Monday, April 30, 2012

Is There A Constitutional Right To Punitive Damages?

We recently came across a post on a Bricker & Eckler blog, about a recent Ohio Supreme Court case, Havel v. Villa St. Joseph, 963 N.E.2d 1270 (Ohio 2012), upholding the constitutionality of an Ohio statute imposing mandatory bifurcation in punitive damages cases.  Havel held, after considerable back and forth:

[The statute] does not violate the Ohio Constitution and is constitutional because it is a substantive law that prevails over a procedural rule.  Inherent in our conclusion is rejection of the argument that dicta contained in Sheward [an infamous anti-tort reform decision], which described the former version of [the statute] as governing a procedural matter. . . .  Sheward never considered the bifurcation question we confront in this case.  Thus, we are not required to follow out-of-context dicta as precedent.

Havel, 963 N.E.2d 1279 (quoting and following Arbino v. Johnson & Johnson, 880 N.E.2d 420, 443 (2007)).  That’s an excellent result, but by addressing the issue in this way the Court did not have to pass on a more fundamental question that we’ve been pondering, which is whether a plaintiff has any constitutional right punitive damages in the first place.

In that regard, the Bricker post helped us out.  In discussing Havel, it mentioned that “Ohio’s caps on punitive damages have been upheld as constitutional (in Arbino v. Johnson & Johnson).”  There’s that decision again.  Arbino seemed like a pretty good place to start looking for an answer to the basic constitutional question, so we took a look.  Sure enough, Arbino turned out to be a recent example of what we’ve now come to conclude is a virtually universal rule that, until a judgment in an individual case is actually entered, there is no “vested right” to pursue a claim for punitive damages.  Nor for that matter is elimination of a punitive damages remedy a “taking.”  Basically, punitive damages are a form of punishment, not compensation, to which no constitutional right attaches.  As the Ohio Supreme Court stated in Arbino:

[R]egulation of punitive damages is discretionary and that states may regulate and limit them as a matter of law without violating the right to a trial by jury. . . .  [P]unitive damages are not compensation for injury.  Instead, they are private fines levied by civil juries to punish reprehensible conduct and to deter its future occurrence.  The purpose of punitive damages is not to compensate a plaintiff, but to punish and deter certain conduct.
880 N.E.2d at 441 (citations and quotation marks omitted).

As it turned out, Arbino is hardly alone.  Here’s what some other state supreme courts have said on the issue:


[A] party has no prejudgment property interest in a punitive damages award. . . .  [T]here is no vested property right in an award of punitive damages. . . .  [U]nder either the federal or the [state constitution] Takings Clause, there is no property right in a claim for punitive damages. Rather, consistent with their punitive nature, punitive damages are akin to a fine exacted by the government . . . to deter and punish wrongdoers.

Cheatham v. Pohle, 789 N.E.2d 467, 474 (Ind. 2003) (citations and quotation marks omitted).


[A] plaintiff has no right or entitlement to punitive damages as a remedy . . . and, as a result, the jury has complete discretion not to award punitive damages, even if a plaintiff successfully proves all elements of a claim.  Consequently, before entry of a final judgment, a plaintiff . . . always has had, at most, an expectation of such an award. . . .  A vested right must be something more than a mere expectation based upon the anticipated continuance of existing laws; it must have become a title legal or equitable to the present or future enjoyment of property.  We therefore hold that plaintiffs do not have a vested prejudgment property right in punitive damages.

Demendoza v. Huffman, 51 P.3d 1232, 1245 (Or. 2002) (citations omitted).


[A]ll of our cases recognized that a plaintiff has no vested right to punitive damages and that no right, cause of action, or remedy existed . . . separate and apart from an action for compensatory damages.  Exemplary damages are in no case a right of the plaintiff, but are assessed at the discretion of the jury for the purpose indicated. . . .  [N]o citizen has a right to recover punitive damages; therefore, there is no life, liberty, or property interest of a plaintiff involved where punitive damages are concerned.

Smith v. Printup, 866 P.2d 985, 997 (Kan. 1993) (citations and quotation marks omitted).


A plaintiff has no vested property right in the amount of punitive damages which can be awarded in any case, and the legislature may lawfully regulate the amount of punitive damages which can be awarded.

Mack Trucks, Inc. v. Conkle, 436 S.E.2d 635, 639 (Ga. 1993) (citations omitted).


[Plaintiff] has no cognizable, protectable right to the recovery of punitive damages at all.  Unlike the right to compensatory damages, the allowance of punitive damages is based entirely upon considerations of public policy.  Accordingly, it is clear that the very existence of an inchoate claim for punitive damages is subject to the plenary authority of . . . the legislature.  In the exercise of that discretion, it may place conditions upon such a recovery or even abolish it altogether . . . .  The right to have punitive damages assessed is not property; and it is the general rule that, until a judgment is rendered, there is no vested right in a claim for punitive damages.  It cannot, then, be said that the denial of punitive damages has unconstitutionally impaired any property rights of appellant.

Gordon v. State, 608 So.2d 800, 801-02 (Fla. 1992).


Plaintiff also contends that the punitive damage award constitutes property entitled to constitutional protection under both the federal and [state] constitutions. . . .  [A] plaintiff has no vested right in a particular measure of damages. . . .  [P]unitive damages are remedial and that a plaintiff has no vested right to such damages prior to the entry of a judgment.  Consequently, a statutory provision limiting a punitive damage award may be applied retrospectively without violating due process or equal protection . . . .  [P]unitive damages are not allowed as a matter of right and are discretionary. . . .  [P]unitive damages are not intended to be compensatory and that a plaintiff is a fortuitous beneficiary of a punitive damage award simply because there is no one else to receive it.  Under our view of punitive damages . . ., plaintiff did not have a vested right to punitive damages prior to the entry of a judgment.

Shepherd Components v. Brice Petrides-Donahue & Associates, Inc., 473 N.W.2d 612, 619 (Iowa 1991) (citations and quotation marks omitted).


[P]unitive damages are remedial and a plaintiff has no vested right to such damages prior to the entry of judgment.  Punitive damages are never allowable as a matter of right and their award lies wholly within the discretion of the trier of fact.  The purpose of punitive damages is to inflict punishment and to serve as an example and deterrent to similar conduct. . . .  Such damages being allowed in the interest of society, and not to recompense solely the victim, to deny them cannot be said to deny any constitutional right or to encroach upon any judicial function, or to violate any constitutional guaranty of separation of powers.

Vaughan v. Taft Broadcasting Co., 708 S.W.2d 656, 660 (Mo. 1986) (citations omitted).  See also Rhyne v. K-Mart Corp., 594 S.E.2d 1, 14 (N.C. 2004) (“plaintiffs do not have a vested prejudgment property right in punitive damages”); Evans v. State, 56 P.3d 1046, 1058 (Alaska 2002) (as to “a cap on punitive damages, limiting them before they are awarded to successful plaintiffs, no constitutional problem exists”; punitive damages may be “limited or abolished”); Meech v. Hillhaven West, Inc., 776 P.2d 488, 503 (Mont. 1989) (“no vested right to exemplary damages”); Fust v. Attorney General, 947 S.W.2d 424, 431 (Mo. 1997) (a plaintiff has “no vested property interest” in punitive damages claim); Smith v. Hill, 147 N.E.2d 321, 325 (Ill. 1958) (“a vested right to punitive, exemplary, vindictive or aggravated damages arises only when such damages have been allowed by a judgment); Langford v. Vanderbilt University, 287 S.W.2d 32, 34 (Tenn. 1956) (“[p]unitive damages . . . are allowed as a mere penalty”; “[a] mere penalty never vests but remains executory”); Louisville & Nashville Railroad v. Street, 51 So. 306, 307 (Ala. 1909) (no property right in punitive damages award).

For once, we didn’t have to delve too deeply to find an answer to a legal question (or a subject for a blog post – coming up with ideas daily is no easy matter).  Those are just the state Supreme Court cases that we know about which hold that there is no constitutional right to pursue punitive damages.  Lots of lower court opinions echo these same rulings.  Constitutional challenges have been rejected under due process, taking, jury trial, open courts and various other state constitutional provisions.  It makes sense.  While compensatory damages might present a closer question (depending on issues such as retroactivity), there’s simply no constitutional right for one private party to demand that another private party be punished.

Friday, April 27, 2012

Who Needs TwIqbal?

Don’t misunderstand us.  TwIqbal’s great.  It’s left a lot of badly pleaded carnage in its wake over the last five years.  But at times it makes sense to mix things up, to give the bench players a chance.  Take standing for instance.  Standing arguments don't make it into motions to dismiss all that often, at least not in products class action cases.  But when it makes legal and tactical sense, standing can be effective.  The defendant in Young v. Johnson & Johnson, 2012 U.S. Dist. LEXIS 55192 (D.N.J. Apr. 19, 2012), thought it was a good fit for its motion to dismiss, so it put standing in the starting line-up.  And, like so often happens, the bench player came through.  The court dismissed the complaint. 

Young was a putative class action.  The plaintiff claimed that a J&J subsidiary was able to charge a premium price for its margarine substitute, Benecol Spread, through misrepresentation.  Id. at *1.  The alleged misrepresentations included promotional claims that Benecol was a heart healthy choice, contained no trans fatty acids and could reduce cholesterol through ingredients such as plant stanol esters.  Id. at *1-2.  The plaintiff asserted that these product claims were misleading principally because Benecol did in fact contain unhealthy levels of trans fatty acids and partially hydrogenated oils.  Id. at *6-7.

The court’s standing inquiry focused on injury-in-fact, which is often determinative in a standing analysis.  Id. at *6.  Where was the injury?  Certainly, the plaintiff did not allege that he had suffered any unhealthy outcome from using the product.  Id. at *6-7.  But worse, he couldn’t meaningfully allege that he got anything less than what the defendant promoted. 

Sure, the product contained a small amount of trans fat, but less than 0.5 grams per serving.  FDA regulations require such low levels to “be expressed as zero.”  Id. at *8.  “Zero trans fat” means “no trans fact,” which is exactly what the defendant promoted.  And the defendant’s packaging wasn’t coy about any of this (the court considered the language of the packaging because the plaintiff referenced it in his complaint).  Benecol’s packaging contains a disclaimer about trans fats and partially hydrogenated oils that reads like a legal argument you’d expect to see on a motion to dismiss:

A small amount of partially hydrogenated oils are used in Benecol Spreads . . . As a result, Benecol Spreads contain an extremely low level of trans fat.  The FDA allows foods containing less than 0.5 grams of trans fat/serving to be labeled 0 grams trans fat, since this is considered an insignificant amount.

Id. at *9.  Benecol’s ingredient list also says, flat out, that it contains partially hydrogenated oil.  Id.  As to the cholesterol-reducing claims regarding plant stanol esters, the FDA authorized that too.  FDA regulations state that “scientific evidence establishes that including plant stanol esters in the diet helps to lower blood-total and LDL cholesterol levels.”  Id. at *8 n.2.

In other words, the plaintiff suffered no injury.  He got what he paid for:

[B]eyond relying on his own subjective belief as to the unhealthy nature of even small amounts of trans fats, [plaintiff] does not set forth allegations as to how he paid a premium for Benecol or received a product that did not deliver the advertised benefits. . . . [Plaintiff’s allegations] are insufficient to establish injury-in-fact, particularly in light of Plaintiff's failure to allege any adverse health consequences, the consistency of Defendant's claims with relevant FDA regulations, and the disclosures made on Benecol's packaging indicating the presence of small amounts of partially hydrogenated oils and trans fats.

Id. at *10-11.  So there was no injury and, for plaintiff, no standing.
We should note that standing did not stand alone.  Plaintiff’s claims were also preempted.  The Federal Food, Drug and Cosmetic Act (“FDCA”), as amended by the Nutrition Labeling and Education Act (“NLEA”), governs food nutritional labeling.  And the NLEA has an express preemption clause.  States can’t impose a nutritional labeling requirement “that is not identical to the requirement” imposed by the FDCA.  Id. at *13.  And since plaintiff’s claims sought to do just that, the court held that they were preempted.  Id. at *13-14. 

So the bench player – standing – got the job done – with a little help from preemption. 

By the way, if you’re wondering whether TwIqbal could also have won the day, well . . . it could have.  The court said as much in a footnote at the end of its opinion: “[T]he Court notes that Defendant's argument that Plaintiff's complaint is subject to dismissal for failure to sufficiently plead the requisite elements of his claims appears to have merit.”  Id. at *18 n.8.  But that’s for another day.  For now, let’s let standing have its moment.

Wednesday, April 25, 2012

Darvocet Plaintiffs' Hail Mary Batted Away

We’ve posted before about MDLs – and the Darvocet MDL in particular – being the new “heavyweight” division for the one-two punch of product identification (can’t sue non-manufacturers) and generic preemption (can't sue generic manufacturers) to dispose of meritless claims involving generic drugs on a large scale.

At the risk of mixing our sports metaphors, we can now report that the Darvocet plaintiffs’ attempted Hail Mary pass (if we were sticking to boxing, we might have gone with a head butt) to state court has been batted down.

After concluding that a positive product identification is required by the settled law of just about every state in the union, the MDL judge in Darvocet rejected plaintiffs’ attempt to tilt at that windmill through certification of the issue to no less than six state supreme courts simultaneously:  those being Arizona, Kentucky, Maryland, Oklahoma, South Carolina, and West Virginia.  We note that the original Darvocet order (we’ll call it “Darvocet I” to avoid confusion) involved far more than just those six states.  Darvocet I at 5 (citing precedent from Georgia, Indiana, Louisiana, Minnesota, Mississippi, New Jersey, New York, Ohio, Pennsylvania, Tennessee, and Texas, in addition to the six states).

We assume that plaintiffs cherry-picked those courts that they thought would be best for them (we’d do the same; lawyers are supposed to press such procedural edges).  We doubt it’s an availability issue, because the one state that we’re instantly familiar with – Pennsylvania – also has a certification procedure.  But why these six particular states, we don’t know.  None of the six has ever adopted market share liability in any context (the Oklahoma Supreme Court expressly rejected it in a DES case), so product identification is not in any sense an open question in any of them.

We guess that’s why the MDL court ruled the way it did.  Certification of an issue that’s not really open to serious question – as the court had already found the product identification requirement to be, Darvocet I at 9 (“many states have expressly rejected”), 12 (“overwhelming majority of courts” reject plaintiff’s position) – is a waste of time and effort.  On the other hand, where a court may be inclined to allow a novel theory of liability in a case that would otherwise be over without it, certification makes a lot of sense.  That’s why, as we’ve mentioned before, the same issue is currently teed up in the Alabama Supreme Court in a case we can’t say much about due to Dechert’s involvement.

Anyway, the latest Darvocet order doesn’t take away plaintiffs’ ordinary appeal rights in the federal system – denying only an extraordinary form of federal-to-state review.  What it does mean is that, having filed in federal court, plaintiffs cannot avoid the consequences of diversity jurisdiction, including the Erie principle (expressly referenced in Darvocet I, at 13 ) that federal courts are not supposed to predict radical changes in state law.  Plaintiffs can, of course, file a new certification motion in the Court of Appeals.  As to that, we can only point out that the Sixth Circuit had no trouble predicting on its own that Kentucky would follow established law.  Smith v. Wyeth, 657 F.3d 420, 423 (6th Cir. 2011).

Tuesday, April 24, 2012

A 100% Naturally Bad Preemption Decision

            Sometimes a decision bounces around a bit before it lands on our plates.  But when we finally spot it and read it, we realize it might be worth a quick chew.  It may be a tasty little tidbit like a particularly good Twiqbal decision outside the drug/device arena.  A savory morsel on a regulatory scheme and preemption involving an agency other than the FDA.  And, sometimes it can be a sour bite – the type that makes your lips pucker and want to spit it out.  That’s precisely what we’d like to do with almost all of a recent decision by the Central District of California – spit it out and throw it away.  Since we can’t do that – we decided we’d blog about it. 

            If our above metaphors weren’t obvious enough, we’re talking about a food case – Briseno v. ConAgra Foods, Inc., 2011 U.S. Dist. LEXIS 154750 (C.D. Cal. Nov. 23, 2011).  And, I guess we can start with the good news – the case was dismissed without prejudice under Rule 9(b) for failure to plead fraud with particularity.  Id. at *29-41.  While we applaud the court for getting it right on the deficiency of the pleadings – they left the door wide open for this suit to spring back to life.  That’s the sour part. 

            The case is about oil – not the black gold kind – the kind we pour on salads and use to fry chicken.  Wesson Oil to be exact.  Do you remember the Florence Henderson TV commercials from the 1970s – “Your chicken has a certain Wessonality” and 1980s – “with every bite you know you’re frying right.”    Who wouldn’t buy cooking oil from Mrs. Brady (wait a minute, didn’t Alice do all the cooking?).  In fact, some form of Wesson cooking oil has been on the market since the 1860s.  So, who can possibly have a problem with it?  Answer:  a group of plaintiffs who filed a nationwide putative class action alleging that Wesson’s labeling of the product as “100% Natural” is false and misleading because the manufacturer “uses plants grown from genetically modified organism seeds.”  Briseno, at *4.  We direct your attention back to the 1980s Mrs. Brady ad – Wesson’s label has said 100% Natural since at least then – 25 years ago.  So what’s the problem?  And, if this is a food labeling issue – why isn’t it preempted?  Like we said, we’re making the lemon face.

            Plaintiffs alleged causes of action for violations of California’s false advertising law (“FAL”), unfair competition law (“UCL”), Consumer Legal Remedies Act (“CLRA”), and breach of express warranty.  In addition to restitution, plaintiffs sought 1) “a permanent injunction enjoining ConAgra from continuing to harm [plaintiffs]” and 2) “an order requiring ConAgra to adopt and enforce a policy that requires appropriate disclosure of genetically modified ingredients and/or removal of misleading natural claims.”  Id. at 5-6.  We mention these two requests because somehow the court found #2 was preempted but #1 was not.  If the alleged harm is that the FDA-approved label says “100% Natural” and doesn’t identify genetically modified ingredients, then isn’t an injunction to stop that harm a court-ordered revision of the label?  In other words, a state law requirement that ConAgra label its product differently than what is required by the FDA?  We fail to see how the requested injunctive relief is different from an order requiring removal of “natural” claims.  They both have the same effect – a change of the label contrary to the requirements of the FDA.  So shouldn’t both be preempted?

            To try to understand the court’s reasoning, let’s start where it did – the Nutrition Labeling and Education Act (“NLEA”) which contains an express preemption provision:

[N]o State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce . . . any requirement respecting any claim . . . made in the label or labeling of food that is not identical to the requirement . . .  of this title.

21 U.S.C. § 343-1(a)(5).  We think this is the equivalent of “Check, please.”  This meal is over – case preempted.  But even if there remain a few notches on the belt that can be loosened to allow for another course, we don’t think the analysis leads to the conclusion the court reached here.
            The Briseno court cites other cases where plaintiffs claimed to have been misled by a manufacturer’s use of the term “all natural” (usually dealing with the inclusion of high fructose corn syrup) and those claims were held to be not preempted.  We’d probably disagree with the reasoning of those decisions as well.  What we found more interesting was the court’s attempt to distinguish this case from others where plaintiffs were asking the court to require a manufacturer to change a label that was permissible by the FDA.  For example, they dismiss the holding in Dvora v. General Mills, Inc., 2011 U.S. Dist. LEXIS 55513 (C.D. Cal. May 16, 2011) as inapplicable.  There plaintiffs alleged that the manufacturer’s advertising of “Total Blueberry Pomegranate” cereal was false and misleading.  In finding the claims preempted, that court said:

Defendant persuasively argues that Plaintiff's lawsuit seeks to impose requirements that are not identical to th[e] regulatory scheme. First, Plaintiff apparently seeks to forbid General Mills from labeling its product “Total Blueberry Pomegranate,” even though such descriptions of “characterizing flavor” are expressly authorized by federal law. Second, Plaintiff appears to demand that General Mills affirmatively state on the package that the cereal “does not actually contain blueberries or pomegranates,” even though FDA regulations would not require this. Third, Plaintiff objects to the depiction of brown colored “clusters” that (according to Plaintiff) allegedly “resemble blueberries and/or pomegranate seeds,” even though FDA regulations would have permitted General Mills to depict even fresh blueberries and pomegranates on its box.

Dvora, at *4.  That’s different from the Wesson Oil case how?  The FDA regulations don’t prohibit pictures of blueberries on the cereal box just like they don’t prohibit defendant from putting “100% Natural” on its bottle.  If the lawsuit “seeks to impose requirements that are not identical to the regulatory scheme” – the claims are preempted.  The regulatory scheme here seems to have allowed a claim of “100% Natural” for at least 25 years. A court order that requires that claim be removed is most certainly “not identical.”  Indeed, the Briseno court itself found:

Congress and the FDA have thoroughly regulated the manner in which ingredients must be listed on packages, including specifying how oil products must be labeled. See, e.g., 21 U.S.C. § 343(i)(2); 21 CFR § 101.4(b)(14).  Entering an order of the type Briseno seeks would impose a requirement that is not identical to federal law, and his prayer for such relief is thus preempted.

Briseno, at *26-27 (emphasis added).  Again, we are left perplexed by the court’s ability to use this analysis to reach different conclusions on two claims that seek the same relief – a change in the label.   

The court seemed to be singularly focused on the fact that despite the “considerable interest to consumers and industry,” FDA has not sought to define terms like “natural” in the food context (FDA invokes the “limited resources” defense).  Id. at *16.  But that doesn’t change the fact that Congress has empowered FDA – not the judiciary – with controlling the labeling content of food.  So, we also support ConAgra’s second argument, that if not preempted, the case should be dismissed or stayed under the doctrine of primary jurisdiction.

[P]rimary jurisdiction is properly invoked when a claim is cognizable in federal court but requires resolution of an issue of first impression, or of a particularly complicated issue that Congress has committed to a regulatory agency.

Id. at *28 (citation omitted).  Essentially, the doctrine provides that courts may decide that for the sake of “better informed and uniform legal rulings,” initial decision-making responsibility should be performed by an agency with “specialized knowledge, expertise, and central position within a regulatory regime.”  Id. at *27.  If the agency entrusted to decide these issues has yet to resolve the question, why should the courts? 

            This is something we like to call “judicial triumphalism” – the use of tort litigation for social purposes to induce courts to step in and make decisions on issues that are more competently addressed by other branches of government – here the FDA.  If people want to attack the use of genetically modified food, they should be going to Congress and the FDA and courts should be stepping aside, rather than be used as a platform for the advancement of social causes.  If you haven’t already guessed, the court was not persuaded by the primary jurisdiction argument either. One of the court’s reasons was because FDA has not shown an indication that will “provide guidance on the use of the term ‘natural’ in the immediate future.”  Id. at *29.  Well, maybe if the champions of this cause were properly blocked from using the courthouse to fight their battle, they would re-direct their efforts where they belong – at the FDA.

            FYI – plaintiffs did file an amended class action complaint and defendant has filed another motion to dismiss set to be heard next month – so stay tuned, we haven’t reached the final course. Although we aren’t optimistic that what’s coming will be any easier to swallow.

Monday, April 23, 2012

If At First You Don't Succeed....

Sometimes good ideas don’t prevail the first time – or even the first few times – they make their appearance.  With that in mind we bring to your attention Windle v. Synthes USA Products, Inc., 2012 U.S. Dist. Lexis 52397 (N.D. Tex. April 13, 2012).  Windle was a removal attempt – an unsuccessful one – in a PMA device case.  Premarket approval means, of course, that preemption bars virtually every claim, except the so-called “parallel violation” claim, that is, a state-law claim that parallels some sort of FDCA violation.

Such claims are relatively hard to come by, as our post-Riegel preemption scorecard indicates.

And as some of the cases on our post-Riegel preemption scorecard also hold, under TwIqbal (at least a lot of courts’ interpretations of it), the plaintiff must plead what was violated, the nature of the violation, how the violation caused injury – things like that.  Some states, the so-called “fact-pleading” states (like Pennsylvania) have traditionally required even more intensive pleading than the federal courts.  Some other states have adopted TwIqbal.

Windle highlights an interesting possible consequenceof TwIqbal-compliant “parallel violation” claims.  That is, it’s possible, at least in some cases, that the very same factual pleading necessary to push a parallel violation claim over the TwIqbal pleading threshold might also plead a sufficient embedded federal issue to justify removal of the case to federal court under the oft-cited but rarely met federal question test enunciated in Grable & Sons Metal Products, Inc. v. Darue Engineering & Manufacturing, 545 U.S. 308 (2005).  Usually, plaintiffs get to hide behind the “well-pleaded complaint rule” and frame their claims as state-law causes of action in order to keep them out of federal court.  However, to the extent that a combination of Riegel preemption and TwIqbal pleading flush plaintiffs out from under the well-pleaded complaint rule and require the pleading of FDCA violations with considerable exactitude, then the complaint starts looking more and more like the kind of action that could be removed to federal court under Grable.

Now, the defendant in Wimble didn’t get to the promised land of the federal courts, but consider how it stated the Grable test:

[F]ederal question jurisdiction exists where (1) resolving a federal issue is necessary to resolution of the state-law claim; (2) the federal issue is actually disputed; (3) the federal issue is substantial; and (4) federal jurisdiction will not disturb the balance of federal and state judicial responsibilities.
2012 U.S. Dist. Lexis 52397, at *16 (citation and quotation marks omitted).

The court in Wimble didn’t dispute that item one (an FDCA violation being “necessary”) and item two (the violation being “actually disputed”) are met in post-Riegel PMA preemption cases.  2012 U.S. Dist. Lexis 52397, at *18-19.  Rather the defendant came up short because the violation was not necessarily “substantial.”  Id. at *19-20.  Instead, the violation “could be as straightforward as deciding whether the responsible party did or did not furnish the information required by FDA regulation.”  Id. at *20.

For the purposes of this post, we’ll take the Wimble court’s statement as gospel.  Some, perhaps even most, claimed “parallel violation” claims might well be simple and straightforward enough to flunk the “substantial” federal question prong of Grable.

But we invite our readers to ponder whether the converse is also true.  There may well be other PMA preemption cases where the plaintiff’s FDCA violation claims are complex and involved.  The violation allegations could well run on for several pages in the complaint – especially if the plaintiff copied some complicated MDL or similar pleading verbatim (it does happen).

Further, to the extent that these instances of complicated and pervasive FDCA violation allegations are, indeed, relatively few, then pushing them into federal court would be less likely to “disturb the balance” between the state and federal courts.  Many, perhaps most, Grable arguments that we’ve seen fail because they prove too much – their adoption would open the door to removal of large number of state tort cases because some federal matter (say, preemption) is merely at issue.  It’s something of a tautology, but the fewer and farther between the Grable-worthy cases are, the more likely they are to be held Grable-worthy in the first place.

In light of all that, we’re not recommending any particular action in any particular case – only alerting our colleagues to the possibility of the argument that:  (1) the more that post-Riegel PMA preemption cases rise or fall on allegations of violations of the federal FDCA, and (2) the more that plaintiffs are forced plead these purported federal violations in gory detail, then (3) the chances increase that the prerequisites to Grable federal question jurisdiction are met, as long as (4) the defendant’s arguments are sufficiently tied to a particularly involved claim of FDCA violation so that the plaintiff can’t make a plausible floodgates argument.

We’ll be looking for cases that fit this syllogism, and we invite our readers to do the same.

Friday, April 20, 2012

Trying to Sanction Away Preemption (and Failing)

We always try to keep things lively around here.  Law can sometimes be drudgery.  But we don’t ever want that type of atmosphere to seep into this blog.  That’s one of the reasons the blog is here: to discuss what we do without the boredoms and formalities that sometimes saturate our every-day practices.  So, here, if we’re ever being stared down by work that threatens to be laborious and soul-sucking – we just change it.  Sometimes it only needs a small change, something that makes it silly or at least fun. 

We did that two weeks ago, you may recall, when we updated our Mensing preemption scorecard.  Scorecards, lists and categories, Oh my!  You can see why we’d want to change that.  So it became a question-and-answer format that allowed us to play-act as if we were important interviewees (and ignoring on some level that we were just interviewing ourselves).  The format change was enough to make it interesting, at least for us.

Now, if at the time we had seen the decision in Phelps v. Wyeth, 2012 U.S. Dist. LEXIS 45865, (D. Or. Feb. 24, 2012), the substance of the post would have gotten a little more interesting too.  We could have added this unexpected question: Have plaintiffs had success reversing Mensing using discovery sanctions?  There’s no way you could anticipate that one.  But it’s a legitimate question now, and one that we like for a couple of reasons: (1) it’s unexpected and therefore interesting; and (2) the answer is “No.” 

In Phelps, the plaintiffs brought failure-to-warn (and other) claims against a generic manufacturer of metoclopramide.  Id. at *2.  While the action was stayed pending release of the Supreme Court’s decision in Mensing, plaintiffs’ counsel discovered certain defendant product labels that had not been produced and that didn’t match, as required, the brand-name label.  After being informed of this, the defense counsel realized its mistake and immediately produced them to a broad group that included the plaintiffs and others, and even the Supreme Court.  Id. at *3-4.

Thereafter, the Mensing decision was issued, and a host of motion practice followed in Phelps.  The upshot was that the court granted summary judgment to the defense based on the Mensing decision (that’s another one for the list) but allowed the plaintiffs to amend their complaint to proceed on a claim that the defendant failed to properly update its label for a certain period of time.  Id. at *4-6.  That’s not surprising.  But the Plaintiffs wanted more than just their new claim.  They wanted to somehow revive their old, preempted claim.  How?  Through sanctions.  They asked the magistrate to strike the defense’s preemption defense because of its failure to produce the labels.  In other words, plaintiffs asked the court to use discovery sanctions to reverse its Mensing preemption order.  Id. at *6-7.

Well, the court didn’t do it.  It didn’t believe that the conduct was sanctionable.  The court stressed that the plaintiffs hadn’t been prejudiced in any meaningful way by the delay in production of the labels and that the initial failure to produce the labels was nothing more than an oversight.  Id. at *8-11.  In other words, despite the importance of the labels, it was just a mistake and one that did little to no harm. 

Denying the motion in its entirety, however, sidestepped the question of whether a proper sanction actually could involve reversal of the Mensing preemption.  We have serious doubts that it ever could.  Under Mensing, the state law failure-to-warn claims are preempted.  They’re gone.  It’s hard to see how a party’s failure to meet a discovery obligation could somehow re-animate them.  Mensing preemption is based on more than just the fact that state claims place additional and conflicting requirements on defendants.  It’s based on the reality that the state law claims improperly invade an area explicitly covered by a federal regulatory scheme, one that is guarded from such invasion by nothing less than the United States Constitution and its Supremacy Clause.  That protection isn’t something that could or should be wiped away by any particular litigant’s discovery failures.

Maybe that will be a discussion for another day (or, better yet, a question and answer session). But for now the answer is “No,” plaintiffs have had no success trying to sanction away Mensing preemption.

Thursday, April 19, 2012

Uninjured Docs' Suit Tossed

Sometimes it all depends on the docs.  One of the reasons that the Bone Screw litigation never really went anywhere is that the prescribing physicians were all tertiary care spine surgeons who by and large knew the devices they were implanting inside and out.  In almost a decade of litigation, the Bone Screw plaintiffs couldn’t get a single one of them to testify – even as a paid expert – that the devices were defective.

In other litigation defendants aren’t that fortunate.

And then there’s Drew v. AHPC, Inc., 2012 U.S. Dist. Lexis 49319 (E.D. Pa. April 9, 2012).  In Drew the prescribers actually tried to become plaintiffs themselves – alleging that they “operated weight-loss clinics or other facilities where they prescribed the [product].”  These prescribers alleged that they didn’t know squat about the drugs they were prescribing:

According to the complaint, [defendant] engaged in a fraudulent scheme to conceal the risks associated with these drugs and aggressively to market the drugs to healthcare providers.  Plaintiffs do not assert that they purchased diet drugs directly from [defendant] but rather that they acted as “conduits” for the sale of [the products] by prescribing the drugs to patients.
Id. at *2.

The plaintiffs did not allege that they, certainly, suffered any physical injury – or even that their patients did.  Rather they claimed that, when the risk information became known, their businesses (substantially based on the prescription of these drugs) dried up:

Plaintiffs allegedly had their businesses ruined, years of good will undercut, their livelihood destroyed, their standing in their respective communities impaired, and the[ir] investment rendered substantially worthless when [defendant] withdrew the drugs from the market.
Id. ad *2-3 (quoting complaint)

It’s a somewhat peculiar theory, since these businesses were based on prescribing drugs that, allegedly, shouldn’t have been sold, and that the plaintiffs would have been more than happy to go on prescribing had the supply not dried up.

Fortunately, the court thought so too.  Even the capacious California consumer protection statute (“UCL”) wasn’t broad enough to permit this sort of claim:

Plaintiffs have not alleged an injury sufficient to confer standing under the UCL.  Plaintiffs built profitable clinics and do not assert that they lost money while the [drugs] were on the market.  Instead, plaintiffs allege that they lost future business profits when [defendant] withdrew the drugs from the market at the request of the FDA.  Plaintiffs simply have no legally protected interest in [defendant's] continuing to manufacture and sell the drugs in issue.
Drew, 2012 U.S. Dist. Lexis 49319, at *4.  They weren’t injured by any “sale” of the product, but only by their inability to go on prescribing it.  That is, they didn't have a claim that they were injured because they couldn't continue prescribing allegedly dangerous drugs.

The UCL doesn’t allow classic “damages.”  There wasn’t any basis for an injunction because the drugs had not been sold for years.  Nor was there a basis for “restitution,” since none of the purported injury consisted of monies retained by the defendants.  Id. at 5.  The mere loss of business opportunities to go on selling an allegedly defective product simply isn’t recoverable:

Compensation for a lost business opportunity and nonrestitutionary disgorgement of profits are not available as remedies under the UCL.
Id.  Bye-bye UCL.

The remaining claims just didn’t fit at all.  Strict liability and negligence had no application where the plaintiffs alleged no physical injury, but only “economic loss.”  Drew, 2012 U.S. Dist. Lexis 49319, at *6-7.  Implied warranty was just as off the wall, since there was no contractual privity at all – indeed, the prescribing physician plaintiffs didn’t buy or sell the drug at any point; they only prescribed it.  Id. at *8-9.  Nor were they “ultimate consumers,” only self-described “conduits.”  Id. at *9.  Finally, even if plaintiffs had adequately pleaded fraud (which they didn’t), they once again didn’t have a cognizable injury, only loss of future expectations:

Even if sufficiently pleaded, plaintiffs’ fraud claim fails because they have suffered no damage.  While the product in issue was on the market, plaintiffs made a profit from [prescribing it].  They have not alleged that [defendant] represented to them that [the drugs] would be on the market indefinitely or that [it] guaranteed the success of their investments.
Id. at *10-11.

Thus, prescribing physicians cannot become plaintiffs (at least in California).  The theory was downright bizarre to begin with – strict liability turned on its head – since the plaintiffs sought damages for not being allowed to continue prescribing the purportedly defective product to their patients.

Good riddance.

Wednesday, April 18, 2012

Guest Post - Not Ooey Gooey This Time Around

Here's a guest post, authored by Clem Trischler and Jason M. Reefer of Pietragallo Gordon.  It's about ultimately winning a fentanyl patch trial where the plaintiff pursued a res ipsa or "malfunction theory" case.  It's a counterpoint to the horrible case out of Illinois that we ranked as our #1 worst case last year.  We don't really want to talk about that much, so without further mucking around, here's the guest post:


Litigation involving fentanyl pain patches isn’t the most frequently discussed topic on the Drug and Device Law Blog, but it’s certainly had its moments.  For example, the Blog lamented the Eastern District of Pennsylvania’s “generic reasoning” in the aftermath of Mensing, where the federal court refused to rule on the validity of failure-to-warn claims in the context of fraudulent joinder.  Even worse, Bexis described DiCosolo v. Janssen Pharmaceuticals, Inc., 951 N.E.2d 1238 (Ill. App. 2011), a case involving the name-brand Duragesic® patch, as “ooee gooey.”  In DiCosolo, an Illinois appellate court allowed the plaintiff to proceed on a “malfunction theory,” even though, inter alia:  (1) the allegedly defective product was lost by the plaintiff and, therefore, unavailable for inspection; (2) there was no observable malfunction; and (3) the plaintiff did not rule out other secondary causes for the decedent’s death . Factor in an improper and inflammatory closing by plaintiff’s counsel and an $18 million verdict, and you have the “worst drug/device product liability decision of 2011.”

Mylan, which manufacturers a generic fentanyl patch, recently found itself in a similar situation in Mardegan v. Mylan (S.D. Fla.).  The Blog last discussed this case here, where the Court allowed the plaintiff to re-plead several iterations of a failure-to-warn claim to comport with the learned intermediary doctrine.  But those were the days before Mensing (the motion was filed in December 2010, but not ruled upon until August 2011), so those claims went by the wayside at summary judgment, and the plaintiff proceeded (for all intents and purposes) only on a manufacturing defect theory.

Mardegan, much like DiCosolo, was fairly typical as far as fentanyl litigation is concerned.  Someone with a variety of health issues died while using (and misusing) a galaxy of medications, including multiple central nervous system (“CNS”) depressants.  Fentanyl is a potent analgesic, often prescribed for patients with debilitating, constant pain that cannot be controlled by other narcotics.  The fact that fentanyl is even prescribed suggests that the patient is probably dealing with serious health issues and likely taking a combination of drugs, which must be carefully monitored.

The decedent in Mardegan was no different, suffering from a long list of medical and personal issues.  Making matters worse, the evidence at trial established that the decedent lied to her physician to obtain fentanyl patches in the first place, was using more medication than was prescribed, and was using medications that weren’t prescribed for her.  The medical examiner attributed the decedent’s death to “drug toxicity, including fentanyl.”

Undeterred, the decedent’s father hired a lawyer and brought a lawsuit against Mylan, alleging that unspecified defects in the patch caused it to deliver fentanyl at an excessive rate.  But the allegedly defective patch in Mardegan was discarded by the police and therefore unavailable for inspection.  And unlike DiCosolo, the plaintiff in Mardegan had no evidence of a recall or a self-serving, eleventh-hour affidavit from the plaintiff suggesting a problem with the patch.

Without evidence of any problem with the product itself, the plaintiff in Mardegan retreated to the “last refuge of a plaintiff without a case,” namely the “malfunction theory,” to prove a manufacturing defect.  The malfunction theory is similar to res ipsa loquitur in the negligence context and allows a plaintiff to use the circumstantial evidence of a product malfunction to infer the existence of a defect.  In Florida, this is commonly referred to as the “Cassisi inference,” named after a decision out of the Florida District Court of Appeal.  See Cassisi v. Maytag Co., 396 So.2d 1140 (Fla. 1st DCA 1981).

The plaintiff’s predictable argument went something like this:

1. Mylan’s labeling states that the mean maximal concentration of fentanyl delivered from a 50 mcg/hr patch in a living subject’s blood stream is expected to be 1.4 ± 0.5 ng/ml;

2. Accordingly, a patient’s serum fentanyl concentration should not exceed 1.4 ± 0.5 ng/ml if the 50 mcg/hr patch is functioning properly;

3. The decedent died while wearing a 50 mcg/hr patch;

4. The decedent’s postmortem blood fentanyl level, drawn over 30 hours after death, was measured at 8.5 ng/ml;

5. The patch, therefore, malfunctioned.

Thus, the plaintiff’s case rested entirely on a purported “elevated” fentanyl level, measured in a postmortem blood sample collected over thirty hours after the decedent was found dead.  When you boil this theory down, it amounts to nothing more than the circular (and flawed) premise that the product is defective because it malfunctioned, and it malfunctioned because it is defective.

While there may be some appeal to its simplicity, the plaintiff’s malfunction theory was invalid both legally and factually (from a defense perspective).  The Court saw it differently, and allowed the case to go to a jury. Let’s start with the legal arguments, since this is a legal blog.

First, the malfunction theory has no place in the context of a complex pharmaceutical product liability action, where the sole evidence of malfunction – ergo, defect – depends upon an interpretation of postmortem toxicological testing well beyond the common knowledge of jurors.  Res ipsa loquitur and, by extension, the malfunction theory, find their roots in the law school favorite Byrne v. Boadle, 159 Eng. Rep. 299 (Ex. 1863), where a barrel of flour fell from a second story window and injured a pedestrian.  It doesn’t take a rocket scientist (i.e. an expert witness) to conclude that when a barrel inexplicably crushes a passerby, someone was negligent.  To wit, Cassisi involved a self-igniting dryer that burnt down a house, Cassisi, 396 So.2d at 1250, 1252, while the foundational case upon which the Cassini malfunction doctrine rests, dealt with a machine that “erratically” retracted and amputated the plaintiff’s fingers.  Greco v. Bucciconi Engineering Co., 283 F. Supp. 978, 980 (W.D. Pa. 1967).  Any layperson understands that a household appliance does not spontaneously combust but for a defect, or that a machine does not suddenly and inexplicably retract unless it malfunctions.  In those scenarios, “the jury’s knowledge from common experience” allows for an inference of a defect.  Liberty Mutual Insurance Co. v. Sears, Roebuck & Co., 35 Conn. 687, 406 A.2d 1254 (1979) (cited in Cassisi, 396 So.2d at 1150) (emphasis supplied).

Cases involving complex pharmaceutical products, which carry inherent risks, are inapposite.  A lay juror is simply not equipped to evaluate the performance of a fentanyl patch, based solely on an interpretation of postmortem toxicological testing.  Put differently, an average person cannot look at a fentanyl level in a toxicology report and jump to the conclusion that there was a problem with a fentanyl patch.  The simple fact that expert testimony is required to interpret and explain the relevance of a postmortem blood fentanyl level underscores the inapplicability of the malfunction theory.  Cf. Anderson v. Gordon, 334 So.2d 107, 109 (Fla. 3rd DCA 1976) (“[Res ipsa loquitur] may not be applied where expert medical evidence is required to show not only what was done, but how and why it occurred since the question is then outside the realm of the layman’s experience.”).  No matter, ruled the Court, since the plaintiff’s expert testified at deposition that a defect in the product was the “most probable” cause of the decedent’s death.

Next Mylan argued that the plaintiff failed to meet the second Cassisi element, namely his burden of demonstrating that direct evidence of a defect is unavailable due to the nature of the occurrence or malfunction.  As recognized by Cassisi itself, an inference of a defect is proper in “those cases in which the product was so badly damaged by a malfunction as to render impossible the plaintiff's ability to point with specificity the exact one of several potentially dangerous conditions which caused the accident.”  Cassisi, 396 So.2d at 1149.  The rationale of the malfunction doctrine is that a plaintiff should not be put out of court because the defect itself prevents plaintiff from proving the existence of a defect.

But unlike an exploding tire or a self-igniting machine, the fentanyl patch used by the decedent did not self-destruct due to a purported defect.  It was available for inspection for months after the decedent’s death, and presumably could have been tested for residual fentanyl content to determine whether it did, in fact, deliver more fentanyl than it should have.  The plaintiff, however, allowed the product to be destroyed as part of the police department’s standard protocol relating to evidence retention, then showed up in court and asked for an inference of defect because the product was unavailable.  The Court obliged, thereby creating a perverse incentive for a plaintiff to lose the allegedly defective product and gain the benefit of a Cassisi inference – a policy that Bexis railed against in his discussion of DiCosolo, the ooey gooey).

Mylan still had one more bullet in the chamber to take down the monstrous malfunction doctrine:  the plaintiff’s failure to rule out reasonable secondary causes for the decedent’s death.  Even the plaintiff’s expert testified at his deposition that there were no less than four explanations for the death separate and apart from a defective patch, and he could not rule out any of them.  Given controlling Eleventh Circuit case law requiring the exclusion of secondary causes, see Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296, 1302 (11th Cir. 2011), this appeared to be a recipe for a defense win.

Not so fast, said the Court.  Even though the plaintiff could not rule out secondary causes, the Court held that it was enough to reach the jury because his expert testified that the “most probable” scenario was a defective patch.  Putting aside the fact that, as a pathologist, the expert was in no way qualified to render an opinion regarding transdermal drug delivery systems, the Court’s decision erroneously shifted the burden to Mylan to disprove the plaintiff’s theory of defect.  But in Florida, even when the malfunction theory is applicable, it remains a plaintiff’s burden to prove a defect.  See West v. Caterpillar Tractor Co., 336 So.2d 80, 87 (F1a. 1976). A manufacturer is not an insurer, and the Court’s ruling improperly blurred this important distinction.

Against this wave of bad law (or, as it were, bad interpretations of the law), Mylan had to win the case the old fashioned way – on the facts.  To do so, Mylan was able to demonstrate to the jury that their fentanyl patch could not and did not do what the plaintiff claimed it did – deliver fentanyl faster than its chemically controlled rate.  The “could not” part was rather straightforward; Mylan’s corporate representatives, including the inventor of the product, explained that the patch’s design features chemical rate control that ensures predictable delivery of fentanyl consistent with the pharmacokinetic information in Mylan’s label.

Plaintiff’s counsel countered, “But then how do you account for the decedent’s 8.5 ng/ml postmortem fentanyl level?”  The answer is simple: postmortem redistribution (“PMR”).  PMR, as a toxicological principle, has been recognized for over two decades and is a generally accepted phenomenon.  See Pounder, D.J., and Jones, G.R., “Post-Mortem Drug Redistribution – A Toxicological Nightmare,” Forensic Science International 1990; 45:253-63.  In laymen’s terms, what happens with PMR is that certain chemicals (such as fentanyl) are stored in adipose tissue (such as fat) during lifetime, but will “redistribute” after death to aqueous tissues (such as blood) due to natural changes that occur when life ends.  Why is this important in pharmaceutical litigation?  Because PMR renders wholly speculative and inherently unreliable any attempt to infer a defect in a drug delivery system based on a postmortem blood sample.  See, e.g. Andresen, et al., “Fentanyl: Toxic or Therapeutic? Postmortem and Antemortem Blood Concentrations After Transdermal Fentanyl Application,” Journal of Analytical Toxicology, 2012;36:182-94.

Courts have become increasingly aware of PMR, see, e.g. Battle v. Gold Kist, Inc., No. 3:06-cv-782-J-32TEM, 2008 WL 4097717 at *8 (M.D. Fla. Sept. 2, 2008) (discussing the “highly problematic validity of post-mortem blood testing” due to PMR), and are growing skeptical of expert opinions that fail to properly account for its impact.  In fact, PMR was the final nail in the coffin of the Digitek MDL, as discussed here. See also, In re Digitek Products Liab. Litig., ___ F. Supp. 2d ___, 2011 WL 5282595 (S.D.W. Va. Nov. 3, 2011).

While the plaintiff in Mardegan was able to get around the law, he could not escape science.  The jury returned a unanimous verdict for Mylan after just twenty minutes of deliberation, expressly finding that the Mylan patch is not defective.  There’s nothing “ooee gooey” about that.

Tuesday, April 17, 2012

Excellent New Pain Pump Preemption Decision – The Details

            We were so enthused by this new decision, we gave you the link to it yesterday.  Stengel v. Medtronic, Inc., No. 10-17755, slip op.  (9th Cir. April 16, 2012).  Nothing lifts our spirits quite like a dismissal based on both explicit and implied preemption.  But, if like us, you had a busy Monday, and haven’t had a chance to read it yet – here are the highlights.

            First, the product -- a Class III pain pump that received initial PMA in 1988 (modifications received PMA about a decade later).  Slip op. at 4089.  Next, the claims – state law tort claims for “strict liability, negligence, and breaches of express and implied warranties.”  Id.  Huh?  Someone is still filing these cases?  The Ninth Circuit didn’t even blink when it dismissed these claims pursuant to Reigel v. Medtronic, Inc., 552 U.S. 312 (2008):

The Stengels’ claims, as they appear in the initial complaint, are expressly preempted under section 360k and Riegel.  The claims generally challenged the safety and effectiveness of Medtronic’s pump without any hint of an allegation that Medtronic’s conduct violated FDA regulations.  To be successful, the claims would have required the trier of fact, as a matter of state tort law, to conclude that the device should have either been designed differently from what the FDA required through premarket approval, or labeled with warnings different from what the FDA required. Therefore, the district court correctly dismissed the Stengels’ initial complaint.

Stengel, slip op. at 4092. 
So the plaintiff, having belatedly become familiar with Riegel, attempted to amend his complaint to allege the same four causes of action, but this time tried to beef up his failure to warn claim with a “newly-proffered theory” that plaintiff’s injury was caused by defendant’s failure “to report information to the FDA, as was required by FDA regulations.”  Id. at 4089.  In short, the plaintiff tried to put forward a parallel violation claim.  But, plaintiff should have kept studying, because in his attempt to dodge Riegel and express preemption, he ran head first into our old friend Buckman v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001) and implied preemption.

While the Ninth Circuit acknowledged that Riegel left open the possibility (as not expressly preempted) for a state law claim for alleged violations of federal regulations (a parallel violation claim), it also found that for such a claim to survive, it had to pass the test for implied preemption.  Stengel, slip op. at 4092-93.  In this case, that means Buckman.  Briefly, in Buckman the Supreme Court held that:  (1) implied preemption operates independently in the absence of express preemption, 531 U.S. at 352, and (2) claims for fraud-on-the-FDA were implied preempted because they interfere with the operation of the FDA’s enforcement and oversight responsibilities.  Id. at 348.  Similarly, in Stengel, “although the defendant had allegedly violated federal requirements, allowing the plaintiffs to bring a state cause of action to remedy the injuries caused by the violations would interfere with the congressional scheme.”  Slip op. at 4093. 

The Supreme Court reasoned that where a claim – such as fraud-on-the-FDA – is not based on a state law cause of action, but rather “exist[s] solely by virtue of the FDCA disclosure requirements,” Buckman, 531 U.S. at 352-53, it is preempted.  Relying on 21 U.S.C. § 337(a) (no private right of action to enforce FDCA), the Court found “it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions.”  Id. at 349 n.4. 

And, that’s where plaintiff Stengel’s parallel violation claims failed – they were nothing more than statutorily prohibited attempts to raise private claims that the defendant violated the FDCA.  Functionally, the failure-to-report claim was indistinguishable from the fraud on the FDA claim in Buckman.  The defendant’s purported lack of disclosure merely being “tacit” rather than “overt”:

There is no meaningful distinction between [plaintiff’s] failure-to-warn claims and the “fraud-on-the-FDA” claims held to be preempted in Buckman. . . .  The only difference is that, in Buckman, the defendant allegedly misinformed the FDA overtly by providing false information, whereas here the defendant allegedly misinformed the FDA tacitly by failing to report information that it had a duty to report. The policing of such conduct in both instances is committed exclusively to the federal government, and recognizing a state cause of action based on such conduct would conflict with the statutory scheme established by Congress. 

Stengel, slip op. at 4095.  The speculative nature of the claim was also the same – that is, like Buckman, Stengel also invited a jury to speculate that the FDA would have done something different (required a label change) had it received different information than it actually did from the defendant manufacturer.  Id. at 4094 (“[plaintiff’s] theory is that if Medtronic had acted with reasonable care in complying with the regulations . . . the FDA would have required Medtronic to warn physicians about the danger of inflammation connected to its pump”).

The plaintiff’s claims were also, as in Buckman, naked allegations of regulatory violations, not resembling any traditional tort claim.  The Stengel decision recognized that failure to report claims were creatures of federal, rather than state, law:

The federal regulations that Medtronic is alleged to have violated, which require investigation and disclosure to the FDA in a particular manner so that the FDA can make a decision whether notification of consumers is necessary, are not tied to this general duty to warn consumers under Arizona law. Thus, the Stengels’ failure-to-warn claims, to the extent they survive express preemption, exist solely by virtue of the FDCA disclosure requirements and are, therefore, impliedly preempted.
. . .

We offer no opinion as to whether a particular state claim that is tied directly to compliance with federal law would be preempted under Buckman. In this case, the duty of manufacturers under federal law to report to the FDA information regarding their devices is not tied directly to the duty of manufacturers under state law to warn consumers of a device’s dangerous condition. On the contrary, the enforcement of the duty to report is an element of the federal scheme that is committed solely to the federal government.

Stengel, slip op. at 4096 and 4097.   
            So, plaintiff tried another dodge – arguing that his case was distinguishable from Buckman because here, unlike in Buckman, the FDA had sent the defendant a warning letter, “show[ing] that the FDA had already determined that [defendant] violated its federal disclosure obligations.”  Id. at 4097.  Plaintiff, therefore, contended that he could prove his claims “without second-guessing the FDA’s decision making.”  Id.  But, the Ninth Circuit made short work of this argument because it was based on the concurrence in Buckman (see 531 U.S. at 354 (Stevens, J., concurring in the judgment)).  A concurrence “which disagreed with the majority specifically because the majority did not take the position now advocated by the Stengels.”  Stengel, slip op. at 4097.  Hence, it is not the law.

            The remainder of the Ninth Circuit’s discussion on preemption is about the circuit split on the very issue of whether state failure to warn claims based on a defendant’s alleged failure to provide the FDA with information are preempted by Buckman.  The Ninth Circuit joined the Eighth Circuit in finding the claims preempted, see In re Medtronic Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200, 1205-06 (8th Cir. 2010), and rejected the reasoning – which we also criticized – of the Fifth Circuit in Hughes v. Boston Scientific Corp., 631 F.3d 762, 775-76 (5th Cir. 2011) which reached an opposite conclusion.  See Stengel, slip op. at 4098-99.   Since Hughes also earned our #2 worst decision ranking for last year , we think you can figure out who we think got it right.

            And finally, the cherry on top:  Stengel (like practically every recent decision) approves of taking judicial notice of FDA approval documentation to establish the PMA nature of the defendant’s device.  Slip op. at 4099-4100. That means plaintiffs can’t resort to strategic omissions in their complaints to avoid Rule 12 dismissal.

            Today’s lesson:  what Riegel giveth (parallel violation claim), Buckman taketh away – at least when the allegation is based solely on FDA disclosure requirements (and except in the Fifth Circuit).

Monday, April 16, 2012

Excellent New Pain Pump Preemption Decision - Ninth Circuit

Here's a copy of a brand new Ninth Circuit decision upholding dismissal of a pain pump case on the grounds of express (Riegel) and implied (Buckman) preemption:  Stengel v. Medtronic, Inc., slip op. (9th Cir. April 16, 2012).  It's good on a lot of things.  A full report tomorrow (sorry, too busy today).

The Long Goodbye

Coming up with a last line is not easy. A good conclusion is both a summary and a revelation. Think of Thoreau's Walden: "There is more day to dawn. The sun is but a morning star." Or The Great Gatsby: "So we beat on, boats against the current, borne back ceaselessly into the past." Those exit lines are beautiful in themselves. They shine. They stay with us.

More often, a last line acquires force through context. Examples include 1984 ("He loved Big Brother"), The Invisible Man ("Who knows but that, on the lower frequencies, I speak for you"), and Lolita ("And this is the only immortality you and I may share, my Lolita").

A lot of people think the greatest last line in cinematic history is from Some Like it Hot. The line is simply, "Nobody's perfect." It is what leads up to that line that makes it shocking and hilarious. Some people prefer the ending of The Maltese Falcon: "The stuff that dreams are made of." But in fact the last line in that film is the cop's puzzled response: "Huh?" Not so inspiring. Our own favorite movie ending is from Richard Linklater's Before Sunset: "Baby, you are gonna miss that plane". "I know." Again, it's all in the context. And it doesn't hurt to have a sultry Julie Delpy uttering the line. Most great movie endings leave one exhilarated or numb because of the way they comment on, or undercut, everything that happened before it. "Louie, I think this is the beginning of a beautiful friendship." "I was cured all right." "Forget it Jake, it's Chinatown."

Television has a mixed history of finales. They range from wonderful (Newhart and Six Feet Under) to weird (St. Elsewhere and The Sopranos) to wretched (Seinfeld and Cheers). The Fugitive was an early example of a show that wrapped things up successfully. M*A*S*H ended on a surprisingly maudlin note, but that did not prevent it from commanding a record-setting audience. The Mary Tyler Moore show ended in a group hug, with the cast members displaying their reluctance to part ways. But can anyone out there explain the ending to The X Files? And how could Roseanne, which had always been a sharply-written show about blue collar reality, descend into an ending that managed to be surreal, pompous, and stupid? The better the show is, the more betrayed we feel when the last episode disappoints. That disappointment ends up coloring our perception of the whole series.

Last lines matter in litigation. Trial lawyers exploit the rules of primacy and recency. Get the audience's attention up front and zing them at the end. As a trial-line Assistant U.S. Attorney, we sometimes lifted a closing by the DA (Michael Moriarty, not Sam Waterston) in Law & Order: "I represent the people. It's been my job to show you the defendant's crimes. Now it's your job to do justice". (Now comes "the Clang" -- the chung-chung notes that sound vaguely like a judge's gavel. Richard Belzer, one of the actors in the series, says the sound is actually the producer's cash register ringing.)

Once we tried out a clever rebuttal passionately daring the jury to acquit the defendant if they believed his crazy story. Guess what? They did. We were shocked and dismayed at this result. How could a jury buy the defendant's absurd tale that he had accidentally found 15 social security checks in the slot of a dumpster? Then, two years later, we investigated a mail-theft ring, where the villains traipsed through East LA neighborhoods on the 1st and 15th of the month pilfering government checks. After being purloined from mailboxes, the checks were then hidden in drop points. One of those drop points was -- wait for it -- a dumpster. In retrospect, we have never been so happy to have lost a case.

It is harder as a product liability defense lawyer to strike gold with the last word. The reason for that is self-evident: it is the plaintiff who gets the last word. Even if the defense lawyer comes up with a nice riff, the plaintiff lawyer can turn it around. One common motif is to talk about the verdict and the truth. The defense lawyer can end by telling the jury that the word "verdict" means to speak the truth. 'And the truth is that the plaintiff never showed that the product was defective. The truth is that the plaintiff never showed a safer alternative. The truth is that the plaintiff never showed that the product, rather than an alternative cause, played any role in harming the plaintiff.' Etc. Great. Then the plaintiff lawyer can rush up to the lectern and say, 'You want to talk about the truth? The truth is that the plaintiff enjoyed a happy, healthy life before using this product. The truth is that it would have been simple and easy for the defendant to tell the truth about the product's risks.' Etc. Cue the Clang. The plaintiff can completely appropriate the emotional force of the defense peroration. Often the defense closing contains a pathetic plea to the jury along the lines of, 'The plaintiff gets the last word because she bears the burden of proof. I won't have the chance to come up here and answer the plaintiff's arguments, but you know that I would have answers to each and every one of them. I am asking you to think about what my responses would be.' Good luck with that.

Last lines are important in written arguments, too. Our eyes burn when we read the rote conclusion, "For the foregoing reasons, the defendant's motion should be granted." Really? How colorless and perfunctory can you get? Why squander a final chance to remind the judge of your key argument? It is not especially hard to say something like, "Because the plaintiff's failure-to-warn claim is completely foreclosed by the Buckman decision, this Court should grant summary judgment." That conclusion does not exactly contain poetry, but at least it's an argument rather than an empty gesture.

We were hoping to come up with sparkling last lines from judicial opinions. But it turns out that judges (even Posner) do not write like Thoreau or Fitzgerald. Nor should they, we suppose. Let's be honest: the most important, riveting words we look for at the end of a judge's decision are GRANTED, DENIED, AFFIRMED, or REVERSED.

When we talk about final lines, we end up talking about farewells. If last lines are hard, farewells are the hardest. If you made a film of your life, many of the most poignant scenes would be of farewells: the kiss at the threshold of the jetway (at least before airport security tightened up and squashed all the romance out of departures); leaving a family gathering and spotting, just as you were about to drive off, a five-year-old pressing his face against the window and forlornly waving bye-bye; and sitting in a hospital room and struggling to say something meaningful but not awkward.

This Summer, on some too-far-away college campus, we will be saying goodbye to the Drug and Device Law Daughter. We can hardly write that sentence without blurry eyes. This Monday column has previously alluded to the Drug and Device Law Daughter's proclivity for challenging and vexing her father, but we will miss her far beyond our poor power of expression. (By the way, we recognize that there is something presumptious in referring to the Drug and Device Law Daughter. Several of us who work on this blog have daughters. But permit us one last time.) The DDLD hasn't been at all shy about criticizing things we have said and done. An ongoing source of complaint is her name, especially her middle name. She objects that we assigned her the name of a frivolous male character from a 90's sitcom. Not so. We were thinking of the last name of our favorite 20th Century American (at least from Los Angeles, where the DDLD was born) writer. Raymond Chandler wrote some of the best last pages in American literature. Check out the ending of The Big Sleep, for example. You might not know who actually committed the murder, but you almost do not care. Some higher truth is at stake. In The Long Goodbye, Chandler writes that to say goodbye is to die a little.

This is the last Monday post by this particular writer. It's been a pleasure. Some of you took issue with the columns, attacking moldy or biased thinking. Sometimes you were right. That's okay. Nobody's perfect.

Friday, April 13, 2012

On Getting Jobbed

Paradise this one isn’t.

The way we look at it the defendant got jobbed. It was a ridiculous case (at least as a product liability matter) to start with. The jury agreed and found no product defect.  Then, on appeal, it turns out that the trial judge made an "error" in a jury instruction on a point that the jury never reached. So the plaintiff gets a new trial due to an instructional “error” that, to a reasonable degree of litigation certainty, had nothing to do with the verdict.

That, in a nutshell, is Dolan v. Hilo Medical Center, ___ P.3d ___ 2012 WL 1071464 (Haw. App. March 30, 2012).  It’s a ridiculous product liability case because:
  • The manufacturer-defendant had testimony and a “packing list” for the device kit (consisting of several components) to establish it had shipped the kit with all of the necessary pieces. 2012 WL 1071464, at *13
  • The hospital-defendant admittedly never inventoried the device kit after it arrived, in violation of its own policies.  Id. at *1.
  • This wasn't the first time something like this had happened at the defendant-hospital.  Id. at *13.
  • The defendant-surgeon, who had a very checkered professional history, commenced plaintiff’s surgery knowing there had been no inventory.  Id. at *1, 3.
  • When, in the middle of surgery, nobody could find essential components (two spinal rods), the manufacturer-defendant offered to have one flown there on an emergency basis in 90 minutes.  Id. at *2.
  • Rather than wait, the defendant-surgeon went ahead, using a cut up a screwdriver as an improvised spinal rod.  Id.
  • “The screwdriver shaft was not intended or approved for human implantation.”  Id. (no kidding).
  • “Following the surgery, [nobody] inform[ed] [plaintiff] that a screwdriver shaft had been implanted in his spine.”  Id.
  • Instead, plaintiff is instructed to “commence physical therapy” as if nothing unusual had happened.  Id.
  • The very next day, the screwdriver, not designed to serve as a spinal rod, shatters.  Id.
  • Over the objections of a nurse (who turned whistle-blower), the medical defendants don't come clean about what happened.  Id.

The jury gets that case and it hits the surgeon and hospital with a mid-seven figure verdict, including punitive damages against the surgeon.  2012 WL 1071464, at *3.  The jury finds in favor of the manufacturer-defendant, deciding that the device kit wasn’t defective.  Id.  Well, duh.  Obviously, they resolved the disputed question of fact about whether all the pieces of the kit had been shipped in favor of the manufacturer - which had all the evidence.

On appeal, however, it turned out that the judge had made a boo-boo. The trial court gave an out-of-date instruction on “substantial change” – that is, using a screwdriver as a spinal rod:
Here, there is no question that at least part of the “product” was substantially changed or modified, particularly from a lay person's point of view.  [The surgeon] cut up a screwdriver . . . and inserted it in [plaintiff’s] back. . . .  However, that fact alone should not have dictated a finding that the Kit was not defective, without regard to the jury’s finding on whether the Kit was shipped with or without the titanium rods . If the jury determined that the Kit was shipped without the titanium rods, that determination alone could have supported a finding that the product was defective, notwithstanding [the surgeon’s] actions.  Accordingly, the Circuit Court erred in giving this instruction.

2012 WL 1071464, at *14.

Well, we think that’s a load of … well, let's say rotten pineapples.  The opinion had just finished explaining that substantial change was an affirmative defense, on which the defendant bore the burden of production.  Id. at 13 (discussing Stender v. Vincent, 992 P.2d 50 (Haw. 2000)).  Nonetheless, under Hawaiian law, “the plaintiff maintains the ultimate burden of proof that the product was dangerously defective when it left the hands of the defendant.”  Dolan, 2012 WL 1071464, at *12 (emphasis added - keep that point in mind).

Why wouldn’t the jury have used its common sense in finding the product not defective?  The “substantial change” point that the court alluded to – using a screwdriver as a spinal implant – wasn’t disputed.  Rather the dispute centered on whether the original shipment was complete.  That issue never involved “substantial change” at all.  If the manufacturer shipped the kit without essential parts, then it simply would have been defective when it “left the hands” of the defendant; forget about substantial change.  The only change after “leaving the hands” of the defendant would be if persons unknown cannibalized the kit.  That was the defense view of the facts.  Thus, for substantial change (that is, something happening after the kit was shipped) ever to become relevant, the plaintiff must have already lost the issue of improper shipment.

Nor was the screwdriver incident – however bizarre it might be from a standard of care perspective – a significant disputed issue of fact.  Only the state of the kit when shipped was in controverted, and as to that, the manufacturer had documentary and testimonial evidence, while the plaintiff had less than nothing, since the hospital admitted never conducting the inventory that was required by its own procedures.

All of this leads us to conclude to a litigation certainty that the jury’s no-defect verdict was based upon its resolution in favor of the defendant of the primary disputed issue – having nothing to do with substantial change – of what was (or wasn't, but the jury found "was") originally shipped in the kit.  If the jury had erroneously found substantial change having to do with the screwdriver (as Dolan speculated) it would have first found the product defective (due to missing parts), and then would have held that the defect was non-causal due to substantial change caused by intervening medical malpractice.  But that purported error was belied by how the jury in fact completed the verdict form.

Given how the jury actually rendered its verdict, the purported “substantial change” instructional error was at worst harmless error, involving an issue that the jury could not have reached.  What did Dolan say about harmless error?  Not much, all of one sentence:
Erroneous jury instructions are presumptively harmful, [defendant] makes no argument overcoming the presumption of harm, and we cannot conclude that the Circuit Court's error in giving this instruction was harmless error.

2012 WL 1071464, at *14 (citation omitted).

Okay … if you say so – but we also find it hard to believe that defense counsel wouldn’t have pointed out that the jury’s “no defect” verdict implies its rejection of the plaintiff’s shipping error theory, without “substantial change” (and thus the erroneous instruction) playing any part in their deliberations.  Once again, a product shipped without necessary components (assuming that happened), would have simply been defective when it left the defendant’s hands, and no amount of substantial change would have changed that.

So we think that the defendant got jobbed in Dolan – deprived of an eminently factually sustainable verdict on the basis of an irrelevant instructional error.  Most states tend to presume jury verdicts are valid and give them the benefit of all doubt.  Maybe Hawaii doesn’t do this.

So what happens next?  Well, we hope that the defendant perfects a further appeal and wins, but if Dolan were remanded in its current form, we’d have to say "probably not much."  The plaintiff’s substantial verdict against the malpractice defendants was affirmed in all respects, so the plaintiff can collect his entire judgment against them.  A plaintiff only gets one full recovery for the same injury.

Only if the malpractice defendants for some reason can’t pay (bankruptcy? caps?) would the plaintiff need to retry.  Perhaps, after satisfying the judgment, those defendants might bring a contribution action – but on these facts, we question whether that would be a prudent thing to do.