Monday, August 03, 2009

Iqbal Saves Some Dough

We love Iqbal:

"sitaaro.n se aage jahaa.N aur bhii hai.n
abhii ishq ke imtihaa.N aur bhii hai.n"

That is, of course, from Sir Muhammed Iqbal's classic poem, "Ahead of the Stars."

(If only we spoke Urdu, we'd probably appreciate it a little more.)

(We told you this blogging was good for us. How would we ever have learned about Sir Muhammed if we weren't googling "Iqbal" to research this post?)

Enough of poetry, erudition, love, and life. Let's talk law.

Not just law; let's talk pleading.

In ninety percent of pharmaceutical product liability complaints, plaintiffs plead claims for manufacturing defect and design defect.

And those claims are almost always hokum -- plaintiffs plead 'em, but plaintiffs don't have any facts to support 'em, and those claims eventually disappear.

But they disappear only after the defendant answers those claims, and the defendant serves interrogatories asking for supporting facts (and is told that "discovery isn't yet complete, so the facts will come later"), and the plaintiff's expert doesn't say anything about those claims, and defendant throws a paragraph into the summary judgment papers saying the claims are bogus, and the plaintiff doesn't bother defending the claims, and the court finally throws 'em out ten minutes before the trial of a failure-to-warn case, which is what the whole spat was really all about from the start.

Can't we save the trouble?

After Ashcroft v. Iqbal, 129 S. Ct. 1937 (2009), the answer is "yes."

In Frey v. Novartis Pharmaceuticals Corp., No. C-1-07-317, 2009 U.S. Dist. LEXIS 64731 (S.D. Ohio July 23, 2009), Amanda Frey suffered multi-organ hypersensitivity after ingesting Novartis' antiepileptic drug Trileptal. She sued Novartis under Ohio state law for manufacturing defect, design defect, inadequate warnings, failure to conform to representation, supplier liability, and punitive damages. Novartis moved to dismiss the manufacturing, design, and supplier causes of action.

Plaintiff had pled the manufacturing defect claim precisely the way it's always pled -- fact-free. In the words of the Freys' complaint:

"Defendants failed to design, manufacture, test, and control the quality of Trileptal such that when it left the control of the Defendant, it deviated in a material way from the design specifications, formula or performance standards of the manufacturer, or from otherwise identical units manufactured to the same design specifications, formula or performance standards"

In other words -- hokum.

Before Twombly and Iqbal, courts might have found that type of pleading to pass muster.

Not so after Iqbal. In the words of Iqbal:

"sitaaro.n se aage jahaa.N aur bhii hai.n
abhii ishq ke imtihaa.N aur bhii hai.n"

No, wait:

A claim is facially plausible only when the plaintiff "pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged." Iqbal, 129 S. Ct. at 1949.

Judge Herman Weber applied Twombly and Iqbal to dismiss some of the Freys' claims. As to manufacturing defect, plaintiffs "have done nothing more than provide a formulaic recitation of the elements of a claim under the statute. They have failed to allege any facts that would permit the Court to conclude that a manufacturing defect occurred and that the defect was the proximate cause of Amanda Frey's alleged injuries." Frey, 2009 U.S. Dist. LEXIS at *19.

So, too, for the design defect claim: "They have not alleged any facts that would permit the Court to conclude that there was a defect in the design or formulation of Trileptal and that the defect was the proximate cause of Amanda Frey's injuries." Id. at *20.

Finally, the supplier liability claim fell because the Ohio statute defines "supplier" to exclude "manufacturer." Id. at *9. Since plaintiffs pled that Novartis was the manufacturer of Trileptal, the supplier claim could not survive. Id. at *20.

Nice work, Judge Weber.

That result is, as you might imagine, poetry to our ears.


Max Kennerly said...

It'd be much more helpful if she filed a complaint filled with detailed allegations about the biochemistry behind her injury and the defendants' knowledge of such biochemistry.

Except that, she can't do that, not unless Novartis willingly provides her with access to all of their clinical trials and research.

Which they won't.

In sum: you can't file a lawsuit without alleging detailed facts, but you can't get that factual detail without discovery in a lawsuit.


I don't see how that serves the interests of justice.

Anonymous said...

Cry me a river Max.

She has legitimate claims that survived the motion. They may even be meritorious.

She has no reason to believe that there was a defect in the manufacturing or design. There is no reason that she should be able to force the expense of discovery on the defendant in relation to claims.

JB said...


Good job actually responding to Max's argument. Pray tell how a plaintiff can satisfy this pleading requirement prior to discovery?
Waaaaah, the poor pharma corp. would have been subject to the expense of discovery.
Discovery wouldn't be so expensive if corporations didn't hire biglaw firms, charging by the hour, to resist divulging every responsive document that would hurt their position in litigation.
Great, so we've pared down claims we have no clue as to the verity thereof. Given how impossible it is to get product liability cases past dispositive motion practice, it's not like defendants need yet another device at their disposal. This is only a good thing if you think even legitimate claims shouldn't get their day in court.

Soronel Haetir said...

Yet she'll be free to amend her complaint if something does come out during discovery on her supported claims. I see no reason the system should condone out and out fishing expeditions. Or would you prefer a situation where any plaintiff can plead any fanciful claim and then force discovery expenses on the defendant before the case can be killed?

Bring those actions you can at least support with some facts.

If you don't have anything, Buckman should probably kill your case anyway.

Craig N said...

I have to agree with Max on this and yes, I am a plaintiff's lawyer, but I practiced as a defense lawyer for many years doing products work and it is completely a catch 22. In the pharma world, yes you can obtain certain public information through published studies and reports that can assist you in obtaining certain factual information. But alleging specific facts regarding what the defendant manufacturer knew and when it knew it is virtually impossible until you obtain discovery from the company.

Same goes with issues of manufacturing defect. As an example in auto products litigation, until you obtain the internal specs of the component at issue, which you can only obtain through discovery (and after agreeing to a overlybroad protective order)it is very difficult to confirm that in fact the component was not made to specification.

There is a reason the courts have referred to the term as "discovery"...its your ability to discover information that supports your claim.