Thursday, May 31, 2012

A Silver Lining?

We really don’t like it when state aspiring governors (that’s what “AG” stands for, isn’t it?) come after our clients − especially when our clients were merely exercising their First Amendment rights to make truthful statements about this or that off-label use.  But then, the state AGs never cared what we thought before, so why should they start now.

Stuff, like state AG litigation, happens.

But we’d like to let folks know about a possible silver lining around at least some of those big, dark, state AG clouds.  We’re talking about the recent Minnesota Supreme Court decision, Curtis v. Altria Group, Inc., No. A10-0215, slip op. (Minn. May 30, 2012).  It’s not a drug/device case (it involves cigarettes), but the legal principles should carry over with respect to at least some state AGs and their copycats who come to play in our sandbox.

The relevant legal rule recognized in Curtis is this: since a state AG acts on behalf of the citizens of that state (we lawyers call that “parens patriae”), the resolution (usually by settlement) of a state AG action precludes private copycat plaintiffs from later suing over the same allegations.

Here’s what happened in Curtis.  In 1994, the Minnesota state AG brought a consumer fraud action against the defendants over “light” cigarettes (but it could have been anything), seeking among other things, restitution and damages.  Slip op. at 4-5.  This AG action settled a few years later for over $100 million.  Id. at 6.  Not too long after that, copycat plaintiffs came to Minnesota and brought private suits under the same consumer protection statutes, alleging the same violations, and also seeking restitution and damages.  Id. at 7.

The issue before the Court was, can private plaintiffs get away with this kind of repetitive litigation?

Fortunately, the Minnesota Supreme Court said no.  We’ll spare you a lot of detailed discussion because the important points are well-encapsulated in the Court’s syllabus:

Under [the Minnesota act], the Minnesota Attorney General (State AG) has the authority to bring a lawsuit . . . and to seek not only the relief available to the State . . ., but also the relief available to a private litigant. . . . It logically follows that the State AG has the authority to settle and release a private litigant’s claims.

The 1998 Settlement Agreement entered into by the State AG and [defendant] expressly released and barred [copycat plaintiffs’] consumer protection claims . . . and is binding on [those plaintiffs].

Curtis, slip op. at 2-3, syllabus points 1, 3 (emphasis added).  Syllabus point 2 dealt with the reverse situation, and isn’t really relevant to this discussion.

What this means − at least in Minnesota − is that, if our clients have the misfortune to be sued by a state AG, and they settle the action, that settlement can preclude copycat private litigation involving the same allegations.  Given that the state AG can assert the public’s consumer protection rights, the Court concluded that private consumer protection litigation was merely “part of the broader authority of the State AG to bring a lawsuit . . . to enforce all remedies available to it,” including those remedies also provided to private litigants.  Curtis, slip op. at 11-12.  “[I]t logically follows” that since the AG can pursue private as well as public remedies, the AG “has authority to settle and release” those claims, including those of subsequent private litigants.  Id. at 14.

That “release,” moreover, was a nice, big, fat general one − including “all claims that the State of Minnesota made, or could have made.”  Curtis, slip op. at 17.  The release had the usual “broad and comprehensive” provisions we expect to see in general releases:  “any and all manner,” “known or unknown, suspected or unsuspected, accrued or unaccrued, whether legal, equitable or statutory,” “relating to the subject matter,” “directly or indirectly based on, arising out of or in any way related to” - that kind of thing.  Id. at 18.  The Court applied the general release generally.  The copycat plaintiffs’ claims easily satisfied the “related to” test since they “assert[ed] violation of the same consumer protection statutes arising from the same fraudulent and deceptive misrepresentations.”  Id. at 18-19 (emphasis original).

The copycats’ last stand was a provision in the settlement providing that “no portion . . . shall bind any non-party.”  Curtis, slip op. at 20.  Because the state AG was acting on behalf of the public, members of the public couldn’t claim to be “nonparties”:

We read the words “representatively” and “derivatively” to encompass [private copycats’] right as private litigants to bring [monetary] claims against [defendant].  Because the State AG brought and released those claims, including [monetary] consumer protection claims that could have been brought on behalf of private litigants, the release expressly determined [private copycats’] right to bring a [monetary] consumer protection claim.

Id. at 21.  Bingo.  The tagalongs got tagged out.

Since our clients are all too often on the receiving end of the same sort of litigation − both state AG actions and follow-up copycat litigation − Curtis suggests to us that the same silver lining might be available in elsewhere.  The relevant state law would have to allow the state AG to recover the same monetary damages as private litigants, but once that happens, the rest should flow.  Since the AGs almost always claim to act on behalf of the public, their monetary settlements using general release language should also bind individual copycat plaintiffs and thus preclude relitigation of those claims.

Thanks to Scott Smith at Nilan Johnson (who filed a amicus brief for the right side of the “v.”) for passing Curtis along.

Wednesday, May 30, 2012

A Quick Mensing Note

            It has been almost one year since the Supreme Court decided PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and it is undeniable that it has dominated the world of pharmaceutical litigation for all eleven months – and likely will continue to do so for a while longer.  This is clearly evidenced by our ever-growing generic drug preemption scorecard.    While you can always find the latest Mensing decisions there, we like to separately point out those that add something new to the discussion – at least we don’t think we’ve seen these particular twists yet. 

            So, today we draw your attention to Johnson v. Teva Pharmaceuticals USA, Inc., 2012 U.S. Dist. LEXIS 71384 (W.D. La. May 21, 2012).  This is a metoclopramide case and as our regular readers know, Dechert is involved in this litigation and therefore, we can’t offer commentary.  But, we can report what this court had to say on two issues. 

            First, plaintiff made an argument that has become commonplace since Mensing:  Mensing doesn’t apply when a generic defendant doesn’t timely update its label to conform to the brand label.  The Johnson court, like the others to have considered this argument, agreed.  “[I]mpossibility preemption would not apply to any [state law] requirement . . . that the Generic Defendants update their product label to reflect changes made by the brand name manufacturer.”  Id. at *10.  However, it is what the court did next that we don’t think we’ve seen explicitly spelled out in any other Mensing decision:
     Nevertheless, the court finds that amendment would be futile because Ms. Johnson cannot state a plausible claim for relief based on the Generic Defendants' delay in adopting the 2004 labeling changes. The proposed amendment is wholly inconsistent with the allegations of Ms. Johnson's original complaint. The original complaint includes an allegation that the FDA-approved warning label for Reglan remained "inadequate" until the FDA issued a "boxed warning" in 2009. Essentially, therefore, Ms. Johnson seeks leave to amend her complaint to assert a claim that the Generic Defendants are liable for failing to update their label to one that was still inadequate.
Id. at *10-11.  In other words, failure to implement an inadequate warning is not a viable cause of action. 
            Second, plaintiff attempted to dodge Mensing’s preemption of failure to warn claims by couching her cause of action as a design defect.  Plaintiff alleged that “the Generic Defendants could have employed an alternative packaging design that would have mitigated the risks posed by metoclopramide.”  Id. at *12.  To which the court responded:
     This, however, is merely another way of stating that the Generic Defendants failed to provide adequate warnings about the risks associated with the long term-use metoclopramide. As explained above, Mensing forecloses any such claim. The FDCA prohibits generic manufacturers from employing any labeling that contains information that differs from that contained in the labeling used by brand-name manufacturers. Under the FDCA, "labeling" includes any written material accompanying the product. Accordingly, there was no alternative packaging design available to the Generic Defendants that could have conveyed stronger or different warnings about metoclopramide’s side effects.
Id.  In other words, any argument about “alternative packaging” is a preempted failure to warn claim.
            Plaintiff’s failure to warn, breach of warranty, and failure to withdraw from the market claims were likewise dismissed. 

Tuesday, May 29, 2012

What Defect?

After a Memorial Day weekend filled with picnics, barbeques and full stomachs, we have a quick post for you. We recently read the opinion in Mattos v. Eli Lilly & Co., 2012 U.S. Dist. LEXIS 71519 (D. Ka. May 23, 2012), which, much like those barbeques and picnics, had a lot of good things to digest. But a portion of the ruling was like the extra hamburger that you shouldn’t have had. It’s just sitting there, feeling not right, and worrying you.

The Mattos plaintiff claimed that Cymbalta, a depression medication, caused her diagnosis of Stevens-Johnson Syndrome. She brought failure to warn and design defect claims under the Kansas Product Liability Act (KPLA), along with a Kansas Consumer Protection Act Claim and a host of common law negligence, warranty and misrepresentation claims. Id. at *1. The easily digestible portion of the opinion is the court’s decision to dismiss all the common law claims because, like with many states’ product liability statutes, they were merged into or subsumed by the KPLA. Id. at *4-9.

The portion that makes us a bit queasy – the part that sticks in our craw (or “sticks in our crow” if you believe this explanation of that old phrase) – is the court’s decision not to dismiss plaintiff’s design defect claim. The defense argued that, under TwIqbal, the plaintiff needed to plead an actual defect to state a design defect claim. Id. at *17-18. That seems reasonable. The court even agreed that TwIqbal requires plaintiff to plead supporting facts, not just conclusory or formulaic allegations. Id. at *19.

But then the court went on to accept a set of allegations that appear to be as formulaic as they come: plaintiff was injured; the drug had an unnamed defect that tended to cause that injury; due to the unnamed defect the drug’s risks outweighed its benefits, particularly when compared to alternative drugs; and it was somehow feasible to make an alternative drug without the unnamed defect. Id. *19-20. Those allegations can be made in just about any pharmaceutical case, with no particular supporting facts needed at all. It smacks of pleading by formula – find template, insert name of drug and injury, state claim – which is what TwIqbal does not allow.

Also, reference to other drugs on the market doesn’t help. As we’ve said before, other products are just that – other products. They are not alternative designs. They are merely a list of “completely different drugs that [plaintiff] could have taken.” Salvio v. Amgen, Inc., 2012 U.S. Dist. LEXIS 19009, *22 (W.D. Pa. Feb. 15, 2012).

Now, we understand that the plaintiff might have difficulty alleging a particular defect. As the court admitted in the Bartlett opinion that we recently criticized, drugs are often comprised of one-molecule and inactive ingredients, and therefore identifying a defect or alternative design is almost impossible. But that’s a reason to dismiss a claim, not allow it.

In any event, fortunately, the Mattos opinion is only on a motion to dismiss, not on a summary judgment motion like in Bartlett. There is still time for the court, presumably after some discovery, to re-address plaintiff’s design defect claim on summary judgment and dismiss it. Maybe that would alleviate that uneasy feeling in our stomachs.

Friday, May 25, 2012

Is That a Pomegranate You Have There?

It’s Memorial Day weekend, and it’s time for barbeques.  While many of us will choose an alcoholic drink to enjoy during the festivities, there may be non-alcoholic drinks involved too.  Maybe a nice juice drink.  That usually means grape, apple or cranberry juice, or some combination of them.  Lately some people are even choosing pomegranate juice.  Yeah, we know, but some people are drinking it.  But when those people pick their pomegranate juice, do they always know what they’re getting? 

That’s what the plaintiff complained about in Pom Wonderful LLC, v. Coca-Cola Co., 2012 U.S. App. LEXIS 9921 (9th Cir. May 17, 2012).  The plaintiff claimed that the defendant misled consumers with the naming and labeling of its juice product, “Pomegranate Blueberry” a/k/a “Pomegranate Blueberry Flavored Blend of 5 Juices,” because the drink actually contained only 0.3% pomegranate juice and 0.2% blueberry juice, with the vast majority of the juice being apple and grape.  Id. at *2-3. 

Now, this was a business dispute.  The plaintiff was a rival juice distributor.  But it has broader implications because it addresses what can happen when two federal statutes clash. 

The plaintiff brought its claim under the Lanham Act, which broadly prohibits false advertising and authorizes a lawsuit by anyone who believes that s/he will likely be damaged by the false advertising.  Id. at *7 (citing 15 U.S.C. § 1125(a).  The FDCA, as we know, broadly regulates food and beverage labeling.  But, while the Lanham Act authorizes private plaintiff lawsuits, the FDCA does not.  It is solely enforced by the FDA.  Id. 

The plaintiff’s Lanham Act allegations at issue in the appeal were that (i) the name “Pomegranate Blueberry” misrepresented the actual contents of the drink, and (ii) the phrase “Flavored Blend of 5 Juices” was misleadingly smaller and less conspicuous than the name “Pomegranate Blueberry.”  

But FDA regulations and the FDCA itself address naming beverages, the words and statements that must or may be included in labeling, and their prominence and conspicuousness.  Id. at *11-14 (citing 21 U.S.C. §§343(f), (i); 21 C.F.R §§102.33 (c), (d)).  That’s a conflict between plaintiff’s claims under the Lanham Act and the FDCA. 

So which applies?  The court noted that courts should “try to give as much effect to both statutes as possible.”  Id. at *8 (citing Schering--Plough Healthcare Prods., Inc. v. Schwarz Pharma, Inc., 586 F.3d 500, 508 (7th Cir. 2009)).  But when it comes to the FDCA, courts have focused on the fact that Congress entrusted the FDA with enforcement, not private plaintiffs.  Under that reasoning, courts have held that the FDCA limits all sorts of Lanham Act claims:
A plaintiff may not, for example, sue under the Lanham Act to enforce the FDCA or its regulations because allowing such a suit would undermine Congress’s decision to limit enforcement of the FDCA to the federal government.  Nor may a plaintiff maintain a Lanham Act claim that would require a court originally to interpret ambiguous FDA regulations, because rendering such an interpretation would usurp the FDA’s interpretive authority.  Where the FDA has not concluded that particular conduct violates the FDCA, we have even held that a Lanham Act claim may not be pursued if the claim would require litigating whether that conduct violates the FDCA.
Id. at *8-9 (citations omitted). 
Not surprisingly, then, the court held “that the FDCA and its regulations bar pursuit of both the name and labeling aspects of [plaintiff’s] Lanham Act claim.”  Id. at *11.  The Court reasoned, properly, that Congress and the FDA have already spoken to such naming and labeling and that the FDA, not litigants and the courts, should impose any further restrictions or, if it so finds, declare defendant’s label misleading:
Congress and the FDA have . . .  considered and spoken to what content a label must bear, and the relative sizes in which the label must bear it, so as not to deceive.  . . . [T]he FDA has not (so far as we can tell) required that all words in a juice blend’s name appear on the label in the same size or that words hew to some other standard that [plaintiff] might have us impose.  If the FDA thought such a regulation were necessary . . .  it could have said so.  If the FDA believes that more should be done to prevent deception, or that [defendant’s] label misleads consumers, it can act.
Id. at *13-14 (citations omitted).
The Court finished by explaining that it is not the place of litigation to displace the expertise of the FDA:
[W]e must respect the FDA’s apparent decision not to impose the requirements urged by [plaintiff].  And we must keep in mind that we lack the FDA’s expertise in guarding against deception in the context of juice beverage labeling. In the circumstances here, “the appropriate forum for [plaintiff’s] complaints is the [FDA].”
Id. at *16. 
That is a nice way to finish.  So enjoy your Memorial Day weekend and, if you want, your Pomegranate Blueberry juice.  But know that there might be a lot of apple and grape in that drink.  Maybe a beer or mojito  is simpler.

New Stuff

Miscellaneous day today, just before Memorial Day (remember to raise a glass to the common foot soldier this holiday) and the official start of summer − courtesy of our readers.

Number one:

A tip of the cyber-cap to Mike Imbroscio at Covington and Bart Sullivan at Fox Galvin for sending us Aranda v. Walgreen Co., No. 12-cv-337-DRH, slip op. (S.D. Ill. May 23, 2012).  Aranda demonstrates that, after the Seventh Circuit’s Walton decision finding fraudulent joinder of pharmacies under Illinois law, plaintiffs in the southern Illinois hellholes (St. Clair, this time) still haven’t given up.  After getting caught falsely alleging the diversity of another party (slip op. at 3-4), the plaintiffs (71 of them) argued in Aranda that despite Walton, a pharmacy could be liable.

The plaintiffs in Aranda correctly observed that there is an exception to pharmacy non-liability in Illinois where the pharmacist has actual, subjective knowledge of a reason why a particular drug is contraindicated in a particular patient.  Happel v. Wal-Mart Stores, Inc., 766 N.E.2d 1118 (Ill. 2002) (actual knowledge of synergistic adverse effect of two drugs).  See slip op. at 8-10 (discussing Happel).

But so what?

None of the 71 blatantly misjoined plaintiffs in Aranda alleged any facts suggesting that the actual knowledge exception in Happel had anything whatsoever to do with their purported claims.  To the contrary, the only allegations were the usual “knew or should have known” failure-to-warn boilerplate.  Slip op. at 11-12. Thus, the Aranda plaintiffs had nothing to take their cases outside of the Seventh Circuit’s controlling Walton opinion:

Despite plaintiffs’ arguments to the contrary, the Court finds that this is the Walton case all over again.  Plaintiffs allege that the manufacturing defendants and [the pharmacist] did not provide adequate warnings; they do not allege that [the pharmacist] had specific knowledge of each individual plaintiffs’ susceptibility to the adverse side effects of [the drug].  Clearly it is possible to allege for each plaintiff individually his or her medical susceptibility and how [the pharmacist] knew of that condition.  While this may seem like a daunting task with so many plaintiffs in one complaint, it is perhaps not as daunting as preparing a different complaint for each plaintiff or paying a filing fee for each plaintiff.  Nonetheless, this is what Walton requires, and the allegations in this case come nowhere near the situation in Happel where the Illinois Supreme Court found a narrow duty existed. Accordingly, the motion to remand is denied.

Aranda, slip op. at 12 (emphasis added).  Boilerplate pleaded on behalf of a large number of improperly joined plaintiffs − hence the dig about failing to pay filing fees − doesn’t cut it.  And so these 71 plaintiffs will stay in federal court, where they will almost certainly be severed and required to pay the proper filing fee.

Good job.

Number two:

There’s also this hearing transcript in Lukas-Werner v. Novo Nordisk, A/S, No. 1009-13177 (Or. Cir. Multnomah Co. May 11, 2012), rejecting Conte and the entire concept of brand-name liability in generic drug consumer cases.  Here’s the decisive part of the hearing:

THE COURT:   Well, this is really interesting.  I think plaintiff’s argument has a lot of appeal, but that's not my job here today.  I am required to attempt to predict -- and I need a much bigger crystal ball than I am using -- what the Oregon Supreme Court would do with this theory.  And my best prediction is that the Oregon Supreme Court would not recognize the innovator liability theory in these circumstances.

Frankly, I was thinking I don’t really care about defendant’s arguments about what causes of action the plaintiffs might have still brought against [other parties].  That's not the question before me.  The question is does this particular pleading state a cause of action under the Oregon common law, regardless of what other things might have been there and weren't there.

The only reason I think there is any place for that argument in this motion, actually, is thinking that the Oregon Supreme Court, when it takes this issue up, will look at Article I, Section 10 of the Oregon Constitution and look at the Mensing case and say where that provision in our constitution says every man (sic) shall have a remedy by due course of law for injury done him (sic), and his person, property or reputation, would they say that in light of the U.S. Supreme Court's ruling in Mensing there has to be innovator liability for that remedies clause to be given effect and meaning?  And they would look and say, “Well, even if it’s not that particular remedy, are there others and so on.”  So, you know, I’m not ignoring that argument completely, but I think it's really tangential to the core issue here.

And I do not think the Oregon Supreme Court would conclude that the innovator, the original manufacturer of a drug responsible for its labeling, has a duty arising out of the FDA regulations to the consumers or prescribers of all generic versions of its drug.

And the plaintiffs acknowledge that foreseeability alone won’t get them there.  That really is kind of what it amounts to, because the regs don’t permit the manufacturer of a generic that doesn’t want to go through the labeling process to do anything other than use the innovator’s labeling. That makes the harm foreseeable to the innovator.

I don’t think we can get there from here.  So I’m granting the defendant's motion.  I do it reluctantly, but I’m granting it.

Transcript at 25:2-26:21.

Reading the rest of the transcript, we’re pleased (but not at all surprised) to see that defendants have picked up on the fact (which we discussed here) that Conte itself is an endangered species in California since the California Supreme Court’s rejection of pure foreseeability as a basis for product liability in O’Neil v. Crane Co., 266 P.3d 987 (Cal. 2012).  See Transcript at 4:15-21 (“the O’Neil decision . . . swallows Conte up and spits it out”).  Nice metaphor.  There follows (pp. 4-5) admitted “speculation” about why the California Supreme Court didn’t accept an appeal in Conte itself.  Since Bexis briefed the Conte petition for PLAC, he has his own speculation on that front to pass along.  At the time, Bexis heard from long-time members of the California bar that the justices largely didn’t come from civil litigation backgrounds, and weren’t all that interested in the area.  Only really “big” products cases − such as the asbestos-related issue in O’Neal can get their attention − despite Bexis letter brief in Conte laying out the parade of horribles.  Anyway, it’s all speculation.

On the merits, this particular Conte win is particularly gratifying because:  (1) it rejects a new plaintiff’s argument that we can expect to see elsewhere;  (2) it’s in state, rather than federal court;  (3) Oregon is not a particularly conservative jurisdiction, and (4) Oregon borders California, indicating that Conte isn’t having the kind of reach that earlier California product liability craziness (can you say "market share liability"?) did.

Thanks to Angela Higgins at Baker Sterchi for passing the transcript along.

Thursday, May 24, 2012

Bexis Brings Home Some Fryed Bacon

Bexis doesn’t limit his product liability horizons to drugs and devices − except usually on this blog.  A few years ago Bexis got involved in asbestos-related expert witness issues in a big way, and in particular has devoted almost a decade (working through the Product Liability Advisory Council (“PLAC”)) trying to stamp out so-called “any exposure” causation opinions in asbestos litigation in Pennsylvania (and more lately, elsewhere).  Asbestos plaintiffs attempt to recover without having to prove individual exposure histories by routinely offering expert testimony that “each and every breath” of asbestos-contaminated air is causal, particularly in mesothelioma cases.

Those kind of opinions turn our stomachs.

Yesterday, Bexis' effort (and that of a lot of people, including asbestos-specific amici) was successful.

A unanimous Pennsylvania Supreme Court decided Betz v. Pneumo Abex LLC, No. 38 WAP 2010, slip op. (Pa. May 23, 2012), holding that such opinions offered in meso cases violated the Pennsylvania Frye-based “generally accepted” standard for the admissibility of expert testimony.  Bexis’ PLAC brief in Betz was cited in several places, and his arguments were adopted even more frequently.

Because almost every drug/device case involves the admissibility of expert testimony, Betz is also highly relevant to what we do here on the blog.  First of all, in what we consider the most important of the many good holdings in Betz, the Court rejected as "ineffectual" a lot of the usual garbage that the other side tends to offer in support of novel causation opinions:

[Plaintiff’s] efforts to invoke case reports, animal studies, and regulatory standards are also ineffectual in terms of substantial-factor causation, since the most these can do is suggest that there is underlying risk from the defendants’ products.

Betz, slip op. at 48 (emphasis added).  The Court had previously described the defense arguments on these issues in more depth.  See Id. at 32-33 (discussing the “limited role” of “anecdotal reports”; problems with “reliance on animal studies”; and the “cautionary, propylactic nature” of “regulatory standards and thresholds”).

Since most of Bexis’ PLAC brief addressed precisely these issues, it’s cause for high fives all around here.

In another critical Grady/Frye ruling, the Supreme Court affirmed the importance of dose response in cases (which would include drug cases − less so with devices) involving exposure to allegedly harmful substances.  “Simply put, one cannot simultaneously maintain that a single fiber among millions is substantially causative, while also conceding that a disease is dose responsive.”  Betz, slip op. at 48.  Dose-response is important:

[The trial court] was right to be circumspect about the scientific methodology underlying the any-exposure opinion. [The court] . . . was unable to discern a coherent methodology supporting the notion that every single fiber from among, potentially, millions is substantially causative of disease. [The court] appreciated the considerable tension between the any-exposure opinion and the axiom (manifested in myriad ways both in science and daily human experience) that the dose makes the poison.

* * *

A dose-response curve shows the relationship between different exposure levels and the risk of cancer [or any other disease] associated with those exposure levels. Generally, exposure to higher levels carries with it a higher risk, and exposure to lower levels is accompanied by a reduced risk.

Id. at 44 & n.33 (citation and quotation marks omitted).

Dose-response was another major argument in Bexis’ PLAC brief.  More high fives.

Also of great general importance is the scope of Grady/Frye (the leading Pennsylvania Frye opinion is called “Grady”) challenges under Pennsylvania law − do they apply only to the most “novel” of scientific testimony, narrowly construed (the view adopted by the Pennsylvania Superior Court in Trach v. Fellin, 817 A.2d 1102, 1110 (Pa. Super. 2003), and in its now-thoroughly-reversed opinion in Betz), or are Grady/Frye challenges more broadly available whenever an expert purports to use scientific techniques, even if not “novel” in the abstract” in unusual ways.

We’re pleased to report that the Pennsylvania Supreme Court took the broader view of the Grady/Frye test’s scope.  The Court rejected various rationales given for the narrow view taken by Trach and its unfortunate Superior Court progeny.  Betz, slip op. at 43 (mentioning “increase [in] the number of challenges”; concerns over “the competency of trial judges to accept or reject scientific theories”; and “reluctance . . . to deprive litigants of their day in court”).  Instead, the Court focused on “the potential that [expert] distortions have to mislead laypersons”:

It would be naïve, in this [the “influential nature” of expert opinions] regard , to assume that the possibility for distortion is limited to the very newest realms of science. . . . We therefore agree with [defendants] that a reasonably broad meaning should be ascribed to the term “novel.” Furthermore, we conclude that a Frye hearing is warranted when a trial judge has articulable grounds to believe that an expert witness has not applied accepted scientific methodology in a conventional fashion in reaching his or her conclusions. We believe a narrower approach would unduly constrain trial courts in the appropriate exercise of their discretion in determining the admissibility of evidence.

Betz, slip op. at 43-44 (emphasis added). Bexis had been trying to get the Pennsylvania Supreme Court to take a look at Trach ever since Trach itself, and finally that happened.

Ding-dong the Trach is dead.  More high fives.

Also, although it didn’t discuss the point as much as we would have liked, the Betz court rejected the Superior Court’s expansive reading of Trach (see slip op. at 25-26, describing Superior Court decision) as allowing both upward and downward extrapolation without distinction.  Instead the Supreme Court held, “we agree with [defendants] that the breadth and character of an expert’s extrapolations are relevant to the scientific acceptance of his methodology.”  Betz, slip op. at 52.  So, while Trach extrapolation (unlike the  Trach straitjacketed scope) isn’t completely dead, at least acceptable Grady/Frye use of extrapolation doesn’t include downward extrapolation without “the requirement of sufficiently strong logic supporting the inference.”  Slip op. at 34 n.20.

Another technical point also applicable to drug/device cases is the standard of review when a summary judgment motion (where the losing party gets the benefit of all evidentiary inferences) is based on a Grady/Frye expert exclusion (evaluated under an abuse of discretion standard).  Betz rightly held that “the appropriate appellate standard of review is the one pertaining to the underlying ruling.”  Slip op. at 45.  This is another useful ruling for defendants, who regularly win dispositive motions based upon Grady/Frye or other discretionary evidentiary rulings with dispositive effect.  Make a note of it.

The Court in Betz also didn’t allow a pathologist (a recurrent plaintiff’s asbestos causation expert named Maddox) get away with testifying about an epidemiological subject without mentioning epidemiology.  The court pointed out that the expert had “no familiarity whatsoever with [the plaintiff’s] individual circumstances.”  Slip op. at 46 (something we’ve seen in drug/device cases, too).  Therefore, the expert was necessarily treading on epidemiologic territory.  Id. (“[i]n doing so, he took it upon himself to address (and discount) the range of the scientific literature, including pertinent epidemiological studies”).  Thus, the trial court appropriately relied upon epidemiologic proof to evaluate the purported pathologist expert.  Id. at 47. “[W]here epidemiology is available, it cannot be ignored.”  Id. at 52.  That’ll also be quite useful in our cases.

The Court also pointed out how an “any exposure” causation opinion is fundamentally at odds with Pennsylvania’s longstanding “substantial factor” test for causation.

The any-exposure opinion, as applied to substantial-factor causation, does not consider the three factors [these being “potency,” “intensity,” and “duration”] which . . . need to be considered in trying to estimate the relative effects of different exposures.

* * *

The comments to the Second Restatement of Torts recognize that a proportionate evaluation may be required in a reasoned assessment of substantial-factor causation. RESTATEMENT (SECOND) OF TORTS, §433, cmt. d (1965) (“Some other event which is a contributing factor in producing the harm may have such a predominant effect in bringing it about as to make the effect of the actor’s negligence insignificant and, therefore, to prevent it from being a substantial factor.”). Notably, this Court has cited Section 433 as consistent with Pennsylvania law.
Betz, slip op. at 49 & n. 36.  Bexis hammered this issue in his PLAC brief − and just broke his arm patting himself on the back.

Thus, the Court reaffirmed − this time in the specific context of Grady/Frye − its criticism of “any exposure” causation opinions in Gregg v. V-J Auto Parts Co., 943 A.2d 216 (Pa. 2007) (the first case where Bexis briefed these issues):

[W]e do not believe that it is a viable solution to indulge in a fiction that each and every exposure to asbestos, no matter how minimal in relation to other exposures, implicates a fact issue concerning substantial-factor causation in every “direct evidence” case. The result, in our view, is to subject defendants to full joint-and-several liability for injuries and fatalities in the absence of any reasonably developed scientific reasoning that would support the conclusion that the product sold by the defendant was a substantial factor in causing the harm.

Betz, slip op. at 50 (quoting and following Gregg, 943 A.2d at 226-27).  See Id. at 51 (finding “no scientific basis for concluding that a single cigarette of the potentially half-million a person might smoke in a lifetime is substantially causative of such person’s lung cancer”).

Finally, the Betz court rejected any notion of “de minimus” exposure liability in meso cases under Tragarz v. Keene Corp., 980 F.2d 411, 421 (7th Cir. 1992) (applying Illinois law), a case the Court had unfortunately cited in Gregg.  Regardless of Illinois law, “discounting of the substantiality in exposure would be fundamentally inconsistent with Pennsylvania law.”  Betz, slip op. at 53.  This aspect of Betz will also be useful in disposing of expert testimony in “low-dose” exposure cases involving prescription drugs.

Thus, we have to conclude that Betz is the best − and Bexis' PLAC brief wasn’t bad either.

Tuesday, May 22, 2012

A Little Sunshine in Philadelphia

            The Sixers lost Game 5 to the Celtics last night while the Nationals beat the Phillies 2-1.  The Flyers have been eliminated, and it’s not football season yet.  Philadelphians can’t even look to soccer right now: the Union have only won 2 games this season.  So, we thought a good decision from the Eastern District of Pennsylvania might just lift all our Philly fans’ moods.  It’s not ground-breaking or earth-shattering – but it is another solid win in a prescription medical device case and a win is a win, so here you go.

            Even the facts are fairly routine.  Plaintiff undergoes knee replacement surgery.  A few years later, she experiences pain and is told one of the implants has loosened.  She has revision surgery and then sues the manufacturer of the artificial knee.  Kee v. Zimmer, Inc., 2012 U.S. Dist. LEXIS 68862 (E.D. Pa. May 17, 2012).  Plaintiff asserted all the standard product liability claims:  strict liability design defect and failure to warn; violation of Pennsylvania’s Unfair Trade Practices and Consumer Protection Law (“UTPCPL”) and fraud; breach of implied warranties; breach of express warranty; negligence; and punitive damages.  Id. at *2-3.  Defendant moved to dismiss all but the negligence claim and ultimately, that’s all that survived.

            The opinion reads like a checklist of Pennsylvania claims that cannot be brought and/or how not to plead them:

ü  As a matter of Pennsylvania law, strict liability and breach of implied warranty claims are barred against manufacturers of prescription medical devices. 

Is this really still open for debate?  The Pennsylvania Supreme Court adopted this hard line rule for prescription drugs in Hahn v. Richter, 673 A.2d 888 (Pa. 1996), sixteen years ago.  And the Pennsylvania Superior Court extended it to prescription medical devices six years ago.  See Creazzo v. Medtronic, Inc., 903 A.2d 24 (Pa. Super. Ct. 2006).  The reasoning of these courts also has been extended to implied warranty claims.  See Kee, 2012 U.S. Dist. LEXIS 68862 at *7-8, n.3.  So, why do Pennsylvania plaintiffs continue to file these claims?  Well, this plaintiff argued the Hahn line was actually quite soft.  Plaintiff claimed Hahn did not impose a “blanket exemption on medical device manufacturers” but rather required a “case-by-case, product-by-product analysis.”  Kee at *9.  But the court was quick to point out that plaintiff had no authority whatsoever for her interpretation of Pennsylvania law, which was at odds with the overwhelming majority of courts to consider the issue.  Id.   No strict liability and no implied warranty.  Check.

ü  For breach of warranty of claims, plaintiff is a buyer and must plead notice.

In order to maintain a breach of warranty claim, Pennsylvania law requires the buyer “within a reasonable time after he discovers or should have discovered any breach [to] notify the seller of the breach or be barred from any remedy.”  13 Pa. Cons. Stat. Ann. §2607(c)(1).  Plaintiff bears the burden of proving compliance with the statute.  Since plaintiff here failed to plead notice, she tried to get around the requirement by arguing that she was not a buyer, but rather a “third-party beneficiary of the relationship which existed between the plaintiff’s treating orthopedic surgeon . . . and the defendant enjoying standing to advance the instant theory of recovery.”  Kee at *12.  Wrong again.  The third-party payer case plaintiff attempted to rely on, in fact, held that third-party payers are buyers under the UCC.  Id.  No express warranty.  Check.

ü  Consumer fraud claims are barred by the learned intermediary doctrine.

We are going to give it to you straight from the decision – we don’t think we could sum it up any better:

     Under Pennsylvania law, a consumer does not have a cause of action under the UTPCPL against the manufacturer of prescription drugs because prescription drug manufacturers do not have a duty to disclose information directly to consumers. Permitting a cause of action under UTPCPL would result in effectively making prescription drug manufacturers absolute guarantors of any anticipated effects of the drug.  This is so because a claim under the UTPCPL requires proof of causation and reliance, and the learned intermediary doctrine breaks the chain in terms of reliance, [because] the patient cannot obtain prescription drugs without the physician no matter what [the patient] believe[s] about them. In other words, a private right of action under the UTPCPL requires proof of justifiable reliance and causation, and such requirements cannot be present when the defendant is a pharmaceutical company that did not sell its product directly to the patient.  The same reasoning extends to manufacturers of prescription medical devices.

Id. at *13-14 (citations and quotation marks omitted).  No consumer fraud violation.  Check.

ü  Fraud and UTPCPL claims must be pled with particularity.

As if the learned intermediary doctrine wasn’t enough to get rid of the fraud claims, plaintiff also failed to meet the requisite standard of particularity under Rule 9(b).  Plaintiff’s claims of fraud were vague and general at best:   defendant knew of “risks” and “complications” that they failed to disclose; defendant misled customers by failing to notify them of an increased risk; defendant failed to disclose that the product did not perform safely.  Id. at *17-18.  The court found these allegations lacking:

     Plaintiff fails to allege facts supporting the nature of her reliance or specific representations Defendant made relating to the reliance. Plaintiff fails to allege facts indicating the date, time, and place of the alleged fraud, or, alternatively, inject any precision or measure of substantiation into her fraud allegations that would place the defendant on notice of the precise misconduct with which it is charged.

Id. at *18.  No fraud.  Check.

ü  No outrageous conduct equals no punitive damages.

This one is also very straightforward.  Plaintiff alleged she was injured from the malfunction of a prescription medical device.  That’s it.  She “failed to muster any facts indicating that Defendant acted with reckless indifference to Plaintiff’s rights.”  Id. at *19-20.  No allegations of intentional, willful, wanton or reckless conduct; no punitive damages.  Check.

So, under Pennsylvania law, plaintiff’s case was stripped of all but her negligence claim, which is all she should have pled from the beginning.  So, if Philadelphia’s sports scene doesn’t improve, maybe we can take our foam fingers and rally caps to the courthouse where, at least for today, we have something to cheer about.

Monday, May 21, 2012

Breaking News - Pain Pump State Of The Art Affirmed

As anyone following the Pain Pump litigation knows, the state-of-the-art issue - whether it was possible for the defendant to know of the alleged risk of its products given the state of scientific knowledge at the time of a plaintiff's surgery - is critical.  Well, today the first court of appeals to consider that question has affirmed summary judgment.  Rodriguez v. Stryker Co., No. 11-5335, slip op. (6th Cir. May 21, 2012) (applying Tennessee law).

The court in Rodriguez examined some 13 articles published over the course of seven decades that the plaintiffs claimed that established a jury question on the state of the art (that is, that the risk was knowable).  It concluded (as had the district court) that these articles proved nothing about this particular device at the time in question:

When all is said and done, not one of [plaintiff's] thirteen articles shows that medical experts understood in 2004 that infusing a joint with [the drug] for two days could cause irreversible cartilage damage.  [Defendant] had no duty to understand what the relevant medical literature did not.

Rodriguez likewise founs that the plaintiff's expert couldn't make anything more out of the same 13 articles than the articles themselves:

[Plaintiff's] theory requires two speculative leaps.  It requires the inference that evidence of harm resulting from other solutions meant that anesthetics would cause the same harm.  And it requires the inference that evidence of transient harm to joints meant that irreversible cartilage damage was likely.  Both are far too conjectural and too many steps removed from the problem that developed.

The court went on to demolish plaintiff's regulatory theory - that because the FDA had denied §510k clearance to the device, that that somehow put the manufacturer on notice of unknowable risks.

The FDA’s action means only that no other device on the market carried that indication for use.  It does not mean that the pump was (or might potentially be) dangerous to use in the joint space.  The 510(k) process does not comment on safety.
Slip op. at 8.  Ironically, the defendants won because of the adverse preemption decision in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).  Plaintiffs were thus prevented from having their cake and eating it, too.  That is, plaintiffs who deny preemption because a §510k clearance doesn't address safety, can't play fast and loose by turning around and claiming that lack of §510k clearance has safety connotations.

Rodriguez also becomes the last in a very long line of cases to confirm that an independent "duty to test" does not exist at common law.  Rather, such a duty "collapses into the failure-to-warn claim."   Slip op. at 8.  A plaintiff cannot resort to a "duty to test" to avoid the state-of-the-art defense.  "The law does not require a company to test for hidden risks that neither it nor the medical community had a reasonable basis to suspect."  Id.

Nor can a claim of off-label marketing succeed where plaintiff's other theories have failed.  The common law is unconcerned with mere off-label marketing.  It would be concerned with concealment of risks (regardless of on or off-label), but once again, the state of the art precluded the concealment claim:
[I]t makes no difference that [defendant] knew surgeons would use its pump in the joint space or even encouraged them to do so since [plaintiff] has failed to show that Stryker knew or should have known that the use was dangerous.

Slip op. at 9.

Next, putting state of the art and legal theorizing aside, the claim in Rodriguez failed independently on the facts of the case because the implanting physician knew all about this device (having used it many times) and thus did not rely on any of the defendant's warnings - so the opinion is also a good "already knew" learned intermediary warning causation case.  Slip op. at 10-11 (citing one of Bexis' Bone Screw summary judgment wins).

Finally, we've commented on plaintiffs' attempts in other cases to create some new duty to send a "Dear Doctor" letter in cases where their warning claims fail.  Well, last and least, the plantiff tried that tack in Rodriguez - and got nowhere. 

[Plaintiff] argues that [defendant] should have known that it needed to “revise its instructions or at least circulate a Dear Doctor Letter” when the FDA rejected its requests to approve the pump specifically for use in a joint.  As shown, however, the FDA position did not obligate [defendant] to send any such letter.

Slip op. at 11.  "Dear Doctor" letters are a regulatory invention.  If the FDA doesn't require them in a particular situation, the court in Rodriguez wasn't about to create some new, broader common-law Dear Doctor letter theory.

We can only hope that other courts are as sensible as the Sixth Circuit was in Rodriguez.
Slip op. at 7 (emphasis added).  The expert had improperly attempted to substitute "hindsight negligence" for "common law negligence.  Id.
Slip op. at 5. Actually, the court had a lot more to say, but that's the bottom line.

Friday, May 18, 2012

No, That's Not Justifiable Reliance

Sometimes we feel like pulling our hair out − those of us who still have some, anyway.  One things that gets us in that mood is the other side claiming that the prescribing physician (who went to med school and typically has loads of experience with the relevant product) would have treated as gospel this or that piece of information, if only s/he had been told about by the sales rep (no med school, no clinical experience).  It just doesn’t work that way.  Most doctors think quite highly of their own abilities and knowledge and aren’t about to listen to a sales rep on a medical question.

But try finding a decision anywhere that makes this rather obvious point.

We found one.

There’s a new case, Hall v. Horn Medical, L.L.C., 2012 U.S. Dist. Lexis 68482 (E.D. La. May 16, 2012), that makes this point − in a case with a rare prescriber willing (or desparate enough) to say what the plaintiff wanted.

As you might guess, Hall was a medical malpractice case, or at least had a strong medmal component.  The product was a spinal fusion device, and the surgeon who implanted it ignored an explicit statement in the package insert only to use the device with bone grafting material.  The doc didn’t and guess what?  The fusion failed.

When asked why he ignored the manufacturer's warning, the doctor said that he performed the procedure the way he did because the sales rep told him that the device was OK for this particular “off-label use.” 2012 U.S. Dist. Lexis 68482, at *9-10 (prescriber “emphasized that he ‘would not use it without bone graft unless the rep said that it could be used without bone graft’”).

The sales rep, of course, flatly denied ever recommending the device for a use that was not only off-label, but positively contraindicated by the aforementioned warning.  Id. at *9.  For one thing, promotion of off-label use is a major regulatory sin for which the FDA can, and has, prosecuted sales reps.

For his part, the plaintiff sued the sales rep for negligent misrepresentation.  Justifiable reliance is an element of that tort.

The rep moved for summary judgment.

But, there’s a he-said-she-said conflict here that prevents summary judgment, innit?  One says yes; the other no.  Classic credibility dispute, right?


The court held that a physician cannot justifiably rely on anything a sales rep might have said with respect to a medical issue:

Even if [the rep] told [the doctor] a that he could use the [product] without a bone graft, the Court finds that any reliance by [the doctor] on that statement to be unreasonable as a matter of law. These representations . . . addressed what type of spinal procedure [the doctor] should perform on [plaintiff]. As a seasoned neurosurgeon, it is patently unreasonable for [the doctor] to rely on a sales representative's opinion about the type of procedure that should be employed in operating on a patient’s spine.

2012 U.S. Dist. Lexis 68482, at *10 (emphasis added).

Sw, while it’s not 100% on point, since a product liability claim was not involved in the litigation, this excerpt from Hall is as good a statement as we’ve seen for the proposition that doctors do not − and legally cannot − rely on sales reps for medical information.

Thursday, May 17, 2012

Not A WIn, Not A Loss

The recent decision in Mims v. Wright Medical Technology, Inc., 2012 WL 1681810 (N.D. Ga. May 11, 2012), is really neither a win nor a loss.  Like Gaul, the decision contains three parts, and we have comments as to each.

Very briefly, the case involves a total hip implant constructed from titanium.  After being implanted for over three years, it broke.

Design Defect

The first part of the opinion denied summary judgment on design defect claims.  The plaintiff’s expert, as is common in such cases, alleged that instead of being made out of titanium it should have been made out of cobalt-chrome alloy (“CCA”).  Mims, 2012 WL 1681810, at *2.  Of course, if the defendant had used CCA, the expert would then have alleged it should have been made out of titanium − anything to claim a defect.

The defendant moved for summary judgment, arguing that merely claiming an alternative design was not enough.  Id. at *3. That struck us as a little odd, since defendants are usually the foremost advocates of a strong alternative design requirement. The court held that since alternative design was essential to design defect litigation, that was enough to survive summary judgment:

One factor consistently recognized as integral to the assessment of the utility of a design is the availability of alternative designs, in that the existence and feasibility of a safer and equally efficacious design diminishes the justification for using a challenged design. The alternative safer design factor reflects the reality that it often is not possible to determine whether a safer design would have averted a particular injury without considering whether an alternative design was feasible. The essential inquiry, therefore, is whether the design chosen was a reasonable one from among the feasible choices of which the manufacturer was aware or should have been aware. Alternative safe design factors include: the feasibility of an alternative design; the availability of an effective substitute for the product which meets the same need but is safer; the financial cost of the improved design; and the adverse effects from the alternative.

Id. at *2.

Frankly, we don’t mind that particular ruling too much.  We could even see using this quote in one of our cases.

The real problem in Mims was that the defendant hadn’t separately moved to exclude the plaintiffs’ expert under Daubert.  The court latched onto that and refused to “consider the reliability” of the expert testimony on summary judgment.  Id. at *3.  This procedural two-step is worrisome in that it allows an expert opinion that may well be inadmissible to defeat summary judgment.  The general rule has been that only admissible evidence counts on summary judgment, and the court’s wielding of a procedural fine-toothed comb undercuts that rule.  One take-away from Mims is to make sure to file Daubert motions separately and in advance of summary judgment, depending of course on the pre-trial schedule in any given case.

Another more unusual suggestion:  We’ve had some success using preemption against this type of claim, see Greenwood v. Pennsylvania Hospital, 1999 WL 1133313, at *2-3 (Pa. C.P. Philadelphia Co. June 9, 1999) (claim that implant should not have been made from stainless steel held preempted), but it depends on the classification regulation.  We’ll explain.  There’s usually no preemption in Class II metallic implants like hip implants under Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), but there can be − if there’s a “device-specific” regulation, and the plaintiff’s particular claim is “different from or in addition to” something in that regulation under 21 U.S.C. §360k(a).

There are device-specific regulations for essentially all medical devices − but unfortunately they’re usually one-paragraph long and thus don’t cover many aspects of the device.  These are the FDA’s identification and classification regulations.  However, they do frequently say something about the metallic composition of implants. There are several hip implant I&C regs, see 21 C.F.R. §§888.3300-3350, and we don’t know which one applies specifically to Mims.  Most of them mention only “cobalt-chromium-molybdenum,” which was the plaintiff’s proposed design alternative in Mims, so the preemption argument wouldn’t fly.

However, if §888.3310 were applicable to this implant, or if some plaintiff’s expert offered the same opinion against the manufacturer of a §888.3310 implant, there’s a decent preemption argument.  That’s because this section states, as to composition, that such devices are “made of alloys, such as cobalt-chromium-molybdenum and titanium alloys.”  Emphasis added.  In this device-specific regulation, the FDA has expressly stated that “titanium alloys” are okay.  Thus, our preemption argument in such a situation would be that since a device specific regulation specifies “titanium” as acceptable composition, a common-law claim that titanium construction alone is a defect would be preempted even under Lohr.

Warning Defect

The second part of the Mims opinion also denied summary judgment as to the plaintiffs’ warning claim.  2012 WL 1681810, at *4.  The defendant moved based solely on the warning’s adequacy.  That’s hard to do unless the relevant part of the warning is really detailed.  The description of the warnings in Mims suggests otherwise in that case.

We find it much easier to win summary judgment in warning cases on causation − that the prescriber already knew the allegedly omitted information or that the information wouldn’t have changed what the prescriber did or the warnings.  Supporting facts would also include the prescriber continuing to utilize the device, with no change in procedure, after the plaintiff’s injury.

The lesson from Mims is that warning summary judgment motions ideally should have a double-barreled approach of both adequacy and causation.

The court in Mims seemed to assume, without any evidence (at least none was cited) that a different warning might have led to a different outcome.  Maybe the issue simply wasn’t raised in the Mims motion, but again the court’s willingness to rely on less than admissible evidence is troubling, since summary judgment can be sought on the grounds that the plaintiff has no evidence on an essential element where the plaintiff bears the burden of proof.

Punitive Damages

The final third of the Mims opinion dismissed punitive damages claims as a matter of law because the defendant demonstrated that the implant complied with FDA regulations:

[T]he Court concludes that the Plaintiffs would not be able to establish by clear and convincing evidence culpable tortious conduct that would authorize the imposition of punitive damages. Moreover, punitive damages are typically not appropriate where the manufacturer has complied with regulatory standards.

Mims, 2012 WL 1681810, at *5 (citing Stone Man, Inc. v. Green, 263 Ga. 470 (1993); Welch v. General Motors Corp., 949 F.Supp. 843 (N.D.Ga.1996)).

This part of Mims almost makes up for the rest of it.  Preclusion of punitive damages by regulatory compliance is something we’ve advocated before, here.  We prominently mentioned the Stone Man decision that the court followed in Mims.  So we take this opportunity to applaud the third part of Mims.

Wednesday, May 16, 2012

More Nails in the Coffin of Third Party Payor Actions

In a pair of precedential opinions, the Third Circuit affirmed today the dismissal - for lack of standing- of the Intron off-label promotion RICO class action.

See:  In Re: Schering Plough Corp. Intron/Temodar Consumer Class Action, No. 10-3046, 3047, slip op. (3d Cir. May 16, 2012), and In Re: Schering Plough Corp. Intron/Temodar Consumer Class Action, No. 10-3047, slip op. (3d Cir. May 16, 2012).  You don't need to read both.  They're the same opinon

In both cases the court affirmed dismissal for want of standing. Third party payers aren't legally injured by off-label promotion. 

[T]o establish standing, [plaintiff] must allege facts showing a causal relationship between the alleged injury - payments for [the drug] that was ineffective or unsafe for the use for which it was prescribed - and [defendant's] alleged wrongful conduct.
3046, slip op. at 21.  Can't be done, held the unanimous court:

Local 331 must allege facts sufficient to show that the [the drug] which it paid for was prescribed to its members for ineffective off-label uses because of [defendant's] alleged misconduct.  There are no averments that come close to satisfying this standard.
 Id. at 23 (emphasis original).

Nor could another plaintiff (an individual - what a terrible plaintiff) establish standing when that plaintiff didn't even use the drug alleged in the complaint:

[T]he allegedly phony trial did not even concern a treatment regimen that [plaintiff's] doctor prescribed to her is dispositive.  There is no allegation of fact that supports a connection between [defendant's] unlawful conduct of involving [the prescriber] in a phony trial, and [his] prescription for a different drug therapy.
Id. at 31.

In addition, the opinion makes a couple of interesting procedural points:  (1) a plaintiff cannot incorporate by reference lengthy documents into its complaint since that would make answering the complaint impossible.  Id. at 29.  (2) "Information and belief" allegations, where the basis for the information and belief is not stated, "allege insufficient facts" to support any cause of action.  Id. at 33.  These will be useful rulings in obtaining dismissal of similarly poorly pleaded complaints in the future.

Tiptoeing Through TwIqbal

First, Bexis wishes to welcome the Blog's readership from his new office at Reed Smith.  A fair amount of PR occurs with significant lateral hires in the law biz, but Bexis promises that it won't go to his head, even though the folks at 360 decided he deserved a promotion to "guru" status.


Anyway, enough of that.  Let's get back to our blogging.  The other day we saw a TwIqbal article on a BNA news letter written by a couple of Arnold & Porter lawyers (Agneshwar  and Sharpe).  We had to read it, if only because it used the term “TwIqbal,” since the Blog has, if not outright invented the term (we heard it used at a PLAC meeting years ago) at least popularized it.  It turns out that the A&P article cited heavily to the blog − in particular our 2009 survey of TwIqbal law and our TwIqbal cheat sheet.

So reading the A&P article, and its reliance on the blog, got us thinking.  In particular, it got us thinking about a dirty little secret.  That secret is that our TwIqbal cheat sheet is probably not as comprehensive as our other cheat sheets and scorecards.  We haven’t done a thorough TwIqbal review in over six months.  That’s partially because there are simply so blasted many TwIqbal opinions and partially because we’re particularly selective on that scorecard.  We don’t put cases in our TwIqbal cheat sheet if they deny dismissal of any significant TwIqbal issue, even if a particular opinion is favorable on other pleading points.

Anyway, the A&P article has spurred us into action to find cases that we may have missed through our somewhat catch-as-catch-can updating process for the TwIqbal cheat sheet.  We’ve done some research into drug/device related TwIqbal cases (all product liability cases is just too much work, now) and here’s what we’ve found:

Cases TwIqballed for failure to allege any facts in support of the claims.

Deese v. Immunex Corp., 2012 WL 463722, at *5-7 (S.D. Miss. Feb. 13, 2012); In re Pamidronate Products Liability Litigation, ___ F. Supp.2d ___, 2012 WL 272889, at *3 (E.D.N.Y. Jan. 30, 2012) (all arguably unpreempted claims); Fullington v. PLIVA, Inc., 2011 WL 6153608, at *5 (E.D. Ark. Dec. 12, 2011) (all arguably unpreempted claims); Callaway v. American Medical Systems, Inc., 2011 WL 7724268, at *4 (W.D. La. Dec. 8, 2011).

Cases TwIqballed for failure to allege the identity of the manufacturer.

Callaway, 2011 WL 7724268, at *4; Esposito v. I-Flow Corp., 2011 WL 5041374, at *4-5 (E.D. Pa. Oct. 24, 2011).

Cases TwIqballed for failure to allege causation.

Bartlett v. Pfizer, Inc., 2012 WL 718782, at *3 (D.R.I. March 5, 2012); Callaway, 2011 WL 7724268, at *4.

Cases TwIqballed for failure to allege injury.

Ironworkers Local Union 68 v. AstraZeneca Pharmaceuticals, LP, 634 F.3d 1352, 1360-66 (11th Cir. 2011) (plaintiff had not pleaded recoverable economic injury); Polk v. KV Pharmaceutical Co., 2011 WL 6257466, at *6, 8 (E.D. Mo. Dec. 15, 2011).

Cases TwIqballed for failure to plead the nature of claimed FDA violations.

Metz v. Wyeth LLC, ___ F. Supp.2d ___, 2012 WL 1058870, at *6 (M.D. Fla. March 28, 2012) (negligence per se claim); Gross v. Stryker Corp., ___ F. Supp.2d ___, 2012 WL 876719, at *19-22 (W.D. Pa. March 14, 2012); Viserta v. St. Jude Medical, Inc., 2012 WL 667814, at *3-4 (D.S.C. Feb. 29, 2012); Erickson v. Boston Scientific Corp., ___ F. Supp.2d ___, 2011 WL 7036060, at *6 (C.D. Cal. Dec. 12, 2011); Tierney v. AGA Medical Corp., 2011 WL 7400469, at *4 (D. Neb. Nov. 18, 2011); Rhynes v. Stryker Corp., 2011 WL 5117168, *5 (N.D. Cal. Oct. 27, 2011).

Cases TwIqballed because res ipsa loquitur was too vaguely pleaded to establish negligence.

Gross, 2012 WL 876719, at *10.

Warning claims TwIqballed for failure to plead what was inadequate about the warning.

Reed v. Pfizer Inc., ___ F. Supp.2d ___, 2012 WL 859729, at *3-4 (E.D.N.Y. March 14, 2012).

Warning claims TwIqballed for failure to plead causation as to the
prescribing physician under the learned intermediary rule.

Deese, 2012 WL 463722, at *5; Grinage v. Mylan Pharmaceuticals, Inc., ___ F. Supp.2d ___, 2011 WL 6951962, at *4 (D. Md. Dec. 30, 2011).

Warning claims based on failure to provide any FDA mandated package insert
TwIqballed for failure to plead any facts to support the claim.

Salvio v. Amgen, Inc., 2012 WL 517446, at *3 (W.D. Pa. Feb. 15, 2012).

Failure to update warning claims TwIqballed for failure to plead any facts to support the claim.

In re Darvocet, Darvon and Propoxyphene Products Liability Litigation, 2012 WL 718618, at *4 (E.D. Ky. March 5, 2012); Bowman v. Wyeth, LLC, 2012 WL 684116, at *7 (D. Minn. March 2, 2012); Coney v. Mylan Pharmaceuticals, Inc., 2012 WL 170143, at *4 (S.D. Ga. Jan. 19, 2012); Del Valle v. PLIVA, Inc., 2011 WL 7168620, at *7 (S.D. Tex. Dec. 21, 2011) (all generic drug preemption cases).

Design defect claims TwIqballed for failure to plead risk-utility.

Grinage, 2011 WL 6951962, at *6.

Design defect claims TwIqballed for failure to plead alternative design.

Reed, 2012 WL 859729, at *5; Salvio, 2012 WL 517446, at *7.

Manufacturing defect claims TwIqballed for failure to nature of defect.

Eckhardt v. Qualitest Pharmaceuticals Inc., ___ F. Supp.2d ___, 2012 WL 1511817, at *5 (S.D. Tex. April 30, 2012) (generic preemption case); Cooley v. Medtronic, Inc., 2012 WL 1380265, at *4 (E.D. Ky. April 20, 2012) (PMA preemption case); Reed, 2012 WL 859729, at *5; In re Fosamax Products Liability Litigation, 2011 WL 5903623, at *5 (D.N.J. Nov. 21, 2011).

Implied warranty of fitness for a particular purpose claims
TwIqballed due to failure to allege any facts to support the claim.

Reed, 2012 WL 859729, at *6; Grinage, 2011 WL 6951962, at *6-7

Express warranty claims TwIqballed for failure to plead the language of the warranty.

Gross, 2012 WL 876719, at *26; Reed, 2012 WL 859729, at *6; Deese, 2012 WL 463722, at *6.

Express warranty claims TwIqballed for failure to plead failure to plead basis of the bargain.

Gross, 2012 WL 876719, at *27; Horsmon v. Zimmer Holdings, Inc., 2011 WL 5509420, at *4 (W.D. Pa. Nov. 10, 2011).

Res ipsa loquitur claims TwIqballed for failure to plead how
possible alternative causes are ruled out.

Gross, 2012 WL 876719, at *24-25.

FDCA violation claims TwIqballed for failure to plead causation by the violation.

Bartlett, 2012 WL 718782, at *4; Viserta, 2012 WL 667814, at *4.

We've simultaneously updated the cheat sheet to reflect these cases.  You might ask if that's redundant information but (aside from wanting to maintain our lists), the cheat sheet is set up in a fundamentally different fashion from this post.  This post is organized by subject, whereas the cheat sheet is strictly chronological by case.

Anyway, there's the newest TwIqbal ammunition.  Now get out there and win us some more cases to put on the list.

Tuesday, May 15, 2012

Another Homework Failure By Plaintiffs

            Yesterday, we blogged about a case where plaintiff failed to do even the most basic investigation to identify the product at issue before filing suit.  She was hoping her case would survive with some vague pleadings in the alternative and a request for discovery.  Unfortunately, for now it is.  So, since that case left us feeling a little down, we decided to focus today on a case that similarly suffered from a lack of facts -- but this one got tossed out.  Happy faces back in place. 

As this blogging team is made up of parents with children of varying ages, we are all too familiar with homework.  So, we are also familiar with phrases such as:  “Take your time;” “show all your work;” “follow the directions;” and most importantly – “do your best!”  We tell our children that we understand they want to go to the park, text their friends, or drive to the mall -- but they have to do their homework.  Why?  Not just because it is required, but because they will learn something.  That’s the point of homework, isn’t it?  Not just to torture kids (and parents), but to teach them something.  Well, the same is true for lawyers – we need to do our homework.  For plaintiffs’ lawyers that means learning the basic facts that support their clients’ claims before they file their lawsuits.  And, just like kids who don’t do their homework get zeros – so should plaintiffs.

That is precisely what recently happened in the Darvocet MDL in the context of personal jurisdiction – or lack thereof.  The Darvocet litigation involves injuries alleged to have been caused by the prescription pain medication propoxyphene, which is manufactured by several pharmaceutical companies (brand and generic).  Shortly after propoxyphene was withdrawn from the market, Endo Pharmaceuticals purchased three companies that had previously manufactured or distributed the drug.  In re: Darvocet, Darvon and Propoxyphene Products Liability Litigation, MDL Docket No. 2226 (E.D. Ky. Apr. 18, 2012), slip op. at 2.  Plaintiffs filed suit against both Endo and its newly purchased subsidiaries.  Id.  

As one of several reasons why these cases should be dismissed (including our new one-two preemption punch, see prior post re: Darvocet MDL), Endo asserted lack of personal jurisdiction.  While plaintiffs bear the burden of proving personal jurisdiction, as this court recognized, the burden is “relatively slight.”  Slip op. at 4.  But slight is at least one degree up from nothing, which is what plaintiffs had. 

On specific jurisdiction, plaintiffs argued that it could be established over Endo “through successor liability or other liability theories.”  Slip op. at 6.  Plaintiffs’ sole support for their argument was the following statement in their complaints:
The extent to which Defendant [Endo] may have assumed responsibility for the acts, omissions or liability of other . . .  Defendants, contractually or otherwise, is unknown at this time, and Plaintiff requires discovery as to this issue.  
Slip op. at 7.   The court had the same question we do:  “But what facts?”  Id.   Accepting that statement as true all it establishes is that Endo “may have somehow assumed the liabilities of their subsidiaries.”  Id.  OK.  And there “may have” been a second shooter on the grassy knoll.  And “maybe” John Lennon, Elvis Presley, Andy Kaufman and Tupac Shakur are all hanging out on a deserted island in the South Pacific.  Oh, the power of “maybe.”  But it isn’t good enough to state a legal claim:
[T]he only factual assertion [plaintiff’s allegation] contains is that the plaintiffs do not have the information they need to establish personal jurisdiction.  Thus, even if the plaintiffs were permitted to stand on their pleadings, they would fall woefully short of the necessary prima facie showing.
Slip op. at 7 (quotation marks and citation omitted).         
            More to our liking than yesterday’s case, this court didn’t leave the door open:  “Nor is the Court persuaded by the plaintiffs’ insistence that jurisdictional discovery is needed, since the lenient prima facie standard is premised on the assumption that plaintiffs will not have had the benefit of such discovery.”  Slip op. at 8.  As an aside, plaintiffs’ reliance on successor liability was also misplaced because there is no successor liability if the original entity still exists.  Slip op. at 7-8.  You’ve got to do your homework, people.

            Having failed on specific jurisdiction, plaintiffs turned to general jurisdiction.  After making basically the same erroneous successor liability arguments, plaintiffs also argued that jurisdiction exists because Endo has pharmaceutical representatives in the forum states.  Slip op. at 10.  Plaintiffs seemed to think that this fact alone was sufficient to confer jurisdiction under Goodyear Dunlop Tires Operations, S.A. v. Brown, 131 S. Ct. 2846 (2011).  But, since in that decision the Supreme Court rejected “a sprawling view of general jurisdiction,” “the fact that some (non-proproxyphene) products manufactured by [Endo] may have been sold in the forum states is not dispositive, as such products did not give rise to the plaintiffs’ alleged injuries.”  In re: Darvocet, slip op. at 10-11.  Thus, “the mere presence of a corporation’s sales representatives in a forum state is insufficient to establish personal jurisdiction over the company.”  Slip op. at 11.   

            While we don’t like when our kids don’t do their homework, we are generally OK when plaintiffs don’t if the result is a dismissal at the pleadings stage (well, we like a dismissal at any stage really).  Congratulations to Mark Cheffo, Katherine Armstrong, and Rachel Passaretti-Wu of Skadden, Arps, Slate, Meagher & Flom LLP   for this win and to Lincoln Wilson  for forwarding it along.