Subpoenaing the Enablers

Interesting new decision out of the Asbestos MDL the other day, In re Asbestos Products Liability Litigation (No. VI), 2009 WL 466381 (E.D. Pa. Feb. 25, 2009). The asbestos defendants largely defeated a motion to quash their subpoenae ("ae" is Latin for "s") for documents from doctors who had purported to diagnose asbestos-related conditions in probably thousands of plaintiffs.

We see the same phenomenon in a number of the larger MDLs. The same doctors file virtually the same largely conclusory reports diagnosing whatever the relevant condition is in scads of plaintiffs. When these diagnoses are reviewed, 99% of them turn out to be questionable at best.

Well, the asbestos MDL defendants (or some of them) fought back, and subpoenaed these doctors' "screening medical documents." 2009 WL 466381, at *1. The doctors tried to hide behind HIPAA, the physician/patient privilege, and their supposed status as "consulting experts" exempt from discovery under F.R. Civ. P. 26(b)(4)(B).

Didn't work.

First the court determined that, as an MDL judge, it had jurisdiction to rule on motions to quash subpoenae anywhere in the country. MDL junkies will like the discussion of MDL power versus F.R. Civ. P. 45. Bottom line, "[t]o hold that a court presiding over an MDL case could not enforce a motion to compel would hamper the ability of an MDL court to coordinate and consolidate pretrial proceedings." 2009 WL 466381, at *2.

Then the fun begins. The assembly-line doctors tried to claim that the records of their screening tests were protected by the patient privacy provisions of HIPAA. That got shot down in flames. "Because [the subpoenaed doctors] did not provide physician services to plaintiffs, they are not covered entities under HIPAA and, therefore, HIPAA does not prevent enforcement of the subpoenas." Id.

The physician/patient privilege failed for the same reason. These doctors were acting as litigation consultants, not real doctors:

[The doctor] was not consulted by the Plaintiffs in order to provide treatment. Rather, he was consulted by Plaintiffs to provide a diagnosis, which would be relied upon by the individual Plaintiffs to support a personal injury claim. Therefore, under the circumstances, no physician-patient privilege attached to the information obtained from Plaintiffs. . .during the screening examinations.

Id. Further, even if there had been a privilege, it was waived. "When a patient uses a physician's diagnosis in litigation, the patient places the essence of this information at issue, effectively waiving physician-patient privilege." Id. at *3 (multiple citations omitted).

Finally, the court refused to let doctors whose diagnoses were the only reason the plaintiffs could be in court evade discovery concerning that diagnosis by masquerading as "consulting experts" under Rule 26:

[T]he only evidence of the scope and nature of Plaintiffs' injuries are the reports made by [the doctors] in the course of their screening examinations of Plaintiffs. These diagnostics constitute the Doctors' opinion as to whether the Plaintiffs they examined were afflicted with an asbestos related disease or malignancy. Without the Doctors' opinions, the diagnostic reports are meaningless. By producing and relying upon the opinion of the Doctors, the Plaintiffs have, de facto, designated the Doctors as expert witnesses in this case. Plaintiffs, having produced and relied upon the opinions of [the doctors] in this litigation, cannot now claim that [they] are non-testifying experts entitled to the consulting expert privilege.

Id. at *4. The court found In re Silica Products Liability Litigation, 398 F. Supp.2d 563(S.D. Tex. 2005) - that's the case that exposed the silicosis diagnosis racket - to be directly on point.

So if there's funny business happening with qualifying diagnoses in a mass tort, Asbestos provides a road map for going to the core of the problem and exposing the grounds for these diagnoses to the light of day (and to a Daubert motion, at the very least).

There are a couple of cautionary notes as to procedure: (1) only try for documents relevant to the plaintiffs in the litigation, 2009 WL 466381, at *4-5; (2) make sure you serve opposing counsel with subpoena at the same time as the targeted docs. Id. at *5. Beyond that, if defendants think that there's dodgy diagnosing going on, they have the right to go to the source.

That's something nice to know, although one might think it would go without saying.

As we said recently in another context, it might come as a shock to the other side, but mass tort defendants have the right to defend themselves.

Class Actions and Punitive Damages – Unconstitutional Together

Back when Philip Morris USA v. Williams, 549 U.S. 346 (2007), had just come down, we put up a post about the case being a death knell for the prosecution of punitive damages through class actions. We explained that the handwriting had been on the wall since State Farm Mutual Auto Insurance Co. v. Campbell, 538 U.S. 408, 416-417 (2003). Since Campbell there had been only a couple of outlier cases, one of those being Dukes v. Wal-Mart, Inc., 474 F.3d 1214, 1239 (9th Cir. 2007).

Last week we pointed out that the Ninth Circuit – taking its own sweet time about it – had agreed to rehear the Dukes decision en banc, something that’s pretty rare, especially in that circuit. Since even the Dukes panel had been uncomfortable with the class action-punitive damages issue, we could have the outliers whittled down to one, that being the West Virginia Supreme Court’s ducking the issue in State v. Madden, 655 S.E.2d 161, 167 (W. Va. 2007) (refusing to address question before there is a trial). Come to think of it, having the West Virginia Supreme Court duck an issue isn't the worst thing in the world.

With the reargument in Dukes, we think this would be a good time to go over the constitutional reasons why class actions and punitive damages can’t mix, since the defense side could be close to closing out this particular abuse of class actions for good - very good.

Going back to Campbell, the Supreme Court found constitutional error in allowing a punitive damages award made under a single state’s law to be based upon evidence of the defendant’s supposed sins all over the country. The conduct giving rise to punitive damages “must have a nexus to the specific harm suffered by the plaintiff,” which this sort of blunderbuss approach lacked. 538 U.S. at 422.

A defendant’s dissimilar acts, independent from the acts upon which liability was premised, may not serve as the basis for punitive damages. A defendant should be punished for the conduct that harmed the plaintiff, not for being an unsavory individual or business. Due process does not permit courts, in the calculation of punitive damages, to adjudicate the merits of other parties’ hypothetical claims against a defendant under the guise of the reprehensibility analysis.

Id. at 422-23. Since class actions, by definition, aggregate the claims of a large number of plaintiffs, they necessarily muddle the constitutionally-mandated “nexus” that the Supreme Court found essential in Campbell.

A class action approach to punitive damages was also at odds with the considerations in Campbell’s second prong – the ratio between a plaintiff’s compensatory and punitive damages. The constitutionally permissible ratio isn’t a fixed number, but rather a range that varies in any given case depending upon factors such as: if “a particularly egregious act has resulted in only a small amount of economic damages,” “the injury is hard to detect,” or “the monetary value of noneconomic harm might have been difficult to determine.” 538 U.S. at 425. Thus, as to the ratio factor, it’s determination “must be based upon the facts and circumstances of the defendant’s conduct and the harm to the plaintiff.” Id. This factor as well doesn’t seem at all amenable to the one-size-fits-all approach inherent in class actions.

Thus Campbell alone was enough to kill quite a few punitive damages class actions: In re Simon II Litigation, 407 F.3d 125, 139 (2d Cir. 2005) (Campbell requires decertification of punitive damages class); Johnson v. Ford Motor Co., 113 P.3d 82, 94-95 (Cal. 2005) (applying Campbell to reject “aggregate disgorgement”); Engle v. Liggett Group, Inc., 945 So.2d 1246, 1265 (Fla. 2006) (Campbell requires decertification of punitive damages class and reversal of $145 billion verdict); EEOC v. International Profit Associates, Inc., 2007 WL 3120069, at *10 (N.D. Ill. Oct. 23, 2007) (applying Campbell to bar mass actions, as well as class actions, for punitive damages); Colindres v. QuitFlex Manufacturing, 235 F.R.D. 347, 378 (S.D. Tex. 2006); O’Neal, v. Wackenhut Services, Inc., 2006 WL 1469348, at *22 (E.D. Tenn. May 25, 2006).

But Campbell wasn’t enough to deter the district court in Dukes from certifying a punitive damages class in an employment discrimination case – and a whopper of a class it was, including more than a million people. Dukes, 474 F.3d at 1237. Not only that, the certification order explicitly precluded individual injury hearings, adopting instead a “formula approach” that permitted awards to both “potential victims” and “actual victims.” Dukes v. Wal-Mart, Inc., 222 F.R.D. 137, 184-185 (N.D. Cal. 2004). All this was just fine with the original Ninth Circuit panel:

Relying on [Campbell], [defendant] argues that a punitive damages award in the absence of individualized hearings would violate its due process rights because it might punish legal conduct and award damages to non-victims. However, [Campbell] is readily distinguishable from this case. [Campbell] involved an action brought on behalf of one individual under state law. Moreover,. . .there is no danger in this case that [defendant] will be punished for conduct that is legal where it occurred, because Title VII is a [uniform] federal law. . . . Caselaw supports the district court’s findings that substantive law does not mandate individualized hearings and that [defendant’s] Constitutional rights will not be violated if statistical formulas are employed to fashion the appropriate remedy.

Dukes, 474 F.3d at 1242.

Then along comes Williams, which establishes outright that punitive damages cannot be based on anything other than the defendant’s conduct towards a particular plaintiff. “We did not previously hold explicitly that a jury may not punish for the harm caused others. But we do so hold now.” Williams, 549 U.S. at 356-57. Thus, a class-wide determination of everybody’s punitive damages all a once is is precisely what Due Process prohibits. Indeed, while Williams did not itself involve a class action, the Supreme Court specifically held that punitive damages could not constitutionally be awarded on a “represent[ative]” basis:

[T]he Constitution’s Due Process Clause forbids a State to use a punitive damages award to punish a defendant for injury that it inflicts upon nonparties or those whom they directly represent, i.e., injury that it inflicts upon those who are, essentially, strangers to the litigation.

Williams, 549 U.S. at 343 (emphasis added).

Furthermore, Williams recognized a proposition that seems to shock the other side – that defendants have the right, a constitutional right, to defend themselves. “[T]the Due Process Clause prohibits a State from punishing an individual without first providing that individual with an opportunity to present every available defense.” Id. And it's clear from the Williams opinion that these constitutionally protected defenses include individualized inquiries such as a plaintiff’s knowledge (“knew that smoking was dangerous”) and reliance (“did not rely upon. . .defendant[]”). Id. In short, what the Due Process Clause requires for punitive damages cannot be squared with the “common issues” necessary to maintain a class action.

And there's more. Classwide punitive awards encompassing absent class members who never appear in court to pursue their claims are necessarily “standardless” and “speculative” in violation of Due Process:

To permit punishment for injuring a nonparty victim would add a near standardless dimension to the punitive damages equation. How many such victims are there? How seriously were they injured? Under what circumstances did injury occur? . . .The jury will be left to speculate. And the fundamental due process concerns to which our punitive damages cases refer – risks of arbitrariness, uncertainty, and lack of notice – will be magnified.

Id. (citations omitted). A jury therefore may not punish a defendant for harm to others – to the absent class members. Id. at 1064 (“a jury may not go further. . .and use a punitive damages verdict to punish a defendant directly on account of harms it is alleged to have visited on nonparties”).

Because class actions are inherently the sort of “representative” litigation that Williams holds cannot constitutionally be employed to pursue punitive damages, the defendant’s first motion for reargument in Dukes included the position that intervening Supreme Court authority required decertification of the punitive damages class. A slam dunk, right?

Wrong.

The panel granted reargument, but it's replacement opinion backpedaled furiously on the punitive damages aspects of the class, now perceiving only “possibilities” that were not concrete enough to bother discussing at all:

[T]he district court outlined a trial plan based, in large part, on how other courts have handled similarly large and complex class action suits. [Defendant] contend[s] that at least some aspects of this trial plan violate [its] due process rights. . . . At this pre-merits stage, we express no opinion regarding [defendant’s] objections to the district court’s tentative trial plan (or that trial plan itself), but simply note that, because there are a range of possibilities-which may or may not include the district court's proposed course of action-that would allow this class action to proceed in a manner that is both manageable and in accordance with due process, manageability concerns present no bar to class certification here.

Dukes v. Wal-Mart, Inc., 509 F.3d 1168, 1190-91 (9th Cir. 2007) (footnote omitted) (emphasis added). Fortunately, the dissent called out the majority for dodging the issue:

In its first opinion, the majority explicitly approved of the district court’s trial plan in the face of the Due Process deprivations. In this second opinion, the majority “express[es] no opinion regarding [defendant’s] objections. . .and finds it sufficient to “note” that “there are a range of possibilities. . . .” [Defendant] has appealed precisely the unconstitutionality in the district court’s order, so it is incumbent upon
us to correct it.

Id. at 1198 (dissenting opinion).

That was the state of play in Dukes before last week’s grant of en banc reargument. Given the panel’s reaction – trying to duck the Due Process issue in the face of Williams – they didn’t have a good answer to Williams back then. It’s unlikely that there’s any better answer now, since the only post-Williams precedent on whether punitive damages class actions may constitutionally be certified are two more holdings that such class actions are unconstitutional. In re Conagra Peanut Butter Products Liability Litigation, 251 F.R.D. 689, 701-02 (N.D. Ga. 2008); Nelson v. Wal-Mart Stores, Inc., 245 F.R.D. 358, 376 (E.D. Ark. 2007), although we note Cook v. Rockwell International Corp., 564 F. Supp.2d 1189 (D. Colo. 2008), in which class certification wasn’t the issue.

We’re old enough to remember the way drug and device litigation was before the decisions in Amchem Products, Inc. v. Windsor, 521 U.S. 591 (1997), and Ortiz v. Fibreboard Corp., 527 U.S. 815 (1999), essentially slammed the door on product liability/personal injury class actions. Before that, it was distressingly common for plaintiffs’ counsel to try to extort settlements with extravagant class actions, including demands for classwide punitive damages.

Those are not fond memories, so we’d like to see the stake driven firmly through the heart of the idea of punitive damages class actions once and for all. Thus, we offer these arguments to our colleagues on the defense side and recommend that they use and expand upon them whenever any plaintiff, in any kind of case, makes class action allegations that encompass a demand for punitive damages. If you win, let us know.

We’ll be make it a point to let you know how Dukes turns out.

Welcome, Lawyers Weekly Readers!

After Herrmann published his two heretical posts (here and here) about whether blogging is a decent business development tool, a Canadian publication, The Lawyers Weekly, asked him to draft an article based on those posts.

The article, "Is blogging worth it?," appeared in the February 27 print and on-line issues of The Lawyers Weekly.

We offer both this link to the article and a warm welcome to our new readers from The Lawyers Weekly. We're glad you joined us!

Following Up On Our Conte Thought Experiment

One of the joys of blogging is receiving feedback from our readers.

We had two reactions to Monday's "Thought Experiment On Conte v. Wyeth" that we thought we'd share with you.

One reader notes that the manufacturer of a patented drug might be able to include a disclaimer in its package insert (and thus in the PDR) that advises prescribers to consult the generic label before writing a generic or substitutable prescription. Perhaps that disclaimer would prevent prescribers from reasonably relying on the innovator's package insert.

Another reader suggests that the Hatch-Waxman Act reflected a tradeoff, allowing earlier access to market for generics while providing for patent term extension for brand name drugs. Imposing liability on a brand name manufacturer based on the ingestion of a generic version of a drug fundamentally alters the Hatch-Waxman tradeoff and is therefore preempted under a conflict preemption theory.

We're still kicking this around, and we're not sure either of these musings gets us anywhere, but we figured we'd share them with our readers. If you have better ideas, please don't be shy.

Trans-substantivism

Trans-substantivism.

That's the notion that we should have one set of procedural rules that applies equally to all substantive areas of the law. It's a cornerstone assumption of modern American procedure. In the federal system, we call our trans-substantive rules -- which apply equally to slip-and-falls, massive securities fraud cases, and everything in between -- the Federal Rules of Civil Procedure.

Courts don't always like trans-substantivism. When courts are deciding particularly tough cases, judges sometimes decide that the rules should be changed -- just this once! -- to accommodate unique circumstances. And judges often don't foresee the unintended consequences of what they've done.

Take, for example, In re OxyContin II, No. 700000/07, 2009 N.Y. Misc. LEXIS 289 (N.Y. Sup. Ct. Feb. 10, 2009). This arises in the New York statewide coordinated proceeding for product liability claims arising out of the ingestion of the painkiller OxyContin.

You would ordinarily think that a Georgia resident, who was prescribed OxyContin in Georgia by a Georgia physician, and who ingested the drug (and was allegedly injured by it) in Georgia, and who received medical treatment for the injuries in Georgia, should bring his lawsuit in, say, Georgia.

And, in ordinary cases, that's the right result. See id. at **6-**7 (describing precedents in which New York courts dismissed the cases of out-of-state Viagra and Lipitor plaintiffs under the doctrine of forum non conveniens).

But, according to Judge Maltese, "Mass Torts Are Different." Id. at **8. (The bold and initial capitalization are in the original; this is the heading of a section of the opinion.) "Mass torts generally are handled as either coordinated matters before one judge . . . or, if appropriate, as a class action before one judge." Id. "[T]he state and national trend is to aggregate and resolve these cases in a judicially efficient manner." Id. at **14.

According to the court, this is particularly important because the Judicial Panel on Multidistrict Litigation denied plaintiffs' effort to coordinate the cases at the federal level. Id. at **11. Unless the cases -- all of the cases, including those involving out-of-state plaintiffs -- are heard in New York, who knows what evil may befall us?

The court thus denied motions to dismiss (on the ground of forum non conveniens) the claims of 284 non-resident plaintiffs who chose to file their cases in New York state court.

Our tone here really doesn't reflect our mood. We understand what Judge Maltese is thinking, and we appreciate that he's doing his best to manage a tough administrative problem. But there's always the option of doing what courts have done since time immemorial -- let people sue in their home states, where it's easy to conduct discovery, subpoena live witnesses to testify at trial, and apply local state law to facts decided by a jury of people from the local community.

By creating a new rule of forum non conveniens that applies only to mass torts, the court overlooks a bunch of competing interests. For example:

First, maybe the MDL Panel was correct, and these cases can be resolved without creating a single aggregated proceeding? It's not crazy to look at the MDL Panel's decision as a compelling precedent, rather than an excuse to jury-rig a nationwide aggregated proceeding in New York.

Second, there are disadvantages to creating aggregated proceedings. Among other things, those proceedings suffer from the "Field of Dreams" problem: "If you build it, [they] will come." Once plaintiffs' lawyers know that they can lob cases into a huge proceeding, with a judge likely unable to focus on any individual case, counsel will solicit more clients and not hesitate to file questionable claims. The court won't have time to weed out those claims, and there may always be a chance of participating in some later settlement.

And that would be true even if the coordinated proceeding involved only New York plaintiffs.

By opening the coordinated proceeding to non-resident plaintiffs, the aggregated proceeding will grow still larger, and the New York courts will become a dumping ground for cases from all over the country. Moreover, New York will disproportionately be the dumping ground for meritless cases. After all, if a plaintiff has a good case, you should file it individually and have a judge focus on it. That puts pressure on the defendant. On the other hand, if you have cases that can't stand the light of day, park 'em in the aggregated mass.

Finally, once plaintiffs' counsel realize that coordinated proceedings in New York -- unlike, say, coordinated proceedings in California -- are open to all plaintiffs nationally, plaintiffs' counsel will in the future strive to create more coordinated proceedings in New York. Smart lawyers notice when courts create tactically useful exceptions to general rules, and future lawyers will try to take advantage of those exceptions.

New York created its procedure for statewide coordinated proceedings only in 2002, and the state didn't adopt rules of practice until 2003. Society managed to handle many mass torts in the years before those rules existed, and society can still do so today.

If the legislature wanted to change the rules governing forum non conveniens in mass torts, it could have done so in 2002 when it created the Litigation Coordinating Panel. But it didn't.

Courts should hesitate to change our trans-substantive rules, which apply equally to all cases, to fit the circumstances of one "special" case or set of cases. Once courts create those exceptions, zealous counsel will strive to take advantage of them, courts will suffer unexpected consequences, and the administration of justice may ultimately suffer.

Discount For FDA Boot Camp

Herrmann has agreed to speak at the American Conference Institute's "FDA Boot Camp" in New York City on March 30 and 31. Here's a link to additional information about the program.

ACI offers an early bird registration discount (of $200) to those who register before this Friday, February 27th. And ACI has now extended an additional $200 discount to readers of this blog. Use the code "FLB" to get the additional "law blog reader" discount.

If you choose to attend the conference, please take advantage of this discount, and introduce yourself when you're there.

A Thought Experiment On Conte v. Wyeth

We've kicked Conte v. Wyeth, No. A116707, A117353, 2008 WL 4823066 (Cal. App. Nov. 7, 2008), three ways from Tuesday (here, here, and here, for example). Well, it's Monday -- so we're kicking again.

In Conte, the California appellate court held that the manufacturer of a name-brand drug may be liable for injuries caused by a patient's ingestion of the generic version of that product.

You read that right: If the prescribing physician relied on the innovator's product labeling, then the innovator might be tagged for damages, even if the innovator did not manufacture the product that allegedly injured the plaintiff.

Here's today's thought experiment about Conte:

Suppose you market a new, name-brand drug. When you submit your draft labeling to the FDA, include the following two sentences at the end of the labeling:

"The statements contained in this package insert apply only to the name-brand version of this drug. The statements in this insert do not apply to any generic version of this drug."

There! You would eliminate any possibility that the purchaser of a generic version of the drug could rely on the package insert! You'd be insulated from liability.

But the FDA would never allow you to include that disclaimer on your package insert. The statutes governing generic drugs require generic manufacturers to use labeling and warnings on the generic drug that are identical to those approved for the name-brand drug. See 21 U.S.C. Sec. 355(j)(2)(A). So the FDA would disapprove the disclaimer on your labeling and require you to print the labeling without the disclaimer.

Perfect!

Now you have a preemption defense! You tried to tell purchasers that the statements made in your labeling did not apply to generic versions of the drug, and the FDA prohibited you from making that statement. Surely you can't be liable when the FDA has barred you from making the very statement that would have disclaimed liability.

Moreover, that result is inevitable: There's simply no way the FDA would ever allow any manufacturer to include on the name-brand labeling the sort of disclaimer that we just proposed. Given that truth, why should the innovator have to propose the label (and have it be rejected) to obtain the benefit of preemption? Why can't the manufacturer just explain that any disclaimer of liability to purchasers of the generic drug would be forbidden under federal law, so the innovator can't be liable to a plaintiff who bought the generic?

We realize that some disclaimers are not permitted because they are, for example, unconscionable. But surely it's not unconscionable for a company to disclaim liability to purchasers of a product that the manufacturer did not sell.

And we realize that our proposed disclaimer is legal in nature ("we're not liable"), rather than scientific in nature ("our drug is [or is not] associated with an adverse reaction"), but surely there's some way around that obstacle.

Maybe we need help with our thought experiment: Maybe the proposed language would say that, "The statements contained in this package insert apply only until [the date on which the patent expires], at which time the name-brand manufacturer will stop selling the product and expressly disclaims all future representations or warranties of any kind."

Or maybe even that doesn't do the trick, and there's some other statement that would work.

We told you that this was only a thought experiment, and if you have better ideas, we're all ears.

We're just searching for a (more) vivid way to make courts recognize that name-brand manufacturers shouldn't be held liable (among many other reasons) because the law forbids them from disclaiming the liability that the court is now seeking to impose.

Medical Monitoring In The Air – The Guinan Parody

The fascinating, and ultimately frustrating, pair of decisions in Guinan v. A.I. duPont Hospital for Children, ___ F. Supp.2d ___, 2009 WL 307019 (E.D. Pa. Feb. 6, 2009) ("Guinan I"), and Guinan v. A.I. Dupont Hospital for Children, ___ F. Supp.2d ___, 2009 WL 311113 (E.D. Pa. Feb. 6, 2009) ("Guinan II"), demonstrate how judicial sympathy for a plaintiff attempting to pound a square liability peg into a round legal hole can cause serious damage to the law. If there had been a third opinion, maybe we’d call this a trilogy. As it is, we’ve only got a parody.

Guinan is another of those lawsuits in which what are really malpractice or informed consent cases have been stretched to try to make out product liability claims. Levine and Riegel come to mind as other examples, as we’ve discussed here (Levine) and here (Riegel). To some extent this phenomenon comes from plaintiffs’ lawyers looking to involve deeper pocketed defendants, something that's been around since the beginning of legal time. But to a large extent we see it as something more recent - an unintended consequence of tort reform efforts that have made it more difficult and less remunerative for plaintiffs to pursue actions against medical professionals.

We don’t bear any grudges against the docs for that, but this does make things more difficult for our clients at times, and Guinan is one of those times.

Guinan involved some innovative surgery designed to correct a set of congenital heart defects ("tetralogy of Fallot," "complete common atrioventricular canal defect," and "severe pulmonary stenosis" – don’t ask us about these, we’re simply reporting what we’re reading) that frequently accompany Downs Syndrome. Guinan I, 2009 WL 307019, at *1. The patient was a new born. To deal with resultant circulatory problems, the doctors who ultimately ended up as defendants tried something called a “Fontan procedure.” That required two rounds of open heart surgery to complete. Unfortunately it couldn’t be completed because “severe leakage of [the] atrioventricular valves.” Id.

There was a dispute (decently prepped plaintiffs always deny informed consent) whether the parents were informed about this complication or the change in surgical plans that resulted. Id.

Instead of the normal method of surgical completion, the doctors inserted a medical device – a “covered stent” – via catheter. This “relatively new” procedure avoided a second open-heart procedure. Id. at *2. Once the device gets involved, we get interested.

And it does get interesting.

For one thing, the device that was implanted wasn’t FDA-approved – for anything. Id. The manufacturer had been making these stents available under a number of (it thought) exceptions to FDA approval: (1) as a “humanitarian use device” (for treatment of rare conditions), (2) as an “investigational” device for use in clinical trials, and (3) as a “custom device” made to fit the patient-specific “order of an individual physician.” Guinan II, 2009 WL 311113, at *2-3. This particular stent was supplied as a custom device. Id. at *3.

However the docs got their hands on this unapproved stent, it was supposed to be used in accordance with procedures overseen by the defendant’s hospital’s institutional review board (“IRB”). Remember, this is pediatric surgery, and very few companies sell either drugs or devices specifically intended and approved for use in children. Guinan I, 2009 WL 307019, at *2.

So in went the stent. It seemed to work for a little while, but the “cold” that the infant got about a month later turned out not to be a cold at all, but the onset of two more “rare and potentially life-threatening conditions”: "protein losing enteropathy" and "plastic bronchitis." Id. at *2 (again, just because we blog about this stuff, don't assume we know what it is).

At this point, plaintiffs changed doctors and hospitals - ending up at the best children's hospital in the country. The new doctors decided they couldn’t risk removing the stent. But to do what they thought needed to be done (lower the venous blood pressure), they had to punch a hole in the stent, something called “fenestration” (not to be confused with “defenestration” of the sort the Czechs practiced in the Middle Ages). The new docs also found stenosis (narrowing) in another artery and implanted a second stent. Guinan I, 2009 WL 307019, at *2.

But the hole that the second set of doctors punched in the stent wasn’t big enough, because the plastic covering on the stent (the first one) started covering it back up. To deal with that, the docs (second set) decided to implant another stent (the third one) at the hole in the first stent. Id. at *3. Got that?

Didn’t work. The plastic bronchitis persisted. That’s where things stood at the time of the litigation. The only thing left to do, if anything could be done, would be to remove everything (except maybe the second stent, we’re not sure) and start over – something called a “take-down Fontan procedure.” Id. at *3.

So plaintiffs sue everybody. There are factual disputes all over the place, as the plaintiff parents claimed they weren’t told anything, and the defendant doctors swore they told the parents everything. One of these disputes was whether the doctors used an informed consent form provided by the defendant manufacturer, which explained what the first stent was all about. Id.

After the inevitable winnowing down of the plaintiffs’ extravagant pleading, including dismissal of class action allegations, id. at *4, all the defendants moved for summary judgment. The judge wrote two opinions, one involving the medical defendants (Guinan I) and the other involving the medical device manufacturer and its CEO (Guinan II). The court threw out a lot of claims but not all of them.

We’re going to go through Guinan I first, but quickly (yeah, right, we know you guys), because it’s necessary to understand Guinan II – the one we’re most interested in.

The remaining claims in Guinan I were malpractice (medical negligence), informed consent, fraud/misrepresentation, and medical monitoring.

The first question was choice of law. Plaintiffs were residents of New Jersey, and the complained-of surgery occurred in Delaware. That would be too easy, so plaintiffs sued in the Eastern District of Pennsylvania, making for a three-ringed circus. Guinan I, 2009 WL 307019, *5. There were bunches of real conflicts that we won’t bore our readers or ourselves with because they involve the medical claims. Suffice it to say that, if plaintiffs had wanted either Delaware or New Jersey law to apply, they would have sued there.

Because the state where the complained-of medical treatment occurred had the most meaningful contacts, the court applied Delaware law. Id. at *6-8.

That caused big problems with plaintiffs' medical monitoring claim, because while New Jersey and Pennsylvania recognized medical monitoring in some situations, no Delaware court ever had. Worse than that, the Delaware Supreme Court more or less rejected medical monitoring as a separate cause of action in Mergenthaler v. Asbestos Corp., 480 A.2d 647, 651 (Del. 1984), an asbestos case (obviously), but that was as much because of lack of exposure as due to any evaluation of the viability of the underlying claim.

Moreover, Guinan I stated that not only was medical monitoring itself uncertain under Delaware law, but plaintiffs advocated a “novel theory that a tort claim for medical monitoring can be applied to medical procedures and devices.” 2009 WL 307019, at *7 (emphasis added).

We’ll skip over the lengthy discussion of the Delaware Health Care Malpractice Insurance and Litigation Act. Suffice it to say that the vague report filed by plaintiffs’ expert didn’t come close to supporting a claim for medical negligence. Id. at *9-14. Next up was informed consent. Because the plaintiff parents signed an informed consent form, their claims sounded in negligence. To prove negligence they needed the expert whose report had already been thrown out. Bye-bye informed consent. Id. at *14-15. Plaintiffs didn't even get close to establishing fraud. Id. at *15.

So that left medical monitoring, and that’s where things go off the rails.

Plaintiffs had some good facts. Once they found out the first stent hadn’t been approved, they complained to the FDA. The FDA got on the IRB’s case and demanded a report. The IRB concluded that, in violation of procedures, the defendant doctors “had implanted an unapproved device in several patients, and had handled Plaintiff's parents' complaints poorly.” Id. at *16. After that, the FDA went to the device manufacturer (which it directly regulated) and “urged” (the court’s word) it to tell similarly situated patients that they should “seek long-term medical follow-up.” Id. The manufacturer not only did what the FDA suggested, but sent a letter to every doctor and hospital that had ever used one of its devices.

That letter (which came back to haunt everyone) stated that “[t]he safety and effectiveness of the C.P. stent is unknown at this time; therefore [the manufacturer] is concerned that patients receive appropriate follow-up care.” It went on to suggest that patients who had these stents implanted should be evaluated on an annual basis “until full growth is reached” and that the evaluation should "include a history and physical exam, a chest x-ray, an echocardiogram, an EKG, and an MRI or spiral CT." Guinan I, 2009 WL 307019, at *16. There was no evidence (at least none mentioned in either opinion) that the manufacturer had any idea that the defendant doctors weren’t following the procedures established by their own hospital’s IRB.

So in the hallowed tradition that, in litigation, no good deed goes unpunished, Guinan I used this recommendation as the jumping off point in concluding that plaintiffs had a viable claim for medical monitoring.

Even though the Delaware Supreme Court had never recognized such a claim in any context.

Even though application of medical monitoring to medical procedures and products was admittedly “novel.”

The court, of course, had to make an Erie prediction (that means take a guess at what a state court might do with an undecided issue under principles first established in Erie Railroad Co. v. Tompkins, 304 U.S. 64 (1938)). We lawyers like to name our shorthand jargon after cases.

First, it reviewed the Mergenthaler decision and quite correctly determined that the Delaware Supreme Court’s dismissal of that particular monitoring claim wasn't conclusive on whether such a claim could ever be brought. Guinan I, 2009 WL 307019, at *17-18. The court didn’t bother to delve further into Delaware precedent, thus it did not consider a second dismissal of a medical monitoring claim by a Delaware trial court. See Alderman v. Clean Earth, Inc., 2007 WL 1930664, at *2 (Del. Super. June 26, 2007).

Instead, Guinan I found “several considerations” that “militate[d] in favor” of medical monitoring in the case:

• “Plaintiff has a Class III medical device in her body.”
• “[I]t is undisputed that the device did not have premarket approval from the FDA at the time the Medical Defendants implanted it in Plaintiff and was thus considered an ‘adulterated’ device.”
• “Plaintiff had contact with the adulterated device[, which] remains in her body.”
• “[T]he FDA, [the manufacturer], and the Institutional Defendants have all suggested that Plaintiff should receive follow-up care to monitor the CP stent.”

2009 WL 307019, at *18. Relying on a number of decisions from other jurisdictions, the court concluded that “considerations of fairness, efficiency, and deterrence favor recognizing a cause of action for medical monitoring here.” Id.

It looks like there was simply no way that this injured baby was getting thrown out of court – not when one of the defendants’ own IRBs had admitted there was a screw up.

There’s just one little, slight problem with that.

It’s not allowed.

Not only haven’t Delaware state courts recognized medical monitoring, but expansion of medical monitoring to the use of prescription medical products is admittedly “novel.” Guinan I, 2009 WL 307019, at *7.

Under universally accepted Erie principles, it’s beyond the proper power of a federal court exercising diversity jurisdiction to predict a novel expansion of state-law liability because, as in Guinan I, the court thinks such an expansion is a better approach. We’ve discussed this before, but Guinan I is the most egregious violation of this principle we’ve seen, at least since the decisions that prompted our earlier post.

It’s also against the Third Circuit’s repeated admonitions to the district courts. Lexington National Insurance Corp. v. Ranger Insurance Co., 326 F.3d 416, 420 (3d Cir. 2003):

[A] federal court in a diversity case should be reluctant to expand the common law. . . . [T]here has to be a limit somewhere. Our duty here is to predict how the [state] Supreme Court would view this case and we will discharge that duty by holding that it would reject [plaintiff’s] claims.

Werwinski v. Ford Motor Co., 286 F.3d 661, 680 (3d Cir. 2002):

[E]ven if we were torn between two competing yet sensible interpretations of [state] law. . ., we should opt for the interpretation that restricts liability, rather than expands it, until the Supreme Court of [the state] decides differently.

City of Philadelphia v. Beretta U.S.A. Corp., 277 F.3d 415, 421 (3d Cir. 2002):

[I]t is not the role of a federal court to expand state law in ways not foreshadowed by state precedent. Instead, a federal court follows the precedents of the state’s highest court and predicts how that court would decide the issue presented. [State] precedent does not support the. . .claim plaintiffs advance here, and we cannot predict that the [state] Supreme Court will choose to expand state. . .law in the manner plaintiffs urge.

Camden County Board of Chosen Freeholders v. Beretta, U.S.A. Corp., 273 F.3d 536, 541-42 (3d Cir. 2001):

[This] is a matter of state law, and the role of a federal court ruling on a matter of state law in a diversity case is to follow the precedents of the state’s highest court and predict how that court would decide the issue presented. It is not the role of a federal court to expand or narrow state law in ways not foreshadowed by state precedent. . . . While it is of course conceivable that the Supreme Court. . .may someday choose to expand state [] law in the manner that the County urges, we cannot predict at this time that it will do so.

Northview Motors, Inc. v. Chrysler Motors Corp., 227 F.3d 78, 92 n.7 (3d Cir. 2000):

[W]e have stated that a federal court in a diversity case should be reluctant to expand state common law. . . . [R]egardless of the source of its jurisdiction, the principle is valid because a federal court is applying state law.

Leo v. Kerr-McGee Chemical Corp., 37 F.3d 96, 101 (3d Cir. 1994):

[F]ederal courts may not engage in judicial activism. Federalism concerns require that we permit state courts to decide whether and to what extent they will expand state common law. . . . Our role is to apply the current law of the jurisdiction, and leave it undisturbed.

City of Philadelphia v. Lead Industries Ass’n, 994 F.2d 112, 123 (3d Cir. 1993):

A federal court in a diversity case is not free to engraft onto those state rules exceptions or modifications which may commend themselves to the federal court, but which have not commended themselves to the State in which the federal court sits. . . . In a diversity case. . .federal courts may not engage in judicial activism. Federalism concerns require that we permit state courts to decide whether and to what extent they will expand state common law. Our role is to apply the current law of the appropriate jurisdiction, and leave it undisturbed.

Bottom line, if plaintiffs in Guinan had wanted to argue for this sort of doubly novel expansion of Delaware law, they shouldn’t have played games with choice of law by filing in a federal forum having nothing to do with their cause of action. They should have filed in a Delaware state court. Basically, the Guinan plaintiffs played forum-shopping games – and the court ended up rewarding them for it.

So Guinan I leaves the plaintiffs hanging on by their fingernails against the medical defendants, able to pursue only a medical monitoring claim that has no basis in relevant state law. In Guinan II, the court decided to visit the sins of the medical defendants upon the device manufacturer.

But not before making some interesting and useful rulings concerning the plaintiffs' other claims.

The rulings are interesting because the manufacturer was also investigated by the FDA. Even though undisputed evidence established that the manufacturer had not affirmatively promoted the use that supposedly injured the plaintiff, see Guinan II, 2009 WL 311113, at *3 (the doctors “approached” the manufacturer), the FDA charged it with “marketing an adulterated device” – presumably because it had run afoul of the “custom device” process by which it sold the device. Id. at *4. In the end, both the company and its principal officer pleaded guilty to misdemeanors. Id.

The stent, however, wasn’t found to be unsafe. Quite the contrary. As part of the manufacturer’s plea agreement, the FDA required it to fund a clinical trial for another pediatric use of the stent, and on top of that “to supply it to health care providers who request it for [the studied] treatment . . . free of charge.” Id.

The Agency would never have demanded, as part of a legal settlement, that the manufacturer distribute the device for free if it thought the device was actually dangerous. So from a product liability perspective, Guinan deals with claims brought against a convicted violator of the FDCA over the unapproved use of a safe product.

As to the manufacturer as well, the plaintiffs played the same choice-of-law games, only this time there was a fourth state involved – New York, where the manufacturer was incorporated.

So the possible choices were: (1) New Jersey, where the plaintiffs lived, (2) Delaware, where the doctors used the device in surgery, (3) New York, the state of incorporation (and presumably principal place of business), and Pennsylvania, where suit was filed. We’ll spare you the details, but the court held that the place where the medical treatment using the device occurred, rather than either the plaintiffs’ residence or the defendant’s principal place of business, had the greatest interest in the application of its laws. Guinan II, 2009 WL 311113, at *5. That is, except for plaintiff’s attempt at piercing the corporate veil, which, being a matter of corporate law, was governed by the state of incorporation. Id. at *6.

So that’s the first interesting and useful ruling – on choice of law. It's yet another rejection of principal place of business as a dispositive contact, something we've denounced before.

Plaintiffs brought three types of negligence claims against the manufacturer: “failure to test, failure to warn, and negligence per se based on violation of the FDCA.” Id. at *6. They’re all interesting, but regular readers know of our near obsession with FDCA based negligence per se. Rather than clutter up the post with links, we direct your attention to the “negligence per se” label at the bottom of this post. By clicking on that, you’ll get a list of each and every one of our prior posts on that subject (even us Luddites recognize the value of these labels).

But unfortunately, Guinan II doesn’t get into the really juicy stuff.

That’s because, once again, the plaintiffs’ experts let them down. The first ground on which plaintiffs’ negligence claims failed was lack of expert testimony on causation. The expert “offers no opinion regarding the causal connection between” the “stent and Plaintiff's claimed injuries.” Id. at *7. A win is a win is a win, but that’s not a rationale we find very interesting.

But things look up from there. The next cause of action is for fraud/misrepresentation. The first issue is whether the learned intermediary rule applies to fraud. The court held that it does:

This reasoning [for the learned intermediary rule] certainly makes sense in the context of this case, where Plaintiff could not have obtained independent access to the [device], where the Medical Defendants had to order the [device] from [the manufacturer] by prescription, and where the Medical Defendants inserted the [device] into Plaintiff during a medical procedure.

Guinan II, 2009 WL 311113, at *9.

Interesting and useful ruling number 2: the learned intermediary rule applies to fraud claims.

Plaintiffs then claimed that, because the manufacturer didn't give the doctors any information at all about the safety of the device for use in the Fontan procedure, it was necessarily liable. Id. at *10. But that mistated the facts. Instead, the manufacturer (through its principal) “did not assure the doctors that the [device] was safe to use in the Fontan completion.” Id. The device was unapproved (with evidence establishing that its FDA status was stated on the informed consent form the company gave the doctors, id. at *11), and the doctors, not the manufacturer chose to it for this purpose. Therefore, no fraud.

We’ll skip the battery (informed consent) discussion in Guinan II because it dodged the interesting question (whether a manufacturer’s provision of an informed consent form could be a voluntary undertaking to obtain informed consent), and dismissed the claim for the same reasons as Guinan I. We’ll also skip strict liability, which was dismissed on the very Delaware-specific ground that the state’s law has never adopted the doctrine. 2009 WL 311113, at *13-16.

Delaware never adopted strict liability because the legislature had already provided warranty causes of action. Express warranty is usually the weak sister of the two, and was so here as well. That claim was dismissed because, while plaintiffs claimed they relied on the device being “custom” when in fact it was unapproved for anything, there was no evidence that they even knew of that description:

[W]e will grant summary judgment in favor of [the manufacturer] for the same reason: Plaintiff has not proffered evidence that the nature of the stent was “part of the basis of the bargain” to constitute an express warranty. To the extent that [the manufacturer] made any representations about the stent prior to the sale of the stent, Plaintiff was not aware of them. . . . Plaintiff's argument that she relied on [the manufacturer’s] description of the stent as “custom” is without merit.

Guinan II, 2009 WL 311113, at *20.

Interesting and useful ruling No. 3: In express warranty, if the plaintiff was not told about the alleged express warranty by the prescribing doctor, the claim fails for lack of reliance/benefit of the bargain.

Implied warranty is where the real action is, since that claim substitutes for strict liability in Delaware. To establish a product defect, plaintiffs hauled out an FDA expert – not a design expert – who testified essentially that the device was “not safe for use in humans” because it had “not been shown to be safe.” Guinan II, 2009 WL 311113, at * 21. That, of course, was a blatant attempt to use FDA-speak to flip the common-law burden of proof from the plaintiff to the defendant. Whatever a manufacturer’s burden might be before the FDA, in a product liability action, it’s the plaintiff’s job to produce evidence affirmatively establishing a defect:

The expert testimony on which Plaintiff relies fails to support an inference that the stent was defective. . . . Plaintiff maintains that [expert] testimony that the [device] was not “shown to be unsafe” supports an inference that [it] was unsafe or defective. Plaintiff therefore relies on an absence of evidence of defect as support for the proposition that a defect exists. Plaintiff commits the logical fallacy of argumentum ad ignorantiam, that is, an argument from ignorance. . . . Plaintiff mistakenly assumes that an absence of evidence to support its proposition establishes the proposition. However, an absence of evidence that the [device] was defective does not establish defectiveness. Plaintiff’s logical fallacy underscores her failure to carry her burden of proffering evidence that allows an inference of defect.

Id. at *21 (emphasis added) (citations to five Bone Screw cases omitted).

And there’s more along these lines. The Guinan II court similarly rejects the proposition that lack of FDA approval for a use means that a product is not “fit” for that unapproved use:

Implicit in Plaintiff’s argument is the proposition that Fontan completion is an “ordinary purpose” for which the [device] is used. Plaintiff therefore relies on the [device’s] lack of FDA approval as evidence of its defective design or manufacture. A lack of FDA approval is not a per se defect of design or manufacture under Delaware law. . . .[T]he lack of FDA approval of the [device] here does not constitute a defect under the applicable UCC provision. Plaintiff has identified issues regarding FDA approval. . ., but Plaintiff has not pointed to evidence of a manufacturing or design defect in the stent itself . . . . The lack of FDA approval, without more, is not enough to create an inference of a manufacturing or design defect.

Id. at *22 (emphasis added) (citations to three more Bone Screw cases and a footnote citing one of Bexis’ articles omitted).

Interesting and useful ruling No. 4: Resolved: Lack of FDA approval is neither evidence of, nor supports an inference of, a defect.

To us that’s the most interesting and useful ruling in Guinan. We’ve seen plaintiffs try to flip the burden of proof like that quite a bit over the years, mostly in litigation over off-label uses, and the devastating refutation in Guinan II is as thorough and well-reasoned as we’ve ever seen – and we’ve done this issue to death.

We’ll pass over the discussion of the implied warranty of fitness for a particular purpose, id. at *23, and piercing the corporate veil, id. at *24-15, because they’re both dependent upon the case-specific factual record in the case. Also, we’re getting tired.

That brings us back to the kicker – medical monitoring. Once again, the court denies summary judgment. There’s no independent review of the claim, only a reference to the discussion in Guinan I, and a statement that the Erie prediction is “based. . .in large part on the fact that. . . the FDA [and all the defendants] have advised that medical monitoring is necessary because, inter alia, the safety of the [device] is unknown.” Guinan II, 2009 WL 311113, at *23.

Sorry, we don’t buy that in Guinan II any more than in Guinan I. We’ve already addressed the infirmity of the court’s Erie prediction, so we’ll close with the other question we have.

Where’s the tort?

There’s no negligence – that claim was dismissed for lack of any viable expert opinion on either liability or causation. There’s no product defect either. There’s no fraud. Despite the defendant’s regulatory transgressions, the FDA didn’t order the product off the market, and instead required the manufacturer to make it even more available than it had been.

There’s just no tortious conduct upon which to predicate medical monitoring - even if the court had the power to recognize such a novel cause of action in the first place.

And there’s no such thing as medical monitoring in the air. Every state we know of that allows medical monitoring requires, as an element of the claim, proof of tortious conduct. Between them, Guinan I and Guinan II cite medical monitoring cases from Pennsylvania and New Jersey. In Pennsylvania one of the seven essential elements of medical monitoring is an increased risk “caused by the defendant’s negligence.” Redland Soccer Club, Inc. v. Department of the Army, 696 A.2d 137, 145 (Pa. 1997). In New Jersey, medical monitoring is not allowed at all in product liability actions. Sinclair v. Merck & Co., 948 A.2d 587, 594-95 (N.J. 2008). See also, e.g., Potter v. Firestone Tire & Rubber Co., 863 P.2d 795, 823 (Cal. 1993) (“as a result of a defendant's tortious conduct”); Meyer v. Fluor Corp., 220 S.W.3d 712, 717 (Mo. 2007) (“consequences of the defendant’s tortious conduct”); Hansen v. Mountain Fuel Supply Co., 858 P.2d 970, 979 (Utah 1993) (“which exposure was caused by the defendant’s negligence”); Bower v. Westinghouse Electric Corp., 522 S.E.2d 424, 432 (W. Va. 1999) (“through the tortious conduct of the defendant”); Petito v. A.H. Robins Co., 750 So.2d 103, 106 (Fla. App. 1999) (“caused by the defendant’s negligence”).

Thus, in the end, we have to conclude that the pair of Guinan decisions produced a parody of established medical monitoring law. Delaware hasn’t recognized medical monitoring at all, and certainly hasn’t applied it to drug/device product liability cases. A federal court sitting in diversity has no business making that kind of decision for a state. Beyond that, even if Delaware were to recognize this very controversial tort – it’s still a tort. Medical monitoring isn’t free health insurance – the law doesn’t make a product manufacturer pay for somebody’s medical tests simply because it admits that those tests might be a good idea. There has to be a tort – some form of wrongful conduct – and in Guinan there simply wasn’t. The court recognized that, by dismissing every other cause of action that the plaintiffs had, whether based on negligence, strict liability, warranty, or fraud, but decided to let the plaintiffs proceed anyway.

We think Justice Cardozo said it best:

The judge, even when [s/]he is free, is still not wholly free. [S/]He is not to innovate at pleasure. [S/]He is not a knight-errant roaming at will in pursuit of [her/]his own ideal of beauty or of goodness. [S/]He is to draw his[/her] inspiration from consecrated principles. [S/]He is not to yield to spasmodic sentiment, to vague and unregulated benevolence.

Benjamin N. Cardozo, "The Nature of the Judicial Process," at 141 (1921) (sexist language from the period cleaned up).

Simply stated, the tort law should not give away defendants’ money like Christmas presents, and judges should not play Santa Claus.

Generic Drug Preemption - Reconsideration denied in Morris

A tip of the cyberhat to Kennedy Simpson over at Thompson, Morris & Simpson for passing along the good news that reconsideration was just denied in the generic drug preemption case, Morris v. Wyeth. Here's the slip opinion. This isn't your usual two paragraph denial of reconsideration, either. It's a 20-pager.

The rulings: (1) McKenney v. Purepac Pharmaceutical Co., 83 Cal. Rptr. 3d 810 (Cal. App. 2008), got it wrong in finding generic and name-brand preemption indistinguishable, and in any event was bound by a prior California Supreme Court decision; (2) Demahy v. Wyeth, Inc., 586 F. Supp.2d 642 (E.D. La. 2008), incorrectly read the FDA's regs and administrative history with respect to CBEs and generic drugs; (3) neither Swicegood v. Pliva, Inc., 543 F. Supp. 2d 1351 (N.D. Ga. 2008), nor Sharp v. Leichus, 2006 WL 515532 (Fla. Cir. 2006), were preemption decisions; (4) the after-the-fact views of an individual congressman don't qualify as legislative history, thus there was "no reason to view Representative Waxman’s views as indicative of congressional intent"; and (5) the views of a state attorney general could not possibly express federal congressional intent.

Keep those wins coming.

FAS 5 Update: Roundtable Meeting On March 6

We've posted before about the Financial Accounting Standard Board's proposal to revise how the accounting rules deal with loss contingencies, such as pending litigation. (Our most recent post on that subject was back in December. An earlier post was here.)

FASB has now announced that its roundtable meeting on contingencies will take place on Friday, March 6, 2009, at the FASB offices located at 401 Merritt 7, Norwalk, CT. Seating is available to members of the public on a first-come, first-served basis. The morning session will be from 9–11:30 a.m. and the afternoon session will be from 2–4:30 p.m. If you are unable to observe the meeting in person, the roundtable sessions will be available via audiocast on the FASB’s website.

Upcoming Events Featuring . . . Us!

Both of your humble scribes have agreed to participate in upcoming academic symposia to discuss the issue of preemption.

Herrmann will participate in the NYU Annual Survey of American Law Symposium, "Tort Law in the Shadow of Preemption," in New York City on Friday, February 27. Other speakers include Richard Nagareda, Peter Schuck, Catherine Sharkey, Richard Epstein, Elizabeth Cabraser, and Allison Zieve.

Bexis will particpate in the Hamline Law Review Symposium, "The Food, Drug and Cosmetic Act: Searching for the Crossroads of Safety and Innovation," in Saint Paul on Friday, April 3. Other speakers include Richard Samp, Robert Weiner, Catherine Sharkey (she gets around, doesn't she?), David Prince, and David Vladeck.

And, in a slightly less scholarly mode, Herrmann will be presenting his "book talk" about The Curmudgeon's Guide to Practicing Law at Harvard Law School at noon on Wednesday, March 11. For information about that event, contact Elaine Ventola in Harvard Law's Office of Career Services.

If you read the blog and choose to attend any of those events, please do introduce yourself.

Supplemental PMA = Preemption

Any time that a manufacturer of a PMA device modifies that device in a way that affects its safety or effectiveness, the manufacturer must file a PMA "supplement". We've posted before that PMA supplements should be, and generally are, accorded the same preemptive effect as initial PMAs. The other day the Wisconsin Supreme Court agreed. Its discussion of why PMA supplements are every bit as preemptive as initial PMAs is the most thorough we've yet seen. If you're interested in preemption and PMA supplements, you'll want to read it. Blunt v. Medtronic, Inc., ___ N.W.2d ___, 2009 WL 367768, at *7-11 (Wis. Feb. 17, 2009)

Appeal Allowed In De Bouse v. Bayer

This post discusses a piece of the Baycol litigation, in which Bexis's firm is involved. Herrmann alone is thus serving as your humble scribe.

It's altogether fitting and proper that he should do this, because the news relates to Illinois, Herrmann's (relatively) new home state.

Chicagoans were justifiably proud on Election Night, as crowds poured into Grant Park to celebrate the election of a favorite son to the presidency. Just two months later, Chicagoans hid their faces in shame, as the state legislature impeached and convicted Governor Rod Blagojevich.
Four months ago, Chicago defense lawyers hid their faces in grief, as the Fifth District Court of Appeals (downstate of Chicago, by the way) decided De Bouse v. Bayer AG, 385 Ill. App. 3d 812, 896 N.E.2d 882 (Ill. App. 5 Dist. 2008). But last month (on January 28), those lawyers should have poured into Grant Park to celebrate, as the Illinois Supreme Court allowed an appeal in the case, offering a chance to restore sanity.

De Bouse is a putative class action pleading that Bayer AG and others committed common law fraud and violated the Illinois Consumer Fraud and Deceptive Business Practices Act by concealing negative safety and efficacy data about the prescription cholesterol drug Baycol.

At her deposition, plaintiff testified that she "had not seen, read, or heard" anything about Baycol and that "she relied on her physician's judgment in purchasing the product." Defendants moved for summary judgment on the ground that plaintiff "could not have been actually deceived or damaged by any misrepresentation or concealment by the defendants." The St. Clair County trial court denied defendants' motion for summary judgment and certified questions of law for interlocutory appellate review.

The questions the appellate court answered were: (1) whether a consumer can state a Consumer Fraud Act claim even though the drug company didn't communicate directly with the consumer, but rather allegedly made fraudulent statements or omissions to third parties, and (2) whether the purchase of an effective product that didn't hurt the plaintiff involved any compensable injury. We dealt with the second of these issues earlier, so if that's what interests you, go there. If the first issue tickles your fancy, read on.


As for reliance, the majority tiptoed through the precedents, distinguishing cases involving "affirmative representations" from cases involving "silent concealment" and distinguishing cases involving "direct deception" from cases involving "indirect deception." The majority held that "indirect deception by silent concealment" was sufficient to state a claim for statutory consumer fraud.

The dissent, in contrast, would have followed a string of Illinois precedent holding that a consumer who seeks statutory redress must see and be deceived by the statements in question. That was particularly true since De Bouse had not pled that her own prescribing physician "had seen, read, or heard any promotional material or advertisements or received any product literature from the defendants and in fact been deceived." There was thus no proximate causation -- nothing linking the alleged fraud to the plaintiff -- anywhere in the neighborhood.

De Bouse illustrates the dangers of courts interpreting statutory causes of action to create unlimited liability for defendants. The Illinois Supreme Court's allowance of an appeal may mean that the high court recognizes, and will correct, the appellate court's interpretation.

Good News on the Class Action Front

The Ninth Circuit has granted en banc review of a panel decision affiming the largest class action in history in Dukes v. Wal-Mart. While it's mostly a labor law/discrimination case, and thus outside our sphere, one aspect of the class action is whether constitutional law permits punitive damages to be awarded on a class-wide basis. We've argued strenuously here and here (and Bexis filed two amicus briefs in Dukes, with another one possibly coming) that the answer to that latter question has to be "no" after the Supreme Court's decision in Williams v. Philip Morris.

We Finally Show Mixed Emotions: Banning DTC Ads For Two Years

We spoke recently to an in-house lawyer at a generic drug company.

(Aw, c'mon, innovator clients! You can't fire us for that! Surely we're allowed to talk to the guys, even if we can't represent 'em.)

The generic guy was outraged that Representative Waxman wants Congress to pass a bill barring direct-to-consumer advertising for the first two years that a new drug is being sold. (Here's a press report on that effort. And another, more recent, one.) Waxman's worried that aggressive DTC marketing "increases the number of consumers exposed to safety risks of new products long before those risks are truly understood.”

Why was the generic guy disturbed about a statute limiting advertising by innovators? You're not thinking hard enough: Generic manufacturers want the innovators to spend a ton of money on catchy musical jingles and celebrity spokespatients so there's plenty of demand for the product when it goes generic years later. The innovators' advertising expenses redound in part to the generics' benefit.

But how should the innovators themselves feel about banning DTC ads for the first two years of a new drug's life?

As a rule, we never have mixed emotions at the Drug and Device Law Blog. We're making an exception here.

On the one hand, the FDA weighs the risks and benefits of new drugs. If a drug is approved, then the FDA has decided that the drug is sufficiently safe and effective to be made available to the public. Is there a reason to limit that decision?

Moreover, we're big believers in the First Amendment, and drug companies shouldn't lightly be barred from making truthful statements about the risks and benefits of their products.

And, on a completely non-legal front, if sales of new drugs are artificially depressed for the first two years of a new product's life cycle, there will be less revenue available for investigating and developing new drugs. That's a substantial cost to impose on society.

On the other hand, your dynamic blogging duo basically works in legal, not marketing. That makes us naturally conservative. If the company sells less of a product, then there are fewer people exposed to the product, and fewer potential plaintiffs. That would make mass torts less massive and all litigation easier to defend.

And, of course, if the law barred DTC advertising for two years, we could explain to juries that the law requires not just FDA approval of a new drug, but also an intentionally slow introduction to the market to help protect public safety, even if that slow introduction reduces corporate profits.

So we're of two minds on this issue.

But we can't stop there: Remember the decision in West Virginia ex rel Johnson & Johnson v. Karl, 647 S.E.2d 899 (W. Va. 2007), which rejected the learned intermediary doctrine? (If you don't remember it, you can refresh yourself by reading one of our outraged earlier posts here.)

Karl reasoned in part that direct-to-consumer advertising "obviates each of the premises upon which the [learned intermediary] doctrine rests." If Congress bans DTC ads for the first two years of a drug's life, then Congress may help to undo Karl, which we deemed one of the worst decisions of 2007.

By passing what purports to be a consumer protection bill, Congress may unintentionally help to undo a purportedly consumer-friendly decision from West Virginia's Supreme Court.

Even if your emotions are mixed on other issues, you've gotta be tickled by the irony in that possibility.

Recusal Follies

Last week we encountered arguments from the other side that any justice (at least any justice that might be defense oriented) owning any stock in any pharmaceutical company ought to recuse him/herself from Wyeth v. Levine because that ruling might affect the stock price of any drugmaker - even though not currently involved in the case.


This week, the recusal craziness focuses on the Sprint Fidelis litigation, according to an article in today's Wall Street Journal (subscription required). The plaintiffs in that MDL - having lost big-time on preemption - are apparently now seeking to recuse the judge, Hon. Richard Kyle, because his son represents the defendant (Medtronic) in unrelated, non-litigation matters.


We've been practicing a long time, and can't remember ever seeing a recusal under such circumstances. First, it's not the judge himself, but a member of his family. Second, it doesn't involve any law firm that's ever been involved in the litigation. Third, it doesn't even involve a positional conflict - the son's representation of Medtronic apparently was limited to business advice (mergers and intellectual property, according to the article).


If this toxic mixture of crocodile tears and sour grapes goes anywhere, we might as well just set a rule that none of a federal (or state, there doesn't seem to be any ethical difference) judge's relatives can practice law. That's what the argument that the plaintiffs are making comes down to.


What's a judge supposed to do? Must the judge require every one of his/her lawyer relatives to run a conflict check for every party to every matter (a judge can have hundreds of cases on his/her docket at any given time) that s/he gets assigned?


We sure hope not. Judges aren't paid enough for what they have to do as it is.


This sort of recusal mania has nothing to do with ethics. It's simply forum shopping by another name.


It's hard for us to have much sympathy with the plaintiffs' position. We haven't seen any plaintiffs' lawyers express any problem in litigating cases before state-court judges to whom they (or their firms) have given large campaign contributions. Some enterprising investigative reporter should take a look at the campaign contributions of the plaintiffs' firms active in the Sprint Fidelis (or any other mass tort) litigation.


If there needs to be any expansion of the reasons for judicial recusal, and we're not entirely convinced that there is, it's not in the area of a relative's representation in matters having nothing to do with anything. The area that needs to be looked at is campaign contributions. There should be some process for seeking recusal of a judge where s/he has received significant campaign contributions from the lawyers or other members of the law firms representing actual parties to actual litigation.


A recusal rule in this area would forestall a lot more funny business - and a lot more actual impropriety - than any of this bleating that we've heard lately about recusal for indirect, incidential economics or relatives' unrelated representations.

Defeating FDCA-Based Negligence Per Se On State-Law Grounds

We’ve been keeping an eye on some interesting litigation in the District of Columbia, Iacangelo v. Georgetown University, C.A. No. 05-2086 (PLF). It’s not even a drug or device case, but rather a suit against a hospital and some doctors over their off-label use of certain "substances" in a medical procedure that went awry. We’re not entirely clear from the opinion whether the stuff involved were considered drugs or devices (we suspect devices, but weren’t that motivated to research the point). We know that the plaintiffs alleged that they were “injected into [the] brain.” Id. at *1.

What makes Iacangelo different from the vast majority of medical malpractice litigation is that the plaintiffs did not sue as much for malpractice as over what they claimed were violations by the doctors of the Food, Drug and Cosmetic Act (“FDCA”).

The case first came to our attention when the District Court excluded an expert witness for the plaintiffs who offered opinions on what was, and was not, legal under the FDCA. We posted about that here.

Well, Iacangelo is back again, and as interesting as ever.

The new opinion, Iacangelo, v. Georgetown University, ___ F. Supp.2d ___, 2009 WL 250478 (D.D.C. Feb. 3, 2009), grants summary judgment against plaintiff’s negligence per se claim based upon claimed FDCA violations. As we’ve discussed before, “negligence per se” is one way that plaintiffs in medical device product liability litigation try to package the kinds of “parallel violation” claims that they argue gets them around the preemption ruling in Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008). If Levine comes down the right way, we would expect to see similar efforts on the drug side.

So any case that throws out an FDCA-based negligence per se claim as a matter of law is sure to grab our attention as we prepare for what might well be a preemption-dominated landscape in our area of practice.

So what happened in Iacangelo and why?

The off-label use in the case occurred in a therapeutic rather than research setting. That means that the doctors used the drugs the way they did only to try to cure one particular patient, and not to study the drug's safety or effectiveness in that use. Thus the doctors and hospital never applied for an Investigational Drug Exemption (“IDE”), did not set up an Institutional Review Board, nor established any of the other trappings of an FDA-regulated clinical study.

Plaintiffs tried to turn that into a tort. They alleged that the defendants violated the FDCA in conducting off-label use outside of the IDE context and alleged that this violation constituted negligence per se. Iacangelo, 2009 WL 250478, at *1. The defendants moved for judgment on the pleadings against this claim, but the magistrate said no. Iacangelo v. Georgetown University, 580 F. Supp.2d 111, 119-20 (Mag. D.D.C. 2008). The defendants appealed to the Article III judge.

And won (actually the procedure was considerably more complicated, but not in anything that matters to what we want to discuss).

Here’s how that happened.

The plaintiffs based their negligence per se action on the defendants’ use of “adulterated” or “misbranded” drugs/devices – the alleged violation solely being related to their off-label use. They alleged nothing intrinsically wrong with the substances in question. The defendants were liable for “adulterated” or “misbranded” products because they supposedly: (1) introduced them into interstate commerce, (2) used them together, (3) received them from interstate commerce, (4) created an unapproved “new” drug/device by using them together, and/or (5) ignored the FDA labeling. 2009 WL 250478, at *2-3.

Without getting into any preemption arguments, the court held that these allegations did not state a cause of action for two reasons.

We dealt with the first reason for dismissal before: that the standard set by the particular FDCA section the plaintiff relied upon was too open-ended to provide a common-law legal standard. The District of Columbia, like most states, requires that the allegedly violated statute set out a standard more specific than the usual negligence “reasonableness” standard:

[W]e conclude that the trial court’s modified instruction was not error because [the provision] is too general a statute to be the subject of a negligence per se instruction. A statute or regulation offered to establish a standard for negligence per se purposes must not merely repeat the common law duty of reasonable care, but must set forth ‘specific guidelines to govern behavior. [A] negligence per se instruction [is] improper because [the] generality of [the] regulation. . .did not differ significantly in particulars from the common law standard of reasonable care in the circumstances.

Chadbourne v. Kappaz, 779 A.2d 293, 296 (D.C. 2001) (citations omitted).

The section that plaintiffs relied upon was 21 U.S.C. §331. But the court found that §331 merely prohibited “adulteration” and “misbranding” without going into any detail about what that means. It wasn’t enough that §331 “governed behavior.” Rather, it didn’t govern behavior any more than telling somebody they had to get a license:

The principal problem with plaintiffs’ attempt to base claims of negligence per se on §331 is that §331 simply sets forth – in prohibitory terms – the basic requirement of the FDCA and its implementing regulations that FDA approval is required for commercial distribution. . . . That basic requirement does not embody a substantive standard of care, but rather an administrative requirement aimed at furthering the FDCA’s regulatory goals.

2009 WL 250478, at *4 (footnote omitted) (citing Talley v. Danek Medical, Inc., 179 F .3d 154, 161 (4th Cir. 1999); King v. Danek Medical, Inc., 37 S.W.3d 429, 456-60 (Tenn. App. 2000)). Thus, for common-law purposes, §331 is simply “an administrative requirement – not a substantive standard of care that can support plaintiffs' negligence per se claim.” 2009 WL 250478, at *4.

This ruling falls about midway between the “mere licensing statute” and “too general” defenses to negligence per se that we discussed in our prior post. With respect to the first (licensing) aspect of the court’s ruling, in addition to the cases cited in Iacangelo, a number of other FDCA-based negligence per se claims have met the same fate: Knoth v. Smith & Nephew Richards, 195 F.3d 355, 358 (8th Cir. 1999); Lillebo v. Zimmer, Inc., 2005 WL 388598, at *4-5 (D. Minn. Feb. 16, 2005); Barnett v. Mentor H/S, Inc., 133 F. Supp.2d 507, 511-12 (N.D. Tex. 2001), affirmed mem., 31 Fed. Appx. 156 (5th Cir. Dec. 13, 2001); Alexander v. Smith & Nephew, P.L.C., 98 F. Supp.2d 1310, 1321 (N.D. Okla. 2000) (and several adjacent identical opinions with the same name); Little v. Depuy Motech, Inc., 2000 WL 1519962, at *7 (S.D. Cal. June 13, 2000); Holland v. Smith & Nephew Richards, Inc., 100 F. Supp.2d 53, 56 (D. Mass. 1999); Minisan v. Danek Medical, Inc., 79 F. Supp.2d 970, 978 (N.D. Ind. 1999); Menges v. Depuy Motech, Inc., 61 F. Supp.2d 817, 828 (N.D. Ind. 1999); Wheat v. Sofamor, S.N.C., 46 F. Supp. 2d. 1351, 1361 (N.D. Ga. 1999); Sita v. Danek Medical, Inc., 43 F. Supp.2d 245, 257 (E.D.N.Y. 1999); Baker v. Smith & Nephew Richards, Inc., 1999 WL 1129650, at *6 (N.D. Ga. Sept. 30, 1999); Johnson v. Smith & Nephew Richards, Inc., 1999 WL 1117105, at *2 (N.D. Okla. Sept. 30, 1999); Uribe v. Sofamor, S.N.C., 1999 WL 1129703, at *15-16 & n.9 (D. Neb. Aug. 16, 1999); Bell v. Danek Medical, Inc., 1999 WL 335612, at *4 (E.D. La. May 24, 1999); Lester v. Danek Medical, Inc., 1999 WL 1061973, at *4 (M.D.N.C. Apr. 16, 1999); Clark v. Danek Medical, Inc., 1999 WL 613316, at *2 (W.D. Ky. Mar. 29, 1999); Richardson v. Smith & Nephew Richards, Inc., 1998 WL 1166780, at *5 (Mag. E.D.N.C. Sept. 22, 1998), adopted, 1999 WL 1132962 (E.D.N.C. Jan. 10, 1999); Kirkman v. Sofamor, S.N.C., 1998 WL 666706, at *4 (W.D.N.C. July 21, 1998); United States v. Barr Laboratories, Inc., 812 F. Supp. 485, 486 (D.N.J. 1993); Flynn v. Biomet, Inc., 1993 WL 540570, at *9 (E.D. Va. July 23, 1993); United States v. 789 Cases of Latex Surgeons’ Gloves, 799 F. Supp. 1275, 1286 (D.P.R. 1992); Southard v. Temple University Hospital, 781 A.2d 101, 107 (Pa. 2001); Freeman v. Hoffman-La Roche, Inc., 618 N.W.2d 827, 837 (Neb. 2000); Bish v. Smith & Nephew Richards, Inc., 2000 WL 1294324, at *5 (Tenn. App. Aug. 23, 2000), appeal denied (Tenn. Oct. 29, 2001); Baker v. Smith & Nephew Richards, Inc., 1999 WL 811334, at *9 (Tex. Dist. June 7, 1999), aff’d mem., 2000 WL 991697 (Tex. App. July 20, 2000).

With respect to the vagueness point, a number of other negligence per se claims based upon alleged “adulteration”/”misbranding” have also been found wanting based upon the vagueness of the statutory standard. Baraukas v. Danek Medical, Inc., 2000 WL 223508, at *4 n.2 (M.D.N.C. Jan. 13, 2000); Shanks v. Upjohn Co., 835 P.2d 1189, 1200-01 (Alaska 1992) (“adulteration” under state “little FDCA” statute); Goodman v. Wenco Foods, Inc., 423 S.E.2d 444, 452 (N.C. 1992) (same); In re Shigellosis Litigation, 647 N.W.2d 1, 10-11 (Minn. App. 2002), review denied (Minn. Aug. 20, 2002); Jones v. GMRI, Inc., 551 S.E.2d 867, 873 (N.C. App. 2001), cert. dismissed, 559 S.E.2d 787 (N.C. 2002) (same as Goodman).

The second state-law ground upon which the Iacangelo court dismissed the FDCA-based negligence per se claim was causation. Nothing in the pleadings suggested that the claimed statutory violation caused or contributed to the plaintiff’s injury. In short, it didn’t matter whether the use was on or off-label – the injury would have been the same. “Mere” lack of FDA approval didn’t have anything to do with the plaintiff being injured. 2009 WL 250478, at *4.

Here, the statutory violation at issue is the use of “adulterated” and/or “misbranded” devices. Plaintiffs therefore would have to show that the mere fact that defendants used “adulterated” and/or “misbranded” devices contributed to [plaintiff’s] injuries. This they cannot do. . . . [I]t is no more logical to infer a causal connection between [these products’] unapproved status and [plaintiff’s] injuries than it is to infer a causal connection between a driver’s lack of a drivers license and injuries he causes while driving.

Id. (citing, inter alia, Talley, 179 F.3d at 161).

Iacangelo thus highlights another inherent problem in many of the “parallel violation” claims that we can expect to see so much of should preemption do away with our opponents’ real claims. Causation in the context of negligence per se is a two step process, a lot like warning defect causation under the learned intermediary rule. Before a plaintiff can even get to the broad causation question of “did the drug/device cause the injury?” s/he must first establish that the violation – the negligence per se equivalent of a defect – caused the injury. In a lot of cases, especially off-label use cases where the violation only concerns regulatory status and not the product’s actual condition, proof that the violation caused any injury will be very difficult.

Finally, a word to the wise for our fellows. If the plaintiffs get pushed heavily into “parallel violation” claims as a result of preemption (knock on wood), we’re going to find ourselves in some new territory. Negligence per se is not something most of us (save yours truly and other Bone Screw veterans) have really had to deal with all that much. We’re going to find ourselves looking at a lot of unfamiliar cases involving car crashes, building fires, and the like. That’s where negligence per se came from – and where, we think, it belongs.

But to win negligence per se cases, it’s critical to know what the defenses are, because they vary from state to state and they aren't evident from the Restatement formulation. Some states, for instance, allow negligence per se only for violations of statutes, and not for administrative regulations, such as Title 21 of the Code of Federal Regulations. These are things that a lot of us haven’t had to think about before, so it behooves us to start now. Every time a plaintiff comes up with a new cause of action, it’s our job to respond with the new defenses.

So while we’re waiting for something new and exciting to come out of the Supreme Court in Wyeth v. Levine, it might be a good idea to crack a book and read up on something old and stodgy like negligence per se.

Special Masters Reject Autism-Vaccine Link

The Blog of Legal Times reports that three special masters for the Court of Federal Claims have issued reports rejecting an alleged link between childhood vaccines and autism. The reports themselves are here.

Giles, An SSRI-Suicide Defense Verdict, Affirmed

The Seventh Circuit just released its published opinion affirming the judgment entered on a defense verdict in an SSRI-suicide case. Giles v. Wyeth, No. 07-3149, slip op. (7th Cir. Feb. 12, 2009) (link here). Since Herrmann both tried the case and argued the appeal, we'll be circumspect with what we say here.

Jeff Giles was 46 years old, unemployed, and in chronic pain in fall 2002, when his physician diagnosed him with major depressive disorder and prescribed the antidepressant Effexor. Giles took three Effexor pills over the course of two days and then committed suicide by gunshot. Giles' widow filed a product liability complaint, alleging that Giles' ingestion of the antidepressant caused him to kill himself.

After a three-week jury trial, the 12-person jury took three hours to render a unanimous defense verdict.

On appeal, plaintiff challenged the trial judge's decisions to (1) exclude warnings that accompanied Effexor after Giles' death in 2002 and (2) admit scientific knowledge learned after Giles' death, which suggests that SSRI or SNRI antidepressants are not associated with suicidality in adults over the age of 24.

The Seventh Circuit first held that the trial court had excluded the later warnings under Federal Rule of Evidence 403, and that decision was reviewable only for abuse of discretion. The trial court did not abuse its discretion because, among other reasons, "the excluded warnings did not help establish that Wyeth knew or should have known about an increased risk of suicidality in adults of Mr. Giles' age. Mr. Giles was forty-six years old when he took Effexor. The excluded post-2002 warnings, however, focused on children and adults younger than twenty-five years old." Slip op. at 8-9.

The trial court also did not abuse its discretion by admitting scientific evidence learned after Giles' suicide. "The question at trial was not whether scientific knowledge in existence in 2002 demonstrated that Effexor caused Mr. Giles to take his life, it was whether Effexor caused him to take his life. If later studies shed light on that answer, all the better." Id. at 12.

With all due respect to ourselves, the legal issues involved in this appeal were routine. The main significance of the decision is simply the fact that another defense verdict in an SSRI-suicide case has been affirmed.

Hither and Yon

Here are three items we saw that might interest you:



First, on Monday, Judge Mark Bernstein (in Philadelphia Common Pleas) decertified a Neurontin off-label use class action, granted summary judgment on express warranty claims, and otherwise permitted the claims of two individual plaintiffs to proceed (they promptly asked for a continuance). Gregory Clark and Linda Meashey v. Pfizer Inc. and Warner-Lambert Co., LLC, No. 1819, Control Nos. 061293/061291, Slip op. (Pa. Ct. Com. Pleas -- Philadelphia County Feb. 9, 2009). Russell Jackson reports on the case here, and we'll defer to his description. But Russell didn't provide a link to the decision itself. As a public service, we provide that link here.



Second, yesterday's New York Times had this piece about the FDA's investigation of dietary supplements used for weight loss that may contain active pharmaceuticals. We don't typically report on stuff that may foment litigation, but we figure that, once a story has hit the front page of the business section of the Times, what we say on our little blog isn't likely to effect things too much. (And, having represented both manufacturers of drugs and manufacturers of dietary supplements, we'll simply note that those two seemingly related industries are often in fact worlds apart.)



Finally, whatever you think of their politics, most people agree that Judges Reinhardt and Kozinski (on the Ninth Circuit) are both exceptionally bright guys. It's thus fun to see the two of them have at it, as they did in the majority and dissent in the recent criminal case of United States v. Cruz. Hat tip to Volokh Conspiracy (which describes the language in Kozinski's dissent), and another hat tip in turn to How Appealing (which simply calls Kozinski's dissent "blistering").

Waiting For Levine

Everyone keeps asking us when the Supreme Court will decide the big preemption case of Wyeth v. Levine. The parties argued the case on November 3; when will the Court rule?

We don't have a clue.

The Supreme Court decides all cases argued during a Term before the Court adjourns for the Summer in the last week of June. So we'll get a decision before the end of June.

We probably won't have to wait that long, because the Court has already been thinking about the case for three months. But you don't have to check the Court's website every morning to see if the decision has been posted, because the Supreme Court doesn't release opinions every day.

The Court typically releases opinions on "Tuesday and Wednesday mornings and on the third Monday of each sitting, when the Court takes the Bench but no arguments are heard." The exceptions to this rule are for (a) time-sensitive matters (such as election rulings); and (b) the end of the term, typically beginning in mid-June, when the Court releases opinions on additional days.

Wyeth v. Levine has no time urgency, so the Court may release its opinion on the following days this Term:

February 23 - 25 (argument days);

March 2 - 4 (argument days);

March 9 (designated Monday);

March 23 - 25 (argument days);

March 30 - April 1 (argument days);

April 6 (designated Monday);

April 20 - 22 (argument days);

April 27 - 29 (argument days);

May 4, 18, and 26 (designated Mondays and the Tuesday after Memorial Day); and

June 1, 8, 15, 22, and 29 (designated Mondays).

And, as noted above, the Court typically releases opinions on additional days beginning in mid-June.

Those are the mornings to watch.

Or you can just stay tuned here. We'll do our best to let you know as soon as we hear a peep from the Court.

He Likes It! -- We Think

Scott Greenfield blogs at Simple Justice, and he prides himself on being a curmudgeon. He even has a "curmudgeons' club," and he knows who the members are. Herrmann ain't one.

Greenfield thus wasn't amused to hear about Herrmann's book, The Curmudgeon's Guide to Practicing Law. Greenfield was The Curmudgeon; Herrmann wasn't entitled to this antonomasia.

But Greenfield's now read the book, and he likes it! -- we think. We're not quite sure, because he's got an odd sense of humor. Here's a link to his review; judge for yourself.

For those interested in less quirky opinions, here's a compilation of other reviews of the book.

Back to drug and device law later today.

The Second Shoe Drops In Seroquel

On January 30, Judge Anne Conway granted summary judgment in favor of AstraZeneca in the first of two Seroquel test cases in the federal MDL.

At the end of last week -- on Friday, February 6 -- Judge Conway entered the order granting summary judgment in the second test case, Haller v. AstraZeneca Pharmaceuticals LP, No. 6:07-cv-15733-Orl-22DAB, slip op. (M.D. Fla. Feb. 6, 2009) (here's the obligatory link to the opinion).

Bexis's firm is still involved in these cases, so Bexis is still not participating in drafting posts about the cases. Herrmann alone is responsible for what follows.

And Herrmann's heading off to court in less than an hour. And this opinion weighed in at 68 pages. Forgive the brevity of what follows, but we're struggling to keep you abreast of the drug and device news while continuing to practice law in our spare time.

Haller is another Seroquel-diabetes case. The plaintiff, David Haller, is 47 years old. He had a troubled childhood, was in and out of juvenile detention centers and psychiatric hospitals in his teens, and completed formal education only through third grade. He "accumulated a lengthy criminal record" over time and was involuntarily committed to "psychiatric hospitals on at least seven separate occasions."

Haller suffered from several chronic non-psychiatric health conditions, including gastroesophageal reflux disease, high cholesterol, and high blood pressure, and he experienced significant weight fluctuations throughout his adult life. In addition, he has a history of alcohol abuse, smoking, and not exercising.

Haller was first prescribed Seroquel (presumably for bipolar disorder, with which he had been diagnosed in 1987) in October 2002, and continued taking the drug through at least July 2008. He was diagnosed with diabetes in August 2004.

Haller offered two expert witnesses to support specific causation in his case -- Dr. Brian Tulloch an endocrinologist, and Dr. I. Jack Abramson, a psychiatrist. The court found that neither expert's testimony was admissible under Daubert.

During his deposition, Dr. Tulloch admitted that he didn't physically examine Haller, speak to him, or review all of his medical records before Tulloch gave his expert opinions. Moreover, Tulloch's expert report was filled with errors and omissions. It gave the wrong date on which Haller had begun taking Seroquel. Tulloch didn't know what dose of Seroquel Haller had taken during certain time periods. Tulloch didn't know how much Haller weighed when he started taking Seroquel. And so on.

Tulloch also "could not rule out" sedentary lifestyle and psychosis "as the sole cause of Haller's weight gain when he was on Seroquel." Slip op. at 11. Tulloch agreed that the complications that Haller supposedly suffered from diabetes "may have been solely caused by pre-existing obesity, years of smoking, metabolic syndrome, and uncontrolled hypertension that preceded Haller's ingestion of Seroquel." Id. at 12. Tulloch also conceded (among many other things) that "Haller would have developed diabetes at some point even if he had never taken Seroquel." Id. at 13. Tulloch couldn't explain why Seroquel was responsible for weight gain when Haller had lost an equal amount of weight while taking Seroquel, and Tulloch couldn't isolate what contribution Haller's other medications might have made to his weight gain.

After AstraZeneca moved to exclude Tulloch's testimony and for summary judgment, Tulloch filed a declaration to try to repair the damage done by his deposition testimony. The opinion describes that declaration, and Tulloch's testimony at a later Daubert hearing, at some length. Id. at 20-45. Those 25 pages provide very little to help the plaintiff's side. The Court ultimately decided to exclude Tulloch's testimony under both the reliability and relevance prongs of Daubert, noting that "there are so many Daubert problems associated with Dr. Tulloch's opinions that it is difficult to know where to begin." Id. at 45. The court also made a point of saying that it had "not seen a clearer case of an expert being maneuvered by counsel to elicit an opinion with which he is not really comfortable." Id. at 50.

Dr. Abramson, the psychiatrist, fared no better. Abramson was unqualified to express a diabetes causation opinion because he had never diagnosed a patient with diabetes, doesn't treat patients for diabetes, and has no expertise in diagnosing the cause of diabetes in individuals. Id. at 56-57. Abramson's testimony also suffered from "many of the relevance and reliability concerns raised by Dr. Tulloch's testimony." Id. at 57.

As in the other test case of Guinn, the court concluded that plaintiffs had offered no evidence from which a reasonable jury could find causation under Florida law, and so granted summary judgment in favor of AstraZeneca. Id. at 67. As in Guinn, the court emphasized that its ruling applied only "to the specific facts" of this case, and that other cases may present distinguishable facts or arise under other states' laws and so might fare differently. Id.

The Haller decision, like Guinn, turns on specific causation, and so leaves open the possibility that plaintiffs might prevail in other cases in the Seroquel MDL. On the other hand, the huge collection of gaps in the expert witnesses' testimony suggests that many hurdles stand between the plaintiffs and recovery in these cases.

Bert Rein On The Politics Of Preemption

Bert Rein, of Wiley Rein LLP, prepared the following guest post. We thank him for the contribution, and the credit for what follows naturally goes to Bert alone:

As we anticipate decision in Wyeth v. Levine when the Supreme Court reconvenes on February 23, we continue to see how contentious an issue preemption has become in public and political debate. Congressman John Dingell, for example, has jumped on the salmonella-contaminated peanut butter bandwagon to introduce legislation expanding food safety inspection and civil penalty powers and added a sweeping savings clause precluding the FDCA, or any amendment to FDCA from “modifying or otherwise affecting any action or the liability of any person … under the law of any state.” The AAJ (formerly ATLA), never hesitant to endorse an opportunity for expanded litigation, has applauded Mr. Dingell’s recognition that “FDA enforcement is not enough” and that we need “the right of consumers to seek justice on these issues in the court system.”

It would only be realistic to anticipate a similar political response to a pro-preemption ruling in Levine. Whether a savings clause would succeed in overriding implied Constitutional preemption – as one failed to do in Geier – is a difficult question. Nevertheless, future preemption litigation would be complicated by such an expression of Congressional intent, even one that glosses over the fact that the real issue in preemption is not whether a legal remedy exists for the plaintiff, but what standard (a priori federal regulatory or ex post common law) will be used to evaluate the defendant’s conduct.

To complicate the political picture, there are instances in which those seeking the benefit of preemption push it to extremes that can obscure the core standards issue and conflate preemption and immunity from suit. A prime example is the position taken by generic companies, as recently evidenced in the Conte v. Wyeth case, that label-based liability cannot be asserted against them so long as their labeling is identical to the labeling of the branded drugs they copy. Since only NDA holders can initiate labeling changes, they argue, faulting generics for failing to initiate a labeling change even when they dominate the market and have access to significant new safety information would make it impossible for them to comply with both state and federal law.

The flaw in this argument is its failure to distinguish between the identical labeling required for a generic to gain ANDA approval and the FDA responsibilities incurred by an ANDA holder after approval. FDA has made it clear that ANDA holders may initiate labeling changes by sNDA, regardless of the position of the branded manufacturer. Moreover, by informing FDA of new safety information, an ANDA holder can prompt FDA to take persuasive and now compulsory action to modify the labeling of all manufacturers of the drug. Thus, a generic manufacturer seeking to disclaim the possibility of modifying its label on the basis of information that would require a branded manufacturer to make a change is crying wolf and crying wolf on a basis that disparages the compelling arguments for the preemptive effect of fully-informed FDA labeling decisions. That is not to say, of course, that a preemption defense should not be available to generic manufacturers. It is simply to point out that generic preemption should be subject to the same conditions and limitations as branded preemption.

Courts that have thoughtfully considered generic responsibility have concluded that Hatch-Waxman was not intended to absolve generic manufacturers of responsibility for their labeling. Foster v. American Home Products Corp., 29 F.3d 165, 169 (4th Cir. 1994); Kelly v. Wyeth, No. Civ. A. MICV200303314B WL 4056740 at *54 (Mass. Super. Ct. May 6, 2005); Sharp v. Leichus, Case No. 2004-CA-0643, 2006 WL 515532 at *7 (Fla. Cir. Ct. Feb. 17, 2006). Conversely, courts that have given generics a free pass -- either on preemption grounds or by permitting them to rely on the branded PDR for commercial purposes while disavowing it for legal purposes as in Conte -- have contorted product liability law to foist unwarranted liability on branded manufacturers.

If preemption and uniform federal conduct standards are to be preserved against the inevitable onslaught from those who never saw a lawsuit they didn’t like, we who advocate preemption must be sensitive to potential excesses, cognizant of promising preemption on the decisions of a properly informed FDA and willing to avoid taking positions that allow preemption to be portrayed as a “get out of jail free” card rather than a vehicle for ensuring uniform, nationwide regulation under scientifically-based standards.

Wyeth Letter to Supreme Court re Pfizer Acquisition

The blogosphere has raised an issue about the possible effect of Pfizer's acquisition of Wyeth on the pending Supreme Court case of Wyeth v. Levine.

To keep our readers abreast of the situation, we post here a link to Seth Waxman's letter to the Supreme Court (on behalf of Wyeth) explaining that Pfizer and Wyeth "expect the transaction to close at the end of the third quarter or during the fourth quarter of 2009," and that the proposed acquisition does not warrant "amendment of the corporate disclosure statement in [Wyeth's] previously-filed briefs."

As a practical matter, the justices presumably voted on Wyeth v. Levine during their conference immediately after the argument on November 3, and later developments are thus unlikely to create an appearance of impropriety.

The New Voice In The Blogosphere

It's a pleasure to have an intelligent, articulate, defense-minded voice join us in the blogosphere.

(Lord knows, we can use all the help we can get.)

So we welcome aboard our new visitors who came through this link from Russell Jackson's Consumer Class Actions and Mass Torts blog.

We're also delighted to be spared the effort of writing up Williams v. Nidek Co., Ltd., 2009 WL 226024 (Cal. App. 4th Dist. Feb. 2, 2009), in which the California Court of Appeal affirmed the denial of class certification in a case involving people who had undergone Lasik surgeries to correct far-sightedness, and had not suffered personal injuries. Russell writes up the case here, and we're delighted to rely on that analysis and save ourselves the effort of thinking about it separately.

No Injury Consumer Fraud Claims

As readers who use our No Injury Scorecard know, we’re very interested in identifying situations where plaintiffs – and especially consumer fraud plaintiffs – get dismissed because they don’t have (or don’t choose to allege) a legally sufficient injury.

Why?

Class actions, mostly. As we’ve pointed out before, the plaintiff-side class action aggregators have pretty much been expelled from the product liability/personal injury temple. This trend – that personal injuries and class actions don’t mix – is so pronounced that even more recent drafts of the ALI’s Principles of Aggregate Litigation (which we think has an inordinate fondness for class actions) admit it.

So to keep their straws in the prescription medical product honey pot, the class action purveyors had to find something else to sue over – several things, actually. They now like pure economic loss claims. But they can’t use (at least in most places) traditional tort causes of action because of other impediments, such as reliance requirements that bar most traditional fraud class actions and the economic loss rule, which precludes purely economic losses from being recovered in negligence or strict liability. Maybe one day we'll post about those, but not today.

Hence the recent emphasis on consumer fraud statutes.

But in the consumer fraud arena, most of these statutes (even California, now) require that there be some sort of actual, concrete loss. The more favorable statutes require a loss of money or property. Others, with vaguer damage provisions (such as New Jersey’s “ascertainable loss” standard) have, not surprisingly, seen more action from the other side of the v.

In those cases – as far as the damage requirement goes – our bottom line is this: if a particular individual (whether a class representative or just a class member) took/used the drug/device and (1) it provided effective relief of the condition it was prescribed to treat, and (2) the person didn’t suffer whatever risk allegedly wasn’t warned about, then the case shouldn’t be in court.

In that situation, not only wasn’t there any harm (the stuff worked and caused no other injury) but it would be unfair to the defendant to permit any recovery. Basically, that particular plaintiff/class member got exactly what s/he paid for. Whatever unwarned-of risk is being litigated didn’t affect this person. There’s no injury, and thus no basis for recovery. Any recovery amounts to a windfall.

Not only is this the right result for a whole host of social and jurisprudential reasons – but it has an extra added benefit that (from our perspective as defense lawyers) is even better. It should defeat class certification.

Why?

The spiel used to justify economic loss class actions is that economic damages can simply be calculated on the basis of some formula, and because of that, they aren’t an “individualized” issue (like calculating personal injury damages) that defeats class certification. But if the fact of injury – putting aside the amount – is dependent upon the existence of personal injury, then most if not all of the individualized issues that surround personal injuries get reincorporated into the consumer fraud action, even if the only damages actually recoverable are economic.

So the argument that the plaintiff wasn’t hurt because s/he got exactly what s/he paid for has the added bonus (beyond simply making logical sense) of defeating class certification. How does it do in court?

Pretty well, most of the time.

The first time we ever ran across the argument was in a rather weird context – constitutional, that is “case or controversy,” standing. Rivera v. Wyeth-Ayerst Laboratories, was (predictably) a class action for economic loss. Insurers were suing over their (alleged) payment for prescriptions for a drug with an unwarned-of risk. But the drug was effective, and only a few people (twelve) ever encountered the risk. Despite that, the insurers sought reimbursement for every prescription they reimbursed during whatever class period was alleged.

Well, pigs get fat, but hogs get slaughtered. And this overreach got slaughtered.

The Rivera court held “no way.” The class alleged no injury that could even count as a case or controversy under Article III of the U.S. Constitution. First, there was no claim in contract/warranty:

By plaintiffs’ own admission, [the class representative] paid for an effective pain killer, and she received just that - the benefit of her bargain. An award of damages for breach of contract is supposed to place the injured party as nearly as possible in the position that he would have occupied had the defaulting party performed the contract. [The drug] worked. Had [defendant] provided additional warnings or made [the drug] safer, the plaintiffs would be in the same position they occupy now. Accordingly, they cannot have a legally protected contract interest.

283 F.3d 315, 320 (5th Cir. 2002). Second, there was no claim in tort:

The plaintiffs apparently believe that if they keep oscillating between tort and contract law claims, they can obscure the fact that they have asserted no concrete injury. Such artful pleading, however, is not enough to create an injury in fact. . . . By definition, [plaintiff’s] no-injury “damages” will not vary with [defendant’s] degree of negligence or the drug's propensity for harm. [Plaintiff] has not even indicated what additional warnings [defendant] should have included. . .perhaps because as one not injured by the drugs, she does not know.

Id. at 320-21.

Hard on the heels of Rivera, came a similar decision involving the diabetes drug Rezulin. That drug allegedly carried inadequate warnings about liver injury. A class of alleged users brought consumer fraud claims even though they never got hurt by the drug, and it had treated their conditions (diabetes) effectively. The court held that there were no damages, even under the capacious terms of the New Jersey consumer fraud statute:

Every one of these theories would involve issues individual to the particular class member. . . . Plaintiffs’ contention that everyone who took [the drug] sustained an ascertainable loss presumes that [it] was worthless. But that is not a defensible position. Even plaintiffs’ experts acknowledge that [the drug] was enormously beneficial to many patients. Those patients presumably got their money's worth and suffered no economic injury. And the question whether an individual class member got his or her money’s worth is inherently individual. Indeed, it involves very much the same questions as would a claim for money damages for personal injury.

In re Rezulin Products Liability Litigation, 210 F.R.D. 61, 68-69 (S.D.N.Y. 2002); see Zehel-Miller v. Astrazenaca Pharmaceuticals, LP, 223 F.R.D. 659, 664 (M.D. Fla. 2004) (quoting and following Rezulin).

A year later, another court put the question thusly: “The question. . .is whether patients who were prescribed a drug for pain, and who personally suffered no ill effects or lack of efficacy, can sue for money damages. . .as consumers injured by. . .allegedly-fraudulent advertising claims.” Williams v. Purdue Pharma Co., 297 F. Supp. 2d 171, 172 (D.D.C. 2003). After reviewing the plaintiffs and their allegations, the court noted the disconnect between the two. Id. at 176 (“[t]he class these plaintiffs seek to represent, however, has not had those problems”) (emphasis original). The class could not sue over alleged injuries to other people:

Although the plaintiffs allege a “benefit of the bargain” theory of injury, they do not allege that [the drug] failed to provide them effective pain relief or that they suffered any adverse consequences from their use of [the drug]. . . . Without alleging that a product failed to perform as advertised, a plaintiff has received the benefit of his bargain and has no basis to recover purchase costs. . . . Those patients who purchased [the drug]. . ., and who obtained effective pain relief without addiction received the “benefit of their bargain.” Those who did not, as plaintiffs concede, can be compensated through tort law.

Id. To the extent there were misrepresentations without injury, the government, but not private plaintiffs, could enforce consumer protection statutes. Id. at 177.

Almost simultaneously, another court adopted essentially the same argument – although the class action claims involved were unjust enrichment and warranty, rather than consumer fraud. Again, economic loss does not occur where the drug is effective and the plaintiff was not injured:

The Court cannot accept this argument, however, for it is based on the premise that Baycol did not provide any benefit. . . . [T]o succeed on either the unjust enrichment or breach of warranty claims, Plaintiffs would have to demonstrate that they were either injured by [the drug], or that [the drug] did not provide them any health benefits.

In re Baycol Products Liability Litigation, 218 F.R.D. 197, 213-14 (D. Minn. 2003). See also Heindel v. Pfizer, Inc., 381 F. Supp.2d 364, 379-80 (D.N.J. 2004) (class action claim that purchasers of a “medicine whose benefits they clearly enjoyed” were nevertheless “entitled to reimbursement for some or all of the purchase price” was “patently absurd”; “recoveries by those whose products function properly means excess compensation”).

Then, in Prohias v. Pfizer, Inc., 485 F. Supp.2d 1329, 1336 (S.D. Fla. 2007), similar allegations were made against a drug manufacturer, this time for supposed promotion of an off label use. Ruling under the consumer fraud statutes of New York and New Jersey, the court pointed out that not only wasn’t the drug harmful – but these plaintiffs still took it, even after filing suit:

I cannot come up with any theory upon which [plaintiffs] are actually injured or aggrieved by the allegedly misleading advertisement. Rather, as explained above, the fact that they currently take [the drug], in light of the information they have, requires me to conclude that they take [the drug] for its. . .undisputed health benefits, and therefore cannot claim to have suffered any damage from the allegedly misleading statements about [its other] benefits.

* * * *

Moreover, [plaintiffs] (or their physicians) obviously believe that they continue to receive benefits from taking [the drug], notwithstanding any alleged limitations as to its efficacy, and continue to pay the price charged by [defendant] and its distributors. Thus, to show any damages under the “price inflation” theory, would require evidence of the hypothetical price at which [the drug] would sell if not for the allegedly misleading advertisements. Determination of such hypothetical price, even with expert proof, is too speculative to be the premise of an “actual injury.”

Id. at 1336-37. The utter lack of damages is one reason we previously referred to this litigation as a “strike suit.”

Most recently – only a couple of months ago – another federal court reached held that allegedly illegal off-label promotion was not actionable where the plaintiff did not allege ineffectiveness or inferiority. This time a RICO class action bit the dust:

Plaintiffs allege that Defendants’ fraud is their misrepresentation of the safety and efficacy of [the drug] for off-label uses and that it is worth less than what they paid for it, without alleging that the drug harmed the beneficiaries in any way or that the drug lacked safety or efficacy; as such, the Court must infer that the drug did not harm the beneficiaries. Without alleging that a product failed to perform as advertised, a Plaintiff has received the benefit of his bargain and has no basis to recover purchase costs. Therefore, Plaintiffs do not plead a concrete financial loss in the form of overpayment, absent allegations that the drug was inferior on some level and worth less than what they paid for it. Because Plaintiffs fail to sufficiently allege a cognizable RICO injury under federal or New Jersey law, they lack standing to bring such claims.

District 1199P Health and Welfare Plan v. Janssen, L.P., 2008 WL 5413105, at *9 (D.N.J. 2008. Dec. 23, 2008).

State courts have drawn similar conclusions. In Baron v. Pfizer, Inc., 840 N.Y.S.2d 445 (App. Div. 2007), the first state appellate court to consider such an argument concluded, in an off-label promotion case, that a company’s promotion of an effective off-label use – while illegal – was not actionable consumer fraud:

[W]e note that plaintiff failed even to allege. . .that [the drug] was ineffective to treat her neck pain, and her claim that any off-label prescription of [the drug] was potentially dangerous both asserts a harm that is merely speculative and is belied in any event by the fact that off-label use is a widespread and accepted medical practice. In short, because plaintiff failed to allege actual harm or that she sustained a pecuniary injury, [the trial court] properly determined that she failed to state a claim.

Id. at 448. Similar allegations were dismissed in Kansas:

[T]he plaintiffs did not suffer “loss or injury” and were not aggrieved within the meaning of the statute. . . . The plaintiff. . .suffered no physical injury and received a drug that provided relief for her pain. Thus, she has no loss. The attorney general may bring an action against defendant if he believes that the citizens of Kansas have been aggrieved by defendant's actions, even if no loss has been suffered.

Porter v. Merck & Co., 2005 WL 3719630, at *3 (Kan. Dist. Aug. 19, 2005). And in Indiana:

[Plaintiff] does not allege that she had to supplement her [drug] with other pain relievers or incur any other cost because [the drug] was not safe or effective. Nor does she allege. . .that she suffered any injury because [the drug] was less safe than [the defendant] represented it to be. . . . [Plaintiff] has not alleged any actual damages as required by the [consumer fraud act].

Kantner v. Merck & Co., 2007 WL 3092779, at ¶¶17-19 (Ind. Super. Apr 18, 2007).

But all is not sweetness and light. Last year the court in De Bouse v. Bayer AG, 896 N.E.2d 882, (Ill. App. 2008) – the Fifth District (the court with jurisdiction over Illinois’ infamous Madison and St. Clair litigation centers) – allowed a class action to proceed that, in practical terms, was indistinguishable from that rejected in In re Baycol (the nominal causes of action being different, however). The reasoning in De Bouse relied more on Gestalt psychology than on legal causation principles:

The dissent suggests that the plaintiff cannot establish that she suffered actual damages, even if the purchase was based on deceptive conduct, if the drug lowered the plaintiff’s cholesterol without causing any side effects, because the plaintiff would have gotten exactly what she paid for: a safe, cholesterol-lowering drug. In our view, a consumer who is fortunate to avoid a known but concealed adverse reaction associated with the use of a medication does not necessarily “get her money's worth.” Product value is determined by the price, the product’s efficacy and benefits, the product’s safety risks, and the availability of other products relative to price, performance, and risk. A consumer cannot judge “true value” where known information regarding product performance is withheld. A consumer is entitled to make an informed choice, in conjunction with her health care professionals, about the actual risks and benefits of a prescription drug.

896 N.E.2d at 891.

By contrast, the dissent in De Bouse accepted the majority-rule argument – effective treatment without encountering the alleged risk means no legally cognizable injury:

[T]he plaintiff cannot establish that she suffered actual damage as a result of her purchase of [the drug]. . . . The plaintiff purchased and paid for a cholesterol-lowering drug. The complaint does not allege that the plaintiff suffered any personal injury as a result of using the drug, nor does she allege that the drug did not work to lower her cholesterol. If, in fact, the drug lowered the plaintiff's cholesterol without causing any adverse side effects or personal injuries, then the plaintiff got exactly what she paid for: an effective, safe, cholesterol-lowering drug.

Id. at 901.

But the outlier decision that is De Bouse might not be around much longer. In our pursuit of completeness, we actually checked the citing references for every case in this post – even cases from 2008. Sometimes, compulsive behavior is rewarded. Checking De Bouse revealed a very recent development:

Appeal Allowed by, No. 107528, ___ N.E.2d ___ (Ill. Jan. 28, 2009).

That means that less than a week ago, the Illinois Supreme Court agreed to review De Bouse. We can only hope that the court will appreciate the wisdom embodied by the majority rule and will reject strike-suit class actions on behalf of uninjured persons.

One Two Medical Device Punch

A tip of the cyberhat to Tom Stayton at Baker & Daniels for passing along this little gem. In Feusting v. Zimmer, No. 02-2251, 2009 WL 174163 (C.D. Ill. Jan. 26, 2009), a case involving a prosthetic knee joint, the court granted summary judgment, after concluding under a Daubert analysis that the plaintiff's expert wasn't up to snuff. The plaintiff alleged that a common sterilization process for medical devices - gamma ray irradiation - damaged the device itself and caused it to fail. The implanted device lasted nine years before failure.

The plaintiff's expert was Dr. Robert Rose, a name familiar to just about anybody who's defended prosthesis manufacturers over the last decade or more. Getting him excluded is a pretty big deal. The basic problem with Dr. Rose's opinion is that it had no basis. There was nothing to show that this kind of sterilization was any worse, in terms of deterioration (oxidation) after implantation than any other method - and even Dr. Rose conceded that devices have to be sterilized somehow. Slip op. at 7.

Not only that, before Dr. Rose got his hands on the device, it had been steamed sterilized and then left lying around for six years after being removed from the plaintiff's body. But he didn't even try to account for the oxidation that necessarily occurred during this period:

[Plaintiff's] prosthesis had been sterilized with GIA at least sixteen years earlier, and was stored in air for at least six years after explantation and before testing. That in vivo oxidation accounts for most of the oxidation in [plaintiff's] implant is not supported by citation to any reference nor does Dr. Rose explain this conclusion.

Slip op. at 8. Oops. There was also nothing in the opinion that could convert Dr. Rose's "related to" opinion to an actual statement that the deterioration caused the actual failure of the device. Id. So the opinion was not only insufficiently supported, but insufficiently definite as well.

That's all well and good - and if that was all the opinion was about, we might have told Tom "thanks but no thanks."

But there is more. As astute readers have no doubt already figured out, a lot of time passed after this case was filed (it has a 2002 docket number) and Dr. Rose getting involved (six years between explantation and testing is a really long time).

That's right. There's a great deal of discussion in the opinion about a previous trial and appeal in the case. The previous appeal generated two opinions: Fuesting v. Zimmer, 448 F.3d 936 (7th Cir. 2006), and Fuesting v. Zimmer, 421 F.3d 528 (7th Cir. 2005). Deja vu all over again - that earlier appeal was also mostly about Daubert, and the Court of Appeals held that the plaintiff's first expert's opinions also failed to pass muster. The district court, having been reversed once already, made sure to discuss the outcome of that prior appeal at some length:

The Seventh Circuit rejected Dr. Pugh's testimony on causation because he "did not conduct any scientific tests or experiments to bolster his theory relating polyethylene delamination to gamma irradiation in air, nor did he produce or rely on any studies to verify his conclusions." Moreover, Dr. Pugh "did not bridge the analytical gap between [the] basic principles [which Zimmer did not dispute] and his complex conclusions." The court had not been presented with evidence that Dr. Pugh's delamination theory had been published or subjected to peer review, or had gained acceptance in the scientific community - specifically, that "his untested and unpublished theory that polyethylene delamination from oxidation triggered by gamma irradiation results in an appearance distinctive from delamination from other causes - leaving a readily identifiable `signature' or `hallmark'- has not received any, let alone general, scientific acceptance." That Dr. Pugh developed his opinion expressly for this case also supported a finding that "Pugh's testimony on causation stacks up quite poorly against most all indicia of reliability[.]"

Slip op. at 4-5 (all quotations from Fuesting, 421 F.3d 528).

The "Pugh" mentioned in the opinion was Dr. James Pugh, who if anything has been even more frequently employed by plaintiffs in this type of case than Dr. Rose.

And it means that in the same case Zimmer succeeded in getting both Pugh and Rose thrown out on Daubert grounds - and that's a one-two punch worth blogging about. Keep up the good work.

Seroquel MDL Summary Judgment Order

Shoot!

We reported last week that Judge Anne Conway had orally granted summary judgment in the first two test cases in the Seroquel MDL, and that a written order would be forthcoming.

We checked the MDL docket last night and didn't see an order, so we told you this morning that the promised written order had not yet been entered.

We lied.

Judge Conway docketed the order in the individual case, Guinn v. AstraZeneca, No. 6:07-cv-10291-Orl-22DAB, slip op. (M.D. Fla. Jan. 30, 2009), rather than in the general MDL docket, so we missed it. (Those judges can be awfully sneaky.)

Anyway, the court entered the order granting summary judgment on Friday; here's a link to the 15-page decision.

Since Bexis has recused himself from writing about the Seroquel MDL, this report again is written by Herrmann alone.

AstraZeneca faces about 9000 lawsuits involving 15,000 plaintiffs generally pleading that patients' ingestion of the atypical antipsychotic Seroquel caused the plaintiffs to develop diabetes and related disorders.

The MDL transferee court selected several test cases to be presented at bellwether trials. As of last week, two of those cases remained pending. The MDL court then granted AstraZeneca's motion for summary judgment in both cases.

The Guinn opinion involves the case of Linda Guinn, a 61-year-old former legal secretary who had been unemployed for roughly 20 years as a result of medical ailments including schizophrenia, bipolar disorder, depression, epilepsy, and a bunch of others. Slip op. at 2. Most recently, she began to suffer from diabetes. Id. Guinn has had dramatic fluctuations in her weight during her life (ranging from 111 pounds in 1988 to 200 pounds in 1994) and was a lifelong heavy smoker. Id.

The court recited the usual description of the burden of proving causation in a medical product liability case: The plaintiff must prove both general causation -- that the drug is capable of causing an injury in the abstract -- and specific causation -- that the drug caused this particular plaintiff's ailment. Id. at 5. The "big win" for a defendant would be on the ground of general causation, because that would mean that no plaintiff could prevail. The smaller win is on the ground of specific causation, which means that this particular plaintiff loses, but some other plaintiff might theoretically still be able to prove a case.

Judge Conway decided the Guinn decision on the ground of specific causation. Id. at 6-7.

Guinn's medical expert witness, Dr. Marks, testified that Seroquel was a "substantial factor" in Guinn's weight gain and diabetes. But Marks was "unable to identify any mechanism by which Seroquel causes weight gain and, further, could not articulate even an average amount of weight gain that could be attributed to Seroquel." Id. at 12.

Marks also conceded that Guinn had "numerous pre-existing health conditions that could equally have contributed to her weight gain during the time she was on Seroquel, and that Guinn had numerous risk factors for diabetes." Id. at 13. Marks didn't try to quantify the relative contribution of those other factors to Guinn's injury because "'it is not possible or practical' to do so." Id. Marks conceded that "Guinn's pre-existing health conditions alone could have caused her to develop diabetes and that it was more likely than not, to a reasonable degree of medical probability, that Guinn would have developed diabetes whether or not she ever took Seroquel." Id. at 14.

(We don't know who did the cross-examination of that witness, but it was plainly a job well done.)

On that record, the court naturally granted summary judgment in favor of AstraZeneca, although the court went on to stress "that its ruling herein is strictly confined to the application of Florida law to the specific facts of Ms. Guinn's case. Other cases . . . may fare differently." Id. at 15.

That's a huge win for AstraZeneca, and kudos go to Steve Weisburd (who argued the motion) and his team at Dechert for a job well done.

It remains to be seen whether experts in future Seroquel cases will be able to provide the scientific evidence of causation that was missing from Guinn's case.

And Judge Conway's decision notes that AstraZeneca presented "numerous [other] grounds for summary judgment in its motion," which the court didn't reach because of its decision on specific causation. Id. at 1 n.2. That suggests that AstraZeneca still has a bunch of unused arrows in its quiver.

When those arrows get shot, we'll be here to tell you where they land.

Seroquel MDL: Motions In Limine Granted

We reported last week that Judge Anne Conway, who's overseeing the Seroquel MDL, had granted summary judgment in favor of AstraZeneca in the bellwether cases involving the first two plaintiffs. She had not yet issued her written decision at that time.

She still hasn't entered that written decision. (We just couldn't leave you hanging there.)

But she did choose to rule on AstraZeneca's motions in limine, and the news there is good for the defense. Here's a link to Judge Conway's one order that decides AstraZeneca's six motions.

Since Bexis is involved in the Seroquel cases, he's recused himself from this report. Herrmann alone gets to describe the happy result.

AstraZeneca moved first to exclude evidence and argument about alleged "ghostwriting" of articles in scientific journals. Judge Conway split the baby, holding that plaintiffs cannot use the words "ghostwriting" or "plagiarism" to characterize the process by which articles were written, but plaintiffs can present evidence that third parties prepared drafts of certain articles authored by physicians. In re Seroquel Prods. Liab. Litig., No. 6:06-md-1769-Orl-22DAB, slip op. at 3-5 (M.D. Fla. Jan. 30, 2009).

AstraZeneca moved, second, to exclude evidence about the alleged risks of Seroquel in pediatric and geriatric populations. Because none of the plaintiffs in the first trial group fell into either of those populations, the court granted that motion. Id. at 5.

AstraZeneca moved, third, to exclude evidence of alleged misconduct (including criminal misconduct resulting in incarceration) of two clinical investigators of Seroquel. The court found that the alleged financial improprieties had nothing to do with the credibility of AstraZeneca's testing and the evidence was more prejudicial than probative. The court thus granted the motion to exclude that evidence. Id. at 7.

AstraZeneca moved, fourth, to exclude evidence about three letters the FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) sent to AstraZeneca discussing certain of AstraZeneca's promotional materials. The court held that the plaintiffs' prescribing physicians had never been exposed to the challenged promotional materials and so granted the motion to exclude. Id. at 8.

AstraZeneca moved, fifth, to exclude evidence of Seroquel's labeling in countries outside the United States and regulatory actions taken overseas. The court found the foreign materials to be irrelevant and, if minimally relevant, more prejudicial than probative, and so excluded them. Id. at 10-12.

Finally, AstraZeneca moved to exclude evidence of its settlement with the federal government relating to its pricing of another drug, Zoladex. The court again found the evidence to be irrelevant and, if relevant, more prejudicial than probative. Id. at 13.

Those rulings might seem less important in light of the court's grant of summary judgment in favor of AstraZeneca. In reality, however, the decisions will control the introduction of evidence in any cases that survive the summary judgment ruling (or are resurrected on appeal) and may well influence state court judges faced with similar issues at trial.

All in all, last Friday was a pretty good day for AstraZeneca.

Refunds and Ascertainable Loss

There's an interesting new decision from the appellate division of the NJ Superior Court, Hoffman v. Hampshire Labs, link here. It's not a prescription drug case - rather it's about one of those products typically advertised in those emails that then (we hope) go off to die unread in our spam filters. Hoffman was brought under the New Jersey Consumer Fraud Act. That interests us because a lot of our New-Jersey-based clients get sued under that act, or at least did until the New Jersey Supreme Court put significant restrictions on CFA suits in product liability cases.

Hoffman is basically a pleading case, but one part of it we found especially useful because the product came with a money back guarantee: "The advertisement also stated that, if the purchaser was not satisfied with the product, the purchaser would not have to 'pay a single penny.'" Hoffman, slip op. at 6.

Was the guarantee bogus? We'll never know, because plaintiff never demanded his money back. The Superior Court (Appellate Division) held that where there's a money-back guarantee, to plead "ascertainable loss" (damages under the CFA statute) where there's such a guarantee, the plaintiff first has to invoke the guarantee unsuccessfully:

Plaintiff has not alleged that he used the product and it failed. Nor did plaintiff allege that he was dissatisfied with the product, demanded his money back, and defendants had refused to provide a refund. Thus, plaintiff's claimed monetary loss is purely hypothetical. Therefore, the facts as alleged in thecomplaint do not constitute an "ascertainable loss" under [the CFA].

Slip op. at 11-12.

We think that's right. This product might well be every bit the fraud the plaintiff makes it out to be; we don't know. But in the absence of tangible injury to consumers, enforcing the act is the job of the Attorney General - not a pro se lawyer-plaintiff who only bought the product to start a lawsuit. See slip op. at 5-6 (describing how lawsuit was commenced).

That's the big takeaway from Hoffmann - if the product comes with a money-back guarantee, there are no damages under the CFA (at least in New Jersey) unless and until the guarantee is dishonored.

The Procedural Effect of MDL Master Complaints

By now, you know the drill:

Plaintiffs file complaints in federal courts in, say, Alabama, Illinois, and Florida. Ordinarily, the choice-of-law rules of the courts in which the cases were filed -- Alabama, Illinois, and Florida, respectively -- would govern those cases.

But what happens if the Judicial Panel on Multidistrict Litigation transfers all of those cases to New York and orders plaintiffs to file a new master complaint in New York? Do New York's choice of law rules then apply, because the complaint was filed in New York? Or is the master complaint merely an administrative convenience, so the choice-of-law rules of the original states still apply?

Because we're odd, we've scratched our heads about this issue before.

But there's another wrinkle.

Ordinarily, if plaintiffs filed complaints in Alabama, Illinois, and Florida, the MDL Panel (normally at the request of the MDL transferee court) would be required, at the end of pretrial proceedings, to remand the cases back to their home courts for trial. See 28 U.S.C. Sec. 1407(a); Lexecon, Inc. v. Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26 (1998).

But if the MDL Panel ships the cases to New York and orders plaintiffs to file a master complaint in New York, exactly what would be remanded, and to where?

The New York complaint presumably includes plaintiffs from several states, may include causes of action not pleaded in some or all of the original complaints, and may otherwise differ from the original complaints. When the time comes for remand, what is remanded? The New York complaint? Or the original complaints?

And to where? Is the New York master complaint remanded to Alabama and Illinois and Florida? That puts certain plaintiffs' claims in play in multiple courts simultaneously. Or are the original complaints somehow resurrected, conformed to pretrial rulings made on the basis of the master complaint, and then remanded?

Lord knows.

The Seventh Circuit has now chimed in on a related issue.

In Armstrong v. LaSalle Bank National Association, No. 07-2280, slip op. (7th Cir. Jan. 13, 2009) (link here), plaintiffs filed complaints in federal courts in Alabama, Illinois, and Florida. The MDL Panel transferred all of the cases to the Northern District of Illinois for coordinated pretrial proceedings. The Illinois judge ordered plaintiffs to file two consolidated cases (on behalf of differently situated plaintiffs), and the plaintiffs did. Plaintiffs also, for the first time, joined LaSalle Bank in one of those complaints, and LaSalle Bank could apparently "only fairly be sued in" Illinois. Slip op. at 3.

The consolidated complaint pleaded that venue was proper in Illinois. Plaintiffs participated in pretrial proceedings in Illinois for several years, during which the Illinois court repeatedly set specific trial dates. Plaintiffs ultimately settled with all defendants other than LaSalle Bank.

At the close of pretrial proceedings, plaintiffs moved for remand under 28 U.S.C. Sec. 1407. (The Seventh Circuit opinion doesn't tell us to which court -- Alabama or Florida -- the plaintiffs sought remand.)

The trial judge, concerned that it would be a "nightmare scenario" to retain jurisdiction and try the case, only to learn on appeal that he lacked jurisdiction, granted the motion to remand, but certified two questions about MDL procedure to the Seventh Circuit.

The Seventh Circuit held that "plaintiffs may waive their right to . . . remand and consent to venue in the transferee court, here the northern District of Illinois." Slip op. at 5. The standard for waiving the right to remand under Section 1407 "must be at least as strong as that employed in" the Seventh Circuit's previous cases addressing waiver of an arbitration clause. Id. at 7. And even under the arbitration standard, "the defendant has failed to demonstrate waiver here." Id.

The district court thus "properly granted the plaintiffs request for a suggestion of remand to the [MDL] Panel." Id. at 13.

What does this case illustrate?

First, it made us gin up some more MDL humor:

Why is MDL practice like Soviet-era Russia?

It is a riddle, wrapped in a mystery, inside an enigma.

Second, if your client intends to seek remand at the conclusion of pretrial proceedings in an MDL transferee court, don't accidentally waive your right to remand by your conduct. Remind the court, as appropriate during the course of proceedings, that your client ultimately intends to move for remand.