and others.

Among the others are the two exceptions -- both of your foolish blogging duo. Bexis contributed a paper called "First Amendment Implications of Restrictions Upon Truthful Promotion of Off-Label Use," in which he argues, shockingly enough, that the First Amendment permits manufacturers to say true things about the off-label uses of their products.

Herrmann (and co-author Pearson Bownas) contributed a paper called "Keeping The Label Out of the Case," which argues that a package insert may be admissible in a medical malpractice case where a particular use of a drug or device is, for example, contraindicated. But if a use is simply off-label, then the package insert is irrelevant and more prejudicial than probative, and it should be excluded from evidence.

In addition to having contributed papers, we'll both be speaking at the seminar -- and on the same panel toward the end of the day.

What a rare treat for us to be together in the same city.

It would be a treat for us to meet you, too, if you happen to be there. Please don't be a stranger.

Thursday, May 08, 2008

Warning Causation – Greatest Hits

As we’ve mentioned previously, we were both involved in the briefing in Ackermann v. Wyeth Pharmaceuticals, 2008 WL 1821379 (5th Cir. Apr. 24, 2008). That case is an excellent example of how defendants can win inadequate warning cases (which is what probably 90% of our drug/device product liability cases are) under the learned intermediary rule on the ground that the allegedly inadequate warning did not affect the prescribing physician’s decision to prescribe the drug.

As we’ve also pointed out, there have been a lot of defense wins on the warning causation issue recently. We’re not about to repeat everything we said there about how warning causation works in learned intermediary cases – but we will repeat this: we’d much rather have the warning causation question turn on the testimony of an independent, trained professional than on that of a self-interested layperson like the plaintiff who’s suing our client.

What defense counsel wouldn’t? Anyway, the Ackermann victory (which for obvious reasons we’re not at liberty to discuss in any depth until the appeal is completely over) got us thinking about what we’d consider to be some of the “greatest hits” in this area – not just the most recent hits (which are in our prior post), but the best examples – reasonably recent ones anyway – of this summary judgment genre.

So if you’re a defense lawyer (like us) preparing a motion for summary judgment on warning causation where you’ve got favorable prescriber testimony on the “I would have prescribed anyway” issue, here are some cases you might want to look at.

At the top we’d put Motus v. Pfizer Inc., 358 F.3d 659 (9th Cir. 2004). Procedurally, this is the closest thing to Ackermann out there. They’re both anti-depressant suicide cases where, if the court of appeals didn’t affirm on the warning causation issue, it would have to address a preemption defense lurking in the background. The doctor testified that he neither read nor relied upon the defendant’s warnings in prescribing the product. Id. at 661. No matter how strong an alternative warning would have been, it wouldn’t have made a difference since the doctor didn’t read it. Id. at 661-62. Short and sweet. Summary judgment affirmed.

Eck v. Parke, Davis & Co., 256 F.3d 1013 (10th Cir. 2001), is an instructive case because the court affirmed summary judgment despite controlling state law allowing one of those “read and heed presumptions. Id. at 1018-19. This presumption is one of the ways that pro-plaintiff courts have tried to put the thumb on the scale, by switching the burden of proving warning causation from the plaintiff to the defendant. We “presume that the plaintiff would have heeded an adequate warning, had it been given,” some courts say – even though what they’re really “presuming” is that the existing warning is inadequate in the first place, which is what the plaintiff is supposed to have to prove.

Yeah, we know, it doesn’t make much sense, particularly in a prescription product case where the presumption involves a medical professional treating a sick person – but we’ve blogged about that before, so we’re not going to reinvent that wheel either. The defendant won in Eck because the prescriber knew of the claimed risk, and considered it outweighed in his risk/benefit analysis by the risk of the disease that the medication was used to treat. Id. at 1021. This prescriber testimony was uncontroverted, so the defendant won, despite the state-law presumption.

Odom v. G.D. Searle & Co., 979 F.2d 1001 (4th Cir. 1992), also illustrates some of the warning causation options that defendants have. Odom involved a relatively rare injury (sterility) from an IUD. The prescriber testified that he already knew of this risk, and furthermore that the defendant’s product was the best on the market, and thus he still would prescribe it. Id. at 1002. Due to this confluence of “already knew and chose not to warn patient” with “I would still do it today” testimony, summary judgment for the defendant was affirmed for lack of causation by the allegedly inadequate warning. Id. at 1003.

An absolutely essential case if you’re in a jurisdiction that hasn’t definitively determined the heeding presumption issue is Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806 (5th Cir. 1992). Thomas provides probably the best substantive discussion of why the heeding presumption doesn’t make sense as applied to products with inherent, unavoidable risks. Id. at 812-14. On the warning issue itself, Thomas is a prior knowledge case – the prescriber testified that he already knew about the risk (seizures) and that an additional warning would not have led him not to prescribe the drug. Id. at 817. That testimony destroyed any possibility that a different warning would have changed the result. Id.

An “oldie but goodie” – unilaterally determined by us to be more than 20 years old – is Plummer v. Lederle Laboratories, 819 F.2d 349 (2d Cir. 1987) (applying, oddly, California law). Plummer is a vaccine case, and the physician testified that he didn’t warn about this particular risk (catching the disease from the live vaccine) because it was small and doing so would discourage patients from using the vaccine, and thus obtaining the vaccine’s substantially greater benefits. Id. at 352. Moreover, even if the prescriber’s testimony were discounted, the plaintiff had nothing affirmative with which to prove causation. Id. at 359 (That’s an argument we can make when there’s not a heeding presumption). Hence, judgment for the defendant notwithstanding the verdict.

Another case along the Plummer line is Stanback v. Parke, Davis & Co., 657 F.2d 642 (4th Cir. 1981). Once again, the prescribing doctor said that, although knowing of a relatively rare vaccine-related risk (Guillain-Barre Syndrome), it was not “his practice” to warn about it because the benefits of vaccination far outweighed the risks. Id. at 644. “Whatever may be said about [the prescriber’s] policies and decisions from the standpoint of the patient, it is clear that they precluded [defendant’s] failure to warn from having any effect whatsoever on [plaintiff’s] injury.” Id. at 645. The prescriber’s knowing decision not to give a warning, in short, is not a product liability defendant’s problem.

In the district courts, we’re not going back as far, given the number of decisions, but you’ll want to read Koenig v. Purdue Pharma Co., 435 F. Supp.2d 551, 556 (N.D. Tex. 2006), if you’re in one of those jurisdictions where the law’s unclear about whether there’s a heeding presumption. What we like best about Koenig is that, before the opinion, there was a plausible argument that Texas might apply such a presumption in a learned intermediary case, but after Koenig there wasn’t anymore. See 435 F. Supp.2d at 556-57. That’s certainly the way the Ackermann court viewed it. 2008 WL 1821379, at *7 (citing Koenig on the heeding presumption). The doctor’s testimony that defeated warning causation in Koenig was simple – I knew all about that risk (addiction to a narcotic drug) but decided to prescribe it anyway because I thought the patient needed it. 435 F. Supp.2d at 555.

Vanderwerf v. SmithKlineBeecham Corp., 529 F. Supp.2d 1294 (D. Kan. 2008), is another really good suicide warning case – really good because Kansas is one of those states that has fallen for the heeding presumption, so the affirmative evidence (the prescriber’s testimony) also had to overcome the presumption for the defendant to win. In Vanderwerf the prescribers (there were two of them) gave some testimony that was bad and some that was good, but the good stuff made the bad stuff irrelevant. The key fact was that there was nothing in the patient’s medical history that suggested that he was suicidal. Id. at 1313. That fact meant that prescriber testimony about “increased monitoring” of the patient was irrelevant, because without some reason to monitor in the first place (e.g. a suicide risk), there wouldn’t have been any monitoring, “increased” or otherwise.

Vanderwerf illustrates an important point – plaintiffs love to engage in flights of “what if” fancy in warning causation situations. It’s our job to bring those flights back to earth. Earth, in this case (as in many) is represented by the facts in the medical records. Attention to such facts is what makes lots of the plaintiffs’ flights of fancy untenable. Know the facts, and use them to cut off speculative “might have beens.”

Another really good suicide case is Allgood v. GlaxoSmithKline, 2008 WL 483574 (E.D. La. Feb. 20, 2008). One of the many problems with such cases is that treating psychiatrists are often loath to discuss suicide risks with depressed patients, for fear of being interpreted by such patients as suggesting that course of action. That was the case in Allgood, where the prescriber testified that even “knowing what he knows today” – including various label changes, dear doctor letters, and medical studies – he would not have changed his treatment because he does not warn patients about suicide risks. Id. at *15-17. Allgood illustrates another place for defense counsel to look for favorable causation testimony. There are often affirmative reasons why doctors choose not to give particular warnings about particular risks.

Another possible line of attack is illustrated in Nix v. SmithKline Beecham Corp., 2007 WL 4219157 (D. Ariz. Sep. 5, 2007), reconsideration denied, 2007 WL 4219157 (D. Ariz. Nov. 28, 2007), where the prescriber testified that he still continued prescribing the drug, and still believed it is a safe and effective treatment for condition plaintiff suffered. Id. at *3. Thus even though the prescriber also testified that he would have liked to have known more about the risk in question, ultimately that testimony didn’t matter because there was nothing to indicate that the prescription or treatment would have been different. Id. at *3-4. On reconsideration the court rejected the plaintiff’s attempt to substitute “reasonable physician” testimony in place of what his own prescriber actually did. 2007 WL 4219157, at *2-3. We’ve blogged about why allowing “reasonable physician” testimony to controvert causation is a bad idea before.

We also like Stafford v. Wyeth, 411 F. Supp.2d 1318 (W.D. Okla. 2006), because it’s another of these affirmative reason not to warn cases. The case involved fen-phen, a weight loss drug. The risk in question was potentially fatal heart disease. The doctor, however, testified “unequivocally” that the risk to the patient’s health (including her heart) from her obesity was significantly greater than the relatively remote risk from the drug. Id. at 1321. Even knowing everything he later found out about the drug’s risks, the prescriber reiterated that he still would prescribe drug to this patient. Id. Even in the face of a heeding presumption, this testimony defeated causation. Id. The “knowing everything you now know, would that have made a difference” question can be a powerful way of defeating warning causation in a learned intermediary case. Stafford also rejected the ploy of attempting an end run around what the prescriber actually did with “reasonable physician” expert testimony about what somebody else might have done. Id. at 1322.

The defendant in Madsen v. American Home Products Corp., 477 F. Supp.2d 1025 (D. Mo. 2007), defeated causation when the prescriber testified that he continued to prescribe the drugs in question even after he learned about the increased risk that the defendant had not warned about. Id. at 1036. The only reasonable inference was that if the doctor had been warned about the same risk at the time he treated plaintiff, the prescription decision would have been the same. Id. at 1-36-37.

In Ferguson v. Proctor & Gamble Pharmaceuticals Inc., 353 F. Supp.2d 674 (E.D. La. 2004), the physician had already looked into the drug risk in question and determined that it was “extraordinarily rare.” Id. at 676. In light of that, he testified that he would still prescribe the drug for the patient based upon his overall risk/benefit analysis. Id. at 677. The court granted summary judgment “[b]ased upon [the prescriber’s] representation that he would have prescribed the drug knowing of the risk of developing the condition of which plaintiff suffers….” Id. at 679.

In Miller v. Pfizer Inc., 196 F. Supp.2d 1095 (D. Kan. 2002), aff’d on other grounds, 356 F.3d 1326 (10th Cir. 2004), still another suicide case, the prescriber knew of reports of suicidal ideation, but at the time he prescribed the drug he believed it was a safe and effective treatment. Indeed, he testified that he “knew more” about the drugs than anyone the defendant could send to visit him. Id. at 1100. Even if he had received the additional warnings urged by plaintiffs, he would have prescribed the drug anyway. Id. at 1101. That testimony “br[o]k[e] the causal chain as to [defendant’s] allegedly inadequate warnings” and justified summary judgment. Id. at 1130.

Several prescribers in several cases testified in In re Norplant, 955 F. Supp. 700 (E.D. Tex. 1997), aff’d, 165 F.3d 374 (5th Cir. 1999), that none of the warning changes that subsequently appeared on the defendant’s labeling would have led them not to prescribe the drug to the plaintiffs. Id. at 711 & n.63. They also testified that they continued to believe the drug was safe and effective and continued to prescribe it. Id. In all the cases, the court granted summary judgment because this testimony precluded proof of warning causation. Id. at 711.

In Woulfe v. Eli Lilly & Co., 965 F. Supp. 1478 (E.D. Okla. 1997), still another suicide case, the prescriber already knew about the claimed risk and continued to prescribe the drug for patients, like the plaintiff, who had not reported suicidal thoughts. Id. at 1481. Since the plaintiff did not exhibit those signs, an additional warning would not have brought about a different treatment. Thus, the court granted summary judgment. Id. at 1482-83. Expert testimony that a “reasonable physician” would have done something different was rejected because it “ignore[d] the conduct of the actual prescriber. Id. at 1484.

Finally, a few relevant state court decisions. In a case near and dear to Bexis’ heart (because he worked on it), in Lineberger v. Wyeth, 894 A.2d 141 (Pa. Super. 2006), the prescriber testified that “I still would have prescribed” the drug even if the warning in question had been included. Id. at 150. The plaintiff’s predictable testimony that she would not have taken the drug if that same warning had been passed along to her was therefore immaterial, since the no different warning would have reached her. Id.

And a couple of Texas cases: In Ethicon Endo-Surgery, Inc. v. Meyer, ___ S.W.3d ___, 2007 WL 4462713 (Tex. App. Dec. 20, 2007), the prescriber knew all about the risk from previous experience, and could not affirmatively testify that an additional warning would have changed anything. Id. at *4. That, the court held, precluded the plaintiff from proving that a different warning would have made a difference in the result, id. at *5, since the only testimony the plaintiff had to establish causation was “speculative.” Id.

In Guzman v. Synthes, 20 S.W.3d 717 (Tex. App. 1999), there was affirmative prescriber testimony that at the time he treated the patient, he knew about the risk in question (fatigue fracture), that he would not have heeded any additional warnings about that risk, and that he would have treated the patient in the exactly the same when he testified as he did at the time of surgery. Id. at 720. The defendant was therefore entitled to judgment notwithstanding the verdict. Id.

In light of all these cases, and lots more we didn’t discuss, our advice to defense counsel seeking to defeat drug warning claims on causation grounds would be well advised to seek the following testimony from prescribers:
  • That the physician already knew about the risk from his/her prior experience and training, and knew more about the risk than any sales representative could have known.
  • That because the prescriber knew all about the risk, s/he did not need and would not have paid attention to, additional warnings.
  • That the prescriber still believes in the product and still prescribes it today to patients in the same position as the plaintiff.
  • That for one reason or another, the prescriber would not have passed an additional warning along to the plaintiff even if it had been included in the product’s labeling.
  • That, in the prescriber’s individual risk/benefit calculus for the plaintiff, s/he concluded that the benefit still outweighed the risk, even with new information.
  • That the prescriber simply didn’t read or rely upon the defendant’s warnings.
  • In a non-heeding presumption case, that the prescriber can’t say one way or the other whether an additional warning would have made a difference.

Also, in taking testimony and collecting other evidence from prescribers designed to set up a dispositive motion on warning causation, keep the following points in mind:

  • If the plaintiff gets some adverse speculative testimony from the prescriber, go to the specific facts of the case – in the medical records – to show that the speculative situation didn’t occur in this particular case.
  • Don’t let plaintiffs get away with arguing a heeding presumption unless you have to, and if there is a presumption, good affirmative testimony will rebut it anyway.
  • If there’s not a presumption, then if the plaintiff can’t get affirmative causation testimony from the prescriber, plaintiff loses.
  • Don’t let plaintiffs get away with trying to replace the prescriber’s actual testimony with some hypothetical “reasonable physician” (one of their own hired experts) who was never part of the plaintiff’s treatment.